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 1-10 are pending and examined on the merits.
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.
Claims 1-3 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nittoli et al (WO2014/145090, reference of the IDS filed 8/18/2023).
Nittoli et al disclose the drug-linkers of (V)(b,) (V)(d) and (V)(e);
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which meet the limitations of claim 1, wherein R1 is a substituted alkyloxy carbonyl, claim 2 wherein R2 is a substituted acyl. Drug-linker (V)(b)meets the limitations of claim 3 wherein R3 is a substituted acyl.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Nittoli et al (WO2014/145090) in view of Doronina et al (WO2005/081711) and Chari et al (Angew. Chem, Int. Ed. 2014, Vol. 53, pp. 3796-3827).
Nittoli et al (‘396) teach drug-linker:
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.
Nittoli et al do no teach the macrolide joined to the linker
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Doronina et al teach compound 17:
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wherein the identical linker is joined to a auristatin.
Chari et al teach that lysine residues of an antibody can react with an activated ester of a heterobifunctional linker to provide a conjugate (page 3805, lines 5-7 under the heading “Preparation of ADCs with Maytansinoids”).
It would have been prima facie obvious at the time prior to the effective filing date to substitute
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for the
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in the linker-drug of Nittoli et al. One of skill in the art would have been motivated to do so because the linker with the active ester terminus is an art recognized alternative for the maleimide terminus of Nittoli et al. Doing this would produce the drug linker having the structure as indicated in claim 6, the drug-linker of claims 4 and 5 wherein R4 is succinimidyloxy, and n=3 in claim 4.
Claim 10 is included with this rejection because it is a product-by-process claims. Section 2113 of the MPEP states:
PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE
MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE
IMPLIED BY THE STEPS
“[E]ven though product-by-process claims are limited by and defined by the process,
determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
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 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 and 30-32 of U.S. Patent No.12,545,735. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 13 and 30 of ‘735 anticipate instant claim 1 wherein R1 is a substituted acyl. Claims 16 and 33 anticipate instant claims 1 and 2, wherein R1 in claim 1 is a substituted acyl, R2 in claim 2 is substituted alkyloxy carbonyl, R3 in claim 3 is a substituted acyl..
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 and 30-32 of U.S. Patent No.11,142,578. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 7of ‘578 anticipate instant claim 1 wherein R1 is a substituted acyl. Claims 9 and 19 anticipate instant claims 1 and 2, wherein R1 in claim 1 is a substituted acyl, R2 in claim 2 is substituted alkyloxy carbonyl, R3 in claim 3 is a substituted acyl..
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of U.S. Patent No.12,583,939. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 11-12 of ‘939 anticipate instant claim 1 wherein R1 is a substituted acyl. Claims 13 and 14 anticipate instant claims 1 and 2, wherein R1 in claim 1 is a substituted acyl, R2 in claim 2 is alkyloxy carbonyl, R3 in claim 3 is a substituted acyl..
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of U.S. Patent No.11,958,910. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 11-12 of ‘910 anticipate instant claim 1 wherein R1 is a substituted acyl. Claims 13 and 14 anticipate instant claims 1 and 2, wherein R1 in claim 1 is a substituted acyl, R2 in claim 2 is substituted alkyloxy carbonyl, R3 in claim 3 is a substituted acyl..
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No.12,378,258. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 1 and 4 of ‘258 anticipate instant claim 1 wherein R1 is a substituted acyl; claims 2, wherein, R2 in claim 2 is H.
Claims 1 and 2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No.11,345,715. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 1-5 of ‘715 anticipate instant claim 1 wherein R1 is a substituted acyl; and claim 2, wherein, R2 in claim 2 is a substituted acyl. Claim 4 of ‘715 anticipates instant claim 2 wherein R is H..
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 14 and 15 of U.S. Patent No.10,752,690. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 12 of ‘715 anticipate instant claim 1 wherein R1 is a substituted acyl; claim 14 of ‘690 anticipates instant claim 2, wherein, R2 in claim 2 is a substituted alkyloxy carbonyl. Claim 15 of ‘690 anticipates instant claim 3 wherein R3 is substituted acyl.
. Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 26 and 44 of U.S. Patent No.9,951,141 Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims. Claims 16 and 44 of ‘141 anticipates instant claim 1 wherein R1 is a substituted acyl; claim 26 of ‘141 anticipates instant claim 1, wherein R1 is substituted acyl; instant claim 2, wherein R2 is substituted alkyloxy carbonyl; and instant claim 3 wherein R3 is subtitled alkyloxy carbonyl.
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-51, and 58-61 of copending Application No. 19/255,790 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the application anticipate the instant claims. Claims 48-51 and 58-61 anticipate instant claims 1 and 2, wherein R1 is substituted acyl, and R2 is substituted alkoxy carbonyl.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 7-9 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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