W. L. Gore & Associates, Inc.

Patent Trials and Appeals Board

Sep 30, 2020

14714685 - (D) (P.T.A.B. Sep. 30, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/714,685 05/18/2015 Keith A. Knisley MP/406A 1633
28596 7590 09/30/2020
W. L. GORE & ASSOCIATES, INC.
551 PAPER MILL ROAD
P. O. BOX 9206
NEWARK, DE 19714-9206
EXAMINER
SCHALL, MATTHEW WAYNE
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
09/30/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
InfoIP@WLGore.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEITH A KNISLEY, VISHNU T. MARLA,
RACHEL RADSPINNER, PAUL A. SILVAGNI, JASON J, STRID,
and MICHAEL J. VONESH

Appeal 2019-003612
Application 14/714,685
Technology Center 3700
Before: FRANCISCO C. PRATS, JOHN E. SCHNEIDER, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision to reject claims 1–5 and 18–23.1 We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies W.L. Gore & Associates, Inc. as the real
party in interest. Appeal Br. 1.
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Application 14/714,685

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CLAIMED SUBJECT MATTER
The claims are directed to improved biocompatible surfaces and
devices incorporating the same. Claim 1 reproduced below, is illustrative of
the claimed subject matter:

1. A blood contact surface comprising
a synthetic biomaterial having a microstructure of
interconnected fibrils morphologically analogous to
microstructure of a natural human fibrin mat.

The prior art relied upon by the Examiner is:

Name Reference Date
Xu et al.
(hereinafter “Xu”)
US 2011/0039960 A1 February 17, 2011

The Examiner has rejected claims 1–5 and 18–23 under 35 U.S.C.
§ 102 as anticipated by Xu. 2, 3

2 Claims 6–17 are pending in the application but have been withdrawn from
consideration. Final Act. 1.
3 Claims 1–5 and 18–23 were also rejected under 35 U.S.C. §112, second
paragraph as indefinite. Final Act. 2. That rejection has been withdrawn.
Ans. 2.
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OPINION
Issue
The issue to be decided in this appeal is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1–5 and 18–23
are anticipated by Xu.
The Examiner finds that Xu discloses a synthetic biomaterial having
microstructure comprising expanded polytetrafluoroethylene (“ePTFE”) that
is morphologically analogous to the microstructure of a natural mammalian
fibrin mat. Final Act. 3.
Appellant contends that the microstructure shown in Figure 1 of Xu
(reproduced below), as compared with the microstructure of a natural fibrin
mat as shown in figure 21A (reproduced below) is “markedly different” and
that Xu “does not teach or suggest” the material of the present Application
shown in Figure 21 B (reproduced below). Appeal Br. 7.

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Figure 1 of Xu showing a Scanning Electron Micrograph (“SEM”) of an
expanded sheet of functional TPE copolymer taken at 10,000x
magnification.

Figure 21A of the present Application showing a SEM of a natural fibrin
mat.

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Figure 21B of the present Application is a SEM of a biocompatible surface
of the present invention taken at 10,000x.

Appellant contends that the fibril structure of Xu I is “much thicker
and more convoluted” and has “distinctly larger nodes” than the claimed
invention of the natural fibrin mat. Appeal Br. 7. Appellant also argues that
Xu does not teach or suggest “creating a blood contact surface with a
structure that mimics or is morphologically similar to natural fibrin.” Id.
With respect to claims 4 and 23, Appellant contends that these claims
are limited to ePTFE. Id. Appellant contends that Xu discloses the use of
tetrafluoroethylene copolymers and not “a blood contact surface of expanded
PTFE with a morphology of natural human fibrin mat.” Id at 7–8.
With respect to claims 2, 3, 5, and 17–22, Appellant argues that Xu
does not disclose the limitations recited in these dependent claims. Id. at 8–
9.
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Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case of unpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the [S]pecification.” In re Hyatt,
211 F.3d 1367, 1372 (Fed. Cir. 2000).
“The ordinary and customary meaning of a claim term may be
determined by reviewing a variety of sources. Some of these sources
include the claims themselves; dictionaries and treatises; and the written
description, the drawings, and the prosecution history.” Brookhill-Wilk 1,
LLC v. Intuitive Surgical, Inc., 334 F.3d. 1294, 1298 (Fed. Cir. 2003)
(citations omitted).
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
“[N]ot unlike a determination of infringement, a determination of
anticipation, as well as obviousness, involves two steps. First is construing
the claim,[] followed by, in the case of anticipation or obviousness, a
comparison of the construed claim to the prior art.” Key Pharms. v. Hercon
Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998).
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Analysis
Appellant has presented separate arguments for three groups of
claims, claim 1, claims 4 and 23, and claims 2, 3, 5, and 17–22. We will
address the patentability of each group in turn.
Claim 1
The issue with respect to claim 1 is whether the expanded sheet of
TFE copolymer disclosed in Xu meets the claim limitation “morphologically
analogous to a mat comprising natural human fibrin.” See Appeal Br. 5–7;
Ans. 2–4.
To resolve this issue we must first construe the term “morphologically
analogous.” The Specification does not use or define the term. See, e.g.,
Spec. ¶¶ 105–106 (comparison of the surface of the present invention with a
natural fibrin surface). As used in claim 1, the term “morphologically
analogous” does not require exact similarity but only requires some degree
of similarity with a natural human fibrin mat. See Appeal Br. 10 (Claims
App.).
We next look at the ordinary meaning of the term. Webster’s defines
the word analogous as “similar or comparable to something else either in
general or in some specific detail.” Merriam-Webster.com (accessed Sept.
18, 2020), https://www.merriam-webster.com/dictionary/analogous. Using
this definition, we construe the term “morphologically analogous” to mean
“having a generally similar morphology.”
This construction is consistent with the discussion in the Specification
where the material of the present invention is compared with a mat of natural
fibrin. The Specification teaches “[i]t is interesting to note that there is some
similarity in morphology between the inventive surface of the present
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invention and natural fibrin surfaces occurring in a mammalian body that
may foster attachment of endothelial cells.” Spec. ¶ 105. The Specification
goes on to state “the artificial microstructure of the present invention
presents a morphology remarkably similar to that of natural fibrin, including
having short fibrils (with a less than 5 micron internodal distance), fibrils
intersecting at small nodal points, and the microstructure being
approximately balanced in the x and y directions.” Id. ¶ 106.
Applying this construction we agree with the Examiner that the fibrin
mat disclosed in Figure 1 of Xu is morphologically analogous with the
mammalian fibrin mat shown in Figure 21A of the Specification. Ans. 3. A
comparison of Figure 1 of Xu with Figure 21A of the Specification shows
“some similarity in morphology” with both structure having short fibrins
intersecting at small nodal points. Compare Xu, Fig. 1 with Spec. Fig. 21A
(Both reproduced above.)
Appellant contends that the structure of Xu is markedly different than
the structure of the present invention. Appeal Br. 6–7. Appellant contends
that the microstructure of Xu has a thicker and more convoluted
microstructure and distinctly larger nodes. Id. We are not persuaded by
Appellant’s argument.
Appellant has not offered any evidence to support its contentions
regarding the morphology of the structure shown in Xu but only presents
attorney argument. “Attorneys’ argument is no substitute for evidence.”
Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
A visual comparison of Figure 1 of Xu with Figure 21A of the
Specification reveals structures that are similar in morphology with fibrins
of about the same length intersection nodes of about the same size.
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Appellant also contends that Xu does not disclose creating a blood
contact surface. Appeal Br. 7. We remain unpersuaded. The recitation of
blood contact surface in the preamble of claim 1 merely describes an
intended use of the material and does not otherwise limit the claim as the
remainder of the claim is structurally complete. “Where . . . a patentee
defines a structurally complete invention in the claim body and uses the
preamble only to state a purpose or intended use for the invention, the
preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478, 42
USPQ2d 1550, 1553 (Fed. Cir. 1997).
Based on the foregoing we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that claim 1 is anticipated by
Xu.
Claims 4 and 23
Claim 4 depends from claim 1 and adds the limitation that the surface
of claim 1 comprises expanded polytetrafluoroethylene. Appeal Br. 10
(Claims App.). Claim 23 depends from claim 4 and thus includes the
limitations of claim 4. 35 U.S.C. § 112, fourth para.
The Examiner contends that Xu discloses this limitation. Ans. 4. The
Examiner contends that Xu uses ePTFE as a starting material and that
polymerization reactions may not result in TFE copolymers. Id.
Appellant contends that Xu is specifically directed to functionalized
TFE copolymers that comprise TFE and at least one copolymer having a
functional group. Appeal Br. 8. Appellant contends that this is not the same
as ePTFE. Id.
We have considered the arguments advanced by the Examiner and
Appellant and find that Appellant has the better positon. Xu consistently
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refers to the material used as “a functional TFE copolymer.” See, e.g., Xu,
Abstr., ¶¶ 25, 45, 47, and 72. Xu defines a TFE copolymer as
a TFE polymer comprising one or more comonomer at any
concentration. As used herein the term functional TFE
copolymer is defined as a TFE copolymer having functional
groups that are pendant to the polymer chain wherein the
functional TFE copolymer is formed by copolymerizing TFE
with comonomers having a functional group.
Xu. ¶ 26.
The Specification teaches that while ePTFE and TFE copolymers are
both fluoropolymers, they are separate species. See Spec. ¶ 80 (Listing
ePTFE and TFE copolymer as separate examples of fluoropolymers.). We
discern no teaching in Xu that teaches the use of ePTFE.
The Examiner contends that Xu teaches starting with ePTFE and then
polymerizing the material to form the copolymer. Ans. 4 (citing Xu ¶ 31).
The Examiner contends that “the polymerization reactions may or may not
be performed on the ePTFE.” Id.
We are not persuaded by this argument. Paragraph 31 of Xu teaches
“At least one functional comonomer may be polymerized with TFE to
provide a copolymer having a multiplicity of pendant functional groups.”
Xu ¶ 31. TFE in not the same as ePTFE which is a monomer used to make
the polymers. See id. ¶ 25 (“The functional TFE copolymer comprises a
polymer of TFE and at least one comonomer that contains a functional
group.”).
The Examiner also cites to paragraph 71 which refers to “Break
Strength Test of Microporous ePTFE.” Ans. 4. When read in context, this
heading in Xu does not support the Examiner’s finding that Xu discloses the
use of ePTFE. In the very next paragraph Xu discloses that the material
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tested is expanded TFE copolymer. Xu. ¶ 72. We find this disclosure fails
to show “all of the claim elements and their limitations [] in a single prior art
reference.” In re Skvorecz, 580 F.3d at 1266. Based on the foregoing, we
conclude that a preponderance of the evidence does not support the
Examiner’s conclusion that claims 4 and 23 are anticipated by Xu.
Claims 2, 3, 5, and 17–22
Claims 2, 3, 5, and 17–22 depend from claim 1 and add limitations
calling for the use of fluoropolymers, specify various lengths of the fibrils,
and recite the incorporation of the material into certain medical devices. See
Appeal Br. 10–11 (Claims App.).
While the Examiner states that these claims are anticipated by Xu, the
Examiner makes no specific findings with respect to the limitations recited
in these claims. See Final Act. 3; see also Ans. 2–4. While Xu may disclose
the elements recited in the dependent claims, the Examiner has not met the
initial burden, on review of the prior art or on any other ground, of
presenting a prima facie case of unpatentability. See, e.g.¸ Xu ¶ 70, Fig. 1.
For this reason we reverse the rejection of claims 2, 3, 5, and 17–22.

CONCLUSION
The Examiner’s rejection is affirmed in part.
More specifically,
A preponderance of the evidence supports the Examiner’s conclusion
that claim 1 is anticipated by Xu.
A preponderance of the evidence does not support the Examiner’s
conclusion that claims 4 and 23 are anticipated by Xu.
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The Examiner has not established a prima facie case that claims 2, 3,
5, and 17–22 are anticipated by Xu.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 17–23 102 Xu 1 2–5, 17–23

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED-IN-PART