Ex Parte Vale et al

Patent Trial and Appeal Board

Sep 7, 2016

12887272 (P.T.A.B. Sep. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/887,272 09/21/2010
52034 7590 09/09/2016
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
AUSTIN, TX 78746
FIRST NAMED INVENTOR
Wylie Vale
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.
CLFR.P0240US .D 1 2173
EXAMINER
SKELDING, ZACHARY S
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
09/09/2016 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WYLIE VALE, CRAIG A. HARRISON, and PETER C. GRA Y1
Appeal2014-001928
Application 12/887,272
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RICHARD J. SMITH, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
using a protein, called "Cripto," to inhibit the activity of activin-B, a protein
involved in the regulation of cell growth. The Examiner rejected the claims
for lack of enablement.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses that activin-B is a member of the
transforming growth factor b (TGF-b) superfamily of proteins. Spec. 1-2.
The Specification discloses that "[ d]isruption or dysregulation of activin and
1 Appellants state that the "real party in interest for this appeal is the
assignee Research Development Foundation." App. Br. 3.
Appeal2014-001928
Application 12/887,272
TGF-b signaling is associated with multiple pathological states including
carcinogenesis." Id. at 1.
The Specification discloses that "Cripto is a developmental
oncoprotein that is highly expressed in human tumors but not their normal
tissue counterparts. Overexpression of Cripto transforms mammary
epithelial cells in vitro. The present invention shows that Cripto can
antagonize activin and TGF-b signaling." Id. at 10.
In particular, the Specification describes "a method of using a Cripto
mutant that lacks the EGF [epidermal growth factor-like] domain to
selectively antagonize activin-B signaling." Id. at 16. The Specification
states:
Id.
Results disclosed herein show that the EGF-like domain of
Cripto is required to antagonize activin-A, activin-B and TGF-b
while the CFC [Cripto, FRL-1, Cryptic] domain [of Cripto] is
sufficient to block activin-B but not activin-A or TGF-b.
Therefore [a] Cripto mutant that lacks the EGF domain will be
a usefi.11 research tool to distinguish the relative importance of
activin-A as opposed to activin-B signaling in various
biological contexts.
Specifically, in Example 8, in cells transfected with a vector encoding
a mutant Cripto ("DEGF") lacking the EGF domain, the mutant Cripto was
shown to be capable of inhibiting activin-B signaling in a system using a
luciferase indicator. See id. at 26 ("[T]he Cripto DEGF mutant blocked
roughly half of the luciferase activity induced by activin-B (Figure 10).").
The Specification discloses:
Blocking TGF-b/activin signaling may have therapeutic
benefit in several contexts including, but are not limited to,
cancer, wound healing and liver regeneration .... [D]uring
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Application 12/887,272
later stages of tumorigenesis tumor cells secrete TGF-b and
activin that cause effects favoring further tumor growth and
metastasis due to their effects on blood vessels, cells of the
immune system and organs which are targets for metastasis.
Directing Cripto expression or administering soluble forms of
Cripto to these sites may help to slow tumor progression.
Id. at 36.
The sole rejection before us for review is the Examiner's rejection of
claims 36, 37, 39, 40, and 51-54 under 35 U.S.C. § 112, first paragraph, for
failure to comply with the enablement requirement. Ans. 2---6.
Claim 36 is the sole independent claim on appeal and reads as follows
(Br. 13):
36. A method of selectively inhibiting activin-B
signaling, the method comprising administering a Cripto mutant
that lacks the EGF domain or has a mutation of the threonine
residue that is the site of fucosylation of the EGF domain.
The Examiner explains that, due to Appellants' election without
traverse in response to a species election requirement, the claims on appeal
only have been examined to the extent "they read on a method of selectively
inhibiting activin-B signaling, ... wherein said species of Cripto mutant, 1)
is 'soluble,' 2) is 'a human Cripto protein,' and 3) 'lacks the EGF domain."'
Final Action 2.
We, therefore, limit our analysis of claims 36, 37, 39, 40, and 51-54
to the patentability of the elected species, and the extent to which the claims
read on them. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
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Appeal2014-001928
Application 12/887,272
ENABLEMENT
In rejecting claims 36, 37, 39, 40, and 51-54 for lack of enablement,
the Examiner contends that the broadest reasonable interpretation of
independent claim 3 6, when viewed in light of the Specification,
encompasses in vivo treatments in which activin-B signaling is inhibited.
Ans. 2--4. The Examiner concedes that the Specification enables such an in
vivo method encompassed by claim 3 6--the method of treating a male
patient in need of disrupted spermatogenesis, recited in claim 55. Id. at 2, 4
(withdrawing enablement rejection as to claim 55).
The Examiner concludes, however, that, when viewed in light of the
Specification, claim 36 also encompasses the in vivo treatment of "a cancer
patient, or a patient in need of wound healing or liver regeneration." Id. at 4
(citing Spec. 36 (Example 16)). As to those in vivo treatments, the Examiner
contends:
[A] s stated in the prior Office Actions, []. . . with respect to
generally administering a cripto mutant that lacks an EGF
domain to any subject so as to selectively inhibiting activin-B
signaling, in any setting, for example, in cancer, the skilled
artisan would be quite uncertain as to the ability of such a
treatment to have a beneficial effect given that activin A and
activin B were generally considered to be tumor suppressors.
Ans. 4 (internal quotations omitted; citing Schnepp, 2 McPherson3).
2 Robert Schnepp and Xianxin Hua, A Tumor-Suppressing Duo[,] TGF/J and
Activin Modulate a Similar Transcriptome, 2 Cancer Biol. & Ther. 171-172
(2003) ("Schnepp").
3 S.J. McPherson et al., Growth inhibitory response to activin A and B by
human prostate tumour cell lines, LNCaP and DUI 45, 154 J. Endocrinol.
535-545 (1997) ("McPherson").
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Appeal2014-001928
Application 12/887,272
As stated in Jn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prim a 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.
We agree with Appellants that a preponderance of the evidence does
not support the Examiner's prima facie case of lack of enablement.
As our reviewing court has explained, the Examiner "bears an initial
burden of setting forth a reasonable explanation as to why it believes that the
scope of protection provided by that claim is not adequately enabled by the
description of the invention provided in the specification of the application."
In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993).
"The scope of enablement ... is that which is disclosed in the
specification plus the scope of what would be known to one of ordinary skill
in the art without undue experimentation." National Recovery Technols. Inc.
v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999).
While the Specification must enable the skilled artisan to practice the
full scope of the claimed subject matter, " [ i ]t is well settled that patent
applicants are not required to disclose every species encompassed by their
claims, even in an unpredictable art." In re Vaeck, 947 F.2d 488, 496 (Fed.
Cir. 1991 ). Moreover, a claim does not lack enablement merely because it
encompasses inoperative embodiments. Atlas Powder Co. v. E.I. du Pont
De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984).
Rather, as our reviewing court has noted:
[T]here must be sufficient disclosure, either through illustrative
examples or terminology, to teach those of ordinary skill [in the
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Appeal2014-001928
Application 12/887,272
art] how to make and how to use the invention as broadly as it
is claimed. This means that the disclosure must adequately
guide the art worker to determine, without undue
experimentation, which species among all those encompassed
by the claimed genus possess the disclosed utility.
Vaeck, 947 F.2d at 496 (footnote omitted).
In the instant case, claim 36, the sole independent claim on appeal, as
examined, recites a method of selectively inhibiting activin-B signaling by
administering a soluble Cripto mutant protein that lacks the EGF domain.
App. Br. 13. As Appellants point out (id. at 5---6), and the Examiner does not
dispute (see Ans., generally), the Specification, as noted above, discloses an
example in which administration to cells of a Cripto mutant lacking the EGF
domain results in inhibition of activin-B signaling. Spec. 26 (Example 8)
("[T]he Cripto DEGF mutant blocked roughly half of the luciferase activity
induced by activin-B (Figure 10) .... ").
The Specification, thus, undisputedly provides an in vitro working
example which demonstrates the selective inhibition of activin-B signaling
by the claimed Cripto mutant, precisely the process recited in claim 36. In
addition, as the Examiner concedes effectively by withdrawing the
enablement rejection as to claim 55, the Specification enables an in vivo
embodiment encompassed by claim 3 6---treatment of a male patient in need
of disrupted spermatogenesis. See Ans. 2, 4. Accordingly, because the
Specification includes undisputedly enabling disclosures of both in vivo and
in vitro embodiments of the process recited in claim 36, the Examiner does
not persuade us that the Specification fails to adequately enable the full
scope of the subject matter encompassed by claim 36. See Johns Hopkins
Univ. v. CellPro, Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) ("The
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Application 12/887,272
enablement requirement is met if the description enables any mode of
making and using the invention.") (quoting Engel Indus., Inc. v. Locliformer
Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
Because the Specification includes undisputedly enabling disclosures
of both in vivo and in vitro embodiments of the process recited in claim 36,
the Examiner's identification of a potentially inoperative embodiment
encompassed by claim 36 (see, e.g., Ans. 6 (treating "any cancer patient")),
does not persuade us that the Specification fails to adequately enable claim
36. See Atlas Powder v. DuPont, 750 F.2d at 1576 (a claim does not lack
enablement merely because it encompasses inoperative embodiments); see
also In re Anderson, 471F.2d1237, 1242 (CCPA 1973) ("It is always
possible to put something into a combination to render it inoperative. It is
not the function of the claims to exclude all such matters but to point out
what the combination is.").
Thus, we are not persuaded that the Examiner has advanced
persuasive evidence, or otherwise explained adequately why, based on the
relevant disclosures in the Specification, including those noted above, an
ordinary artisan would have been unable to "determine, without undue
experimentation, which species among all those encompassed by the
claimed genus possess the disclosed utility." In re Vaeck, 947 F.2d at 496.
Accordingly, for the reasons discussed, we are not persuaded that a
preponderance of the evidence supports the Examiner's prima facie case of
lack of enablement as to claim 36. We, therefore, reverse the Examiner's
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Appeal2014-001928
Application 12/887,272
rejection of claim 36, and its dependent claims 37, 39, 40, and 51-54, for
lack of enablement under 35 U.S.C. § 112, first paragraph,.
REVERSED
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