Estetra S.P.R.L.

Patent Trials and Appeals Board

Dec 28, 2020

2020003287 (P.T.A.B. Dec. 28, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/405,968 01/13/2017 Wout Wouters 587154: ETA9-003CIP 5912
12779 7590 12/28/2020
Lathrop GPM LLP
28 State Street
7th Floor
Boston, MA 02109
EXAMINER
HOWELL, THEODORE R.
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
12/28/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
bostonpatent@lathropgage.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WOUT WOUTERS, HERMAN JAN TIJMEN,
LUDIVINE PETIT, and JEAN-MICHAEL FOLDART

Appeal 2020-003287
Application 15/405,968
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected claims 1–13 under 35 U.S.C. § 103 as obvious
and under obviousness-type double-patenting. Pursuant to 35 U.S.C.
§ 134(a), Appellant appeals from the Examiner’s decision to reject the
claims.1 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies ESTETRA S.P.R.L., as the real party in
interest. Appeal Br. 3.
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Application 15/405,968

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STATEMENT OF THE CASE
The Examiner rejected claims 1–13 in the Final Office Action as
follows:
1. Claims 1–13 under pre-AIA 35 U.S.C. § 103(a) as obvious in view
of Bunschoten et al. (US 2004/0192620 A1, published Sep. 30, 2004)
(“Bunschoten”) and Van Look et al. (US 2005/0032755 A1, published Feb.
10, 2005) (“Van Look”). Office Action 3 (dated Apr. 24, 2019) (“Office
Act.); Ans. 3.
2. Claims 1–13 on the ground of nonstatutory obviousness-type
double patenting as obvious in view of US Patent No. 9,579,329 B2 (“the
’329 patent”). Office Act. 8; Ans. 4.
3. Claims 1–13 on the ground of nonstatutory obviousness-type
double patenting as obvious in view of US Patent No. 7,732,430 B2, issued
Jun. 8, 2010 (“the ’430 patent”) and Van Look. Office Act. 8; Ans. 5.
4. Claims 1–13 on the ground of nonstatutory obviousness-type
double patenting as obvious in view of US Patent No. 9,987,287 B2, issued
Jun, 5, 2018 (“the ’287 patent”) and Van Look. Non-Final Act. 8; Ans. 5.
5. Claims 1–13 on the ground of nonstatutory obviousness-type
double patenting as obvious in view of US Patent Nos. 7,871,995 B2, issued
Jan. 18, 2011 (“the ’995 patent”) and Van Look. Non-Final Act. 9; Ans. 5.
Claim 1, the only independent claim on appeal, is reproduced below:
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1. A method of emergency contraception in a mammalian
female comprising the administration to a female in need
thereof, of an emergency contraceptive comprising
tetrahydroxylated estrogen represented by the general
formula (I):

wherein R1, R2, R3, R4 independently are a hydrogen
atom; a hydroxyl group, or an alkoxy group with 1-5 carbon
atoms;
wherein each of R5, R6, R7 is a hydroxyl group; and
wherein no more than 3 of R1, R2, R3, R4 are hydrogen
atoms,
in an effective amount to inhibit ovulation and pregnancy
in the female.

A Reply Brief was filed March 30, 2020 (“Reply Br.”). The Reply
Brief repeats arguments made in the Appeal Brief (see Reply Br. 6), as well
as making new arguments regarding the use of an estrogen as an emergency
contraceptive (Reply Br. 7–9). These arguments have not been considered
because they are not in compliance with 37 C.F.R. § 41.41. Under 37 C.F.R.
§ 41.41:
Any argument raised in the reply brief which was not raised in
the appeal brief, or is not responsive to an argument raised in
the examiner's answer, including any designated new ground of
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Application 15/405,968

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rejection, will not be considered by the Board for purposes of
the present appeal, unless good cause is shown.
Appellant did not explain how the arguments on, e.g., pages 7–9 of
the Reply Brief are responsive to an argument in the Answer not raised
before by the Examiner.
An Oral hearing was held December 3, 2020. A written transcript of
the hearing will be entered into the record in due course.

1. 35 U.S.C. § 103 REJECTION
Claim 1 is directed to a method of emergency contraception
comprising administering a formula I estrogen in an effective amount to
inhibit ovulation and pregnancy in the female. The Examiner found that
Bunschoten describes administering the same formula I estrogen recited in
the claim, and in combination with a progestogenic compound in an amount
to inhibit ovulation, but not as an emergency contraceptive as required by
claim 1 Office Act. 3, 7. The Examiner further cited Van Look which
describes a dosage regime for emergency contraception, as well as a
composition in its background section comprising an estrogen and progestin
as an emergency contraceptive. Office Act. 3. The Examiner stated it would
have been obvious to use Bunschoten’s composition as an emergency
contraceptive because its mechanism of action in inhibiting ovulation is the
same mechanism of action described in Van Look as useful for an
emergency contraceptive. Office Act. 4.
In making the rejection, the Examiner found that Van Look teaches
that an emergency contraceptive inhibits ovulation and that Bunschoten’s
composition has this property, providing a reason to use Bunschoten’s
composition as an emergency contraceptive as described in Van Look.
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Office Act. 4. Appellant argues that this reasoning is erroneous because Van
Look teaches that “the anti-ovulatory effect is appr. 42% of the total effect,
while the rest is distributed among the effects on the cervical mucus, the
migration of sperms, zygote transport through the fallopian tube, the
endometrium and the implantation.” Appeal Br. 5 (quoting Van Look ¶ 12).
Therefore, Appellant contends that there would be no reason to use the
estrogen of Bunschoten as an emergency contraceptive because it does not
possess all the necessary activity to be effective.
We are not persuaded by Appellant’s argument that the Examiner
erred. The rejection is not based on the administration of the formula (I)
compound alone. Office Act. 6, 7.2 Indeed, Appellant already has a patent
covering administration of a compound of formula (I) as the “sole active
ingredient.” See US Patent No. 9,579,329 B2, issued Feb. 8, 2107 (claim 1).
The rejection is based on using the composition of Bunschoten comprising
the estrogen of formula (I) and a progestogenic component (Bunschoten,
Abstract) as the emergency contraceptive described in Van Look. Rejected
claim 1 recites the term “comprising” which is open-ended and does not
exclude the inclusion of other ingredients, including the progestogenic
component described by Bunschoten.
In paragraph 6 of Van Look, cited by the Examiner, an emergency
contraceptive comprising the estrogen ethinyl-estradiol and the progestogen

2 “Bunschoten discloses a method of contraception with compounds of
formula (I), albeit in combination with a progestogenic component. The
critical difference between the prior art and the claims at issue is that
Bunschoten does not specifically disclose ‘emergency’ contraception. Van
Look is cited as evidence that the anti-ovulatory effect described in
Bunschoten would have suggested the desirability of such emergency use.”
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norgestrel is described, namely estrogenic and progestogenic components.
Bunschoten discloses that the progestogen in its composition can be
norgestrel, as well as other progestogens. Bunschoten ¶ 82. Thus, while Van
Look discloses that the anti-ovulatory effect is only part of the total effect of
the emergency contraceptive, the estrogen of Bunschoten is not the sole
active ingredient of the claim, but rather the progestogenic compound of
Bunschoten is also present, and rejected claim 1 is open to the presence of
both the estrogenic and progestogenic components described by Van Look
as an effective emergency contraceptive (Van Look ¶¶ 6, 7). Consequently,
Appellant’s arguments about the sufficiency of the estrogen as the
emergency contraceptive are not persuasive. Appeal Br. 6.
Appellant also argues that neither Bunschoten nor Van Look “teach or
suggest the use of estetrol as an emergency contraceptive, inherently or
otherwise. Appeal Br. 6. Estetrol is a formula (I) compound and the species
recited in dependent claim 6. Appellant states that Van Look “teaches than
an estrogen component, like estetrol, would cause unacceptable side effects
and not improve the efficacy of the emergency contraceptive.” Id., and 8.
Appellant also asserts that “Van Look teaches away from the combination of
an estrogen component and a progestogen component. Van Look teaches
that high doses of the estrogen component led to high incidence of nausea
and vomiting.” Id. at 7. Appellant argues that Van Look describes a
progestogen as an emergency contraceptive and that estrogens have severe
side effects. Id. at 5.
It is correct that Van Look teaches disadvantages of an estrogen in an
emergency contraceptive and describes an improvement of administering
only the progestogen levenorgestrel. Van Look ¶¶ 7, 14, Abstract; Appeal
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Br. 8. However, Van Look teaches that an estrogen and a progestogen, such
as norgestrel or levonorgestrel, had been used successfully in the prior art as
an emergency contraceptive. Van Look ¶¶ 6, 7. While Van Look sought to
improve the prior art emergency contraceptive by omitting the estrogen, “a
known or obvious composition does not become patentable simply because
it has been described as somewhat inferior to some other product for the
same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). “[J]ust because
better alternatives exist in the prior art does not mean that an inferior
combination is inapt for obviousness purposes.” In re Mouttet, 686 F.3d
1322, 1334 (Fed. Cir. 2012). A “finding that the prior art as a whole suggests
the desirability of a particular combination need not be supported by a
finding that the prior art suggests that the combination claimed by the patent
applicant is the preferred, or most desirable, combination.” In re Fulton, 391
F.3d 1195, 1200 (Fed. Cir. 2004). Thus, while an emergency contraceptive
comprising an estrogen and progestogen may not have been preferred by
Van Look, it had been used in the prior art and shown to be effective. “[A]
reference may teach away from a use when that use would render the result
inoperable.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1381
(Fed. Cir. 2007). In this case, even if the estrogen and progestogen is inferior
in some respects, it was still known in the prior art as an effective emergency
contraceptive and therefore the composition is not inoperable and a teaching
away.
With respect to the lack of a teaching of the use of estetrol in an
emergency contraceptive as asserted by Appellant, Appellant did not explain
why it would not have been obvious to use estetrol as the estrogen in the
composition described by Van Look in paragraph 6. Appeal Br. 6.
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Specifically, Appellant did not rebut the Examiner’s finding that estetrol
possesses estrogen activity like other estrogens, including having an anti-
ovulatory effect. The only difference between the emergency contraceptive
described in Van Look and the claimed emergency contraceptive is the type
of estrogen used. Appellant did not provide a reason why the formula (I)
compound, such as estetrol, would not have been expected to work as the
estrogen in the prior art emergency contraceptive described by Van Look.
Appellant asserts that the two estrogens are not interchangeable, but
provided no objective evidence in the Appeal Brief to support this assertion.
Appeal Br. 7.
Appellant argues “that the pending claims do not encompass a
repetitive, sequential, multiple dosing regimen as is taught by Bunschoten.”
Appeal Br. 7. This argument is not persuasive. The Examiner did not rely on
the administration regime described in Bunschoten, but rather expressly
cited Van Look for this teaching of when and how to administer the steroid
hormones for the emergency contraceptive purpose. Office Act. 4. Appellant
states that this regimen is for levonorgestrel, a synthetic progestogen.
Appeal Br. 7. However, Van Look describes the administration regimen for
an emergency contraceptive comprising an estrogen and progestogen. Van
Look ¶ 6.3

3 “The composition was administered within five days of the unprotected
coitus. Later the method was modified. On the one hand the period of the
possible use of the composition was reduced from 5 days to 72 hours, on the
other hand the dose was doubled that way that the administration was
repeated 12 hours after the first one. [Fertility and Sterility, 28, 932-936,
(1977), ibid. 37, 508-513 (1982); International Journal of Gynaecology and
Obstetrics, 15, 133-136, (1977)]. This modification increased the success of
the method.”
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Appellant argues that the Specification provides evidence that
“estetrol prevented pregnancy in 11 female rats who were ovulating after
sexual intercourse,” which is unexpected. Appeal Br. 5. This evidence is not
persuasive because the claims are not limited to the administration of
estretrol as the sole active ingredient of the emergency contraceptive.

Claims 9, 10
Claim 9 depends from claim 1 and further recites “wherein the
administration is performed in a single dosage.” Claim 10 depends from
claim 1 and further recites “wherein the administration is performed in a
double dosage.”
Appellant contends that there is “no teaching or suggestion in
Bunschoten of a single or double dose regimen and in fact there is a teaching
that anything less than 10 days of uninterrupted repetitive dosing would not
prevent pregnancy.” Appeal Br. 9. This argument is not persuasive because
the Examiner cited Van Look for these dosing regimens. Office Act. 4.
Appellant did not identify a defect in Van Look’s teaching with respect to
these claims.

2. OBVIOUSNESS-TYPE DOUBLE PATENTING OVER ’329 PATENT
Appellant requested the obviousness-type double-patenting rejection
over the claims of the ’329 patent be held in abeyance until subject matter is
held allowable. Appeal Br. 9. Because this rejection is before us and
Appellant did not identify a deficiency in the rejection, we summarily affirm
it.

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3. OBVIOUSNESS-TYPE DOUBLE PATENTING OVER ’430 PATENT
The Examiner rejected claims 1–13 over the claims of the ’430 patent
and Van Look. Appellant argues that “[n]one of the claims of the '430 patent
specify the administration of the instantly claimed tetrahydroxylated
estrogen in an effective amount to be used as an emergency contraceptive.”
Appeal Br. 10. Appellant further contends that Van Look does not cure the
deficiencies of the ’430 patent. Id.
Appellant’s arguments are the same unpersuasive arguments made for
the combination of Bunschoten and Van Look. Like Bunschoten, the claims
of the ’430 cover the administration of a progestogenic component and a
compound having the same formula as claimed, although in precursor form.
Appellant did not distinguish the compound recited in the claims of the ’430
patent from the claimed compound or identify a reason it would not be
expected to work as an emergency contraceptive in combination with a
progestogenic component as described in Van Look. The rejection is
therefore affirmed for the same reasons discussed above for the obviousness
rejection based on Bunschoten and Van Look.

4. OBVIOUSNESS-TYPE DOUBLE PATENTING OVER ’287 PATENT
Appellant requested the obviousness-type double-patent rejection over
the claims of the ’287 patent and Van Look be held in abeyance until subject
matter is held allowable. Appeal Br. 11. Because this rejection is before us
and Appellant did not identify a deficiency in the rejection, we summarily
affirm it.

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5. OBVIOUSNESS-TYPE DOUBLE PATENTING OVER ’995 PATENT
The Examiner rejected claims 1–13 over the claims of the ’995 patent
and Van Look. Appellant’s arguments are the same unpersuasive arguments
made for the combination of Bunschoten and Van Look. Appeal Br. 12. The
claims of the ’995 patent are directed to a drug delivery system that
“comprising an estrogenic component and a progestogenic component, said
drug delivery system being selected from the group consisting of
suppositories, systems for intravaginal delivery, injectable,” where the
estrogenic component covers the same estrogen of formula (I) which is
claimed, although in precursor form.4 Appellant did not distinguish the
compound recited in the claims of the ’995 patent from the claimed
compound or identify a reason it would not be expected to work as an
emergency contraceptive in combination with a progestogenic component as
described in Van Look. The rejection is therefore affirmed for the same
reasons discussed above for the obviousness rejection based on Bunschoten
and Van Look.

4 Appellant incorrectly characterized the claims of the ’995 patent,
describing the claims of the ’287 patent instead. Appeal Br. 12.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–13 103 Bunschoten, Van
Look
1–13
1–13 ’329 patent;
obviousness-type
double-patenting
1–13
1–13 ’430 patent, Van
Look;
obviousness-type
double-patenting
1–13
1–13 ’287 patent, Van
Look;
obviousness-type
double-patenting
1–13
1–13 ’995 patent, Van
Look;
obviousness-type
double-patenting
1–13
Overall
Outcome
1–13

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). See 37
C.F.R. § 1.136(a)(1)(iv).

AFFIRMED