Edwards Lifesciences Corporation

Patent Trials and Appeals Board

May 25, 2021

2020003016 (P.T.A.B. May. 25, 2021)

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.
15/167,730 05/27/2016 Sophie M. Carpentier HVTTS-6423US03 4024
30452 7590 05/25/2021
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
EXAMINER
PATURY, SRIKANTH
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
05/25/2021 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):
USDOCKET@edwards.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte SOPHIE M. CARPENTIER and
ALAIN F. CARPENTIER
____________________

Appeal 2020-003016
Application 15/167,7301
Technology Center 1600
____________________

Before DEBORAH KATZ, JON M. JURGOVAN, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

JURGOVAN, Administrative Patent Judge.

DECISION ON APPEAL

Appellant seeks review under 35 U.S.C. § 134(a) from a Final
Rejection of claims 1–5, 8–15, and 17–20.2 We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM.3

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. According to Appellant, the real party in interest is
Edward Lifesciences Corporation. Appeal Br. 2.
2 Claims 6 and 7 were canceled and claim 16 was withdrawn. See Appeal
Br. 12–13.
3 Our Decision refers to the Specification (“Spec.”) filed May 27, 2016; the
Final Office Action (“Final Act.”) mailed May 17, 2019; the Appeal Brief
(“Appeal Br.”) filed October 21, 2019; the Examiner’s Answer (“Ans.”)
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CLAIMED INVENTION
The claims relate to a packaged bioprosthetic device with dry
collagenous tissue having double cross-linkages between free amine and free
aldehyde functional groups to enhance post-implantation durability.
Spec. ¶ 2. Schiff bases of the free aldehyde functional groups are reduced
by a reducing agent such as sodium borohydride. Id. ¶¶ 15, 44. Glycerol
replaces at least a portion of the water in the dry collagenous tissue. Id.
¶¶ 13, 36, 48, 50, 52, 63.
Claim 1 is independent. Claims 12–5, 8–15 and 17–20 are dependent
from claim 1.
Claim 1, reproduced below, is representative of the claimed subject
matter:
1. A packaged bioprosthetic device comprising:
a dry collagenous tissue comprising at least first and
second sets of crosslinkages,
wherein the first set of crosslinkages is provided between
free amine functional groups on the collagenous tissue,
wherein the second set of crosslinkages is provided
between free aldehyde functional groups,
wherein Schiff bases formed by at least the second set of
crosslinkages are reduced by a reducing agent, and
wherein at least a portion of the water initially present in
the dry collagenous tissue has been replaced with glycerol; and
a packaging containing the dry collagenous tissue.
Appeal Br. 12 (Claims App.).

mailed January 13, 2020; and the Reply Brief (“Reply Br.”) filed March 13,
2020.
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REJECTION4
Claims 1–5, 8–15 and 17–20 stand rejected under 35 U.S.C. § 1035
based on Zilla6 and Dove.7 Final Act. 4–6.

ANALYSIS
Standard of Review
We undertake a limited de novo review of the appealed rejections for
error based upon the issues identified by Appellant, and in light of the
arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d
1072, 1075 (BPAI 2010) (precedential).
§ 103 Rejection
A. Legal Principles Concerning Obviousness
Title 35, section 103, provides:
A patent for a claimed invention may not be obtained though the
invention is not identically disclosed or described as set forth in
section 102, if the differences between the subject matter sought
to be patented and the prior art are such that the subject matter as
a whole would have been obvious at the time the invention was
made to a person having ordinary skill in the art to which said
subject matter pertains.

4 Appellant canceled claim 6 so the rejection under 35 U.S.C. § 112, 4th
paragraph is moot. See Final Act. 3; Appeal Br. 12.
5 This application has an asserted effective filing date before March 16,
2013. Accordingly, we apply the version of 35 U.S.C. § 103 preceding the
Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat.
284 (2011).
6 Peter Zilla et al., Diamine-extended Glutaraldehyde- and Carbodiimide
Crosslinks Act Synergistically in Mitigating Bioprosthetic Aortic Wall
Calcification, J. HEART VALVE DIS., Vol. 14 No. 4, July 2008.
7 US 2009/0164005 A1, published June 25, 2009.
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The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) any differences between the claimed subject matter and the prior art;
(3) the level of ordinary skill in the art; and (4) where present, objective
evidence of nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18
(1966).
B. Grouping of Claims
Appellant argues for patentability of claims 1–5, 8–15, and 17–20
together as one group. See Appeal Br. 7–11. Accordingly, we select claim 1
as representative of the argued group of claims and unless otherwise
indicated will restrict our analysis to this claim only.
37 C.F.R. § 41.37(c)(1)(iv) (“When multiple claims subject to the same
ground of rejection are argued as a group or subgroup by appellant, the
Board may select a single claim from the group or subgroup and may decide
the appeal as to the ground of rejection with respect to the group or subgroup
on the basis of the selected claim alone.”).
C. Examiner’s Findings
The Examiner’s rejection relies on the combination of Zilla and Dove.
Final Act. 4–6 (citing Zilla, Abstract, Fig. 4, Scheme 2; Dove ¶¶ 12–14, 28,
29, 31, 35, 36, 39, 128, 140–147). The Examiner finds that Zilla teaches
treating collagenous tissue with glutaraldehyde, which would create a first
set of crosslinks with free amines. Id. at 4. The Examiner also finds that
Zilla teaches fixing the tissue with a diamine (L-lysine), which would create
a second set of crosslinks between the free aldehyde groups. Id. The
Examiner further finds that Zilla teaches that the reaction of lysine and
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aldehyde groups results in the formation of Schiff bases. Id. (citing Fig. 4,
Scheme 2, product of R4).
The Examiner finds that Zilla does not teach reducing the Schiff bases
with a reducing agent, replacing at least a portion of the water initially
present in the collagenous tissue with glycerol, dry collagenous tissue, and
packaging the tissue. Id. at 4. However, the Examiner relies on Dove to
teach these features. Id.
Specifically, the Examiner finds that Dove teaches reducing Schiff
bases that formed from interaction of the aldehyde and an amine by reacting
with sodium borohydride. Id. (citing Dove ¶ 35). The Examiner further
finds that Dove teaches dehydrating the tissue in a glycerol solution, as well
as packaging the dehydrated tissue. Id. (citing Dove ¶¶ 12, 36, 39, 135, 146;
see also ¶ 38).
The Examiner finds that one of ordinary skill in the art would have
been motivated to combine the teachings of Zilla and Dove in order to
reduce toxicity and calcification of the tissue. Id. at 5.
D. Summary of Appellant’s Arguments
Appellant argues that Zilla teaches that Schiff bases reduce
calcification, whereas Dove teaches that Schiff bases cause tissue
calcification. Appeal Br. 8 (citing Zilla 541, 543; Dove ¶¶ 8, 35). Appellant
contends that Zilla and Schiff thus teach away from their combination, and
that the Examiner has engaged in impermissible hindsight construction to
pick and choose among isolated disclosures to arrive at the claimed
invention. Id. at 8–9; Reply Br. 3–4.
Appellant further contends that the Examiner’s conclusion was based
on a misconstruction of the chemistry that would result from the
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combination of Zilla and Dove, which would not achieve the benefits of
tissue hydration, flexibility and cell interactions, which were identified by
the Examiner as motivating the combination of references. Reply Br. 1–2.
E. Alleged Teaching Away
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.” Polaris Industries, Inc. v. Artic
Cat, Inc., 882 F.3d 1056 (Fed. Cir. 2018) (citing DePuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)
(quoting Ricoh Co., Ltd. v. Quanta Computer Inc., 550 F.3d 1325, 1332
(Fed. Cir. 2008))). A reference does not teach away when it does not
“criticize, discredit, or otherwise discourage” investigation into the invention
claimed. DePuy, 567 F.3d at 1327 (quoting In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004)).
Contrary to Appellant’s argument, we do not read Zilla to state that
Schiff bases per se reduce calcification. Rather, we agree with the Examiner
that Zilla states that Schiff bases may play a role in forming cross-links that
prevent or reduce calcification, such as by occupying space that calcium
could otherwise occupy. Ans. 7–8; Zilla 543–544. Dove teaches that Schiff
bases created by glutaraldehyde form potential calcium binding sites, and
that the Schiff bases can be reduced with sodium borohydride to prevent
attraction of calcium. Dove ¶¶ 8, 35. One would have understood that using
Schiff bases to form cross-links as taught by Zilla, followed by reducing the
Schiff bases as taught by Dove, would be useful in preventing or reducing
calcification. Thus, we agree with the Examiner that these teachings are not
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inconsistent with each other, nor do they “criticize, discredit or otherwise
discourage” each other or the claimed device. Consequently, we are not
persuaded by Appellant’s arguments that the combination of Zilla and Dove
teaches away from the claimed device.
F. Alleged Hindsight
Appellant’s hindsight argument is predicated on the teaching away
argument. Appeal Br. 9. As we do not find the teaching away argument
persuasive for the reasons explained, we likewise are not persuaded that the
Examiner engaged in improper hindsight. In this regard, we note that any
judgment on obviousness is in a sense necessarily a reconstruction based
upon hindsight reasoning, but so long as it takes into account only
knowledge which was within the level of ordinary skill in the art at the time
the invention was made, and does not include knowledge gleaned only from
Appellant’s disclosure, such a reconstruction is proper. See Ans. 9 (citing In
re McLaughlin, 443 F.2d 1392 (CCPA 1971)).
G. Alleged Misconstruction of Chemistry
Appellant disputes the Examiner’s conclusion that reduction of a
Schiff base ultimately converts an aldehyde to a hydroxyl group which may
be beneficial for tissue hydration, flexibility, and cell interactions. Reply Br.
1–2. Appellant argues that reduction of Schiff bases in Zilla with Dove’s
reducing agent would not result in hydroxyl groups as found by the
Examiner, but instead would result in creation of a secondary amine. Id. at
2. Appellant contends that the hydroxyl group in Dove is not provided by
reduction of the Schiff base but by ethanolamine reacting with caps of the
aldehyde associated with the tissue. Id.
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Appellant provides no evidence that the reduction of Zilla with
Dove’s reducing agent would result in the reaction that Appellant asserts, or
that the benefits identified by the Examiner would not be achieved.
Attorney argument is not evidence that could support Appellant’s view of
the reaction that occurs by combining Dove’s reducing agent with Zilla’s
chemistry. Icon Health and Fitness, Inc. v. Strava, Inc., 849 F.3d 1034,
1043 (Fed. Cir. 2017) (citing Gemtron Corp. v. Saint-Gobain Corp., 572
F.3d 1371, 1380 (Fed. Cir. 2009)).
H. Alleged Lack of Motivation
Appellant further argues that the combination of Zilla and Dove
would not achieve the benefits of tissue hydration, flexibility and cell
interactions identified by the Examiner as reasons to combine the references.
Reply Br. 2. Appellant provides no evidence for its view of the reaction that
occurs by combining Dove’s reducing agent with Zilla’s chemistry and,
thus, we are not persuaded by Appellant’s argument.
Even if we assume that Appellant is correct that the benefits of tissue
hydration, flexibility, and cell interactions would not result from the
combination of Zilla and Dove, Appellant’s argument does not address that
the Examiner’s rejections also relied on reduced toxicity and reduced
calcification as motivations to combine the references. Final Act. 5. As
Appellant has not shown these motivations to be in error, we find
Appellant’s argument unpersuasive for this additional reason.
I. Summary
For the foregoing reasons, we sustain the rejection of independent
claim 1 and dependent claims 2–5, 8–15 and 17–20, for which no separate
arguments were presented. See 37 C.F.R. § 41.37(c)(1)(iv), supra.
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CONCLUSION
The Examiner’s rejections of claims 1–5, 8–15, and 17–20 under
35 U.S.C. § 103 are affirmed.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 8–15,
17–20
103 Zilla, Dove 1–5, 8–15,
17–20

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