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 1-9, 11-13, 23-35 have been canceled. Claims 10, 14, 21 and 22 have been amended. Claims 36-41 have been added. Claims 10, 14-22 and 36-41 are pending and under consideration.
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.
Claim 21 is 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.
Claim 21 is vague and indefinite in the recitation of the antibody being in a CAR-T format. It is unclear if this means that the antibody is part of a T-cell, or in the alternative, if the antibody is not part of a T-cell, it is unclear if the antibody is required to have a transmembrane region and be connected to an intracellular signaling domain.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a polynucleotides encoding a heavy chain only anti-CD22 antibody of claim 10 fused to a transmembrane region operably linked to at least one intracellular signaling domain, wherein the extracellular domain of the chimeric antigen receptor comprises the single chain only CD22 antibody or a T-cell comprising the encoded polynucleotide, does not reasonably provide enablement for isolated polypeptides encoded therefrom outside of the context of a T cell. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re wands, 858 F.2d 731, 737.8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
When given the broadest reasonable interpretation, claim 21 reads, in part, on an isolated fusion polypeptide comprising the required CAR based on the heavy chain only anti-CD22 antibodies of claim 10.
Gilham et al (Trends in Molecular Medicine, 2012, Vol. 18, pp. 377-384) teach that surface expression of a CAR endows a T cell with redirected functional activity whereby CAR-T cells recognize the target cells through the antigen-specific binding of the antibody-defined targets on the cell surface (page 377, lines 3-7). Without a cell capable of integrating these various intracellular signals into a functionally activated T cell, there is no expectation that the fusion protein had any functional activity.
Thus, the specification is enabling for the polynucleotide encoding the chimeric receptor comprising a single domain antibody of claim 10, a CAR-T cell comprising an extracellular domain comprising a single domain antibody of claim 10, but not the isolated fusion protein encoded by the polynucleotide.
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 10, 14, 15, 18-20, 22, and 36-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,873,336. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-14 render anticipate and obvious the instant claims
Claim 1 of ‘336 anticipate instant claim 10 to the extent that the patented claim encompasses the CDR1 sequence of SEQ ID NO: 2-4 and 6-10. The CDR2 sequence in part (b) of claim 1 renders obvious the instant CDR2 sequence comprising SEQ ID NO: 13-17 based on the alternatives for X7, X8, X9, X10 and X11. The CDR3 sequence of claim 1 anticipates the instant CDR3 sequence in claim 10. Claim 2 of the patent teaches the limitations of instant claim 36; claims 3-7 teach the limitations of instant claims 37-41. Claim 8 and 9 teach the limitations of instant claims 14 and 15. Claims 10-12 teach the limitations of claims 18-20. Claim 14 renders obvious instant claim 22 directed to a pharmaceutical composition because it would have been obvious to make the pharmaceutical composition for administration in the method of claim 14.
Allowable Subject Matter
Claims 16 and 17 are 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.
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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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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