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 .
Status of the Claims
Claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims.
IDS
The references cited on the information disclosure statement(s) were considered and have been made of record.
Notably, one or more of the disclosure statements filed to date lists the following documents: Search Reports, PCT Written Opinion.
The listing of the document(s) noted above is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the document(s) noted above have not been considered.
Furthermore, the listing of references in the specification or claims is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the document(s) noted above are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Priority
The effective filing date of the claims is deemed the filing date of the provisional application (i.e., 63/221,340), namely July 13, 2021.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86 are rejected under 35 U.S.C. 103 as being unpatentable over Altintas1 in view of Demarest2 and Ma3.
Altintas discloses: bispecific CD40-001-HC6LC1-FEAL x CD137-009-HC7LC2-FEAR which arms are defined in table 1 (p.18-20) by SEQ ID NO:119+ SEQ ID NO:122 for the antiCD40- FEAL arm and SEQ ID NO125 + SEQ ID NO:128 for the anti-CD137-FEAR arm. Said 4 sequences are 100% identical to the sequences encoding GEN1042-DuoBodyCD40x4-1 BB as defined on p.130, 1.15-p.131, 1.2, with the CD40-FEAL arm consisting of SEQ ID NO: 9 + SEQ ID NO:25 (HC) and SEQ ID NO:10 + SEQ ID NO:27 (LC), and the CD137-FEAR arm consisting of SEQ ID NO: 19 + SEQ ID NO:26 (HC) and SEQ ID NO:20 + SEQ ID NO:27 (LC). Exp. 10 shows enhanced proliferation of CD8 cells, comparable to the parent antibody. Exp. 11 shows increase of viable count of tumor infiltrating T cells in an ex vivo model for melanoma and non-small cell lung cancer. Altintas further teaches the antibody mutations, features, kits, dose regimens, and cancer types, required by the instant claims (see, e.g., p. 34-35, 69-77, 114, 118-120; reads on instant claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86).
The prior art of Altintas differs from the instantly claimed invention as follows: Altintas does not expressly disclose combining the bispecific antibody with a PD-1 inhibitor, as required by the instant claims.
Demarest discloses CD137xPD-1 which enhances IFNy production by human PBMC, induces T cell activation in a mixed leukocyte reaction and inhibits tumor growth in vivo (see, e.g., p.26-36).
Ma teaches synergy between anti-CD40 and -PD-1 in cancer treatment (see, e.g., col. 1 of p.429).
Obviousness Analysis:
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than: combining the prior art elements of the cited references according to known methods to yield predictable results e.g., combining the bispecific antibody, directed to CD137 and CD40, with a PD-1 inhibitor, as PD-1 inhibitors have previously been combined with antibodies directed to both CD137 and CD40; combining the antibody mutations, features, kits, dose regimens, and cancer types, set forth in the instant claims, all of which are known in the prior art. See MPEP 2143(I)(A),(G). Furthermore, it is prima facie obvious to combine two compositions to each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose, e.g., the bispecific antibody, directed to CD137 and CD40, with a PD-1 inhibitor, both of which are known in the art as treatments for cancer.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). (Renders obvious instant claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the methods of the instant invention, as the prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86 are rejected.
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.
Copending Application No.: 19/133,873 (unpublished application)
Claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 82-102 of Copending Application No. 19/133,873 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
MPEP § 804(II)(B)(2)-(3) identifies that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). The following rejection is based upon an anticipation analysis.
Anticipation analysis: Regarding the instant claims, the reference application claims a method for reducing or preventing progression of cancer, said method comprising administering a bispecific binding agent, directed to CD40 and CD137, with a PD-1 inhibitor (see reference claims 82-102). Said binding agent comprises sequences that are identical to those instantly claimed.
Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the methods recited in the reference claims using the exact, explicitly recited methods presently claimed (see, e.g., MPEP § 804(II)(B)(2)). The specification discloses the term "cancer" according to the present disclosure comprises head and neck cancer (page 47, lines 1-10).
Accordingly, instant claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86 are not patentably distinct relative to reference claims 82-102.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 8, 11, 15, 20, 23-24, 26, 30, 35, 41, 46, 48, 70, 74, 78-79, 81, 85-86 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00 AM to 6:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached on (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 WO2018011421A1; cited on the IDS
2 WO2020018354A1; cited on the IDS
3 MA HAYLEY S. ET AL: "A CD40 Agonist and PD-1 Antagonist Antibody Reprogram the Microenvironment of Nonimmunogenic Tumors to Allow T-cell-Mediated Anticancer Activity", CANCER IMMUNOLOGY RESEARCH, vol. 7, no. 3, 1 March 2019 (2019-03-01), pages 428-442, XP055921323, DOI: 10.1158/2326-6066.CIR-18-0061; cited on the IDS
