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
Status of the Claims
Applicant’s cancelation of claims 1, 2, 4, and 8 in the response filed on May 1st 2026 is acknowledged. Claims 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108, 110, 114, 116, 120, 123, 125, 129, 132-134, 136, 138, 140, 144-147, 149, 153, 154, 156, 160, 163, 165, and 169 are withdrawn from further consideration as being directed towards nonelected inventions.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 11, 13, 17, 20, 22, 28, 30, and 34 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statement filed on May 1st 2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
35 U.S.C. § 102 Rejections Overcome by Amendment & Argument
Applicant’s amendments and arguments in the response filed on May 1st 2026 are acknowledged. Applicant has canceled claims 1, 2, 4, and 8, thus rendering moot all 102 rejections over Pingshan Institute (CN113698405A).
Applicant argues that the 102 rejections of claims 11, and 13, 20, 22, 28, and 30 should be withdrawn, because the compound of Bunyan (U.S. Patent No. 11,926,645) differs structurally from the compound of the instant application. Applicant’s argument is found persuasive, and the 102 rejections over U.S. Patent No. 11,926,645 are thereby withdrawn.
Nonstatutory Double Patenting Rejections Overcome by Amendment & Argument
Applicant’s amendments and arguments in the response filed on May 1st 2026 are acknowledged. Applicant has canceled claims 1, 2, 4, and 8, thus rendering moot the nonstatutory double patenting rejections over U.S. Patent No. 12,297,226 and U.S. Patent No. 11,814,406.
Applicant argues that the nonstatutory double patenting rejections of claims 11, and 13, 20, 22, 28, and 30 should be withdrawn, because the compound of Bunyan (U.S. Patent No. 11,926,645) differs structurally from the compound of the instant application. Applicant’s argument is found persuasive, and the nonstatutory double patenting rejections over U.S. Patent No. 11,926,645 are thereby withdrawn.
35 U.S.C. § 112(a) Rejections Maintained
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.
The rejection of claims 11, 20, 28, and their dependent claims 17 and 34 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 is maintained.
Applicant argues in the response filed on May 1st 2026 that, in view of the specification and figures, one of ordinary skill in the art would recognize applicant as being in possession of the crystal forms described.
Examiner does not dispute that applicant is in possession of the crystal forms described in the specification in Figures 8-10, 37-42, but only that claims 11, 20, 28, and their dependent claims 17 and 34 do not fully describe the three crystal forms.
It is unpredictable whether particular polymorphs will share aspects of their XRPD spectrum. See Wang (Wang et al., Polymorph transformation in paracetamol monitored by in-line NIR spectroscopy during a cooling crystallization process. Aaps Pharmscitech. 2011;12(2):764–770) below, who teaches XRPD patterns for 2 polymorphic forms of the common drug, paracetamol:
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[Wang, pg. 766, Figure 2]
It is shown that the two forms share a major defining peak, and little else. One of ordinary skill in the art therefore could not reasonably distinguish between the two polymorphic forms from the presence of a single peak. I.e., while the major peak is one of the defining features of the two polymorphs, additional peaks would be necessary in order to properly distinguish the two structures.
Noting the substantial effect that a given crystal form can have on a compound’s pharmacological properties, and the differing XRPD patterns between polymorphic forms, applicant’s crystal forms as described in claims 11, 20, 28, and their dependent claims 17 and 34 are insufficient to describe the complete crystal form.
35 U.S.C. § 112(a) Rejections Reiterated
Claims 11, 20, 28, and their dependent claims 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.
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.
Allowable Subject Matter
Claims 13, 22, and 30 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.
Applicant has developed three novel crystal forms of the compound,
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.
Crystalline forms of the compound are found in CN113698405A, but applicant’s three particular forms are not found in the art and would not be predictable from the art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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