Ex Parte Secrist et al

Board of Patent Appeals and Interferences

Jun 14, 2011

12053970 (B.P.A.I. Jun. 14, 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.
12/053,970 03/24/2008 John A. Secrist III 21381-00089-US2 5272
10574 7590 06/14/2011
CONNOLLY BOVE LODGE & HUTZ LLP
(Southern Research Institute)
1875 EYE STREET, N.W.
Suite 1100
WASHINGTON, DC 20006
EXAMINER
BAEK, BONG-SOOK
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
06/14/2011 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 JOHN A. SECRIST III, WILLIAM R. WAUD,
ZHICAN QU, and XIANGMIN CUI
__________

Appeal 2011-003687
Application 12/053,970
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating or preventing rheumatoid arthritis. The Patent Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Application 12/053,970

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STATEMENT OF THE CASE
Claims 1-6, 8-10, 12, and 14-16 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for treating or preventing rheumatoid arthritis which
comprises administering to a host in need of said treating or preventing
rheumatoid arthritis, an amount effective for treating or preventing
rheumatoid arthritis of at least one compound represented by the formula 1:

wherein each R individually is H, an aliphatic acyl group containing
1-6 carbon atoms or an aromatic acyl group containing 6-10 carbon atoms in
the aromatic group;
A is selected from the group consisting of

wherein X is selected from the group consisting of hydrogen, halo,
alkoxy containing 1-6 carbon atoms, alkyl containing 1-6 carbon atoms,
haloalkyl containing 1-6 carbon atoms, alkenyl containing 2-6 carbon atoms,
haloalkenyl containing 2-6 carbon atoms, alkynyl containing 2-6 carbon
atoms, amino, monoalkylamino containing 1-6 carbon atoms,
dialkylamino containing 1-6 carbon atoms in each alkyl group, cyano and
nitro.
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The Examiner rejected claims 1-6, 8-10, 12, and 14-16 under
35 U.S.C. § 103(a) as unpatentable over Secrist1 and Schinazi.2, 3
Claims 2-6, 8-10, 12, and 14-16 have not been argued separately and
therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issues
The Examiner’s position is that Secrist taught a thioarabinofuranosyl
cytosine compound and 1-(4-thio-β-D-arabinofuranosyl) cytosine, the
elected compound of the instantly claimed invention. (Ans. 6.) The
Examiner found that Secrist also taught a method for treating a mammalian
host suffering from melanoma, prostrate cancer, mammary cancer, renal
cancer, colon cancer or lung cancer, comprising administering to the host an
effective anticancer amount 1-(4-thio-β-D-arabinofuranosyl) cytosine. (Id.)
Further, the Examiner found that Secrist taught that the same compound, and
others in a described genus, effectively inhibited DNA replication in
mammalian cells, and explicitly disclosed that the compounds may also be
useful immunomodulators for treating autoimmune diseases. (Id. at 6-7.)
The Examiner found that Schinazi taught nucleoside compounds that
share a similar structure with Secrist’s compound. (Ans. 7.) The Examiner
also found that Schinazi taught that its nucleoside compounds are useful for

1 US Patent No. 6,576,621 B1 issued to John A. Secrist, III et al., Jun. 10,
2003.
2 US Patent No. 6,911,424 B2 issued to Raymond F. Schinazi, et al., Jun. 28,
2005.
3 The Examiner withdrew the remaining grounds of rejection that Appellants
raised for review. (Ans. 3; App. Br. 5-6.)
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treating abnormal cell proliferation such as malignant tumors (cancer) and
rheumatoid arthritis. (Id.)
According to the Examiner, it would have been obvious to a person of
ordinary skill in the art at the time the invention was made to use the
nucleoside analog compounds taught by Secrist, including 1-(4-thio-β-D-
arabinofuranosyl) cytosine, for treating rheumatoid arthritis as taught by
Schinazi because Secrist’s 1-(4-thio-β-D-arabinofuranosyl) cytosine and the
compounds taught by Schinazi were similar compounds known for their
anticancer effects, and Schinazi taught that its compounds were useful for
treating both cancer and rheumatoid arthritis. (Id.) According to the
Examiner, the skilled artisan would have been motivated to combine these
prior art teachings with a reasonable expectation that compounds similar in
structure and function would also have similar biological activities. (Id. at
8.)
Appellants contend that Secrist did not disclose that its compounds
could be used to treat rheumatoid arthritis and that Schinazi did not
overcome this deficiency. (App. Br. 6, 10.) In particular, Appellants assert
that Schinazi’s disclosed nucleosides are distinguished from those recited in
the instant claims because Schinazi’s compounds require a fluoro group in
the 2´position of the sugar moiety of the nucleoside, “which is not present in
the nucleosides according to the present invention.” (Id. at 10.) According
to Appellants, “nothing in Schinazi suggests to persons skilled in the art that
the uses enumerated and speculated upon by Schinazi apply to other
nucleosides and especially those lacking the 2´ fluoro substituent.” (Id. at
11.) Additionally, Appellants assert that rheumatoid arthritis is not “a
disease involving abnormal cell proliferation.” (Id.)
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Appellants further assert that the cited prior art did not suggest the
“significant and unexpected effects in preventing and treating rheumatoid
arthritis that have been shown in the present application.” (App. Br. 11,
citing Spec. 8-9, 11-12, 14, 16, 18.) According to Appellants, “[c]learly not
any and all nucleosides would provide the [results reported in the instant
Specification.]” (Id. at 14.)
The issues with respect to this rejection are whether the record
supports the Examiner’s conclusion that the cited references would have
made the claimed method prima facie obvious, and if so, whether Appellants
have provided evidence of unexpected results such that the totality of
evidence weighs in favor of nonobviousness.

Findings of Fact
1. We agree with the Examiner’s explicit findings regarding the scope
and content of the prior art references. (See Ans. 5-8.)
2. Schinazi disclosed examples of abnormal cell proliferation treatable
by its active compound including melanoma, breast cancer, leukemias,
lymphomas, and rheumatoid arthritis. (Schinazi, col. 63 ll. 33-61.)

Principles of Law
Compounds that are structurally similar may be expected to have
similar properties. E.g., In re Merck& Co., 800 F.2d 1091, 1096 (Fed. Cir.
1986).
“[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).
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Analysis
After considering all the evidence and arguments, we conclude that
the record supports a conclusion of prima facie obviousness. In particular,
we are not persuaded by Appellants’ assertion that a skilled artisan would
not have reasonably expected the nucleoside compounds of Secrist and the
claimed invention, e.g., 1-(4-thio-β-D-arabinofuranosyl) cytosine, to have
the same uses mentioned by Schinazi, i.e., treatment of rheumatoid arthritis.
(See App. Br. 10.) Appellants support their assertion with the fact that the
Secrist’s compounds and those in claimed invention do not have a fluoro
group located on the 2´ position of the sugar moiety of the nucleoside, in
contrast to Schinazi’s compounds. (Id.) According to Appellants, this
difference makes the compounds “vastly different.” (Id.)
However, absent evidence to the contrary, compounds that are
structurally similar may be expected to have similar properties. See Merck
& Co., 800 F.2d at 1096. It is undisputed that both Secrist’s and Schinazi’s
compounds are nucleosides and have the function of being useful against
cancer. Appellants have not provided evidence that a skilled artisan would
consider the difference at the 2´ position so distinctive that the compounds
would not be considered similar in structure. Nor have Appellants provided
any evidence that a skilled artisan would not have expected these
compounds having similar structures and the same function against cancer to
also have other similar biological activities, as the Examiner found.
The prior art supports an expectation of similar activities because
Secrist taught that its nucleoside (lacking the fluoro group) was suitable for
treating various cancers, including melanoma, mammary cancer, leukemias,
and lymphomas, which Schinazi also disclosed that its nucleoside
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(containing the fluoro group) was suited to treat. (See Ans. 6-7; FF-2.) The
art further supports this expectation because Secrist suggested that its
nucleoside (lacking the fluoro group) was suitable for treating autoimmune
diseases, and Schinazi disclosed that its nucleoside (containing the fluoro
group) was suitable for treating rheumatoid arthritis, a known autoimmune
disease. (See Ans. 6-7.) Thus, we agree with the Examiner that those
skilled in the art would have considered both nucleoside analogs to have
other activities in common, including the ability to treat rheumatoid arthritis.
Moreover, to the extent Appellants assert that rheumatoid arthritis is
not “a disease involving abnormal cell proliferation” (App. Br. 11), we
disagree. Schinazi expressly disclosed rheumatoid arthritis as an example of
abnormal cell proliferation. (FF-2.) Appellants have not established
otherwise with any persuasive evidence.
Appellants additionally assert that the cited prior art did not suggest
the “significant and unexpected effects in preventing and treating
rheumatoid arthritis that have been shown in the present application.” (App.
Br. 11.) In support of this contention, Appellants quote various passages
from their Specification describing the effectiveness of the preferred
compound, 1-(4-thio-β-D-arabinofuranosyl) cytosine, in the claimed
method. (Id., citing Spec. 8-9, 11-12, 14, 16, 18.) According to Appellants,
“[c]learly not any and all nucleosides would provide [these] results.” (Id. at
14.) The issue is not whether “any and all” nucleosides would provide these
results. It is instead whether Secrist’s nucleosides would provide the result
that Schinazi’s nucleosides provided. On that question, the evidence
supports the reasonableness of the Examiner’s expectation of success. What
is missing from Appellants’ evidence is a showing that their results would
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have been unexpected compared with the closest prior art, for example, a
comparison against Schinazi’s corresponding fluoro-compounds, explicitly
taught to be useful for treating rheumatoid arthritis. See Baxter Travenol
Labs., 952 F.2d at 392. The passages of the Specification referenced by
Appellants did not provide a comparison with any other nucleoside
compounds. (See App. Br. 11-14.) Consequently, Appellants have not
established that their results were unexpected, as required to overcome prima
facie obviousness.

CONCLUSIONS OF LAW
The record supports the Examiner’s conclusion that the cited
references would have made the claimed method prima facie obvious.
Appellants have not provided evidence of unexpected results such that
the totality of evidence weighs in favor of nonobviousness.

SUMMARY
We affirm the rejection of claims 1-6, 8-10, 12, and 14-16 under 35
U.S.C. § 103(a) as unpatentable over Secrist and Schinazi.

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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