Ex Parte Weiss

Board of Patent Appeals and Interferences

Jun 15, 2012

10867951 (B.P.A.I. Jun. 15, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ROBERT H. WEISS
____________

Appeal 2011-009891
Application 10/867,951
Technology Center 1600
____________

Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 2, 9, 40, 41, 43,
and 44 (App. Br. 7). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method for: (1) inhibiting cyclin-
dependent kinase-mediated cell growth and proliferation in (claim 2), (2)
inhibiting a cancer associated with abnormal cell growth and proliferation in
(claims 9, 43, and 44), (3) inducing apoptosis of (claim 40) vascular smooth
muscle cells. In addition claim 41 is directed to a method for inhibiting
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Application 10/867,951

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production of matrix protein by a cell. Claim 2 is representative and is
reproduced in the “CLAIMS APPENDIX” of Appellant‟s Brief.

Claims 2, 9, 40, 41, 43, and 44 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Ross,
1
Paul,
2
Gorospe „97,
3

and Gorospe „96.
4

We affirm.
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellant‟s invention relates to methods . . . for regulating cell
growth and proliferation, mediated by cyclin dependent kinases, by
inhibiting p21
Waf1/Cip1
(Spec. 1: 17-18).
FF 2. Ross suggests a method for inhibiting cell growth that comprises
subjecting cells to a treatment which induces a WAF-1 dependent pathway
and administering antisense WAF-1 oligonucleotides to the cells (Ans. 4-5).
FF 3. Ross suggests that “the antisense oligonucleotides targeting WAF-1
are complementary to and capable of hybridizing to a WAF1 mRNA
transcript and act[ ] as a WAF1 inhibitor” (id. at 5).
FF 4. Ross suggests that the method is “useful only with cells in which the
WAF1 (p21/Cip1) gene is being expressed” (id.).

1
Ross et al., WO 97/03681, published February 6, 1997.
2
Paul et al., US 2005/0214295 A1, published September 29, 2005.
3
Myriam Gorospe, et al., p21
Waf1/Cip1
protects against p53-mediated
apoptosis of human melanoma cells, 14 Oncogene 929-935 (1997).
4
Myriam Gorospe et al., Role of p21 in Prostaglandin A2-mediated Cellular
Arrest and Death, 56 Cancer Research 475-479 (1996).

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FF 5. Paul suggests a method for treating cancer that comprises
administering a therapeutically effective amount of a catalytic antibody in
combination with an antisense oligonucleotide targeting p21 (id. at 5-6).
FF 6. The combination of Ross and Paul fails to suggest the treatment of
vascular smooth muscle cells (id. at 6).
FF 7. Gorospe ‟97 suggests that “p21 (WAF1/Cip1) expression has been
implicated in the survival response” or factor “against p53 mediated
apoptosis in vascular smooth muscle cells” and “that therapies aimed at
preventing the expression of p21 may prove most successful for the
elimination of cancer cells”(id.).
FF 8. Gorospe ‟96 suggest “that strategies to preferentially block p21
expression in tumor cells could lead to enhanced antitumor activity of
chemotherapeutic agents” (id.).
FF 9. Examiner finds that Nakanishi5 “does not address whether the WAF-
1 dependent pathway [w]as . . . induced in the . . . human fibroblast treated
with the p21 antisense” (id. at 11).
FF 10. Examiner finds that Appellant‟s evidence of unexpected results
“comprising the administration of antisense oligonucleotides of specific
nucleotide sequence to mouse breast cancer cells” are “not commensurate in
scope with the instant claims” (id.).

5
Ross cites and discusses Nakanishi (see Ross 3: 24-29). Appellant refers to
Nakanishi as it is cited and discussed in Ross (see App. Br. 15, citing
Appellant‟s “Amendment filed August 24, 2009 beginning at page 11; see
also Appellant‟s August 24, 2009 Amendment 11 (“Nakanishi et al. (1995)
(discussed and cited in Ross)).
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ANALYSIS
Based on the combination of Ross, Paul, Gorospe „97, and Gorospe
‟96 Examiner concludes that, at the time of Appellant‟s claimed invention, it
would have been prima facie obvious to a person of ordinary skill in this art
to modify the method suggested by the combination of Ross and Paul with
Gorospe‟97 and „Gorospe ‟96 to obtain a method for inhibiting cyclin-
dependent kinase-mediated cell growth and proliferation in vascular smooth
muscle cells from a mammalian subject (see Ans. 7).
Appellant relies on Nakanishi to establish that “administration of a
p21 antisense in normal human fibroblasts resulted in promoting cell
proliferation and not inducing cell death” (App. Br. 15). Accordingly,
Appellant contends that “[t]his field was highly unpredictable” at the time of
Appellant‟s claimed invention (id.). We are not persuaded.
As Examiner explains, Ross suggests a method for inhibiting cell
growth that comprises subjecting cells to a treatment which induces a WAF-
1 dependent pathway and administering antisense WAF-1 oligonucleotides
to the cells (FF 3). As Examiner further explains, there is no suggestion in
Nakanishi that a WAF-1 dependent pathway was induced in the human
fibroblast treated with the p21 antisense (FF 9). Accordingly, Appellant
fails to establish an evidentiary basis on this record to support a conclusion
that Ross‟ methodology would have led to unpredictable results when
applied to different cell that express p21.
We acknowledge Appellant‟s contentions regarding unexpected
advantages, but find that the preponderance of evidence falls in favor of
Examiner‟s conclusion that the evidence of unexpected results is “not
commensurate in scope with the instant claims” (FF 10).
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CONCLUSION OF LAW
The preponderance of evidence on this record supports a conclusion
of obviousness. The rejection of claim 2 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ross, Paul, Gorospe „97, and Gorospe
„96 is affirmed. Claims 9, 40, 41, 43, and 44 are not separately argued and
fall together with claim 2. 37 C.F.R. § 41.37(c)(1)(vii).

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

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