Ex Parte Chvatchko et al

Patent Trial and Appeal Board

Sep 30, 2016

12791052 (P.T.A.B. Sep. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121791,052 06/01/2010 Yolande Chvatchko
50828 7590 10/04/2016
DAVIDS, RESNICK
NIXON PEABODY LLP
100 SUMMER STREET
BOSTON, MA 02110-2131
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
057878-000015-C 1917
EXAMINER
JIANG, DONG
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
10/04/2016 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):
bostonpatent@nixonpeabody.com
ipairlink@nixonpeabody.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YOLANDE CHVATCHKO, ALAIN TEDGUI, and
ZIAD MALLAT 1
Appeal2015-004170
Application 12/791,052
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
NEW, Administrative Patent Judge.
1 Appellants state the real parties-in-interest are Merck Serono SA and Yeda
Research and Development Company Ltd. App. Br. 3.
Appeal2015-004170
Application 12/791,052
DECISION ON APPEAL
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Non-Final Rejection of claims 9, 18, 19, 21, 24, and 25 2 as
unpatentable under 35 U.S.C. § 103(a) as being obvious over the
combination of Sims et al. (US 2002/0098185 Al, July 25, 2002) ("Sims"),
Novick et al. (US 6,605,280 Bl, August 12, 2003) ("Novick"), and Palumbo
et al., Peripheral Vascular Disease and Diabetes, 401-08, in DIABETES IN
AMERICA, Ronald Aubert, ed. (2d ed. 1995).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to the use of IL-18 binding protein to
increase tissue perfusion in patients having symptoms of gangrene and/or
ulcer of the limb resulted from limb ischemia. Abstract.
REPRESENTATIVE CLAIM
Appellants argue the claims together. App. Br. 9. Claim 9 is
representative and recites:
9. A method for stimulating neovascularization in an
individual having symptoms of gangrene and/ or ulcer of the limb
resulted from limb ischemia
the method comprising administering to the individual
having symptoms of gangrene and/or ulcer an effective tissue
perfusion increasing amount of a composition comprising an IL-
18 binding protein and a pharmaceutically acceptable carrier.
2 Claims 1-18, 10-17, 20, 22, and 23 are canceled. Ap. Br. 17.
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Application 12/791,052
App. Br. 17.
ISSUE
Appellants argue the Examiner erred because the combination fails to
disclose, suggest, and/or provide a reasonable expectation of success for the
invention recited in independent claim 9. App. Br. 9.
ANALYSIS
Appellants argue the cited combined prior art references fail to either
teach or suggest that IL-18BP could be used to stimulate neovascularization.
App. Br. 9. Appellants contend that Sims focuses on inflammatory
processes and is silent with respect to "neovascularization." Id. at 10 (citing,
e.g., Sims i-fi-162-62). According to Appellants, there is no suggestion or
teaching that IL-18 antagonists can be used to stimulate neovascularization
in any context, much less treat gangrene and/ or limb ulcers via such a
mechanism. Id. Appellants contend that, although these conditions may
result from inflammation, the claims are not directed to prevention of these
conditions, but rather to treatment of such conditions once they have
occurred. Id. Appellants assert that the claims are specifically directed to
stimulating neovascularization in a condition that requires such correction
(e.g., already developed gangrene and/or ulcer of the limb). Id.
With respect to the Examiner's finding that Sims teaches IL-18
antagonists for the treatment of "vascular occlusion" and that the art teaches
that subjects with vascular occlusion can develop gangrene or ulcers,
Appellants argue that treatment of a primary disease has no necessarily
assumed relationship to treatment of secondary diseases. App. Br. 11.
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Application 12/791,052
Consequently, Appellants argue, there would be no reasonable expectation
of success in treating gangrene and limb ulcers, regardless of their
pathological origin, with a treatment for vascular occlusion. Id. Appellants
assert that this is particularly the case when the art that is alleged to suggest
the use of IL-18 antagonists for the treatment of vascular occlusion, in the
same paragraph, indicates that IL-18 antagonists do not have the activity
which is necessary for the treatment of gangrene and limb ulcers.
Finally, Appellants point to a prior art reference, Christy C. Park, et
al., Evidence of IL-18 as a Novel Angiogenic Mediator, 167 J. IMMUNOL.
1644-1653 (2001) ("Park"), which they append as Appendix A to their
Appeal Brief. App Br. 13. Appellants argue Park teaches that IL-18, rather
than IL18BP (i.e., IL-18 Binding Protein, an IL-18 antagonist), is an
angiogenic mediator. Id. Therefore, Appellants contend, the prior art
teaches against using IL-18BP at the point when an inflammatory disease
has already resulted in reduction of blood vessels. Id. According to
Appellants, a person of ordinary skill in the art would have found the pro-
angiogenic nature of IL-18BP to be unexpected, as it was counter to the
teachings presented by Park. Id.
The Examiner responds that it is well known in the art that most
arterial vascular occlusive conditions, including cerebral, coronary, and
peripheral artery occlusions, are commonly the result of inflammation. Ans.
6. (citing, e.g., R. Ross, The pathogenesis of atherosclerosis: a perspective
for the 1990s, 362(6423) NATURE, 801-09 (1993) ("Ross"). Furthermore,
the Examiner finds it was well-known in the contemporary art that IL-18 is a
pro-inflammatory factor, with increased production seen in atherosclerotic
plaques, and that IL-18 may directly control both mononuclear cell
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Application 12/791,052
accumulation and cell death within the plaque (two important determinants
of plaque disruption and thrombosis). Id. at 6-7.
The Examiner finds Sims discusses the role of IL-18 in inflammation,
and the use of IL-18 antagonists as treatment for inflammatory conditions
such as vascular occlusion, including cerebral artery occlusion. Ans. 7.
Consequently, the Examiner concludes, it would have been obvious to an
artisan of ordinary skill to use an IL-18 antagonist such as Sims' IL-18BP to
reduce inflammation in a peripheral vascular occlusion, which can cause
gangrene due to ischemia. Id. The Examiner states that, although Sims does
not recognize the effect of IL-18BP in stimulating neovascularization, it is
not necessary that the prior art suggest the combination to achieve the same
advantage or result discovered by Appellants. Id. (citing In re Kahn, 441
F.3d977, 987 (Fed. Cir. 2006).
The Examiner also finds that, although Appellants have recognized
another advantage of using IL-18BP (viz., stimulating neovascularization) in
the disease treatment as taught by Sims, such a property would flow
naturally from following the suggestion of the prior art since the method
taught by the combined teachings of the prior art references comprises the
same active ingredient and method steps, and encompasses the same patient
population as that of the present invention. Ans. 11 (citing Ex parte Obiaya,
227 USPQ 58, 60 (BPAI 1985); In re Wiseman, 596F.2d1019 (C.C.P.A.
1979).
In rejecting claims under 35 U.S.C. § 103, the Examiner bears the
initial burden of presenting a prima facie case of obviousness. See In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). We are not persuaded by the
Examiner that the combination of Sims, Novick, and Palumbo teach or
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suggest the method claimed, which requires administering an effective tissue
perfusion increasing amount of an IL-18 binding protein and a
pharmaceutically acceptable carrier to the individual having symptoms of
gangrene and/or ulcer carrier. The Examiner does not address the use of an
effective tissue perfusion increasing amount of IL-18 binding protein to
individuals exhibiting symptoms of gangrene; rather, the Examiner finds the
references teach the use of IL-18 antagonists in the treatment of
inflammatory diseases that can result in vascular occlusion, which may
result in ischemia and, consequently, gangrene and it would be obvious to
treat peripheral arterial occlusion in light of the "common pathology" with
central artery occlusions: "atherosclerosis, which is an inflammatory
condition." We find, contrary to the Examiner's implicit finding, that using
IL-18 antagonists to reduce the inflammatory response caused by IL-18
(Sims i-f 12) is different than effecting increased tissue perfusion.
The Examiner does not point to any of the cited prior art references as
teaching or suggesting that administration of an effective amount of IL-18
binding protein can or would increase tissue perfusion , nor can we find any
such teaching in the references. 3 Moreover, Park, as cited by Appellants,
3 The Examiner points to Z. Mallat et al., Interleukin-18/Interleukin-l 8
Binding Protein Signaling Modulates Ischemia-Induced Neovascularization
in Mice Hindlimb, 91 CIRC. REs. 441--448 (2002), a post-filing reference, as
teaching the uncertainty of the angiogenic effects of IL-18 and/ or IL-18BP
and also teaching IL-18BP inhibits plaque formation and may therefore
promote neovascularization in cases of ischemic injury. See Mallat, Abstr.
We take the Examiner's point, but a reference published post-filing and not
communicating what was known in the art at the time of filing cannot
establish what the prior art taught or suggested to a person of ordinary skill
at the time of filing. See In re Wilson, 311 F .2d 266, 269 (CCP A 1962).
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teaches that IL-18, and not IL-18 antagonists as claimed by Appellants, can
mediate angiogenesis, i.e., the development of new blood vessels, in a model
of rheumatoid arthritis. See Park, Abstr. The development of new blood
vessels would likely lead to increased tissue perfusion. Thus, we do not
agree with the Examiner's implicit conclusion that a person of ordinary skill
would have expected there would be an amount of an IL-18 antagonist that
would be effective to increase tissue perfusion ..
Consequently we reverse the Examiner's rejection of claims 9, 18, 19,
21, 24, and 25.
DECISION
The Examiner's rejection of claims 9, 18, 19, 21, 24, and 25 as
unpatentable under 35 U.S.C. § 103(a) is reversed.
REVERSED
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