DETAILED ACTION
This office action is in response to applicant’s filing dated August 7, 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 of claims
Claims 1, 4 – 6, 13, 14, 18 and 22 - 29 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group I (Claims 1, 4-6, 13, 14, 18, 22-25 and 29) drawn to a salt of compound represented by formula (A), and a crystalline composition thereof in the reply filed on August 7, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 26 – 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 7, 2026.
Claims 1, 4-6, 13, 14, 18, 22-25 and 29 are under consideration in the present office action, as related to an elected Group I invention.
Priority
The present application is a 371 of PCT/CN2022/137298, filed December 7, 2022, and claims the benefits of priority to China Application No. CN202111494667.8, filed December 8, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/07/2024, 04/16/2025 and 09/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Acknowledgement is made of the drawings received on June 7, 2024.
The drawings are objected to because Fig. 1 – 6 have a poor images quality, which makes them unreadable. 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 Objections
Claims 6, 14, 22, 23, 24, 25 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claims 1, 4, 5, 13 and 18 are rejected under 35 U.S.C. 103 as being obvious over Zhao et al (US 20230183206 A1, cited in IDS, filed 04/16/2025, hereinafter Zhao) in view of in view of Stahl et al (Handbook of Pharmaceutical Salts: Properties, Selection, and Use / International Union of Pure and Applied Chemistry (IUPAC) Weinheim: VHCA, 2002, hereinafter Stahl).
The applied reference has a common assignee 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).
Instant claims are drawn to an inorganic (sulfate or phosphate) or an organic (such as malate, oxalate, succinate, tartrate, adipate) addition salt of a compound of formula (A):
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, such as
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or
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where n is 1 – 1.5. Instant claims are further drawn to a pharmaceutical composition comprising the salt of compound of formula (A).
Zhao teaches a compound PR-4:
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and its pharmaceutically acceptable salts (page 27, [0239]). Zhao defines "pharmaceutically acceptable salt" as a salt, which is suitable for contact with the tissues of mammals (in particular human beings) without undue toxicity, irritation, allergic response or the like and commensurate with a reasonable benefit/risk ratio. Unless otherwise specified herein, the term "salt" includes both acid addition salts derived from inorganic acids and acid addition salts derived from organic acids (page 7, [0107]. Zhao further teaches a pharmaceutical compositions, comprising said compound or its pharmaceutically acceptable salt (page 3 – 4, [0057]). Zhao does not teach where the salt is sulfate, phosphate, malate or succinate, or the specific acid:base molar ratio in the addition salt.
However, Stahl in “Pharmaceutical Salts” handbook teaches sulfuric acid, phosphoric acid, malic acid and succinic acids as suitable to form a salt with a basic drug molecules (pages 212 – 214, chapter 8). Although Stahl does not explicitly teach specific acid:base molar ratio in the addition salts, it would be within the skills in the art to optimize the molar ratio of base to acid to arrive at the salts of the instant claims. It is noted that "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, since Zhao teaches pharmaceutically acceptable salts and pharmaceutical compositions of the drug of an identical chemical structure as instantly claimed, and Stahl teaches inorganic and organic acids suitable to form corresponding addition salts with basic drugs, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine teachings of prior art and make various pharmaceutically acceptable salts from the known drug and known acids to arrive at the salts of the instant claims with a reasonable expectation of success.
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 reference, especially in the absence of evidence to the contrary.
This rejection under 35 U.S.C. 103 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); 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 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. See generally MPEP § 717.02.
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, 4, 5, 13 and 18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4 -15 of U.S. Patent No. US 12,522,584 B2 in view of Stahl et al (Handbook of Pharmaceutical Salts: Properties, Selection, and Use / International Union of Pure and Applied Chemistry (IUPAC) Weinheim: VHCA, 2002).
Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims are directed to an inorganic (sulfate or phosphate) or an organic (such as malate, oxalate, succinate, tartrate, adipate) addition salt of a compound of formula (A):
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and a pharmaceutical composition comprising the salt of compound of formula (A).
Patented claims are directed to a compound of formula (I):
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, such as the compound:
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, its pharmaceutically acceptable salts and a pharmaceutical composition comprising compound of formula (I) or its pharmaceutically acceptable salts.
Although patented claims are silent about where the salt is sulfate, phosphate, malate or succinate, or the specific acid:base molar ratio in the addition salt, Stahl in “Pharmaceutical Salts” handbook teaches sulfuric acid, phosphoric acid, malic acid and succinic acids as suitable to form a salt with a basic drug molecules (pages 212 – 214, chapter 8). Although Stahl does not explicitly teach specific acid:base molar ratio in the addition salts, it would be within the skills in the art to optimize the molar ratio of base to acid to arrive at the salts of the instant claims. It is noted that "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Thus, instantly claimed compound, its salts and compositions would be obvious over patented compounds and compositions in view of teachings of Stahl.
Conclusion
Claims 1, 4, 5, 13 and 18 are rejected.
Claims 6, 14, 22, 23, 24, 25 and 29 are objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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