Ex Parte Siber

Board of Patent Appeals and Interferences

Jul 22, 2010

10441059 (B.P.A.I. Jul. 22, 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.
10/441,059 05/20/2003 George R. Siber 38523.000031 1066
21967 7590 07/22/2010
HUNTON & WILLIAMS LLP
INTELLECTUAL PROPERTY DEPARTMENT
1900 K STREET, N.W.
SUITE 1200
WASHINGTON, DC 20006-1109
EXAMINER
STOICA, ELLY GERALD
ART UNIT PAPER NUMBER
1647
MAIL DATE DELIVERY MODE
07/22/2010 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 GEORGE R. SIBER
__________

Appeal 2010-003908
Application 10/441,059
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating Severe Acute Respiratory Syndrome (SARS). The
Patent Examiner rejected the claims on the ground of obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

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 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-003908
Application 10/441,059

2
STATEMENT OF THE CASE
Claims 36-41 and 48-50, which are all the pending claims, are on
appeal. Claim 38 is representative and reads as follows:
38. A method for treating a patient having Severe Acute Respiratory
Syndrome (SARS) comprising:
administering to the patent [sic] a therapeutically effective amount of
an inhibitor of TNF.

The Examiner rejected the claims under 35 U.S.C. § 103(a) as
unpatentable over Nicholls2, Cheung3, Pluenneke4, and Tobinick5.
Appellant requested an oral hearing in this appeal. We find an oral
hearing unnecessary and have decided the appeal on the basis of the written
record, as authorized by 37 C.F.R. § 41.47(f).

OBVIOUSNESS
The Issue
The Examiner reviewed the prior art and concluded:
It would have been obvious for a person of ordinary skill
in the art . . . to have used the critical observations of Nicholls
et al. that the macrophages are present in the dead SARS
patients, combined with the teachings of Cheung et al., that
viruses are potent inducers of TNFα in macrophages, to come to
the conclusion that the TNFα likely explains the etiology and

2 John M Nicholls et al., Lung pathology of fatal severe acute respiratory
syndrome, 361 LANCET 1773-78 (2003).
3 C Y Cheung et al., Induction of proinflammatory cytokines in human
macrophages by influenza A (H5N1) viruses: a mechanism for the unusual
severity of human disease?, 360 LANCET 1831-37 (2002).
4 Patent Appl. Pub. No. US 2001/0021380 A1, by John D. Pluenneke,
Sep. 13, 2001.
5 Patent No. US 6,419,934 B1, issued to Edward L. Tobinick, Jul. 16, 2002.
Appeal 2010-003908
Application 10/441,059

3
severity of the SARS and would lead the person of ordinary
skill in the art to treat SARS with TNFα inhibitors. . . . The
motivation to do so would have come from the constant desire
of a person of ordinary skill in the art to find solutions to the
problems which are posed in the art by employing
methodologies that are well within her or his skills and chosen
from a finite number of options.

(Ans. 6.)
Appellant contends that “[c]lose inspection of the cited references
exposes critical deficiencies,” and that “[a]pplication of the appropriate legal
standard to the facts compels reversal.” (App. Br. 10.) Appellant argues
that the rejection did not state a specific rationale to support the conclusion
of obviousness (id. at 10-11); that the rejection is based on an incorrect
“obvious to try” standard (id. at 11-12); and that a prima facie case of
obviousness was not established (id. at 12-27, analyzing the references).
The issue with respect to this rejection is whether the rejection is
supported by the evidence.

Findings of Fact
1. Nicholls disclosed that “SARS is associated with epithelial-cell
proliferation and an increase in macrophages in the lung.” (Nicholls
p. 1773, “Interpretation”.)
2. According to Nicholls, “[a] virus from the family Coronaviridae has
been identified as the cause, but the pathogenesis is still unclear.”
(Id., “Background”.)
3. Cheung disclosed that “[t]he H5N1/97 [influenza] viruses are potent
inducers of proinflammatory cytokines in macrophages, the most
notable being TNF α.” (Cheung p. 1831, “Interpretation”.)
Appeal 2010-003908
Application 10/441,059

4
4. Tobinick disclosed “administering a TNF antagonist for reducing the
inflammation of neuronal tissue.” (Tobinick, col. 4, ll. 23-27.)
5. Tobinick disclosed that for viral-associated neurological disorders,
also administering an antiviral agent with the TNF antagonist to
reduce the inflammation of the neuronal tissue. (Id. at col. 4, ll. 37-
43.)
6. Pluenneke disclosed treating disorders “characterized by abnormal or
excessive TNFα levels by administering a TNFα antagonist.”
(Pluenneke [0002].)

Principles of Law
“[K]nowledge of a problem and motivation to solve it are entirely
different from motivation to combine particular references to reach the
particular claimed method.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d
1363, 1373 (Fed. Cir. 2008). “Obviousness does not require absolute
predictability of success. . . . [A]ll that is required is a reasonable
expectation of success.” In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir.
1988).

Analysis
The record evidences that at the time the Appellant made the
invention, SARS was a known problem, but there was little guidance to an
effective treatment. Given the facts in evidence, we find that too little was
known at the time to conclude that the invention would have been obvious.
Nicholls did not disclose that abnormal TNFα levels were implicated in
SARS, nor did Cheung, Tobinick, or Pluenneke. We agree with the
Appeal 2010-003908
Application 10/441,059

5
Examiner that those of skill in the art would have been motivated to look for
an effective treatment. But we agree with Appellant, that the existing
motivation to solve the problem was not sufficient to render Appellant’s
solution obvious. (App. Br. 15, citing Innogenetics.)
Assuming the “macrophage” link was enough to combine the Nicholls
and Cheung disclosures concerning different viruses, we do not see evidence
that their combined teachings provided more than a promising field of
experimentation. We agree with Appellant that the Examiner’s “obvious to
try” rationale does not support the obviousness conclusion. (Id. at 11-12;
Reply Br. at 5, discussing In re Kubin.) The fact pattern in this case is the
kind of “impermissible” obvious to try situation where the prior art provided
only a general, exploratory approach insufficient to render a specific,
defined invention obvious. See, e.g., In re Kubin, 561 F.3d 1351, 1359-60
(Fed. Cir. 2008) (contrasting prior art that contained detailed enabling
methodology with prior art that gave no direction on which of many possible
choices were likely to be successful, or gave only a promising field of
exploration), quoting In re O’Farrrell, 853 F.2d 894, 903 (Fed. Cir. 1988).

CONCLUSION
The prior art of record contained insufficient guidance to have
rendered it obvious to treat SARS by administering a TNF inhibitor.

Appeal 2010-003908
Application 10/441,059

6

SUMMARY
We reverse the rejection of claims 36-41 and 48-50 under 35 U.S.C.
§ 103(a) as unpatentable over Nicholls, Cheung, Pluenneke, and Tobinick.

REVERSED

alw

HUNTON & WILLIAMS LLP
INTELLECTUAL PROPERTY DEPARTMENT
1900 K STREET, N.W.
SUITE 1200
WASHINGTON DC 20006-1109