DETAILED ACTION
Claims 1-14 are currently pending in the instant application.
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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to claims 1-8 and 13-14 in the reply filed on 06/10/2026 is acknowledged. The traversal is on the ground(s) that the special technical feature linking Groups I-III is a compound of formula (IIa) in crystalline form having high diastereoisomeric purity obtained through selective crystallization, which is not taught in the prior art. Applicant’s arguments have been found persuasive. Thus the restriction requirement between inventions I-III, as set forth in the Office action mailed on 04/14/2026, is hereby withdrawn and claims 9-12 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
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Information Disclosure Statement
Applicant's Information Disclosure Statement filed on 01/19/2024 has been considered. Please refer to Applicant's copies of the 1449 submitted herewith.
Claim Rejections - 35 USC § 112
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 1-8 and 13-14 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 term “high diastereoisomer purity” in claim 1 is a relative term which renders the claim indefinite. The term “high diastereoisomer purity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically it is unclear what would be considered “high diastereoisomer purity” as the term “high” means a greater degree, amount, cost, value, or content than average, usual, or expected but since there is no definition in the Specification for what would be considered average or usual, one could not determine how pure the compound of formula (IIa) needs to be. Since claims 2-8 and 13-14 do not fix the issue, they have been rejected as well.
Allowable Subject Matter
Claims 9-12 are allowed.
The closest prior art of record: WO 2013/034780 teaches preparation of
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but does not teach said compound in crystalline form or preparation of said crystalline form.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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