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 106-120 are pending and currently under consideration.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Binding Proteins to CD137 and/or PD-L1.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 108, 109, 111, and 112 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 108-109 are rejected because claim 108 recites “…wherein the binding protein or binding fragment thereof comprises….” There is insufficient antecedent basis for “the binding protein or binding fragment thereof” in the claims
Claim 111 recites “The anti-CD137 antibody or antigen binding fragment thereof of claim 106 comprising a light chain constant region comprising SEQ ID NO: 65 or SEQ ID NO: 66.” There is insufficient antecedent basis for “The anti-CD137 antibody or antigen binding fragment thereof of claim 106 comprising a light chain constant region comprising SEQ ID NO: 65 or SEQ ID NO: 66” in the claim. The following amendment is suggested to obviate this rejection: “The anti-CD137 antibody or antigen binding fragment thereof of claim 106, wherein the anti-CD137 antibody or antigen binding fragment thereof comprises a light chain constant region comprising SEQ ID NO: 65 or SEQ ID NO: 66.”
Claim 112 is rejected because the metes-and-bounds of the claim are unclear. It is unclear how, or if, text after the term “preferably” limits the claim.
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 106-109, 111-113, and 115-120 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 26, 27, and 62-67 of copending Application No. 18/688630 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims drawn to bispecifc antibodies comprising CD137 binding domains(and products comprising polynucleotides encoding said bispecific antibodies, methods of making said bispecific antibodies, and methods of administering said bispecific antibodies) are directed to species of the instant claims drawn to anti-CD137 antibodies (and products comprising polynucleotides encoding said antibodies, methods of making said antibodies, and methods of administering said antibodies). Instant SEQ ID NOs: 17, 5, 22-26, 64, and 65 are identical to copending SEQ ID NOs: 24, 39-44, 69, and 70, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 110 is objected to for being dependent upon a rejected claim.
Allowable Subject Matter
Claim 114 is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN E AEDER whose telephone number is (571)272-8787. The examiner can normally be reached M-F 9am-6pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571)270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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