NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/US2021/052063, filed Sep. 24, 2021, which claims benefit of priority to Provisional Application 63/083,663, filed Sep. 25, 2020.
Claims 1-17 and 26, as amended, are pending.
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 .
Priority
Applicant' s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Aug. 28, 2023, Dec. 16, 2024, Apr. 1, 2025, and Nov. 12, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to crystalline polymorph Form A of Compound 1 (ethyl (R)-4-((1-(2-cyanoacetyl)piperidin-3-yl)amino)-1H-pyrrolo[2,3-b]pyridine-5-carboxylate, a.k.a. lepzacitinib), and a method of preparing crystalline polymorph Form A of Compound 1, in the reply filed on Dec. 1, 2025 is acknowledged.
Claim 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Dec. 1, 2025.
Claims 1-17 are currently pending and under consideration.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-16 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.
Specifically, claims 1-4 and 13-16 are drawn to crystalline polymorph Form A of compound 1, "characterized by," "further characterized by," or "further comprising" a PXRD pattern comprising numerically specified peaks, endotherms, water loss as measured by TGA, and/or FT-Raman spectral peaks.
Similarly, claims 5-8 are drawn to crystalline polymorph Form A of compound 1 "characterized by" or "further comprising" numerically specified FT-Raman spectral peaks.
Finally, claims 9-12 are drawn to crystalline polymorph Form A of compound 1 "characterized by" or "further comprising" numerically specified PXRD peaks.
However, the instant specification exemplifies and characterizes crystalline polymorph Form A of compound 1 (paras. [0071]-[0075]), and its preparation (paras. [0076]-[0082]), which demonstrate that all of the claimed PXRD peaks, FT-Raman spectral peaks, endotherms, water loss as measured by TGA, and/or FT-Raman spectral peaks, shown in Figs. 1-6, are intrinsic properties of crystalline polymorph Form A of compound 1. I.e., a claim drawn to "crystalline polymorph Form A of compound 1" inherently embodies all of the claimed properties disclosed in the specification as characteristic of Form A.
Thus, claims 1-16 recite quantitative characterization data which do not further limit the claimed crystalline polymorph Form A of compound 1, as recited by independent claims 1, 5, and 9, because these limitations are already inherent in the claimed crystalline polymorph Form A. Such redundant recitations fail to further limit "crystalline polymorph Form A," rendering the metes and bounds of the claims indefinite.
Claims 13 and 16 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.
Specifically, claim 13 recites the crystalline polymorph of claim 1, "further characterized by a PXRD pattern substantially as shown in FIG. 2 or FIG. 3."
Similarly, claim 16 recites the crystalline polymorph of claim 1, "further characterized by a FT-Raman spectra substantially as shown in FIG. 6."
However, the claims are to be complete in themselves. As recognized by MPEP § 2173.05(s), incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Therefore, a claim which refers to an external figure or table renders the metes and bounds of the claim indefinite.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 2-16 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Allowable Subject Matter
Claim 17 is allowed.
Statement of Related Art
Anderson et al. (WO2019/090158, of record), exemplify and claim the compound of Example 117,
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(paras. [0326]-[0329]); claim 19, p. 239), which is identical to compound 1 (a.k.a. lepzacitinib) as recited by independent claims 1, 5, 9, and 17.
Anderson et al. further disclose that "it is understood by those skilled in the art that the inventive compounds and salts may exist in different crystalline or polymorphic forms . . . all of which are intended to be within the scope of embodiments herein" (para. [0135]).
However, this is merely a generic assertion of the existence of crystalline polymorphs of the disclosed compounds, without any exemplified embodiments or specific guidance as to how to prepare such crystalline polymorphs. While stable form screening and characterization techniques are well known in the art, the preparation of specific crystalline polymorphs is known to be unpredictable and not necessarily achievable by routine experimentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. 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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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629