Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s preliminary amendment of 7 March 2025, in which claim 4 has been amended, and claims 5-68 have been cancelled, is acknowledged.
Claims 1-4 are pending in the instant application.
Claims 1-4 are being examined herein.
Priority
This application is a Continuation of U.S. Patent Application 18/517,460, filed on 22 November 2023, now abandoned, which is a Continuation of U.S. Patent Application 17/699,582, filed on 21 March 2022, now abandoned, which is a Continuation of U.S. Patent Application 16/734,135, filed on 3 January 2020, now U.S. Patent 11,312,718, which is a Divisional of U.S. patent application 15/799,612, filed on 31 October 2017, now U.S. patent 10,550,122, which is a Continuation of U.S. patent application 15/016,117, filed on 4 February 2016, now U.S. patent 9,840,505, which is a Divisional of U.S. patent application 14/327,499, filed on 9 July 2014, now U.S. patent 9,290,497, which is a Divisional of U.S. patent application 13/347,423, filed on 10 January 2012, now U.S. patent 8,809,349, which claims priority from U.S. Provisional Patent Application No. 61/578,655, filed on 21 December 2011, and from U.S. Provisional Patent Application No. 61/431,304, filed on 10 January 2011.
Information Disclosure Statement
No information disclosure statement was submitted.
Claim Objection
Claims 1, 2, 3 are objected to for the following reason: the chemical structures are not clear. Applicant is required to redraw the chemical structures so that all the chemical bonds can be clearly seen.
Claim 1 is objected to because it recites twice Formula (I) on line 3, and on line 4, before “wherein the compound […]”. Correction is required.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-4 are rejected under 35 U.S.C. 102(b) as being anticipated by Ren et al. (US 2009/0312319, published 17 December 2009, cited in PTO-892).
Ren (US 2009/0312319) teaches (page 105, Example 14b) compound 4904 below, which is the very compound of instant formula (I):
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Ren Compound 4904, page 105, Example 14b
Ren further teaches (on page 14, [0164]) the compound includes crystalline and amorphous forms of the compound, including polymorphs, pseudopolymorphs, solvates, hydrates, unsolvated polymorphs, including anhydrates, conformational polymorphs, and amorphous forms of the compound, as well as mixtures thereof. Ren teaches ([0164]) that the terms “crystalline form,” “polymorph,” and “novel form" may be used interchangeably, and are meant to include all crystalline and amorphous forms of the compound, and mixtures thereof.
Thus, instant claims 1-4 are anticipated by Ren.
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.
Claims 1-4 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18, 20, 23, 25-29, 31, 33-36 and 38 of US patent 8,193,182 (cited in PTO-892).
Claims 1-18, 25-29, 33-36 and 38 are drawn to a genus, while claims 20, 23 and 31 of US patent 8,193,182 are drawn to a compound of the following structure:
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and a pharmaceutical composition thereof.
Further, the Specification of US 8,193,182 defines (column 25, lines 55-67) a compound as encompassing its crystalline and amorphous forms, including polymorphs, pseudopolymorphs, solvates, hydrates, unsolvated polymorphs, including anhydrates, conformational polymorphs, and amorphous forms of the compound, as well as mixtures thereof.
Instant claims 1-4 are drawn to specific polymorphs of the compound of the structure above.
As such, claims 1-18, 20, 23, 25-29, 31, 33-36 and 38 of US patent 8,193,182 render obvious instant claims 1-4.
Claims 1-4 are rejected under the judicially created doctrine of obviousness type double patenting as being unpatentable over claims 1-46, 52-66 of U.S. patent RE46,621 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-46, 52-66 of U.S. patent RE46,621 anticipate or render obvious the instant claims.
Instant claims 1-4 are drawn to a compound of Formula (I), wherein the compound is polymorph Form B, C, D, E, F, G, H, I, J or an amorphous form of a compound of formula (I).
Claims 1-46, 52-66 of U.S. patent RE46,621 are drawn to a compound of formula (I) or to a pharmaceutical composition comprising such compound, wherein the compound is, for example, polymorph Form C, or polymorph B, or polymorph D, or polymorph E, having the very same characteristic X-ray Powder Diffraction (XRPD) peaks as in the instant claims.
As such, the instant claims are anticipated or rendered obvious by claims 1-46, 52-66 of U.S. patent RE46,621.
Claims 1-4 are rejected under the judicially created doctrine of obviousness type double patenting as being unpatentable over claims 1-34 of U.S. patent 11,312,718 (cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-34 of U.S. patent 11,312,718 anticipate or render obvious the instant claims.
Instant claims 1-4 are drawn to a compound of Formula (I), wherein the compound is, for example polymorph Form C, alone or in a mixture with other non-form C polymorphs or an amorphous form of a compound of formula (I).
Claims 1-34 of U.S. patent 11,312,718 are drawn to a formulation or to an oral dosage form comprising polymorph Form C of a compound of formula (I), having characteristic X-ray Powder Diffraction (XRPD) peaks.
As such, the instant claims 1-4 are anticipated or rendered obvious by claims 1-34 of U.S. patent 11,312,718.
Conclusion
Claims 1-4 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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