Dome Patent, L.P. v. Rea

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
_________________________________________
)
DOME PATENT, L.P., )
)
Plaintiff, )
)
v. ) Civil Action No. 07-1695 (PLF)
)
TERESA STANEK REA, Acting Under Secretary )
of Commerce for Intellectual Property and )
Acting Director of the United States Patent )
and Trademark Office, )
)
Defendant.1 )
_________________________________________ )
OPINION, FINDINGS OF FACT AND CONCLUSIONS OF LAW
Dome Patent L.P. owns United States Patent No. 4,306,042 (the “Neefe Patent”),
which was issued on December 15, 1981. The Neefe Patent is entitled “Method of Making a
Contact Lens Material With Increased Oxygen Permeability,” and it is based on an application
filed by Russell A. Neefe. See JTX-1. In 2007, the United States Patent and Trademark Office
(the “PTO”) found that claim 1 of the Neefe Patent should be cancelled as obvious in light of the
prior art. Dome timely filed a civil complaint under 35 U.S.C. §§ 145 and 306, requesting that
this Court set aside the PTO’s decision. See Compl. ¶ 20. After considering the parties’
arguments, the administrative record, the decision of the PTO’s Board of Patent Appeals and
Interferences, the evidence presented during a three-day bench trial, and the relevant legal
authorities, the Court concludes that the process recited in claim 1 of the Neefe Patent is
1
Pursuant to Rule 25(d) of the Federal Rules of Civil Procedure, the Court
substitutes as defendant the acting Under Secretary, Teresa Stanek Rea, for the former Under
Secretary, David J. Kappos.
unpatentable, as it would have been obvious to a person of ordinary skill in the art at the time the
patent application was filed. The Court therefore will enter judgment in favor of the defendant,
Teresa Stanek Rea (“the Director”), Acting Under Secretary of Commerce for Intellectual
Property and Acting Director of the PTO.1
I. BACKGROUND
A. The Neefe Patent and the Procedural History
The Neefe Patent contains four claims, the first of which is relevant to this action.
Claim 1 recites:
1
The exhibits presented at trial – Joint Trial Exhibits (“JTX”) 1-34, Plaintiff’s Trial
Exhibits (“PTX”) 1-6, and Defendant’s Trial Exhibits (“DTX”) 1-2 – are listed in the appendix to
this decision. In addition, the Court reviewed the following papers in connection with this
matter: the complaint (“Compl.”) [Dkt. No. 1]; defendant’s answer [Dkt. No. 4]; plaintiff’s trial
brief (“Dome’s Trial Brief”) [Dkt. Nos. 54/52 (sealed/public)]; defendant’s response to
plaintiff’s trial brief (“Director’s Trial Brief”) [Dkt. Nos. 57/59]; plaintiff’s reply trial brief [Dkt.
Nos. 65/71]; the parties’ joint pretrial statement (“Jt. Pretrial Stmt.”) [Dkt. Nos. 61/62];
defendant’s motion in limine to exclude the testimony of Dr. Melamed pursuant to Fed. R. Evid.
702 [Dkt. Nos. 70/67]; plaintiff’s opposition to defendant’s motion to exclude the testimony of
Dr. Melamed [Dkt. Nos. 76/79]; defendant’s reply in support of her motion in limine to exclude
the testimony of Dr. Melamed [Dkt. Nos. 82/85]; defendant’s motion in limine to exclude the
testimony of Dr. Melamed and portions of the testimony of Dr. Long pursuant to Fed. R. Evid.
401 [Dkt. Nos. 69/66]; plaintiff’s opposition to motion in limine to exclude the testimony of Dr.
Melamed and portions of the testimony of Dr. Long [Dkt. Nos. 77/80]; defendant’s reply to
opposition to motion in limine to exclude the testimony of Dr. Melamed and portions of the
testimony of Dr. Long [Dkt. Nos. 83/84]; plaintiff’s surreply in opposition to motion in limine to
exclude testimony of Dr. Melamed and portions of the testimony of Dr. Long [Dkt. Nos. 89, 88];
plaintiff’s supplemental trial brief [Dkt. No. 81]; defendant’s brief in response to plaintiff’s
supplemental trial brief [Dkt. No. 87]; plaintiff’s reply supplemental trial brief [Dkt. No. 91];
defendant’s proposed findings of fact and conclusions of law (“Director’s PFF.” or “Director’s
Prop. Concl. of Law,” as appropriate) [Dkt. No. 100]; plaintiff’s proposed findings of fact and
conclusions of law (“Dome’s PFF.” or “Dome’s Prop. Concl. of Law,” as appropriate);
defendant’s response to plaintiff’s proposed findings of fact and conclusions of law (“Director’s
Resp. PFF.” or “Director’s Resp. Concl. of Law,” as appropriate) [Dkt. No. 104]; plaintiff’s
response to defendant’s proposed findings of fact and conclusions of law (“Dome’s Resp. PFF.”
or “Dome’s Resp. Concl. of Law,” as appropriate) [Dkt. No. 105]; and transcripts of the January
15, 2013 pretrial conference and of the bench trial held from January 28 through January 30,
2013, designated by way of example as “Jan. 28 AM Tr.”.
2
A method of making an oxygen permeable material for the
manufacture of contact lens [sic] by the synthesization of the
monomer 1,1,1-tris(methylsiloxy)methacryloxypropylsilane (a
siloxanyl alkyl ester) by the following procedures:
(a) a mixture is prepared having the relationship of one
mole of methacryloxypropyltrimethoxysilane with three to forty
moles of trimethylchlorosilane;
(b) the mixture is then added to water whose volume is
from 3 to 10 times that of the mixture;
(c) agitation is maintained for 30 minutes to 48 hours;
(d) then allow the mixture to separate into layers, remove
and filter the upper organic layer;
(e) the unwanted by-product (hexamethyldisiloxane) is then
removed by vacuum distillation;
(f) forming an oxygen permeable contact lens material by
copolymerizing from 5% to 90% by weight of the 1,1,1
tris(trimethylsiloxy)methacryloxypropyl-silane prepared above;
3% to 90% by weight of an ester of acrylic or methacrylic acid;
from 0.5% to 90% by weight of a surface wetting agent, from
0.01% to 90% by weight of an oxygen permeable crosslinking
agent selected from the class of multifunctional siloxanyl alkyl
esters in the presence of a free radical or a photo initiator.
JTX-1 at col.5 lines 38-64 (emphasis added); id., Certificate of Correction. Steps (a) through (e)
of this claim recite a process for manufacturing a chemical compound commonly known as
“Tris.” Step (f) describes a process for synthesizing Tris with three other compounds to create a
rigid, gas permeable material suitable for manufacturing a contact lens.2
In December 1997, Dome sought to enforce the Neefe Patent in an infringement
action against several defendants. See Dome Patent L.P. v. Permeable Technologies, Inc., et al.,
Civil Action No. 98-6247 (filed in the Western District of New York, after being transferred
2
The first underlined term refers to a chemical compound commonly known as
“Tris.” The second underlined term refers to a Tris-type cross-linking agent.
3
from the Eastern District of California). One of these defendants, Optical Polymer Research,
Inc., filed a request with the PTO for reexamination of the Neefe Patent. JTX-34 at 53-95
(Request for Reexamination, Aug. 27, 1998). On May 23, 2002, an examiner at the PTO
concluded that claims 2, 3, and 4 of the Neefe Patent should be confirmed, but that claim 1 of the
Neefe Patent – recited above – should be cancelled because the method it described “would have
been obvious at the time the invention was made to a person having ordinary skill in the art.” 35
U.S.C. § 103(a); JTX-34 at 1110-20 (Office Action in Ex Parte Reexamination). Dome timely
appealed the examiner’s ruling to the Board of Patent Appeals and Interferences (the “Board”).
JTX-34 at 1134-35 (Notice of Appeal dated July 12, 2002).3 On July 31, 2007, the Board issued
an order affirming the examiner’s decision. JTX-34 at 1270-93 (In re Neefe, Appeal 2007-
1366).
On September 24, 2007, Dome timely filed this civil action pursuant to 35 U.S.C.
§§ 145 and 306 for review of the Board’s decision. Compl.; Jt. Pretrial Stmt. at 3. The Court
conducted a three-day bench trial from January 28 through January 30, 2013, during which the
parties introduced the expert testimony of Timothy E. Long, Ph.D., Mark A. Melamed, M.D.,
and William J. Benjamin, O.D., Ph.D., as well as testimony from the patent’s author, Robert A.
Neefe. Dr. Long, called as a witness by Dome, is a professor of chemistry at the Virginia
Polytechnic Institute and State University and an expert in the field of polymer chemistry. Dr.
Melamed, also Dome’s witness, is an ophthalmologist with a large private practice in which he
spends a substantial part of his time prescribing and fitting contact lenses. He also is a Professor
of Ophthalmology at New York University School of Medicine. Dr. Melamed is an expert on
the use and prescription of rigid gas permeable contact lenses and on the medical benefits of
3
The Board is now known as the Patent Trial and Appeal Board.
4
contact lenses with improved oxygen permeability.4 The Director’s expert, Dr. Benjamin, is a
Professor of Optometry and Vision Science at the University of Alabama School of Optometry.
He is an expert in the measurement of the oxygen permeability of contact lenses and the
wettability of rigid contact lenses.5
B. The Parties’ Positions
As discussed in the Findings of Fact below, many of the relevant facts in this case
are undisputed. The parties agree that a usable hard contact lens must be clear, rigid, oxygen
permeable, and wettable (i.e., hydrophilic). The parties also agree that the field of contact lens
development witnessed a breakthrough in the 1970’s with the advent of rigid gas permeable
lenses, which combined the clarity, rigidity, and wettability of one prior technology (PMMA
lenses) with the oxygen permeability of another prior technology (soft silicone lenses). One of
the lead inventors in this field, Norman Gaylord in New Providence, New Jersey, created the first
commercially viable rigid gas permeable lens material using a novel “polymer,” composed of
4
The Director filed a motion in limine to exclude the testimony of Dr. Melamed
relating to the commercial success of Bausch & Lomb’s Boston IV lens pursuant to Rule 702 of
the Federal Rules of Evidence. Because the purpose of Rule 702 and Daubert v. Merrell Dow
Pharm., Inc., 509 U.S. 579 (1993) is for the judge to serve a gatekeeping role for the jury, see
Jacobsen v. Oliver, Civil Action No. 01-1810, 2007 WL 5527513, at *1 (D.D.C. Nov. 2, 2007)
(collecting cases), the Court declined to exclude Dr. Melamed’s testimony during this non-jury
trial. See Jan. 15 AM Tr. at 33:24–34:06. But the Court has given little weight to Dr.
Melamed’s testimony relating to the reasons for the Boston IV lens’ commercial success, as his
opinion on this matter is not based on any study, survey, or reliable methodology, but is simply
based on his experience with his own patients.
5
The Court granted Dome’s motion during trial to exclude those portions of Dr.
Benjamin’s testimony relating to the polymer chemistry underlying contact lens production, as
this topic does not fall within the scope of Dr. Benjamin’s expertise. Goodman v. Harris
Cnty., 571 F.3d 388, 399 (5th Cir. 2009) (an expert may not “go beyond the scope of his
expertise in giving his opinion”); Sosna v. Binnington, 321 F.3d 742, 746 (8th Cir. 2003) (same).
5
different “monomers.” In making this polymer, Gaylord began by using a silicone-containing
monomer called Tris, which is very oxygen permeable but not wettable (that is, it is
hydrophobic). Gaylord next added other monomers similar to those used in PMMA lenses,
which are highly wettable but not oxygen permeable. Gaylord then joined the hydrophobic Tris
monomers and the hydrophilic comonomers together, using a hydrophilic cross-linking agent.
This material could then be machined into a reasonably usable contact lens. Several other
scientists subsequently refined and expanded on Gaylord’s invention.
A few years later, a group of scientists led by Kyoichi Tanaka in Japan patented a
different rigid gas permeable contact lens material using a non-Tris monomer with a range of
cross-linking agents. One of Tanaka’s preferred cross-linkers was a hydrophobic multifunctional
siloxanyl alkyl ester, which is similar in molecular structure to the Tris monomer.
Less than two years later, Robert Neefe of Big Spring, Texas, combined the
monomers used by Gaylord with the cross-linker used by Tanaka to develop a usable rigid gas
permeable lens. Neefe’s process was patented as claim 1 of U.S. Patent No. 4,306,042, recited
above and referred to here as the Neefe Patent.
This case centers on the parties’ disagreement as to whether it would have
occurred to a person of ordinary skill in the art to do what Neefe did: to combine the first three
compounds listed in step (f) of claim 1 of the Neefe Patent – i.e., Gaylord’s compounds – with
the fourth compound listed in step (f) – i.e., Tanaka’s cross-linker. Dome contends that it would
not have occurred to a person of ordinary skill to attempt this combination. According to Dome,
one with ordinary skill would have been deterred from using both the Tris monomer from
Gaylord and the Tris-type cross-linker from Tanaka in the same formulation, out of concern that
the resulting compound would be unwettable or otherwise unusable for contact lens production.
6
See Dome’s Trial Brief at 10 (“[U]sing both a hydrophobic Tris monomer and a hydrophobic
cross-linker would have been expected to yield a hydrophobic polymer that would be unsuitable
as a contact lens material.”); id. at 9 (“Neefe offered a novel and counter-intuitive solution to the
oxygen permeability problem: a polymer that contains both a hydrophobic Tris monomer and a
hydrophobic Tris-type cross-linker.”) (emphasis in original). Dome also attempts to show that
the success of a commercial contact lens made using the Neefe process demonstrates the
nonobviousness of that process, supporting its patentability. Id. at 1 (describing evidence of
“surprising and counter-intuitive results achieved by the method disclosed and claimed in the
Neefe Patent” and “evidence of large scale commercial exploitation and use of the method
disclosed and claimed in the Neefe Patent”).
The Director disagrees, arguing that it was established that the hydrophobicity of
both the Tris monomer and the Tris-type cross-linker could be offset by the hydrophilic
monomers suggested by Gaylord, particularly within the broad ranges identified by Neefe. See
Director’s Trial Brief at 28 (“Any concern about wettability arising from the use of a small
amount of Tris (as low as 5% by weight), therefore, easily could be alleviated by use of a wetting
agent (up to 90% by weight), while still remaining within the scope of the claim.”). And while
the Director does not dispute that the contact lens referenced by Dome was commercially
successful, she argues that this success cannot be attributed to the Neefe process for several
reasons, and therefore any evidence of success is irrelevant to the question of obviousness. See
id. at 5-7, 13-14, 16-25.
7
II. FINDINGS OF FACT
The following findings of fact are based on the evidence submitted by the parties
during the bench trial, the administrative record before the Board, the Board’s opinion, the
parties’ stipulations of undisputed facts, and the record as a whole.
A. The Polymer Chemistry of Contact Lens Material Production
a. Properties of Rigid Gas Permeable Contact Lenses
1. Claim 1 of the Neefe Patent recites a process for making material for the
manufacture of a rigid gas permeable (“RGP”) contact lens. JTX-1 at [57] (Abstract).
2. A material for use in a RGP contact lens should have the following four
characteristics: it should be optically clear; it should be hard and rigid; it should be wettable; and
it should be oxygen permeable. Jan. 28 AM Tr. at 49:8–50:13 (Long); Jan. 29 AM Tr. at 14:25–
16:7, 17:2-21, 100:9-11 (Melamed); Jan. 29 PM Tr. at 48:3-11 (Benjamin).
3. Optical clarity is important in order for the material to provide a clear visual
image for the user. See Jan. 28 AM Tr. at 49:8-10 (Long); Jan. 29 PM Tr. at 48:3-7 (Benjamin).
4. Rigidity is required so that the lens can be machineable into a precise enough
shape to provide crisp, consistent visual acuity. Jan. 28 AM Tr. at 49:16-21 (Long); Jan. 29 PM
Tr. at 48:3, 48:7-11 (Benjamin).
5. Wettability, which is the interaction of water with a surface (such as the surface of
a contact lens), is necessary for a contact lens to be comfortable on the eye of the wearer. Jan. 28
AM Tr. at 50:7-13 (Long); Jan. 29 AM Tr. at 15:12–16:7, 17:7-9 (Melamed).
6. Wettability is important because contact lenses do not actually sit on the surface
of the cornea of the eye; instead, they float on a thin film of tears on the surface of the cornea.
Jan. 29 AM Tr. at 14:12-14 & 15:19-23 (Melamed). Contact lenses must be tolerated in the eye
8
without eliciting a painful foreign body sensation, so an even coating of tears must be spread
across the surface of the lens. Id. at 15:12–16:3 (Melamed).
7. A hydrophobic polymer is one that is water repellent, while a hydrophilic
polymer can readily absorb water. Jan. 28 AM Tr. at 10:2 (Long); Jan. 30 AM Tr. at 13:25
(Benjamin).
8. Adequate oxygen permeability is necessary to prevent long-term damage to the
eye of the wearer. Jan. 28 AM Tr. at 49:22–50:6 (Long); Jan. 29 AM Tr. at 14:25–15:11, 17:2-6,
17:19-21, 100:9-11 (Melamed).
9. Oxygen permeability is important because a constant flow of oxygen to the cornea
is essential to avoid degenerative changes in its cells. Jan. 29 AM Tr. at 14:25–15:11
(Melamed). The cornea has no blood supply to bring it oxygen, so it gets its oxygen from the
atmosphere, through the open lids of the eye. Jan. 29 AM Tr. at 14:14-17 (Melamed).
10. Anything that covers the cornea – either a contact lens or the eyelid – impedes the
flow of oxygen to the cornea. Jan. 29 AM Tr. at 14:17-20 (Melamed). Thus, the oxygen flow to
the cornea is impeded during sleep. Id. at 16:10-21 (Melamed).
11. Even with a contact lens in place, oxygen can reach the front surface of the cornea
in two ways: (1) it can permeate through the body of the contact lens itself; or (2) it can be
carried by tears around the edge of the contact lens. Jan. 29 AM Tr. at 14:20-24 (Melamed).
12. The oxygen permeability of a material is measured in Dk, or “barrers.” JTX-4 at
62; Jan. 29 AM Tr. at 25:22-23 (Melamed); Jan. 30 AM Tr. at 35:25 (Benjamin).
13. Ideally, a contact lens material will meet all four criteria: clarity, hardness,
oxygen permeability, and wettability. Jan. 28 AM Tr. at 53:21-24 (Long). As Dome’s counsel
9
noted at trial, these criteria can be remembered with the acronym “CHOW.” Jan. 28 AM Tr. at
9:7-8; see also Jan. 28 AM Tr. at 48:16-17 (Long).
b. The Polymer Chemistry Behind Contact Lens Manufacturing
14. The technology at issue in this case is the polymer chemistry required to
manufacture RGP contact lenses.
15. A RGP contact lens is made from material that permits the passage of oxygen
through the lens to the eye of the wearer. Jan. 29 AM Tr. at 40:9-10 (Melamed); JTX-4 at 63.
16. A “polymer,” also known as a “macromolecule,” is a large molecule made up of
many smaller units called “monomers.” JTX-3 at 3.
17. The process of synthesizing a polymer from monomers is called
“polymerization.” JTX-3 at 3.
18. A “copolymer” is a type of polymer that is formed from two or more different
types of monomers. JTX-3 at 7.
19. The process of synthesizing a copolymer is known as “copolymerization.”
PTX-4, at tab 2; Director’s PFF. 14.
20. Polymers can take different forms, including linear, branched, and cross-linked
(i.e., networked). JTX-3 at 8-10. Illustrative examples of these different forms were provided at
trial and are reproduced below. See PTX-4 at Tab 3; Jan. 28 AM Tr. at 57:10-63:20 (Long).
10
21. The materials that make up a polymer can alter the polymer’s chemical structure
and therefore its physical properties. Jan. 28 AM Tr. at 63:1-20 (Long).
22. For example, the use of one cross-linking agent instead of another can affect the
size of the gaps in the polymer’s structure, which can affect the polymer’s oxygen permeability.
Jan. 28 AM Tr. at 62:3-63:20 (Long).
23. Cross-linked polymers can be exceptionally complex; the cross-linking agents
may be close together or far apart, short or long, few or plentiful. Jan. 28 AM Tr. at 61:8-22
(Long).
B. The Prior Art: The Comonomers Used by Neefe Were Known in the Prior Art and, When
Used in Combination, Could Be Expected to Promote Oxygen Permeability
This case centers on a dispute about whether Neefe’s invention would have been
obvious to a person of ordinary skill in the art, in light of the technology existing and known in
the field at the time of Neefe’s invention – i.e., the prior art. Although the facts discussed in the
section below are undisputed, the Court makes the following findings relating to the prior art and
the Neefe Patent, with the purpose of providing background and context.6
6
Some of the facts in Section B (FF. 24-89) are dismissed by one party or the other
as irrelevant or misleading, but there are no genuine disputes as to their factual accuracy.
11
a. The Prior Art
24. The first practical plastic contact lens was made out of polymethyl methacrylate
(“PMMA”), which was first branded commercially as Plexiglas. See Jan. 28 AM Tr. at 50:25-
51:1 (Long); Jan. 30 AM Tr. at 12:2-18 (Benjamin).
25. PMMA is a rigid, glass-like thermoplastic with relatively little flexibility. Jan. 28
AM Tr. at 51:9-10 (Long), 70:17-18; JTX-4 at 61-62.
26. PMMA is highly wettable, but it also is completely impermeable to oxygen. See
Jan. 28 AM Tr. at 51:13-21 (Long); Jan. 30 AM Tr. at 12:2-18 (Benjamin).
27. This lack of oxygen permeability of PMMA lenses led to the development of so-
called “contact lens over-wear syndrome” in users. Wearing these lenses for an extended period
of time could cause pain, death of nerve endings in the cornea, blurred or filmy vision, glare, and
halos around lights. Jan. 29 AM Tr. at 15:2-9 (Melamed); see also JTX-10 at col.1 lines 28-32;
Jan. 30 AM Tr. at 16:10-21 (Benjamin); JTX-27 at 279.
28. In response to the problem of contact lens over-wear, many scientists began
exploring polymers containing siloxanes for use in contact lens materials. Jan. 28 AM Tr. at
51:22–53:24 (Long); JTX-4 at 7, 60-63.
29. Siloxanes are chemical compounds containing carbon atoms (C), oxygen atoms
(O), and silicon atoms (Si), in which two silicon atoms are bonded directly to one oxygen atom
in the form –Si–O–Si–. JTX-4 at 60-62. The –Si–O–Si– chain can be thought of as the
polymer’s backbone, to which other atoms and molecules are attached. Id.
12
PTX-4 at tab 8.
30. Siloxanes are highly oxygen permeable. They also, however, are hydrophobic –
that is, water repellant. In addition, siloxanes are soft and difficult to machine. Jan. 28 AM Tr.
at 52:10-25 (Long); Jan. 30 AM Tr. at 13:22-23 (Benjamin); JTX-4 at 17, 61-62; JTX-5 at 272;
JTX-13 at col.1 lines 33-34, 40-43.
31. A significant breakthrough in the field of contact lens materials took place in the
1970’s, when Norman G. Gaylord had the idea of using a rigid material for a contact lens that
still allowed oxygen to pass through the lens to reach the cornea of the eye. Gaylord introduced
the first RGP lens, an oxygen permeable contact lens made from a mixture of PMMA and
silicone (siloxane). JTX-4 at 17; Jan. 29 AM Tr. at 22:24-25 (Melamed); id. at 53:19-24
(Melamed); see JTX-7; JTX-8.
32. In his invention, Gaylord combined four ingredients: (i) a silicone -based
monomer; (ii) an acrylate; (iii) a wetting agent; and (iv) a cross-linking agent. Jan. 28 AM Tr. at
70:18-23 (Long); JTX-4 at 64; JTX-7 at col.1 lines 57-60; JTX-8 at col.1 lines 52-56, col.5 lines
39-46, col.6 lines 3-12; see Board Decision, JTX-16 at F.10.
33. In Gaylord’s polymer, the silicone is the chemical compound 1,1,1-
tris(trimethylsiloxy)methacryloxypropylsilane, which is commonly known in the contact lens
13
field as a “Tris” monomer. Jan. 28 AM Tr. at 69:11-70:5 (Long); JTX-1 at col.3 lines 13-14;
JTX-4 at 63; JTX-7 at col.2 lines 26-35; JTX-8 at col.2 lines 32-44.
34. After Gaylord, the Tris monomer became the “industry standard” siloxy-
methacrylate monomer in the field of RGP contact lenses. JTX-4 at 63.
35. Tris is a siloxanyl alkyl ester compound. Jan. 28 PM Tr. at 66:8 (Long); JTX-1 at
col.3 lines 12-14, col.5 lines 40-41.7
36. Tris is very hydrophobic, i.e., water repellant. Jan. 28 AM Tr. at 66:2-4, 74:20-21
(Long); JTX-6 at col.1 lines 63-66.
37. In addition to Tris, Gaylord used methyl methacrylate (“MMA,” the monomer in
PMMA) as the acrylate, and he employed methacrylic acid as the wetting agent. Both MMA and
methacrylic acid are hydrophilic: these comonomers therefore increased the wettability of the
polymer. Jan. 28 AM Tr. at 67:3-12 (Long); Jan. 28 PM Tr. at 68:14-21 (Long); JTX-7 at col.3
line 29, col.4 lines 50-59; JTX-8 at col.3 line 65, col.5 lines 39-48; see also JTX-4 at 17.
38. The fourth ingredient, which Gaylord used to bind these comonomers together,
was a hydrophilic, non-siloxane based cross-linking agent, such as ethylene glycol
dimethacrylate. Jan. 28 AM Tr. at 70:9-13 (Long); PTX-4 at Tab 9.
39. Contact lenses manufactured using the Gaylord polymer were introduced into the
marketplace in the late 1970’s by Syntex, Inc. under the trade name Polycon. Jan. 30 AM Tr. at
40:2-7 (Benjamin); JTX-4 at 17; JTX-10 at col.2 lines 29-32; JTX-12 at 238.
40. The first Polycon lens (Polycon I) had an oxygen permeability of approximately 5
Dk; the second (Polycon II), an oxygen permeability of approximately 10 to 12 Dk. The Polycon
7
Tris was first disclosed by George J. Quaal in U.S. Patent No. 3,377,371 (issued
April 9, 1968). JTX-6 at 1.
14
lenses thus exhibited much better oxygen permeability than PMMA lenses, which were
completely impermeable. JTX-4 at 67; JTX-12 at 238; JTX-27 at 273.
41. Gaylord explains that the reason for the increased oxygen permeability of his lens
materials is the inclusion of silicone (i.e., the use of the siloxanyl alkyl ester), which “is highly
permeable to oxygen.” JTX-8 at col.1 lines 31-32; see generally id. at col.1 lines 19-56.
42. At noted at FF. 30 and 36, although the presence of silicone improves the oxygen
permeability of a contact lens material, it detracts from its wettability.
43. Gaylord addresses the issue of wettability in his patent. He states that “[w]hile
some of the copolymers [disclosed in his patent] are inherently wettable by human tears, it may
be necessary to improve the wettability of others.” JTX-8 at col.5 lines 39-41.
44. Gaylord discloses four alternate methods for improving the wettability of these
copolymers, including adding hydrophilic monomers to the copolymerization mixture and
applying wetting agents to the surface of the contact lenses. JTX-8 at col.5 lines 42-58.
45. Although Gaylord’s invention represented a significant improvement in oxygen
permeability, the first lenses incorporating Gaylord’s polymer still could not be used for
prolonged daily wear. See Jan. 29 AM Tr. at 91:13–92:8 (Melamed).
46. After Gaylord’s technique was known, several scientists worked to increase the
oxygen permeability, wettability, and hardness of Gaylord’s formulation. See Jan. 28 AM Tr. at
73:10–79:10 (Long); see, e.g., JTX-9 at col.1 lines 11-41.
47. One pair of scientists – Edward J. Ellis and Joseph C. Salamone at Polymer
Technology Corporation in Massachusetts – improved Gaylord’s technique by employing Tris
but also adding an additional hydrophilic comonomer to improve the material’s wettability and
15
structural integrity. Jan. 28 AM Tr. at 73:20–74:21 (Long); see generally JTX-9. Ellis applied
for a patent based on this invention on February 15, 1978. JTX-9 at [22].
48. The Ellis patent was issued on May 1, 1979. It was later used to create the Boston
II lens, which had an oxygen permeability of approximately 12 to 14 Dk. JTX-9 at [45]; Jan. 29
AM Tr. at 25:22-25, 54:4-9 (Melamed); Jan. 30 AM Tr. at 69:25–70:2, 75:21-25 (Benjamin);
JTX-4 at 66; JTX-12 at 238; JTX-21 at BL8556; JTX-27 at 273.
49. Another scientist, Nick N. Novicky of Wheeling, Illinois, attempted to solve the
problems of the Gaylord polymers by replacing the Tris monomer with novel silicones of his
own design. Jan. 28 AM Tr. at 75:23-25 (Long); see JTX-11 at col.3 lines 22-23, col.14 lines
37-45, col.18 lines 8-13.
50. Like Tris, the novel monomer employed by Novicky contains a methacrylate
component and a tris(trimethylsiloxy) component. Jan. 28 AM Tr. at 76:22–77:9 (Long);
JTX-11 at col.3 lines 49-53, col.3 lines 64-67, col.4 lines 25-39 (general formula), col.18 lines
28-39 (formula in claim 1).
51. Unlike Tris, the Novicky monomer contains an additional siloxane unit. JTX-11
at col.4 lines 25-39, col.18 lines 28-39; Jan. 28 AM Tr. at 76:1-4, 77:7-9 (Long).
52. This additional siloxane unit makes the novel Novicky monomer even more
hydrophobic than Tris. Jan. 28 AM Tr. at 75:22-76:12 (Long).
53. In addition to the novel monomer, Novicky’s polymer also contains hydrophilic
wetting agents and hydrophilic MMA. JTX-11 at col.3 lines 44-48, col.6 line 65, col.7 line 27,
col.18 lines 66-68, col.19 lines 1-3.
16
54. The Novicky polymer uses the same type of hydrophilic cross-linker used by
Gaylord and Ellis; as noted supra at FF. 38, this cross-linker does not contain a siloxane group.
JTX-11 at col.7 lines 15-24; Jan. 28 AM Tr. at 77:12-18 (Long).
55. The Novicky patent was issued on August 5, 1980. JTX-11 at [45].
56. RGP contact lenses incorporating the Novicky polymer reportedly were marketed
by Fused Contacts as the Sil-O2-Flex lens. JTX-10 at col.8 line 23, col.8 line 38; JTX-12 at 238.
57. The Sil-O2-Flex lens had an oxygen permeability level of approximately 5 to 8
Dk. JTX-10 at col.8 line 38; JTX-12 at 238.
58. On September 22, 1978, a group of scientists led by Kyoichi Tanaka in Japan
applied for a patent based on a novel polymer to be used for making an RGP contact lens.
JTX-13 at [57].
59. Tanaka discloses that his copolymers have an excellent oxygen permeability and a
good hydrophilic property (i.e., they are wettable). Jan. 28 PM Tr. at 79:17-19 (Long).
60. Tanaka departed from Gaylord (and Ellis) in two ways. First, rather than using
the Tris monomer, Tanaka employed a novel non-Tris silicone monomer containing
siloxanylalkyl ester groups, which are hydrophobic, and internal glycerol or polyether groups,
which are hydrophilic. Tanaka’s novel monomer thus was “amphiphilic,” and had a higher
affinity for water – i.e., was less water repellant – than the Tris monomer used by Gaylord and
Ellis. Jan. 28 PM Tr. at 5:5-8, 5:13-14, 6:11-7:3, 9:14-21 (Long). Strands were then formed by
polymerizing this novel non-Tris monomer and MMA as comonomers. Jan. 28 PM Tr. at 5:3-8,
7:7-10 (Long); JTX-13 at col.7 lines 39-41.
61. Second, Tanaka proposed a variety of cross-linking agents, including some cross-
linkers that were not employed by Gaylord and Ellis. Although Tanaka stated that a cross-linker
17
used by Gaylord, ethylene glycol dimethacrylate, could be used in his polymer, JTX-13 at col.8
lines 2-14, Tanaka’s “preferred” cross-linking agents were multifunctional siloxanyl alkyl esters
having a siloxane bond (which he described as formula [IV] cross-linkers) and multifunctional
siloxanyl alkanol esters, also having a siloxane bond (formula [V] cross-linkers). JTX-13 at
col.8 lines 11-46; see also Jan. 28 PM Tr. at 77:25–78:22 (Long); JTX-16 at 5 (Board Finding
No. 26).
62. Tanaka says that these cross-linking agents are preferred because the siloxane
bonds provide increased oxygen permeability to the cross-linked copolymer:
Since these cross-linking agents of the general formulas [V] and
[VI] have siloxane bonds in their molecules, the oxygen
permeability of the obtained cross-linked copolymers is high and,
therefore, they are preferably employed in the present invention.
JTX-13 at col.8 lines 35-39; see Jan. 28 PM Tr. at 77:25–78:16 (Long); JTX-16 at 5-6 (Board
Finding 27).
63. Tanaka states that the novel siloxanyl alkynol esters of formula [V] are
“particularly useful” because they contain hydrophilic hydroxyl groups. That is, not only do
these cross-linkers promote a material’s oxygen permeability, but they also promote its
wettability. JTX-13 at col.8 lines 39-46.
64. The multifunctional siloxanyl alkyl esters referenced by Tanaka had been known
in the field of polymer chemistry since at least 1958, and had been disclosed in the Mercker
Patent, see PTX-1; Jan. 28 PM Tr. at 107:8-23 (Long), but there is no evidence that it had been
purposely employed in contact lens production prior to Tanaka. See Jan. 28 PM Tr. at 107:8–
108:6.
65. Tanaka’s patent was issued on November 25, 1980. JTX-13 at [45].
18
b. The Neefe Invention
66. Beginning around 1977, Russell Neefe undertook to create a rigid gas permeable
material suitable for contact lenses. Jan. 29 PM Tr. at 6:18-22 (Neefe).
67. At some point between 1977 and 1980, Neefe had the idea to cross-link the
silicone-containing Tris monomer not with the cross-linkers used by Gaylord, Ellis, or Novicky,
but with a cross-linking agent based on Tris. Jan. 29 PM Tr. at 15:16-23 (Neefe). This type of
cross-linking agent – a multifunctional siloxanyl alkyl ester – was one of the agents preferred by
Tanaka. See FF. 61-62.8
68. The initial material created by Neefe using the process of claim 1 had a Dk value
of 14. Jan. 29 PM Tr. at 19:15-20:1 (Neefe).
69. On September 8, 1980, Russell Neefe submitted his application for the patent at
issue in this suit. A patent was issued to Neefe on December 15, 1981. JTX-1 at [45].
70. The Neefe Patent is entitled “Method of Making a Contact Lens Material With
Increased Oxygen Permeability.” JTX-1.
71. The Summary of Invention in the Neefe Patent specification states that the
“primary object of this invention is to provide a novel contact lens material which is prepared
from a combination of monomers so as to have high oxygen, carbon dioxide permeability, and a
hydrophilic surface.” JTX-1 at col.1 lines 61-64.
72. The Neefe Patent contains four claims, three of which were not subject to
reexamination because the PTO found no substantial question of patentability as to those claims.
JTX-34 at 1112.
8
Multifunctional siloxanyl alkyl esters (which can serve as cross-linking agents)
are distinct from monofunctional siloxanyl alkyl esters such as Tris (which cannot). See infra at
FF. 128 n.11.
19
73. As noted supra at 3, claim 1 of the Neefe Patent outlines a six-step process for
making a rigid gas permeable contact lens material, labeled (a) through (f). JTX-1 at col.5 lines
38-64.
74. The first five steps of the claim (steps (a)-(e)) recite a process of making 1,1,1-
tris(trimethylsiloxy)methacryloxypropylsilane, or “Tris.” JTX-1 at col.5 lines 44-54; JTX-16 at
2 (Board Findings 4-6); Jan. 28 AM Tr. at 69:1-70:5 (Long). There is no dispute that Tris was
known in the prior art. Director’s PFF. 34; Dome’s Resp. PFF. 34.
75. Step (f) of the claim instructs that four chemical ingredients, including Tris, are
combined to form “an oxygen permeable contact lens material.” JTX-1 at col.5 lines 55-64.
76. The four ingredients combined in step (f) are as follows: (1) “from 5% to 90% by
weight” of the Tris monomer; (2) from “3% to 90% by weight of an ester of acrylic or
methacrylic acid;” (3) “from 0.5% to 90% by weight of a surface wetting agent;” and (4) “from
0.01% to 90% by weight of an oxygen permeable crosslinking agent selected from the class of
multifunctional siloxanyl alkyl esters.” JTX-1 at col.5 lines 55-64; id., Certificate of Correction.
77. The first three ingredients listed in step (f) of claim 1 of the Neefe patent were
previously disclosed by Gaylord. The only significant difference between the contact lens
material taught by Gaylord and the contact lens material in claim 1 of the Neefe Patent is the
fourth ingredient: Gaylord’s material includes a hydrophilic cross-linking agent rather than the
hydrophobic multifunctional siloxanyl alkyl ester used by Neefe. JTX-8 at col.6 lines 3-12;
JTX-1 at col.2 lines 43-44 at col.5 lines 61-63; Jan. 28 PM Tr. at 16:3-5, 16:12-13, 17:4-10, 18:2,
70:15-20 (Long).
20
78. As noted supra at FF. 61-63, Tanaka suggested the use of a siloxanyl alkyl ester
cross-linker in order to promote oxygen permeability, although Tanaka suggested its use with a
different (non-Tris) monomer.
79. Four years later, Neefe created another material using the process of claim 1 of
the Neefe Patent, which was commercialized and sold under the trade name TransAire. Jan. 30
AM Tr. at 79:25–80:4, 83:3-5 (Neefe). The TransAire polymer had a Dk value of 45. Jan. 30
AM Tr. at 81:15-18 (Neefe); JTX-27 at 273.
c. An Artisan of Ordinary Skill Would Have Known That Tris Monomer and a Siloxanyl Alkyl
Ester Cross-Linker (like Tris Dimer or Trimer) Could Be Combined to Form an Oxygen
Permeable Polymer
80. A person of ordinary skill in the art of making RGP contact lens materials, as of
September 8, 1980, would have had at least an undergraduate degree – and very likely a graduate
degree or some graduate training – in chemistry, coupled with experience in the development,
manufacture and use of polymers suitable for the manufacture of RGP contact lenses. Jan. 28
PM Tr. at 60:15-19 (Long).
81. The person having ordinary skill in the art was aware of the reasons for and
desirability of high oxygen permeability in contact lens materials. JTX-16 at 8 (Board Finding
50); see Director’s PFF. 46; Dome’s Resp. PFF. 46.
82. A person of ordinary skill in the art would have fully understood the
copolymerization chemistry used to make contact lens materials, including the mechanism
involved in cross-linking different comonomers. JTX-16 at 8:10-23; see Director’s PFF. 47;
Dome’s Resp. PFF. 47; Dome’s PFF. 69; Director’s Resp. PFF. at 3, 5-6.
83. The person having ordinary skill in the art also would have understood and been
familiar with the processes and chemistry for making the comonomers that are copolymerized in
21
making contact lens materials. JTX-16 at 8 (Board Finding 53); see Director’s PFF. 49; Dome’s
Resp. PFF. 49.
84. One having ordinary skill in the art would have been familiar with the properties
of Tris and the chemistry necessary to make it. JTX-16 at 8 (Board Finding 54); see Director’s
PFF. 50; Dome’s Resp. PFF. 50.
85. One having ordinary skill in the art would have understood that cross-linking
takes place through terminal unsaturated carbon bonds. JTX-16 at 8, 16; see Director’s PFF. 48,
84; Dome’s Resp. PFF. 48, 84.
86. One having ordinary skill in the art would have understood that ethylene glycol
dimethacrylate, described as a cross-linker by both Gaylord and Tanaka, may be represented by
the following formula showing terminal unsaturated carbons (=CH2):
One having ordinary skill in the art would have understood that Tanaka’s preferred oxygen
permeable cross-linkers similarly have terminal unsaturated carbons (=CH2). For example, the
multifunctional siloxanyl alkyl esters employed by Tanaka include those represented by the
following general formula:
22
JTX-16 at 15 n.5; Director’s PFF. 83; Dome’s Resp. PFF. 83.
87. A person of ordinary skill in the art would have expected that these
multifunctional siloxanyl alkyl ester cross-linking agents, having terminal unsaturated carbons
(=CH2), would be effective cross-linking agents with the comonomers suggested by Gaylord.
See JTX-16 at 16.
88. The person having ordinary skill in the art would have recognized that the oxygen
permeability of Tanaka’s lens material was due in part to the use of Tanaka’s preferred cross-
linking agents, which contain siloxane bonds. See JTX-13 at col.8 lines 35-39; Jan. 28 PM Tr. at
79:15-16 (Long); see also JTX-16 at 6, 14.
89. A person of ordinary skill in the art would reasonably expect that combining the
comonomers suggested by Gaylord and the multifunctional siloxanyl alkyl ester cross-linking
agent suggested by Tanaka would likely yield positive results in terms of oxygen permeability.
See JTX-16 at 6 (Board Finding 28); Director’s PFF. 78-86; Dome’s Resp. PFF. 78-86 (asserting
that an artisan of ordinary skill would have been deterred from combining Gaylord’s and
Tanaka’s compounds for other reasons, but not disputing that such artisan would know that these
materials could be combined to promote oxygen permeability); Dome’s Trial Brief at 4 (“It was
known that incorporating a type of chemical called a ‘silicone’ (of which Tris is an example) in
the contact lens material would improve its oxygen permeability.”).
23
C. A Person of Ordinary Skill in the Art Would Not Be Deterred, Because of Concern about
Wettability or Opacity, from Using the Siloxanyl Alkyl Ester Monomor Suggested by Gaylord
(Tris) with the Siloxanyl Alkyl Ester Cross-Linker Suggested by Tanaka
As noted, a person of ordinary skill in the art would have known that the
multifunctional siloxanyl alkyl ester cross-linking agent referenced by Tanaka could be used
with the Tris monomer, and that such combination would promote oxygen permeability. See FF.
89. Nevertheless, Dome maintains that the artisan of ordinary skill would have been dissuaded
from using these materials together, due to the hydrophobic properties of both. See Jan. 30 PM
Tr. at 8:2–9:18, 10:6-20 (Dome closing argument). The Director disagrees, arguing that the
artisan of ordinary skill would know that she could offset the hydrophobicity of the two
compounds by adding hydrophilic comonomers within the broad ranges identified by Neefe.
Jan. 30 PM Tr. at 17:2-7; 18:14–20:6 (Director closing argument).
Upon consideration of the entire record, the Court finds as follows:
90. A person of ordinary skill in the art at the time of the invention would understand
that any candidate material for making RGP contact lenses must simultaneously achieve design
goals that are often in tension with one another. Jan. 28 PM Tr. at 61:5-10 (Long).
91. Tanaka teaches that polymers “consisting essentially of” a siloxanyl alkyl ester
(such as Tris) and having no hydrophilic groups have very strong water repelling properties and
therefore are unsuitable for contact lenses. JTX-13 at col.3 lines 10-23.
92. Tanaka teaches that the water repelling nature of polysiloxanyl alkyl ester
monomers can be repressed by reducing the number of hydrophobic alkylsiloxy groups in the
polymer. Such reduction, however, will lead to a reduction in oxygen permeability:
In case of such a polysiloxanylalkyl ester monomer, when the
water repelling property is repressed by reducing the number of the
alkylsiloxy groups in the obtained polymer, the oxygen
permeability becomes low, and then the oxygen permeability is
24
raised by increasing the number of the alkylsiloxy groups in the
obtained polymer, the water repelling property becomes strong. In
any case, there cannot be obtained a polymer suited for preparing a
contact lens which can be comfortably worn continuously for a
long period of time.
JTX-13 at col.3 lines 41-51; see also Jan. 28 PM Tr. at 8:13–9:8 (Long).
93. Tanaka also warns that a polysiloxanyl alkyl ester monomer such as Tris could
become opaque when combined with hydrophilic monomers.
[T]he polysiloxanylalkyl ester monomer may be copolymerized
with a hydrophilic monomer to provide the obtained copolymer
with a proper hydrophilic property, but since it is hard to
copolymerize with the hydrophilic monomer, the copolymer is
liable to become opaque. This is a fatal defect for use as contact
lens materials. Therefore, the polymerization ratio of the
hydrophilic monomer to the polysiloxanylalkyl ester monomer is
limited to produce a transparent copolymer, and it is very difficult
to decrease the water repelling property by copolymerizing with a
hydrophilic monomer.
JTX-13 at col.3 lines 23-41.
94. Tanaka sought to create a continuous wear lens (i.e., an extended or overnight
wear lens), not a daily wear lens or a prolonged daily wear lens. JTX-13, Abstract (describing
invention as contact lenses that “can be comfortably worn continuously for a long period of
time”); id. at col.1 lines 9-10; id. at col.1 lines 31-32; id. at col.3 lines 50-51; id. at col.3 lines
60-63; id. at col.11 lines 4-5; id. at col.11 lines 13-14; id. at col.11 lines 50-52; id. at col.27 lines
43-65 (noting that Tanaka contact lenses “were worn on rabbit eyes continuously for 21 days,”
and “could be continuously worn without change in eyes”).9
9
Dome disputes the Director’s assertion that Tanaka sought to create a continuous
or extended wear lens, noting that Tanaka never used the phrase “continuous wear” or “extended
wear” in his patent. See Dome’s Resp. PFF. 103. After reviewing the record, however, and in
particular the patent specification language cited above at FF. 94, the Court agrees that Tanaka’s
invention is directed towards a continuous wear lens.
25
95. “Continuous wear” is a term that is analogous to “extended wear,” where the
individual continues to wear the same lens without interruption for several days, even while
sleeping. Jan. 30 AM Tr. at 10:20–11:1 (Benjamin); see also Jan. 29 AM Tr. at 28:10-12
(Melamed).
96. The oxygen permeability of a contact lens worn in extended wear or continuous
wear needs to be much greater than the oxygen permeability of a lens to be worn for daily wear.
Jan. 30 AM Tr. at 21:20-24 (Benjamin).
97. Although Tanaka warned that it could be difficult to increase a Tris-based
polymer’s wettability simply by adding hydrophilic monomers, prior references in the art taught
that hydrophilic monomers could be used, within limits, to offset hydrophobic monomers such as
Tris.
98. For example, Gaylord discloses that other ingredients can be added to a siloxanyl
alkyl ester to materially affect the basic properties of a contact lens material. Specifically,
Gaylord discloses using from 30 to 90 parts by weight acrylic or methacrylic acid ester, JTX-8 at
col.4 lines 14-16, both of which are hydrophilic. Jan. 28 PM Tr. at 64:11-19 (Long).
99. Gaylord also explains that, even if the resulting contact lens material is not
sufficiently wettable on its own, “several alternate methods” can be used “to improve the
wettability of” contact lenses. JTX-8 at col.5 lines 39-58.
100. For example, “wettability can be imparted to the copolymer by the addition of
from about 0.1% to about 10% by weight of one or more hydrophilic monomers.” JTX-8 at col.5
lines 42-45.
101. Gaylord also states that “the wettability of the surface of contact lenses made
from the copolymers can be improved by the application of a wetting agent[,] . . . by exposure of
26
the surface to a corona discharge or by chemical treatment of the surface with a strong oxidizing
agent such as nitric acid.” JTX-8 at col.5 lines 51-58.
102. Gaylord further describes that those methods are effective at yielding a wettable
material – a lens made with 55 parts Tris (which is hydrophobic), 45 parts methyl methacrylate
(which is hydrophilic), and 2 parts methacrylic acid (which is a hydrophilic wetting agent) “is
readily wetted with a wetting agent solution.” JTX-8 at col.8 lines 5-19.
103. Gaylord also states that these materials will yield a “transparent” material, JTX-8
at col.8 lines 5-22, and thus Gaylord teaches that Tris can be copolymerized with hydrophilic
monomers like MMA and surface wetting agents without making the copolymer opaque.
104. In addition, Gaylord teaches that a material can contain relatively high amounts of
hydrophobic monomers and still be wettable. For example, Gaylord discloses that lenses with as
much as 70 parts by weight of Tris are wettable, even though Tris is hydrophobic. See JTX-8,
Abstract; id. at col.1 lines 17-18; id. at col.12 line 50 (claiming material that is up to 70 parts by
weight of Tris); id. at col.7 line 21 (disclosing material of 55 parts Tris); id. at col.7 line 38
(disclosing material of 60 parts Tris).
105. Claim 1 of the Neefe Patent permits as little as 0.01% of the hydrophobic cross-
linking agent, along with 5% of Tris, which is hydrophobic, so it permits as much as 94.99% of
hydrophilic comonomers. JTX-1 at col.5 lines 55-64. The prior art does not teach that a material
composed 5% of Tris, .01% of a hydrophobic cross-linking agent, and 94.99% of hydrophilic
comonomers would be unwettable. See FF. 102, 104.
106. Dr. Long states that as of September 8, 1980, a person of ordinary skill in the art
would not have reasonably expected that the siloxanyl alkyl ester cross-linker preferred by
Tanaka could be used with a Tris-based polymer in order to create a contact lens. See Jan. 28
27
PM Tr. at 108:1-6. But this conclusion is not consistent with other evidence presented at trial.
See FF. 90-105.
107. Dr. Long testified that he did not know what continuous wear or extended wear
lenses are, and that such knowledge was beyond the scope of his synthetic polymer chemistry
skills. Jan. 28 PM Tr. at 81:14-21 (Long). This lack of knowledge may have affected and
limited Dr. Long’s understanding of Tanaka and his teachings.
108. In light of Findings of Fact 90 through 107, the Court finds that even if the
Tanaka patent “teaches away” from the use of hydrophobic compounds such as Tris, it only
discourages using such compounds when seeking to make a material that “can be comfortably
worn continuously for a long period of time.” It did not teach away from using such compounds
for daily wear or prolonged daily wear.
109. In light of Findings of Fact 90 through 108, the Court finds that a person of
ordinary skill in the art would not be deterred, out of concerns about wettability or opacity, from
using the Tris monomer suggested by Gaylord along with the siloxanyl alkyl ester cross-linker
preferred by Tanaka to create a daily wear or prolonged daily wear contact lens, provided that
other, hydrophilic comonomers also were employed.
D. Dome’s Evidence of Secondary Considerations
Dome argues that the process recited in claim 1 of the Neefe Patent satisfied a
long-felt need for a contact lens that could be worn throughout the entire day. Dome notes that a
variety of first generation lenses (such as Polycon II and Boston II) based on prior art could not
be comfortably worn from when the wearer woke up in the morning until she went to bed in the
evening. By contrast, the Boston IV lens, a second generation lens that Dome contends
embodies claim 1 of the Neefe Patent, could be worn without interruption from morning until
28
evening. The Boston IV lens achieved considerable commercial success as compared to its
predecessor, the Boston II lens, which Dome asserts was not manufactured in accordance with
claim 1. Dome argues that the positive results achieved in the Boston IV lens and the ensuing
commercial success provides objective evidence of the nonobviousness of claim 1. See Jan. 30
PM Tr. at 12:6–13:10.
The Director maintains that many of the assumptions underlying Dome’s
arguments are flawed. To begin with, the Director takes issues with Dome’s assertion that the
Boston IV lens embodies claim 1 of the Neefe Patent, since the Boston IV process does not
strictly comply with the sequence of steps for making Tris as specified in claim 1. Therefore,
according the Director, the popularity of Boston IV cannot be used to shed light on the novelty of
claim 1. The Director next argues that the success of the Boston IV lens was attributable to a
number of factors, only one of which possibly relates to the Neefe Patent. Finally, the Director
contends that the positive, commercially desirable properties of the Boston IV lens are unlikely
to be present in other embodiments falling within the claim’s broad range. Thus, even if the
success of the Boston IV lens suggests that the process for the Boston IV lens was not obvious,
the evidence is irrelevant to the obviousness of other processes falling within the range of claim
1.
The parties’ disagreements turn both on questions of law and questions of fact.
The factual disputes center on how a person of ordinary skill in the art would interpret the
language of claim 1 of the Neefe Patent; whether a person of ordinary skill in the art would view
certain steps in the Boston IV and Boston II processes as equivalent to steps specified in claim 1;
and the reasons for Boston IV’s success. Upon consideration of the entire record, the Court finds
as follows:
29
a. The Boston II and Boston IV Lenses
110. As noted supra at FF. 47-48, on May 1, 1979, a patent was issued for the
invention of Edward J. Ellis and his colleague, working at the Polymer Technology Corporation
(“PTC”), which is owned by Bausch & Lomb. JTX-9 at [54], [75], [45], [73].
111. Similar to the Gaylord polymer, the Ellis polymer used the hydrophobic Tris
monomer, a hydrophilic MMA monomer, a hydrophilic methacrylic acid as a wetting agent, and
traditional, hydrophilic cross-linking agents. Jan. 28 AM Tr. at 73:25–74:2 (Long); 75:1-11;
JTX-9 at col.3 line 68, col.4 lines 24-27, col.5 line 4, col.10 lines 28-33.
112. The Ellis polymer differed from the Gaylord polymer, however, in that Ellis
added an additional hydrophilic monomer called itaconate in order to improve the stability and
the wettability of the polymer. Jan. 28 AM Tr. at 73:10-16, 74:2-14 (Long); JTX-4 at 64; JTX-9
col.10 lines 28-33.
113. Contact lenses incorporating the Ellis polymer were introduced into the
marketplace in 1983 by PTC as the Boston II lens. JTX-10 at col.2 lines 48-51; PTX-3 at
BL5513; see also JTX-4 at 64, 66.
114. A year later, in 1984, PTC introduced the Boston IV lens as part of a “second
generation” of RGP contact lenses. Jan. 29 AM Tr. at 23:12-15, 55:5-7 (Melamed); Jan. 29 AM
Tr. at 43:16–44:22.
115. Both the Boston II contact lens and the Boston IV contact lens are made from an
oxygen permeable material formed by a process that includes the copolymerization of Tris by
procedures specified in Bausch & Lomb manufacturing protocols. JTX-21 at BL8556-57. Both
procedures begin with the synthesis of TX-91, a specific formulation of Tris. Jan. 28 PM Tr. at
56:4-7 (Long); JTX-17 at BL31.
30
116. As discussed in FF. 117 to FF. 129, the five step process used to formulate TX-91
corresponds to steps (a) through (e) of the Neefe Patent.10
b. Formulation of TX-91
117. First, the production of TX-91, a specific formulation of Tris, begins by mixing
600 mL methacryloxypropyltrimethoxysilane (“MPS”) and 1200 mL trimethylchlorosilane
(“TMCS”), for a molar ratio of TMCS to MPS of 3.75 to 1, in a 3 liter round bottom flask. JTX-
18 at BL3, Step 7.1.2.
118. This process is performed in the exact manner as set forth in step (a) of claim 1 of
the Neefe Patent. Jan. 28 PM Tr. at 27:20-28:2 (Long); JTX-1 at col.5 lines 38-64.
119. Second, the mixture of MPS and TMCS is added to one-third volume of water and
cooled with an external ice/water bath. JTX-18 at BL4, step 7.1.3-7.1.4.
120. This combined use of one-third volume of water (which catalyzes the hydrolysis
reaction) and an external ice/water bath (which acts as a heat sink to absorb the excess heat
produced in the exothermic reaction) is not performed in the exact manner as any step recited in
the Neefe Patent. See JTX-1 at col.5 lines 38-64. This combined use performs substantially the
same functions, however, as the 3 to 10-fold excess volume of water recited in step (b) of claim 1
of the Neefe Patent (i.e., catalyzing the hydrolysis reaction and absorbing excess heat), in
substantially the same way (i.e., by providing the water needed for incorporation during the
chemical reaction and serving as a heat buffer), to achieve substantially the same result (i.e.,
forming Tris and limiting the formation of undesired by-products that can form under conditions
10
The parties introduced no evidence at trial suggesting that the Boston II or the
Boston IV processes were intentionally based on the Neefe Patent.
31
of excessive heat). JTX-18 at BL4, step 7.1.3-7.1.4; Jan. 28 PM Tr. at 33:16-34:20 (Long); see
also JTX-6 at col.1 lines 52-54.
121. Third, the mixture of MPS, TMCS, and water is stirred slowly for 12 to 16 hours.
Jan. 28 PM Tr. at 36:1-14 (Long); JTX-18 at BL4, Step 7.1.5.
122. This process is performed in the exact manner as set forth in step (c) of claim 1 of
the Neefe Patent. Jan. 28 PM Tr. at 36:21-37:1 (Long); JTX-1 at col.5 lines 38-64.
123. Fourth, the mixture of MPS, TMCS, and water is transferred to a separatory
funnel, allowed to separate, and the upper organic layer is retained. Jan. 28 PM Tr. at 37:21-25,
38:1-5 (Long); JTX-18 at BL4, Step 7.1.6.
124. Fifth, volatiles (including the unwanted by-product hexamethyldisiloxane) are
then removed under vacuum using a rotary evaporator or its equivalent. Jan. 28 PM Tr. at
39:17–40:1 (Long); JTX-18 at BL4, Step 7.1.9. The mixture is then filtered. Jan. 28 PM Tr. at
38:9-17 (Long); JTX-18 at BL5, Step 7.2.2. See generally JX-18.
125. The separation step and the vacuum distillation and filtration steps correspond to
steps (d) and (e) of claim 1 of the Neefe Patent. The order in which each action is performed,
however, differs from the sequence described in claim 1, which requires that the upper organic
layer of the mixture is “remove[d] and filter[ed]” in step (d), and that the hexamethyldisiloxane
“is then removed by vacuum distillation” in step (e). JTX-1 at col.5 lines 51-54 (emphasis
added).
126. Nevertheless, a person of ordinary skill in the art would view filtration followed
by vacuuming as equivalent to vacuuming followed by filtration. Jan. 28 PM Tr. at 40:12-15,
54:23-25, 87:8-9, 94:14-15 (Long). The Court bases this finding on the following facts:
32
a. Both the filtration process and the vacuum distillation process are used to purify
the desired Tris by removing unwanted materials. Jan. 28 PM Tr. at 54:7-14
(Long).
b. Dr. Long testified that the presence of insoluble impurities or by-products will not
alter the way in which the vacuum distillation process works, or its effectiveness
in removing soluble materials. Jan. 28 PM Tr. at 54:7-14, 54:23-25 (Long). He
also testified that the presence of unwanted soluble, organic impurities or
byproducts will not alter the way in which the filtration process works, or its
effectiveness in removing particulate materials. Jan. 28 PM Tr. at 54:7-14,
54:23-25 (Long).
c. No evidence was presented at trial indicating that the effectiveness of the filtration
process depends on whether the filtration occurs before or after vacuum
distillation; nor was any evidence presented that the effectiveness of the vacuum
distillation process depends on whether distillation occurs before or after
filtration.
127. After the five steps described above are completed, the resulting solution is
TX-91. TX-91 consists of at least 85% Tris monomer; the remaining percentage is Tris dimer or
trimer. JTX-17 at BL 31; Jan. 28 PM Tr. at 23:8-16 (Long).
128. Tris dimer and Tris trimer are both in the class of multifunctional siloxanyl alkyl
esters required for step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:6–59:1 (Long).11
11
Although the parties did not introduce extensive evidence at trial about the nature
of Tris dimer and trimer, they appear to agree that the term multifunctional signifies that the
monomer has two or more ends that can react and join with other comonomers. It is this
property that enables a multifunctional compound – such as Tris dimer (two ends) or trimer
(three ends) – to serve as a cross-linking agent. By contrast, a Tris monomer (one end) can be
33
129. TX-91 is the first ingredient used in both the Boston II manufacturing process and
the Boston IV process. See generally JX-18; Jan. 28 PM Tr. at 56:4-13 (Long); Jan. 28 PM Tr.
at 56:4-7 (Long). From this point, however, the Boston II process and the Boston IV process
diverge.
c. The Boston II Lens
130. As noted, the first compound used in the Boston II copolymerization process is
TX-91. Jan. 28 PM Tr. at 56:4-13 (Long).
131. TX-91, as prepared in steps (a) through (e) above, comprises approximately
41.7% by weight of the Boston II copolymer. JTX-17 at BL24, BL31. The main component of
TX-91, the Tris monomer, therefore comprises 35.5% to 41.7% by weight of the Boston II
copolymer. Jan. 28 PM Tr. at 56:14-15 (Long); JTX-17 at BL24, BL31.
132. This percentage of Tris falls within the range specified for this reactant in step (f)
of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 56:18–57:1 (Long); JTX-1 at col.5 lines 38-64.
133. The second comonomer used in the copolymerization process is an ester of acrylic
or methacrylic acid. Jan. 28 PM Tr. at 57:2-8 (Long).
134. An ester of acrylic or methacrylic acid comprises 21.8% by weight of the
copolymer. JTX-17 at BL24, BL31.
135. This percentage of an ester of acrylic or methacrylic acid falls within the range
specified for this reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 57:2-12
(Long); JTX-1 at col.5 lines 38-64.
cross-linked, but it cannot itself serve as a cross-linker. See Jan. 30 PM Tr. 5:14-18 (Dome
closing arg.); Director’s Trial Brief at 10.
34
136. The third class of comonomers used in the copolymerization process are the
surface wetting agents tetraethyleneglycol dimethacrylate (“CL”) and N-Nvinylpyrrolidone
(“NVP”). Jan. 28 PM Tr. at 58:1-3 (Long).
137. Together, these surface wetting agents comprise 9.9% by weight of the
copolymer. JTX-17 at BL24, BL31 (CL is 8.4% by weight; NVP is 1.5% by weight).
138. This percentage of surface wetting agents falls within the range specified for this
reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:1-5 (Long); JTX-1 at
col.5 lines 38-64.
139. No additional multifunctional siloxanyl alkyl esters are added to this mixture for
the Boston II process. JTX-17 at BL 24, 31.12
140. Multifunctional siloxanyl alkyl esters nevertheless are often present in the mixture
used to create the Boston II lens. This is because, as noted supra at FF. 127-128, TX-91 consists
of up to 15% Tris dimer or trimer, each of which is an example of the multifunctional siloxanyl
alkyl ester called for in step (f) of claim 1. JTX-17 at BL 31; Jan. 28 PM Tr. at 23:8-16,
24:19-23, 98:18–99:3 (Long).
141. Neefe himself disclosed embodiments using Tris dimer or trimer as the cross-
linking agent. Examples II and IV in the Neefe Patent specification employ a dimer of Tris. Jan.
28 PM Tr. at 17:24-18:2, 19:1-5 (Long); see also JTX-1 at col.3 lines 30-40, 62. Example VI of
the Neefe Patent employs a trimer of Tris. JTX-1 at col.4 lines 36-37.
142. Because TX-91 makes up 41.7% of the Boston II lens by weight (JTX-17 at BL
24; Jan. 28 PM Tr. at 56:10-11 (Long)), the Boston II lens can be comprised up to 6.2% by
12
Other compounds were present in the Boston II lens as well, including dimethyl
itaconate. See JTX-17 at 24, 31.
35
weight of Tris dimer and trimer (i.e., 41.7% (percentage of TX-91 in the lens) multiplied by 15%
(maximum percentage of Tris dimer and trimer in TX-91)). See Director’s PFF. 149; Dome
Resp. PFF. 149.
143. PTC sought to minimize the presence of dimers and trimers in at least one of its
formulations of Tris. JTX-19 at BL 68, 70. There is no evidence, however, that the amount of
Tris dimer or trimer was minimized below .01% by weight. In fact, PTC calculated that the
Boston II lens contained approximately 1.3 mole percent of Tris dimer and trimer. JTX-21 at
8557, 8577.13
144. If Tris dimer and trimer are present in TX-91, then they will be cross-linked in the
copolymer. Jan. 28 PM Tr. at 97:18–98:6 (Long).
145. As noted supra at FF. 76, step (f) of claim 1 of the Neefe Patent requires that at
least .01% of the hydrophobic cross-linking agent – such as Tris dimer or Tris trimer – be
copolymerized with the Tris, the ester of acrylic or methacrylic acid, and the surface wetting
agent. JTX-1 at col.5 lines 55-64.
146. The maximum amount of Tris dimer and trimer permitted in the Boston II lens –
6.2% – falls well within the “0.01% to 90%” range of siloxanyl alkyl ester cross-linking agent
required in Step (f) of claim 1 of the Neefe Patent. See JTX-1 at col.5 lines 55-64.
147. The minimum amount of Tris dimer and Tris permitted in the Boston II lens – 0%
– falls narrowly outside of the “0.01% to 90%” range of siloxanyl alkyl ester cross-linking agent
required in Step (f) of claim 1 of the Neefe Patent. See id.
148. As noted supra at FF. 48, the oxygen permeability of the Boston II lenses
consistently was reported to be approximately 12 to 14 Dk. Jan. 29 AM Tr. at 25:22-25, 54:4-9
13
The parties have neither defined mole percent nor have they testified as to how to
convert mole percent to percent by weight for this copolymer.
36
(Melamed); Jan. 30 AM Tr. at 69:25-70:2, 75:21-25 (Benjamin); JTX-4 at 66 (12-14 Dk);
JTX-12 at 238 (12.6 Dk); JTX-21 at BL8556 (14.6 Dk); JTX-27 at 273 (12 Dk); PTX-2 at
BL4760 (14.6 Dk); but see JTX-20 at BL8328 (16.4 Dk).
d. The Boston IV Lens
149. Like the Boston II lens, the first compound employed in the Boston IV
copolymerization process is TX-91. Jan. 28 PM Tr. at 56:4-7 (Long); JTX-17 at BL31.
150. Sufficient amounts of TX-91 are used so that the Tris monomer comprises 38.3%
to 41.0% by weight of the copolymer. JTX-17 at BL31; Jan. 28 PM Tr. at 56:14-15 (Long).
151. This percentage of Tris monomer falls within the range specified in step (f) of
claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 56:18–57:1 (Long).
152. As in the Boston II process, the second comonomer employed in the
copolymerization set forth in the Boston IV process is an ester of acrylic or methacrylic acid.
Jan. 28 PM Tr. at 57:2-8 (Long).
153. An ester of acrylic or methacrylic acid comprises 19.7% by weight of the
copolymer used for the Boston IV process. JTX-17 at BL24, BL31.
154. This amount of ester of acrylic or methacrylic acid falls within the range specified
in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 57:2-12 (Long).
155. As in the Boston II process, the third class of comonomers employed in the
copolymerization set forth in the Boston IV process are the surface wetting agents tetraethylene
glycol dimethacrylate and N-Nvinylpyrrolidone. Jan. 28 PM Tr. at 58:1-3 (Long).
156. Together, these surface wetting agents comprise 8.1% by weight of the
copolymer. JTX-17 at BL24, BL31 (CL is 2.9% by weight; NVP is 5.5% by weight).
37
157. This percentage of surface wetting agents falls within the range specified for this
reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:1-5 (Long).
158. Unlike in the Boston II process, in the Boston IV process TX-91 is modified to
become TX-82. TX-82 is prepared by adding substantial quantities of Tris dimer and Tris trimer
to the TX-91 formulation produced through steps (a) through (e), so as to increase the percentage
of Tris dimer to between 19.5 and 21 percent and Tris trimer to between 3 and 9.5 percent. Jan.
28 PM Tr. at 24:5-18, 58:20–59:1 (Long); JTX-17 at BL24, BL31; JTX-21 at BL8599-8603.
159. As noted supra at FF. 128, Tris dimer and trimer are each an “oxygen permeable
crosslinking agent selected from the class of multifunctional siloxanyl alkyl esters” as specified
in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:6-24 (Long).
160. These percentages of Tris dimer and trimer fall within the range specified for this
reactant in step (f) of claim 1 of the Neefe Patent. Jan. 28 PM Tr. at 58:15-59:1, 59:25–60:7
(Long); JTX-1 at col.5 lines 38-64.
161. The reported oxygen permeability of the Boston IV lens was 19 to 28 Dk,
depending on the measurement technique used. Jan. 29 AM Tr. at 26:1-2, 56:1-4 (Melamed);
Jan. 30 AM Tr. at 37:24, 66:12-13 (Benjamin); JTX-4 at 66; JTX-21 at BL8556, BL8578;
JTX-22 at BL8739; JTX-23; JTX-27 at 273; PTX-2 at BL4760, BL4776; PTX-3 at BL5507.14
e. Boston II versus Boston IV
162. The only substantial difference between the Boston II and the Boston IV
manufacturing processes was that the Boston IV process involved the purposeful addition of Tris
dimer and trimer. One internal Bausch & Lomb document stated that the final concentration of
14
As with the Boston II lens, other compounds were present in the Boston IV lens,
including dimethyl itaconate. See JTX-17 at 24, 31.
38
Tris dimer and trimer in the Boston IV lens was 3.9 mole percent, three times that of the Boston
II lens (1.3 mole percent). JTX-21 at BL8557, BL8577.
163. There was at least a 50% increase in the oxygen permeability of the Boston IV
polymer over the Boston II polymer without impairment of wettability. Jan. 29 AM Tr. at
26:1-4, 62:11-13 (Melamed); JTX-4 at 66; PTX-3 at BL5513.
164. When calculating how much oxygen passes through an actual lens, one considers
its oxygen transmissibility, which takes into account the material’s thickness. Jan. 29 AM Tr. at
63:21-22 (Melamed); Jan. 30 AM Tr. at 23:18-19 (Benjamin); JTX-4 at 62.
165. Oxygen transmissibility is expressed as Dk/L, where Dk is the oxygen
permeability and L is the thickness of the given polymer. Jan. 29 AM Tr. at 65:11-14
(Melamed); JTX-4 at 62.
166. The Dk/L of a contact lens must be approximately 18 to 20 to prevent damage to
the cornea over the course of a prolonged wearing day. JTX-26 at 11.3 (“To produce virtually
no change in corneal thickness under daily wear conditions, a lens must provide an equivalent
oxygen percentage (EOP) of no less than 10%. Theoretically, this requires a Dk/L of
approximately 18-20.”). Jan. 29 AM Tr. at 91:13-21 (Melamed).
167. The oxygen transmissibility of the Boston IV lens is approximately 18.7 Dk/L,
and thus the lens is suitable for prolonged daily wear. JTX-4 at 206; Jan. 29 AM Tr. at 65:15-17,
76:7-20 (Melamed); JTX-26 at 11.3-11.4. By contrast, the oxygen transmissibility of the Boston
II lens is approximately 8.0 to 9.3 Dk/L, and thus the Boston II is not suitable for prolonged daily
wear. PTX-2 at BL4760; JTX-4 at 66, 206; Jan. 29 AM Tr. at 75:22-76:3 (Melamed); see also
Dome’s PFF. 291-96; Director’s Resp. PFF. at 14.
39
168. The Boston IV lens was an improvement over the Boston II lens because of
increased oxygen permeability and oxygen transmissibility. Jan. 29 AM Tr. at 27:8-13
(Melamed).
169. The Boston IV lens largely displaced sales of the Boston II lens. Jan. 29 AM Tr.
at 45:7-16 (Melamed); PTX-3 at BL5513; JTX-31 at BL8309.
170. By 1988, the Boston IV lens commanded 65% of Bausch & Lomb’s total material
sales distribution, while the Boston II lens accounted for 10% of sales. JTX-31 at BL8309.
171. The Boston IV lens is still widely available today. Jan. 29 AM Tr. at 46:12-13
(Melamed); JTX-4 at 17.
172. Other factors in addition to increased oxygen permeability likely contributed to
the Boston IV lens’ commercial success: (i) patients could easily get a replacement lens for the
Boston IV lens because they were “consistent and readily reproducible” (Jan. 29 AM Tr. at
68:11-24 (Melamed)); (ii) patients were attracted to the Boston IV lens because it was durable
and lasted a long time (id. at 68:25 – 69:10 (Melamed)); (iii) the long-term costs of purchasing
the Boston IV lens were low for the consumer, so economics was an additional attractive feature
of the lens (id. at 71:3-12 (Melamed)); and (iv) Bausch & Lomb heavily promoted the Boston IV
lens, but not other lenses with higher oxygen permeability (e.g., the Boston Equalens lens) (id. at
80:8-23 (Melamed)).
f. Other Embodiments of Claim One of the Neefe Patent
173. The ranges identified in step (f) of the Neefe Patent are very broad. For example,
as noted supra at FF. 104, claim 1 of the Neefe patent permits as little as 0.01% of the
hydrophobic cross-linking agent, along with 5% of Tris, which is hydrophobic, so it permits as
much as 94.99% of hydrophilic comonomers. JTX-1 at col.5 lines 55-64.
40
174. Dome did not introduce any expert evidence showing that a contact lens made
from ingredients in the amounts at the ends of those ranges would be sufficiently oxygen
permeable or wettable.
175. For example, Dome’s expert, Dr. Long, did not know whether a contact lens
material that is 5% by weight Tris monomer, 90% by weight MMA, 4.99% by weight surface
wetting agent, and 0.01% by weight a multifunctional siloxanyl alkyl ester would be sufficiently
oxygen permeable, even though such a lens material would fall within the scope of claim 1 of the
Neefe Patent. Jan. 28 PM Tr. at 86:7-23 (Long).
176. Nor did Dr. Long know whether a lens material that is 90% by weight Tris
monomer, 3% by weight MMA, 0.5% by weight surface wetting agent, and 6.5% by weight Tris
dimer as a cross-linker would be wettable, even though such a lens material would fall within the
scope of claim 1 of the Neefe patent. Jan. 28 PM Tr. at 85:20–86:6 (Long).
177. Based on the evidence introduced at trial regarding the Boston II lens, a person of
ordinary skill in the art would expect that a contact lens material comprised 35.5% to 41.7% by
weight of Tris monomer, 21.8% by weight of ester of acrylic or methacrylic acid, 9.9% by
weight of surface wetting agents tetraethyleneglycol dimethacrylate and N-Nvinylpyrrolidone,
and between .01% and 6.2% by weight of Tris dimer and trimer, and manufactured in accordance
with claim 1, would be wettable and would have an oxygen permeability of approximately 12 to
14 Dk. See FF. 131, 134, 137, 140, 142, 144, 148.
178. As noted supra at FF. 68, the initial material created by Neefe using the process
of claim 1 had a Dk value of 14. The parties did not introduce any evidence at trial about how
much of each ingredient (Tris monomer, MMA, surface wetting agent, and multifunctional
siloxanyl alkyl ester) was used in the manufacturing process of that material.
41
179. As noted supra at FF. 79, the TransAire polymer, which was based on claim 1 of
the Neefe patent, had a Dk value of 45. The parties did not introduce any evidence at trial about
how much of each ingredient (Tris monomer, MMA, surface wetting agent, and multifunctional
siloxanyl alkyl ester) was used in the TransAire manufacturing process.
III. CONCLUSIONS OF LAW
A. Legal Standards
1. Burden of Proof
Once the PTO has determined that “a substantial new question of patentability” is
raised by a request for reexamination, the PTO initiates a reexamination proceeding. In re
Swanson, 540 F.3d 1368, 1375 (Fed. Cir. 2008) (quoting 35 U.S.C. § 303(a)). In a
reexamination proceeding, as in the initial examination of a patent application, the patent
examiner bears the initial burden of showing by a preponderance of the evidence that the
invention is unpatentable as obvious. See Rambus Inc. v. Rea, 731 F.3d 1248, 1255 (Fed. Cir.
2013) (“In reexamination proceedings, ‘a preponderance of the evidence must show
nonpatentability before the PTO may reject the claims of a patent application.’”) (internal
quotation omitted); In re Etter, 756 F.2d 852, 856 (Fed. Cir. 1985) (en banc). Once a prima facie
showing of obviousness is made, however, the burden shifts to the patent holder to demonstrate
nonobviousness. In re Giannelli, 739 F.3d 1375, 1379 (Fed. Cir. 2014); In re Glaug, 283 F.3d
1335, 1338 (Fed. Cir. 2002).
Dome objects to the application of this legal standard here, arguing that claim 1 of
the Neefe Patent may be cancelled only if the Director proves obviousness under a clear and
convincing evidence standard. In support of its position, Dome points to the standard of proof in
patent infringement proceedings initiated under 35 U.S.C. § 282. See Dome’s Prop. Concl. Law
42
11 (citing Microsoft Corp. v. i4i Limited Partnership, 131 S. Ct. 2238 (2011)). In Section 282
proceedings, a party accused of infringement may claim, as an affirmative defense, that the
relevant patent is invalid due to obviousness. To prevail on this defense, the accused infringer
must show obviousness by clear and convincing evidence. Section 282 is a fundamentally
different context than the present one, and the burdens of proof governing those proceedings are
inapplicable here. See In re Swanson, 540 F.3d at 1377 (noting that PTO examination and
reexamination proceedings “have distinctly different standards, parties, purposes, and outcomes”
than Section 282 infringement proceedings); In re Etter, 756 F.2d at 855-59; cf. Sciele Pharma
Inc. v. Lupin Ltd., 684 F.3d 1253, 1260 (Fed. Cir. 2012) (noting that the clear and convincing
standard applicable in Section 282 proceedings is rooted in a “necessary deference to the PTO”)
(internal quotation omitted).
The Court therefore considers whether the Director has shown by a
preponderance of the evidence that claim 1 of the Neefe Patent is prima facie obvious, and, if so,
whether Dome has rebutted this initial showing.
2. Standard of Review
A party subject to an adverse reexamination decision by the Board may seek
review of that decision in this Court under 35 U.S.C. § 145, or it may appeal the decision directly
to the Federal Circuit pursuant to 35 U.S.C. § 141.15 Unlike a Section 141 appeal, a Section 145
15
35 U.S.C. § 141 was amended on November 29, 1999, to provide the Federal
Circuit with exclusive jurisdiction of any challenge to the Board’s final decision in a
reexamination proceeding. 35 U.S.C. § 141; see generally Teles AG v. Kappos, 846 F. Supp. 2d
102, 111 (D.D.C. 2012). 35 U.S.C. § 145 was amended on September 16, 2011, changing the
venue for Section 145 actions from this Court to the United States District Court for the Eastern
District of Virginia. See Kappos v. Hyatt, 132 S. Ct. 1690, 1694 n.1 (2012). Neither amendment
43
proceeding in district court is a “unique ‘hybrid of an appeal and a trial de novo.’” Alberts v.
Kappos, 917 F. Supp. 2d 94, 104 (D.D.C. 2013), aff’d sub nom., Alberts v. Lee, 552 F. App’x
986 (Fed. Cir. 2014). In a Section 145 action, the parties may present new evidence that was not
presented to the PTO, and in so doing, are restricted only by the Federal Rules of Evidence and
the Federal Rules of Civil Procedure. Kappos v. Hyatt, 132 S. Ct. 1690, 1694 (2012). Where
new evidence is presented on a disputed question of fact, “[t]he district court must assess the
credibility of new witnesses and other evidence, determine how the new evidence comports with
the existing administrative record, and decide what weight the new evidence deserves.” Id. at
1700. The Court then “must make de novo factual findings that take account of both the new
evidence and the administrative record before the PTO.” Id. at 1701. Where no new evidence is
presented at all or with respect to certain facts found by the Board, the Court “must [instead]
apply the APA’s substantial evidence standard to Patent Office fact findings.” Hyatt v. Kappos,
625 F.3d 1320, 1336 (Fed. Cir. 2010) (en banc), aff’d, 132 S. Ct. 1690 (2012). Because new
evidence was presented on every significant, contested factual issue in this case, the Court’s
factual findings are largely de novo. Questions of law also are reviewed de novo. Cytologic,
Inc. v. Biopheresis GmbH, 682 F. Supp. 2d 1, 12 (D.D.C. 2010).
B. Analysis
1. The Director Has Made a Prima Facie Showing of Obviousness
“Whether a claim would have been obvious under 35 U.S.C. § 103(a) is a legal
conclusion based on underlying factual determinations.” Rambus Inc. v. Rea, 731 F.3d at
1251-52 (citing In re Kotzab, 217 F.3d 1365, 1369 (Fed. Cir. 2000)). These factual
is retroactive or applicable here, as the request for reexamination in this case was filed on August
27, 1998.
44
determinations “include (1) the scope and content of the prior art; (2) the differences between the
claims and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence of
nonobviousness.” Id. at 1251 (citing Graham v. John Deere Co. of Kansas City, 383 U.S. 1,
17-18 (1966)). The inquiry into obviousness “entails ‘an expansive and flexible approach.’”
Sciele Pharma Inc. v. Lupin Ltd., 684 F.3d at 1259 (quoting KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 415 (2007)). If any embodiment within the scope of the claim is determined to be
obvious, then the entire claim is unpatentable for obviousness, regardless of whether other
embodiments are nonobvious. See ArcelorMittal France v. AK Steel Corp., 700 F.3d 1314, 1325
(Fed. Cir. 2012) (“‘[C]laims which are broad enough to read on obvious subject matter are
unpatentable even though they also read on nonobvious subject matter.’”) (quoting Muniauction,
Inc. v. Thomson Corp., 532 F.3d 1318, 1328 n.4 (Fed. Cir. 2008)).
It is undisputed that each of the compounds recited in claim 1 of the Neefe Patent
– the Tris monomer, the ester of acrylic or methacrylic acid, the surface wetting agent, and the
siloxanyl alkyl ester cross-linking agent – was known in the prior art. This fact alone, however,
does not establish obviousness. KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 418-19 (“[A] patent
composed of several elements is not proved obvious merely by demonstrating that each of its
elements was, independently, known in the prior art.”); see also Stryker Spine v. Biedermann
Motech GmbH, 750 F. Supp. 2d 107, 122 (D.D.C. 2010). Where all of the elements of a claim
are known in the prior art, as is the case here, the obviousness inquiry generally will turn on two
factual questions:
(1) whether the prior art would have suggested to those of ordinary
skill in the art that they should make the claimed composition or
device, or carry out the claimed process; and
(2) whether the prior art would also have revealed that in so
making or carrying out, those of ordinary skill would have a
reasonable expectation of success.
45
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1164 (Fed. Cir. 2006) (quoting Velander v.
Garner, 348 F.3d 1359, 1363 (Fed. Cir. 2003)); see also In re Rosuvastatin Calcium Patent Litig.,
703 F.3d 511, 518 (Fed. Cir. 2012) (“[I]n cases involving new chemical compounds, it remains
necessary to identify some reason that would have led a chemist to modify a known compound in
a particular manner to establish prima facie obviousness of a new claimed compound.”) (internal
quotation marks omitted). A court “need not seek out precise teachings directed to the specific
subject matter of the challenged claim,” KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 418, as the
analysis “can take account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id.
In this case, the Director has demonstrated both the reason for combining the
compounds recited in claim 1 of the Neefe Patent and a reasonable expectation of success. A
person of ordinary skill in the art would have known that the ideal contact lens would have a
relatively high level of oxygen permeability, and would be motivated to combine comonomers
and cross-linkers to create an oxygen permeable polymer. See FF. 8-11, 81. This artisan also
would have known that the siloxanyl alkyl ester cross-linkers discussed by Tanaka promoted
oxygen permeability, as these cross-linkers contained a siloxane bond. FF. 61-62. And the
artisan would have known that the siloxanyl alkyl ester cross-linkers could effectively cross-link
the comonomers used by Gaylord and Ellis. FF. 80-88. It therefore would have been obvious to
a person of ordinary skill in the art that these materials, when combined with traditional
hydrophilic comonomers and wetting agents, could potentially be used to create an oxygen
permeable contact lens. FF. 89. The Director has established a prima facie case of obviousness,
and the burden shifts to Dome to prove nonobviousness.
46
2. The Prior Art Does Not Teach Away from Combining the Elements in Claim 1 of the
Neefe Patent
A patentee may rebut a prima facie showing of obviousness by demonstrating that
the prior art “teaches away” from the claimed invention in any material respect. In re Peterson,
315 F.3d 1325, 1331 (Fed. Cir. 2003); see KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 416
(“[W]hen the prior art teaches away from combining certain known elements, discovery of a
successful means of combining them is more likely to be nonobvious.”). Dome has taken this
tack, arguing that while it may have been apparent that both Tris monomer and siloxanyl alkyl
ester cross-linker promote oxygen permeability, the prior art “taught away” from attempting this
combination.
“A reference may be said to teach away when a person of ordinary skill, upon
reading the reference, would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the applicant.” In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (collecting cases). The degree to which a reference
teaches away will depend on the particular facts, but the basic question is whether the reference
“suggests that the line of development flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.” Id. “What a reference teaches and whether a
person of ordinary skill in the art would have been motivated to combine the teachings of
separate references are questions of fact.” Pregis Corp. v. Kappos, 700 F.3d 1348, 1353 (Fed.
Cir. 2012). When considering apparently conflicting references in the prior art, the fact-finder
must weigh each reference “for its power to suggest solutions to an artisan of ordinary skill . . .
consider[ing] the degree to which one reference might accurately discredit another.” Medichem,
S.A. v. Rolabo, S.L., 437 F.3d at 1165 (quoting In re Young, 927 F.2d 588, 591 (Fed. Cir.
1991)).
47
As discussed above, see FF. 90-109, the prior references of Tanaka did not teach
away from combining Tris with a siloxanyl alkyl ester cross-linking agent, at least for daily wear
and prolonged daily wear lenses. Granted, Tanaka warned that in constructing a lens that “can
be comfortably worn continuously for a long period of time,” it was difficult, when using the
Tris monomer, to achieve high levels of oxygen permeability, clarity, and wettability, and that a
highly hydrophobic solution could not always be made wettable by simply adding high levels of
hydrophilic monomer – there were limits. FF. 91-94. But other references in the prior art taught
that Tris could be used effectively in the manufacturing of contact lenses, so long as hydrophilic
comonomers were used to offset the water-repellant properties of Tris. See, e.g., FF. 42, 97-104
(discussing Gaylord’s patent, which taught that Tris could be synthesized with hydrophilic
monomers like MMA and surface wetting agents without making the copolymer opaque);
FF. 47- 48 (discussing Ellis’s patent, which combined Tris and hydrophilic comonomers).16
Indeed, Tanaka himself recognized that the hydrophobic properties of Tris could be successfully
repressed – within limits – by the addition of hydrophilic compounds. To the extent that Tanaka
teaches away from using Tris altogether, the Court finds that such teaching can be fairly read as
confined to continuous wear lenses, see FF. 94, not to daily wear or prolonged daily wear lenses,
and that the teaching is outweighed by the teachings of Gaylord and Ellis.
16
Dome correctly points out that the Board twice suggested, erroneously, that a
multifunctional siloxanyl alkyl ester would be hydrophilic. See JTX-16 at 5:20-23 (describing
hydrophilic formula [V] as a multifunctional siloxanyl alkyl ester); id. at 16:6-8 (describing
hydrophobic “polyfunctional siloxanyl ester cross-linking agents” as hydrophilic). Dome argues
that this factual error infected the Board’s analysis. After reviewing the evidence presented to
the Board de novo, along with the evidence presented at trial, the Court is convinced that the
Board’s errors do not affect the correctness of the Board’s result.
48
The Court therefore concludes that Dome has not rebutted the prima facie case of
obviousness by demonstrating that the prior art taught away from the method recited in claim 1.17
As the Board found, a person of ordinary skill in the art would have had a reasonable expectation
of success in combining the comonomers suggested by Gaylord and Ellis with the cross-linking
agents suggested by Tanaka.
3. Dome’s Evidence of Secondary Considerations Does Not Indicate Nonobviousness.
Dome also attempts to rebut the Director’s prima facie case using evidence of
secondary considerations, and in particular, evidence of commercial success. Secondary
considerations, “[s]uch as commercial success, long felt but unsolved needs, failure of others,
etc.,” often can “give light to the circumstances surrounding the origin of the subject matter
sought to be patented.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 406 (quoting Graham v. John
Deere Co. of Kansas City, 383 U.S. at 17-18). Evidence that a patented invention attained
significant commercial success may provide an independent basis for inferring that the invention
was not obvious, “because the law presumes an idea would successfully have been brought to
market sooner, in response to market forces, had the idea been obvious to persons skilled in the
art.” Merck & Co., Inc. v. Teva Pharm. USA, Inc., 395 F.3d 1364, 1376 (Fed. Cir. 2005); see
also 3 MOY’S WALKER ON PATENTS § 9:62 (4th ed. 2013). Commercial success of an invention
over the prior art also implies that the difference between an invention and the prior art is
significant or substantial. 3 MOY’S WALKER ON PATENTS § 9:62. Although secondary
considerations must be taken into account, they do not necessarily control the obviousness
17
This question alternatively can be viewed as part of the inquiry into whether a
person of ordinary skill attempting the patented combination would have had a reasonable
expectation of success. Assuming arguendo that it is the Director’s burden of showing that
success would be reasonably expected despite the hydrophobicity of both the Tris monomer and
the siloxanyl alkyl ester cross-linking agent, the Court concludes that such burden has been
satisfied.
49
conclusion. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) (citing Newell
Cos., Inc. v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988)); see Wyers v. Master Lock
Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010) (“[S]econdary considerations of nonobviousness . . .
simply cannot overcome a strong prima facie case of obviousness.”).18
Dome asserts that an embodiment of claim 1 achieved unexpected results that led
to substantial commercial success. Dome also argues, with less force, that this embodiment
satisfied a long felt but unsolved need. See, e.g., Dome’s PFF. 351-402; Dome’s Prop. Concl.
Law at 36-40, 52; Dome Resp. Prop. Concl. Law 159, 194-95, 199, 229-30. The Director
contends that the evidence presented by Dome is irrelevant and unpersuasive.
a. Unexpected Results Leading to Commercial Success
Dome focuses on the commercial success of the Boston IV lens, which, according
to Dome, was manufactured using the process recited in claim 1 of the Neefe Patent. It is
undisputed that the Boston IV lens achieved significant commercial success over prior Bausch &
Lomb RGP lenses. See FF.169-71. But this success is only relevant to the obviousness inquiry
if Dome can establish the following: first, that the Boston IV lens embodies claim 1 of the Neefe
Patent – that is, that the lens is made in accordance with claim 1 of the Neefe Patent, see Brown
& Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000);
second, that the success of the Boston IV lens was the result of the novel feature claimed in the
Neefe Patent, and not the result of some feature in the prior art, or some unrelated feature such as
increased marketing, see Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d 1358, 1369 (Fed. Cir.
18
Secondary considerations are often referred to as objective evidence of
nonobviousness. See Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1391
(Fed. Cir. 1988) (“The rationale for giving weight to the so-called “secondary considerations” is
that they provide objective evidence of how the patented device is viewed in the marketplace, by
those directly interested in the product.”).
50
2011); and third, that other embodiments of claim 1 could be expected to exhibit the same
commercially beneficial properties exhibited by the Boston IV lens, see MeadWestVaco Corp. v.
Rexam Beauty & Closures, Inc., 731 F.3d 1258, 1264-65 (Fed. Cir. 2013).
As discussed below, the Court agrees with Dome that there is a product – the
Boston IV lens – that embodies claim 1 of the Neefe Patent and that achieved some commercial
success. But the Court also finds that Dome has failed to present persuasive evidence that the
success of the Boston IV lens is the result of the novel feature claimed in the Neefe Patent, or
that other embodiments of claim 1 could be expected to exhibit the same commercially beneficial
properties as those possessed by the Boston IV lens. The Court discusses each of these points in
turn.19
i. The Boston IV lens Falls Within the Scope of Claim 1
Although neither Neefe nor Dome created the Boston IV lens, the success of this
product nevertheless may shed light on the obviousness (or nonobviousness) of Neefe’s
invention, so long as Dome shows that the Boston IV lens “embodies the claimed features” of
the patented invention – i.e., that it is made in accordance with claim 1 of the Neefe Patent.
Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d at 1130.
As noted supra at FF. 149-159, the Boston IV lens is manufactured using the
following materials: 38.3% to 41.0% by weight of Tris; 19.7% of an ester of acrylic or
methacrylic acid; 8.1% of surface wetting agents (tetraethylene glycol dimethacrylate and
N-Nvinylpyrrolidone); and 19.5 to 21% and 3 to 9.5%, respectively, of Tris dimer and Tris
19
The Director moved to exclude testimony relating to the differences between the
Boston II and the Boston IV lens as irrelevant, based on a purported lack of nexus and
commensurateness. See Director’s Mot. in Limine to Exclude the Testimony of Dr. Melamed
and Portions of the Testimony of Dr. Long Pursuant to Rule 401 of the Federal Rules of
Evidence, Dkt. No. 66 (filed under seal, Dkt. No. 69) (Oct. 23, 2012). The Court declined to rule
on the motion at trial, but now will deny it.
51
trimer. These ranges fall within the ranges recited in claim 1 of the Neefe Patent, which calls for
from 5% to 90% by weight of Tris; from 3% to 90% of an ester of acrylic or methacrylic acid;
from .5% to 90% of a surface wetting agents; and from .01% to 90% of a siloxanyl alkyl ester
cross-linker, such as Tris dimer or trimer. See FF. 76. But as the Director points out, there are
two ways in which the synthesis of these compounds in the Boston IV lens process appears to
deviate from the process recited in claim 1.
First, as discussed in FF. 123-125, the manufacture of the Boston IV lens requires
that two steps – the vacuuming and the filtration of unwanted byproducts – occur in a different
order than the order recited in claim 1 of the Neefe Patent. Generally speaking, however, a claim
is not restricted to the performance of its steps in the order recited where sequence is not a clear
limitation in the claim, and where neither logic nor any aspect of the specification or prosecution
history requires a limiting construction. See Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
1370-71 (Fed. Cir. 2003); cf. Loral Fairchild Corp. v. Sony Corp., 181 F.3d 1313, 1322 (Fed.
Cir. 1999) (“Although not every process claim is limited to the performance of its steps in the
order written, the language of the claim, the specification and the prosecution history support a
limiting construction in this case.”). Although the ordering of the steps and the use of the word
“then” suggests an order, neither logic nor anything in the specification or prosecution history
suggests that the order of these steps would matter. See FF. 126. The Court therefore finds that
the vacuuming and filtering elements recited in claim 1 are literally present in the Boston IV
lens, and that the sequence of these steps is not a separate limitation of the claim. The variation
in sequence does not take the Boston IV lens outside the scope of claim 1.
Second, claim 1 of the Neefe Patent requires at step (b) that the mixture of
methacryl-oxypropyltrimethoxysilane and trimethylchlorosilane is added to water whose volume
52
is from 3 to 10 times that of the mixture. See JTX-1 at col.5 lines 38-64. By contrast, the
Boston IV manufacturing process calls for the addition of one-third volume of water to this
mixture of methacryloxypropyltrimethoxysilane and trimethylchlorosilane, followed by an
external ice/water bath. See FF. 119. Both parties agree that this step of the Boston IV process
is different from step (b) of claim 1; the water addition element of claim 1 thus is not literally
met by the Boston IV process. See Dome PFF. 308-11; Director’s Resp. PFF. 308-11. The
parties also agree that the addition of one-third volume of water in the Boston IV step, followed
by an ice/water bath, is substantially equivalent to claim 1’s step (b). See Dome PFF. 308-11;
Director’s Resp. PFF. 308-11. The Director asserts that this technical departure from the claim 1
process establishes that the Boston IV lens falls outside the scope of claim 1. Dome disagrees,
maintaining that the Boston IV lens falls within the scope of claim 1 under the doctrine of
equivalents, and therefore can inform the obviousness inquiry.
The doctrine of equivalents arose in the context of infringement disputes, and it
“grow[s] out of a legally implied term in each patent claim that ‘the claim extends to the thing
patented, however its form or proportions may be varied.’” Warner-Jenkinson Co., Inc. v. Hilton
Davis Chemical Co., 520 U.S. 17, 35 (1997); see also Festo Corp. v. Shoketsu Kinzoku Kogyo
Kabushiki Co., 535 U.S. 722, 733 (2002) (“The doctrine of equivalents allows the patentee to
claim those insubstantial alterations that were not captured in drafting the original patent claim
but which could be created through trivial changes.”). To evaluate whether a product or process
infringes under the doctrine of equivalents, the court asks “whether an asserted equivalent
represents an ‘insubstantial difference’ from the claimed element, or ‘whether the substitute
element matches the function, way, and result of the claimed element.’” Deere & Co. v. Bush
53
Hog, LLC, 703 F.3d 1349, 1356 (Fed. Cir. 2012) (quoting Warner-Jenkinson Co. v. Hilton Davis
Chemical, 520 U.S. at 40)).
Although neither party has pointed to any case directly addressing this question,
the Court is persuaded that the commercial success of a product that infringes a patent claim
under the doctrine of equivalents can inform whether the patent claim is obvious. To begin with,
the Director’s contention that a process that infringes by equivalence is outside the scope of a
claim is inconsistent with the established principle that “[t]he scope of a patent is not limited to
its literal terms but instead embraces all equivalents to the claims described.” Festo Corp. v.
Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. at 732. In this vein, courts have considered
the commercial success of a competitor’s infringing product or process as a secondary
consideration, without distinguishing between literal infringement or infringement by
equivalence. See, e.g., Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d at
1130. Moreover, fact-finders in patent cases are instructed to take an “expansive and flexible
approach” when considering obviousness. KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 415.
Where the differences between the process used to create a successful product and the process
claimed in the patent are insignificant, and where all evidence indicates that a product
manufactured in strict accordance with the claim language would be identical to the successful,
equivalent product, the commercial success of the equivalent product can shed light on the
patent’s obviousness. The Court therefore finds that the Boston IV lens falls within the scope of
claim 1 for purposes of the obviousness inquiry.
ii. Nexus Between Commercial Success and Claim 1
In order to rely on the commercial success of the Boston IV lens as evidence of
nonobviousness, Dome must show a legally and factually sufficient connection – a “nexus” –
54
between the merits of claim 1 of the Neefe Patent and the evidence of the Boston IV lens’
commercial success. Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d at 1369; Wyers v. Master
Lock Co., 616 F.3d at 1246; Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387,
1392 (Fed. Cir. 1988). “A prima facie case of nexus is generally made out when the patentee
shows both that there is commercial success, and that the thing (product or method) that is
commercially successful is the invention disclosed and claimed in the patent.” Demaco Corp. v.
F. Von Langsdorff Licensing Ltd., 851 F.2d at 1392; see also Ormco Corp. v. Align Tech., Inc.,
463 F.3d 1299, 1312 (Fed. Cir. 2006) (“[W]hen a patentee can demonstrate commercial success,
usually shown by significant sales in a relevant market, and that the successful product is the
invention disclosed and claimed in the patent, it is presumed that the commercial success is due
to the patented invention.”) (internal quotation omitted); but see In re Huang, 100 F.3d 135, 140
(Fed. Cir. 1996) (requiring additional proof that increased sales “were a direct result of the
unique characteristics of the claimed invention”). Where the evidence shows that the
commercial success derived from some aspect of the prior art, or was the result of “economic
and commercial factors unrelated to the quality of the patented subject matter,” evidence of
commercial success will not be sufficient to demonstrate nonobviousness of a claimed invention.
In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008); see also Tokai Corp. v. Easton Enterprises,
Inc., 632 F.3d at 1369-70.
As discussed in the preceding subsection, the Boston IV lens falls within the
scope of claim 1 of the Neefe patent. And as noted, the parties do not dispute that the Boston IV
lens achieved significant commercial success over prior Bausch & Lomb rigid contact lens
products. See FF. 169-171. Dome therefore is entitled to a presumption that this commercial
success relates to claim 1 of the Boston IV lens. Demaco Corp. v. F. Von Langsdorff Licensing
55
Ltd., 851 F.2d at 1392. But several factors undercut the persuasiveness of the evidence offered
at trial.
First, the evidence of commercial success in the market is not particularly strong.
Although Dome introduced evidence that the Boston IV lens achieved significant commercial
success over prior Bausch & Lomb products, there is little evidence in the record of this
product’s success as compared to competitors’ products. Rather, other RGP lenses with
comparable or improved oxygen permeability levels came on the market at or near the same
time, and there is no evidence that the Neefe process was used in developing these lenses. See
JTX-4 at 206; JTX-26 at 11.3-11.4; JTX-27 at 23. Dome puts forth a narrative that could be
compelling – artisans struggling in vain to create an extended wear lens, a problem finally solved
by Neefe, to great commercial advantage – but provides no market data to support this narrative.
Second, on the issue of nexus, Dome has done little more than show that the
Boston IV lens falls within the scope of claim 1 and achieved some commercial success. To
bolster its nexus argument, Dome introduced the testimony of Dr. Mark Melamed, who
explained why oxygen permeability would be a desirable property, and the Court has no doubt
that increased oxygen permeability was one of the reasons for the Boston IV’s popularity. See
FF. 8-13, 81, 168. But Dr. Melamed’s suggestion that oxygen permeability drove Boston IV’s
success is not reliable expert testimony, as such statements are outside the scope of his medical
expertise. Moreover, Dr. Melamed himself indicated that at least some of the commercial
success of the Boston IV lens is due to factors other than the lens’ oxygen permeability – factors
such as the lenses’ durability, the ease of replacing them, and low long-term costs, as well as
heavy marketing by Bausch & Lomb. See FF. 172.
56
Dome also attempted to show a nexus by contrasting the successful Boston IV
lens, which falls within claim 1, with the less successful Boston II lens, which, according to
Dome, does not. For the reasons described below – reasons that intersect with the
commensurateness requirement – this evidence is not persuasive.
iii. Commensurateness with the Scope of Claim 1
For evidence of secondary considerations such as commercial success to be
persuasive, the evidence “must be commensurate in scope with the claims which the evidence is
offered to support.” MeadWestVaco Corp. v. Rexam Beauty & Closures, Inc., 731 F.3d at
1264-65 (internal quotation omitted). Evidence of secondary considerations “is not
commensurate with the claims if the claims are broader than the scope” of such evidence. Joy
Technologies, Inc. v. Manbeck, 751 F. Supp. 225, 229 (D.D.C. 1990) aff’d, 959 F.2d 226 (Fed.
Cir. 1992). “The claims are broader in scope than the objective evidence if a limitation or
element recited in the claim is broader than the limitation or element in the objective evidence
. . . or if the objective evidence contains limitations or elements not recited in the claims.” Id. at
229-30 (citations omitted).
At least two rationales underlie the commensurateness requirement. First, a claim
can be patented only if it is nonobvious throughout the range of the patent claim. Evidence of
nonobviousness of one embodiment in a broad claim is of limited value, as it leaves open the
question of whether other embodiments were obvious. See, e.g., Therasense, Inc. v. Becton,
Dickinson & Co., 593 F.3d 1325, 1336 (Fed. Cir. 2010) (rejecting evidence that claimed
invention solved a longstanding problem, where claims were broad enough to cover both devices
that solved the problem and devices that did not); In re Clemens, 622 F.2d 1029, 1036 (C.C.P.A.
1980) (finding narrow range of data could not “be reasonably extended to prove the
57
unobviousness of a broader claimed range”); In re Tiffin, 448 F.2d 791, 792 (C.C.P.A. 1971)
(“the objective evidence of non-obviousness is not commensurate with the scope of claims 1-3
and 10-16, reciting ‘containers’ generally, but establishes non-obviousness only with respect to
‘cups’ and processes of making them”). Second, evidence that commercially desirable properties
are not commensurate with the patent claim suggests that the commercial success of one
particular embodiment results from something different (or more specific) than the claim. In
other words, if one embodiment of Neefe claim 1 has desirable properties, but another one does
not, claim 1 does not necessarily cause those desirable properties. Viewed this way, the
commensurateness requirement bears on the nexus inquiry, and has occasionally been described
as such. See Regent Lighting Corp. v. FL Indus., Inc., 60 F.3d 840, 1995 WL 331122, at *5
(Fed. Cir. 1995) (unpublished table disposition); Joy Technologies, Inc. v. Manbeck, 751 F.
Supp. at 229.
As a general matter, the requirement that evidence of secondary considerations be
reasonably commensurate with the scope of the claim “does not mean that an applicant is
required to test every embodiment within the scope of his or her claims.” In re Kao, 639 F.3d
1057, 1068 (Fed. Cir. 2011); In re DBC, 545 F.3d at 1384 (“[A] patentee need not show that all
possible embodiments within the claims were successfully commercialized in order to rely on the
success in the marketplace of the embodiment that was commercialized.”) (internal quotation
omitted). The Federal Circuit has recognized that it is “unlikely that a company would sell a
product containing multiple, redundant embodiments of a patented invention.” In re Glatt Air
Techniques, Inc., 630 F.3d 1026, 1030 (Fed. Cir. 2011). Thus, “[i]f an applicant demonstrates
that an embodiment has an unexpected result and provides an adequate basis to support the
conclusion that other embodiments falling within the claim will behave in the same manner, this
58
will generally establish that the evidence [of secondary considerations such as unexpected results
and commercial success] is commensurate with scope of the claims.” In re Kao, 639 F.3d at
1068 (emphasis added). Where it appears that commercially desirable properties appear only in
a subset of a patent’s embodiments, however, a court may not extend evidence of commercial
success to the entire patent range. See In re Peterson, 315 F.3d at 1331 (affirming finding of
obviousness where patent applicant claimed alloy with 1% to 3% rhenium and presented
unexpected results only for alloy with 2% rhenium, where evidence suggested that alloy with 3%
rhenium possessed inferior properties). Dome’s evidence of commercial success falls into the
latter category, as there are several reasons to doubt that other embodiments of claim 1 will
behave in the same manner – i.e., achieve the same commercially desirable levels of oxygen
permeability – as the Boston IV lens.
First, it is undisputed that the material first manufactured by Neefe in accordance
with his patent had a Dk value of 14. This level is only marginally better than the oxygen
permeability levels obtained by the Polycon II lens based on Gaylord’s patent, and is in the range
obtained by the Boston II lens based on Ellis’s patent. See FF. 40 (noting the 10 to 12 Dk for
Polycon II lenses); FF. 148 (12-14 Dk for Boston II lenses). Dome agrees that this oxygen
permeability level would be insufficient for prolonged daily wear and would not drive
commercial success. See Dome Prop. Concl. Law 400 (discussing how the Boston II lens, with a
Dk value of 12 to 14, accounted for only 10% of Bausch & Lomb’s total material sales
distribution).
Second, as noted supra at FF. 177, the evidence indicates that a contact lens
material comprised of 35.5% to 41.7% by weight Tris monomer, 21.8% by weight ester of
acrylic or methacrylic acid, 9.9% by weight surface wetting agents tetraethyleneglycol
59
dimethacrylate and N-Nvinylpyrrolidone, and between .01% and 6.2% by weight Tris dimer and
trimer – all amounts falling within the range specified in claim 1 of the Neefe Patent – and
manufactured in accordance with that claim would have an oxygen permeability around 12 to 14
Dk. See FF. 131, 134, 137, 140, 142, 144, 148. This expectation would be reasonable because
the Boston II lens, which has this composition, see FF. 131, 134, 137, 140, 142, has an oxygen
permeability of 12 to 14 Dk, see FF. 148. Dome notes that the Boston II lens differs from the
claim 1 process in that a Tris-based cross-linker is not deliberately added to the Boston II
material – rather, it is a byproduct created during the process of making the Tris monomer, and it
simply remains in the mixture. But the evidence indicates that this distinction is not a
meaningful one in terms of the end result. As Dr. Long explained, Tris dimer and trimer will
serve as cross-linking agents regardless of when they are created or added. FF. 144.20
Third, Dome provides minimal evidence that other successful products could be
manufactured with Neefe’s ingredients at other amounts within the ranges disclosed by Neefe,
despite the fact that the disclosed ranges are very broad. See FF. 76 (calling for (1) “from 5% to
90% by weight” of Tris, (2) from “3% to 90% by weight of an ester of acrylic or methacrylic
acid;” (3) “from 0.5% to 90% by weight of a surface wetting agent;” and (4) “from 0.01% to
90% by weight of an oxygen permeable crosslinking agent selected from the class of
multifunctional siloxanyl alkyl esters”). Other than the Boston IV lens, Dome presented
evidence of only one other highly oxygen permeable lens manufactured under claim 1 – the
20
The Director argues that the Boston II lens therefore falls within the scope of
claim 1 of the patent, arguing that step (f) should be construed as being satisfied so long as Tris
dimer and trimer were present in the TX-91 formula. Although the Court finds that the inclusion
of some amount of Tris dimer and trimer through the TX-91 formula, rather than the purposeful
addition of the same amount later, is unlikely to affect the end result, the Court is hesitant to
provide a definitive construction of step (f) or its equivalence without further expert evidence or
briefing. And it is unnecessary to do so to resolve the issue of obviousness in this case.
60
TransAire lens invented in 1984, with a Dk value of 45 – and did not introduce evidence on how
that lens was manufactured. See FF. 79. Dome’s expert, Dr. Long, could not provide an opinion
on whether polymers containing comonomers in amounts at the outer ends of the ranges
identified by Neefe would have high oxygen permeability. FF. 173.
Although the Boston IV lens had increased oxygen permeability and achieved
commercial success, there is not “an adequate basis to support the conclusion that other
embodiments falling within [claim 1 of the Neefe Patent] will behave in the same manner.” In re
Kao, 639 F.3d at 1068. That is, there is no basis for inferring that other embodiments throughout
the range of claim 1 will demonstrate high levels of oxygen permeability or achieve commercial
success. Dome has thus failed to present evidence of commercial success that is commensurate
with the broad scope of claim 1 of the Neefe Patent.
b. Satisfaction of Long-Felt Need and Failure of Others
Although Dome focuses mainly on evidence of commercial success, Dome also
argues that the Court should consider evidence of a long-felt, unsatisfied need for a contact lens
suitable for prolonged daily wear, which Dome asserts was ultimately obtained through the claim
1 process, in the form of the Boston IV lens. Dome’s PFF. 279-302; Dome’s Prop. Concl. Law
52. Specifically, Dome points to the inventions of Novicky and Ellis as evidence that other
scientists struggled to create an oxygen permeable contact lens that could be worn comfortably
throughout the day. Novicky’s polymer had an oxygen permeability of 5 to 8 Dk, Ellis’s
61
polymer had an oxygen permeability of 12 to 14 Dk, and both were unsuitable for prolonged
daily wear.21
Dome’s arguments are undermined by the same commensurateness defect that
limits its evidence of commercial success. Although the record indicates that the Boston IV lens
satisfied the need for a lens suitable for a prolonged wearing day, the record is also clear that
other embodiments of claim 1 would fail to satisfy the long-felt need identified by Dome.22
c. Dome’s Evidence of Secondary Considerations Is Not Sufficient To Overcome the Prima
Facie Case of Obviousness.
Even where evidence of commercial success and other secondary considerations
is clear and commensurate with a patent claim, it may be insufficient to outweigh a strong prima
facie case of obviousness. See Tokai Corp. v. Easton Enterprises, Inc., 632 F.3d at 1370 (“Even
if [the patentee] could establish the required nexus, a highly successful product alone would not
overcome the strong showing of obviousness.”) (internal quotation omitted); Wyers v. Master
Lock Co., 616 F.3d at 1246 (collecting cases). Given that the evidence of secondary
considerations in this case is neither compelling nor commensurate with the patent claim, the
Court concludes that Dome has not rebutted the Director’s strong prima facie showing of
obviousness.
21
Dome also presented limited evidence relating to the process developed by
Donald J. Ratkowski and Ping-Chang Lue, which led to a patent issued on December 6, 1983.
See JTX-10; Jan. 28 AM Tr. at 77:19–79:22 (Long).
22
The Court also notes that while the need for a highly oxygen permeable contact
lens was indisputably long-felt, only a relatively short amount of time passed between the
relevant teachings in the prior art and the introduction of the process recited in claim 1: Neefe
applied for his patent less than two years after Tanaka submitted his application.
62
IV. CONCLUSION
For the foregoing reasons, the Court finds that the differences between the process
recited in claim 1 of the Neefe Patent and the prior art “are such that the claimed invention as a
whole would have been obvious” before September 8, 1980 (the filing date of the Neefe Patent
application) “to a person having ordinary skill in the art” of the polymer chemistry of contact
lens material. 35 U.S.C. § 103. Accordingly, the decision of the Board of Patent Appeals and
Interferences will be upheld. An appropriate Order will issue this same day.
/s/
PAUL L. FRIEDMAN
United States District Judge
DATE: July 1, 2014
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APPENDIX – TRIAL EXHIBITS
A. Joint Trial Exhibits 1-34
1. U.S. Patent No. 4,306,042 to Neefe, issued December 15, 1981.
2. Curriculum Vitae of Timothy E. Long, Ph.D.
3. POLYMER CHEMISTRY: AN INTRODUCTION (Malcolm P. Stevens, ed., 3d ed. 1999)
(Excerpts - title pages and pp. 3-1 0).
4. CONTACT LENSES (Anthony J. Phillips and Lynne Speedwell, eds., 5th ed. 2007)
(Excerpts - title pages and pp. 17-18, 60-64, 66-67, 206).
5. FITTING GUIDE FOR RIGID AND SOFT CONTACT LENSES: A PRACTICAL APPROACH
(Harold L. Stein, et al., eds., 4th ed. 2002) (Excerpts - title pages and pp. 167-68, 272).
6. U.S. Patent No. 3,377,371 to Quaal, issued April 9, 1968.
7. U.S. Patent No. 3,808,178 to Gaylord, issued April 30, 1974.
8. U.S. Patent No. 4,120,570 to Gaylord, issued October 17, 1978.
9. U.S. Patent No. 4,152,508 to Ellis et al., issued May 1, 1979.
10. U.S. Patent No. 4,419,505 to Ratkowski et al., issued December 6, 1983.
11. U.S. Patent No. 4,216,303 to Novicky et al., issued August 5, 1980.
12. FITTING GUIDE FOR RIGID AND SOFT CONTACT LENSES: A PRACTICAL APPROACH
(Harold L. Stein, et al., eds., 2d ed. 1984) (Excerpts - title pages and p. 238).
13. U.S. Patent No. 4,235,985 to Tanaka et al., issued November 25, 1980.
14. U.S. Patent No. 4,153,641 to Deichert, issued May 8, 1979.
15. U.S. Patent No. 4,189,546 to Deichert, issued February 19, 1980.
16. Decision of the Board of Patent Appeals and Interferences in Ex parte Neefe, dated July
31, 2007.
17. “Boston Product Information.” (Excerpt - BL24, BL31 ).
18. “Manufacturing of TX-91 Monomer.” (BL 1-23).
19. “Synthesis of Methacrylate/Siloxane Monomer,” dated November 17, 1978. (BL67-73).
20. Polymer Technology Corporation, PMA 820065 - Boston Lens II, Volumes 7, 9 and 11.
(Excerpts - BL8325-29, BL8344-48, and BL8478-8512).
21. Polymer Technology Corporation, Special Supplement to PMA 820065 - Boston Lens
II. (Excerpts - BL8553-57, BL8576-82, and BL8599-8603).
22. Polymer Technology Corporation, Premarket Approval Application for the Boston
Equalens. (Excerpts - BL8732-BL8742).
23. “Introducing the Boston Lens IV.” (BL4303).
24. Curriculum Vitae of Mark A Melamed, M.D.
25. 3 CUNNINGHAM’S MANUAL OF PRACTICAL ANATOMY (14th ed. 1979). (Excerpt - title
pages and p. 152).
26. CONTACT LENS FITTING, A CLINICAL TEXT ATLAS. (Frank J. Weinstock, ed., 1989).
(Excerpt - title pages and pp. 11.1-11.16).
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27. FITTING GUIDE FOR RIGID AND SOFT CONTACT LENSES: A PRACTICAL APPROACH
(Harold L. Stein, et al., eds., 4th ed. 2002) (Excerpt - title pages and pp. 167-68, 271-
79).
28. CONTACT LENSES: A GUIDE TO SELECTION, FITTING AND MANAGEMENT OF
COMPLICATIONS (Susan Stenson, ed., 1987). (Excerpt - title pages and p. 48).
29. CONTACT LENSES: A TEXTBOOK FOR PRACTITIONER AND STUDENT (Anthony J. Phillips
and Janet Stone, 3d ed., 1989). (Excerpt - title pages and p. 761).
30. Letter dated October 17, 1984 from Harold A. Stein, M.D. to Patrick J. Caroline of
Polymer Technology Corp.
31. Annual Report for the period of November 1987 to June 1988, Volume II. (Excerpt -
BL8282, BL8309).
32. Curriculum Vitae of William J. Benjamin, O.D., Ph.D.
33. Prosecution history of U.S. Patent No. 4,306,042 including references of record therein
34. Reexamination history of U.S. Patent 4,306,042 (Control No. 90/005,090)
B. Plaintiff’s Trial Exhibits 1-6
1. U. S. Patent No. 2,793,223, issued May 21, 1957.
2. Excerpt of Boston Product Guide (BL4760, BL4776) (1999)
3. Excerpt of Polymer Technology Consultants Reference Manual, Boston Lenses
Physical Properties (BL5507, BL5513) (1992)
4. Demonstrative Exhibit - Notebook tabs 1, 2,3, 9, 10, 11, 12, 13, 16, 18, 19
5. Demonstrative Exhibit - Flip Chart by Dr. Long
6. Demonstrative Exhibit Board
C. Defendant’s Trial Exhibits 1-2
1. William J. Benjamin & Quido A. Cappelli, Oxygen Permeability (Dk) of Thirty-Seven
Rigid Contact Lens Materials, 79 OPTOMETRY AND VISION SCIENCE 103 (2002).
2. Excerpts from Dr. Long’s deposition testimony (pp. 1-2, 94-122).
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