DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s response from 7/9/2026 is acknowledged.
Claim Objections
Applicant’s claim amendments overcome the objections of record.
Claim Rejections - 35 USC § 112
Applicant’s claim amendments overcome the rejections of record. However, a new rejection has been made over amended claim 1.
Claim Rejections - 35 USC § 102
Applicant has argued regarding Duesterberg as follows:
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In response, Duesterberg very specifically discloses and claims a pharmaceutical preparation comprising estrogens and progestins. Both of these are well known and defined genuses of compounds. The dependent claims specifically list among them Applicant’s specifically claimed estrogen and progestin. Further, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2123.
Applicant has also argued:
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In response, this distinction is difficult to appreciate, because, again, endometriosis is taught, as admitted by Applicant. Further, amelioration is an aspect of treatment.
Regarding Applicant’s arguments on inherency, the discloses combination here is not merely possible or probable. It is present in the claims themselves.
Claim Rejections - 35 USC § 103
Applicant has argued as follows:
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In response to Appellant’s arguments against the references individually, it is noted that one cannot shown nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See also In re Merck, 800 F.2d 1091 (Fed. Cir. 1986) (non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references).
For the foregoing reasons, the rejections are still deemed to be proper, and are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to:
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The claim has a missing word, and hence it is unclear what “pharmaceutically acceptable [?]” is included.
In the interest of compact prosecution, in view of the language of new independent claim 11, the Examiner interprets that the claim recites a “pharmaceutically acceptable excipient”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-7, 9 and 13 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by US 20050113350 A1 to Duesterberg et al. (“Duesterberg”, of record).
Duesterberg relates to an extended use of a pharmaceutical preparation comprising estrogens and progestins where a progressive increase of the estrogens and/or progestins dosage after the typical 28 day time period achieves a continues stimulation of the endometriums.
Claim 1 of Duesterberg recites: “A pharmaceutical preparation to obtain a continuous hormonal treatment over a desired period of time longer than 21-28 days comprising a first composition containing at least one estrogen and/or at least one progestin in a predetermined amount to be administered in the first 21-28 days and a second composition characterised in that it contains at least one estrogen and/or at least one progestin in a predetermined amount higher than the amount of the first composition and comprises a mono or multiphase sequence of pharmaceutical dosages.” Per claim 8, the estrogen from the pharmaceutical composition of claim 1 is selected from estetrol. Per claim 11, the progestin from the pharmaceutical composition of claim 1 is selected from progesterone. Claim 16 recites daily units of the pharmaceutical composition, and claim 23 recites administration in daily doses. Claim 15 recites oral administration. The composition can be in the form of tablets. ([0007]).
Claim 17 recites use of a pharmaceutical preparation according to claim 1 for the manufacture of an agent for inhibiting ovulation in a mammal, in particular a human. Claim 19, which depends from claim 17, recites the agent is for the manufacture of an agent for diminishing symptoms related to hormonal withdrawal such as premenstrual symptoms, dysmenorrhea, endometriosis, menstrual migraine. Claim 18 recites that administration of the preparation extends over a time of 56, 84, 112, 140 or 168 days.
Since the same composition is recited for treating the same disease, it will result in the same not generating a reduction in the levels of progesterone receptors, the same increase of levels of progesterone receptors in endometric cells, and the same increase of an Era/ Erb ratio in endometriotic cells of the patient.
Applicant’s claim 1, as amended, recites a carrier. It is noted that nowhere does Applicant’s specification define “a carrier”, nor does it disclose specific examples of one. Thus, this appears to refer to a merely conventional carrier known in the art. To that end, Duesterberg discloses that, for instance, “the pharmaceutical preparation according to the invention may also be in the form of a plaster (transdermal application)” ([0047]). Plaster is one example of a carrier in a transdermal patch.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 3, 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 20050113350 A1 to Duesterberg et al. (“Duesterberg”, of record) as applied to claims 1, 4-7, 9 and 13 in the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above, and further in view of Geraghty et al., The Next Generation of Oral Contraception: Advances in Estrogens, Supplement to OBG Management, S1-S4, June 2021 (“Geraghty”, of record) and Stanczyk et al., Progestogens Used in Postmenopausal Hormone Therapy: Differences in Their Pharmacological Properties, Intracellular Actions, and Clinical Effects, Endocrine Reviews, April 2013, 34(2):171-208 (“Stanczyk”, of record) and Gallez et al., Estetrol Combined to Progestogen for Menopause or Contraception Indication Is Neutral on Breast Cancer, Cancers 2021, 13(10), 2486 (“Gallez”, of record).
Duesternberg is discussed in the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above.
Applicant’s claim 8 recites “wherein the medication comprises between 1 to 50 mg of estetrol and between 50 to 200 mg of progesterone.” Applicant’s claim 2 further recites ratios of E4 to P4 of 1:10 to 1:100, and Applicant’s claim 3 recite a narrower ratio of 1:10.
Concerning doses, Duesterberg discloses that the daily oral hormone units for use preferably contain the biogenic estrogen (selected from the group consisting of estradiol, estetrol, etc.) in an amount equivalent to 0.1-5 mg of estradiol ([0036-0037])
Gerarghty discloses how to convert an amount equivalent to 0.1-5 mg of estradiol (E2) to the same amount of estetrol (E4). Table 1 provides that E4 has 1/5-1/10 of the potency of E2.
Therefor the equivalent amount of 0.1-5 mg of estradiol of Duesterberg is from 0.5-25 mg to 1-50 mg of estetrol, which falls exactly within the claimed range of Applicant’s claim.
Duesterberg similarly discloses that the daily hormone units for use during the whole extended treatment preferably contain the at least one progestin in an amount of 0.05-0.25 mg of levonorgestrel and/or 0.5-5 mg of dienogest and/or 0.03-0.15 mg of gestodene, and/or 0.5-5 mg of drospirenone or equivalent dosages of other progestins. ([0041]).
Stanczyk similarly discloses that the potencies of the various progestins have also been studied and compared. See, e.g., Table 5.
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Based on that table, it can be seen that an amount of 0.05-0.25 mg of levonorgestrel needs to be considerably upward adjusted for achieving the same potency as progesterone.1 It discloses that the study provides new evidence that a therapeutic dose of estetrol for menopause treatment or contraception, combined with progesterone or drospirenone, may provide a better benefit/risk profile toward breast cancer risk compared to the hormonal treatments currently available for patients. (Abstract). In the mouse model of the study, E4 was combined with P4 (1.25 or 4.25 mg/kg/day) administered through subcutaneous slow-releasing pellets. (Section 2.6.).
Applicant’s new claim 11 recites a specific ratio (addressed above), as well as that the composition is free of estradiol. It is noted that nowhere does Duesterberg require estradiol to be a part of the composition. Although some claims disclose its use too, the language of claim 1 is explicit that what is required is “at least one estrogen”. Per claim 8, this at least one estrogen is selected from the group consisting of following synthetic estrogens: ethinylestradiol, mestranol, quinestranol, or a precursors capable of liberating such an synthetic estrogen and/or from the group of the following biogenic estrogens: estradiol, estrone, estran, estriol, estetrol, conjugated equine estrogens, precursors capable of liberating such a biogenic estrogen.
Applicant’s new claim 12 recites the transitional phrase “consisting essentially of”. The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., See, e.g., PPG Indus. v. Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed. Cir. 1998). If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention. In re De Lajarte, 337 F.2d 870, 143 USPQ 256 (CCPA 1964). See also Ex parte Hoffman, 12 USPQ2d 1061, 1063-64 (Bd.Pat. App. & Inter. 1989). MPEP 2111.03.
Duesterberg does not specifically discloses controlled release of the formulation.
Gallez relates to estetrol combined to progestogen (progesterone or drospirenone) to treat menopause symptoms are known to increase breast cancer risk. It discloses that E4 was combined with P4 (1.25 or 4.25 mg/kg/day) administered through subcutaneous slow-releasing pellets.
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to optimize the amounts of estetrol and progesterone, and their ratios, and to further use a controlled release formulation of the two drugs, based on the disclosure of Duesterberg, as further modified by Gerarghty, Stanczyk and Gallez, with a reasonable expectation of success. The skilled artisan would have been motivated to do so since these amounts are explicitly disclosed by Duesterberg, to include in overlapping ratios, and since the relative potencies of the two drugs were also known in the art and were available as guidance for conversion for a combination of Applicant’s specifically claimed two agents. The skilled artisan would have been further motivated to specifically do the study for these two drugs combined specifically, and in a controlled release formulation (which is a form of slow release), motivated by the disclosure of Gallez of this very specific combination of the two drugs and in a slow-release form.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
1 The Examiner also notes for the record the following post-priority relevant art.
Progestogens and endometrial protection, BMS Tools for Clinicians, British Menopause Society, Copyright Feb. 2026, available at 14-NEW-BMS-TfC-Progestogens-and-endometrial-protection-FEB2026-B.pdf (“British Menopause Society”).
To take dienogest, as an example, per British Menopause Society, p. 8-9, 2 mg of dienogest is the equivalent for micronized progesterone of 200 mg orally 12 days/cycle (cyclical), 100 mg PO daily (continuous combined). Taking the second number of 100 mg of prosterone equivalent to 2 mg of dienogest, which equals 50 mg mg prosterone equivalent to one mg of dienogest, it is possible to determine that 0.5-5 mg of dienogest equals 25 mg-250 mg of progesterone, which overlaps with the claimed range of Applicant’s claims.
Thus, the disclosed amounts of Duesterberg further fall within the claimed ratio of Applicant’s claims.
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