Ex Parte Srivastava

Board of Patent Appeals and Interferences

Jun 10, 2009

10380442 (B.P.A.I. Jun. 10, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte PRAMOD K. SRIVASTAVA
____________

Appeal 2009-003454
Application 10/380,442
Technology Center 1600
____________

Decided1: June 10, 2009
____________

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 1-7, 9-13, 15-27,
66, 67, 70-78, 82-86, 101-107, and 110-126, the only claims pending in this
application. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2009-003454
Application 10/380,442

STATEMENT OF THE CASE
The claims are directed to a method of inducing an immune response
against a type of cancer (claims 1-3, 7, 9-13, 15-27, 70-78, 101-107, and
110-112 ); a method of treating cancer (claims 4-7, 9-13, 15-27, 66, 70-78,
and 101-107, and 110-120); and a kit effective for the treatment of a type of
cancer (claim 67, 82-86, and 121-126). Claim 1 is illustrative:
1. A method of inducing an immune response against a type of cancer
in a human subject having cancer, comprising administering to said subject a
composition comprising an amount of unfractionated cytosolic soluble
proteins obtained from human cells of said type of cancer or metastasis
thereof effective to induce said immune response, wherein the proteins are
not subjected to any methods that selectively remove particular soluble
proteins, and wherein the proteins substantially lack intact cells, cell debris,
nuclei, organelles and membranes.

The Examiner relies on the following evidence:
Kwak et al. US 6,562,347 B1 May 13, 2003

Nair et al. WO 97/41210 Nov. 6, 1997
Srivastava et al. WO 98/34641 Aug. 13, 1998

The rejection presented by the Examiner is as follows:
Claims 1-7, 9-13, 15-27, 66, 67, 70-78, 82-86, 101-107, and 110-126
stand rejected under 35 U.S.C § 103(a) as unpatentable over the combination
of Srivastava, Kwak and Nair.
We affirm-in-part.

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Appeal 2009-003454
Application 10/380,442

ISSUE

Did Appellant establish that the Examiner erred in concluding that the
combination of references make obvious the administration of a composition
comprising unfractionated cellular proteins, wherein the proteins
substantially lack intact cells?

FINDINGS OF FACT
FF 1. Srivastava teaches a method that comprises administering (1) a heat
shock protein noncovalently bound to a first antigenic molecule and (2)
antigen presenting cells (APCs) sensitized in vitro with a second heat shock
protein non covalently bound to a second antigenic molecule (Ans. 3;
Srivastava 63: 3-9 and 72: 14-21; see also App. Br. 5).
FF 2. Srivastava does “not teach the administration of unfractionated
cellular proteins” (Ans. 4; see also App. Br. 6-8).
FF 3. Kwak teaches “that Il-2, Il-4, INFg and TNF function as adjuvants”
(Ans. 4; see also App. Br. 12).
FF 4. Nair teaches APCs “sensitized with unfractionated RNA derived
from a tumor cell for the induction of a therapeutic immune response against
cancer” (Ans. 4; see also App. Br. 9).
FF 5. Appellant’s Specification defines the term “unfractionated cytosolic
soluble proteins” as a “collection of proteins contained within a clarified
extract of lysed cells, wherein the clarified extract is not subjected to any
methods that selectively remove particular soluble proteins, and substantially
lacks not only intact cells, but also cell debris, nuclei, organelles and
membranes” (Spec. 24: 24-30).
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Appeal 2009-003454
Application 10/380,442

FF 6. “The term ‘unfractionated cellular proteins’ . . . encompasses
‘unfractionated cytosolic soluble proteins’” (Spec. 24: 31-33).

PRINCIPLES OF LAW
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992). On appeal to this Board, Appellants must show that the Examiner
has not sustained the required burden. See (1) Ex parte Yamaguchi,
http://www.uspto.gov/web/offices/dcom/bpai/ prec/fd074412.pdf, slip op. at
5 and 23 (BPAI Aug. 29, 2008) (precedential); (2) Ex parte Fu,
http://www.uspto.gov/web/offices/ dcom/bpai/prec/fd080601.pdf, slip op. at
5 and 20 (BPAI Mar. 31, 2008) (precedential); (3) Ex parte Catan,
http://www.uspto.gov/web/ offices/dcom/bpai/prec/fd070820.pdf, slip op. at
3 and 21 (BPAI Jul. 3, 2007) (precedential), and (4) Ex parte Smith,
http://www.uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf, slip op. at
4, 9 and 23 (BPAI Jun. 25, 2007). Obviousness requires a suggestion of all
the elements in a claim (CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003)) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).

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Appeal 2009-003454
Application 10/380,442

ANALYSIS
Notwithstanding the Examiner’s discussion of Srivastava (Ans. 3-4),
we note that while every claim on appeal requires unfractionated cytosolic
soluble proteins or “unfractionated cellular proteins” (see, e.g., Claims 1 and
66); the Examiner finds that Srivastava does not teach the administration of
unfractionated cellular proteins to induce an immune response to a cancer
cell (Ans. 4). To be complete, Srivastava also fails to teach unfractionated
cytosolic soluble proteins.
The Examiner’s reliance on Kwak to teach “that Il-2, Il-4, INFg and
TNF function as adjuvants” (FF 3) fails to make up for the deficiency in
Srivastava (see, e.g., App. Br. 12).
The Examiner relies on Nair to teach priming APCs with
unfractionated tumor cell RNA (Ans. 4). As Appellant explains
“[a]ccording to Nair, the RNA is translated within the antigen presenting
cells and the resulting protein is processed by the MHC class I or class II
pathways for presentation to the immune system” (App. Br. 9). Thus, Nair
teaches the administration of APCs expressing tumor cell protein in the
context of MHC class I or class II. Nair does not, however, teach the
administration of unfractionated protein the substantially lacks intact cells
(see, e.g., Claim 1).
Accordingly, we find that the Examiner has failed to establish a prima
facie case of obviousness with regard to claims 1-7, 9-13, 15-27, 66, 67, 70-
78, 82-86, 101-107, 110-112, and 121-126. All of these claims require
cytosolic soluble protein or unfractionated cellular protein, wherein the
proteins substantially lack intact cells.

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Appeal 2009-003454
Application 10/380,442

Claims 113-120 stand on a different footing. As Appellant recognizes
[c]laim 113 is directed to a method of treating cancer in a
human subject, comprising administering to said subject a
composition comprising an amount of [(unfractionated cellular
proteins)] UCPs obtained from human cells of said type of
cancer or a metastasis thereof, wherein the UCPs are from 107
cell equivalents or less of said human cells, and wherein the
UCPs comprise proteins associated with organelles and cellular
membranes.

(App. Br. 19.) Claims 114-120 depend directly from claim 113.
As Appellant recognizes, Nair teaches unfractionated proteins (e.g.,
the proteins expressed by the unfractionated RNA introduced into the APCs)
that are associated with cellular membranes (e.g., are processed by the MHC
class I or class II pathways for presentation to the immune system) (App. Br.
9). As Appellant recognizes, according to the teachings of Nair, APCs
express “unfractionated RNA as a means for directing antigens into an
immune presentation pathway” (App. Br. 17). In contrast to Appellant’s
argument, claims 113-120 do not require the administration of “UCPs
directly to a patient” (id.). To the contrary, claims 113-118 are open to
include the presentation of antigen (e.g., unfractionated protein) through the
administration of APCs directly to a patient. As Appellant recognizes “Nair
teaches the administration of recombinant antigen presenting cells” (App.
Br. 20).
Accordingly, we are not persuaded by Appellant’s contention that
“Nair, alone or in combination with Srivastava, does not give reason to
administer a composition comprising unfractionated proteins, much less the
UCPs . . . for eliciting an immune response or treating cancer” (id.).

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Appeal 2009-003454
Application 10/380,442

CONCLUSION OF LAW
Appellant established error in the Examiner’s conclusion that the
combination of references make obvious the administration of a composition
comprising unfractionated cellular proteins, wherein the proteins
substantially lack intact cells. Therefore, the rejection of claims 1-7, 9-13,
15-27, 66, 67, 70-78, 82-86, 101-107, 110-112, and 121-126 under 35 U.S.C
§ 103(a) as unpatentable over the combination of Srivastava, Kwak and Nair
is affirmed.
Claims 113-120 do not require the proteins substantially lack intact
cells. Therefore, the rejection of claims 113-120 under 35 U.S.C § 103(a) as
unpatentable over the combination of Srivastava, Kwak and Nair is reversed.

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-IN-PART

Ssc:
JONES DAY
222 EAST 41ST STREET
NEW YORK, NY 10017
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