Ex Parte Chiang et al

Board of Patent Appeals and Interferences

Jul 31, 2012

11323964 (B.P.A.I. Jul. 31, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHIH-SHENG CHIANG, JOHN J. L. SIMARD,
DAVID C. DIAMOND, ADRIAN ION BOT, and XIPING LIU
__________

Appeal 2011-003657
Application 11/323,964
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
LORA M. GREEN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for lack of written description and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
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Application 11/323,964

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STATEMENT OF CASE
30. A method of matching a cancer condition in a patient
with an immunotherapeutic regimen, comprising the steps of:
assaying the patient's tumor tissue for two or more expressed tumor-
associated antigens (TuAAs) in a preselected panel wherein the panel
includes a growth factor or a signal transduction protein, to develop an
antigen profile for the tumor; and
selecting an immunotherapeutic regimen based on the profile, the
regimen comprising administration of one or more immunotherapeutic
agents, available on the market or in clinical trials, targeting two or more
antigens in the profile.

3l. The method of Claim 30, wherein the regimen comprises
administering both an active immunotherapeutic agent and a passive
immunotherapeutic agent.

32. The method of Claim 30, wherein said growth factor is VEGF-A.

33. The method of Claim 30, wherein said signal transduction protein
is PLKI.

37. The method of Claim 30, wherein the one or more
immunotherapeutic agents is available on the market.

Cited References

Beer et al. US 2004/0063120 A1 Apr. 1, 2004

Anon, A Kinder, Gentler Type of Cancer Therapy, Clinical Update on
Vaccine Technology, 2 PHARMACEUTICAL AND DIAGNOSTIC INNOVATION 3-8
(2004).

Janice Reichert and Alex Pavlou, Monoclonal antibodies market, 3 NATURE
REV. DRUG DISCOV. 383-384 (2004).

Klaus Strebhardt and Axel Ullrich, Targeting polo-like kinase 1 for cancer
therapy, 6 NATURE REV. CANCER 321-330 (2006).
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Grounds of Rejection
Claims 30-33 and 37 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
Claims 30, 32 and 37 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Beer in view of Reichert.

FINDINGS OF FACT
The Examiner‟s findings of fact are set forth in the Answer at pages 4-
11.

Discussion
Claims 30-33 and 37 are rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.

ISSUE
The Examiner concludes that the claims are drawn to a genus of
immunotherapeutic agents, both active and passive, to TuAAs. The
Examiner finds that
the art discloses that there are only a handful of passive
immunotherapeutic agents and no active immunotherapeutic
agents to specific TuAAs on the market at the time the present
application was filed. Furthermore, there was only a small
number of active and passive immunotherapeutic agents in
clinical trials compared to the multitude of TuAAs that have
been discovered or will be discovered in the future.

(Ans. 6.)
Appellants argue that the claims of the instant application are drawn
to methods not products.
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Appellants further reiterate that the assaying and
selecting steps have been adequately described in the
specification in a way that would enable a person of ordinary
skill in the art to make and use the claimed matching process.
For example, the instant specification describes that assaying a
patient's tumor tissue can be carried out using a variety of
techniques known in the art, for example, TCR tetramer-based
assays allow simultaneous confirmation of both MHC and
target antigen (indeed, even target epitope) expression and are
inherently type specific. Approaches for designing a panel of
antigens for use in the assaying step are described-for
example, the panel of antigens can be assembled from more
commonly expressed TuAAs for which targeting
immunotherapeutics are available (marketed or in
development).

(App. Br. 8.)

Appellants submit that one of ordinary skill in the relevant art
would know that active immunotherapeutics were available in
clinical trials or on the market. This is evidenced by a simple
Google search which reveals multiple active
immunotherapeutics that were in clinical trials or on the market
prior to or at the time of filing. Indeed, the Examiner has
confirmed from a search of the art that certain
immunotherapeutic agents were, in fact, available on the market
or in clinical trials at the time of filing. Appellants reiterate that
what is conventional or well known to one of ordinary skill in
the art need not be disclosed in detail.

(Id. at 10.)

Appellants argue that

to the extent that features common to all members of the
genus of passive and active immunotherapeutic agents are
concerned, Appellants respectfully submit that the features
common to all members of the genus are at least that the
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immunotherapeutic agents are available on the market or in
clinical trials and that the immunotherapeutic agent(s) target
two or more identified antigens … [and] that these common
features are a relevant identifying characteristic of the
immunotherapeutics that can be matched according to the
claimed methods, and thus, the immunotherapeutics have been
adequately described even in the absence of disclosing the
structure of the agents.

(App. Br. 9.)
The issue is: Does the written description describe active
immunotherapeutics available on the market, such as PLK1, as claimed?

PRINCIPLES OF LAW
The purpose of the written description requirement is to “ensure that
the scope of the right to exclude, as set forth in the claims, does not
overreach the scope of the inventor‟s contribution to the field as described in
the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345
(Fed. Cir. 2000). To that end, to satisfy the written description requirement,
the inventor “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 1555, 1563-64 (Fed. Cir.
1991). “One shows that one is „in possession‟ of the invention by describing
the invention, with all its claimed limitations” [emphases in original].
Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997).
It is not necessary for the specification to describe the claimed invention
ipsissimis verbis; all that is required is that it reasonably convey to those
skilled in the art that, as of the filing date sought, the inventor was in
possession of the claimed invention. Union Oil of California v. Atlantic
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Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000); Vas-Cath Inc. v.
Mahurkar, 935 F.2d at 1563-64; In re Gosteli, 872 F.2d 1008, 1012 (Fed.
Cir. 1989); In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978).

ANALYSIS
We preliminarily note that a restriction requirement and election of
species selection was made by the Examiner in an Office Action dated July
16, 2007. In a response dated August 16, 2007, Appellants elected Group II,
and cancelled claims 34-36 from the Application which Appellants argued
rendered the election of species moot. Thus, claims 30-33 and 37 are
pending with no species election.
We reverse the written description rejection as to claims 30-32 and 37,
but maintain the written description rejection of claim 33.
More particularly, the Examiner concludes that the claims are drawn
to a genus of immunotherapeutic agents, both active and passive, to TuAAs.
The Examiner finds that the art discloses that there are only a handful of
passive immunotherapeutic agents and no active immunotherapeutic agents
to specific TuAAs on the market at the time the present application was
filed. Thus, the Examiner concludes that the genus of immunotherapeutics
within the scope of the pending claims has not been adequately described in
the Specification.
However, Appellants‟ Specification, paragraph [0081] lists several
passive immunotherapeutic agents known in the art. Spec. 20. The
Examiner has not established that these passive immunotherapeutic agents
were not on the market or in clinical trials.
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As to active immunotherapeutic agents, Appellants submit that one of
ordinary skill in the relevant art would know that active immunotherapeutics
were available in clinical trials or on the market. This is evidenced by a
simple Google search which reveals multiple active immunotherapeutics that
were in clinical trials or on the market prior to or at the time of filing.
According to Appellants, the Examiner has confirmed from a search of the
art that certain immunotherapeutic agents were, in fact, available on the
market or in clinical trials at the time of filing and acknowledge this fact in
an office action dated May 27, 2009, page 3. Appellants reiterate that what
is conventional or well known to one of ordinary skill in the art need not be
disclosed in detail.
“It is not necessary that the application describe the claim limitations
exactly, but only so clearly that persons of ordinary skill in the art will
recognize from the disclosure that appellants invented processes including
those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976)
(citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d
1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).
The Examiner has acknowledge from a Google search that certain
active immunotherapeutic agents were, in fact, available on the market or in
clinical trials at the time of filing and acknowledge this fact in an office
action dated May 27, 2009, page 3. The Examiner has not come forth with
additional evidence to rebut that the general description of “active
immunotherapeutic agents” in the Specification is not sufficient that persons
of ordinary skill in the art will not recognize from the disclosure that
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Appellants invented processes including those limitations, with the
exception of PLK1. Thus, we reverse the written description rejection of
claims 30-32 and 37.
We however, affirm the written description rejection of claim 33. The
Examiner has provided evidence on this record, Strebhardt, that PLK-1 was
not available on the market or in clinical trials, as claimed. Appellants have
come forth with no evidence to show that PLK-1 was available on the
market or in clinical trials as of the filing date of the application.

Rejection 2
Claims 30, 32 and 37 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Beer in view of Reichert.

ISSUE
The Examiner argues that
One of ordinary skill in the art would have been
motivated to apply Reichert et al‟s disclosure of monoclonal
antibodies to VEGF-A and ERBB2 available on the market to
Beer et al‟s method for treating patients with monoclonal
antibodies based on the expression of tumor antigens because
Reichert et al discloses specific antibodies that target TuAAs
listed by Beer et al. It would have been prima facie obvious to
combine Beer et al‟s method for treating patients with
monoclonal antibodies based on the expression of tumor
antigens with Reichert et al‟s disclosure of monoclonal
antibodies to VEGF-A and ERBB2 available on the market to
more specifically define the monoclonal antibodies that will be
selected based on the expression of TuAAs.

(Ans. 11.)

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Appellants argue that
even if one accepts for the sake of argument that the reference
[Beer] teaches assaying a patient's tumor tissue to develop an
antigen expression profile for the tumor and the development of
antibodies that target a subset of the cancer markers disclosed in
the reference, there is no teaching or suggestion in Beer
regarding how a patient's antigen profile may be used to select a
treatment regimen. That is, Beer does not teach or suggest
“selecting an immunotherapeutic regimen based on the profile”
as is claimed in the instant application.

(Reply Br. 17.)

The issue is: does the cited prior art support the Examiner‟s
conclusion that the claimed subject matter is obvious.

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
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ANALYSIS
We agree with the Examiner‟s fact finding, statement of the rejection
and responses to Appellants‟ arguments as set forth in the Answer. We find
that the Examiner has set forth a prima facie case of obviousness on the
evidence before us. We provide the following additional comments for
emphasis.
Appellants argue that Beer does not teach or suggest “selecting an
immunotherapeutic regimen based on the profile” as is claimed in the instant
application. (Reply Br. 17.) We are not persuaded. The Beer abstract
plainly suggests that the expression profiles disclosed therein associated with
lung cancers can be used in therapeutic applications. We agree with the
Examiner for the reasons of record, for example Answer page 24, that
there is no evidence in Beer to support Appellants statement
that Beer did not consider VEGF-A and ERBB2 markers to be
suitable targets of immunotherapy. The fact that there were
already immunotherapeutic agents available for VEGF-A and
ERBB2 would make VEGF-A and ERBB2 suitable as targets
for immunotherapy. Furthermore, there would be a reasonable
expectation of success in arriving at the claimed invention using
the cited combination of Beer and Reichert given the fact that
there were already immunotherapeutic agents available for
VEGF-A and ERBB2 on the market.

Appellants have come forth with no evidence to establish that there would
have been no reasonable expectation of success to one of ordinary skill in
the art combining the disclosures of Beer and Reichert.
As we understand it, Appellants‟ position is that, unlike the present
invention, Beer is limited to a single cancer condition, e.g., lung cancer
(App. Br. 19). Thus, “there i[s] no teaching or suggestion in the reference to
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use the markers to match a cancer condition [generically] to an
immunotherapeutic regimen, much less to do so independent of the cancer
type or condition” (id.). Appellants also contend that Examiner‟s reliance on
VEGF and ERBB2 are misdirected since Beer refers to these markers as
“prognostic” – which are “not necessarily suitable as a target of
immunotherapy” (App. Br. 20-21).
The Examiner addressed these arguments of Appellants in the Answer
at pages 22-23. Essentially, the Examiner finds that the lung cancer
disclosed by Beer is interpreted as being a cancer condition and thus the
disclosure by Beer et al would fall within the scope of the present claims.
In addition, Beer et al clearly states that genes expression profiles associated
with lung cancer provide targets for cancer drug screens and therapeutic
applications. (paragraphs 37, 148, 172, Abstract). (Ans. 23.)
Thus, we agree with the Examiner’s arguments set forth in the
Answer, and the obviousness rejection is affirmed for the reasons of record.

CONCLUSION OF LAW
The cited references support the Examiner‟s obviousness rejection.
The written description rejection of claims 30-32 and 37 is reversed. The
written description rejection of claim 33 is affirmed.
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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