C.R. Bard, Inc. v. Angiodynamics, Incorporated ( 2018 )

NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
C.R. BARD, INC., BARD PERIPHERAL VASCULAR,
INC.,
Appellants
v.
ANGIODYNAMICS, INCORPORATED,
Cross-Appellant
______________________
2017-1851, 2017-1865, 2017-1906, 2017-1931, 2017-1943
______________________
Appeals from the United States Patent and Trade-
mark Office, Patent Trial and Appeal Board in Nos.
95/002,089, 95/002,090, 95/002,092.
______________________
Decided: September 28, 2018
______________________
VINCENT JOSEPH BELUSKO, Morrison & Foerster LLP,
Los Angeles, CA, argued for appellants. Also represented
by NICOLE MARIE SMITH; SETH W. LLOYD, BRIAN ROBERT
MATSUI, Washington, DC.
DANIELLE VINCENTI TULLY, Cadwalader, Wickersham
& Taft LLP, New York, NY, argued for cross-appellant.
Also represented by CHRISTOPHER A. HUGHES, JOHN
THOMAS MOEHRINGER, MICHAEL BRIAN POWELL, MICHAEL
2 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
J. SEBBA.
ALFRED W. ZAHER, Buchanan Ingersoll & Rooney PC,
Philadelphia, PA, for amicus curiae Medical Components,
Inc. Also represented by RALPH GEORGE FISCHER, Pitts-
burgh, PA.
______________________
Before O’MALLEY, TARANTO, and STOLL, Circuit Judges.
O’MALLEY, Circuit Judge.
These consolidated appeals involve three of C.R. Bard,
Inc.’s and Bard Peripheral Vascular, Inc.’s (collectively,
“Bard’s”) medical device patents. In several inter partes
reexamination proceedings requested by AngioDynamics,
Inc., the Patent Trial and Appeal Board invalidated
thirty-four of the patents’ forty-one claims as anticipated
and/or obvious over the prior art. 1 Both parties appealed
various aspects of the Board’s rulings.
With respect to the Board’s decision that a particular
prior art reference qualifies as a “printed publication”
1 See AngioDynamics, Inc. v C.R. Bard, Inc., Appeal
2015-001533, 2016 WL 923521 (P.T.A.B. Mar. 10, 2016)
(“’302 Decision”); AngioDynamics, Inc. v C.R. Bard, Inc.,
Appeal 2015-001533, 2017 WL 542597 (P.T.A.B. Jan. 31,
2017) (“’302 Rehearing Decision”); AngioDynamics, Inc. v
C.R. Bard, Inc., Appeal 2015-004554, 2016 WL 1239176
(P.T.A.B. Mar. 28, 2016) (”’022 Decision”); AngioDynam-
ics, Inc. v C.R. Bard, Inc., Appeal 2015-004554, 2017 WL
766740 (P.T.A.B. Feb. 17, 2017) (“’022 Rehearing Deci-
sion”); AngioDynamics, Inc. v C.R. Bard, Inc., Appeal
2015-004506, 2016 WL 1166545 (P.T.A.B. Mar. 24, 2016)
(“’615 Decision”), AngioDynamics, Inc. v C.R. Bard, Inc.,
Appeal 2015-004506 (P.T.A.B. February 21, 2017) (J.A.
146) (“’615 Rehearing Decision”).
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 3
under 35 U.S.C. § 102(b), we vacate and remand for the
Board to clarify its findings. We also conclude that some
of the Board’s anticipation and obviousness rulings are
predicated on an erroneous claim construction. As to
these rulings, we reverse the Board’s anticipation findings
and remand certain of its obviousness findings for further
consideration under the proper construction and in light
of any further findings on the printed publication ques-
tion. We affirm in all other respects.
I. BACKGROUND
C.R. Bard, Inc.’s and Bard Peripheral Vascular, Inc.’s
U.S. Patent Nos. 7,785,302 (“’302 patent”), 7,947,022
(“’022 patent”), and 7,959,615 (“’615 patent”), all titled
“Access Port Identification Systems and Methods,” are
related by way of a provisional application filed in March
2005, and have similar specifications. 2 The patents
describe medical devices, called access ports, implanted
beneath a patient’s skin to enable direct access to a cen-
tral vein for delivery of medicine or other fluids. ’302
patent, col. 1, ll. 13–19. These ports typically include a
bio-compatible housing, a septum, and a cavity. Once the
port is implanted, a doctor punctures the patient’s skin
and the septum with a needle to deliver fluid into the
cavity. The fluid is then transmitted from the cavity into
a catheter, which is sutured to one of the patient’s central
veins. For patients requiring frequent and long-term
intravenous therapy, these devices allow medical profes-
sionals to easily and repeatedly access a major vein
without having to go through tissue or muscle each time.
2 The ’615 patent and ’022 patent are a continua-
tion and continuation-in-part of the ’302 patent, respec-
tively. For simplicity, we cite only to the specification of
the ’302 patent unless otherwise specified.
4 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
The patents explain that prior art “access ports of dif-
ferent manufacturers or models . . . typically exhibit[ed]
substantially similar geometries.” Id. col. 1, ll. 46–49.
Because of these similarities, doctors were unable to
identify and distinguish specific types of ports after they
were implanted. This prevented doctors from distinguish-
ing so-called “power injectable ports” from ordinary ones.
Power injectable ports are designed to be “injected and
pressurized by mechanical assistance” at high flow rates.
Id. col. 3, ll. 43–47. By contrast, regular access ports are
not manufactured to withstand high-pressure injections.
Power injecting a non-power injectable port can cause the
port to fracture while in the patient’s body, leading to
serious bodily injury or even death.
The patents generally describe access ports having “at
least one identifiable characteristic that may be sensed or
otherwise determined subsequent to subcutaneous im-
plantation.” Id. col. 1, ll. 55–58. In some embodiments,
the “identifiable characteristic” is a message that “may be
perceived via x-ray or ultrasound imaging.” Id. col. 4, ll.
15–24. In other embodiments, medical professionals can
use the port’s geometry to identify whether the port is
power injectable by touch, even after it is implanted.
The patents collectively recite forty-one claims, which
the parties classify into two partially overlapping groups.
In the first group, which includes all claims of the ’302
and ’022 patents, the identifiable characteristic is a
“radiopaque alphanumeric message.” The message is
opaque to radiation, so it is visible on an x-ray, and “in-
dicat[es] that the assembly is power injectable.” Id. col.
13, ll. 18–19. Claim 5 of the ’302 patent is representative
of these “radiopaque claims”:
5. A venous access port assembly for implantation
into a patient, comprising:
a housing having an outlet, and
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 5
a needle-penetrable septum, the needle-
penetrable septum and the housing to-
gether defining a reservoir,
wherein:
the assembly includes a radio-
paque alphanumeric message ob-
servable through interaction with
X-rays subsequent to subcutane-
ous implantation of the assembly,
and
the alphanumeric message indicat-
ing that the assembly is power in-
jectable.
Id. col. 13, ll. 8–19 (emphasis added).
In the second group of claims, which includes all
claims of the ’615 patent, the identifiable feature is one or
more “concave side surfaces” that curve inward toward
the port housing. Like the alphanumeric message in the
radiopaque claims, a concave side allows a doctor to
identify the access port, albeit by palpation, after implan-
tation. Claim 1 of the ’615 patent is representative of
these “concave side” claims:
1. An access port for providing subcutaneous ac-
cess to a patient, comprising:
a body defining a cavity accessible by in-
serting a needle through a septum, the
body including a plurality of side surfaces
and a bottom surface bounded by a bottom
perimeter, the bottom surface on a side of
the port opposite the septum, the bottom
perimeter including a concave portion, the
side surfaces including a first side surface
through which an outlet stem extends;
and
6 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
at least one structural feature of the ac-
cess port identifying the access port sub-
sequent to subcutaneous implantation as
a particular type of access port, the at
least one structural feature comprising a
concave side surface in a second side sur-
face different from the first side surface,
the concave side surface extending to the
bottom perimeter concave portion.
Id. col. 12, ll. 52–67 (emphasis added).
In August 2012, AngioDynamics filed three requests
for inter partes reexamination of the ’302, ’022, and ’615
patents, challenging all forty-one claims. A patent Exam-
iner granted the requests as to all but one claim. In a
series of decisions, the Board ultimately affirmed in part
and reversed in part, holding thirty-four of the forty
claims addressed by the Examiner invalid as anticipated
and/or obvious over the prior art of record. 3 Both parties
filed requests for rehearing, which were denied.
Bard and AngioDynamics timely appealed and cross-
appealed various aspects of the Board’s decisions. We
have jurisdiction under 28 U.S.C. § 1295(a)(4)(A).
II. DISCUSSION
We review the Board’s conclusions of law de novo and
its findings of fact for substantial evidence. In re Gart-
side, 203 F.3d 1305, 1316 (Fed. Cir. 2000). Substantial
3 The Board invalidated claims 5–10 of the ’302 pa-
tent, claims 1–20 of the ’022 patent, and claims 1–5 and
8–10 of the ’615 patent. See ’302 Decision, 2016 WL
923521, at *21; ’022 Decision, 2016 WL 1239176, at *21;
’615 Decision, 2016 WL 1166545, at *16. The Board
upheld claims 1–4 of the ’302 patent and claims 6–7 of the
’615 patent. Id.
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 7
evidence is “such evidence as a reasonable mind might
accept as adequate to support a conclusion.” Transocean
Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA,
Inc., 699 F.3d 1340, 1347 (Fed. Cir. 2012). But our review
of the Board is also rooted in “basic principles of adminis-
trative law.” Pers. Web Techs., LLC v. Apple, Inc., 848
F.3d 987, 992 (Fed. Cir. 2017). The Board must therefore
provide conclusions that “suffice for us to see that the
agency has done its job and must be capable of being
reasonably . . . discerned from a relatively concise . . .
discussion.” In re NuVasive, 842 F.3d 1376, 1383 (Fed.
Cir. 2016) (internal quotation marks omitted). If it does
not, then we may not be able to determine whether the
Board’s findings are supported by substantial evidence.
In that case, remand may be appropriate. See, e.g., Pers.
Web., 848 F.3d at 994 (remanding for the Board to “recon-
sider the merits of the obviousness challenge” where the
Board’s analysis was insufficient to permit meaningful
judicial review).
A. Bard’s Appeal
Bard makes several arguments for why we should re-
verse the Board’s rulings invalidating claims 5–10 of the
’302 patent, claims 1–20 of the ’022 patent, and claims 8–
9 of the ’615 patent. First, with respect to the ’302 and
’022 patent claims, Bard argues that the Board erred in
concluding that a particular prior art reference used to
invalidate those claims qualifies as a “printed publication”
under 35 U.S.C. § 102(b). 4 Second, Bard argues that the
Board erred in construing certain claims to encompass
both power injectable and non-power injectable access
4 All of the patents at issue here have an effective
filing date before the effective date of the Leahy-Smith
America Invents Act (“AIA”), references are therefore to
the pre-AIA version of 35 U.S.C. § 102. See Pub L. No.
112-29, 125 Stat. 284 (2011); 35 U.S.C. § 102 (2006).
8 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
ports. Finally, Bard argues that the Board improperly
entered a new ground of rejection in violation of the
Administrative Procedure Act (“APA”). We address each
argument in turn.
1. Printed Publication
A reference qualifies as a printed publication un-
der § 102(b) if the reference was “sufficiently accessible to
the public interested in the art.” Blue Calypso, LLC v.
Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016).
“A reference is considered publicly accessible if it was
‘disseminated or otherwise made available to the extent
that persons interested and ordinarily skilled in the
subject matter or art exercising reasonable diligence, can
locate it.’” In re Lister, 583 F.3d 1307, 1311 (Fed. Cir.
2009) (quoting Kyocera Wireless corp. v. ITC, 545 F.3d
1340, 1350 (Fed. Cir. 2008)). Public accessibility is de-
termined case-by-base depending on the “facts and cir-
cumstances surrounding the reference’s disclosure to
members of the public.” Id. Whether a reference ulti-
mately qualifies as a printed publication is a question of
law based on underlying findings of fact. Blue Calypso,
815 F.3d at 1348.
Bard challenges the Board’s determination that a cer-
tain reference, IsoMed Constant-Flow Infusion System
(“IsoMed”), is a “printed publication” under 35
U.S.C. § 102(b).
IsoMed is a clinical reference guide that was devel-
oped by third party Medtronic, Inc. “for physicians and
allied professionals who care for patients using” Medtron-
ic’s implantable reciprocating IsoMed pump device “for
hepatic arterial infusion of chemotherapeutic agents.”
J.A. 512. The guide bears a 2000 copyright date and
indicates that it was revised in September 2000, years
before the asserted patents’ March 2005 priority date.
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 9
Analyzing the content of the guide, the Board found
that the guide was prepared “for distribution to physi-
cians and allied professionals rather than for internal or
restricted use within Medtronic.” ’302 Decision, 2016 WL
923521, at *6. 5 The Board also considered the declaration
of Hank LaForce, a sales representative of a medical
products company later acquired by AngioDynamics.
LaForce said that, beginning in or around January 2001,
his employer “co-promoted” the IsoMed device with Med-
tronic. J.A. 1665. LaForce also stated that he “personally
distributed numerous copies of the . . . publication to
interested medical professionals, including doctors, nurs-
es, surgeons, radiologists, oncologists, and other medical
clinicians,” and that there “were no restrictions or limita-
tions on distribution of the . . . publication.” Id. Although
the Board noted that the declaration included “limited”
detail and that LaForce may have been biased “due to
current employment by” AngioDynamics, it nevertheless
determined that the guide was publicly accessible as of
January 2001. ’302 Decision, 2016 WL 923521, at *6.
Based on the current state of the record and the
Board’s articulated findings of fact, we cannot determine
whether the Board’s findings are supported by substantial
evidence.
On the one hand, the Board noted that the IsoMed
guide bears some indicia of a public-facing document. For
example, it lists phone numbers for customer and tech-
nical service departments within Medtronic as well as
contact information for various Medtronic offices. See id.
This suggests that the publication served as a reference
5 As Bard points out, the Board’s decisions on this
issue for the ’302 and ’022 patents “are largely word-for-
word identical . . . [and] stand or fall together.” Appellant
Br. 20. We therefore only cite the Board’s decision relat-
ing to the ’302 patent unless otherwise noted.
10 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
guide for healthcare professionals outside of Medtronic.
While Bard criticizes the Board for relying on the docu-
ment, the contents of a document can be relevant to
whether the document was publicly accessible. See, e.g.,
Nobel Biocare Servs. AG v. Instradent USA, Inc., No.
2017-2256, 2018 WL 4354227, at *6–9 (Fed. Cir. Sept. 13,
2018) (“[T]he ABT Catalog has the date ‘March 2003’ on
its cover. Although the ABT Catalog’s date is not disposi-
tive of the date of public accessibility, its date is relevant
evidence that supports the Board’s finding of public
accessibility . . . .”).
On the other hand, the only other evidence in the
record—the LaForce declaration—does little to establish
that the document was publicly accessible. At most,
LaForce says he distributed an unidentified number of
copies on an unidentified date to unidentified people. The
Board’s findings regarding the declaration, moreover, are
ambiguous. For example, the Board acknowledged
LaForce’s statement that he distributed copies of IsoMed
without making an express finding that he did so. See
’302 Decision, 2016 WL 923521, at *6
(“LaForce . . . testifies to having distributed ‘numerous
copies’ of IsoMed . . . .”). Instead, the Board seemed to
credit LaForce’s testimony that clinicians could request
copies from Medtronic. See id. (“LaForce infers that
IsoMed was available to any member of the relevant
public who requested a copy . . . we find that LaForce’s
inference is sound.”). It is therefore unclear whether and
to what extent the Board relied on or credited LaForce’s
testimony regarding his purported distribution. See, e.g.,
id. at *10 (“We find that IsoMed was available to the
relevant public as of on or around January 2001; and that
interested members of the relevant public could have
obtained a copy of IsoMed if they wanted to obtain one.
Based on these findings, we find by a preponderance of
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 11
the evidence that IsoMed was publically [sic] accessible on
or around January 2001.” (citations omitted)). 6 It is also
unclear whether, even if a member of the relevant public
could have requested it, there is any evidence that they
would have had a reason to do so.
AngioDynamics asks us to assume the Board found
that IsoMed was distributed along with IsoMed devices.
See Oral Arg. at 20:22–23:20 (“Counsel: Medical devices
are typically sold with product manuals. Court: Where is
that in the record? Counsel: The Board inferred it . . . .”),
available at
http://oralarguments.cafc.uscourts.gov/default.aspx?fl=20
17-1851.mp3. We see no factual findings or record evi-
dence to support this. LaForce’s declaration says nothing
about whether Medtronic distributed the guide and device
together or whether it was even common practice for
medical device manufactures to do so. This case therefore
stands in contrast to In re Enhanced Security Research,
LLC, 739 F.3d 1347 (Fed. Cir. 2014), on which AngioDy-
namics relies. There, the Board credited a declaration
explaining that the manual at issue was associated with a
software product “sold to or installed for approximately a
dozen customers.” Id. at 1354–55. In view of the manu-
al’s inscription date, the declaration, and evidence of the
software product’s advertisements published during the
relevant timeframe directing relevant consumers to reach
out for more information, we concluded that substantial
evidence supported the Board’s finding that the manual
constituted publicly-available prior art under § 102(a)(1).
Id. And, we found that there was a sufficient basis to
6 The Board’s decisions on rehearing with respect to
the ’302 patent and the ’022 patent do not mention the
LaForce declaration at all. See generally ’302 Rehearing
Decision, 2017 WL 542597; ’022 Rehearing Decision, 2017
WL 766740.
12 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
conclude that consumers would have had a reason to
reach out and request it. Id. Here, in the absence of clear
factual findings, we decline to decide whether the present
record would support the same inference.
Accordingly, we vacate the Board’s determination that
IsoMed qualifies as a printed publication and remand for
additional factfinding on this score. 7
2. Claim Construction
We review the Board’s claim constructions de novo ex-
cept to the extent they depend on underlying factual
findings involving extrinsic evidence. Teva Pharm. USA,
Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841–42 (2015).
As described above, the radiopaque claims of the ’302
and ’022 patents require the recited access port to contain
a radiopaque “alphanumeric message indicating that the
assembly is power injectable.” Claims 8–9 of the ’615
patent include a similar limitation. The Board deter-
mined that these claims are broad enough to encompass
both power injectable and non-power injectable ports.
See, e.g., ’615 Decision, 2016 WL 1166545, at *13. Bard
contends that these claims require the access port to be
power injectable and that the Board erred by holding
otherwise. We agree.
“As with any claim construction analysis, we begin
with the claim language.” In re NTP, Inc., 654 F.3d 1279,
1288 (Fed. Cir. 2011) (citing Phillips v. AWH Corp., 415
F.3d 1303, 1312 (Fed. Cir. 2005) (en banc)). Here, the
plain language of the radiopaque claims is clear. For
example, claim 5 explains that the alphanumeric message
“indicat[es] that the assembly is power injectable.” ’302
7 We express no opinion as to whether the Board
may or should consider additional evidence to support this
additional factfinding.
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 13
patent, col. 13, ll. 8–19. This phrasing is definitional.
Claim 8 of the ’615 patent likewise explains that the
recited structural feature “identif[ies] the access port as
being power injectable.” ’615 patent, col. 14, ll. 1–3. We
therefore interpret these claims to “mean precisely what
they say,” Central Admixture Pharmacy Services, Inc. v.
Advanced Cardiac Solutions, P.C., 482 F.3d 1347, 1355
(Fed. Cir. 2007), and we construe them to mean that the
claimed access port is power injectable.
To justify its contrary construction, the Board con-
cluded that the claims merely require that the access port
be labeled as power injectable. The Board based this
conclusion on its view that “it was within the level of
ordinary skill in the art to falsely label an assembly that
was not power injectable.” ’302 Decision, 2016 WL
923521, at *15. But the Board provided no reason why
the claims would contemplate a falsely labeled access
port. As the record evidence makes clear, power injecting
a non-power injectable port can cause serious injury or
death. Distinguishing between the two types of ports is
the crux of what the patents claim. The Board’s reading
of the claims as reaching falsely labeled ports is therefore
unreasonably broad. See PPC Broadband, Inc. v. Corning
Optical Commc’ns RF, LLC, 815 F.3d 747, 755 (Fed. Cir.
2016) (“We will not adopt the position . . . that the broad-
est reasonable construction is always the one which
covers the most embodiments. Above all, the broadest
reasonable interpretation must be reasonable in light of
the claims and specification.”).
That the claims cover power injectable ports, specifi-
cally, is further evidenced by the prosecution history of
the ’302 patent. For example, claim 5 originally required
“at least one feature [that] conveys information indicative
of an attribute of the assembly.” J.A. 8400. After the
Examiner rejected the claim, the Examiner and the
applicant conducted an interview in which they
“[d]iscussed potential amendments to independent claims
14 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
to . . . further describ[e] the port and the attribute as
being power injectable.” J.A. 8598. The applicant then
amended the claim to add the alphanumeric message
limitation at issue here. J.A. 8602. The Examiner ulti-
mately allowed this claim, stating that “the prior art of
record fails to disclose either singly or in combination the
claimed device of an implantable access port that has a
radiopaque message to indicate that this port is specifical-
ly power injectable.” J.A. 8775 (emphasis added). This
exchange demonstrates that the applicant and the Exam-
iner both believed the claim language covered power
injectable ports, which is consistent with the plain lan-
guage of the claim. See Phillips, 415 F.3d at 1317 (noting
that the “prosecution history provides evidence of how the
PTO and the inventor understood the patent”); Master-
Mine Software, Inc. v. Microsoft Corp., 874 F.3d 1307,
1312 (Fed. Cir. 2017) (finding that a statement “presented
by the inventor during patent examination is relevant to
claim construction, for the role of claim construction is to
capture the scope of the actual invention that is disclosed,
described, and patented,” even if the statement does not
amount to a disclaimer).
Accordingly, we vacate the Board’s obviousness rul-
ings regarding claims 5–10 of the ’302 patent, claims 1–20
of the ’022 patent, and claims 8–9 of the ’615 patent. We
remand for the Board to determine, if appropriate, 8
whether, under the correct construction, these claims are
obvious in view of the prior art of record. 9
8 This remand assumes that the Board first finds
sufficient evidence in the record upon which it can base
relevant findings on the question of whether the IsoMed
reference constitutes prior art as to these patents.
9 We also decline to address, at this point, whether
the alphanumeric message limitation, as properly con-
strued, ought to be afforded patentable weight under the
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 15
3. New Grounds for Rejection
Finally, Bard argues that the Board improperly relied
on new grounds to reject claims 1–5 and 8–10 of the ’615
patent. We disagree.
Under the APA, the Patent Office “must assure that
an applicant’s petition is fully and fairly treated at the
administrative level.” In re Kumar, 418 F.3d 1361, 1367
(Fed. Cir. 2005). “This framework limits the Board’s
ability to rely on different grounds than the examiner.”
Rambus Inc. v. Rea, 731 F.3d 1248, 1255 (Fed. Cir. 2013).
But it does not require the Board to merely recite and
repeat an examiner’s findings on review. “The ultimate
criterion is whether the appellant has had before the PTO
a ‘fair opportunity to react to the thrust of the rejection.’”
Id.
Here, the Examiner relied, in relevant part, on two
references to invalidate the claims at issue: (1) European
Patent Application No. 1 238 682 to Reuter (“Reuter”) and
(2) U.S. Patent No. 5,919,160 to Sanfilippo (“Sanfilippo”).
Reuter discloses an access port with a base plate having
concave cutouts that can be used to securely handle the
port during implantation. Sanfilippo discloses a dual-
reservoir port having curved indentations on the sides
thereof that allow a doctor to determine, via palpation,
the reservoirs’ relative orientation. The Examiner found
that it would have been obvious to use Reuter’s cutouts
“to impart to the medical technician the type of implanted
printed matter doctrine. Even if entitled to patentable
weight, the Board would still need to determine whether
the claim as a whole is obvious in light of any relevant
prior art. Since that question likely will be addressed in
the Board’s obviousness assessment, or be mooted by a
finding that IsoMed is not prior art, we need not reach it
now.
16 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
access port” and that general knowledge in the art, as
evidenced by Sanfilippo, “includes relaying information
regarding the port to the medical technician via palpa-
tion.” J.A. 7641. The Examiner emphasized that incorpo-
rating Sanfilippo into Reuter “would be an obvious
extension of this knowledge in the art.” J.A. 7642. These
statements suggest the Examiner found that Sanfilippo
could be used to modify Reuter’s cutouts to be identifiable
by palpation.
The Board likewise found that it would have been ob-
vious to modify Reuter in this respect based on Sanfilippo.
For example, the Board explained that “Sanfilippo would
have provided one of ordinary skill in the art reason to
lower the profile of Reuter’s access port, by shortening the
housing, so as to enable a physician or allied professional
to feel the concave side surfaces formed by the cut-outs
after implantation.” ’615 Decision, 2016 WL 1166545, at
*12. As the Board noted, this analysis at most “merely
made explicit what was implicit in the Examiner’s reason-
ing.” ’615 Rehearing Decision, J.A. 157. We agree. The
Board’s ruling does not amount to a new rejection.
Bard asserts that even if the Board’s rejection was
procedurally proper, it was still erroneous. According to
Bard, there is no evidence in the record explaining why
one skilled in the art would have been motivated to apply
the teachings of Sanfilippo to modify Reuter. Bard also
maintains that, even if there were such a motivation, the
Board failed to address whether there would have also
been a reasonable expectation of success in making these
modifications.
We review the Board’s findings on these factual ques-
tions for substantial evidence. Intelligent Bio-Sys., Inc. v.
Illumina Cambridge Ltd., 821 F.3d 1359, 1366 (Fed. Cir.
2016). As explained above, the Board found that the prior
art, including Sanfilippo, taught using structural features
to identify the type of port being implanted. See ’615
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 17
Decision, 2016 WL 1166545, at *11 (“Sanfilippo also
taught that these curved indentions might be used to
identify a particular type of access port . . . .”). It went on
to conclude that this prior art would have provided ample
motivation for a skilled artisan to modify Reuter and
“enable a physician or allied professional to feel the
concave side surfaces formed by the cut-outs 9, 10 after
implementation.” Id. at *12. The Board also concluded
that if this were done, “the physician or allied professional
could use the cut-outs to identify the particular type of
access port in accordance with the teachings of Sanfilip-
po.” Id. Substantial evidence supports these determina-
tions. We therefore affirm the Board’s ruling invalidating
claims 1–5 and claim 10 of the ’615 Patent. As to claims
8–9, we remand for the Board to determine whether,
under the correct construction, these claims are obvious in
view of the prior art of record.
B. AngioDynamics’ Cross-Appeal
In its cross-appeal, AngioDynamics argues that the
Board’s rulings upholding the validity of claims 1–4 of the
’302 patent and claims 6–7 of the ’615 patent should be
reversed. With respect to the ’302 patent claims, An-
gioDynamics argues that the Board erred in finding that
IsoMed does not disclose a radiopaque alphanumeric
message on a “housing base.” With respect to the ’615
patent claims, AngioDynamics argues that the Board
erred in concluding that it would not have been obvious to
modify Reuter to add a fourth concave side. We address
each argument in turn.
1. Housing Base Limitation
AngioDynamics first challenges the Board’s finding
that IsoMed does not disclose an alphanumeric message
on a “housing base,” as required by certain radiopaque
claims. According to AngioDynamics, that finding was
predicated on an erroneous construction of the “housing
18 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
base” limitation. Even assuming without deciding that
IsoMed qualifies as a printed publication, we disagree.
Some of the radiopaque claims recite a “housing hav-
ing a housing base defining a bottom wall of at least one
reservoir, and an outwardly facing bottom surface.” ’302
patent, col. 12, ll. 57–67. These claims also require the
radiopaque alphanumeric message be inscribed on the
housing base. The Board construed this limitation to
mean that the housing base defines a bottom wall of the
reservoir and an outwardly facing bottom surface of the
access port. See ’302 Decision, 2016 WL 923521, at 13–14.
This construction is reasonable in light of the claims
themselves and the patent as a whole. For example,
claim 3, which depends from claim 1, requires that “the
radiopaque alphanumeric message [be] applied to the
outwardly facing bottom surface of the housing base.”
’302 patent, col. 13, ll. 3–5 (emphasis added). This lan-
guage makes clear that the outwardly facing bottom
surface of claim 1 is a feature of the housing base, not just
the housing. See Phillips, 415 F.3d at 1314–15 (noting
that dependent claims can add helpful context for the
meaning of independent claims). It also forecloses the
argument raised by amicus curiae Medical Components,
Inc. (“MedComp”) that the “housing base” and “an out-
wardly facing bottom surface” are two separate claim
limitations based on the comma separating these parts of
the claim.
The IsoMed device includes, among other things, a
reservoir, a partition separating the reservoir from a
propellent chamber that is filled with pressurized gas,
and a titanium shell. The reservoir expands within the
shell as pressure changes. In its most expanded state, the
reservoir’s lower wall abuts the lower wall of the shell.
The Board determined that IsoMed’s shell cannot be a
“housing base” because, although it defines an “outwardly
facing bottom surface” of the access port, it does not define
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 19
“a bottom wall of the reservoir” as required under its
reading of the claims. The Board determined that the
reservoir’s bottom wall is likewise not a “housing base”
because it does not define “an outwardly facing bottom
surface” of the access port. The Board therefore properly
concluded that the IsoMed device does not have a struc-
ture defining both the bottom wall of the reservoir and
the outwardly facing bottom surface of the port. See ’302
Decision, 2016 WL 923521, at 13–14.
AngioDynamics insists that the bottom wall of the
reservoir is defined by the outwardly facing shell. To
overcome the fact that a partition separates the bottom
wall of the reservoir from the shell, AngioDynamics
argues that the partition is simply an additional, inter-
mediate structure permitted by the “comprising” language
of the claims. But as the Board correctly explained, “the
fact that the bottom wall of the titanium shell . . . set[s] a
limit beyond which the reservoir cannot expand does not
imply that the bottom wall of the shell defines a bottom
wall of at least on reservoir in the ordinary sense of the
language.” ’302 Rehearing Decision, 2017 WL 542597, at
*4 (internal quotation marks and brackets omitted). The
shell therefore does not satisfy the claim.
AngioDynamics also argues that the Board’s reading
of these claims is inconsistent with its reading of claims
5–6 and 8–10 of the ’302 patent. When analyzing those
claims, the Board stated that “it is reasonable to interpret
the term ‘housing’ sufficiently broadly to encompass
[IsoMed’s] combination of the titanium shell with the
propellant chamber and pump device as well as other
structure which might contact the reservoir.” ’302 Deci-
sion, 2016 WL 923521, at *13. And, in its decision on
rehearing, the Board stated with respect to those claims
that “the term ‘defining’ in the ’302 patent is sufficiently
broad to encompass structures that do not contact the
reservoir directly; and the reservoir cannot expand so as
to exceed the confines of the interior of the shell.” ’302
20 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
Rehearing Decision, 2017 WL 542597, at *6. AngioDy-
namics asserts that the Board’s broad reading of “hous-
ing” is inconsistent with its narrow reading of “housing
base.” We see no inconsistency. While the port housing
encompasses a number of components, as the claims make
clear, the housing base, which is one part of the housing,
does not.
We have considered AngioDynamics’ and MedComp’s
remaining arguments—including those invoking judicial
estoppel—and find them unpersuasive. We therefore
affirm the Board’s ruling upholding claims 1–4 of the ’302
patent.
2. Obviousness
AngioDynamics next challenges the Board’s ruling
upholding claims 6–7 of the ’615 patent. According to
AngioDynamics, that ruling is predicated on an incorrect
reading of the claims and an erroneous application of
obviousness law. We disagree.
Claim 6 of the ’615 patent requires four “concave side
surfaces” in the body of the access port. ’615 patent, col.
13, ll. 13–16. Prior art reference Reuter discloses three
cutouts in its base plate. The Examiner concluded that it
would have been obvious to modify Reuter to add a fourth
concave side because doing so would have resulted in
easier and cheaper manufacturing. The Board rejected
this conclusion, noting the absence of any evidence to
support the Examiner’s view. The Board explained that
adding an additional concave side to Reuter “would have
required one of ordinary skill to add a cut-out to Reuter’s
base plate 2, which offered no apparent functional ad-
vantage.” ’615 Decision, 2016 WL 1166545, at *15. While
the Board acknowledged that other references in the art
contained four concave surfaces, it emphasized the lack of
evidence to support a motivation for combining these
references with Reuter in this way. Id. As noted above,
we review the Board’s findings on these factual questions
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 21
for substantial evidence. Intelligent Bio-Sys., 821 F.3d at
1366.
AngioDynamics argues that the Board erred in its ob-
viousness analysis by requiring the prior art to teach
palpating concave surfaces post-implantation. We disa-
gree. As the Board correctly observed, while the prior art
provides reasons why it would be advantageous to have
concave cutouts generally, it does not suggest that having
such cutouts on all sides of an access port is advanta-
geous. Reuter itself explains that its cutouts are used so
that the port “can be handled securely during implanta-
tion and especially during the fastening of the catheter.”
J.A. 6976. There is no reason why this benefit cannot be
achieved with only three cutouts. Another reference
discussed by the Board, Montalvo, states that “[t]he
overall size and shape of the infusion port and its im-
planted location within the patient are chosen for rela-
tively simple and accurate palpable identification through
the skin.” J.A. 7078. This reference clearly suggests that
the geometry of the port can be chosen to optimize palpa-
ble identification, but it does not suggest that having four
concave sides would achieve that benefit. Neither Rein-
icke nor Sanfilippo provide such a motivation either. The
fact that the prior art did not teach palpation using
concave surfaces post-implantation therefore undermines
the notion that a skilled artisan would be motivated to
modify Reuter to add a fourth concave cutout, which is
what the Board found. ’615 Decision, 2016 WL 1166545,
at *15–16.
AngioDynamics’ argument that the Board required
the prior art to disclose specific functionality even though
the art disclosed relevant structure similarly fails. Again,
the Board discussed the functionality of the prior art to
explain why a skilled artisan would not necessarily modi-
fy Reuter based on Reinicke. See ’615 Rehearing Deci-
sion, J.A. 152 (“These structural and functional
differences [between Reinicke and Reuter] reinforce the
22 C.R. BARD, INC. v. ANGIODYNAMICS, INC.
absence of an apparent reason why one of ordinary skill in
the art might have altered Reuter’s access port in the
fashion claimed in claim 6.”). Such a discussion is appro-
priate. See, e.g., Anacor Pharm., Inc. v. Iancu, 889 F.3d
1372, 1385 (Fed. Cir. 2018) (“The obviousness inquiry
often depends on whether there is evidence demonstrating
a nexus between structural similarities (or dissimilarities)
and functional similarities (or dissimilarities).”).
AngioDynamics’ argument that the Board failed to
consider the collective teachings of the prior art is also
without merit. The Board discussed the prior art exten-
sively. See, e.g., ’615 Rehearing Decision, J.A. 150–154.
It went on to conclude that the art did not provide a
motivation to modify Reuter by adding a fourth concave
edge. See, e.g., id. at 153 (“The mere presence of such
concave surfaces, without indication of their function,
would not have provided one of ordinary skill in the art
reason to add a fourth concave cut-out to the base plate of
the access port described by Reuter.”). This finding is
supported by substantial evidence.
Finally, AngioDynamics argues that modifying a geo-
metric shape was well within the capabilities of a skilled
artisan and would have been a simple design choice. But
the Board concluded that the record evidence did not
support this view. Id. at 150–51 (“Neither the Examiner
nor the Requester has adequately explained how adding a
concave cut-out to the side of the base plate 2 opposite the
catheter connector 8 would have improved a surgeon’s
ability to handle the access port.”). It also noted that the
evidence did not suggest modifying Reuter in this way
would have decreased production costs as to justify an
additional manufacturing step. See ’615 Decision, 2016
WL 1166545, at *15. (“The Examiner has not provided
any persuasive evidence or technical reasoning to support
the finding that adding an additional cut-out . . . would
have resulted in greater ease of manufacturing or reduced
C.R. BARD, INC. v. ANGIODYNAMICS, INC. 23
cost in processing.”). We find no reason to adopt a differ-
ent view given the findings of the Board.
In sum, the Board’s rulings upholding claims 6–7 of
the ’615 patent are supported by substantial evidence and
are therefore affirmed.
III. CONCLUSION
We have considered the parties’ remaining arguments
and find them unpersuasive. For the reasons stated
above, we vacate the Board’s ruling that IsoMed qualifies
as a printed publication and remand for the Board to
clarify its factual findings. Additionally, we reverse the
Board’s anticipation rulings, vacate its obviousness rul-
ings regarding claims 5–10 of the ’302 patent, claims 1–20
of the ’022 patent, and claims 8–9 of the ’615 patent, and
remand for the Board to determine whether, under a
construction requiring the ports to be power injectable,
these claims are obvious in view of the prior art of record,
which may or may not include IsoMed. We affirm all
other aspects of the Board’s rulings.
AFFIRMED IN PART, VACATED IN PART,
REVERSED IN PART, AND REMANDED IN CASE
NOS. 17-1851, 17-1906, AND 17-1931.
AFFIRMED IN PART, VACATED IN PART, AND
REMANDED IN CASE NOS. 17-1943 AND 17-1865.
COSTS
No costs.