Ex Parte Kessler et al

Board of Patent Appeals and Interferences

Jul 7, 2010

11432943 (B.P.A.I. Jul. 7, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL D. KESSLER, HENRIK S. RASMUSSEN,
and KAREN W. CHU
__________

Appeal 2009-014956
Application 11/432,943
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating cancer, which the Examiner has rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2009-014956
Application 11/432,943

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STATEMENT OF THE CASE
Claims 1-21, 26, 42-77, 82-104, and 109-111 are on appeal. The
dependent claims have not been argued separately and therefore stand or fall
with the independent claim on which they depend. 37 C.F.R.
§ 41.37(c)(1)(vii). Claims 1 and 50 are representative and read as follows:
1. A method for treating unresectable, locally advanced pancreatic
cancer in a human, which method consists of:
(a) administering to the human a dose of a pharmaceutical
composition comprising (i) a pharmaceutically acceptable carrier and (ii) a
viral vector, wherein the viral vector is an adenoviral vector comprising a
nucleic acid sequence encoding a human TNF-α and operably linked to a
promoter, wherein the dose comprises 4 x 107 to 4 x 1012 particle units (pu)
of adenoviral vector, at least once in a therapeutic period of 1-10 weeks,
(b) administering a dose of ionizing radiation to the human over the
duration of the therapeutic period, and
(c) administering a dose of one or more chemotherapeutics to the
human over the duration of the therapeutic period, whereby the unresectable,
locally advanced pancreatic cancer in the human is treated.

50. A method of treating glioma in a human consisting of:
(a) administering to the human a dose of a pharmaceutical
composition comprising (i) a pharmaceutically acceptable carrier and (ii) a
viral vector, wherein the viral vector is an adenoviral vector comprising a
nucleic acid sequence encoding a human TNF-α and operably linked to a
promoter, wherein the dose comprises 4 x 107 to 4 x 1012 particle units (pu)
of adenoviral vector, at least once in a therapeutic period of 1-10 weeks, and
(b) administering a dose of ionizing radiation to the human over the
duration of the therapeutic period, whereby the glioma in the human is
treated.

Claims 56 and 83, the only other independent claims, are identical to
claim 1 except that they are directed to methods of treating “locally
advanced resectable esophageal cancer” and “locally advanced resectable
rectal cancer,” respectively.
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Issue
The Examiner has rejected claims 1-21, 26, 42-77, 82-104, and 109
under 35 U.S.C. § 103(a) as obvious in view of Park,2 McDonnell,3
Blaszkowsky,4 and Kroep5 (Ans. 6). The Examiner has also rejected claims
110 and 111 as obvious in view of the above references, combined with
Wheeler6 or Seregni,7 respectively (Ans. 22, 24). Since the same issue is
dispositive to all of the rejections, we will consider them together.
The Examiner finds that Park suggests treating pancreatic cancer,
esophageal cancer, and colorectal cancer by “administering Adenovirus
particles encoding the TNF-α gene with chemotherapy and radiotherapy
(page 409, lines 13-14) because ‘Ad.Egf.TNF.11D may enhance the local
effects of combination chemoradiation therapy’” (Ans. 6) and that
McDonnell suggests the dosage and time period recited in the claims (Ans.
7-8). The Examiner therefore concludes that the method of claims 1, 56, and
83 would have been obvious based on the combined teachings of the
references (id. at 20).

2 J.O. Park et al. Transcriptional control of viral gene therapy by cisplatin,
110 J. CLIN. INVEST. 403-410 (2002)
3 McDonnell et al., US 6,899,870, May 31, 2005
4 L. Blaszkowsky, Treatment of Advanced and Metastatic Pancreatic
Cancer, 3 FRONTIERS IN BIOSCIENCE e214-225 (1998)
5 J.R. Kroep et al., Experimental drugs and drug combinations in pancreatic
cancer, 10 ANNALS OF ONCOLOGY SUPPL. 4, S234-S238 (1999)
6 J.M.D. Wheeler et al. Quantification of Histologic Regression of Rectal
Cancer After Irradiation, 45 DIS. COLON RECTUM 1051-1056 (2002)
7 E. Seregni et al. Diagnostic and Prognostic Tumor Markers in the
Gastrointestinal Tract, 20 SEMINARS IN SURGICAL ONCOLOGY 147-166
(2001)
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With regard to claim 50, the Examiner concludes that treating glioma
using Park’s method would have been obvious because Park suggests
treating localized tumors and “many gliomas are localized tumors” (Ans. 6).
Alternatively, the Examiner finds that “the additional limitation of glioma is
taught by McDonnell et al, ‘glioblastoma . . .’ (column 4, lines 64-65)” (Ans.
11) and treating glioma therefore would have been obvious (id. at 21).
Appellants contend that none of the references individually discloses
all of the limitations of the claimed method (Appeal Br. 7-88) and that
McDonnell would not have suggested the relevant limitations (id. at 7 and 9-
10). With regard to claim 50, Appellants argue that Park does not disclose
or suggest treating glioma and the Examiner’s rationale amounts to
speculation (id. at 8-9).
The issues presented are: Does the evidence support the Examiner’s
finding that the cited references would have made obvious a method of
treating the cancers recited in the claims by administering the combination
of active agents recited in the claims?
Findings of Fact
We adopt the Examiner’s findings of fact (Non-final Rejection mailed
Sept. 2, 2008, pages 5-19; Ans. 6-20).
Analysis
We agree with the Examiner that the cited references would have
made obvious the method of independent claims 1, 50, 56, and 83. Park
discloses clinical trials treating a variety of locally advanced cancers,

8 Citations are to the corrected “Argument” section of the Appeal Brief, filed
March 9, 2009.
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including pancreatic cancer and esophageal cancer, with a combination of an
adenoviral vector encoding human TNA-α (Ad.Egr.TNF.11D) and
radiotherapy (Park 409). Park also discloses that the combination of
Ad.Egr.TNF.11D and cisplatin (a chemotherapeutic) was effective against
rat colon adenocarcinoma cells (Park 403, abstract). Finally, Park suggests
that Ad.Egr.TNF.11D “may enhance the local effects of combination
chemoradiation therapy” (Park 4099). We agree with the Examiner that
these teachings would have suggested treating locally advanced esophageal,
pancreatic, or rectal cancer with the combination recited in claims 1, 56, and
83 in order to enhance the local effect of combination chemoradiation
therapy for those cancers. While Park does not specify treating unresectable
locally advanced pancreatic cancer or resectable locally advanced
esophageal or rectal cancer, Appellants have provided no reasoned basis for
concluding that the resectability of esophageal, pancreatic, or rectal cancer
would have affected the applicability of Park’s method.
With regard to claim 50, we agree with the Examiner that it would
have been obvious to apply Park’s method to glioblastoma, 10 because both
Park and McDonnell teach that their methods can be used to treat pancreatic
or esophageal cancer (Park 409; McDonnell, col. 4, l. 62 to col. 5, l. 3), and
McDonnell discloses that its method can also be used to treat glioblastoma.
We also agree with the Examiner’s finding that McDonnell would have
suggested the dosage and therapeutic period recited in the claims (Ans. 8)

9 This passage is illegible in the record copy of Park, but appears in the
original (accessible at www.jci.org/articles/view/15548).
10 We understand the Examiner’s position to be that glioblastoma is a type of
glioma. Appellants have pointed to no evidence that contradicts the
Examiner’s position.
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and his conclusion that claims 1, 50, 56, and 83 as a whole would therefore
have been obvious in view of the cited references.
Appellants argue that none of the references individually teaches the
claimed methods (Appeal Br. 7-8). This argument is unpersuasive of error
because it ignores “what the combined teachings of the references would
have suggested to one of ordinary skill in the art.” In re Young, 927 F.2d
588, 591 (Fed. Cir. 1991).
Appellants also argue that McDonnell would not have suggested the
limitations that are missing from Park because
in order to arrive at the invention defined by the appealed
claims, one of ordinary skill in the art would have to disregard
(i) the disclosure of co-administration of two vectors, one of
which may encode TNF-α, or administration of a single vector
encoding two genes, one of which can be TNF-α, (ii) the
disclosure of numerous genes to include in the viral vector and
select TNF-α, (iii) the disclosure of treating numerous cancer
types (none of which include unresectable, locally advanced
pancreatic cancer (LAPC), locally advanced resectable
esophageal cancer, or locally advanced resectable rectal cancer)
and instead select unresectable LAPC, locally advanced
resectable esophageal cancer, locally advanced resectable rectal
cancer, or glioma, (iv) the disclosure of numerous doses of
adenoviral vector and instead select a dose of 4 x 107 [sic, 107]
to about 4 x 1012 [sic, 1012] pu, (v) the disclosure of numerous
therapeutic periods and instead select a therapeutic period of 1-
10 weeks, and (vi) the disclosure of administering numerous
types of additional cancer therapeutic agents and instead select
ionizing radiation and chemotherapy.
(Appeal Br. 7-8.)
This argument is not persuasive. As to Appellants’ point (i), the
claims recite a vector “comprising” a TNF-α gene and therefore encompass
vectors that encode TNF-α and another gene. Appellants’ points (ii) and (vi)
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are taught or suggested by Park. As to Appellants’ point (iii), for the reasons
discussed above, we conclude that treatment of the specific cancers recited
in the claims would have been obvious based on the combined disclosures of
Park and McDonnell. As to Appellants’ points (iv) and (v), McDonnell
discloses ranges for the viral dosage and length of treatment that overlap the
ranges recited in the claims. “A prima facie case of obviousness typically
exists when the ranges of a claimed composition overlap the ranges
disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003).
With regard to claim 50, Appellants argue that Park does not disclose
a method of treating glioma (Appeal Br. 9) and that the Examiner’s
reasoning – that Park teaches treating localized tumors and glioma is a
localized tumor – is speculation (id. at 8).
This argument is also unpersuasive. Appellants have pointed to no
evidence of record that contradicts the Examiner’s finding that glioma is a
localized tumor. In any case, the Examiner finds that McDonnell suggests
treating glioma with Park’s combination of anti-cancer treatments and
Appellants have not provided any basis for doubting this finding.
Conclusion of Law
The evidence supports the Examiner’s finding that the cited references
would have made obvious a method of treating the cancers recited in the
claims by administering the combination of active agents recited in the
claims.
SUMMARY
We affirm all of the rejections on appeal.
Appeal 2009-014956
Application 11/432,943

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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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