FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed May 29, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
No claims have been amended or canceled, and no new claims have been added.
Claims 18-42 and 44-67 stand withdrawn as drawn to nonelected inventions and/or species.
Thus, claims 1-17, 43, 68, and 69 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on May 29, 2026 was filed after the mailing date of the non-final action on Jan. 30, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
MAINTAINED REJECTIONS
The following rejection is maintained from the previous Office Action dated Jan. 30, 2026, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Claim Rejections - 35 U.S.C. § 112(b) – Indefiniteness
Claims 6, 8, 9, 12, and 16 stand 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 6, 8, and 9 recite the solid form of claim 1, having an XRPD pattern "as substantially shown in FIG. 1"; "as substantially shown in FIG. 2"; and "as substantially shown in FIG. 3," respectively. Claim 12 recites the solid form of claim 10, having an XRPD pattern "as substantially shown in FIG. 22;" and claim 16 recites the solid form of claim 14, having an XRPD pattern "as substantially shown in FIG. 25."
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.
RESPONSE TO ARGUMENTS
Applicant's arguments filed May 29, 2026 have been fully considered but they are not persuasive.
With respect to the rejection of claims 6, 8, 9, 12, and 16 under 35 U.S.C. § 112(b) for indefiniteness, Applicant submits that reference to the figures is necessary to fully define the XRPD, DSC, and TGA data associated with each claimed solid form of Formula (I). Particularly, the rejected claims refer to figures showing XRPD, DSC, and TGA patterns of Formula (I), which are objective, recognized physical characteristics in the art. It is further submitted that the rejected claims are consistent with the requirements for the form of claims as defined in MPEP § 608.01(m) and 37 C.F.R. § 1.75(d)(1). Accordingly, Applicant submits that claims 6, 8-9, 12, and 16 are not indefinite, and respectfully requests reconsideration and withdrawal of this rejection (Remarks, p. 13).
However, MPEP § 2173.05(s) provides that “[w]here possible, claims are to be complete in themselves. 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) (citations omitted).
Claims to solid, crystalline, or polymorphic forms are not an exceptional circumstance with no practical way to define the claimed invention in words; nor are the recited graphical figures necessary to fully define the claimed solid forms. XRPD patterns, DSC thermograms, and TGA curves are routinely and practically defined in words by listing the characteristic numerical values for each: peak positions in degrees 2θ, endotherm/exotherm onset or peak temperatures, weight loss percentages, etc. Listing a number of distinctive peaks or thermal events is standard practice in pharmaceutical solid-form patents, as demonstrated in dependent claims 2-5, 7, 11, 13, 15, and 17, which are definite and thus not subject to this rejection. The figures remain available for support and enablement, and need not be incorporated into the claim itself.
In addition, the phrase “substantially as shown in FIG. X” is ambiguous. XRPD patterns and DSC and TGA traces contain dozens of peaks of varying intensity, plus background and instrument-dependent artifacts. A skilled artisan cannot determine, with reasonable certainty, which features of the figures are limiting, what intensity threshold applies, or how much experimental variation is permitted by the term “substantially,” which is not defined in the specification (see p. 18, line 22 to p. 19, line 7) to eliminate this ambiguity.
See also MPEP § 2173.02.
For the foregoing reasons, the rejection of claims 6, 8, 9, 12, and 16 under 35 U.S.C. 112(b) for indefiniteness is maintained.
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.
CORRESPONDENCE
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 10:00 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.
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.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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