Michael P. Zahalsky

Patent Trials and Appeals Board

Sep 10, 2019

15158101 - (D) (P.T.A.B. Sep. 10, 2019)

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.
15/158,101 05/18/2016 Michael P. Zahalsky DN0294 4685
119489 7590 09/10/2019
Vivex Biologics Group, Inc.
David L. King
5131 NE County Road 340
High Springs, FL 32643
EXAMINER
FAN, LYNN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
09/10/2019 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):
davidlkingsr@windstream.net
uspto@dockettrak.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL P. ZAHALSKY
____________

Appeal 2018-007421
Application 15/158,1011
Technology Center 1600
____________

Before FRANCISCO C. PRATS, TAWEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims directed to
methods of treating Peyronie’s disease. The Examiner rejected the claims
for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellant identifies the inventor, Michael P. Zahalsky, as the real party in
interest. Br. 3.
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Application 15/158,101

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STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 9 and 12 under 35 U.S.C. § 103(a) as being unpatentable over
Williams,2 Injection,3 Tunica,4 and Wegman5 (Ans. 3–7).
Claim 9, the sole independent claim on appeal, is representative and
reads, as follows:
9. A method of treating a subject with Peyronie’s disease
comprising the steps of:
providing a solution of a composition comprising at least
one isolated mesenchymal stem cell, at least one component of
extracellular matrix, and at least one growth factor; and
injecting the composition within the tunica albuginea of a
subject in need of treatment for Peyronie’s disease with at least
50 microliter volumes of the composition injected directly into
scar tissue or plaque configured as a disorganized collagen
structure with irregular vascular structure to induce
reorganization of the collagen and induce vasculogenesis,
wherein the at least one component of extracellular matrix
includes collagenase and collagen.
Br. 18.
DISCUSSION
The Examiner’s Rejection
The Examiner cited Williams as describing a method of treating
Peyronie’s disease, the method involving injecting mesenchymal stem cells

2 US 2011/0218396 A1 (published Sept. 8, 2011).
3 Peyronie’s disease: Diagnostic Work-up and Treatment, www.urology-
textbook.com (2010) (date supplied by Examiner in Notice of References
Cited (entered February 23, 2017)).
4 Peyronie’s disease: Causes and Symptoms, www.urology-textbook.com
(2010) (date supplied by Examiner).
5 US 6,022,539 (issued Feb. 8, 2000).
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Application 15/158,101

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as well as a collagen matrix, as recited in claims 9 and 12. Ans. 3–4. The
Examiner conceded that Williams did not expressly describe injecting its
therapeutic compositions into the tunica albuginea, or the
Peyronie’s-associated plaque, as recited in claims 9 and 12, but concluded
that it would have been obvious to inject Williams’s compositions into the
site required by the rejected claims in view of Injection and Tunica. Id. at 4–
5.
The Examiner cited Wegman as evidence that it would have been
obvious to inject collagenase alongside Williams’s cells and collagen, as
recited in Appellant’s claims 9 and 12, “since collagenase is well known for
treating Peyronie’s disease, as evidenced by Wegman.” Id. at 5. Moreover,
the Examiner reasoned, “at the time of the claimed invention, one of
ordinary skill in the art would have been motivated by the teachings of
Wegman to include collagenase in the composition of Williams with a
reasonable expectation for successfully treating a subject with Peyronie’s
disease.” Id. at 5–6.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
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 KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, id. at 415, it also reaffirmed the importance of
determining “whether there was an apparent reason to combine the known
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elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis
added).
Thus, as the Federal Circuit has since explained, “obviousness
concerns whether a skilled artisan not only could have made but would have
been motivated to make the combinations or modifications of prior art to
arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d
1064, 1073 (Fed. Cir. 2015).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
We are not persuaded that the preponderance of the evidence supports
the Examiner’s conclusion of obviousness. In particular, we are not
persuaded that the cited references would have suggested including
collagenase in Williams’s collagen-containing therapeutic compositions.
Claim 9 recites injecting into the tunica albuginea “a solution” that
contains at least one isolated mesenchymal stem cell, at least one growth
factor, and “at least one component of extracellular matrix . . . wherein the at
least one component of extracellular matrix includes collagenase and
collagen.” Br. 16 (emphasis added). Thus, claim 9 recites a single injected
solution that must contain both collagen and collagenase.
As the Examiner found, Williams discloses an injectable tissue or cell
transplant that contains corpus cavernosum cells, stromal vascular fraction
(SVF) cells, and a biocompatible three-dimensional matrix on which, or in
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which, the cells may be disposed. See Williams ¶ 31; see also id. ¶ 63 (SVF
cells include mesenchymal stem cells).
As the Examiner found, and as required by Appellant’s claims,
Williams discloses that the three-dimensional tissue scaffold used in its
methods can be formed of collagen. See id. ¶ 200. As the Examiner found,
and as required by Appellant’s claims, Williams discloses that Peyronie’s
disease is among the penile defects that may be treated with its cell-
containing compositions. See id. ¶ 266.
Although Williams does not describe using collagenase to treat
Peyronie’s disease, Wegman discloses that collagenase administration is
effective to treat that disease. See Wegman, abstract. In particular, Wegman
discloses that, in one patient, three collagenase injections in four days were
sufficient to allow rupture of a Peyronie’s plaque, with significant plaque
softening after the second injection, ultimately resulting in a 60% decrease
in penile curvature. See id. at 3:35–50. Wegman discloses that “[t]wenty-
two patients have been treated under this regimen and all but one have been
satisfied.” Id. at 3:51–52.
We are not persuaded that a skilled artisan, advised by Wegman that
collagenase degrades collagen to the degree that Peyronie’s plaques are
significantly disrupted structurally in vivo, would have been motivated to
include collagenase in an injected solution that also contained William’s
collagen-containing three-dimensional tissue scaffold. To the contrary,
given Wegman’s teaching that collagenase degrades collagen to the degree
that Peyronie’s plaques are significantly disrupted after injection, a skilled
artisan would have reasonably inferred that collagenase would not have been
desirable to include in Williams’s injected collagen-containing solution. See
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KSR, 550 U.S. at 418 (noting that “a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”).
The fact that neither Williams nor Wegman expressly teaches that
collagenase would act on the collagen present in the injected solution (see
Ans. 9) does not persuade us that a skilled artisan would have failed to
recognize that it would be undesirable to include Wegman’s collagenase in
Williams’s collagen-containing solution, particularly given Wegman’s
teaching of collagenase’s efficacy in degrading Peyronie’s plaques in vivo.
See id. at 421 (“A person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.”).
Because we are not persuaded, for the reasons discussed, that the
combination of Williams and Wegman references would have suggested
preparing and injecting a solution having all of the components required by
Appellant’s claim 9, we reverse the Examiner’s obvious rejection of claim 9,
as well its dependent claim 12.

SUMMARY
For the reasons discussed, we reverse the Examiner’s rejection of
claims 9 and 12 under 35 U.S.C. § 103(a) as being unpatentable over
Williams, Injection, Tunica, and Wegman.

REVERSED