NON-FINAL REJECTION
This application, filed Mar. 28, 2024, is a continuation of PCT/CN2023/130583, filed Nov. 9, 2023, which claims benefit of foreign priority to PCT/CN2022/131179, filed Nov. 10, 2022.
Claims 2-15, 17, and 21-31, 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
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d), based on PCT/CN2022/131179, filed Nov. 10, 2022. It is noted, however, that applicant has not filed a certified copy of the application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Mar. 28, 2024 and Jul. 7, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to crystalline salt forms of Compound (I), compositions thereof, and a method of making the crystalline forms; and the choline salt, Form A as the Compound (I) species, in the reply filed on Jul. 7, 2026, is acknowledged.
Claims 9-14 and 21-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking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 Jul. 7, 2026.
Claims 2-8, 15, 17, and 31 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 3 and 5-7 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, independent claim 3 is drawn to a crystalline Form A of compound (I) choline salt, characterized by an X-ray powder diffractogram comprising diffraction peaks at 12.9, 14.6, and 18.1 degrees 2-theta.
However, three diffraction peaks are insufficient to uniquely and consistently identify the specific crystalline form, so as to distinguish the claimed form A from other polymorphs or mixtures of crystalline forms. The limited data fails to define the metes and bounds of the claimed invention with the required reasonable degree of precision and particularity.
On the basis of only three peaks, one of ordinary skill in the art would be unable to determine with reasonably certainty if a crystalline form with slightly different or overlapping XRPD profile is the claimed form A. Thus, infringing activity cannot be clearly distinguished from non-infringing activity, rendering the metes and bounds of the claims indefinite.
Claim 4 is excluded from this rejection because it recites six numerically specified diffraction peaks, which are sufficient to distinguish crystalline Form A of compound (I) choline salt from other crystalline forms.
Claims 5 and 7 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 5 recites the crystalline form of claim 3, further characterized by an X-ray powder diffractogram “as substantially shown in FIG. 1A.”
Similarly, claim 7 recites the crystalline form of claim 3, further characterized by a DSC “as substantially shown in FIG. 1B.”
The specification defines the phrase “substantially shown in Figure” as applied to an X-ray powder diffractogram to include a variation of ±0.2°2θ or ±0.1°2θ; and as applied to DSC thermograms is meant to include a variation of ±3° Celsius; and as applied to thermogravimetric analysis (TGA) is meant to include a variation of ±2% in weight loss (para. [0049]).
Nonetheless, the phrase “substantially as shown in Figure” is ambiguous, because 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, and to which features this definition would apply.
Moreover, 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
Claim 4 is 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.
Claim 17 is objected to under 37 CFR 1.75(c) as being in improper form because it depends both from claim 2 and from claim 15. However, a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim has not been further treated on the merits.
Allowable Subject Matter
Claims 2, 8, 15, and 31 are allowed.
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 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.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
