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 .
DETAILED ACTION
Priority
This application claims the benefit of and priority of PCT/US2022/035179 filed 06/27/2022, which claims benefit of 63/215151 filed on 06/25/2021, and is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/21/2023 and 07/30/24 was filed prior to the mailing of the instant first Office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. A copy of Form PTO/SB/08 is attached to the instant Office action.
Claim Objections
Claims 7-8 and 11-14 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims and should refer to other claims in the alternative only.. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits. Appropriate corrections is required.
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). 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. 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 filing date of the application will determine what form 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/etermina-disclaimer.
Claim 1-2, 4-5 and 10 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. US 17/510,108 (reference application) in view of Nguyen et al Nguyen et al ("Chiral Drugs: An Overview", Int J Biomed Sci, 2006 Jun, 2(2):85-100).
Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of 2S and 2R (in the instant clams) are disclosed as the claimed racemate of the copending application claims 1 and 2 (reference application).
Nguyen et al teaches that chirality (aka stereoisomerism/enantiomerism/dissemmetry) is a property of an object which is non-superimposable with its mirror image. These non-superimposable mirror-image forms are enantiomers and are further classified as either an L or D-isomer (pdf p3). Nguyen further teaches (generally), the toxicology, pharmacokinetics (pp 11-12), and the chiral separation of the isomers with regards to both the separation and analytic processes. (pp 16-20).
Therefore, according to Nguyen et al , it would be obvious to one skilled in the art and further known that enantiomers contain 50/50 racemate mixture of the two stereochemistry (pdf page 2, ¶1). This would result in someone within the art to isolate a specific stereochemistry (for pharmaceutical purposes) because "…one isomer may produce the desired therapeutic activities, while the other may be inactive or, in worst cases, produce undesired or toxic effects." (Pharmacology, pdf p5, ¶1) .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1-6, 9-10 and 15-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kruegel (WO 2021/134086 A1).
The applied reference has a common applicant (Gilgamesh Pharm) and joint inventor (Kruegel, Andrew) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1-6 and 9-10 the compounds of 1S, 2S, 2R and 3S are anticipated as:
Compound 1S (instant claim 1-3 and 9) is designated as compound 117S (¶169, p79);
Compound 2S and 2R (instant claims 1-2, 4-5, and 10) are disclosed as compounds 18S (¶170, p79) and 18R (¶130, p59);
Compound of 3S (instant claims 1-2, and 6-9) is designated as compound 19S (¶169, p 78).
Regarding claims 15-16 are anticipated where “…method of treating depression, anxious depression, a mood disorder, an anxiety disorder, or a substance use disorder…the method comprising administering to the subject in need thereof…” appears throughout the Kruegel et al (WO 2021…) reference( (col 143-144), and where the embodiments of compounds of 117S=1S (¶169), 18S=2S (¶169), 18R=2R (¶130) and 19S=3S (¶169) are disclosed as a method of treatment as in the instant claims. Specifically, compound 19S (=3S) was administered orally in Example 24: Method A at a dose of 10mg/kg and where compounds were tested as racemates or pure enantiomers (¶402, p175).
Claim(s) 1-3, 6 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanghai Jianhe Pharmaceuticals (EP 3778579 A1, as per the IDS).
Regarding claims 1-3 and 6 the reference art Shanghai Jianhe Pharmaceuticals (as cited in IDS) anticipates the identified compounds 1S and 3S of claims 3 and 6 (instant claims) respectively as known compounds. Compound 1S is identified in Example 4; step c: preparation for 4-d (p27, ¶106) of compound 4 (Shanghai). Compound 3S is identified in Example 2; step d: preparation of 3-d (p25, ¶91) of compound 2 (Shanghai).
Regarding claims 15-16, Shanghai Jianhe Pharmaceuticals (as cited in IDS) anticipates a method of treating depression or disorders associated with; in a subject in need of; as identified in the instant claims and where the compound is administered orally. Shanghai discloses (p.134, ¶748) “As a drug for treatment of depression, as a central nervous system disease, it is necessary for the drug to be distributed into the CNS system such as brain tissue, and the amount of drug entering the brain tissue directly determines its therapeutic effect.” It is further disclosed where “…seen from Table 11 that, when administered orally at 10mg/kg…”. It also disclosed where in Test Example2 (p127, ¶724), mice are administered oral doses of the disclosures to further determine bioavailability.
Summary of the Claims
Claims 1-16 are pending.
Claims 7-8 and 11-14 are objected.
Claims 1-6, 9-10 and 15-16 are rejected.
No claims are in allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVE DROUIN whose telephone number is (571)272-5426. The examiner can normally be reached Monday- Friday 7:30am-5:00pm.
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, Kortney Klinkel can be reached at 571-270-5239. 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.
/S.H.D./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
Prosecution Insights