Ex Parte Retsky

Patent Trial and Appeal Board

Sep 26, 2016

12924162 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/924,162 09/22/2010 Michael W. Retsky
113677 7590 09/28/2016
Perkins Coie LLP - CHI General
PO Box 1247
Seattle, WA 98111-1247
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.
89211-8001.US02 3351
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
patentprocurement@perkinscoie.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL W. RETSKY 1
Appeal2015-001483
Application 12/924, 162
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and DEVON
ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for preventing relapse in a cancer patient undergoing a surgery, which have
been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Background
The Specification discloses: "The invention describes methods and
materials to treat cancer diagnosed at an early stage." Spec ,-i 1 7. The
Specification discloses that "surgery to remove the primary tumor often
1 Appellant identifies the Real Party in Interest as the inventor named above.
App. Br. 2.
Appeal2015-001483
Application 12/924, 162
kick-starts growth of the dormant cells and avascular micrometastases" and
that it has been suggested "that one of the side effects of surgical wounding
is to stimulate division of dormant single malignant cells and stimulate
angiogenesis2 of dormant micrometastases." Id. ii 9.
"The present invention overcomes the limitations of the prior art by
providing, in various embodiments, treatment methods designed to prevent
metastatic relapse which minimize the short and long term effects of surgery
and can be safely administered long-term." Id. ii 16.
"To be most effective the antiangiogenic drugs described must be
initiated preferably at least one day prior to surgical removal of the primary
tumor. This will prevent results of surgery from stimulating angiogenesis of
micrometastatic disease that is much easier to prevent than control after the
fact." Id. ii 17.
In one embodiment, the present invention provides a method
for preventing relapse in a cancer patient undergoing surgery
comprising administering a first drJg that has antiangiogenic
properties starting before the initial surgical incision and
continuing at least until the end of surgery; and administering a
second drug that has antiangiogenic properties starting within
two months past the end of surgery and continuing for at least
one year.
Id. ii 21.
"In a related embodiment, the first drug that has antiangiogenic
properties is a non-steroidal anti-inflammatory drug (NSAID) [that]
2 Angiogenesis is vascularization of a tumor to permit its growth and
development.
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Application 12/924, 162
may be ... a selective COX-2 inhibitor ... Preferably the NSAID
functions as a non-selective cyclooxygenase (COX) inhibitor, thereby
embodiment, the second drug that has antiangiogenic properties is a
non-steroidal anti-inflammatory drug (NSAID) [that] may be ... a
selective COX-2 inhibitor."
Id. iJ 24.
The Issues
Claims 1-13, and 23-26 are on appeal. The following issues are before
us to review (Ans. 2-5):
A. Appellant argues the Examiner improperly denied priority to U.S.
Patent Application Serial No. 12/148,089, filed on April 16, 2008
("the '089 application"). App. Br. 11-14.
B. Claims 1-6, 8, 10-13, 23, and 25-26 are rejected under 35 U.S.C.
103(a) as being unpatentable over Goldfarb3 in view of Forget4 and
Harris. 5
3 Y. Goldfarb and S. Ben-Elihaju, Surgery as a Risk Factor for Breast
Cancer Recurrence and Metastasis: Mediating Mechanisms and Clinical
Prophylactic Approaches, BREAST DISEASE 26:99-114 (2006,
2007)("Goldfarb").
4 Patrice Forget et al., Do Intraoperative Analgesics Influence Breast Cancer
Recurrence After Mastectomy? A Retrospective Analysis, ANESTHESIA &
ANALGESIA, 110( 6): 1630-1635 (201 O)("Forget").
5 Randall E. Harris et al., Aspirin, ibuprofen, and other non-steroidal anti-
injlammatory drugs in cancer prevention: A critical review of non-selective
COX-2 blockade (Review), ONCOLOGY REPORTS, 13:559-583
(2005)("Harris").
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Application 12/924, 162
C. Claims 1-5, 7-13, 24, and 26 are rejected under 35 U.S.C. 103(a) as
being unpatentable over Prior6 in view of Forget.
Claim 1 illustrates the subject matter at issue and reads as follows:
1. A method for preventing relapse in a cancer patient
undergoing a surgery comprising administering a
cyclooxygenase inhibitor starting before an initial surgical
incision; and administering a cyclooxygenase inhibitor for at
least one year after the surgery.
PRIORITY CLAIM
After considering the evidence and the arguments, we conclude that a
preponderance of the evidence favors the Examiner's conclusion that the
instant claims are not entitled to the priority date of the '089 application, but
instead the priority date of the instant application, September 22, 2010.
Accordingly, we adopt the Examiner's reasoning (see Priority, Final
"' • • '7 - ,..,,_ ., ,., ' ,., -.--, • ., ro ., .. .,., ',.. Acnon,' L- 1 ), ana agree mat me bxammer propeny rouna Appellant, s
arguments unpersuasive (see Response to Argument, Ans. 11-14). We
provide the following points for emphasis.
The first paragraph of 35 U.S.C. § 112 recites:
The specification sha11 contain a written description of the
invention, and of the manner and process of making and using
it, in such foll~ clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with vvhich it is
most nearly connected, to make and use the same, and shall set
6 US2003/0004143 Al, published Jan. 2, 2003.
7 Office Action mailed Oct. 17, 2013.
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Application 12/924, 162
forth the best mode contemplated by the inventor or joint
inventor of canying out the invention.
It is well-established, however~ that "[t]he purpose of the 'written
description' requirement is broader than to merely explain how to 'make and
use'; the applicant must also convey with reasonable clarity to those skilled
in the art that, as of the filing date sought, he or she was in possession of the
invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1559, 1563-64 (Fed. Cir.
1991) (emphasis added). Although possession alone is not sufficient to
satisfy the written description requirement of§ 112' s first paragraph, it is
essential to the purpose of the statute. See Enzo Biochem, Inc. v. Gen-Probe
Inc., 323 F.3d 956, 969 (Fed. Cir. 2002). Consequently, Appellant must
demonstrate that he was in possession of the claimed method of the '089
application using the entire class of cyclooxygenase inhibitors.
Appellant argues the following statement from the '089 application
shows Appellant was in possession of the claimed method: "It has been
reported that Celecoxib and Indomethacin are also effective in preventing
wound healing associated tumor growth so those drugs may be also
considered in the list." App. Br. 12, citing '089 Appl. 12:3-5. Appellant
argues Celecoxib and Indomethacin are "well-known COX inhibitor
compounds" that were "known to be involved in inflammatory response
cascades" and "both known to be members of the cyclooxygenase inhibitor
genus" by the time the '089 application was filed. Id. 12-13. Appellant cites
to literature identifying Celecoxib and Indomethacin as COX-2 inhibitors
and noting cyclooxygenase inhibitors were identified in inflammatory
response cascades prior to the filing of the '089 application. Id.
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According to Appellant, "a person having ordinary skill in the art
would understand that the phrase 'celecoxib and indomethacin' as used [in
Appellant's Specification] to describe compounds useful in the claimed
methods referred to common properties of two species of the class of
cyclooxygenase inhibitors," because "[u]niting these species in the
disclosure as possessing similar biological activity further indicates that a
person of ordinary skill in the art would understand their disclosure to be
representative of the class to which they belong." Id. 13-14. Appellant
further argues that the statement in the '089 patent cited above ('089 Appl.
12:3-5) that describes Celecoxib and Indomethacin as "preventing wound
healing" is further evidence of the inventor's possession of the claimed
method with respect to the entire genus because the phrase "describes [the
compounds] in terms consistent with well-known properties of the genus."
Id (emphasis removed).
We are not persuaded that the Examiner erred in denying priority to
the '089 application. Appellant did not cite any inventor affidavit or
declaration supported by evidence of record to indicate he was in possession
of use of the entire class of cyclooxygenase inhibitors (the claimed genus),
for use in Appellant's claimed method, when the '089 application was filed.
While the '089 application identifies two COX inhibitors, the '089
application does not establish that these two COX inhibitors are
representative of the entire genus of COX inhibitors encompassed by
Appellant's claimed method, nor does the '089 application contain an
example showing the use of a cyclooxygenase inhibitor for use in practicing
Appellant's claimed method. See Univ. Of Rochester v. G.D. Searle & Co.,
Inc., 358 F.3d 916, 927 (Fed. Cir. 2004) (holding that despite "substantial
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Application 12/924, 162
description of [a class of compounds for use in the claimed methods],
including the nucleotide sequences of coding and promoter regions of the
genes that encode [proteins to make the compounds] . . . 'assays for
screening compounds"' and "what can be done with any compounds that
may potentially be identified through those assays," the patent at issue was
invalid for lack of written description: "[t]he '850 patent does not disclose
just 'which peptides, polynucleotides, and small organic molecules' have the
desired characteristic of selectively inhibiting PGHS-2 .... Without such
disclosure, the claimed methods cannot be said to have been described.")
See also Regents of the Univ. of Calif. V. Eli Lilly & Co., 119 F.3d 1559,
1567 (Fed. Cir. 2014) ("[a]n adequate written description of a DNA ...
'requires a precise definition, such as by structure, fonnula, chemical name,
or physical properties,' not a mere wish or plan for obtaining the claimed
chemical invention.") (citing Fiers v. Revel, 984 F.2d 1164, 1171, 25
USPQ2d 1601, 1606 (Fed. Cir. 1993).
Nor are we persuaded by Appellant's argument that the language used
in the '089 application to describe celecoxib and indomethacin shows
possession of the method of the instant claims. To the contrary, we find the
'089 application's disclosure that "[t]here have been some suggestions that
Celecoxib may have some long term toxicity." ('089 application ,-i 54)
discourages long term use of cyclooxygenase as claimed in the method at
issue.
For the reasons set forth by the Examiner, we agree with the
Examiner's findings that the preponderance of evidence of record suggests
"at the time the parent application was filed, it was not predictable that the
genus of COX inhibitors possessed anti-tumorigenic effects," because the
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Application 12/924, 162
class of cyclooxygenase inhibitors encompasses a number of COX-1
inhibitors, COX-2 inhibitors, nonselective COX inhibitors, and the data
regarding the mechanisms of the anti-proliferative effect of at least celecoxib
and indomethacin were unclear at the time the application was filed. Ans.
10-12. Accordingly, we affirm the Examiner's denial of the priority claim.
OBVIOUSNESS
A. Claims 1-6, 8, 10--13, 23 and 25-26 over Goldfarb, Forget and
Harris.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's rejection of claim 1 as obvious over
Goldfarb, Forget and Harris. The Examiner provides sound fact-based
reasoning for combining Goldfarb, Forget and Harris. We address the
arguments raised by Appellant on appeal below.
While not explicitly stated, Appellant appears to argue that Goldfarb
teaches away from the claimed method because Goldfarb teaches
"postoperative administrative of a beta blocker and a prostaglandin synthesis
inhibitor," "states that '[i]ndomethacin cannot be used during surgery due to
the risk of bleeding it imposes via COX I -mediated mechanisms," and
teaches use of a cyclooxygenase inhibitor only in conjunction with a B-
blocker, not alone. Ans. 14. Appellant also argues that while Goldfarb
teaches that the use of selective COX2 inhibitors and low to moderate doses
of B-blockers "before and during surgery is a feasible strategy to attenuate
perioperative immunosuppression," Goldfarb "fails to teach or even suggest
that administering a cyclooxygenase inhibitor before and after surgery
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Application 12/924, 162
without also administering the 13-blocker might be expected to have similar
benefits." Id.
We are not persuaded. "Under the proper legal standard, a reference
will teach away when it suggests that the developments flowing from its
disclosures are unlikely to produce the objective of the applicant's invention.
A statement that a particular combination is not a preferred embodiment
does not teach away absent clear discouragement of that combination."
Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005)
(citations omitted). Appellant's arguments do not persuade us as the
teachings of Goldfarb teach away from use of COX inhibitors prior to
surgery as in the claimed method. To the contrary, Goldfarb discloses
"[Prostaglandins] are often released by primary tumors or by immunocytes
recruited by them [], allegedly to suppress immunity. Therefore, it could be
advantageous to commence the above prophylactic drug regimen even prior
to surgery and maintain it throughout and following surgery." Goldfarb,
p. 102, ,-i 3, emphasis supplied. Accordingly, we find Goldfarb does not
teach away from the claimed method. Moreover, Appellant's claim does not
exclude the administration of other substances, such as a 13-blocker,
concurrently with the cyclooxygenase inhibitor.
Appellant argues Harris fails to cure the deficiencies of Goldfarb at
least because it does not disclose or suggest administering a cyclooxygenase
inhibitor starting before an initial surgical incision. Appellant's arguments
regard Harris' failure to teach all elements of the claimed methods. This is
unpersuasive as the Examiner's rejection is based on the combined teachings
of Goldfarb, Harris and Forget. See Ans. 2. Nonobviousness cannot be
established by attacking the references individually when the rejection is
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predicated upon a combination of prior art disclosures. Jn re Merck & Co.,
800 F.2d 1091, 1097 (Fed. Cir. 1986); see also In re Keller, 642 F.2d 413,
426 (CCPA 1981) (finding "one cannot show nonobviousness by attacking
references individually where, as here, the rejections are based on
combinations of references" (citations omitted)). Thus, whether any
individual reference fails to teach nanoparticles designed to carry out
Appellant's method is not dispositive to the sufficiency of the rationale
underlying the rejection.
Appellant raises no argument regarding the substance of Forget's
disclosure, but argues the reference is unavailable as prior art in rejecting the
claims at issue under§ 103(a). As explained above, we find the claims at
issue have a priority date of September 22, 2010. Accordingly, as Appellant
acknowledges, Forget has an effective date as a reference of June 1, 2010,
prior to the claims at issue. App. Br. 15. We agree with the Examiner that
Forget teaches a method of preventing breast cancer relapse by
administering ketorolac as an intraoperative analgesic and diclofenac as a
postsurgical analgesic - both compounds being NSAID cyclooxygenases -
and that ketorolac administration was associated with lowered cancer rates.
Forget Abstract, p. 1631, p. 1632, Table 2.
We agree with the Examiner that a person of ordinary skill in the art,
upon learning the teachings of Goldfarb, Harris and Forget would have
reasonably been led to practice the claimed method of administration of
cyclooxygenase inhibitors to a pre-surgical and post-surgical cancer patient
by combining the teachings as follows: Goldfarb's teachings regarding
ketorolac as the intraoperative analgesic (first drug) used just prior to and
during surgery as taught by Forget with ibuprofen as the postoperative
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analgesic (second drug) taught by Harris. Ans. 4-5. We agree with the
Examiner that one of ordinary skill would be motivated to combine the
teachings by virtue of Forget's demonstrated success with use of ketorolac
and the references' teachings regarding an expectation of achieving
decreased risk of cancer recurrence with use of the compounds. Id.
Accordingly, we affirm the Examiner's rejection of claim 1. Claims 2-5, 8,
10-13, 23 and 25-26 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37( c )(1 )(iv).
B. Claims 1-5, 7-13, 24 and 26 over Prior and Forget.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's rejection of claim 1 as obvious over
Prior and Forget. The Examiner provides sound fact-based reasoning for
combining Prior and Forget. We address the arguments raised by Appellant
on appeal belovv.
Appellant's sole argument in response to this rejection is that "the
Office Action admits [] that Prior does not teach administration ofNSAIDs
before an initial surgical incision. Instead, the Office Action relies on Forget
for its alleged disclosure of an intraoperative analgesic before and after a
surgery. Ans. 15-16. Appellant argues Forget cannot supply the missing
teaching as it is unavailable as a prior art reference.
As discussed above, we find Forget is available as a prior art
reference, and teaches administration of an intraoperative analgesic
(ketorolac) and a postsurgical analgesic ( diclofenac ), both compounds being
NSAID cyclooxygenases. Forget Abstract, p. 1631, p. 1632, Table 2. Prior
teaches a method of preventing metastases in patients with cervical cancer
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and to prevent secondary tumors arriving post-surgery. Prior ii 51. Prior
teaches use ofNSAIDS for up to five years following surgery to prevent
future metastases. Id. ii 46. We agree with the Examiner that one of skill in
the art would find it obvious to combine the teachings of Prior and Forget to
administer NSAIDS during and after surgery due to the risk of cancer
recurrence taught in those references. Accordingly, we are not persuaded
that the Examiner erred in rejecting claim 1 as obvious over Prior and
Forget, and we affirm the rejection. Claims 2-5, 7-13, 24 and 26 have not
been argued separately and therefore fall with claim 1. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm the Examiner's denial of the claim of priority of claims 1-
13, and 23-26 to the '089 application.
We affirm the rejection of claims 1-6, 8, 10-13, 23 and 25-26 under
35 U.S.C. § 103(a) over Goldfarb, Forget and Harris.
We affirm the rejection of claims 1-5, 7-13, 24 and 26 under 35
U.S.C. § 103(a) over Prior and Forget.
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. § l.136(a).
AFFIRMED
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