Ex Parte Smith et al

Board of Patent Appeals and Interferences

Jul 7, 2010

10745308 (B.P.A.I. Jul. 7, 2010)

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.
10/745,308 12/24/2003 Henry John Smith JSMIT-001A 2293
7663 7590 07/08/2010
STETINA BRUNDA GARRED & BRUCKER
75 ENTERPRISE, SUITE 250
ALISO VIEJO, CA 92656
EXAMINER
BLANCHARD, DAVID J
ART UNIT PAPER NUMBER
1643
MAIL DATE DELIVERY MODE
07/08/2010 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 HENRY JOHN SMITH and JAMES ROGER SMITH
__________

Appeal 2010-001048
Application 10/745,308
Technology Center 1600
__________

Before ERIC GRIMES, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL1

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. 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, or for filing a request for rehearing, as
recited in 37 CF.R.§ 41.52, begins to run from July 8, 2010 shown on the
PTOL-90A cover letter attached to this decision.

Appeal 2010-001048
Application 10/745,308
2
STATEMENT OF CASE
The following claim is representative.
1. A method of treating cancer in a patient comprising
administering pathogenic human autoimmune antibodies obtained
from patients having an autoimmune disease distinct from cancer
as carrier agents for therapeutic pharmaceuticals, wherein the
human autoimmune antibodies, and/or binding fragments Fab and
F(ab')2 of the human autoimmune antibodies have the capacity to
bind to intracellular components of the cell that are located
extracellularly within necrotic areas of tumors, and wherein the
human autoimmune antibodies, and/or binding fragments Fab and
F(ab')2 of the human autoimmune antibodies are not directed to
tumor-specific antigens and/or tumor-associated antigens.

Additional appealed claims may be found in the Claims Appendix to the
Brief.
Cited References
Torchilin et al. US 5,780,033 Jul. 14, 1998
Thorpe et al. US 6,342,219 B1 Jan. 29, 2002
Srivastava US 2002/0086276 A1 Jul. 4, 2002

Goldenberg, Radiolabeled Antibodies, Scientific American 64-73 (1994).
Tan, Pathophysiology of Antinuclear Antibodies in Systemic Lupus
Erythematosus and Related Diseases, 10 Adv. Dent. Res. (1):44-46 (1996).

Grounds of Rejection
Claims 1, 3-6 and 10-22 are rejected under 35 U.S.C. 103(a) as being
unpatentable over Torchilin et al. in view of Tan, Srivastava, Goldenberg
and Thorpe et al.

Appeal 2010-001048
Application 10745,308

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Discussion
ISSUE
The issue is: Do the cited references disclose or suggest the limitation
of administering pathogenic human autoimmune antibodies obtained from
patients having an autoimmune disease distinct from cancer as carrier agents
for therapeutic pharmaceuticals?

FINDINGS OF FACT
The Examiner’s fact finding is set forth in the Answer, pages 3-6.

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.
Moreover, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
When evaluating claims for obviousness, “the prior art as a whole
must be considered. The teachings are to be viewed as they would have
Appeal 2010-001048
Application 10745,308

4
been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041
(Fed. Cir. 1986). Thus, “‘[i]t is impermissible within the framework of
section 103 to pick and choose from any one reference only so much of it as
will support a given position, to the exclusion of other parts necessary to the
full appreciation of what such reference fairly suggests to one of ordinary
skill in the art.’” Id. (quoting In re Wesslau, 353 F.2d 238, 241 (CCPA)).
“[T]here must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).

ANALYSIS
The Examiner concludes that
[i]t would have been prima facie obvious to one of ordinary
skill in the art at the time the claimed invention was made to
have produced a method of treating cancer in a patient
comprising administering human antinuclear autoimmune
antibodies from SLE or MCTD patients obtained by blood
donation, plasmapheresis, apheresis, human hybridomas,
transgenic animals or in purified form by apheresis and an
affinity column technology as taught by Srivastava and
conjugated to a radionuclide, a cytotoxic anti-cancer drug, a
cytokine, a toxin or an anti-angiogenic agent for therapeutic
benefit in cancer patients.
(Ans. 4.)
Appellants contend that the prior art does not disclose or suggest
administering pathogenic human autoimmune antibodies obtained from
patients having an autoimmune disease distinct from cancer as carrier agents
for therapeutic pharmaceuticals. (Br. 13.)

Appeal 2010-001048
Application 10745,308

5

Appellants more particularly contend that:
The use of autoantibodies that are pathogenic is also a
significant departure from conventional thinking regarding
disease treatment, which would typically proscribe using a sick
person as a donor or administering materials known to be
pathogenic to an individual in need of treatment. Thus, the
inventive aspects of the invention are so counter-intuitive to
conventional thinking that it is not believed to have been taught
or suggested anywhere in the prior art. This method is distinct
and non-obvious over the cited references because the
references do not teach or suggest that pathogenic autoimmune
antibodies could be used for therapeutic treatment, let alone the
treatment of cancer, and also because the references do not
teach or suggest that antibodies that are not directed to tumor-
associated and/or tumor specific antigens would be at all useful
in the treatment of cancer.

(Br. 15.)

We are persuaded by Appellants’ argument. The prior art, Torchilin
et al., “teach a method of treating cancer in a patient comprising
administering human antinuclear autoantibodies obtained from human
patients with a dysregulated immune system …, wherein the human
antinuclear autoantibodies bind nuclear material released from dead tumor
cells.” (Ans. 3.) The autoantibodies of Torchilin can be polyclonal
antinuclear antibodies (ANA) from an aged mammal. Col. 2, ll. 48-57.
Torchilin further indicates that autoantibodies can be found in older humans
without overt disease. Col. 1, ll. 20-23. Therefore, Torchilin’s
autoantibodies would not reasonably be construed by one of ordinary skill in
the art as being pathogenic autoantibodies.
Appeal 2010-001048
Application 10745,308

6
Thus, Torchilin does not describe the use of autoantibodies which are
pathogenic human autoantibodies, as claimed. While Tan discloses that
ANA are found in systemic lupus erythematosus (SLE) patients, we do not
find that the Examiner has provided a rationale or reason for selecting
pathogenic autoimmune antibodies – i.e., antibodies that cause the
symptoms of an autoimmune disease such as SLE – for use in Torchilin’s
method.
We conclude that the Examiner has not provided sufficient evidence
to support a prima facie case of obviousness.

CONCLUSION OF LAW
The cited prior art does not teach or suggest administering pathogenic
human autoimmune antibodies as carrier agents for therapeutic
pharmaceuticals, as claimed.

REVERSED

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STETINA BRUNDA GARRED & BRUCKER
75 ENTERPRISE, SUITE 250
ALISO VIEJO, CA 92656