HANCOCK JAFFE LABORATORIES, INC.

Patent Trials and Appeals Board

Jun 2, 2021

2021002265 (P.T.A.B. Jun. 2, 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.
15/711,314 09/21/2017 NORMAN JAFFE 072510/01020 8539
31013 7590 06/02/2021
KRAMER LEVIN NAFTALIS & FRANKEL LLP
INTELLECTUAL PROPERTY DEPARTMENT
1177 AVENUE OF THE AMERICAS
NEW YORK, NY 10036
EXAMINER
MATHEW, SEEMA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
06/02/2021 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):
dtorniali@kramerlevin.com
klpatent@kramerlevin.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

Ex parte NORMAN JAFFE
_______________

Appeal 2021-002265
Application 15/711,314
Technology Center 3700
________________

Before BENJAMIN D. M. WOOD, WILLIAM A. CAPP, and
JILL D. HILL, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 13, 14, and 17–23 as unpatentable under 35 U.S.C. § 103
over Duran and Rinaldi. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM, but designate our affirmance of claim 18 as a NEW
GROUND OF REJECTION pursuant to our discretionary authority under 37
C.F.R. § 41.50(b).

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Hancock Jaffe Laboratories, Inc., as
the applicant and real party in interest. Appeal Br. 3.
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THE INVENTION
Appellant’s invention is a biological valve. Spec. ¶ 2. Claim 13,
reproduced below, is illustrative of the subject matter on appeal.
13. A method of manufacturing a replacement venous
valve for a host vein in a subject, the method comprising:
obtaining a xenogeneic heart valve; and
excising a portion of the heart valve so as to include a
leaflet selected to provide adequate obstruction of the host vein
when a free edge of the selected leaflet is in an open position
once the portion of the heart valve is attached to the host vein.
THE REJECTION
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Duran2 non patent literature Mar. 1980
Rinaldi3 non patent literature June 1986
The following rejection is before us for review:4
Claims 13, 14, and 17–23 are rejected under 35 U.S.C. § 103 as being
unpatentable over Duran and Rinaldi.

2 Carlos M.G. Duran, M.D., Ph.D., et al., A new composite xenograft
monocusp patch for reconstruction of the right ventricular outflow tract:
A preliminary report, Vol. 7, BULLETIN OF THE TEXAS HEART INSTITUTE,
CARDIOVASCULAR DISEASES, No. 1, March 1980.
3 Raul Garcia-Rinaldi, M.D., Ph.D., et al., Femoral vein valve incompetence:
Treatment with a xenograft monocusp patch, Vol 3, JOURNAL OF VASCULAR
SURGERY, No. 6, June 1986.
4 A ground of rejection under 35 U.S.C. § 102 has been withdrawn by the
Examiner. Ans. 5–6.
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OPINION
Claims 13, 14, 17, and 19–23
Appellant argues claims 13, 14, 17, and 19–23 as a group. Appeal
Br. 7–16. Claim 13 is representative. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Duran discloses the invention substantially as
claimed except for disposing the prosthetic valve in a vein, for which the
Examiner relies on Rinaldi. Final Act. 5–6. The Examiner concludes that it
would have been obvious to a person of ordinary skill in the art at the time
of the invention to combine the teachings of Duran and Rinaldi to achieve
the claimed invention. Id. at 6. According to the Examiner, a person of
ordinary skill in the art would have done this to treat venous insufficiency in
a patient’s leg. Id.
Appellant argues that Duran is directed to the right ventricular outflow
tract of the heart, not legs. Appeal Br. 8. “Duran necessarily fails to
describe or suggest the claimed heart-to-vein reconstruction.” Id. Appellant
further argues that Rinaldi fails to disclose the use of a natural leaflet of a
xenogeneic heart. Id. “Rinaldi describes use of an artificial (e.g., man-
made) monocusp patch made of bovine pericardium . . . .” Id. According to
Appellant, a person of ordinary skill in the art would not consider it obvious
to combine the teachings of Duran and Rinaldi to achieve a venous valve
replacement as claimed. Id. at 9. Appellant accuses the Examiner of
engaging in improper hindsight analysis to combine the references in the
manner proposed in the rejection. Id.; Reply Br. 5. Appellant further argues
that the Examiner’s proposed modification would change Duran’s principle
of operation. Appeal Br. 10.
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We can quickly dispose of Appellant’s “change the principle of
operation” argument. The Examiner is merely relocating Duran from the
heart to the leg, not changing the way that it operates.
With respect to Appellant’s hindsight argument, the Examiner
explains that the rejection is based on established medical practices of using
a xenogeneic monocusp valve as demonstrated by Duran and Rinaldi.
Ans. 7. The Examiner finds that Duran discloses a monocusp valve excised
from a porcine heart valve for treating valvular deficiency in a pulmonary
outflow tract. Id. (citing Duran, Fig. 2, p. 58, ll. 1–6, p. 59, ll. 2–29). The
Examiner further finds that Rinaldi discloses a xenogeneic monocusp valve
for treating lower extremity blood flow insufficiency. Id. (citing Rinaldi
Figs. 2A–C, abstract, and p. 932, col. 2, ll. 11–26, and p. 933, ll. 18–26).
According to the Examiner, both references treat blood flow incompetency
using monocusp xenogeneic valves. Id. In the final rejection, the Examiner
concludes that it would have been obvious to combine the teachings of
Duran and Rinaldi “to mitigat[e] deep venous incompetency of the lower
extremities.” Final Act. 6. The Examiner’s reasoning and analysis is
sufficient to support the rejection. See In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006) (requiring an obviousness conclusion to be based on explicit
articulated reasoning with rational underpinning), cited with approval in
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The Examiner’s
reasoning, furthermore, is sufficient to overcome Appellant’s hindsight
argument. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016)
(explaining that a hindsight argument is of no moment where the Examiner
provides a sufficient, non-hindsight reason to combine the references).
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Appellant next argues that Duran “teaches away” from the present
claims. Appeal Br. 11; Reply Br. 3. There is no support for this argument in
the record. It is well settled that the “mere disclosure of alternative designs
does not teach away.” In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012).
Teaching away requires “clear discouragement” from implementing a
technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017).
Thus, a reference does not teach away if it merely discloses an alternative
invention but does not “criticize, discredit, or otherwise discourage”
investigation into the invention claimed. In re Fulton, 391 F.3d 1195, 1201
(Fed. Cir. 2004). Appellant presents no language from Duran that criticizes,
discredits, or discourages the use of porcine heart valve leaflets to remedy
venous insufficiency. See generally Appeal Br.; Reply Br. At most,
Appellant argues that the purposes for which Duran and the instant
application are used, i.e., heart versus leg vein valves, are “completely
different.” Appeal Br. 11; Reply Br. 4. In the context of the facts and
circumstances of the instant case, such does not equate to “teaching away.”
Next, Appellant argues that Rinaldi fails to cure the deficiencies of
Duran, because Rinaldi is directed to an artificial patch made of pericardium
tissues instead of a leaflet from a xenogeneic heart valve. Appeal Br. 12.
Appellant argues that “natural xenogeneic heart leaflets and bovine
pericardium tissue have very different tissue characteristics.” Id. at 13.
According to Appellant,
[A]n artificial heterologous patch made of pericardium has
more flexibility due to less tensile strength compared to a
natural heart leaflet. Therefore, one skilled in the art would
understand that Rinaldi’s artificial patch has more flexibility
and thus could be expected to effectively open and close the
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venous valve in responding to differing pressures (e.g., lower
pressure) in the deep venous system.
Id. Appellant further argues that it is “unexpected” that the free edge of a
natural porcine heart leaflet can respond to the low pressure environment in
a vein to provide an acceptable obstruction. Appeal Br. 15.
In response, the Examiner reminds Appellant that the rejection under
review is an obviousness rejection over a combination of references and that
Appellant cannot show non-obviousness by attacking references
individually. Ans. 9 (citing In re Keller, 642 F.2d 413 (CCPA 1981); In re
Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986)). This is a correct statement
and application of prevailing law. The Examiner explains:
Rinaldi was not used to teach how to create an artificial
monocusp patch, instead Rinaldi was used to teach a
xenogeneic monocusp valve for use in a different application
than the teaching of Duran. Rinaldi teaches the use of a
monocusp valve in the lower extremities, in venous veins,
specifically to mitigate blood flow insufficiency to the right
ventricular outflow tract.
Ans. 9.
Duran is directed to a xenograft monocusp patch for reconstruction of
the right ventricular outflow tract. Duran, Abstract. In Duran, porcine aortic
valve cusps are removed and trimmed to allow a cuff of aortic wall and
subaortic tissue. Id. at 59. Duran’s patch is constructed of: (1) a porcine
aortic valve cusp; (2) a Dacron-covered vitalium ring; and (3) a rectangular
patch of porcine pericardium tissue. Id. The aortic cusp is sutured to the
mesothelial aspect of the pericardium. Id. At surgery, the appropriate
monocusp size is selected according to the required enlargement of the
pulmonary annulus. Id. The pericardial patch is trimmed to allow an
adequate length and shape for the outflow tract, pulmonary trunk, and
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branches. Id. Duran reports that the described graft was successfully used
to treat a 12-year old girl suffering from tetralogy of Fallot. Id. at 59–64.
Rinaldi is directed to treatment for femoral vein valve incompetence.
Rinaldi, 932. Rinaldi reports the successful outcome of insertion of a
monocusp patch into the vein of a 36-year-old woman with primary vein
incompetence of the lower extremities. Id. The prosthesis used by Rinaldi
consists of an anatomically exact sinus of Valsalva made of bovine
pericardium mounted on a bovine pericardial patch. Id. at 934. The
xenograft monocusp patch was originally designed for treatment of right
ventricular outflow tract obstruction, such as that in tetralogy of Fallot.
Id. at 932, 934. In other words, Rinaldi’s leg vein prosthetic valve has
previously been successfully used in the exact same prosthetic heart valve
situation described in Duran. Compare id., with Duran, 59–64.
Having considered the competing positions of Appellant and the
Examiner, it is our opinion that the Examiner has the better position.
Appellant’s principal focus appears to be on the alleged differences in
environment in which the prosthetic valve functions. For example, much of
Appellant’s argument and analysis is devoted to the notion that a heart valve
operates in a relatively high-pressure environment whereas leg veins present
a relatively low-pressure environment. Appeal Br. 13–14. Appellant,
however, fails to address the fact that Rinaldi adapts a known, prosthetic
monocusp heart valve for use in a leg vein. Rinaldi, 932, 934.
Appellant’s arguments against the combinability of Duran and Rinaldi
primarily go the issue of whether a person of ordinary skill in the art would
have had a reasonable expectation of successfully treating leg vein
insufficiency with a porcine monocusp valve prosthesis. Appeal Br. 15–16.
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The obviousness inquiry requires a determination that a skilled artisan would
have been motivated to combine the teachings of the prior art references to
achieve the claimed invention, and that the artisan would have had a
reasonable expectation of success in doing so. Kinetic Concepts, Inc. v.
Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012). “The
reasonable expectation of success requirement refers to the likelihood of
success in combining references to meet the limitations of the claimed
invention.” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821
F.3d 1359, 1367 (Fed. Cir. 2016). In other words, “one must have a
motivation to combine accompanied by a reasonable expectation of
achieving what is claimed in the patent-at-issue.” Id.
“For obviousness under § 103, all that is required is a reasonable
expectation of success.” In re O'Farrell, 853 F.2d 894, 904 (Fed.
Cir. 1988). Thus, the expectation of success need not be absolute, only
“reasonable.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed.
Cir. 2007). The Federal Circuit rejects any requirement of conclusive proof
of efficacy for obviousness. Acorda Therapeutics, Inc. v. Roxane Labs.,
Inc., 903 F.3d 1310, 1333 (Fed. Cir. 2018). Here, the fact that Rinaldi
demonstrates that a prosthetic heart valve can be adapted for use in a leg
vein is sufficient for us to conclude that a person of ordinary skill in the art
would have had a reasonable expectation of success in adapting Duran’s
porcine monocusp patch for use in leg veins.
Appellant’s argument that it is “unexpected” that a porcine heart
leaflet can respond to a low-pressure environment in a vein amounts to little
more than unsubstantiated attorney argument. Appeal Br. 15. “It is well
settled that unexpected results must be established by factual evidence.
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Mere argument or conclusory statements in the specification does not
suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
An unexpected results analysis requires consideration of what a
skilled artisan would have expected. Pfizer 480 F.3d at 1371. Here,
Appellant provides no persuasive analysis, supported by facts from the
record, as to what a skilled artisan would or would not have expected in
using a porcine heart valve leaflet in a vein. Appellant merely argues that its
prosthetic valve can tolerate some degree of leakage or backflow. Appeal
Br. 15. We are at a loss to understand how Appellant’s lack of success in
completely controlling venous backflow promotes the non-obviousness of
the claimed subject matter. Indeed, the fact that backflow need not be
completely eliminated, if anything, contributes to the reasonable expectation
of success in adapting Duran to a leg vein application.
Appellant’s unsubstantiated attorney argument is effectively refuted
by the fact that Rinaldi’s prosthetic valve proved effective in both the
environment of a heart valve and the environment of a leg vein. Again, this
is sufficient to provide a skilled artisan with a reasonable expectation that
Duran’s prosthetic valve could be successfully used in a leg vein.
We have considered Appellant’s remaining arguments and find them
to be unpersuasive. The Examiner’s findings of fact are supported by a
preponderance of the evidence and the Examiner’s legal conclusion of
unpatentability is well founded. In view thereof, we sustain the Examiner’s
unpatentability rejection of claims 13, 14, 17, and 19–23.
Claim 18
Claim 18 depends directly from claim 17 and indirectly from claim 13
and adds the limitation: “wherein the selected leaflet is a noncoronary
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leaflet.” Claims App. The Examiner finds that Duran discloses a valve
where the selected leaflet is a noncoronary leaflet. Final Act. 6.
Appellant argues that neither Duran nor Rinaldi explicitly mentions
the use of a natural noncoronary leaflet as a replacement venous valve.
Appeal Br. 16–18. “Absent the teachings of Appellant's invention, it was
not foreseeable that a noncoronary leaflet of an aortic heart valve would be
suitable for the claimed method.” Id. at 17. In its Reply Brief, Appellant
accuses the Examiner of ignoring its Appeal Brief arguments concerning
claim 18 in the Answer. Reply Br. 8.
In the final rejection, the Examiner cites page 58, lines 2–16 of Duran
as providing evidentiary support for the noncoronary leaflet limitation. Final
Act. 6. The Examiner repeats this finding verbatim in the Answer. Ans. 4.
In the “Response to Argument” section of the Answer, the Examiner does
not explicitly discuss claim 18 or otherwise acknowledge that claim 18 is
separately argued by Appellant. See generally Ans. Otherwise, the
Examiner does generally mention that Duran uses a porcine leaflet. Ans. 6.
The Examiner finds that the appropriate monocusp heart valve size is
selected according to its intended use which depends on factors such as
patient size and the amount of diseased or affected area. Id. (citing Duran,
p. 59, ll. 2–9). We have reviewed the passages of Duran cited by the
Examiner and find insufficient evidence to support a finding that Duran
explicitly discloses selecting a noncoronary valve leaflet. Thus, the
Examiner’s findings, on their face, are insufficient to support the rejection.
Nevertheless, as previously discussed, Rinaldi demonstrates that a
prosthetic valve originally designed for use as a heart valve could be
successfully used in a leg vein. Duran’s prosthetic heart valve uses a single
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porcine aortic valve cusp. Duran, 59. The cusp is “removed and trimmed”
to provide a cuff of aortic wall and subaortic tissue. Id. Duran is otherwise
silent as to whether the particular cusp selected is the noncoronary cusp. It
is known that the human aortic valve includes a left coronary cusp, a right
coronary cusp, and a noncoronary cusp.5 It is also known that human and
porcine aortic valves are similar, but not identical. 6
In selecting which aortic valve cusp to use in a monocusp valve, the
skilled artisan is faced with a finite number of choices, namely, three. It is
well settled that when there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable solutions,
skilled artisans have good reason to pursue known options within their
technical grasp. KSR, 550 U.S. at 421. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill and
common sense. Id. Here, Duran teaches the use of a porcine aortic cusp and
Rinaldi teaches that a known prosthetic valve for treatment of right
ventricular outflow obstruction can be successfully used as a valve in a leg
vein. Duran is silent on which cusp should be used. Duran certainly does
not explicitly encourage the selection of the right or left coronary cusps to
the exclusion of the noncoronary cusp. Under the circumstances, it is our
opinion that evaluation and selection of the noncoronary cusp instead of

5 Atlas of Human Cardiac Anatomy, http://www.vhlab.umn.edu/atlas/
anatomy-tutorial/cardiac-valve-nomenclature.shtml (last accessed
May 18, 2021).
6 EK Sim, et al., Comparison of human and porcine aortic valves. Clin
Anat. 2003 May;16(3):193–6. doi: 10.1002/ca.10149. PMID: 12673813.
Abstract located at https://pubmed.ncbi.nlm.nih.gov/12673813/ (last
accessed May 18, 2021).
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either the left or right coronary cusps entails no more than ordinary skill. In
other words, determining whether which of the three known valve cusps is
appropriate for a particular product application involves no more than
routine experimentation, which falls within the ambit of ordinary skill.
In view of the foregoing, we sustain the Examiner’s unpatentability
rejection of claim 18. However, inasmuch as our findings and determination
arguably change the thrust of the Examiner’s original rejection, we designate
our affirmance as a NEW GROUND OF REJECTION. See In re
Biedermann, 733 F.3d 329, 337 (Fed. Cir. 2013) (explaining that applicant is
entitled to fair opportunity to react to the thrust of a rejection).
CONCLUSION
Claims
Rejected
35
U.S.C. §
References Affirmed Reversed New
Ground
13, 14,
17-23
103 Duran, Rinaldi 13, 14,
17-23
18
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b), which provides that “[a] new ground of rejection pursuant
to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
AFFIRMED; 37 C.F.R. § 41.50(b)