Ex Parte Gutterer

Board of Patent Appeals and Interferences

Jul 8, 2003

09147675 (B.P.A.I. Jul. 8, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 37
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte BEATE GUTTERER
___________
Appeal No. 2003-0855
Application No. 09/147,675
__________
HEARD: June 24, 2003
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Before WINTERS, WILLIAM F. SMITH, and SCHEINER, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting claims 3 through
19, which are all of the claims remaining in the application.
The Invention
The invention relates to a process for increasing the proportion of R-epimer in an
R/S-epimer mixture of certain pregna-1,4-diene-3,20-dione 16, 17-acetal 21-esters.
Claim 17, which is illustrative of the subject matter on appeal, reads as follows:
17. A process for increasing the proportion of R-epimer in an R/S-epimer
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Application No. 09/147,675
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mixture of compounds of formula I
wherein R1 is 3-8C-cycloalkyl and R2 is 1-7C-alkylcarbonyl or 3-8C-cycloalkylcarbonyl,
which comprises subjecting the R/S-epimer mixture of the compounds of formula I to
fractional crystallization carried out from a solution of the R/S-epimer mixture of formula
I in a mixture of water and a suitable, water-miscible organic solvent (emphasis added).
The Prior Art Reference
In the Examiner's Answer (Paper No. 28), the examiner cites and relies on a
single prior art reference:
Jakupovic et al. (Jakupovic)
(European Patent Application) 0 262 108 A1 Mar. 30, 1988
The Issue
In the Final Rejection (Paper No. 16), the examiner maintained these rejections:
(1) claims 3 through 19 under 35 U.S.C. § 103(a) as unpatentable over the combined
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Application No. 09/147,675
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1 Uszycka-Horawa, PCT Application No. WO92/11280, July 9, 1992
2 Jakupovic et al. (Jakupovic), European Patent Application No. 0 262 108 A1
(March 30, 1988)
3 Linus Pauling, General Chemistry, Chapter 2, page 14, last paragraph and
page 15, lines 1-2 (W.H. Freeman and Company, San Francisco, Calif. 1947)
teachings of Uszycka-Horawa,1 Jakupovic,2 and Linus Pauling;3 and (2) claims 3
through 19 under 35 U.S.C. § 103(a) as unpatentable over Jakupovic.2 In the
Examiner's Answer, however, the examiner does not repeat or refer to the former
rejection, based on a combination of references; only the latter ground of rejection is
maintained (Paper No. 28, § 10). Accordingly, as a matter of standard procedure, the
rejection of claims 3 through 19 under 35 U.S.C. § 103(a) as unpatentable over the
combined teachings of Uszycka-Horawa, Jakupovic, and Linus Pauling, has been
dropped. See Paperless Accounting, Inc. v. Bay Area Rapid Transit System,
804 F.2d 659, 663, 231 USPQ 649, 651-52 (Fed. Cir. 1986), cert. denied, 480 U.S. 933
(1987)(as a matter of standard procedure, rejection not "repeated or referred to" in
subsequent Office action(s) has been dropped).
The sole issue presented for review is whether the examiner erred in rejecting
claims 3 through 19 under 35 U.S.C. § 103(a) as unpatentable over Jakupovic.

Deliberations
Our deliberations in this matter have included evaluation and review of the
following materials: (1) the instant specification, including all of the appealed claims;
(2) applicant's Appeal Brief (Paper No. 27) and the Reply Brief (Paper No. 29);
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Application No. 09/147,675
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(3) the Examiner's Answer (Paper No. 28); and (4) the above-cited Jakupovic
reference.
On consideration of the record, including the above-listed materials, we reverse
the rejection of claims 3 through 19 under 35 U.S.C. § 103(a) as unpatentable over
Jakupovic. Additionally, we recommend that the examiner evaluate the patentability of
applicant's claims in light of U.S. Patent No. 5,482,934.
The Examiner's Rejection
In the R/S-epimer mixture of compounds of formula I recited in claim 17, variable
R1 is "3-8C-cycloalkyl" attached at position 22 of the fused ring system. Likewise, claim
8 recites a process for preparing an R/S-epimer mixture of a specific compound, and for
increasing the proportion of R-epimer in that mixture, where the specific compound has
a cyclohexyl group at position 22 of the fused ring system. Having carefully reviewed
the Jakupovic reference in its entirety, we agree with applicant that Jakupovic
constitutes insufficient evidence to support a conclusion of obviousness of claims which
require that "3-8C-cycloalkyl," or cyclohexyl, be attached at position 22 of the fused ring
system.
In a nutshell, the examiner has not established that Jakupovic discloses or
suggests a process for preparing the same compounds recited in the claims on appeal.
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Application No. 09/147,675
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The examiner has not established that Jakupovic discloses or suggests a process for
preparing any compound where "3-8C-cycloalkyl," or cyclohexyl, is attached at position
22 of the fused ring system. Again, we refer to the definition of variable R1 in claim 17;
and, again, we note that claim 8 is restricted to a process for preparing a specific
compound having a cyclohexyl group at position 22 of the fused ring system.
Accordingly, the examiner failed to establish a prima facie case of obviousness of
claims 3 through 19 based on the disclosure of Jakupovic alone.
In conclusion, we reverse the examiner's rejection of claims 3 through 19 under
35 U.S.C. § 103(a) as unpatentable over Jakupovic. Where, as here, the examiner
failed to establish a prima facie case of obviousness, we find it unnecessary to discuss
applicant's declaration evidence submitted to rebut any such prima facie case.
Other Issue
One further matter warrants attention. In the instant specification, page 1,
applicant refers to Offenlegungsschrift DE 41 29 535 A1 as relevant prior art.
Subsequently, in the "Supplement to Information Disclosure Statement" (Paper No. 25),
applicant cites U.S. Patent No. 5,482,934 ('934), issued January 9, 1996 to Calatayud
et al. The '934 patent is based on Application No. 278,112, filed July 20, 1994, said to
be a continuation of Application No. 578,942, filed September 7, 1990, now abandoned.
This means to say that U.S. Patent No. 5,482,934 is the "equivalent" of DE 41 29 535
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4 Copies of Offenlegungsschrift DE 41 29 535 A1 and U.S. Patent No.
5,482,934 are enclosed with this opinion.
5 The record reflects that the examiner previously entered a rejection under
35 U.S.C. § 103(a) based on a combination of references, including DE 41 29 535 A1.
See Paper No. 8, page 8; and Paper No. 12, page 7. That rejection has now been
withdrawn (Paper No. 16, page 3). But the record does not reflect that the examiner
considered an English translation of DE 41 29 535 A1 or that the examiner evaluated
the patentability of applicant's process claims in light of U.S. Patent No. 5,482,934.
A1 which, on its face, seeks the benefit of the filing date of U.S. Application No.
578,942, filed September 7, 1990.4
On return of this application to the examining corps, we recommend that the
examiner review U.S. Patent No. 5,482,934 in its entirety. Unlike Jakupovic, the '934
patent discloses compounds which fully meet compounds having formula (I) recited in
claim 17 on appeal. In particular, we invite attention to column 10, example VII of the
'934 patent disclosing preparation of the same R/S-epimer mixture recited in claim 8 on
appeal. Further, example VII of U.S. Patent No. 5,482,934 discloses that:
The mixture of epimers is resolved by preparative HPLC [high-pressure
liquid chromatography], using a 7 µm Lichrosorb RP-18 column (250x10
mm i.d.) and ethanol/water as the mobile phase, and obtaining the (22R)-
epimer practically pure and the (22S)- epimer in a purity greater than
99%.
The product containing the (22R,S)- mixture can also be purified
without having to use column chromatography by a method which is
described in the following example. [See the '934 patent, column 10, lines
37-44 (emphasis added).]
We recommend that the examiner evaluate the patentability of applicant's process
claims in light of U.S. Patent No. 5,482,934, particularly examples VII and VIII.5
Conclusion
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In conclusion, we reverse the rejection of claims 3 through 19 under 35 U.S.C.
§ 103(a) as unpatentable over Jakupovic. Additionally, we recommend that the
examiner evaluate the patentability of applicant's claims in light of U.S. Patent No.
5,482,934.
The examiner's decision is reversed.
REVERSED
)
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
William F. Smith )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
Toni R. Scheiner )
Administrative Patent Judge )
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Application No. 09/147,675
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