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 .
Applicant’s 7-24-26 election of the invention of Group I, and the species of CD3 binding protein comprising the Vh and Vl CDRs of SEQ ID NOs: 29, 24 and 54, and 71, 83 and 28, respectively which are contained within the 2A4 clone and further within the scFv of SEQ ID NO: 19, all without traverse, is acknowledged.
Claims 1, 21, 31- 33 and 35-42 are pending and under examination as they read on the species of CD3 binding protein comprising the Vh and Vl CDRs of SEQ ID NOs: 29, 24 and 54, and 71, 83 and 28, respectively which are contained within the 2A4 clone and further within the scFv of SEQ ID NO: 19.
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.
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Claims 1, 21 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10730954. Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 100 of reference claim 1 comprises the CDRs and scFv sequences of the instant claims as shown below:
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Thus, reference claim 1 anticipates the single chain variable fragment CD3 binding proteins of instant claims 1, 21 and 35.
Claims 1, 21 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 10815311. Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 1898 of reference claim 11 comprises the CDRs and scFv sequences of the instant claims as shown below:
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Thus, reference claim 10 anticipates the instant claims.
Claims 1, 21 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 11623958 (cited herewith). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reason:
According to the first paragraph of the instant specification and the application data sheet filed 5-9-24, the instant specification is a CON of parent U.S. Application No. 16773806 (corresponding to U.S. Patent No. 11623958).
As set forth in MPEP § 804.01, “The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008).” (emphasis added).
While claims 20-24 of the ‘958 are not, per se, drawn to the single chain variable fragment CD3 binding proteins of the instant claims, in practicing a method comprising “…administering a protein, wherein the protein comprises a single chain variable fragment CD3 binding protein comprising a variable heavy chain region (VH) and a variable light chain region (VL), wherein the VH comprises complementarity determining regions HC CDR1, HC CDR2, and HC CDR3, wherein the VL comprises complementarity determining regions LC CDR1, LC CDR2, and LC CDR3…wherein the CD3 binding CDRs are selected from…(xii) HC CDR1 is SEQ ID NO. 29, HC CDR2 is SEQ ID NO. 24, HC CDR3 is SEQ ID NO. 54, LC CDR1 is SEQ ID NO. 71, LC CDR2 is SEQ ID NO. 83, and LC CDR3 is SEQ ID NO. 28….” the ordinarily skilled artisan will necessarily have to make the single chain variable fragment CD3 binding proteins of the instant claims.
Thus, reference claims 20-24 anticipate the instant claims.
Claims 1, 21 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 34 of copending Application No. 18470998 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 1898 of reference claim 34 comprises the CDRs and scFv sequences of the instant claims as shown below:
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Thus, the reference claim anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31-33 and 36-52 are rejected on the ground of nonstatutory double patenting as being unpatentable
over claim 1 of U.S. Patent No. 10730954 as applied to claims 1, 21 and 35 above; or
over claim 10 of U.S. Patent No. 10815311 as applied to claims 1, 21 and 35 above; or
over claims 20-24 of U.S. Patent No. 11623958 (cited herewith) as applied to claims 1, 21 and 35 above; or
provisionally over claim 34 of copending Application No. 18470998 as applied to claims 1, 21 and 35 above;
each of the above further in view of Kufer et al. (20110262439, cited herewith).
While the rejections set forth above explain how the reference claims anticipate the single chain variable fragment CD3 binding proteins of instant claims 1, 21 and 35, the reference claims are not drawn to the polynucleotides, vectors, or host cells of the instant claims.
Kufer describes the production of bispecific single chain antibodies comprising one scFv unit is capable of recruiting cytotoxic cells, for example cytotoxic T cells, while the other scFv unit specifically binds an antigen on a target cell to be eliminated by the recruited cytotoxic cell, wherein bispecific single chain antibodies comprising a first binding domain capable of binding to an epitope of CD3 and a second binding domain capable of binding to the extracellular domain cell surface antigens with a high molecular weight extracellular domain, such as various cancer cell surface antigen such as PSAM, FAPα, c-MET etc. (see, e.g., paras 7-9). Kufer further teaches vectors comprising nucleic acid molecules encoding said bispecific single chain antibody molecules, as well as host cells comprising said vectors (see, e.g., paras 237-238).
Given the teachings of Kufer set forth above, it would have been obvious to one of ordinary skill in the art to make polynucleotides and vectors encoding the single chain variable fragment CD3 binding proteins of instant claims 1, 21 and 35, and further for one of ordinary skill in the art to make host cells comprising, e.g., said vectors, to facilitate convenient and efficient production of the polypeptides of the reference claims.
In view of the reference teachings it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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