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 .
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)(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.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shin et al. (WO 2022220613 A1) published 10/20/2022 with a priority date of 04/14/2021. Applicant has filed a foreign priority application dated 04/14/2021, but have not provided an English translation, therefore the above prior art priority date is applicable.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1-12, shin teaches a method for the preparation of formula 7 comprising preparation of formula 4
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299
540
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by a coupling compound of formula 2
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213
295
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with a compound of formula 3
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264
322
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in the presence of a dimethylacetamide (DMA) solvent, wherein R1 is hydrogen or substituted or unsubstituted alkyl;
R2 is hydrogen, substituted or unsubstituted alkyl, halogen, CN, CF 3 or COCF 3 ; R3 and R4 are each hydrogen, substituted or unsubstituted alkyl, or halogen; R5 is hydrogen, substituted or unsubstituted alkyl or halogen, X is C or N; L is a leaving group (relevant to claims 1-2) (Para. 68-73 and 80-88). Formula 4 is then crystallized by an alcohol-based solvent and water (relevant to claims 3-4) (para. 114)
Shin teaches Formula 3 is prepared by: preparing a compound of Formula 9
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269
304
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by blocking the alcohol group of the compound of Formula 8
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265
276
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; introducing an aldehyde into the compound of Formula 9 to prepare a compound of Formula 10
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282
374
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and preparing a compound of Formula 3 by recovering an alcohol group from the compound of Formula 10; wherein R3-R5 is defined above and Y is an alcohol-protecting group. (relevant to claims 5-6) (para. 187-197). The compound of Formula 3 prepared as described above may be crystallized under acidic conditions by adding hydrochloric acid and H2O (relevant to claims 7-8 and 10-11) (para. 215).
Shin additionally the preparation of Formula 8 may be prepared by a dealkylation reaction of the compound of Formula 11
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306
383
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wherein R3 and R4 are hydrogen and R7 is a substituted or unsubstituted alkyl (relevant to claims 9 and 12) (para. 222-224).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/555,233 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending ‘233 teaches a preparation of a compound of Formula 7 comprising preparation of formula 4
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by a coupling compound of formula 2
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213
295
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with a compound of formula 3
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264
322
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in the presence of a dimethylacetamide (DMA) solvent, wherein R1 is hydrogen or substituted or unsubstituted alkyl;
R2 is hydrogen, substituted or unsubstituted alkyl, halogen, CN, CF 3 or COCF 3 ; R3 and R4 are each hydrogen, substituted or unsubstituted alkyl, or halogen; R5 is hydrogen, substituted or unsubstituted alkyl or halogen, X is C or N; L is a leaving group.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627