Ex Parte LaGuardia

Board of Patent Appeals and Interferences

Jan 25, 2008

10955276 (B.P.A.I. Jan. 25, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KATHERINE D. LAGUARDIA
__________

Appeal 2007-3936
Application 10/955,276
Technology Center 1600
__________

Decided: January 25, 2008
__________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and FRANCISCO C.
PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of contraception. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.1

1 In this decision we consider only those arguments actually made by
Appellant. Arguments that Appellant could have made but chose not to
make in the Briefs have not been considered and are deemed to be waived.
See 37 C.F.R. § 41.37(c)(1)(vii).
Appeal 2007-3936
Application 10/955,276

STATEMENT OF THE CASE
THE CLAIMED INVENTION
The Specification discloses “extended cycle oral contraceptive
regimens for menstruating females. More particularly, the present invention
relates to extended multi-phasic oral contraceptive regimens containing a
progestin and an estrogen” (Spec. 1).
Claims 1-5 are pending and on appeal (Br. 5). The claims have not
been argued separately and therefore stand or fall together. 37 C.F.R.
§ 41.37(c)(1)(vii). Claim 1 is representative and reads as follows:
1. A method of contraception comprising the step of:
administering to a female of childbearing age a
combination of an estrogen and a progestin for at least 42
consecutive days followed by a hormone-free period of from 4
to 8 days, said estrogen and progestin being administered in a
contraceptively effective daily dosage for a sequence of at least
two cycles of at least 21 days, wherein the estrogen dosage
remains constant over each cycle and the progestin dosage
increases in three phases over each day cycle.

THE REJECTIONS
The Examiner applies the following documents in rejecting the
claims:
Shangold WO 00/38691 A1 Jul. 6, 2000

G. T. Kovacs et al., A trimonthly regimen for oral contraceptives, 19 The
British Journal of Family Planning 274-275 (1994).

Claims 1-5 stand rejected under 35 U.S.C. § 103(a) as being obvious
in view of Shangold and Kovacs. (Ans. 3-5.)
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OBVIOUSNESS
ISSUE
The Examiner cites Shangold as teaching a method of contraception in
which an estrogen (ethinyl estradiol) and a progestin (norgestimate) are
administered to females of childbearing age for 21 days, followed by a
hormone-free period of 4-8 days (Ans. 4). The Examiner cites Shangold as
teaching the claimed three-phase increasing dosage of progestin, but
concedes that Shangold does not teach administering the estrogen/progestin
uninterrupted for the number of days recited in the appealed claims (id.).
The Examiner cites Kovacs as teaching a trimonthly method of
contraception in which estrogen and a progestin are administered
uninterrupted for 84 days, and contends that a person of ordinary skill in the
art would have considered it obvious to substitute Shangold’s contraception
method “in the trimonthly regimen for contraception as taught by Kovacs”
(Ans. 4-5). The Examiner reasons that one of ordinary skill “would have
been motivated to make this substitution because of the appreciation by
many women of the ability to decrease the incidence of menstruation” (id. at
5 (citing Kovacs 275, right column, paragraph 1)).
Appellant contends that, because Kovacs administers a constant
dosage of progestin for 84 uninterrupted days, whereas Shangold teaches a
three-phase increasing progestin dosage over 21 days followed by a
hormone-free period, “there is no teaching or even a suggestion in the
combination of references cited by the Examiner of the claimed extended
regimen of uninterrupted estrogen and progestin, wherein the dosage of
progest[i]n is administered in phases over each 21-day cycle in the extended
regimen” (Br. 9). Appellant also contends that, because persons skilled in
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the art would have expected a significant number of bleeding episodes with
a triphasic contraception method, “the data presented in the instant
application showing acceptable cycle control with an extended-use triphasic
regimen establishes an unexpected result which patentably distinguishes the
claimed invention over the art” (id. at 11).
The issue with respect to the obviousness rejection, therefore, is
whether the Examiner erred in concluding that one of ordinary skill would
have considered claim 1 obvious in view of Shangold and Kovacs.
FINDINGS OF FACT
1. Claim 1 recites a method of contraception in which an estrogen and
progestin are administered to a female of childbearing age for at least 42
consecutive days, followed by a hormone-free period of from 4 to 8 days.
The estrogen and progestin are administered for a sequence of at least two
cycles of 21 days. The estrogen dosage remains constant over each cycle,
whereas the progestin dosage increases in three phases over each cycle of at
least 21 days.
2. The Specification discloses a study of a contraceptive regimen
meeting the phased administration recited in claim 1 in which the estrogen
was ethinyl estradiol (“EE”), and the progestin was norgestimate (“NGM”)
(Spec. 5).
3. Shangold discloses a contraceptive regimen in which an estrogen and
“progestogen,” i.e. progestin,2 are administered to a female of childbearing

2 Shangold appears to use the terms “progestogen” and “progestin”
interchangeably (see Shangold Abstract (“A method of contraception in
which an estrogen and a progestogen are administered . . . is disclosed.”);
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age for 21 consecutive days followed by a 4 to 8 day hormone-free period
(Shangold 21 (claim 1)). The estrogen is administered daily at a constant
dosage equivalent to about 23 to 28 micrograms of ethinyl estradiol (id.).
The daily dosage of progestin increases in three phases over the 21 day
hormone administration period (id.). Claim 10 of Shangold recites that “the
estrogen is 17α-ethinylestradiol and the progestogen is norgestimate” (id. at
22). Thus, while Shangold meets claim 1’s limitation requiring a three-
phase increase in progestin dosage over a period of at least 21 days,
Shangold does not disclose repeating the three-phase regimen for another
cycle of at least 21 days for a total of at least 42 consecutive days, as recited
in Appellant’s claim 1.
4. Shangold discloses that the rationale for triphasic contraception
methods “is to lower the total monthly steroid dose in the oral contraceptive
while still obtaining equivalent bleeding patterns and protection against
pregnancy as found with conventional oral contraceptives” (Shangold 3).
Shangold discloses that lowering estrogen dosages in oral contraceptives
decreases incidences “of nuisance side effects, such as, nausea, vomiting,
and gastric upset, as well as . . . decreas[ing the] incidence of serious side
effects, such as, thromboembolism, stroke, and myocardial infarction” (id.
at 1).
5. Kovacs discloses a study “to determine the acceptability and efficacy
of a trimonthly (12 weeks of hormones followed by one week of placebo)
regimen for the administration of combined oestrogen-progestogen oral
contraceptives” (Kovacs 274 (“Summary”)). The female subjects were
1:4-5 (“[T]he present invention relates to a triphasic contraceptive regimen
containing a progestin and low doses of ethinyl estradiol (EE).”)).
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administered “a daily tablet containing ethinyl oestradiol 30 μg [and]
levonogestrel 150 μg . . . for 84 days without a break” (id.). Thus, while
Kovacs meets claim 1’s limitation requiring administration of an estrogen
and progestin for at least 42 consecutive days, Kovacs does not disclose
increasing the progestin dosage in three phases over a 21 day period, as
recited in Appellant’s claim 1.
6. Kovacs discloses that “the trimonthly regimen . . . is a useful and
much appreciated method of contraception for some women” (Kovacs 274
(“Summary”)). Kovacs states that “[t]he advantage of fewer periods and
therefore decreased menstrual loss should decrease the incidence of
anaemia. On theoretical grounds there should be less endometriosis and the
occurrence of endometrial cancer should be further decreased” (id. at 275
(right column)).
7. Kovacs discloses that the trimonthly contraceptive regimen’s “major
disadvantage is found to be some degree of breakthrough bleeding and we
recommend that women placed in this regimen be clearly counseled about
this possibility” (Kovacs 274 (“Summary”)). Thus, the “ability to decrease
incidence of menstruation was appreciated by many women, but to some
degree this was negated by the high incidence of breakthrough bleeding” (id.
at 275 (right column)).
8. Appellant’s Example 1 discloses a study of an extended triphasic oral
contraceptive regimen meeting the limitations of claim 1. Patients first
underwent two 28-day cycles of a “traditional” triphasic regimen in which
hormones were administered for 21 days, with a constant estrogen (ethinyl
estradiol) dosage and a progestin (norgestimate) dosage that increased every
7 days, followed by a 7 day hormone-free period (Spec. 5:20-32). After the
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two 28-day “traditional” triphasic cycles, patients were administered four
consecutive 21-day cycles of the same triphasic regimen, but with no
hormone-free period during the 84 days of the extended period (Spec. 6:1-6).
9. The only data regarding the results of the claimed contraception
regimen appear in Appellant’s Figures 1 and 2. The Specification states:
Figure 1 illustrates the mean number of breakthrough
bleeding and/or spotting days at the transition between
consecutive cycles during the Extended Regimen Treatment
Phase. It is at these transitions where the largest change in
progestin dosage occurs, i.e., the dosage of norgestimate is
lowered from 250 μg per day in the third week of a preceding
cycle to 180 μg per day in the first week of the next consecutive
cycle. According to the understanding of those skilled in the
art, it is at the transition between consecutive cycles where the
most significant amount of bleeding and/or spotting would
occur. The data presented in Fig. 1 unexpectedly shows that
this is not the case. A significant increase in the mean number
of breakthrough bleeding and/or spotting days occurred only
during the transition from the first cycle to the second cycle in
the Extended Regimen Treatment Phase. No significant
increase in the mean number of bleeding and/or spotting days
occur[r]ed during the transition from the second to the third
cycle, or during the transition from the third to the fourth cycle
in the Extended Regimen Treatment Phase.

(Spec. 9 (emphasis added)).
10. Regarding Figure 2, the Specification states:
Fig. 2 illustrates the percentage of subjects with bleeding
and/or spotting for days 1 through 140 of the study. The data in
Fig. 2 show that the large spike in breakthrough bleeding and/or
spotting that occurs in the third week of each cycle
administered in the Traditional Regimen Treatment Phase is not
present during the transitions between the cycles administered
in the Extended Regimen Treatment Phase.

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(Spec. 9.)
Figure 2 shows that from Day 57 (the first day of the extended
triphasic regimen recited in claim 1) to Day 140 (the last day of the study)
the percentage of women experiencing bleeding and/or spotting ranged from
a low of almost none on approximately Day 66 to over 50% on
approximately Day 87. Beginning on approximately Day 80, until Day 140,
the percentage of women experiencing bleeding and/or spotting never fell
below about 25 or 30%, with the percentage being higher than 40% for a
significant portion of the days, including several days at or near 50%. While
the period between Day 57 and Day 140 does not show pronounced spikes in
bleeding and/or spotting similar to those at Days 28 and 56, significant
spikes appear at or about Day 84, Day 105, and Day 130.
11. Appellant cites Hamerlynck (J.V. Th. H. Hamerlynck et al.,
Postponement of Withdrawal Bleeding in Women Using Low-Dose
Combined Oral Contraceptives, 35 Contraception 199-204 (March 1987)) as
evidence of what one of ordinary skill in the art would have expected of an
extended triphasic contraception regimen (Br. 10-11). Hamerlynck
compared two extended monophasic (constant hormone dosage)
contraception regimens to an extended triphasic (three-phase increasing
progestin dosage) regimen (Hamerlynck 199). Hamerlynck found that after
Day 21 of the study, women on the extended triphasic regimen experienced
a statistically significant higher incidence of breakthrough bleeding and/or
spotting compared to those on the monophasic regimens (id. at 201).
Hamerlynck noted that in the triphasic portion of the study, “after having
completed the 41-day regimen, about 50% of the 34 women appeared to
have experienced a bleeding” (id. at 205).
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Figure 2 of Hamerlynck shows the number of women without spotting
or bleeding during the 42-day study period (Hamerlynck 203). The Figure
shows that in each regimen the number of women experiencing
bleeding/spotting increased during the study period, but the monophasic
regimens induced less bleeding/spotting than the triphasic regimen (see id.).
The Figure also shows that at the start of the study period almost none of the
triphasic subjects experienced bleeding/spotting, with the number increasing
to 50% by about Day 30, and ending at about 30% by about Day 42.
12. Appellant cites Clarke (A.K. Clarke et al., The Debate Regarding
Continuous Use of Oral Contraceptives, 35 The Annals of Pharmacotherapy
1480-84 (November 2001)) as evidence of what one of ordinary skill in the
art would have expected of an extended triphasic contraception regimen (Br.
10-11). Clarke discusses Hamerlynck’s study, noting that “withdrawal
bleeding was suppressed in significantly more women receiving the
monophasic regimen compared with those receiving the triphasic regimen”
(Clarke 1482 (left column)), and concluding that “[m]onophasic OCs [(oral
contraceptives)] are the optimal formulation in extended use regimens, as
triphasic OCs may result in increased breakthrough bleeding” (id. at 1483
(right column)).
However, Clarke also suggested that Hamerlynck’s study was
incomplete with respect to whether an extended triphasic regimen would be
tolerated by women despite the downside of unpredictable bleeding:
“The monophasic regimen did provide better prevention against withdrawal
bleeding in comparison with the triphasic regimen. However, information
was lacking on the tolerability and the possible comparison to a conventional
regimen” (Clarke 1482 (left column)).
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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. “[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that 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 (Fed. Cir. 1992) (citations omitted,
bracketed material in original). Thus, as the Supreme Court recently pointed
out, “a patent composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
prior art.” KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007).
The Supreme Court also indicated, however, that it is obvious to apply
known solutions to a problem recognized in the prior art:
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.

Id. at 1742.
It is well settled that evidence of unexpected results may rebut an
examiner’s prima facie case of obviousness. See In re Rouffet, 149 F.3d
1350, 1355 (Fed. Cir. 1998); see also KSR, 127 S. Ct. at 1740 (“The fact that
the elements worked together in an unexpected and fruitful manner
supported the conclusion that Adams’s design was not obvious to those
skilled in the art.”) (discussing United States v. Adams, 383 U.S. 39 (1966)).
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However, it is also “well settled that unexpected results must be
established by factual evidence. ‘Mere argument or conclusory statements
in the specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470,
(Fed. Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir.
1984)). Thus, to establish that claimed subject matter yields an unexpected
result, the claimed subject matter must actually be compared to the prior art.
In re De Blauwe, 736 F.2d at 705 (“When an article is said to achieve
unexpected (i.e. superior) results, those results must logically be shown as
superior compared to the results achieved with other articles.”); see also In
re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.”).
ANALYSIS
We agree with the Examiner that claim 1 would have been prima facie
obvious to a person of ordinary skill in the art.
Specifically, as noted above, Kovacs discloses that, despite incidences
of breakthrough bleeding, a contraception regimen consisting of 84
consecutive days of hormone administration followed by a one week
hormone-free period is suitable for women desiring to decrease the
incidence of menstruation (see Findings of Fact (“FF”) 5 to 7, above).
Kovacs also discloses that the reduced number of periods resulting from
extended hormone administration has the advantage of decreasing the
incidence of anemia, and theoretically should decrease the occurrences of
endometriosis and endometrial cancer (see FF 6).
As also noted above, Shangold discloses that a triphasic
estrogen/progestin contraception regimen in which the progestin dosage is
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increased in three 7-day phases over 21 days is advantageous because less
overall hormone is administered, thereby leading to fewer side effects (see
FF 4). Thus, a person of ordinary skill practicing Kovacs’ regimen of
extended hormone administration would have been prompted to use
Shangold’s triphasic regimen by the disclosure that the triphasic regimen
reduces hormone-related side effects.
Similarly, a person of ordinary skill in the art practicing Shangold’s
monthly triphasic regimen would have been prompted to extend the
hormone administration period to 84 days by Kovacs’ disclosure that
decreasing the incidence of menstruation had potential health advantages, as
well as being appreciated by some women (see FF 5-7, above). Therefore,
because it recites a combination of two contraception regimens having
elements that advantageously solve known problems, we agree with the
Examiner that one of ordinary skill would have considered claim 1 prima
facie obvious.
Appellant argues that “there is no teaching or even a suggestion in the
combination of references cited by the Examiner of the claimed extended
regimen of uninterrupted estrogen and progestin, wherein the dosage of
progest[i]n is administered in phases over each 21-day cycle in the extended
regimen” (Br. 9).
We are not persuaded by this argument. Recently addressing the issue
of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. §
103 “need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
KSR Int'l v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007). The Court
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emphasized that “[a] person of ordinary skill is . . . a person of ordinary
creativity, not an automaton.” Id. at 1742.
Thus, in the instant case, claim 1 is not rendered unobvious simply
because the cited references do not contain explicit teachings suggesting
their combination. Rather, one of ordinary skill, being a person of ordinary
creativity and common sense, see KSR, 127 S. Ct. at 1742-43, would have
reasoned that because the two prior art contraception regimens conferred
known advantages to the subjects using them, it would have been desirable
to combine them.
Appellant argues that, because persons skilled in the art would have
expected a significant amount of unexpected bleeding with a triphasic
contraception method, “the data presented in the instant application showing
acceptable cycle control with an extended-use triphasic regimen establishes
an unexpected result which patentably distinguishes the claimed invention
over the art” (Br. 9-11). Appellant cites Hamerlynck and Clarke in support
of the assertion that “those skilled in the art did not expect that triphasic
regimens could be used effectively in extended use OC [oral contraceptive]
administration because of the observed increase in bleeding episodes during
the pill-taking period” (Br. 11).
We are not persuaded by this argument. As noted above, to establish
that claimed subject matter yields an unexpected result, the claimed subject
matter must actually be compared to the prior art. In re De Blauwe, 736
F.2d 699, 705 (Fed. Cir. 1984) (“When an article is said to achieve
unexpected (i.e. superior) results, those results must logically be shown as
superior compared to the results achieved with other articles.”); see also In
re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen
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unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.”).
In the instant case, Appellant states only that “the data presented in
the instant application showing acceptable cycle control with an extended-
use triphasic regimen establishes an unexpected result which patentably
distinguishes the claimed invention over the art” (Br. 11). Appellant does
not specifically discuss any of the data presented in the Specification, nor
does Appellant actually compare that data to any of the data in any of the
references cited in either the rejection or Appellant’s rebuttal.
Given the absence of a specific comparative explanation why the
Specification’s data demonstrates an unexpected result, we are not
persuaded that Appellant has adequately rebutted the Examiner’s prima facie
case of obviousness. As noted above, it is “well settled that unexpected
results must be established by factual evidence. ‘Mere argument or
conclusory statements in the specification does not suffice.’” In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe, 736 F.2d at
705)).
Moreover, particularly in the absence of a comparative explanation of
the evidence of record, it does not appear that Appellant’s data actually
demonstrates “acceptable cycle control . . . which patentably distinguishes
the claimed invention over the art” (Br. 11). The at least 30%
bleeding/spotting shown in Appellant’s Figure 2, with a number of days
reaching at least 50%, does not appear on its face to be significantly
different from the 50% bleeding incidences found in Hamerlynck’s study
(see FF 11, above). Also, the percentage and pattern of bleeding shown in
Appellant’s Figure 2 appear to be similar to those shown in Hamerlynck’s
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Figure 2. Thus, in our view, the data in the Specification does not support
Appellant’s assertion of “acceptable cycle control . . . which patentably
distinguishes the claimed invention over the art” (Br. 11), given the absence
of a clear and specific explanation by Appellant regarding the significance of
the Specification’s data vis-à-vis the prior art.
In sum, we agree with the Examiner that one of ordinary skill would
have considered the contraception regimen recited in claim 1 prima facie
obvious in view of Shangold and Kovacs. Because we find that Appellant
has not shown that the process recited in claim 1 provides an unexpected
result sufficient to overcome the Examiner’s prima facie case of
obviousness, we affirm the obviousness rejection of claim 1. Because they
were not argued separately from claim 1, we also affirm the Examiner’s
rejection of claims 2-5. 37 C.F.R. § 41.37(c)(1)(vii).
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

Ssc:

PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
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