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
The amendments to the claims filed July 25, 2025 are acknowledged and entered. Claims 1, 4-5, 8-9, 12-17, 20, 24-25, 28-29, 32, 34 and 36-37 are pending.
Priority
This application is a 371 of PCT/US2023/064916, filed March 24, 2023, which claims benefit of 63/269,944, filed March 25, 2022.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on July 25, 2025 and August 26, 2026. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Rejections - 35 USC § 112b
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 1, 4-5, 8-9, 12-17, 20, 24-25, 28-29, 32, 34 and 36-37 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. The claims are indefinite for the reasons that follow:
Claims 1, 17 and 37 recite the limitations “Form C”, “Form A”, “Form B”, “Form D”, “Form E”, “Form F”, “Form G”, “Form H”, “Form I”, and/or “Form J”. These limitations are indefinite because they have not been defined in the specification. For instance, the specification provides no definition of “Form C” and therefore the metes and bounds of “Form C” is unclear. Claims 4-5, 8-9, 12-16, 20, 24-25, 29 , 32, 34 and 36 depend from claims 1 or 17, respectively, include the limitations “Form C” or “Form A” and are also indefinite.
Claims 1 and 17 recite the limitation “substantially free of amorphous Compound 1”. This limitation renders the scope of the claim indefinite because the specification fails to provide a clear definition of the limitation. Paragraph [00355] of the specification teaches "substantially free of amorphous Compound 1" means that the compound contains no significant amount of amorphous Compound 1; however, a person skilled in the art has no way of knowing what Applicant regards as a “significant amount”. “Substantially free of amorphous Compound 1” is ambiguous. Claims 4-5, 8-9, 12-16, 20, 24-25, 29 , 32, 34 and 36 depend from claims 1 or 17, respectively, include the limitation “substantially free of Compound 1” and are also indefinite.
Claims 12, 15-16, 28, 32 and 36 similarly recite the phrases “substantially similar” or “substantially as shown” which render the claims indefinite because “substantially” is not defined and therefore a person skilled in the art has no way of knowing what Applicant intends by, for instance, an XRPD that is substantially similar to Fig. 10 or Fig. 16 (see claim 12).
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, claims 4, 5 and 12 recite the broad recitation “Figure 16”, and the claim also recites “(bottom trace)” which is the narrower statement of the range/limitation. Claims 9 and 12 recite the broad recitation “Figure 10”, and the claim also recites “(top trace)” which is the narrower statement of the range/limitation. Claims 24-25 and 28 recite the broad recitation “Figure 4”, and the claim also recites “(bottom trace)” which is the narrower statement of the range/limitation. The claim(s) 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.
Claim 20 recites the limitations “hydrate, monohydrate, dihydrate, or trihydrate" in line 2. There is insufficient antecedent basis for these limitations in the claim because claim 20 depends from claim 17 which does not recite that the solid form of Compound 1 can be a hydrate.
Claim Rejections - 35 USC § 112d
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 9, 25 and 29 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 5, 9, 25 and 29 are substantial duplicates of claim 4, 8 and 24. The claims respectively depend from claims 4, 8 and 24 and recite further characterized by having additional XRPD peaks. One skilled in the art would understand that these claims are doing no more than reciting additional peaks which are properties that are inherent the crystalline forms recited in claim 4, 8 or 24. Thus, claims 5, 9, 25 and 29 are not teaching a new or different crystalline form of claims 4, 8 or 24, rather they just adding additional peaks which only adds more detail to the claim. The crystalline forms which are present in claim 5, 9, 25 and 29 are identical to the crystalline forms in dependent claims 4, 8 and 24. The claims are thus rejected for failing to further limit the subject matter of the claim upon which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 17 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Masse et al. ( WO2019/023468 A1)(hereinafter “Masse”).
The instant claims are drawn to a solid form of Compound 1 wherein the form is Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I or Form J. The claims do not require that the specific solid forms (e.g. Form A, Form B…) have any distinguishing features. Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I and Form J do not provide any structural limitation and therefore the scope of the claims is regarded as solid form of Compound 1.
Masse teaches Compound 1 of the claims (page 272, compound I-908; pictured below for convenience). Masse does not explicitly recite a solid form of the compound as required by the claims; however, Masse teaches that compounds of the invention may be provided in crystalline (i.e. solid) form in order to prolong the effect of a compound of the invention (see [00230]). Masse does not recite the specific forms of the claims (e.g. Form C); but, as noted above, these forms do not provide any further structure limitation to the claimed compound. A crystalline solid form of Masse is therefore regarded as meeting these limitations.
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The difference between the prior art and the instant claims is that the instant claims require a solid form of Compound 1; however, the claimed invention would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application because Masse had disclosed that the claimed compound could be in a crystalline solid form.
One would have been motivated to obtain the claimed invention because Masse disclosed the compound could be provided in crystalline form in order to prolong the effect of the compound.
One would have had a reasonable expectation of success because Masse taught that the claimed compound could be provided in a solid form as required by the claims.
Allowable Subject Matter
Claims 4, 8, 12-16, 20, 24, 28, 32, 34 and 36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest reference to the instant claims is Masse et al. (WO2019/023468 A1) which was discussed in the rejection herein. Masse does not teach the limitations of claims 4, 9, 12-16, 20, 24, 28-29, 32, 34 and 36. There is no teaching which would have motivated one of ordinary skill in the art before the effective filing date of the instant applicant to modify Masse into the claimed invention with any reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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September 9, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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