Ex Parte Grubb

Board of Patent Appeals and Interferences

Mar 27, 2007

09872250 (B.P.A.I. Mar. 27, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GARY S. GRUBB
__________

Appeal 2007-1072
Application 09/872,250
Technology Center 1600
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ON BRIEF
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Before SCHEINER, ADAMS, and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 1-11. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. An oral contraceptive starter kit comprising at least two cycle
packs of oral contraceptives containing an estrogen and progestin,
and having a penultimate and a last cycle pack, the effective
dosage of steroid in the penultimate cycle pack being greater than
the effective dosage of steroid in the last cycle pack, the last cycle
pack providing no more than about 20 μg estrogen per dosage unit.
Appeal No. 2007-1072
Application No. 09/872,250

Claims 1-11 stand rejected under 35 U.S.C. § 103(a) as being obvious
over the combination of Endrikat,1 Hodgen2 and Katzung.3 We reverse.
DISCUSSION
Claim 1 is drawn to a kit, wherein at least two cycle packs are
packaged together to be given to a patient, wherein one pack has an effective
dosage of steroid that is greater than the effective dosage of steroid in the
second pack, wherein the cycle pack having the lower effective dosage of
steroid has no more than about 20 μg estrogen per dosage unit.
Endrikat is relied upon by the Examiner for teaching that oral
contraceptives having 30 μg of ethinylestradiol have less breakthrough
bleeding in the first three cycles than those having 20 μg of ethinylestradiol
(Answer 3). The examiner also cites Endrikat for its teaching that the
pattern of breakthrough bleeding in the first month may be due to the fact
that the adaptation of the endometrium to the exogenous hormones takes
some time. Id.
Hodgen is cited for teaching “a method of reducing breakthrough
bleeding in the menstrual cycles except for the first cycle employing ultra-
low dose of ethinylestradiol,” wherein the dose is 3-35 μg. Id.
Katzung is relied upon for teaching the various claimed progestins.
Id. at 4. The examiner acknowledges that the “primary references do not

1 Endrikat et al. (Endrikat), A Twelve-Month Comparative Clinical
Investigation of Two Low-Dose Oral Contraceptives Containing 20 μg
Ethinylestradiol/75 μg Gestodene and 30 μg Ethinylestradiol/75 μg
Gestodene, with Respect to efficacy, Cycle Control, and Tolerance,
Contraception, Vol. 55, pp. 131-137 (1997).
2 Hodgen, U.S. Pat. No. 5,552,394, issued September 3, 1996.
3 Katzung, Basic & Clinical Pharmacology, p. 120 (6th Ed. 1995).
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Application No. 09/872,250

expressly teach the combination of the oral contraceptives packs together in
a kit.”
The Examiner concludes:
One of ordinary skill in the art would have been
motivated to combine the oral contraceptive[ ] packs of 30mcg
and 20mcg of Ethinylestradiol together in a kit. Hodgen’s
method of reducing breakthrough bleeding has one drawback,
which cannot reduce the breakthrough bleeding in the first
cycle. Possessing the teachings of Endrikat, one of ordinary
skill in the art would reasonably expect to employ a regimen
comprising a dose of 30mcg of ethinylestradiol in the first cycle
in the Hodgen’s method in order to let the endometrium adapt
to the exogenous hormones as well as reduce the breakthrough
bleeding in the first cycle and thereby improving Hodgen’s
method.

Id. at 4.
Appellant argues that both Endrikat and Hodgen administer oral
contraceptives from one month to the next having “an identical content as
the oral contraceptive administered in the first month” (Br. 10).4 Appellant
asserts that it is only through the use of impermissible hindsight that one
would arrive at the claimed invention—a kit combining a high dose oral
contraceptive pack combined with a low dose oral contraceptive pack. Id. at
15. We agree, and the rejection is reversed.
“[T]he Examiner bears the burden of establishing a prima facie case
of obviousness based upon the prior art. ‘[The Examiner] can satisfy this
burden only by showing some objective teaching in the prior art or that

4 All references to the Brief are to the Revised Brief dated May 12, 2006.
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Application No. 09/872,250

knowledge generally available to one of ordinary skill in the art would lead
that individual to combine the relevant teachings of the references.’” In re
Fritch, 972 F.2d 1260, 1265, 23 USPQ2d 1780, 1783 (Fed. Cir. 1992)
(citation omitted). An adequate showing of motivation to combine requires
“evidence that ‘a skilled artisan, confronted with the same problems as the
inventor and with no knowledge of the claimed invention, would select the
elements from the cited prior art references for combination in the manner
claimed.’” Ecolochem, Inc. v. Southern Calif. Edison Co., 227 F.3d 1361,
1375, 56 USPQ2d 1065, 1076 (Fed. Cir. 2000). “[T]he best defense against
hindsight-based obviousness analysis is the rigorous application of the
requirement for a showing of a teaching or motivation to combine the prior
art references.” Id., 227 F.3d at 1371, 56 USPQ2d at 1073.
Endrikat is drawn to a clinical study “to compare contraceptive
reliability, cycle control, and tolerance of an oral contraceptive containing
20 μg ethinylestradiol (EE2) and 75 μg gestodene (GSD), with a reference
preparation containing a similar dose of gestodene but in combination with
30 μg ethinylestradiol.” Id., abstract. The reference teaches that of the
subjects taking the higher dose of ethinylestradiol, 13.8% reported spotting
in the first cycle, while 22.6% of the subjects taking the lower dose reported
spotting in the first cycle. Id. at 133, col. 2. With respect to breakthrough
bleeding, Endrikat notes that highest incidence was reported by 2.4% of the
subjects in the third 20 μg EE2 cycle and by 2.3% in the first 30 μg EE2
cycle. Id.
Endrikat notes that “the data . . .showed slightly less favorable
bleeding patterns for the 20 μg EE2 preparation,” with the occurrence of
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Application No. 09/872,250

spotting as well as normal/excessive breakthrough bleeding decreasing
during use, and that the highest incidence of any intermenstrual bleeding
occurred during the first cycle. Id. at 136, col. 1. Endrikat concludes “the
results of this comparative study show that the reduction of EE2 content
from 30 μg to 20 μg neither comprises contraceptive reliability nor leads to
clinically unacceptable cycle control.” Id. at 136, col. 2.
Hodgen relates to a method of oral contraception in which the
incidence of breakthrough bleeding is reduced after the first cycle. Hodgen
teaches a oral contraceptive containing “a combined dosage form of estrogen
and progestin monophasically for 23 to 25 consecutive days of a 28 day
cycle, preferably 24 days of the cycle, in which the daily amounts of
estrogen and progestin are equivalent to about 5-35 mcg of ethinyl estradiol
and about 0.025 to 10 mg or norethindrome acetate, respectively, and in
which the weight ratio of estrogen to progesterone is at least 1:45 calculated
as ethinyl estradiol to norethindrone acetate.” Id. at col. 3, ll. 52-61. Thus,
Hodgen solves the problem of breakthrough bleeding in months subsequent
to the first month through the addition of norethindrome acetate to the oral
contraceptive preparation.
Endrikat is drawn to a clinical study comparing oral contraceptives
containing 20 μg of EE2 and 30 μg of EE2, with spotting and breakthrough
bleeding occurring with both preparations, although admittedly with a
slightly lower incidence with the higher EE2 containing preparation.
Hodgen is drawn to reduction of breakthrough bleeding after the first cycle
of use, wherein norethindrone acetate is included in a preparation containing
a combination of estrogen and progestin. Thus, as noted by Appellant, both
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Application No. 09/872,250

references teach the use of a preparation containing an identical content of
the oral contraceptive administered in the first month and each subsequent
month.
We can find no motivation to arrive at the claimed kit containing two
cycle packs of oral contraceptives, one pack containing a lower effective
dosage of steroid than the second pack, either in the prior art or the general
knowledge in the as art set forth in the record by the examiner, except
Appellant’s own disclosure. Thus, as the Examiner has not met the burden
of prima facie case of obviousness, we are compelled to reverse the
rejection.
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Application No. 09/872,250

SUMMARY
Because the examiner has failed to set forth a prima facie case of
obviousness, the rejection is reversed.

REVERSED

Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Donald E. Adams )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )
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Appeal No. 2007-1072
Application No. 09/872,250

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