Ex parte GAST

Board of Patent Appeals and Interferences

May 9, 2002

08886072 (B.P.A.I. May. 9, 2002)

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for publication and is not binding precedent of the Board.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. 15

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL J GAST
__________

Appeal No. 2001-18191
Application No. 08/886,072
__________

ON BRIEF
__________

Before WINTERS, WILLIAM F. SMITH, and ADAMS, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1-17 and 23-29, which are all the claims pending in the
application.
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below:

1. A method of contraception which comprises administering to a
female of child bearing age a combination of a progestin at a daily dosage selected
from the group consisting of 40-500 Tg trimegestone, and 250 Tg – 4 mg
dienogest, and an estrogen at a daily dosage equivalent in estrogenic activity to 1-
20 Tg ethinyl estradiol for 23-25 days beginning on day 1 of the menstrual cycle, and

1 We find this appeal is related to Appeal No. 2001-1023 (Application No. 08/887,163), accordingly
we have considered them together.
Appeal No. 2001-1819 Page 2
Application No. 08/886,072

wherein the same dosage of the progestin and estrogen combination is
administered in each of the 23-25 days.
The references relied upon by the examiner are:

Bennink 5,418,228 May 23, 1995
Barcomb 5,547,948 Aug. 20, 1996
Spona et al. (Spona) 5,583,129 Dec. 10, 1996
Oettel et al. (Oettel) 5,633,242 May. 27, 1997
Upton 0,253,607 Jan. 20, 1988
(European Patent Application)
GROUND OF REJECTION

Claims 1-17 and 23-29 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Bennink, Spona2 and Upton in view of Oettel and Barcomb.
We reverse.
DISCUSSION
As set forth in In re Dow Chemical Co. 837 F.2d 469, 473, 5 USPQ2d 1529,
1531 (Fed. Cir. 1988), “[t]he consistent criterion for determination of obviousness is
whether the prior art would have suggested to one of ordinary skill in the art that this
process should be carried out and would have a reasonable likelihood of success,
viewed in the light of the prior art.”
On this record, the examiner finds (Answer, page 3) that Bennink, Spona and
Upton teach contraceptive methods, compositions and kits “employing

2 We note that Spona, et al., United States Patent No. 5,583,129, relied upon by the examiner in
the Answer, is not the same reference relied upon in the Final Rejection, which was Spona, et al.,
WO 95/17194 (June 29, 1995). The examiner provides no explaination for changing references. We
note, however, that the change in references appears to result in a new ground of rejection. To the
extent the examiner has “switched horses” in the Answer and presents a different ground of
rejection than that developed during prosecution, we note, as set forth in 37 C.F.R. § 1.193(a)(2)
(1998), “[a]n examiner’s answer must not include a new ground of rejection….” We emphasize that
the Answer was mailed after the effective date of this rule, and therefore the examiner erred in
introducing a new ground of rejection in the Answer. Nevertheless, given our disposition, we find
this error harmless.
Appeal No. 2001-1819 Page 3
Application No. 08/886,072

progestogenic and estogenic compounds to be administered in particular amounts
on a specified dosage schedule, are known in the art.” The examiner recognizes
(id.) “[t]he claims differ in that they are drawn to methods and kits employing
particular progestogenic and estrogenic compounds in particular amounts on a
specified dosage schedule.”
To make up for this deficiency in Bennink, Spona and Upton, the examiner
affirmatively states (Answer, page 4) “[a]ny compound with progestogenic activity
would be reasonably expected to be useful in combined oral contraceptive
methods, absent evidence to the contrary.” In support of these conclusions the
examiner cites Oettel and Barcomb (id.) which according to the examiner “show that
progestogenic activity of compounds claimed herein is known in the art.
In reviewing the prior art relied on by the examiner, appellant finds (Brief,
pages 4-6) that none of the prior art teaches dienogest and the only reference that
teaches trimegestone is Barcomb. However, appellant finds (Brief, page 6) that
while Barcomb identifies trimegestone as a hormonal steroid “suitable for
incorporation into the sugar coated formulation [disclosed in Barcomb for the
controlled release of steroid formulations], … Barcomb does not teach or even
suggest the use of the steroid formulation containing trimegestone as a
contraceptive for 23-25 days per menstrual cycle.” According to appellant (id.)
“Barcomb does not even teach the use of trimegestone as a contraceptive at all.”
The examiner recognizes (Answer, page 4) appellant’s arguments “that each
of the references provides a piece of applicant’s invention, that there is no
motivation to combine the references and that hindsight analysis is utilized in the
Appeal No. 2001-1819 Page 4
Application No. 08/886,072

rejection.” Nevertheless, the examiner does not find appellant’s arguments
persuasive “since the references clearly teach the use of a progestogen/ estrogen
combination….”
The examiner, however, appears to miss the point of appellant’s arguments.
Appellant’s claimed method requires, inter alia, administering to a female a
combination of the progestin, trimegestone or dienogest, together with an estrogen
for 23-25 days, wherein the same dosage of the progestin and estrogen
combination is administered in each of the 23-25 days. The examiner recognizes
that the claims differ from Bennink, Spona and Upton in that thy require “particular
progestogenic and estrogenic compounds in particular amounts on a specified
dosage schedule.” See Answer, page 3. Of the two references relied on to make
up for the deficiency in Bennink, Spona and Upton, only Barcomb teaches the
claimed progestin – trimegestone. However, as explained by appellant (Brief, page
6) “Barcomb does not even teach the use of trimegestone as a contraceptive at all.”
Prima facie obviousness based on a combination of references requires that
the prior art provide “a reason, suggestion, or motivation to lead an inventor to
combine those references.” Pro-Mold and Tool Co. v. Great Lakes Plastics Inc., 75
F.3d 1568, 1573, 37 USPQ2d 1626, 1629 (Fed. Cir. 1996). On this record, the
only suggestion to combine the references is found in appellant’s specification and
the examiner’s unsupported conclusion that “[a]ny compound with progestogenic
activity would be reasonably expected to be useful in combined oral contraceptive
methods….”
Appeal No. 2001-1819 Page 5
Application No. 08/886,072

The examiner, however, fails to provide any evidence to suggest that
trimegestone or dienogest are equivalent to the progestins disclosed in the primary
references, wherein one would reasonably expect them to be useful in appellant’s
claimed method. To establish a prima facie case of obviousness, there must be
both (1) a suggestion or motivation to modify the references or combine reference
teachings and (2) a reasonable expectation of success. See Dow; In re Vaeck, 947
F.2d 488, 493, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991).
On this record we find neither a suggestion to combine the prior art, nor a
reasonable expectation of success. Accordingly, we reverse the rejection of claims
1-17 and 23-29 under 35 U.S.C. § 103 as being unpatentable over
Bennink, Spona and Upton in view of Oettel and Barcomb.
REVERSED

Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
William F. Smith )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Donald E. Adams )
Administrative Patent Judge )

DA/dym
Appeal No. 2001-1819 Page 6
Application No. 08/886,072

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Patent Section
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