Tobinick v. Olmarker , 753 F.3d 1220 ( 2014 )

United States Court of Appeals
for the Federal Circuit
______________________
EDWARD TOBINICK,
Appellant,
v.
KJELL OLMARKER AND BJORN RYDEVIK,
Appellees.
______________________
2013-1499
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in Interference No.
105,866.
______________________
Decided: May 19, 2014
______________________
ROBERT HAHL, Neifeld IP Law, PC, of Alexandria,
Virginia, argued for appellant. With him on the brief was
RICHARD A. NEIFELD.
TODD R. WALTERS, Buchanan, Ingersoll & Rooney PC,
of Alexandria, Virginia, argued for appellees. With him
on the brief was ERIN M. DUNSTON.
______________________
Before LOURIE, REYNA, and WALLACH, Circuit Judges.
2 TOBINICK v. OLMARKER
REYNA, Circuit Judge.
This appeal arises out of an interference proceeding
before the Patent Trial and Appeal Board (“Board”) at the
United States Patent and Trademark Office (“PTO”)
relating to drug treatments for spinal nerve injuries. The
Board construed “administered locally” as administering
the claimed therapeutic compound “directly to the site
where it is intended to act, that is, to the location where
the nucleus pulposus is causing the symptoms of the
nerve disorder.” Based on this construction, the Board
found that Edward Tobinick’s (“Tobinick”) patent applica-
tion did not contain written description support for the
interference count. Without written description support
for the count, Tobinick lacked standing to bring the
interference, and the Board dismissed. See 37 C.F.R. §
41.201(2)(ii).
On appeal, the parties dispute the meaning of “admin-
istered locally” and whether Tobinick’s patent application
contains written description support for this claim limita-
tion. We agree with the Board’s claim construction but
reverse its written description decision and subsequent
dismissal. We find that Tobinick’s application contains
sufficient written description support for local administra-
tion because it describes administering the relevant
therapeutic compound to the epidural space adjacent to a
herniated spinal disc, which is the site where the com-
pound “is intended to act” and “the location where the
nucleus pulposus is causing the symptoms of the nerve
disorder.” We therefore reverse.
BACKGROUND
The technology at issue relates to drugs for treatment
of spinal nerve injuries, such as those associated with
herniated discs. Between spinal vertebrae are soft discs,
referred to as “spinal discs,” that permit the spine to flex
and move by absorbing and distributing compressive
forces. A spinal disc becomes herniated when tissue
TOBINICK v. OLMARKER 3
surrounding it tears. As a result, nucleus pulposus, a
substance normally inside the disc, leaks out into the
epidural space of the spine. Nucleus pulposus secretes a
molecule called tumor necrosis factor-α (“TNF-α”), a
powerful signaler of inflammation and other injuries. The
nerve roots that extend from the spinal cord to various
parts of the body pass through the epidural space. When
TNF-α comes into contact with nerve roots, it injures the
nerves and may cause back pain or numbness. The nerve
root injuries may be reduced or eliminated by “inhibiting”
the activity of TNF-α. The patents and application at
issue here disclose methods of inhibiting TNF-α via the
local administration of a monoclonal antibody (the TNF-α
inhibitor) to the site of an affected nerve.
Kjell Olmarker and Bjorn Rydevik (collectively “Ol-
marker”) are the named inventors on the following related
patents, each of which claims priority from an application
filed on September 25, 1998:
U.S. Patent Involved Claims Issue Date
No.
7,708,995 12, 13 May 4, 2010
13, 22, 31, 40, 45,
7,811,990 Oct. 12, 2010
48, 49, 51
7,906,481 2, 20, 22, 32 A.K. Marsh. 15, 2011
8,057,792 10, 11, 23, 24 Nov. 15, 2011
6,649,589 8, 18, 27, 34 Nov. 18, 2003
On December 15, 2011, Tobinick requested an inter-
ference 1 by copying claims from the ’995 and ’990 patents
1 The activities at issue occurred before the enact-
ment of the Leahy–Smith America Invents Act (“AIA”),
Pub.L. No. 112–29, § 3, 125 Stat 284, 285–93 (2011),
which eliminated interference proceedings. Therefore, the
earlier version of the patent statute, 35 U.S.C. § 102(g)(2)
4 TOBINICK v. OLMARKER
in Tobinick’s patent application 12/714,205 (“’205 applica-
tion”). These claims covered methods of treating spinal
nerve injuries by locally or epidurally administering a
TNF-α inhibitor. The following claims represent the
interference counts:
Claim 68: A method of treating or alleviating one
or more symptoms of a nerve disorder mediated by
nucleus pulposus in a mammal in need of such
treatment comprising the step of administering a
therapeutically effective amount of a TNF-α inhib-
itor to the mammal, wherein said TNF-α inhibitor
is an antibody that blocks TNF-α activity, wherein
the antibody is administered locally.
’205 application ¶ 36 (emphasis added).
Claim 69: The method of claim 68, wherein the
antibody is administered epidurally to the mam-
mal.
’205 application ¶ 37 (emphasis added).
Before the Board, Tobinick filed five motions, and Ol-
marker filed eleven motions. As relevant here, Olmarker
moved the Board to dismiss for lack of standing on the
basis that Tobinick’s ’205 application did not contain
written description support for the claim terms “adminis-
tered locally” and “administered epidurally.” According to
Olmarker, the ’205 application failed to describe local
administration of a TNF-α inhibitor and instead only
(2006), governs the activities in this case. See AIA §
3(n)(1), 125 Stat. at 293 (providing that certain AIA
amendments apply to, inter alia, applications, and pa-
tents issued thereon, that have ever contained a claim to
an invention having an effective filing date of March 16,
2013, or later).
TOBINICK v. OLMARKER 5
described systemic administration. The Board held an
oral argument on December 4, 2012.
The Board first construed the term “administered lo-
cally.” Tobinick argued that the term should encompass
all localized forms of drug administration, whereas Ol-
marker argued that the term should require administra-
tion “directly to” the site of injury, and exclude any form
of administration that involves travel or diffusion of the
inhibitor. Based on the ’995 patent specification, expert
testimony, and medical dictionary definitions, the Board
adopted Olmarker’s construction, namely administering a
TNF-α inhibitor “directly to the site where [the TNF-α
inhibitor] is intended to act, that is, to the location where
the nucleus pulposus is causing the symptoms of the
nerve disorder.”
Based upon its construction, the Board then found
that the ’205 application lacked adequate written descrip-
tion support for the construed term because it did not
sufficiently delineate between local and non-local admin-
istration. The Board noted that the ’205 application
described “local” as including administration of medica-
tion near the site of injury followed by diffusion or travel
of the medication to the site of injury. Because this
technique of administration would not fit within the
Board’s construction, the Board concluded that the ’205
application lacked written description support for “admin-
istered locally.” Accordingly, the Board granted Olmark-
er’s motion to dismiss and did not consider the other
pending motions. Tobinick appealed and we have juris-
diction under 35 U.S.C. § 1295 (2006).
On appeal, Tobinick argues that the Board’s claim
construction is improperly narrow and, in the alternative,
that the ’205 application provides adequate written de-
scription support for the interference count. We agree
with the Board’s claim construction but reverse its writ-
ten description decision.
6 TOBINICK v. OLMARKER
CLAIM CONSTRUCTION
We review claim construction de novo. Lighting Bal-
last Control LLC v. Philips Elecs. N. Am., 744 F.3d 1272,
1276-77 (Fed. Cir. 2014) (en banc); Phillips v. AWH Corp.,
415 F.3d 1303, 1312-15 (Fed. Cir. 2005) (en banc). In
interference proceedings, a disputed claim is construed in
the context of its originating disclosure rather than the
interfering application. Robertson v. Timmermans, 603
F.3d 1309, 1312 (Fed. Cir. 2010) (“When a party challeng-
es written description support for an interference count or
the copied claim in an interference, the originating disclo-
sure provides the meaning of the pertinent claim lan-
guage.”) (internal citations omitted). Here, the claim
limitation “wherein the antibody is administered locally”
is construed in light of the ’995 and ’990 patent specifica-
tions, not the ’205 application.
The Board first considered the intrinsic evidence. The
’995 patent 2 discloses “a method for treating nerve disor-
ders . . . by administering . . . a TNF inhibitor.” Col. 1 ll.
21-24. The goal of the method is to treat back pain caused
by TNF-α’s irritation of nerve endings. See id. at col. 2 ll.
1-3; col. 18 ll. 4-7. The ’995 patent contrasts local and
systemic administration. Regarding local administration,
the patent provides an example in which the inhibitor is
applied directly to the nucleus pulposus. Id. at col. 20 ll.
16-29 (“[T]he nucleus pulposus was mixed with . . . the
anti-TNF-alpha antibody.”); see also col. 17 ll. 42-47
(describing experiments in which a “blocking monoclonal
antibody to the TNF-alpha is applied locally in the nucle-
us pulposus”) (emphasis added). Apart from this direct
application, the patent does not discuss or disclose any
2 While both the ’995 and ’990 patents are relevant
to the construction of “administered locally,” we only
discuss the ’995 patent here because both specifications
are essentially the same.
TOBINICK v. OLMARKER 7
other method of local administration. Regarding systemic
administration, the patent discloses the use of a pill taken
orally, whereby the TNF-α inhibitor was “not adminis-
tered locally in the autotransplanted nucleus pulposus,
but instead was administered systemically.” Id. at col. 27
ll. 18-20.
Both parties presented expert testimony to the Board,
including similar medical dictionary definitions of “local.”
Olmarker’s witness, Dr. Andersson, relied on dictionary
evidence to contrast the definition of “local,” as “restricted
to or pertaining to one spot; not general,” Dorland’s Illus-
trated Medical Dictionary 552 (23d ed. 1957), with that of
“general,” as “affecting many parts or all parts of the
organism, not local,” id. at 772. Based on these defini-
tions, Dr. Andersson defined “local administration” as
administration “directly to the site where the medicine is
intended to act,” whereas he defined “systemic admin-
istration” as administration in which “medicine is broadly
distributed before reaching the site of action, such as
being carried . . . by the vascular system.” Dr. Andersson
opined that the ’995 patent described the local admin-
istration of a TNF-α inhibitor to the affected nerve roots
in a manner consistent with these definitions. Specifical-
ly, according to Dr. Andersson, the ’995 patent is con-
sistent with the definitions because it describes local
administration as entailing direct contact of the inhibitor
with the nucleus pulposus, and systemic administration
as entailing administering a pill.
Tobinick’s expert witness, Dr. Richardson, also relied
on dictionary evidence, which defined “local” in essentially
the same way as Dr. Andersson. See Stedman’s Medical
Dictionary for the Health Professions and Nursing 982
(7th ed. 2012). Dr. Richardson also discussed more re-
mote administration techniques. For example, Dr. Rich-
ardson testified that a steroid can be injected up to about
ten centimeters away from the site of the nerve injury and
still remain effective. Dr. Richardson also explained a
8 TOBINICK v. OLMARKER
type of administration called “transpinal administration,”
in which medication is delivered to a venous system,
remote from the nerve injury, known as the Batson’s
plexus.
Based on this evidence, the Board construed “admin-
istered locally” as administered “directly to the site where
it is intended to act, that is, to the location where the
nucleus pulposus is causing the symptoms of the nerve
disorder.” The Board also found that this limitation did
not include “systemic administration away from the site
where the TNF-α is intended to act.”
We agree with the Board. The Board’s conclusion that
the disputed claims cover the administration of TNF-α
inhibitor “directly to” the site of the nerve injury is sup-
ported by the specification and the medical definitions of
“local” presented by both sides. Contrary to Tobinick’s
argument, the Board’s construction does not exclude
administration “adjacent to disc herniation.” Because
leakage of nucleus pulposus from a herniated disc affects
the nerve roots of adjacent discs, a site of nerve injury
“adjacent to disc herniation” may well be where the
inhibitor “is intended to act.” Thus, administration
“adjacent to disc herniation” may fall within the court’s
construction, depending upon the precise location of the
injury. Accordingly, we affirm the Board’s claim construc-
tion.
WRITTEN DESCRIPTION
The parties dispute whether the ’205 application pro-
vides written description support for the term “adminis-
tered locally.” Tobinick argues that the description of
epidural administration in the application supports the
term. Olmarker responds that the ’205 application lacks
written description support because the specification
includes non-local forms of administration within its
description of local administration. We agree with Tobin-
ick and find that the ’205 application contains sufficient
TOBINICK v. OLMARKER 9
written description support because it describes adminis-
tering an inhibitor to the epidural space adjacent to a
herniated disc, which is the location where nucleus pulpo-
sus causes nerve injury.
35 U.S.C. § 112 (2006) provides:
The specification shall contain a written descrip-
tion of the invention, and of the manner and pro-
cess of making and using it, in such full, clear,
concise, and exact terms as to enable any person
skilled in the art to which it pertains, or with
which it is most nearly connected, to make and
use the same, and shall set forth the best mode
contemplated by the inventor of carrying out his
invention.
The purpose of the written description requirement is to
require an inventor to disclose his invention to the public
in such a manner as to allow “a person of skill in the art
to recognize that the patentee invented what is claimed.”
Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332,
1341 (Fed. Cir. 2013) (citing Ariad Pharms., Inc. v. Eli
Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc)). The written description determination depends on
“the nature and scope of the claims and on the complexity
and predictability of the relevant technology.” Id. (citing
Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir.
2005)). Accordingly, we must determine whether the
disclosure of the ’205 application “reasonably conveys to
those skilled in the art” that Tobinick “had possession” of
the claimed local administration. Id. (internal citations
omitted).
“Written description is a question of fact, judged from
the perspective of one of ordinary skill in the art as of the
relevant filing date.” Falko-Gunter Falkner v. Inglis, 448
F.3d 1357, 1363 (Fed. Cir. 2006) (citing Vas-Cath, Inc. v.
Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991)). We
review the Board’s written description finding for sub-
10 TOBINICK v. OLMARKER
stantial evidence and set aside actions that are arbitrary,
capricious, an abuse of discretion, or otherwise not in
accordance with the law. Id. (citing 5 U.S.C. § 706).
The ’205 application discloses “methods for treating
neurological . . . disorders in humans by administering a
[TNF-α inhibitor].” ’205 application ¶ 31. The specifica-
tion distinguishes between local and systemic delivery of
TNF-α inhibitor and lists several unique benefits of local
administration. For instance, the ’205 application ex-
plains that the “[l]ocal perispinal administration [] has
the advantage of providing a depot of therapeutic medica-
tion in the surrounding tissue, which will provide thera-
peutic levels of medication to the treatment site for a
prolonged period of time.” Id. ¶ 34. The application also
states that local delivery of TNF-α inhibitor “produces . . .
greater efficacy[,] more rapid onset, [and] longer duration
of action.” Id. ¶ 114.
The disclosure lists perispinal administration as a
preferred form of localized administration of a TNF-α
inhibitor. Id. ¶ 49. The specification defines perispinal
administration as including a number of different admin-
istration techniques. One such technique is an epidural
injection adjacent to the site of disc herniation. Id. ¶ 47
(“In another preferred embodiment injection of the thera-
peutic molecule to the anatomic area adjacent to the disc
herniation is accomplished by epidural injection.”).
A person of ordinary skill in the art would understand
this type of epidural injection to be an injection into the
location where the TNF-α is injuring spinal nerves. As
explained above, nucleus pulposus leaks from an injured
spinal disc into the epidural space, where spinal nerve
roots are located. The ’995 specification recognizes that
TNF-α in the epidural space harms adjacent nerve roots.
See ’995 patent at col. 22 ll. 37-44. Thus, an epidural
injection adjacent to the site of disc herniation will admin-
ister the drug “directly to the site where it is intended to
TOBINICK v. OLMARKER 11
act, that is, to the location where the nucleus pulposus is
causing the symptoms of the nerve disorder.”
Olmarker contends that the ’205 application does not
adequately describe local administration because it mixes
local administration techniques with non-local tech-
niques. According to Olmarker, the ’205 application
teaches that “anatomic proximity” can include an area as
far as ten centimeters from the spine. Because that area
is “a very large portion of the body,” Olmarker argues that
this teaching refers to systemic, rather than local, admin-
istration. By defining the anatomic proximity so broadly,
Olmarker argues, the ’205 application redefines non-local
methods of administration as local methods of admin-
istration. Olmarker supports this argument with expert
testimony by Dr. Andersson that administering the medi-
cine to the anatomic area adjacent to the disc herniation
is not local administration because it is not administered
directly to the nerve root.
We are not persuaded by Olmarker’s argument. The
specification plainly describes localized, epidural injection
of a TNF-α inhibitor. See ’205 application ¶ 47 (“In an-
other preferred embodiment injection of the therapeutic
molecule to the anatomic area adjacent to the disc herni-
ation is accomplished by epidural injection.”). Because
the epidural space is precisely the area in which the nerve
root extends from the spinal cord, the TNF-α administra-
tion described in the ’205 application is made “directly to
the site where it is intended to act, that is, to the location
where the nucleus pulposus is causing the symptoms of
the nerve disorder.” While the “perispinal” administra-
tion discussed in the ’205 application certainly covers
more than just local administration techniques, this does
not render all perispinal techniques non-local. Some
techniques may be local, others may not. The ’205 appli-
cation need only reasonably convey to one skilled in the
art that Tobinick had possession of at least one embodi-
ment that meets the Board’s construction of local admin-
12 TOBINICK v. OLMARKER
istration. The epidural injection technique is such an
embodiment.
For the above reasons, we conclude that the Board’s
finding of lack of adequate written description is not
supported by substantial evidence. Accordingly, we
reverse the Board’s decision to dismiss the interference
and remand for further proceedings.
REVERSED