DETAILED ACTION
This action is in response to papers filed on 05/28/2024. Claims 2, 4-20, 22, and 24 of GERARD, et al., 18713986 (05/28/2024) are pending examination on the merits: claims 2, 4-15, 16, 17-20, and 22 are amended; claims 24 is newly added; and claims 1, 3, 21, and 23 are canceled. Claim 16 is marked Canceled in the claim set, but this appears this is a typographical error. Clarification is requested. Claims 2, 4-20, 22, and 24 are rejected.
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 .
Priority
This application is a 371 of PCT/EP2022/083611 filed on 11/29/2022 and claims Foreign Priority EUROPEAN PATENT OFFICE (EPO) 21211056.3 filed on 11/29/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 05/28/2024 and 09/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 4-20, 22, and 24 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 4 recites that the method comprises alleviating signs of skin aging, reversing signs of skin aging, and/or reducing signs of skin aging. It is unclear what distinguishes alleviating signs versus reducing signs with respect to skin aging, and the Specification does not provide a basis for this distinction. The limitation is ambiguous and indefinite. All claims dependent claim 4 are also rejected because they do not resolve this ambiguity. See MPEP § 2173.05(d).
Claim 6 recites “… diagnosed to have… or ... is considered to have dermatoporosis...”. Page 22 of the Specification states that:
Dermatoporosis is characterized by a decreased expression of collagen I, a decreased expression of collagen III, a decreased expression of collagen IV, increased expression of matrixmetalloproteinases 1, increased expression of matrix metalloproteinases 2, increased expression of matrix metalloproteinases 3, decreased expression of matrix metalloprotein I, loss of elastic tissue, defective fibroblast synthesis of collagen, loss of hyaluronic acid, or any combination thereof. Thus, in the present context a subject, optionally an elderly subject, that is not diagnosed with dermatoporosis may be considered to nonetheless have, or may be predicted to develop dermatoporosis upon presenting a decreased expression of collagen I, a decreased expression of collagen III, a decreased expression of collagen IV, increased expression of matrix metalloproteinases 1, increased expression of matrix metalloproteinases 2, increased expression of matrix metalloproteinases 3, decreased expression of matrix metalloprotein I, loss of elastic tissue, defective fibroblast synthesis of collagen, loss of hyaluronic acid, or any combination thereof.
It is unclear what distinguishes a patient from being considered to “have” dermatoporosis and being “diagnosed” to have dermatoporosis. The Specification does not provide a clear distinction or a requisite degree to ascertain the difference between the two groups. Clarification is requested. All claims dependent claim 6 are also rejected because they do not resolve this ambiguity. See MPEP § 2173.05(d).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4, 5, 8-18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Taziaux et al., WO 2019/202142 A1 (“Taziaux”), in view of Bennick et al., WO 2003/103685 A1 (“Bennick”).
Regarding claims 2, 4, 5, 17, and 22 Taziaux (c.f., page 4, item 4) discloses a composition for use in alleviating physiological aspects of the menopausal transition selected from changes in skin texture, wherein said composition comprises an estetrol component and wherein said composition is administrated at a daily amount of 15 mg of estetrol, which falls within the recited range of about 10 mg to about 25 mg of estetrol. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
While Taziaux does not expressly teach the changes and/or improvement in skin texture as claimed, Bennick teaches a cosmetic method of treating human skin comprising the administration of estetrol. The method is for improving or preventing the condition of wrinkled, lined, dry, flaky, aged or photodamaged skin and of improving skin thickness, elasticity, flexibility and plumpness, which method includes applying to the skin a composition that contains an estrogenic component and a cosmetically acceptable carrier (Abstract and page 3, lines 4-8). In the study conducted, patients were treated with a formulation containing an estrogenic compound, wherein “The compound formulation is administered to areas of the skin most affected by atrophy twice a day, which is continued for 1 to 3 months…” Example 4, page 16, lines 23-25, and a 1 mg/g estetrol composition was prepared according to Example 3, and administered to patients. In Example 5, estetrol is also discussed.
While Taziaux discusses an overall improvement in skin dryness throughout the disclosure, Bennick teaches that estetrol improves the condition of wrinkled, lined, dry, flaky, aged or photodamaged skin and of improving skin thickness, elasticity, flexibility and plumpness (Abstract and page 3, lines 4-8) at 1 mg/g.
It would have therefore been prima facie obvious, before the time of filing of the instant application, for one of ordinary skill in the art, to combine the teachings of Taziaux and Bennick, and arrive at the claimed method with a reasonable expectation of success. One would have been motivated to do so because both Taziaux and Bennick teach the use of estetrol in improving skin conditions, and because these claims do not contain or recite any additional steps or dosages, the prior art teaching will inherently yield the same result because the prior art administers the same compound within the required dosage range to a subject.
Regarding claims 8, 9, and 10, Taziaux in view of Bennick teaches the method of claim 2. However, the method of treatment requires only those steps that must be performed. MPEP §2111.04. In the instant case, the limitations of claims 8-10 recite results of performing the method of treatment of claim 2, and as such is not considered to be further limiting of the claim from which it depends. The method of claim 2 results in a reduction in interleukin-6, an increase in keratinocyte function, and an increase in fibroblast function. The method of claim 2 is taught by Taziaux in view of Bennick, and both disclosures discuss improvement in skin firmness, thickness and smoothness for example. It would necessarily follow that, the method of claim 2 resulted in a reduction in interleukin-6, an increase in keratinocyte function, and/or an increase in fibroblast function. Bennick teaches “Estrogens and synthetic compounds which act like estrogens are known to increase the thickness of the dermal layer and to reduce wrinkle formation in the ageing skin.”, including the use of estetrol.
Moreover, see In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955) which states, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05. In this instance, administering the compound of claim 2, and comparing it with a control sample is considered a routine process, and is well within the technical skill of an artisan, arriving at the claimed invention with a reasonable expectation of success.
Regarding claims 11-15, Taziaux in view of Bennick teaches the method of claim 2. However, the method of treatment requires only those steps that must be performed. MPEP §2111.04. In the instant case, the limitations of claims 11-14 recite results of performing the method of treatment of claim 2. The claims do not contain or recite any additional steps or dosages, the prior art teaching will inherently yield the same result because the prior art administers the same compound within the required dosage range to a subject. Moreover, Bennick teaches the use of estetrol as one of the estrogenic compounds that is useful for “… for improving or preventing the condition of wrinkled, lined, dry, flaky, aged or photodamaged skin and of improving skin thickness, elasticity, flexibility and plumpness…” (c.f., Abstract). Claim 11-14 are obvious.
Regarding claim 16, Taziaux in view of Bennick teaches claim 2. Taziaux (c.f., page 4, item 4) discloses a composition for use in alleviating physiological aspects of the menopausal transition selected from changes in skin texture, wherein said composition comprises an estetrol component and wherein said composition is administrated at a daily amount of 15 mg of estetrol. ". Applicant claims about 19 mg of estetrol.
Bennick teaches on page 9 that “For practical reasons the present composition will usually not contain more than 50 mg/g of the estrogenic component. Preferably said composition contains not more than 20 mg/g, more preferably not more than 10 mg/g of the estrogenic component.”, encompassing the claimed range of 19 mg. Bennick as discussed above also teaches estetrol as one of the estrogenic compounds. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The claim is obvious.
Regarding claim 18, Taziaux in view of Bennick teaches the claimed invention of claim 2. The composition used in the treatment method discussed by Taziaux in view of Bennick, does not comprise progestogen is administered to the subject. Claim 18 is also obvious.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Taziaux et al., WO 2019/202142 A1 (“Taziaux”) in view of Bennick et al., WO 2003/103685 A1 (“Bennick”), as applied to claims 2, 4, 5, 8-18, and 22, and in further view of Dyer et al., Clin. Aesthet. Dermatol. 2018;11(1):13–18 (“Dyer”).
Regarding claim 6, Taziaux in view of Bennick’s teachings as applied to claims 2, 4 and 5 are applied herein. Taziaux however, does not expressly teach dermatoporosis as claimed.
Bennick teaches a cosmetic method of treating human skin. The method is for improving or preventing the condition of wrinkled, lined, dry, flaky, aged or photodamaged skin and of improving skin thickness, elasticity, flexibility and plumpness, which method includes applying to the skin a composition that contains an estrogenic component and a cosmetically acceptable carrier (Abstract and page 3, lines 4-8). In the study conducted, patients were treated with a formulation containing an estrogenic compound, wherein “The compound formulation is administered to areas of the skin most effected by atrophy twice a day, which is continued for 1 to 3 months…” Example 4, page 16, lines 23-25, In Example 5, estetrol is also discussed.
Taziaux in view of Bennick teach the method of claim 6, wherein the patient is considered to have or is diagnosed with dermatoporosis, a clinical term for a severe, chronic form of dermal atrophy and functional impairment in aging skin. To one of ordinary skill in the art, it would have been prima facie obvious to combine the teachings of Taziaux and Bennick, and arrive at the claimed invention with a reasonable expectation of success because both Taziaux and Bennick teach the use of estetrol in alleviating changes to skin texture, particularly changes associated with menopause. Claim 6 is obvious.
Regarding claim 7, Taziaux in view of Bennick teach the method of claim 6. Taziaux in view of Bennick does not expressly teach the characterization of dermatoporosis.
However, Dyer teaches in Table 2: “Proposed pathogenetic and therapeutic mechanisms in dermatoporosis”, including dermatoporosis characterized by the “decrease gene expression of collagen I, collagen III, and collagen IV…. MMP 1, 2, and 3 are upregulated with age…., and dermal elastosis … associated with MMP overactivity and defective fibroblast synthesis…”. On page 15, Dyer also teaches that: “… dermatoporosis is an important risk factor for the development of chronic wounds, as keratinocytes and fibroblasts lack proliferative capacity in this setting and matrix metalloproteinases (MMPs) might be overexpressed.”. To one of ordinary skill in the art, these are known characterization of dermatoporosis and well known in the literature as discussed in Dyer’s review.
It would have therefore been prima facie obvious to prima facie obvious to one of ordinary skill in the art, at the time of the invention, to combine the teachings of Taziaux in view of Bennick, as discussed above, in view of Dyer teachings of the characterization of dermatoporosis, and arrive at the claimed invention with reasonable expectation of success. One would have been motivated to do so, because Dyer teaches the various pathogenetic and therapeutic mechanisms in dermatoporosis, and in Table 3 discusses the use of oral conjugated estrogens in the clinical treatment and improvement. It would therefore necessarily follow that one or more the characteristics of dermatoporosis are present in all dermatoporosis, so that practicing the method of the prior art would lead to treatment of all variants of dermatoporosis including those described in claim 7 and discussed in claim 6. Claim 7, as is claim 6, is obvious.
Claims 19-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Taziaux et al., WO 2019/202142 A1 (“Taziaux”) in view of Bennick et al., WO 2003/103685 A1 (“Bennick”), as applied to claims 2, 4, 5, 8-18, and 22 in further view of Douxfils et al., Contraception 102 (2020) 396–402 (“Douxfils”).
Regarding claims 19, 20, and 24, Taziaux in view of Bennick teaches the claimed invention of claim 2. Taziaux in view of Bennick does not teach the administration of drospirenone to a subject along with estetrol.
Douxfils teach in the Abstract the effects of use of combined oral contraceptive containing estetrol and drospirenone on hemostasis, where healthy women received either 15 mg estetrol/3 mg drospirenone (E4/DRSP) (n = 39). The findings of the study as concluded by Douxfils teach the combination profile of E4 with drospirenone and that said combination, “The neutral profile of E4/DRSP on hemostasis parameters suggests that it is less likely to be associated with VTE risk...” (VTE: venous thromboembolism). While the study is directed to evaluating hemostasis associated with contraceptive use, to one of ordinary skill in the art, the fragile skin in advanced dermatoporosis can cause frequent or severe hematosis especially from minor trauma, and as such the therapy may be extended to minimize hemostasis in general, while also addressing underlying hormonal concerns.
It would therefore have been prima facie obvious for one of ordinary skill in the art at the time of filing, to further combine the teachings of Douxfils with Taziaux in view of Bennick as applied to claim 2, and arrive at the claimed invention with a reasonable expectation of success of the use of E4 (c.f., page 397, “15 mg E4 as monohydrate”) and drospirenone in improving the skin. One would have been motivated to do so because Douxfil teaches that the combination of E4 with DRSP does not pose a risk for blood clots or further exacerbation of skin issues such as hemostasis, something common with dermatoporosis, and that E4 can essentially be used in combination with DRSP relative other hormone combinations in hormone therapy. The combination is known in the art, and is associated with hematosis. The claims are obvious.
Moreover, regarding the range of DRSP, 3 mg is taught by Douxfils, which falls within the Applicant’s claimed range of 0.25 mg to 4 mg. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 June 7, 2026
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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