DETAILED ACTION
Claim amendments filed 1/11/2024 are acknowledged and entered into the record.
Accordingly, Claims 1, 2, 4, 23, 29, 32, 107, 123, 129, 131, 140-145, 148, 169-170 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
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.
Claims 1, 32, 129, 169-170 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are drawn to an isolated antibody that specifically binds to the same epitope or an epitope within a region of human TIGIT as a human TIGIT antibody comprising CDRs having SEQ ID Nos: 1, 3, 5, 6, 7, and 8 or having CDRs having SEQ ID NOS: 2, 4, 5, 6, 7, and 8, and methods of treatment comprising administering said competing anti-TIGIT antibody. The claims also read on anti-TIGIT antibodies not comprising all 6 CDRs or both heavy and light chains, by reciting “and/or” in instant claims 1 and 129.
The claims read on anti-TIGIT competing antibodies which bind to the same epitope, region, residues or specific sequences as the defined antibody having CDRs comprising SEQ ID Nos: 1, 3, 5, 6, 7 and 8 or CDRs having SEQ ID Nos: 2, 4, 5, 6, 7, and 8. The competing antibodies are not defined by a structure (CDRS, VH/VL sequence) and therefore lack a structure to function correlation.
The claims recite an isolated antibody that specifically binds to the same epitope as the anti-TIGIT antibody with defined CDR sequences, binds to an epitope within a region of human TIGIT, binds to one or more residues of human TIGIT, binds to specific TIGIT residues or amino acid sequences. These limitations do not define the structure of the competing antibody and therefore lack structure to function correlation. Binding to the same epitope as defined anti-TIGIT antibodies does not provide any guidance on the structure or CDR sequences of the competing antibody. Furthermore, a definition by function does not suffice to define the genus because it is only an indication of what the antibody does (ie. Claim 32 parts b-f), rather than what it is. A description of a genus of antibodies may be achieved by means of a recitation of a representative number of antibodies, defined by sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. The written description requirement can be met by showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
The court found that if the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it. The specifically defined antibody sequences disclosed in the specification are not representative of nor predictive of any and all other antibody sequences for the broadly claimed genus. There is no common/shared structure among the antibodies having the claimed TIGIT binding function. However, the instant specification does not describe sufficient representative examples to support the full scope of the claims. Applicants are directed to the recent and relevant decision in AbbVie Deutschland GmbH v. Janssen Biotech, Inc. (Fed. Cir. 2014). The court found that if the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it. In the instant case, the claims broadly encompass an exponential number of potential TIGIT antibodies that function as claimed. The instant specification discloses specific antibodies with variable regions or CDR sequences defined and combined appropriately, however the finite number of antibodies and the other publicly available antibodies disclosed do not share any sequence homology and CDR sequences of one antibody do not predict the CDR sequence/structure of any and all other anti-TIGIT antibodies yet to be discovered that function as claimed. Applicants have not established any reasonable structure-function correlation with regards to the antibody sequences required to bind the designated antigen TIGIT at a specific epitope, region, residue or sequence because the exemplary antibodies do not share sequence homology for the function of binding and capable of targeting TIGIT and treating cancer or an infectious disease when administered.
Applicant are requested to delete “/or” from part (e) of instant claim 1 and delete “/or” from part (a) of instant Claim 129. The recitation of “or” indicates less than all 6 CDRs or lack of having both heavy and light chains. These alterations would affect antigen binding and the instant specification does not provide guidance or written description on what specific alterations can be made and still retain the claimed functional characteristics of the antibody.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4, 23, 29, 32, 107, 123, 129, 131, 140-145, 148, 169-170 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-70 of U.S. Patent No. 11,021,537. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and those of US Patent 11,021,537 are both drawn to the same anti-TIGIT antibodies, nucleic acids encoding said antibodies, host cells, and methods of producing said antibodies and methods of treatment comprising administering same said antibodies.
Conclusion
Claims 1, 2, 4, 23, 29, 32, 107, 123, 129, 131, 140-145, 148, 169-170 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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