DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Current Status of 18/767,228
3. This Office Action is responsive to the claims of 9 July 2024.
4. Claims 1-15 have been examined on the merits.
Priority
6. The effective filing date is 16 January 2022.
Information Disclosure Statement
7. The information disclosure statements (IDS) submitted on 9 January 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
8. Claims 1-5, 8 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The instant claims 1-4, 8 and 10 cite “subject” which includes a variety of subjects- non-vertebrates, newborns, and animals (see para 24). It is unclear how one could practice the method on these populations because they can’t tell you they’re experiencing an SSD. In addition, claims 2-5 cite improving, increasing, decreasing sensitivity and reducing pain, it is unclear how the subject of non-vertebrates, newborns, and animals can express that in a manner that would be understood to one attempting to practice the method. The artisan would not be able to practice the claims.
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.
9. Claims 12-13 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.
Claims 12 recite the limitation “about 1% and 15% by weight” and claim 13 cites “about 1% and 6% by weight”, but the base(s) that the percentages are referred to is/are missing, thus rendering the claims indefinite.
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.
10. Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over PERRICONE (US9439926B2) in view of HANSEN (WO2020198252 A1) further in view of ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed.,1999, pages 48-53).
Determining the scope and contents of the prior art
PERRICONE teaches a method of administering a composition to treat/prevent the sexual dysfunction (e.g. claims 1 and 15), and it’s administered to the penis (e.g. claims 4 and 18), or vulva (e.g. claims 3 and 17).
HANSEN teaches a topical formulation for treatment of peripheral neuropathy using an effective amount of pirenzepine, pirenzepine free base, and pirenzepine salt (claim 2). Peripheral neuropathy generally refers to a disorder that affects one or a combination of the motor, sensory or autonomic nerves (para [0003], p 1). Peripheral neuropathy as used therein is defined as a disorder resulting from damage to peripheral nerves. It may be acquired, caused by diseases of the nerves or as the result of systemic illness (para [0045], p 9). Peripheral neuropathy has also been associated with erectile dysfunction (para [0046], p 9).
ANSEL teaches the effective dose of a drug may vary, depending on the dosage form and the route of administration. Varying rates and degrees of absorption can occur from drug administration from the rectum, gastrointestinal tract, sublingually, via the skin and from other sites. Therefore, for a given drug, different dosage forms and routes of administration are routinely studied through clinical studies to determine the effective dosage (p 53).
Ascertaining the differences between the prior art and the claims at issue
PERRICONE teaches a method of administering a composition to treat/prevent the sexual dysfunction (e.g. claims 1 and 15) for both men and women, but doesn’t teach a composition or method of use of pirenzepine in particular.
HANSEN teaches a topical formulation for treatment of peripheral neuropathy using an effective amount of pirenzepine, pirenzepine free base, and pirenzepine salt (claim 2).
It is worth noting that HANSEN explicitly teaches peripheral neuropathy include erectile dysfunction and specific neuralgias at any location of the body (para [0055], p 12).
ANSEL teaches different dosage forms and routes of administration are routinely studied through clinical studies to determine the effective dosage for a given drug (p 53).
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has
sufficient background in the development of method of use of pirenzepine for treatment of sexual dysfunction and possesses the technical knowledge necessary to make adjustments to the administered composition to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding pirenzepine and understands the solutions that are widely-known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
11. The instant claims are prima facie obvious over PERRICONE and HANSEN in view of ANSEL.
Regarding claims 1 and 7-11, the artisan would be motivated to modify PERRICONE’s method by introducing pirenzepine to treat sexual dysfunction since HANSEN explicitly teaches peripheral neuropathy include erectile dysfunction and specific neuralgias at any location of the body. The composition can take the form of a gel, a cream, a lotion, an ointment, a solution, a solid “stick, etc. that can be rubbed or sprayed onto the skin, e.g., onto the penis, vulva, or other suitable portion of the skin (Lns 33-36, Col 2). Certain Perricone’s compositions may be applied to the genital perineal region or penis or portion thereof of a male subject to treat erectile dysfunction, to the vulva of a female subject to treat sexual dysfunction, e.g. FSAD (or to any other portion at or near the genital perineal region in male or female subjects) (Lns 8-13, Col 4). Since HANSEN teaches using an effective amount of pirenzepine for treatment of peripheral neuropathy including erectile dysfunction, painful scar and specific neuralgias at any location of the body (para [0055], p 12), it’s logic to extend the pirenzepine treatment to the anogenitals as HANSEN suggested. So, it’s obvious to add pirenzepine to PERRICONE’s method to reach the instant claims 1 and 7-11.
12. Regarding claims 2-6, PERRICONE teaches compositions of the invention are effective in promoting subjective arousal (e.g. feelings of arousal, e.g. excitement and/or pleasure) as well as genital arousal (e.g. swelling of the vulva or vaginal lubrication) in females (Lns 31-35, Col 3). A composition as described therein is used to treat sexual
dysfunction or other conditions such as those described therein. To “treat a disorder means to reduce or eliminate a sign or symptom of the disorder, to stabilize the disorder, and/or to reduce or slow further progression of the disorder (Lns 42-47, Col 2).
Therefore, claims 2-6 are obvious over PERRICONE in view of HANSEN.
13. Regarding claims 14 and 15, it’s obvious for an artisan after the teachings are in the combined art to use the pirenzepine in the method of Perricone, the artisan would modify the concentrations, dosage forms, route of administrations, etc. because those are routinely selected by the artisan based on a variety of factors (patient preference, patient ability, etc.- all are known in the art as taught by ANSEL’s teaching that different dosage forms and routes of administration are routinely studied through clinical studies to determine the effective dosage for a given drug (p 53) with expectations for success.
Claims 14 and 15 are obvious over PERRICONE and HANSEN in view of ANSEL.
Double Patenting
14. 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.
15. Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-28 of copending Application No. 17/593,792 in view of HOLLOWAY. (Holloway E. “Sexual Problems in Diabetes” Medicine, Volume 47, Issue 2, February 2019, 106-109)
Reference Application ‘792 discloses a method of treating Pages peripheral neuropathy including diabetic neuropathy and infectious disease (such as HIV) induced peripheral neuropathy by administrating pirenzepine (claims 26-28 of 01/22/2026). HOLLOWAY teaches that sexual problems are prevalent in both men and women diabetes patients (introduction, p 106). It would be obvious to treat sexual dysfunction with the drug (pirenzepine) because ‘792 teaches it is used for neuropathy and diabetic neuropathy is a species within that genus of neuropathies that would benefit from treating sexual dysfunction because it is highly prevalent.
This is a provisional nonstatutory double patenting rejection.
Conclusion
16. No claims are presently allowable as written.
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/B.T./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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