DETAILED ACTION
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 .
Claims 1-20 are pending in the instant application. Claims 3-5 and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 1, 2, 6-8, 10, and 13 are rejected. Claims 9, 11 and 12 are objected.
Information Disclosure Statement
The information disclosure statement filed on September 29, 2023 has been considered and a signed copy of form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13, and compound C9 in the response filed on November 26, 2025 is acknowledged. The restriction requirements are still deemed proper and are hereby made final.
The examiner will follow the guidelines of MPEP 803.02 wherein once a species is elected, it is examined for compliance with all applicable statutes for patentability and if compliance is found, then the examination is expanded to a reasonable number of elected species to determine whether they also comply with the statute. The examiner will determine whether the entire scope of the claims is patentable according to MPEP 803.02.
Applicant's elected species appears allowable over the prior art of record. Therefore, according to MPEP 803.02: should no prior art be found that anticipated or renders obvious the elected species, the search of the Markush-type claim will be extended. If prior art is found that anticipated or renders obvious the Markush-type claim with respect to a nonelected species, the Markush-type claim shall be rejected and claims to the nonelected species held withdrawn from further consideration. The search of the Markush-type claim has been extended to the non-elected species wherein:
G is
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; R1 is -NH(C=O)CH2X wherein X is halo; R2 is –(C=O)NRaR3 wherein Ra is H; and the remaining variables are as defined in the claims.
As prior art has been found which anticipates the above identified nonelected species, the Markush-type claims are rejected as follows and the subject matter of the claims drawn to nonelected species held withdrawn from consideration. Claims 1, 2 and 6-13 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since art was found on the nonelected species, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 6-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Al-Nadaf et al. (Bioorg. Med. Chem. 18 (2010) 3088-3115).
Al-Nadaf et al. discloses the compound 159 (see Scheme 6 on page 3106) which anticipates a compound of the claims (i.e., compound C4) wherein G is
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; R1 is -NH(C=O)CH2X wherein X is chloro; R2 is –(C=O)NRaR3 wherein Ra is H and R3 is phenyl-R4 wherein R4 is -OCH3.
Claims 1, 2 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flipo et al. (J. Med. Chem. 2012, 55, 6391-6402).
Flipo et al. discloses the compound 2[15] (see Table 2 on page 6395) which anticipates a compound of the claims wherein G is
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; R1 is -NH(C=O)CH2X wherein X is chloro; R2 is –(C=O)NRaR3 wherein Ra is H and R3 is phenyl-R4 wherein R4 is -H.
Claims 1, 2, 6, 7, 10, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 12,240,821.
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.
The 35 U.S.C. 102(a)(2) critical reference date of the U.S. patent is entitled to the benefit of the filing date of the provisional application under 35 U.S.C. 119(e) since the provisional application properly supports the subject matter relied upon to make the rejection in compliance with 35 U.S.C. 112, first paragraph (pre-AIA ). See MPEP 2136.03 III.
U.S. Patent No. 12,240,821 discloses the compound
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(see claims 1 and 3) and a pharmaceutical composition thereof (see claims 4 and 6) which anticipates a compound (i.e., compound BE-2-10) wherein G is
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; R1 is -NH(C=O)CH2X wherein X is chloro; R2 is –(C=O)NRaR3 wherein Ra is H and R3 is phenyl-R4 wherein R4 is -O(C1-C6)alkyl and a pharmaceutical composition thereof of the claims.
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, 2, 6, 7, 10, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 6 of U.S. Patent No. 12,240,821. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons given below.
U.S. Patent No. 12,240,821 claims the compound
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(see claims 1 and 3) and a pharmaceutical composition thereof (see claims 4 and 6) which anticipates a compound (i.e., compound BE-2-10) wherein G is
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; R1 is -NH(C=O)CH2X wherein X is chloro; R2 is –(C=O)NRaR3 wherein Ra is H and R3 is phenyl-R4 wherein R4 is -O(C1-C6)alkyl and a pharmaceutical composition thereof of the instant claims.
Claim Objections
Claims 9 and 12 are objected to as being dependent upon a rejected base claim. However, even if the claims are amended to be in independent form, they would still not be in condition for allowance because they contain non-elected subject matter. In other words, the subject matter or species which are not embraced by the elected embodiment or the above identified nonelected species have been withdrawn from further consideration.
Claim 11 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622