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 .
Status of the Claims
Claims 1 – 10 are pending and rejected.
Priority
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 17, 2025 and September 25, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner.
Claim Objections
Claims 3 – 5 are objected to because of the following informalities:
Claim 3, page 4, line 2 of the claim: The term “including” in the limitation “including the following crystals forms…” is grammatically improper. In order to overcome the objection, Applicant may amend to replace the term “including” with “comprising”.
Claim 3, page 12, line 6: The term “including” in the limitation “including the following crystals forms…” is grammatically improper. In order to overcome the objection, Applicant may amend to replace the term “including” with “comprising”.
Claim 4, page 30, line 2 of the claim: The term “including” in the limitation “including the following crystals forms…” is grammatically improper. In order to overcome the objection, Applicant may amend to replace the term “including” with “comprising”.
Claim 4, page 35, line 3: The term “including” in the limitation “including the following crystals forms…” is grammatically improper. In order to overcome the objection, Applicant may amend to replace the term “including” with “comprising”.
Claim 4, page 37, line 8: The term “including” in the limitation “including the following crystals forms…” is grammatically improper. In order to overcome the objection, Applicant may amend to replace the term “including” with “comprising”.
Claim 5, page 56, line 2 of the claim: The term “including” in the limitation “including the following methods…” is grammatically improper. In order to overcome the objection, Applicant may amend to replace the term “including” with “comprising”.
Appropriate correction is required.
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.
Claims 2 – 4 and 6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance,
Claim 2 recites the broad recitation “… the polymorph may be a crystal form of a non-solvate, a hydrate, or a solvate of compound III” (see, page 4, lines 1-2 of the claim), and the claim also recites “preferably, compound III has a structure of compound I or compound II” (see, page 4, line 3 of the claim) which is the narrower statement of the range/limitation.
Claim 3 recites the broad recitation “… the polymorph is a crystal form of a non-solvate of compound I, including the following crystal forms A, B, C, D, E, and F of non-solvates” (see, page 4, lines 1-3 of the claim), and the claim also recites several iterations containing the terms “preferably” and “more preferably” throughout the claim (too exhaustive to list) which are the narrower statements of the range/limitation. See, e.g., pages 5-30.
Claim 4 recites the broad recitation “… the polymorph is a crystal form of a non-solvate of compound II, including the following crystal forms 2A, 2B, 2C, 2D, and 2E of non-solvates” (see, page 30, lines 1-3 of the claim), and the claim also recites several iterations containing the terms “preferably” and “more preferably” throughout the claim (too exhaustive to list) which are the narrower statements of the range/limitation. See, e.g., pages 30-56.
Claim 6 recites the broad recitation “… the organic solvent is selected from alcohols, chloroalkanes, ketones, ethers, cyclic ethers, esters, alkanes, cycloalkanes, benzenoids, amides, sulfoxides, and a mixture thereof” (see, lines 1-4 of the claim), and the claims also recites “… preferably, the organic solvent is selected from methanol, ethanol, n-propanol, isopropanol, n-butanol, trifluoroethanol, acetonitrile, acetone, methyl ethyl ketone, methyl isobutyl ketone, 1,4-dioxane, tetrahydrofuran, 2-methyltetrahydrofuran, N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidone, dimethylsulfoxide, ethyl acetate, isopropyl acetate, dichloromethane, trichloroethane, tetrachloromethane, methyl tertbutyl ether, cyclopentyl methyl ether, 2-methoxyethyl ether, isopropyl ether, diethyl ether, n-heptane, n-hexane, isooctane, pentane, cyclohexane, cyclopentane, methylcyclohexane, benzene, toluene, xylene, and a mixture thereof” which is the narrower statement of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In order to overcome the rejection, Applicant may amend to delete all limitations encompassed by the narrower language “preferably” and “more preferably” in the claims.
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 1 – 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 11 of copending Application No. 19/108,490 (US 2026/0069582 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because
Claim 1 in US ‘490 is directed to a polymorph of compound I:
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Claims 2 – 5 in US ‘490 are directed to specific solvent-free crystal forms A, B and C, hydrate crystal form D, solvate crystal forms E, F, G, H, and I and metastable crystal forms J, K, L, M, and N of compound of formula (I) and recite specific XRPD peaks for each form. The claims overlaps in scope with the instant claims 3 – 4.
Claims 6 – 7 in US ‘490 are directed to a method for preparing the polymorph. The claims overlaps in scope with the instant claims 5 – 6. Claim 8 is directed to a pharmaceutical composition comprising said polymorph and a pharmaceutically acceptable carrier. The claim overlaps in scope with the instant claims 7. Claims 9 – 11 in US ‘490 are directed to an use of the polymorph (method of using) the polymorph. The claims overlaps in scope with the instant claims 8 – 10.
Thus, the claims in US ‘490 render the instant claims unpatentable for anticipatory-type double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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