Ex Parte Dalziel et al

Patent Trial and Appeal Board

Dec 12, 2016

13650274 (P.T.A.B. Dec. 12, 2016)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/650,274 10/12/2012 Gena Dalziel P4651R1 5921
9157 7590 12/14/2016
GENENTECH, INC.
1 DNA WAY
SOUTH SAN FRANCISCO, CA 94080
EXAMINER
CORNET, JEAN P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
12/14/2016 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):
pair_roche@firsttofile.com
docketing-uspto-d@gene.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GENA DALZIEL, BRIAN JAMES DEAN,
MARK JASON DRESSER, ADAM FRYMOYER,
SCOTT NAYLOR HOLDEN, JIN YAN JIN,
JOSEPH ALAN WARE, and LESLIE Z. BENET
Appeal 2016-000202
Application 13/650,2741
Technology Center 1600
Before ULRIKE W. JENKS, ELIZABETH A. LaVIER, and
TAWEN CHANG, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek reversal of the
Examiner’s rejection of claims 1, 3, 4, 6, 9, and 10. We have jurisdiction
under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
1 Appellants state the real parties in interest are Genentech, Inc. and the
Regents of the University of California. Br. 2.
Appeal 2016-000202
Application 13/650,274
BACKGROUND
The Specification describes “methods of treating pharmacological-
induced hypochlorhydria in cancer patients with a re-acidification
compound.” Spec. 7:13—14. Claims 1 and 10, the independent claims, are
illustrative:
1. A method of treating a patient with a hyperproliferative
disorder comprising administering to the patient a re­
acidification compound selected from betaine hydrochloride
and glutamic acid hydrochloride, and GDC-0941 having the
formula:
GDC-0941;
wherein the patient has received-a gastric acid-reducing
therapeutic selected from a proton-pump inhibitor, an H2-
receptor antagonist, and an antacid.
10. A method of increasing the bioavailability of GDC-0941,
having the formula:
"H"
GDC-0941;
comprising coadministering to a patient receiving a gastric acid-
reducing therapeutic agent, an effective amount of a re­
acidification compound effective to enhance the bioavailability
of GDC-0941.
2
Appeal 2016-000202
Application 13/650,274
Br. 8—9 (Claims Appendix).
REJECTION MAINTAINED ON APPEAL
Claims 1,3,4, 6, 9, and 10 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Chuckowree,2 Ogawa,3 Naunton,4 and Knapp.5 Ans. 3.
DISCUSSION
The Examiner’s findings regarding the § 103(a) rejection are set forth
on pages 3—8 of the Final Action. As these findings pertain to understanding
the Examiner’s rejection of illustrative claims 1 and 10,6 the Examiner cites
Chuckowree as teaching treatment of disorders arising from abnormal cell
growth, function, or behavior, including gastric cancer, with a compound
having the same structure as GDC-0941. See Final Action 4 (citing
Chuckowree claims 1, 22, 24,129). Further, Naunton, which discloses that
a significant number of patients diagnosed with gastric cancer undergo long­
term anti-ulcer treatment, with an H2-antagonist or proton-pump inhibitor,
2 Chuckowree et al., US 2008/0076768 Al, published Mar. 27, 2008.
3 Oji et al., Expression of the Wilms ’ Tumor Gene WT1 in Solid Tumors and
its Involvement in Tumor Cell Growth, 90 Jpn. J. Cancer Res. 194 (1999)
(English Abstract only). Appellants and the Examiner both refer to this
reference as “Ogawa,” the name of the second author. For consistency, we
do the same. From the record, it appears that the Examiner relies on the
Abstract of Ogawa, which is in English, rather than the whole article. See
Final Action 4.
4 Naunton et al., Overuse of Proton Pump Inhibitors, 25 J. Clinical Pharm.
& Therapeutics 333 (2000).
5 Knapp et al., Modification of Gastric pH with Oral Glutamic Acid
Hydrochloride, 10 Clinical Pharmacy 866 (1991).
6 The Examiner cites Ogawa as evidence that gastric cancer is a solid tumor,
as is relevant to claim 6. See Final Action 4 (citing Ogawa Abstract).
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Application 13/650,274
prior to their cancer diagnosis. See id. at 4—5 (citing Naunton 334). Due to
reduced stomach acidity, Naunton reports that patients taking proton-pump
inhibitors are susceptible to bacterial enteritis. See id. at 5 (citing Naunton
334). Knapp teaches that hypochlorhydria (physiological or
pharmacologically-induced decrease in gastric acid secretion) “may alter the
dissolution and absorption of certain drugs and dosage forms that have pH-
dependent release characteristics.” Id. at 5 (citing Knapp 866). Knapp
further teaches dosages and regimens of oral glutamic acid hydrochloride
that can be used to lower gastric pH and enhance drug absorption, and
suggests “plasma gastrin levels should be monitored in patients receiving
long-term treatment.” Id. (citing Knapp 867).
The Examiner finds that it would have been obvious to one of
ordinary skill in the art at the time of the invention “to modify the generic
gastric cancer patient population taught by Chuckowree et al to include
patients receiving proton-pump inhibitors such as the ones taught by
Naunton et al.” Final Action 5—6. Naunton’s teaching that many patients
with gastric cancer had long-term anti-ulcer treatment with an H2-antagonist
or proton-pump inhibitor prior to diagnosis would have provided a
reasonable expectation of success. Id. at 6. Further, in view of Knapp, the
ordinarily skilled artisan would have reasonably expected success in
administering glutamic acid hydrochloride to re-acidity the stomach to
physiological pH. Id. Although the Examiner recognizes that the prior art
does not teach increased bioavailability of GDC-0941 in the presence of a
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Application 13/650,274
re-acidification compound, as recited in claim 10, see Final Action 6,7 the
Examiner notes that this is the result of an administration step, and “[sjince
the claimed administration steps are taught by the prior art, these results
would necessarily be achieved,” id.
Appellants first argue that the Examiner’s application of the
references “seems misdirected.” Br. 5. This assertion is supported only by
equally general allegations that the cited references do not teach or suggest
the limitations of claims 1 and 10. See id. These conclusory arguments are
unresponsive and unpersuasive, as they fail to point out with particularity or
explain why the claims are patentable. See Ex parte Belinne, No. 2009-
004693, slip op. at 7—8 (BPAI Aug. 10, 2009) (informative) (discussing the
insufficiency of argument that “restates elements of the claim language” and
fails to explain why Examiner’s findings are erroneous); cf. In re Lovin, 652
F.3d 1349, 1357 (Fed. Cir. 2011) (explaining that the Board has “reasonably
interpreted Rule 41.37 to require more substantive arguments in an appeal
brief than a mere recitation of the claim elements and a naked assertion that
the corresponding elements were not found in the prior art”).
7 The Examiner makes this finding specifically in regard to claims 7 and 8,
which are cancelled. See Final Action 6; Ans. 6. However, the analysis is
the same for claim 10, insofar as claim 10 recites increased bioavailability of
GDC-0941.
5
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Application 13/650,274
Next, Appellants point to two post-filing articles, Ware8 and Yago,9 as
evidence of unexpected results. See Br. 5—7. Ware reports on the effects of
coadministration with rabeprazole (a proton-pump inhibitor) on GDC-0941
pharmacokinetics, for both fasting and fed patients. Br. 6 (citing Ware
4047). Providing an introductory summation of its results, Ware states:
The results of the current investigations emphasize the complex
nature of physicochemical interactions and the importance of
gastric acid for the dissolution and solubilization processes of
GDC-0941. Given these findings, dosing of GDC-0941 in
clinical trials was not constrained relative to fasted/fed states,
but the concomitant use of ARAs (acid-reducing agents) was
restricted. Mitigation strategies to limit the influence of pH on
exposure of molecularly targeted agents such as GDC-0941
with pH-dependent solubility are discussed.
Id. (quoting Ware 4047). Appellants assert that Ware thus shows “surprising
and unexpected effects of the proton-pump inhibitor rabeprazole on the
pharmacokinetics of GDC-0941.” Id. As to Yago, Appellants point to
findings that “re-acidification compounds betaine HC1 (BHC1) and citric
acid greatly improve the in vitro dissolution of GDC-0941, and BHC1
enhances the absorption of GDC-0941 in the famotidine-induced
hypochlorhydric dog (Figures 2A and 2B).” Id. Appellants characterize
Yago as evidence of “surprising and unexpected effects of re-acidification
compounds on GDC-0941.” Id.
8 Ware et al., Impact of Food and the Proton Pump Inhibitor Rabeprazole on
the Pharmacokinetics of GDC-0941 in Healthy Volunteers: Bench to
Bedside Investigation of pH-Dependent Solubility, 10 Mol. Pharmaceutics
4074 (2013).
9 Yago et al., Gastric Reacidification with Betaine HCl in Healthy
Volunteers with Rabeprazole-Induced Hypochlorhydria, 10 Mol.
Pharmaceutics 4032 (2013).
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Application 13/650,274
Like the Examiner, we are unpersuaded that Ware or Yago report
unexpected effects, so much as expected ones. See Final Action 7—8. As the
Examiner finds regarding Yago:
Even if Applicants presented unexpected data that glutamic acid
hydrochloride enhances absorption of GDC-0941, such data
would not be unexpected because Knapp et al teach patient with
hypochlorhydria may experience inadequate dissolution and
absorption of drugs and dosage forms that have pH-dependent
release characteristics; elevation of gastric pH have been
associated with a decrease in bioavailability, (See page 868,
second col). Moreover, Knapp et al teach glutamic
hydrochloride has been used to lower gastric pH and enhance
drug absorption.”
Final Action 8. Further, we agree with the Examiner that Ware focuses not
only on the effect of rabeprazole on the pharmacokinetics of GDC-0941, but
also on the impact of food, while the claims are silent regarding
administration of food. See id. at 7. Accordingly, the alleged unexpected
results of Ware are not commensurate in scope with the claims. Likewise,
we agree with the Examiner that Yago is not responsive to the rejection
because Yago’s data use betaine hydrochloride as the re-acidification
compound, whereas the rejection is based on glutamic acid hydrochloride as
the re-acidification compound. See id.
Finally, Appellants return to arguing that the cited references fail to
teach or suggest the claimed invention:
In particular, there was no teaching or suggestion that the re­
acidification compounds betaine hydrochloride and glutamic
acid hydrochloride improve the bioavailability and
pharmacokinetics of GDC-0941. There is no teaching or
suggestion in the cited references that GDC-0941 has a
pharmacological deficiency related to dissolution or absorption.
Furthermore, there is no teaching or suggestion in the cited
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Application 13/650,274
references that any such deficiency would be influenced by the
administration of a re-acidification compound.
Br. 7. These arguments are unpersuasive to the extent that they address the
references individually, not the Examiner’s findings regarding the
combination of the references. See In re Keller, 642 F.2d 413, 426 (CCPA
1981) (“But one cannot show non-obviousness by attacking references
individually where, as here, the rejections are based on combinations of
references.”). Further, these arguments relate to the properties of GDC-0941
in the presence of a re-acidification compound, and the “[m]ere recognition
of latent properties in the prior art does not render nonobvious an otherwise
known invention.” In re Baxter-TravenolLabs., 952 F.2d 388, 392 (Fed.
Cir. 1991); see also In re Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir.
1990) (obviousness rejection affirmed where using claimed elements in the
manner suggested by the prior art necessarily resulted in claim-recited
effect).
CONCFUSION
The rejection of claims 1,3,4, 6, 9, and 10 is affirmed for the reasons
of record and as explained herein. No time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
8