DETAILED ACTION
This action is in response to papers filed on 06/01/2023. Claims 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 of Cha et al., 18255423 (06/01/2023) are pending examination on the merits: claims 1-2, 5-6, 9-10, 12, 14-15, and 17 are amended, claims 21-38 are newly added, and claims 3-4, 7-8, 11, 13, 16, and 18-20 are canceled. Claims 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 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/IB2021/061268 (12/03/2021) which claims benefit of 63/121,508 (12/04/2020) which claims benefit of 63/121,513 (12/04/2020).
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 06/01/2023 is 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 10, 15, 22, 28 and 34 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.
Regarding claims 10, 22, 28 and 34, the claim in part recites “wherein treatment is in conjunction with psychotherapy…”. Applicant’s Specification on page 30 at lines 11-14 defines “psychotherapy” as:
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It is unclear what the metes and bounds of psychotherapy as it relates to the claimed method of treatment. As defined, psychotherapy renders the claim indefinite.
Regarding claim 15, the claim in part recites “…in an amount from 0.0048 mg/kg, 0.016, 0.048 mg/kg, 0.16 mg/kg, or 0.32 mg/kg. The recitation of 0.016 without any unit of measurement is ambigious. It is unclear whether 0.016 follows the series to include mg/kg. In the interest of compact prosecution, 0.016 is interpreted to mean 0.016 mg/kg.
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 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al., WO 2016049165 A1 (“Anderson”).
Regarding claim 1, Anderson teaches on p. 23, para. [0073], Compound (I) or pharmaceutically acceptable salt thereof for use in the treatment of major depressive disorder (MDD) (pp. 30-31, para. [00104]), by administering an effective amount to a patient in need thereof (p. 29, para. [00100]-[00101]). Claim 1 is obvious.
Regarding claim 2, Anderson teaches on p. 23, para. [0073], Compound (I) or pharmaceutically acceptable salt thereof for use in the treatment of resistant depression (p.29, para. [00101]), by administering an effective amount to a patient in need thereof (p. 29, para. [00100]-[00101]). Claim 2 is obvious.
Regarding claims 5 and 6, Anderson teaches on p. 23, para. [0073], Compound (I) or pharmaceutically acceptable salt thereof for use in the treatment of major depressive disorder (pp. 30-31, para. [00104]), by administering an effective amount to a patient in need thereof (p. 29, para. [00100]-[00101]).
While Anderson does not expressly disclose MDD with suicidal ideation or MDD with suicidal ideation with intent, Anderson does teach that patients with MDD are often at increased risk of suicide (pp. 24-25, para. [0079]).
It would have therefore been prima facie obvious to one of ordinary skill in the art at the time of filing, to modify Anderson’s teachings of the treatment of MDD using Compound (I) or a pharmaceutical salt thereof, to further include MDD with suicidal ideation, with or without intent, and arrive at the claimed invention successful. One of skill in the art would be motivated to do so, with reasonable expectation of success, because Anderson teaches that patients with MDD are often at increased risk of suicide (pp. 24-25, para. [0079]). Therefore, Anderson’s teachings of the treatment of MDD using Compound (I) or a pharmaceutical salt thereof, to further include MDD with suicidal ideation, would have been obvious to one of ordinary skill in the art; thus, arriving at the claimed invention successfully. Claims 5-6 are obvious.
Regarding claims 9-10, 17, 21-22, 26-28, 32-34, and 38, Anderson teaches the methods of claims 1, 2, 5, and 6 as discussed above. Anderson also teaches that Compound (I) may be administered in conjunction with one or more active pharmaceutical ingredient effective in the treatment of, for example, a neurological disease, abnormal brain function or an emotional disorder (p. 31, paras. [00105]-[00106]). The claims are obvious.
Regarding claims 12, 23, 29, and 35. Anderson teaches the methods of claims 1, 2, 5 and 6 as discussed above. Anderson also teaches on pp. 26-27, paras. [0090]-[0091] that Compound (I) or a pharmaceutically acceptable salt thereof can be administered intravenously. The claims are also obvious.
Regarding claims 14, 24, 30 and 36, Anderson teaches the methods of claim 1, 2, 5, and 6 as discussed above. While Anderson does not expressly disclose the administration schedule of Compound (I) as per claims 14, 24, 30 and 36, Anderson does teach on p. 29, para. [0099] that “The dosage regimen utilizing the disclosed compound is selected in accordance with a variety of factors including type, species, age, weight, sex and medical condition of the patient; the severity of the condition to be treated; the route of administration; the renal or hepatic function of the patient; and the particular disclosed compound employed. A physician or veterinarian of ordinary skill in the art can readily determine and prescribe the effective amount of the drug required to prevent, counter or arrest the progress of the condition.”.
Moreover, it is within the skill of an artisan to routinely optimize and formulate the claimed range in order to arrive at the claimed invention with reasonable expectation of success. 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, "II. Optimization of Ranges". 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 effective amounts disclosed by Anderson above overlap in scope with the claimed effective amounts; thus, routinely optimizing the administration schedule based on known factors in the art is well within the technical grasp of one of ordinary skill in the art. The claims are obvious.
Regarding claims 15, 25, 31, and 37, Anderson teaches the methods of claims 1, 2, 5, and 6 as discussed above. Anderson teaches on p. 29, para. [00100] effective amounts in mg: “[00100] Effective dosage amounts of the disclosed compounds, when used for the indicated effects, range from about 0.5 mg to about 5000 mg of the disclosed compound as needed to treat the condition. Compositions for in vivo or in vitro use can contain about 0.5, 5, 20, 50, 75, 100, 150, 250, 500, 750, 1000, 1250, 2500, 3500, or 5000 mg of the disclosed compound, or, in a range of from one amount to another amount in the list of doses. In one embodiment, the compositions are in the form of a tablet that can be scored…”.
While Anderson teaches the effective amounts in mg, the claimed invention teaches units of mg/kg. However, to one of ordinary skill and as disclosed by Anderson on p. 29, para. [0099]: “… A physician or veterinarian of ordinary skill in the art can readily determine and prescribe the effective amount of the drug required to prevent, counter or arrest the progress of the condition.”. Thus, it is within the technical grasp of a person of ordinary skill in the art, to calculate the amounts in mg/kg, and arrive at the claimed invention successfully. 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). The claims are obvious.
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.
Claims 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of copending Application No. 18551699 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and the reference application both teach the instantly claimed compound for use in the treatment of major depressive disorder (c.f., reference application claims 1 and 27).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of copending Application No. 18551739 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and the reference application both teach the instantly claimed compound for use in the treatment of major depressive disorder (c.f., reference application claims 1 and 51).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12145909 (“‘909”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the claims of ‘909 both teach the instantly claimed compound for use in the treatment of major depressive disorder (c.f., ‘909 claims 16-19).
Claims 1-2, 5-6, 9-10, 12, 14-15, 17, and 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12161624 (“‘624”).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the claims of ‘624 both teach the instantly claimed compound for use in the treatment of major depressive disorder (c.f., ‘624 claims 1-20).
Conclusion
No claims are allowed.
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/C A/Examiner, Art Unit 1622 September 13, 2025
/DANAH AL-AWADI/ Primary Examiner, Art Unit 1615