Ex Parte Kulmann

Board of Patent Appeals and Interferences

Dec 18, 2010

10380405 (B.P.A.I. Dec. 18, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HERMANN KULMANN
__________

Appeal 2010-008897
Application 10/380,405
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
LORA M. GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 2-20 and 22-41. We have jurisdiction under
35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Claims 38 and 39 are representative of the claims on appeal, and read
as follows:
38. A method for hormonal contraception comprising administering at least
one contraceptive hormone in a plurality of linked taking periods optionally
having a sequence lasting several years, wherein each of said taking periods
comprises:
at least one taking cycle, wherein each taking cycle comprises
-a duration-constant taking phase lasting several days and
-a taking pause lasting several days,
wherein in each taking phase said hormonal component is
administrated in a daily unit, and in each taking pause either a placebo free
from any hormone component is administered or no unit is administered,
wherein the duration of the taking phase or phases of at least the final taking
period is at least 22 days, and wherein the duration of each taking phase in
any taking period preceding a following taking period is shorter than that in
each of the taking phases in each following taking period.

39. An administration form useful for hormonal contraception, according to
a method for hormonal contraception which comprises administering at least
one contraceptive hormone in a plurality of linked taking periods optionally
having a sequence lasting several years, wherein each of said taking periods
comprises:
at least one taking cycle, wherein each taking cycle comprises
-a duration-constant taking phase lasting several days and
-a taking pause lasting several days,
said form comprising a plurality of packaging units, each of which
comprises at least one set of daily units to be administered within each of
said taking cycles and wherein the duration of said taking phases is constant,
said taking period in each case comprising a number of daily hormone units
corresponding to the duration of each taking phase, as well as optionally a
number of daily placebo units corresponding to the duration of each taking
pause, the duration of the taking phase or phases of at least the last of the
taking periods following the first taking period being at least 22 days, and
wherein the number of daily hormone units in any packaging unit
corresponding to a taking period preceding a following taking period is
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smaller than in the packaging unit corresponding to the in each case
following taking period.

The following grounds of rejection are before us for review:
I. Claim 19 stands rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
II. Claims 2-19, 22-36, and 38-41 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of
Spona2 and Hodgen.3
III. Claims 20 and 37 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Spona and
Hodgen as further combined with Endrikat.4
We summarily affirm rejection I, but reverse rejections II and III.
ISSUE (Indefiniteness)
The Examiner’s statement of the rejection may be found at page 3 of
the Answer. As Appellant does not argue the merits of the rejection, we
summarily affirm the rejection of claim 19 under 35 U.S.C. § 112, second
paragraph, as being indefinite.

2 Spona, US 5,583,129, December 10, 1996.
3 Hodgen, EP 0,911,029 A2, April 28, 1999.
4 J. Endrikat et al., A Twelve-Month Comparative Clinical Investigation of
Two Low- Dose Oral Contraceptives Containing 20µg Ethinylestradiol/75
µg Gestodene and 30 ug Ethinylestradiol / 75 µg Gestodene, with Respect to
Efficacy, Cycle Control, and Tolerance,55 CONTRACEPTION 131-137 (1997).
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ISSUE (Obviousness)
Has the Examiner established by a preponderance of the evidence that
the combination of Spona and Hodgen renders obvious a method of
contraception wherein the duration of each taking phase in any taking period
preceding a following taking period is shorter than that in each of the taking
phases in each following taking period?

FINDINGS OF FACT
FF1 The Examiner initially notes:
The instant claims are construed as follow[s]: the herein
claimed contraceptive method and composition comprises a
treatment plan with different taking periods. Within the
treatment duration, the taking phase in the final taking period is
always longer than that in any other taking periods. In addition
to taking phase, taking period also contains taking pause, which
usually happened after taking phase.

(Ans. 3.)
FF2 The Examiner’s statement of the rejections may be found at pages 4-6
of the Answer.
FF3 Specifically, the Examiner relies on Spona for teaching a method of
contraception comprising administering a hormonal agent, such as
ethinylestradiol and drospirenone, for 23 to 24 days, followed by 5 or 4 pill-
free days, with an administration cycle of 28 days. (Ans. 4.)
FF4 The Examiner notes that Spona “does not expressly teach [that] the
last taking phase is longer than any preceding phase,” and also “does not
expressly teach the taking period lasts at least 40, 50, 60, 70, 80, 90, 100,
110, . . . [to a] maximum of 150 days.” (Id.)
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FF5 The Examiner relies on Hodgen for teaching “the benefit of prolonged
administration of the hormonal components for contraception as better
control of endometrial bleeding and may help the breakthrough bleeding.”
(Id.)
FF6 Specifically, Hodgen teaches:
[A] women [sic] in need of contraception is administered a
combined dosage form of estrogen and progestin, preferably
monophasicly, for 60 to 110 consecutive days, preferably about
80-90 days, followed by an administration free interval of 3 to
10 days, preferably about 5-8 days, 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 of norethindrone
acetate, respectively. On a schedule of 84 days administration
followed by 7 pill free days, there are only four treatment and
menstrual cycles per year.

(Hodgen ¶20.)
FF7 In the Example provided by Hodgen, female monkeys were placed on
ultra low dose oral contraceptive for either 60 consecutive days, followed by
3 non-treatment days, or for 84 consecutive days, followed by 7 non-
treatment days. (Id. at ¶28.) The regimens were continued throughout the
treatment cycle. (Id.)
FF8 The Examiner concludes “[i]t would have been obvious to one of
ordinary skill in the art . . . to adjust[ ] the taking phase to the herein recited
duration.” (Ans. 5.)
FF9 Specifically, according to the Examiner, “[i]t would be a routine
procedure to titrate the dosage for patients that starting the lower dosage or
regular 28-day dosage (i.e., 21-day regimen with 7-day placebo) and then
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gradually prolong the dosage to 23-day, 24-day, then 60-day, and up to 110-
day regimen as taught [by Hodgen].” (Id. at 6.)
FF10 As to the rejection of claims 20 and 37 as being rendered obvious by
the combination of Spona and Hodgen as further combined with Endrikat,
the Examiner relies on Endrikat to meet the limitation of reducing the
dosage of the hormone in successive taking phases. (Id.)

PRINCIPLES OF LAW
While the analysis under 35 U.S.C. § 103 allows flexibility in
determining whether a claimed invention would have been obvious, KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), 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. “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).

ANALYSIS
Appellant argues that the Examiner has not provided a reason as to
why the teachings of Spona or Hodgen, individually or in combination,
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would teach or suggest to the ordinary artisan successively extending the
taking periods. (App. Br. 3-4.5)
We agree. Although the taking periods of Hodgen are longer than
those of Spona, both of Spona and Hodgen teach taking periods of constant
duration. (See, e,g,, FFs 3 and 6.) The Examiner has not provided scientific
reasoning or evidence to support the conclusion that it would have been
obvious to increase the length of each successive taking period as required
by the independent claims on appeal.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the combination of Spona and Hodgen
renders obvious a method of contraception wherein the duration of each
taking phase in any taking period preceding a following taking period is
shorter than that in each of the taking phases in each following taking
period.
We are thus compelled to reverse the rejection of claims 2-19, 22-36,
and 38-41 under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Spona and Hodgen. Moreover, as the Examiner does not
cite Endikrat to remedy the deficiencies of the combination of Spona and
Hodgen, we are also compelled to reverse the rejection of claims 20 and 37

5 As the pages of the Appeal Brief are not numbered, we designate the page
titled “Response to Notification of Non-Compliant Appeal Brief” as page 1,
and number the pages consecutively from there.
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under 35 U.S.C. § 103(a) as being rendered obvious by the combination of
Spona and Hodgen as further combined with Endrikat.

TIME PERIOD FOR RESPONSE
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-IN-PART

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