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 .
Election/Restrictions
Applicant’s election without traverse of Group II, encompassed by claims 31-33, 38-40, and 44, in the reply filed on February 26, 2026 is acknowledged.
Applicant elected neuroactive steroid Compound 1, shown below, as their elected species.
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Examination will be limited to claims directed to the elected species, which are presently claims 31, 38, 39, 44, and 64-67.
Application and Claims Status
Claims 18-20, 24-26, 30-33, 38-40, 44-47, 51-52, 57-59, and 63 were pending. In the amendment as filed on February 26, 2026, applicants have amended claims 31, 38, and 39; cancelled claims 1-30, 32-37, 40-43, and 45-63; and added new claims 64-67. Therefore, claims 31, 38, 39, 44, and 64-67 are currently pending. Additionally, the present specification is amended in order to cross-reference to related applications.
Priority
The instant application is a 35 U.S.C. § 371 of PCT Application No. PCT/US2022/014075, filed on January 27, 2022, which claims the benefit of priority to U.S. Provisional Patent Application No. 63/142,840, filed on January 28, 2021, and U.S. Patent Provisional Application No. 63/142,833, filed on January 28, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) filed on July 11, 2024 and February 26, 2026 are in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action.
Specification - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of Compound 1, or a genus structure, into the abstract, to overcome this objection.
Specification - Drawings
Acknowledgement is made of the drawings received July 7, 2023. These drawings are acceptable.
The drawings are objected to because:
Currently, all sheet numbers (i.e. “1/5”) are oriented in a different direction than the view numbers (i.e. “FIG. 1”) and reference characters (i.e. “Compound 1”). As recited in 37 CFR 1.84:
(p) Numbers, letters, and reference characters.
(1) Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet. Reference characters should be arranged to follow the profile of the object depicted.
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.
Specification – Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 31, 38, 44, 64, 65 and 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Watson et al. (US 2022/0169674 A1, published June 2, 2024, effectively filed August 23, 2016, cited on IDS filed on 7/11/2024)(hereinafter, ‘Watson’).
Regarding claim 31, 44, 64, and 67: Watson teaches a crystalline form of the compound of instant claim 31 as well as methods of using (abstract), as well as a pharmaceutically acceptable salt (“Methods of Use” para 0173).
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Additionally, Watson teaches administering the compound above to treat a mood disorder such as postnatal depression (page 13, para 0204; page 22, claim 56), which can include symptoms of reduced sexual desire (page 13, para 0207). Applicant writes:
Postnatal depression (PND) is also referred to as postpartum depression (PPD), and
refers to a type of clinical depression that affects women after childbirth. Symptoms can
include sadness, fatigue, changes in sleeping and eating habits, reduced sexual desire, crying
episodes, anxiety, and irritability. In some embodiments, the PND is a treatment-resistant
depression (e.g., a treatment-resistant depression as described herein). In some embodiments,
the PND is refractory depression (e.g., a refractory depression as described herein).
Altogether, Watson discloses treating the mood disorder of postpartum depression, which embraces treating the reoccurrence of symptoms like reduced sexual desire, which would entail maintaining sexual function as required by instant claim 31.
Regarding claims 38 and 65: Watson teaches regimens for administering oral doses (“with oral dosing, one to five…”) of about 20 mg/kg of the disclosed compound once a day (page 9, para 0165).
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.
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) 31, 44, 64, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Levin et al. (US 2023/0210870 A1, published July 6, 2023, effectively filed June 8, 2020)(hereinafter, ‘Levin) in view of Saporito et al. (US 2018/0296487 A1, published October 18, 2018)(hereinafter, ‘Saporito’).
Regarding claims 31, 44, 64, and 67: Levin teaches methods of treating female health conditions related to sex hormones through modulation of GABA receptors using compound CV-10155, shown below.
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Furthermore, Levin teaches that the female health condition is postpartum depression (page 12, claim 7; page 6, para 0065-0066). Specifically, Levin teaches (page 6, para 0066) that behavioral symptoms of postpartum depression include “lack of interest or pleasure in usual activities; low or no energy; low libido…”.
Levin does not teach the instantly claimed compound exactly, which differs in a methyl substituent instead of a hydrogen on the decalin scaffold of the steroid compound. While the exact compound of instant claim 31 is not disclosed by Levin, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “methyl” group to a hydrogen. Therefore, claims 31, 38, 44, 64, 65 and 67 would have been practiced with a reasonable expectation of success.
In view of the established case law, Examiner also wants to note the teachings of Saporito.
Levin: Instant claim 31: Saporito:
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Saporito discloses (page 10, 12) the exact compound of instant claim 31 and that it is effective against treating a patient with postpartum depression (claim 16 and 17, page 16; para 0027; and elsewhere throughout).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings Levin in view of Saporito to arrive at the claimed invention. Both Levin and Saporito teach the same class of compound, which is effective against mood disorder, including but not limited to postpartum depression. Furthermore, Levin teaches that a symptom of postpartum depression is low libido Therefore, the invention as a whole is 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.
Claim(s) 31, 38, 44, 64, 65 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez Botella et al. (WO 2016/061527 A1, published April 21, 2016, cited on IDS filed on 7/11/2024)(hereinafter, ‘Martinez Botella’) in view of Saporito.
Regarding claim 31, 44, 64, and 67: Martinez Botella teaches “compositions and methods for treating CNS disorders”, wherein the compound is a steroid (page 16) comparable to the instant claim:
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Additionally, Martinez Botella teaches administering the compound above to treat a mood disorder such as postnatal depression, which can include symptoms of reduced sexual desire (page 79). Applicant writes:
Postnatal depression (PND) is also referred to as postpartum depression (PPD), and
refers to a type of clinical depression that affects women after childbirth. Symptoms can
include sadness, fatigue, changes in sleeping and eating habits, reduced sexual desire, crying
episodes, anxiety, and irritability. In some embodiments, the PND is a treatment-resistant
depression (e.g., a treatment-resistant depression as described herein). In some embodiments,
the PND is refractory depression (e.g., a refractory depression as described herein).
Martinez Botella discloses preventing the disorder wherein prevention embraces preventing the reoccurrence of symptoms, which would entail maintaining sexual function as required by instant claim 31.
Regarding claims 38 and 65: Martinez Botella teaches regimens for administering oral doses of about 20 mg/kg of the disclosed compound once a day (page 70, para 110).
Martinez Botella does not teach the instantly claimed compound exactly, which differs in a methyl substituent instead of a hydrogen on the decalin scaffold of the steroid compound. However, as discussed in 35 USC § 103 above and further in view of Saporito, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings Martinez Botella in view of Saporito to arrive at the claimed invention. Both Martinez Botella teach the same class of compound, which is effective against mood disorder, including but not limited to postpartum depression. Furthermore, Martinez Botella teaches that a symptom of postpartum depression is reduced sexual desire. Therefore, the invention as a whole is 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.
Claim(s) 39 and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Watson as applied to claims 31, 38, 44, 64, 65 and 67, and further in view of Hoffmann et al. (US 2020/0281943 A1, published September 10, 2020, cited on IDS filed 7/22/2024)(hereinafter, ‘Hoffmann’).
Regarding claims 39 and 66: The teachings of Watson (as described in 35 USC § 102 section) disclose methods of treating and preventing CNS disorders which embraces treating sexual disfunction or maintaining sexual function in a patient with postpartum depression by administering instant compound 1 but do not teach dosages of about 50 mg once a day for about 14 days, as required by instant claims 39 and 66.
Hoffmann teaches that instant compound is useful in treating or preventing mood disorders like postpartum depression and discloses once daily oral administration at about 20 mg to about 60 mg (page 2, para 0011 and 0012). Hoffmann further teaches, in para 0016, treatment with Compound 1 once a day for 14 days.
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 forgoing 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 is 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 31, 44, 64, and 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 2 of copending Application No. 18/839,147. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference ‘147 is drawn to the same compound and method of treating postpartum depression as instant claim 31. Reference ‘147 is silent on “of maintaining sexual function” as required by instant claim 31. However, reference discloses in the specification (page 15, para 0223), that an “effective amount” of a compound (or pharmaceutically acceptable salt thereof) refers to an amount sufficient to elicit the desired biological response, e.g., to treat sexual dysfunction, e.g., to treat treatment induced sexual dysfunction…”. Instant claim 31 is drawn to administering a therapeutically effective amount of Compound 1. Reference ‘147 embraces treating sexual dysfunction wherein prevention embraces treating the reoccurrence of symptoms, which would entail maintaining sexual function as required by instant claim 31.
Reference claim 2 recites a method that is more specific than the method of instant claim 31, in that reference claim 2 additionally includes a second treatment to be administered. Reference claim 2 of ‘147 is, in essence, a “species” of the generic invention of application claim 31, and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 31, 44, 64, and 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of copending Application No. 18/557,705. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference ‘705 is drawn to the same compound and method of treating postpartum depression as instant claim 31. Reference ‘705 is silent on “of maintaining sexual function” as required by instant claim 31. However, reference discloses in the specification (page 10, para 0140), that symptoms of postpartum depression include “reduced sexual desire”. Reference ‘705 discloses preventing the disorder wherein prevention embraces preventing the reoccurrence of symptoms, which would entail maintaining sexual function as required by instant claim 31.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.A.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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