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
This Application claims priority to U.S. Provisional Application No. 63/406,556, filed Sept. 14, 2022.
Claim Status – Response to Restriction/ Election
Claims 261-280 are currently pending. Applicant’s election without traverse of Group IV, claims 277-278 in the reply filed on March 12, 2026 is acknowledged.
Claims 277-278 are active and subject to examination. Claims 261-276 and 279-281 are withdrawn.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
“A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.”
Claim(s) 277-278 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mudipalli et al. (US20030199515A1).
Claim 277 is a product-by-process claim directed towards a highly pure compound of Formula III, wherein the compound is prepared by a process comprising the step of converting a crystalline form of a compound of Formula I, or a pharmaceutically acceptable salt, hydrate or solvate thereof, to a crystalline form of a compound of Formula II or a pharmaceutically acceptable salt thereof, and wherein the purity of the compound of Formula III is at least about 90%.
The compound of formula III has the following structure:
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185
360
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(claim 274).
Mudipalli teaches crystalline forms of the compound of Formula III, wherein the compound of Formula III has a purity of at least 90%, specifically 99.7%:
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528
570
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Mudipalli, Specification, p. 47;
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680
542
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199
518
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Id., p. 49.
The patentability of a product-by-process claim is determined based on the patentability of the product, which does not depend on its method of production (MPEP § 2113).
As the product of Mudipalli is the same as the product of claim 277, claim 277 is anticipated.
Claim 278 is directed towards a compound of Formula III, wherein the compound is in crystalline Form II.
Mudipalli teaches a compound of Formula III, wherein the compound is in crystalline Form II:
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746
656
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Mudipalli, Fig. 6.
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415
523
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Id., Fig. 12.
Forms I and II disclosed by Mudipalli are the same Forms I and II as disclosed in the instant Application:
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456
794
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Instant Fig. 11;
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423
626
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Instant Fig. 13;
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455
755
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Instant Fig. 14;
As shown in Mudipalli Fig. 6 and Instant Fig. 11, Mudipalli Form II and Instant Form II appear to be the same form because they have peaks in the same locations. Form II reference also appears to be the same form as the instant sample because the peak locations are substantially identical, seeming to be an admission by the Applicant of Form II in the prior art.
Therefore, claim 278 is anticipated.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (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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/HEATHER DAHLIN/Examiner, Art Unit 1629
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