Ex Parte Baron

Board of Patent Appeals and Interferences

Aug 31, 2009

10382172 (B.P.A.I. Aug. 31, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JOHN A. BARON
____________

Appeal 2009-003389
Application 10/382,172
Technology Center 1600
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Decided: September 1, 2009
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Before DONALD E. ADAMS, DEMETRA J. MILLS, and FRANCISCO C.
PRATS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claim 2, the only claim
pending in this application. We have jurisdiction under 35 U.S.C. § 6(b).

STATEMENT OF THE CASE
Claim 2 is directed to a method for decreasing the risk of developing a
sporadic neoplasia of the large bowel in a patient. Claim 2 is reproduced:

Appeal 2009-003389
Application 10/382,172

Claim 2: A method for decreasing the risk of developing a sporadic
neoplasia of the large bowel in a patient comprising administering to a
patient at risk of developing a sporadic neoplasia of the large bowel an
effective amount of acetylsalicylic acid and a pharmaceutically acceptable
vehicle daily for at least one year, wherein the patient is an individual that
had at least one confirmed large-bowel adenoma, and wherein the effective
amount of acetylsalicylic acid is 81 mg of acetylsalicylic acid so that the risk
of developing a sporadic neoplasia of the large bowel is decreased.

The Examiner relies on the following evidence:
Larson et al. US 5,843,929 Dec. 1, 1998
Ruffin et al., Suppression of Human Colorectal Mucosal Prostaglandins:
Determining the Lowest Effective Aspirin Dose, 89 J. NATIONAL CANCER
INSTITUTE 1152-1160 (1997).

Strul et al., Non-Steroidal Anti-Inflammatory Drugs and Selective Apoptotic
Anti-Neoplastic Drugs in the Prevention of Colorectal Cancer: The Role of
Super Aspirins, 2 IMAJ 695-702 (2000).

Appellant relies on the following evidence:

Goodman & Gilman’s (10th ed., McGraw-Hill, New York) (date and pages
unknown).

Fearon et al., Progressing toward a molecular description of colorectal
cancer development, 6 THE FASEB JOURNAL 2783-2790 (1992).

Cancer Prevention Overview,
http://www.cancer.gov/cancertopics/pdq/prevention/overview/HealthPro...
(Last Modified: 10/24/2006).

The rejection presented by the Examiner is as follows:
Claim 2 stands rejected under 35 U.S.C § 103(a) as unpatentable over
the combination of Strul, Larson, and Ruffin.
We reverse.
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Appeal 2009-003389
Application 10/382,172

ISSUE

Has Appellant met his burden of establishing error in the Examiner’s
conclusion that the combination of Strul, Larson, and Ruffin makes obvious
a method for decreasing the risk of developing a sporadic neoplasia of the
large bowel in a patient comprising administering 81 mg of acetylsalicyclic
acid and a pharmaceutically acceptable vehicle daily for at least one year to
a patient that had at least one confirmed large-bowel adenoma?

FINDINGS OF FACT
FF 1. The Examiner finds that Strul and Larson “do not specifically teach
administering a dosage of aspirin corresponding to 81 mg” (Ans. 5).
FF 2. The Examiner finds that Strul teaches “that it is hypothesized that the
overproduction of PGE2 might promote tumor growth and spread” (id.).
FF 3. The Examiner finds that Ruffin “teaches that aspirin has been found
to effect colorectal cancer carcinogenesis . . ., that prostaglandin E2 levels
are believed to be related to colorectal cancer development . . ., [and] that a
lowest effective dose of aspirin that reduces prostaglandin levels was a
dosage of 81 mg” (Ans. 5-6).
FF 4. The Examiner finds that Ruffin recommends the use of aspirin at
“low dosage as a ‘chemopreventive agent for colorectal cancer’” (Ans. 6).
FF 5. Ruffin reports that their study
has some limitations to be considered before one should
promote the use of colorectal mucosal prostaglandins as a
surrogate endpoint biomarker for colorectal cancer. First, our
study population consisted entirely of healthy, young adults.
The impact of aspirin on colorectal mucosal prostaglandins may
be different in older adults or in patients with significant risk of
colorectal cancer . . . . Second, colorectal mucosal
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Appeal 2009-003389
Application 10/382,172

prostaglandins have not been linked to risk of developing
colorectal cancer. . . .
On the basis of the data presented here, we believe that
additional prospective trials of aspirin as a chemopreventive
agent for colorectal cancer are warranted.

(Ruffin 1159: 1-59.)
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 Ex parte Yamaguchi, 88 USPQ2d
1606, 1608 and 1614 (BPAI 2008) (precedential); Ex parte Fu, 89 USPQ2d
1115, 1118 and 1123 (BPAI 2008) (precedential).
“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). Nevertheless,
while the analysis under 35 U.S.C. § 103 as set forth in KSR allows
flexibility in determining whether a claimed invention would have been
obvious, it still requires showing that “there was an apparent reason to
combine the known elements in the fashion claimed by the patent at issue.”
Id. at 418. “We must still be careful not to allow hindsight reconstruction of
references to reach the claimed invention without any explanation as to how
or why the references would be combined to produce the claimed
invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3
(Fed. Cir. 2008).
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Appeal 2009-003389
Application 10/382,172

[P]rior art fails to provide the requisite “reasonable expectation”
of success where it teaches merely to pursue a “general
approach that seemed to be a promising field of
experimentation, where the prior art gave only general guidance
as to the particular form of the claimed invention or how to
achieve it.”

Medichem S.A. v. Rolabo S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006)
(quoting In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)).

ANALYSIS
The Examiner admits that Strul and Larson fail to teach the use of 81
mg/day of aspirin for one year to treat sporadic neoplasia (FF 1). Appellant
contends that Ruffin also fails to teach the treatment of sporadic neoplasia
with a daily dosage of 81 mg of aspirin for one year (see, e.g., App. Br. 11).
Ruffin itself recognizes the limitations of the work reported and teaches that
more work is necessary before aspirin is used as a chemopreventive agent
for colorectal cancer (FF 5). Accordingly, we agree with Appellant’s
contention that “there is simply no . . . expectation of success of using the 81
mg dose for anything other than inhibiting prostaglandin production” (App.
Br. 13). Medichem S.A. v. Rolabo S.L., 437 F.3d at 1165.

CONCLUSION OF LAW
Appellant met his burden of establishing error in the Examiner’s
conclusion that the combination of Strul, Larson, and Ruffin makes obvious
a method for decreasing the risk of developing a sporadic neoplasia of the
large bowel in a patient comprising administering 81 mg of acetylsalicyclic
acid and a pharmaceutically acceptable vehicle daily for at least one year to
a patient that had at least one confirmed large-bowel adenoma.
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Appeal 2009-003389
Application 10/382,172

The rejection of claim 2 under 35 U.S.C § 103(a) as unpatentable over
the combination of Strul, Larson, and Ruffin is reversed.

REVERSED

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