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
Restriction and Status of the Claims
Applicant’s election of Group I, comprising claims 1, 2, 4, 8, 11, 13, 17, 20, 22, 28, 30, and 34 in the response filed on December 31st 2025 is acknowledged. Claims 1, 2, 4, 8, 11, 13, 17, 20, 22, 28, 30, 34, 39, 41-43, 45, 49, 51, 55, 57, 61, 62, 64, 68, 69, 73-75, 77, 81, 84, 85, 87, 91, 94, 96, 100, 103, 104, 106, 108, 110, 114, 116, 120, 123, 125, 129, 132-134, 136, 138, 140, 144-147, 149, 153, 154, 156, 160, 163, 165, and 169 are pending. Claims 39, 41-43, 45, 49, 51, 55, 57, 61, 62, 64, 68, 69, 73-75, 77, 81, 84, 85, 87, 91, 94, 96, 100, 103, 104, 106, 108, 110, 114, 116, 120, 123, 125, 129, 132-134, 136, 138, 140, 144-147, 149, 153, 154, 156, 160, 163, 165, and 169 are withdrawn from further consideration as being directed towards nonelected inventions. Claims 1, 2, 4, 8, 11, 13, 17, 20, 22, 28, 30, and 34 are examined on their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 120 is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 based on the date of the provisional application 63/356,899 filed on June 29th 2022.
Information Disclosure Statement
The Information Disclosure Statements filed on December 31st 2025, January 9th 2025, February 22nd 2024, and November 28th 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1, 2, 11, 20, 28, and their dependent claims 8, 17, and 34 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
One of ordinary skill in the art would recognize that a single compound, and indeed a single salt, can have multiple packing arrangements, causing distinct changes in the crystal structure, and even in the pharmacological properties of the substance. For example, see Atipamula (Atipamula et al., Cryst. Growth Des. 2012, 12, 5, 2147–2152), who describes the phenomena of different solid forms of active pharmaceutical ingredients (APIs):
“An important aspect of drug development is determining which specific solid form of an active pharmaceutical ingredient (API) should be selected for scale-up, formulation activities, and clinical trials. This process is a nontrivial exercise since an API can be polymorphic, meaning that it can exist in two or more crystal forms. Frequently, the crystal forms of an API exhibit low solubility, and it might be appropriate to use a more soluble amorphous form or a more soluble multicomponent form, such as a salt form — for ionizable APIs — or a cocrystal form for neutral APIs. Furthermore, APIs are typically amenable to formation of multiple component crystals such as solvates and hydrates. In short, as presented in Scheme 1, for most APIs, there are numerous possible solid forms that can be obtained and subsequently must be investigated and characterized as part of drug development. Each solid form of an API has distinct physicochemical properties, and finding the optimal solid form is important to intellectual property, processing, enabling drug delivery and is a key to obtaining regulatory approval.”
[Atipamula, pg. 2148]
Atipamula further describes the polymorphism of cocrystals and demonstrates how a single compound can have multiple packing arrangements, leading to different pharmacological properties:
“Polymorphism in cocrystals (different packing arrangements with the same composition, e.g. carbamazepine saccharin (Figure 3) defy the idea that cocrystal formers play the same role as that of an excipient. Rather, cocrystals are novel solid forms that can be patented and are known to modulate physicochemical properties such as solubility in either direction. This means that they could be applicable in either immediate-release or extended-release formulations unlike the “API-excipient complexes”.”
[Atipamula, pg. 2150]
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[Atipamula, pg. 2151]
Noting the substantial effect that a given crystal form can have on a compound’s pharmacological properties, applicant’s crystal forms as described in claims 1, 2, 11, and 28 are insufficient to describe the complete crystal form.
Regarding claim 1 and its dependent claim 8, the claim is directed to a crystalline form of the compound of Formula (I). No further definition is given of the crystal form. The claim language therefore implies “any and all crystalline forms of a compound of Formula (I).” Applicant’s written description is inadequate to support claim 1 as written and applicant will only be considered to have possession of the crystalline forms fully characterized by XRPD peaks.
Claim 2 is directed to a crystalline form of a salt of formula I, comprising XRPD peaks at 10.1, 16.0, and 19.8 ± 0.2 degrees 2Θ. Applicant provides a single crystal structure in support of this claim (see Figure 2). At least the six major peaks at 9.9. 10.1. 13.5. 16.0. 19.1. and 19. 8 ± 0.2 degrees 2Θ would be considered necessary to identify this crystal structure. Applicant’s written description is therefore inadequate to support claim 2 as written. Applicant will be considered only to be in possession of the crystal structure of the compound having at least the peaks at 9.9. 10.1. 13.5. 16.0. 19.1. and 19.8 ± 0.2 degrees 2Θ.
Claims 11 and 17 are directed to a crystalline form of a salt of formula I, comprising XRPD peaks at 7.9, 16.2, and 23.8 ± 0.2 degrees 2Θ. Applicant provides a single crystal structure in support of this claim (see Figure 8). At least the six major peaks at 7.9, 13.6, 16.2, 18.3, and 23.8 ± 0.2 degrees 2Θ would be considered necessary to identify this crystal structure. Applicant’s written description is therefore inadequate to support claims 11 and 17 as written. Applicant will be considered only to be in possession of the crystal structure of the compound having at least the peaks at 7.9, 13.6, 16.2, 18.3, and 23.8 ± 0.2 degrees 2Θ.
Claims 28 and 34 are directed to a crystalline form of a salt of formula I, comprising XRPD peaks at 6.7, 10.2, and 18.0 ± 0.2 degrees 2Θ. Applicant provides a single crystal structure in support of this claim (see Figure 8). At least the six major peaks at 6.7, 9.0, 10.2, 16.5, 18.0, and 18.6 ± 0.2 degrees 2Θ would be considered necessary to identify this crystal structure. Applicant’s written description is therefore inadequate to support claims 11 and 17 as written. Applicant will be considered only to be in possession of the crystal structure of the compound having at least the peaks at 6.7, 9.0, 10.2, 16.5, 18.0, and 18.6 ± 0.2 degrees 2Θ.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pingshan Institute (CN113698405A published on November 26th 2021, Translation attached).
Claim 1 is directed towards a crystalline form of a compound of Formula (I):
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Pingshan Institute teaches a crystalline form of the compound (Pingshan Institute, Translation, pg. 6), anticipating claim 1.
Claims 2 and 4 are directed towards the compound of claim 1 wherein the crystalline form has an XRPD pattern characterized by peaks at 9.9, 10.1, 13.5, 16.0, and 19.1 ± 0.2 degrees 2Θ. Pingshan Institute’s crystalline form comprises peaks at 9.72, 10.13, 13.31, 15.99, and 19.05 ± 0.2 degrees 2Θ (Pingshan Institute, Translation, pg. 6), anticipating claims 2 and 4.
Claims 1, 11, and 13, 20, 22, 28, and 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bunyan (U.S. Patent No. 11,926,645 effectively filed on August 27th 2020).
Claims 1, 11, and 13 are directed towards a crystalline form of a compound of formula I, wherein the crystalline form has an XRPD pattern characterized by peaks at 7.9, 13.6, 16.2, 18.3, 23.8, and 26.3 ± 0.2 degrees 2Θ. Bunyan teaches a crystalline form of formula I, comprising peaks at 7.8, 13.5, 16.3, 18.1, 23.6, and 26.6 ± 0.2 degrees 2Θ (Bunyan, claim 20), anticipating claims 1, 11, and 13.
Claims 20, and 22 are directed towards a crystalline form of a compound of formula I, wherein the crystalline form has an XRPD pattern characterized by peaks at 6.5, 13.9, 16.0, 18.2, 19.9, and 23.3 ± 0.2 degrees 2Θ. Bunyan teaches a crystalline form of a compound of formula I, comprising said XRPD peaks (Bunyan, claim 12). Bunyan therefore anticipates claims 20 and 22.
Claims 28, and 30 are directed towards a crystalline form of a compound of formula I, wherein the crystalline form has an XRPD pattern characterized by peaks at 6.7, 9.0, 10.2, 16.5, 18.0, and 18.6 ± 0.2 degrees 2Θ. Bunyan teaches a crystalline form of formula I, comprising peaks said peaks (Bunyan, claim 20), anticipating claims 28 and 30.
Nonstatutory 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 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 (note that all claims require a crystalline form of the compound and are thereby anticipatory of claim 1) of U.S. Patent No. 12,297,226. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is directed towards a crystalline form of a compound of formula I, characterized by XRPD peaks at 10.1, 16.0, and 19.1 ± 0.2 degrees 2Θ, and the reference patent teaches a crystalline form of a compound of formula I, characterized by XRPD peaks at 10.2, 16.0, and 19.1 ± 0.2 degrees 2Θ (reference patent, claims 1, 5).
Claims 1, 4, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 (note that all claims require a crystalline form of the compound and are thereby anticipatory of claim 1) of U.S. Patent No. 11,814,406. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is directed towards a crystalline form of a compound of formula I, characterized by XRPD peaks at 9.9, 10.1, 13.5, 16.0, and 19.1 ± 0.2 degrees 2Θ. The reference patent teaches a crystalline form of a compound of formula I, characterized by XRPD peaks at 9.8, 10.2, 13.4, 16.0, and 19.1 ± 0.2 degrees 2Θ (reference patent, claim 9).
Claims 1, 11, 13, 20, 22, 28, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-65 (note that all claims require a crystalline form of the compound and are thereby anticipatory of claim 1) of U.S. Patent No. 11,926,645. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons stated in the above 102 rejection of claims 1, 11, 13, 20, 22, 28, and 30 (see Bunyan, claims 12 and 20).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629