Detailed Action
The present office action is in response to the amendments filed on 27 Mar 2026.
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 .
Status
Claims 1-5, 8-9, 11, 16-17, 19-24, 26, and 28 of the pending application have been examined on the merits. Claims 29 and 32 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 27 Mar 2026. Acknowledgement is made of the cancellation of claims 6-7, 10, 12-15, 18, 25, 27, and 30-31.
Priority
Applicants identify the instant application, Serial #: 18/563,321, filed 13 Dec 2023, as a National Stage Entry of International Patent Application #: PCT/CN2021095700, filed 23 May 2022, which claims foreign priority from Foreign Application #: PCTCN2021095700, filed 25 May 2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 27 Jun 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election with traverse of Group I, claims 1-5, 8-9, 11, 16-17, 19-24, 26, and 28 in the reply filed on 27 Mar 2026 is acknowledged. The traversal is on the grounds that while US 2017/0151263 teaches anordrin, a species of formula (A), the reference does not teach using anordrin for treating insomnia. This is not found persuasive because, as stated in the restriction requirement mailed 02 Feb 2026, the technical feature shared by Groups I and II is formula (A) and not the method of treating insomnia. Therefore, because the reference teaches a compound of formula (A), the technical feature is not special in view of the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 29 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 27 Mar 2026.
Drawings
The drawings are objected to because the chemical structures of Figures 4A and 4B are of low resolution and are on the verge of being illegible. Applicant is respectfully asked to submit replacement figures of higher quality resolution in black and white to overcome this objection. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 8-9, 11, 16-17, 19-24, 26, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/041078, hereinafter ‘078, further in view of Huang et al. (Chin Gen Prac Nurs, 2018, 16:1695-1697; provided in IDS 06/27/24), hereinafter Huang, and Polo-Kantola et al. (Fertil Steril, 1999, 71:873-880), hereinafter Polo-Kantola.
The instant claims are directed to a method of treating insomnia in an individual by administering a composition comprising a compound of formula (A) (claim 1):
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The claims further limit species of formula (A) where variables R9 and R10 are H or C(=O)CH2CH3 (claim 2); R1 and R11 are -CH3 (claim 3); one or more of R2, R3, R4, R5, R5, R6, R7, R8, R12, R13, and R14 is H (claim 4); or the compound is anordrin (claim 5, structure below).
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The claims further limit the patient population to individuals at perimenopause, menopause, post menopause, or that have been subject to the surgical removal of an ovary (claim 8). Further limitations include the dose of the compound (claims 11, 16-17, 21, and 23), the frequency of the dose (claims 19-23), the route of administration (claim 24), having a second agent in the composition (claim 26), and the type of insomnia (claim 28).
‘078 teaches that decreased production of estrogen in ovariectomized or postmenopausal or anti-estrogen therapy women leads to estrogen-deficiency symptoms that may adversely affect their quality of life for decades (paragraph [002]). The main therapy to treat these symptoms, estrogen replacement therapy, can have adverse effects such as increased risk of breast and uterine cancer and that the postmenopausal symptoms remain a problem for many older women (paragraph [004]). ‘078 teaches an alternative to estrogen replacement therapy in the form of preventing or reducing estrogen-deficiency symptoms in ovariectomized or postmenopausal individuals by administering a composition of an effective amount of α-anordrin and optionally an effective amount of an additional agent selected from a selective estrogen receptor modulator and an aromatase inhibitor (paragraphs [006], [0026], [0083], and [0087]). Further, the reference teaches the dosing of compounds, including α-anordrin, alone or in combination with an additional, can be in a range which includes about 0.1 mg to about 0.5 mg and that variation in dosage will likely occur depending on the condition being treated (paragraphs [00131] and [00140]). The dose of the reference compounds may also be administered once every two weeks, three times daily, or daily (paragraph [00134]). The doses of the reference compounds may be administered intravenously, intraarterially, intraperitoneally, intravesicularly, subcutaneously, intrathecally, intrapulonarily, intramuscularly, intratracheally, intraocularly, transdermally, orally, or by inhalation (paragraph [00138]). However, ‘078 does not teach that insomnia is an estrogen-deficiency symptom in ovariectomized or postmenopausal individuals.
Huang teaches that perimenopausal insomnia is a sleep disorder with ovarian function degeneration as the central (pg. 1695, column 1). This insomnia can be long-term, i.e. chronic, which can lead to a decrease in immunity, increase the incidence of cardiovascular and cerebrovascular diseases, and affect work and life (pg. 1695, column 1). Huang further teaches that estrogen replacement therapy can reduce and shorten nighttime sleep latency in women, decrease the frequency of hot flashes and night sweats, reduce the number of awakenings during sleep, and prolong total sleep time (pg. 1696, column 1). However, estrogen replacement therapy can have adverse effects such as increased risk of venous thromboembolism, gallbladder disease, and breast cancer (pg. 1696, column 2).
Polo-Kantola teaches the evaluation of estrogen replacement therapy in postmenopausal women over a 7-month period (Abstract). The results showed that estrogen replacement therapy improves objective sleep quality (Abstract).
Based on the teachings of ‘078, Huang, and Polo-Kantola, the person having ordinary skill in the art would recognize that insomnia is an estrogen-deficient symptom in postmenopausal women, taught by Huang and Polo-Kantola, and treat the estrogen-deficient symptom administering anordrin and optionally additional therapeutic agent, taught by ‘078. The artisan would administer the anordrin in a dose range of about 0.1 mg to 0.5 mg at a frequency between every two weeks to three times a day, taught by ‘078. The artisan would further choose a route of administration of anordrin selected from intravenously, intraarterially, intraperitoneally, intravesicularly, subcutaneously, intrathecally, intrapulonarily, intramuscularly, intratracheally, intraocularly, transdermally, orally, or by inhalation, as taught by ‘078. The artisan would have a reasonable expectation of success that administering anordrin and an additional therapeutic agent would treat estrogen-deficient symptoms in postmenopausal women based on the teachings of ‘078 that anordrin can substitute for estrogen replacement therapy. The artisan would be motivated to substitute estrogen replacement therapy with anordrin because estrogen replacement therapy can have adverse effects such as increased risk of breast and uterine cancer, increased risk of risk of venous thromboembolism, and gallbladder disease, as taught by ‘078 and Huang. Therefore, the reference above make obvious the claims of the instant application.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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