Ex Parte Gurtner et al

Patent Trial and Appeal Board

Oct 31, 2016

13706186 (P.T.A.B. Oct. 31, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/706, 186 12/05/2012 Geoffrey C. Gurtner
77974 7590 11/02/2016
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
1900 University Avenue
Suite 200
East Palo Alto, CA 94303
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.
STAN-892 8885
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
11/02/2016 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@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEOFFREY C. GURTNER, MICHAEL T. LONGAKER, and
VICTOR W. WONG1
Appeal2015-006004
Application 13/706, 186
Technology Center 1600
Before ERIC B. GRIMES, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for reducing scarring which have been rejected for failing to comply
with the written description requirement, as anticipated, and as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as the Board of Trustees,
Leland Stanford Junior University. Br. 1.
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Application 13/706, 186
STATEMENT OF THE CASE
The present invention is directed to a method for reducing the
formation of scars at a wound site comprising administering an effective
amount of an inhibitor of focal adhesion kinase ("PAK"). Spec. i-f 13. The
F AK inhibitor is administered at the wound site for a period of time
sufficient to reduce scarring. Id.
Claims 1, 3-16, and 18-24 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A method of reducing scarring during healing of a skin
wound, comprising: administering to a subject with a skin
wound a pharmaceutical formulation comprising an effective
dose of an inhibitor that specifically inhibits focal adhesion
kinase (F AK), for a period of time sufficient to reduce scarring
as compared to a healed wound of an untreated subject.
The claims stand rejected as follows:
Claims 1, 3-16, and 18-20 stand rejected under 35 U.S.C. § 112, first
paragraph for failing to comply with the written description requirement.
Claims 1, 3-7, 9-16, 19, and 202 stand rejected under 35 U.S.C.
§ 102( e) as anticipated by Rossini. 3
2 The Examiner originally rejected claim 22 as anticipated by Rossini, but
later withdrew that rejection. Ans. 9.
3 Rossini, US 2011/0009332 Al, published Jan. 13, 2011 ("Rossini").
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Application 13/706, 186
Claims 1, 3-16, and 18-24 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Rossini in view of Klemm4 in further view of Slack-
Davis5 and Jennings. 6
THE WRITTEN DESCRIPTION REJECTION
Issue
In rejecting claims 1, 3-16, and 18-20 under 35 U.S.C. § 112, first
paragraph for failing to comply with the written description requirement, the
Examiner finds that the claims recite subject matter that is not described in
the Specification is such a way to convey to one skilled in the art that the
inventors had possession of the claimed invention. Final Act. 3. The
Examiner goes on to find that "[t]he metes and bounds of the genus have not
been appropriately defined. The mere fact that Applicant may have
discovered one type of drug to be an inhibitor of F AK in ... reducing
scarring during skin wound is not sufficient to claim the entire genus." Final
Act. 4. The Examiner also finds that
applicant has not described a reasonable number of members of
the genus now claimed, but rather has presented the public with
an idea of using an inhibitor that specifically inhibits F AK.
Thus one would need to perform an assay that might identify
some agents that fall within the scope of the claim. Of course,
depending on what agents are used in the screening assay, it
may well identify none.
4 Klemm et al., US 4,191,743, issued Mar. 4, 1980 ("Klemm").
5 Slack-Davis et al., Cellular Characterization of a Novel Focal Adhesion
Kinase Inhibitor, 282 J. Bio. Chem. 14845-14852 (2007) ("Slack-Davis").
6 Jennings, US 2009/0214474 Al, published Aug. 27, 2009 ("Jennings").
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Final Act. 8. The Examiner concludes the claims do not comply with the
written description requirement. Id.
Appellants contend the Specification teaches F AK' s role in scar
formation and that PF-573228 effectively inhibits PAK. Br. 3--4.
Appellants go on to argue that F AK inhibitors are known in the art and that
one skilled in the art could determine which compounds can be used in the
claimed method. Br. 4--5.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 1, 3-16, and 18-
20 do not comply with the written description requirement.
Findings of Fact.
FF 1. The Specification states:
A number of F AK inhibitors are known and used in the art.
Nonlimiting examples include PF-573,228; PF-562,271; PAK
Inhibitor 14, bortezomib; (for example see Cabrita et al. (2011)
Mol. Oncol. 5(6):517-26; Ko et al. (2010) Anticancer Agents
Med Chem 10(10):747-52; Li and Hua (2008) Adv. Cancer Res
101 :45-61; WO 2008/115 3 69 which describes inhibitors of
F AK as derivatives of a 5-substituted 2,4-diaminopyridine; WO
2003/035621 which describes protein kinase inhibitors; and
U.S. Patent no. 7,067,522 which describes 2,4,DI (hetero-)
arylamino (-oxy)-5-substituted pyrimidines as inhibitors of
F AK, each of which is herein individually and specifically
incorporated by reference.) Inhibitors of interest include small
molecule inhibitors, as well as biologicals such as antibodies,
RNAi, antisense, peptide inhibitors and peptidomimetics, and
the like.
Spec. i131.
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Principles of Law
A "sufficient description of a genus [] requires the disclosure of either
a representative number of species falling within the scope of the genus or
structural features common to the members of the genus so that one of skill
in the art can 'visualize or recognize' the members of the genus." Ariad
Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en
bane).
Analysis
We agree with Appellants that claims 1, 3-16, and 18-20 satisfy the
written description requirement. The present Specification demonstrates
far more than "an idea of using an inhibitor that specifically
inhibits F AK" as stated in the Office Action. Rather, it is
demonstrated by multiple approaches that F AK is involved in
scar formation and that scar formation is reduced when the
activity is specifically inhibited. These teachings, coupled with
known specific inhibitors of F AK, provide one of skill in the art
with ample evidence that Applicants were in possession of the
invention.
Br. 4--5.
The Examiner contends that Appellants have not shown sufficient
species to support the genus claims. Ans. 10-11. We are not persuaded.
Appellants have disclosed a number of compositions that are known F AK
inhibitors. FF 1. This listing of known F AK inhibitors, coupled with the
teachings of the Specification tying F AK to scar formation, would lead one
skilled in the art to understand that Appellants had possession of the
invention at the time the instant application was filed.
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Conclusion of Law
We conclude that the Examiner has not established that claims 1, 3-
16, and 18-20 do not comply with the written description requirement of
35 U.S.C. § 112, first paragraph.
THE ANTICIPATION REJECTION
Issue
In rejecting claims 1, 3-7, 9-16, 19, and 20 as anticipated by Rossini,
the Examiner finds that Rossini teaches a method for treating a skin wound
by administering an effective amount of a proteasome inhibitor such as
bortezomib. Final Act. 9. The Examiner finds that bortezomib is the same
compound as that taught by the instant Specification as being a F AK
inhibitor. Id. Thus, Rossini anticipates the rejected claims. Id.
Appellants contend that bortezomib is not a specific inhibitor of F AK
but rather is a general inhibitor of multiple proteins including proteasomes.
Br. 5. Appellants go on to argue that proteasomes are structurally and
functionally different from F AK and that there is no reason to extrapolate
from one to the other. Br. 6-7.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claim 1 is anticipated by
Rossini under 35 U.S.C. § 102(e).
Findings of Fact
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
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FF2. Rossini teaches a method of treating a wound to control
scarring by administering an effective amount of a proteasome inhibitor to
the skin. Rossini, i-f 8.
FF3. Bortezomib is a proteasome inhibitor which can be used in the
method of Rossini. Rossini i-f 4 7.
FF4. Rossini teaches administering bortezomib for up to 28 days so
as to reduce scarring. Rossini i-fi-154, 69, 73, and 74.
FF5. The Specification teaches that bortezomib is a PAK inhibitor.
Spec. i-f 31.
Principles of Law
"Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference." In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
Where ... the claimed and prior art products are identical or
substantially identical ... the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. ... [The]
fairness [of the burden-shifting] is evidenced by the PTO' s
inability to manufacture products or to obtain and compare
prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
Analysis
Claim 1 is representative of the rejected claims and is directed to a
method for reducing scarring by applying an effective amount of a F AK
inhibitor to a wound for a time sufficient to reduce scarring.
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We agree with the Examiner that claim 1 is anticipated by Rossini.
Rossini teaches applying bortezomib, a F AK inhibitor, to a skin wound in
order to control scarring. FF2-5. Rossini teaches applying the bortezomib
for a period of time sufficient to reduce scarring. FF4. See also Spec. i-f 54
(sufficient time can vary from 1 day to 3 weeks). Thus, Rossini teaches all
of the limitations of claim 1. See Rowe v. Dror, 112 F.3d 473, 478 (Fed.
Cir. 1997) ("Where ... a patentee defines a structurally complete invention
in the claim body and uses the preamble only to state a purpose or intended
use for the invention, the preamble is not a claim limitation.").
Appellants argue that bortezomib is not a specific inhibitor of F AK;
thus, Rossini does not anticipate the claims. We are unpersuaded.
Appellants' Specification specifically lists bortezomib as a F AK inhibitor
that can be used in the practice of the invention. FF5. Appellants have
offered no persuasive evidence to show that claim 1 does not encompass the
use ofbortezomib as an PAK inhibitor. In re Best, 562 F.2d at 1255.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claim 1 is anticipated by Rossini under 35 U.S.C. § 102(e).
Claims 3-7, 9-16, 19, and 20 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
THE OBVIOUSNESS REJECTION
Issue
In rejecting claims 1, 3-16, and 18-24 as obvious, the Examiner finds
that Rossini teaches reducing of scarring by treating a wound with an
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effective amount of bortezomib, a F AK inhibitor. Final Act. 11. The
Examiner also finds that Slack-Davis teaches the use of PF-573228 for
wound healing. Final Act. 12. The Examiner concludes that it would have
been obvious to one skilled in the art to substitute PF-573228 for bortezomib
as they both are used for wound healing. Final Act 12-13.
Appellants contend that Rossini does not teach F AK inhibition but
looks to a different protein for a different purpose. Br. 8. Appellants argue
that Rossini does not teach the specific agents other than bortezomib. Id.
With respect to claims 22-24, Appellants argue that Slack-Davis does not
teach the use of PF-573228 to reduce scar formation and that the other
references do not teach the use of a specific inhibitor of F AK. Id
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claims 1, 3-16, and 18-
24 would have been obvious over Rossini combined with Klemm, Slack-
Davis, and Jennings under 35 U.S.C. § 103(a).
Findings of Fact
The following findings are included for emphasis and reference
convemence.
FF6. Slack-Davis teaches that PF-573228 is a PAK inhibitor. Slack-
Davis 14845.
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Principles of Law
A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teaching of the
prior art." In re Ochiai, 71F.3d1565, 1572 (Fed. Cir. 1995).
"Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination." Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352,
1360 (Fed. Cir. 2011). "Rather, obviousness requires the additional showing
that a person of ordinary skill at the time of the invention would have
selected and combined those prior art elements in the normal course of
research and development to yield the claimed invention." Id.
Analysis
We agree with the Examiner that the subject matter of claim 1 would
have been obvious to one skilled in the art at the time the invention was
made. As discussed above, Rossini teaches the use of bortezomib to treat
wounds, as required by claim 1. FF2-3. Claims 3-16 and 18-20 were not
argued separately and fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Appellants argue that Rossini does not teach the use of a F AK
inhibitor and is directed to a different protein. Br. 7. We are unpersuaded.
As discussed above, Appellants have specifically identified bortezomib as an
F AK inhibitor. Appellants have offered no persuasive evidence that
bortezomib does not act as a F AK inhibitor.
With respect to claims 22-24, Appellants have the better position.
While Slack-Davis teaches that PF-573288 is a PAK inhibitor, there is not a
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teaching of its use to treat wounds. The passage cited by the Examiner
references an in vitro wound healing assay, however, on closer examination,
the assay used in Slack-Davis is related to cell migration and not the healing
of wounds. Thus we agree with Appellants that the Examiner has not
pointed to any persuasive evidence that one skilled in the art would have
been motivated to substitute PF-573228 for bortezomib in the method taught
by Rossini.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1, 3-16, and 18-20 would have been obvious over
Rossini combined with Klemm, Slack-Davis, and Jennings under 35 U.S.C.
§ 103(a).
We conclude that the Examiner has failed to establish that claims 22-
24 would have been obvious over Rossini combined with Klemm, Slack-
Davis, and Jennings under 35 U.S.C. § 103(a).
SUMMARY
We reverse the rejection of claims 1, 3-16, and 18-20 under
35 U.S.C. § 112, first paragraph for failing to comply with the written
description requirement.
We affirm the rejection of claims 1, 3-7, 9-16, 19, and 20 under
35 U.S.C. § 102(e) as anticipated by Rossini.
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We affirm the rejection of claims 1, 3-16, and 18-20 under 35 U.S.C.
§ 103(a) as unpatentable over Rossini in view of Klemm in further view of
Slack-Davis, and Jennings.
We reverse the rejection of claims 22-24 under 35 U.S.C. § 103(a) as
unpatentable over Rossini in view of Klemm in further view of Slack-Davis,
and Jennings.
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).
AFFIRMED-IN-PART
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