Edwards Lifesciences Corporation

Patent Trials and Appeals Board

Oct 21, 2020

14563866 - (D) (P.T.A.B. Oct. 21, 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.
14/563,866 12/08/2014 Jeffrey S. Dove HVTTS-6416US03 1049
30452 7590 10/21/2020
EDWARDS LIFESCIENCES CORPORATION
LEGAL DEPARTMENT
ONE EDWARDS WAY
IRVINE, CA 92614
EXAMINER
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
10/21/2020 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):
USDOCKET@edwards.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY S. DOVE and TARA J. TOD
Appeal 2020-0014871
Application 14/563,866
Technology Center 1600
Before FRANCISCO C. PRATS, TAWEN CHANG, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims related to
a method of improving the performance of a bioprosthetic implant by
selectively oxidizing antigenic carbohydrates and subsequently treating the
tissue with a secondary oxidizing agent. The Examiner rejected the claims
as obvious under 35 U.S.C. § 103(a). We heard oral argument on October 1,
2020. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Edwards
Lifesciences Corporation. Corrected Appeal Br. (filed July 30, 2019)
(“Appeal Br.”) 2.
Appeal 2020-001487
Application 14/563,866

2
CLAIMED SUBJECT MATTER
Claims 1, 13, 14, and 16–21 are on appeal. Final Act. 2. Claim 1, the
only independent claim on appeal, is illustrative of the claimed subject
matter and is reproduced below:
1. A method for improving the performance of a
bioprosthetic implant, the method comprising:
treating a bioprosthetic tissue with an oxidizing agent that
selectively oxidizes antigenic carbohydrates having vicinal
diols to produce free aldehyde or acid moieties on the antigenic
carbohydrate; and
subsequently treating the bioprosthetic tissue with a secondary
oxidizing agent to convert the free aldehyde moieties to acid
moieties.
Appeal Br. 12 (Claims Appendix).
REFERENCES
The Examiner relied upon the following references:
Name Reference Date
Torrianni US 2003/0118981 Al June 26, 2003
Davidson US 2008/0302372 A1 Dec. 11, 2008
Raghaven, “ECM Stabilization Strategies for Bioprosthetic Heart Valves
for Improved Durability,” Ph.D. diss., (Clemson University, 2008)
(“Raghaven”)
REJECTIONS
Claims 1, 13, 14, 16, 20, and 21 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Raghaven and Torrianni.2 Final Act. 3.

2 Although the heading in the Final Action for this rejection does not
mention claim 20, the Examiner’s analysis for the rejection addresses claim
20. See Final Act. 6–7. Accordingly, we include claim 20 in this rejection.
Appeal 2020-001487
Application 14/563,866

3
Claims 17–19 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Raghaven, Torrianni, and Davidson. Id. at 7.
OPINION
The same issues are dispositive of both obviousness rejections. See,
e.g., Appeal Br. 10–11 (with respect to rejection of claims 17–19, relying on
arguments made for rejection over Raghaven and Torrianni, without
additional arguments); Ans. 13. Accordingly, we address the rejections
together.
The Examiner found that “Raghaven is directed to methods for
stabilizing bioprosthetic heart valves for improving their durability by
employing agents that stabilize glycosaminoglycans (GAGs) by cross-
linking.” Final Act. 3. The Examiner found that Raghaven discloses that
“sodium metaperiodate (i.e. sodium periodate) is used to stabilize GAGs by
allowing the formation of aldehyde groups in the GAG chain, which then
react with other molecules in the valve tissue to achieve GAG fixation.” Id.
at 4–5 (citing, e.g., Raghaven 73–74). The Examiner found that Raghaven
does not teach treating the bioprosthetic tissue with a secondary oxidizing
agent as recited in claim 1, but does teach combining GAG fixation with
anti-calcification treatments to enhance stability of the bioprosthetic heart
valve. Id. at 4 (citing, e.g., Raghaven 77, 80), 5; Ans. 5, 10–11.
The Examiner found that Torrianni teaches anti-calcification
treatments to enhance stability of bioprosthetic heart valves, e.g., treating the
tissue with oxidizing agents such as sodium hypochlorite. Final Act. 4
(citing Torrianni at, e.g., ¶¶ 10, 11, 14). The Examiner found that
Appeal 2020-001487
Application 14/563,866

4
given the intention of Raghaven is to provide bioprosthetic
treatments that help reduce the calcification, and thus stabilize
the implant and extend its durability, and Torianni [sic] teaches
that bioprosthetic valvular calcification can be reduced by
treating the tissue with sodium hypochlorite (i.e. a sodium
chlorite), it would have been prima facie obvious to one having
ordinary skill in the art at the time of the invention to modify
the method of Raghaven, to include treating the tissue with a
secondary oxidizing agent comprising sodium hypochlorite in
order to further reduce calcification, as taught by Torianni [sic],
for the predictable result of successfully stabilizing the implant
and extending its durability, thus meeting the limitation of
claims 1 and 21.
Id. at 5. The Examiner further found that Torrianni “teaches the same
method step of providing the oxidizing agent sodium hypochlorite (a sodium
chlorite), as disclosed in the instant specification (paragraphs [0103]), thus
the method disclosed by Torianni [sic] would necessarily result in the
converting the free aldehyde moieties to acid moieties.”3 Id. at 6.
We agree with and adopt the above-summarized findings, and
determine that the Examiner has established a prima facie case of
obviousness of the appealed claims. We address Appellant’s arguments
below.

3 To the extent the Examiner suggests that the claim limitation “to convert
the free aldehyde moieties to acid moieties” has no patentable weight
because it “simply expresses the intended result of a process step positively
recited” (Final Act. 6), we disagree. The Examiner relies on MPEP
§ 2111.04, but that section relates to claim language that “does not require
steps to be performed.” MPEP § 2111.04(I). Here, we understand the final
limitation of claim 1 to require treating the bioprosthetic tissue with a
secondary oxidizing agent in a manner that effects conversion of free
aldehyde moieties to acid moieties.
Appeal 2020-001487
Application 14/563,866

5
Appellant correctly recognizes that Raghaven teaches stabilization of
bioprosthetic tissue via treatment with sodium metaperiodate to form
aldehyde groups, where the aldehyde groups then crosslink to other
molecules in the tissue. Appeal Br. 7; see also Raghaven 74. Appellant then
argues that “Raghaven teaches away from any additional treatment that
would eliminate the aldehyde groups,” such as a step of using a secondary
oxidizing agent to convert the aldehyde moieties to acid moieties as claimed.
Appeal Br. 8.
We are not persuaded by Appellant’s teaching away argument. The
prior art teaches 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” in the claim. Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731,
738 (Fed. Cir. 2013). Here, we find that Raghaven teaches toward, not away
from, anti-calcification treatments, and that Appellant has not persuasively
established that Raghaven teaches away from the specific anti-calcification
treatment taught in Torrianni.
Raghaven teaches that treatment of bioprosthetic tissue with fixatives
such as periodate “do[es] not prevent the enzyme mediated degradation of
GAGs completely.” Raghaven 75; see also id. at iii (“Crosslinkers such as
. . . sodium metaperiodate were tried as GAG-targeted fixatives; however,
they were unable to completely inhibit the enzyme mediated degradation of
GAGs.”). In view of the incomplete stabilization provided by chemical
fixatives such as periodate, Raghaven teaches adding an anti-calcification
treatment: “[s]tabilization of GAGs by enzyme inhibition strategy along
with anti-calcification treatments may eventually prevent both calcific and
Appeal 2020-001487
Application 14/563,866

6
non-calcific degeneration of valves thus extending their functional life.” Id.
at 77 (emphasis added); see also id. at 79 (discussing “GAG-targeted
fixation coupled with anti-calcification treatments” such as ethanol)
(emphasis added).
Torrianni teaches such an anti-calcification treatment. See, e.g.,
Torrianni ¶¶ 10, 11, 13, 14. It teaches that “[t]he composition containing an
oxidizing agent, such as sodium hypochlorite[,] may act to ‘inactivate’ the
activity of specific proteins such as kinases, phospatases [sic] and others
within the tissue matrices that may be essential for the initiation of the
calcification process.” Id. ¶ 40; see also id. ¶ 11 (“the method of the
invention may inhibit enzymes and other proteins (e.g., calcium binding
proteins) that are present within the tissue from performing their specific
functions”).
Thus, Raghaven teaches that fixatives such as periodate are unable to
completely inhibit the enzyme-mediated degradation of GAGs, and therefore
recommends addition of an anti-calcification treatment. Torrianni’s
treatment is consistent with Raghaven, in that it teaches an anti-calcification
treatment that is thought to inactivate kinases and phosphatases involved in
calcification. Torrianni ¶¶ 11, 40. On this record, Appellant has not
persuasively established that a skilled artisan would have avoided
Torrianni’s treatment for fear that it would interfere with “retaining the
aldehyde functionality of GAG to achieve the desired . . . fixation” (Appeal
Br. 7), particularly given Raghaven’s teaching that fixation with sodium
metaperiodate is incomplete4 and suggestion to add an anti-calcification

4 We note that the admission in the Specification that treating tissue with
periodate to generate aldehydes on GAG “result[s] in residual reactive
Appeal 2020-001487
Application 14/563,866

7
treatment to improve stability, and Torrianni’s teaching that the oxidizing
agent is thought to inactive kinases and phosphatases involved in
calcification. As such, on this record, Appellant has not persuasively
established that Raghaven teaches away from the specific anti-calcification
treatment taught in Torrianni.
Regarding dependent claims 16 and 21, Appellant argues that
“Torrianni’s disclosure of sodium hypochlorite (NaOCl) is distinguishable
from the claimed sodium chlorite (NaClO2), as these are two are distinct
compounds having distinct chemical formulas.” Appeal Br. 9. We are not
persuaded by Appellant’s argument, because it mischaracterizes the
language of claims 16 and 21. These claims recite that the secondary
oxidizing agent is “a sodium chlorite;” they do not recite merely “sodium
chlorite.” Id. at 13, 14 (emphasis added). Under the broadest reasonable
construction standard (see, e.g., In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997)), we agree with the Examiner that the phrase “a sodium chlorite”
“encompasses all types of sodium chlorites, including sodium hypochlorite,”
and that “the claims, as presently written do not exclude sodium
hypochlorite since the claims do not specifically recite that the secondary
oxidizing agent ‘is sodium chlorite’.” Ans. 13.
CONCLUSION
We affirm the rejection of claims 1, 13, 14, 16, 20, and 21 under
35 U.S.C. § 103(a) as being unpatentable over Raghaven and Torrianni.

aldehyde groups, which serve as potential calcium binding sites and thus
destabilize the tissue” (Spec. ¶ 6), appears to be consistent with Raghaven’s
teaching of incomplete stabilization following periodate treatment.
Appeal 2020-001487
Application 14/563,866

8
We affirm the rejection of claims 17–19 under 35 U.S.C. § 103(a) as
being unpatentable over Raghaven, Torrianni, and Davidson.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 13, 14,
16, 21
103(a) Raghaven,
Torrianni
1, 13, 14,
16, 20, 21

17–19 103(a) Raghaven,
Torrianni,
Davidson
17–19
Overall
outcome:
1, 13, 14,
16–21

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