Ex Parte Grassetti et al

Board of Patent Appeals and Interferences

Apr 28, 2011

10044463 (B.P.A.I. Apr. 28, 2011)

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.
10/044,463 01/10/2002 Davide R. Grassetti 107-000110US 9878
22798 7590 04/28/2011
QUINE INTELLECTUAL PROPERTY LAW GROUP, P.C.
P O BOX 458
ALAMEDA, CA 94501
EXAMINER
WANG, SHENGJUN
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
04/28/2011 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVIDE R. GRASSETTI and CAMILLO MORO
__________

Appeal 2010-008088
Application 10/044,463
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and STEPHEN
WALSH, 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 anticipation and obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
Appeal 2010-008088
Application 10/044,463

2
STATEMENT OF THE CASE
The following claim is representative and reads as follows:

1. A method for modulating an immune response comprising:
identifying an individual in need of immune response modulation;
administering to the individual in need of immune response
modulation an effective amount of a thione-forming disulfide comprising

wherein X and Y represent atoms necessary to form a five-membered
or six-membered substituted or unsubstituted heterocyclic ring;
wherein the immune response is selected from the group consisting of:
a cellular response, a humoral response and an innate immune response; and,
wherein the individual is other than an individual infected with a
retrovirus;
thereby modulating the immune response.

Cited References

The Examiner relies on following prior art references:

Grassetti US 4,378,364 Mar. 29, 1983
Oliver et al., T Cell Immune Response to Cancer in Humans and Its
Relevance for Immunodiagnosis and Therapy, (13) A New Look at Tumour
Immunology, 173-204 (1991).
Tagawa, Cytokine Therapy for Cancer, (6) Current Pharmaceutical Design,
681-699 (2000).
Appeal 2010-008088
Application 10/044,463

3

Grounds of Rejection
1. Claims 1-2, 5-6, 10-12 and 20-24 were rejected under 35 U.S.C. §§
102(b) and 103(a) as anticipated and as obvious over Grassetti as evidenced
by Oliver and Tagawa.

FINDINGS OF FACT
The Examiner’s fact findings are set forth in the Answer at pages 3-7.

Discussion
ISSUE
The Examiner concludes that Grassetti teaches each element claimed.
Appellants argue that the Examiner has failed to present a prima facie case
of anticipation and that the cited prior art does not teach the limitations of
“1) identifying an individual in need of immune response modulation, and 2)
administering a thione-forming disulfide… to an individual in need of
immune response modulation.” (App. Br. 6.)
The issue is: Does the cited prior art support the Examiner’s rejection
of the claims for anticipation.

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
“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
Appeal 2010-008088
Application 10/044,463

4
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).
“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s arguments as set forth in the Answer. We
provide the following additional comment.
Appellants argue that the Examiner has failed to present a prima facie
case of anticipation and that the cited prior art does not teach the limitations
of “1) identifying an individual in need of immune response modulation, and
2) administering a thione-forming disulfide… to an individual in need of
immune response modulation.” (App. Br. 6.)
Grassetti teaches administering the same thione-forming compound as
claimed by Appellants to a cancer patient who has had surgery. (Ans. 4.)
Appeal 2010-008088
Application 10/044,463

5
Oliver evidences that cancer patients who have had surgery have suppressed
immune responses. (Ans. 4-5.) Grassetti further discloses that cancer
patients who have had surgery are treated with the thione-forming
compound until their natural defenses have destroyed the remaining
circulating cancer cells. (Ans. 4.) Thus, it is reasonably concluded by one of
ordinary skill in the art that the cancer patient who has had surgery is treated
until the suppressed immune responses have been modulated such that the
natural defenses are again functional. Therefore, we are not persuaded that
Grassetti does not teach an individual in need of immune response
modulation.
Oliver establishes that a cancer patient who has had surgery has a
suppressed immune system and is in need of immune response modulation.
Therefore, Grassetti, by its teaching to administer a thione-forming disulfide
to a cancer surgery patient, teaches administering a thione-forming disulfide
to an individual in need of immune response modulation.
We conclude the Examiner has presented a prima facie case of
anticipation. “[W]hen a prima facie case is made, the burden shifts to the
applicant to come forward with evidence and/or argument supporting
patentability.” In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002).
Appellants argue that the statement in Grassetti that the patient is
treated until natural defenses have destroyed the remaining circulating
cancer cells means that the patient’s “natural (unmodulated) defenses are
adequate to destroy the cancer cells.” (App. Br. 14.) However, this
statement by Appellants is attorney argument and Appellants have not
presented any evidence to support that one of ordinary skill in the art would
understand Grassetti discloses that the natural defenses have been
Appeal 2010-008088
Application 10/044,463

6
unmodified or that a cancer patient who has had surgery does not have a
suppressed immune system.
Appellants argue that not all patients receiving chemotherapy are
necessarily in need of immune response modulation and Grassetti does not
identify any individual in need of immune response modulation. (See App.
Br. 9.) We are not persuaded. As discussed herein, the evidence of record
shows that a cancer patient having had surgery as in Grassetti is immune
suppressed and in need of immune response modulation.
With respect to the obviousness rejection we find that “anticipation is
the epitome of obviousness.” In re McDaniel, 293 F.3d 1379, 1385 (Fed.
Cir. 2002). Moreover, Appellants have not presented sufficient argument or
evidence to rebut the Examiner’s prima facie case of obviousness.
The anticipation and obviousness rejections are affirmed.

CONCLUSION OF LAW
The cited references support the Examiner’s anticipation and obviousness
rejections.
TIME PERIOD
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

alw