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 .
Applicant's arguments filed 7/9/2025 have been fully considered but they are not persuasive.
The anti-latent TGF-beta 1 antibodies of claim 1 are free of the prior art. The prior art of record does not disclose or suggest antibodies with the recited CDRs.
Claims 1 and 9-15 are allowable.
The anti-latent TGF-beta 1 antibody TBA0946 (having the CDRs recited in claim 1, part (1)) has the property recited in claim 9. Antibodies TBA0947 and TBA1172 (having the CDRs recited in claim 1, parts (2) and (3), respectively) do not. See at least Figure 7 and Example 5, part 7, on pages 79-80 of the specification.
Specification
The replacement sequence listing submitted 7/9/2025 is acknowledged.
The substitute specification filed 7/9/2025 has been entered.
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 2-8 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 is directed to an anti-latent TGF-beta 1 antibody that binds to the same epitope as a reference antibody, wherein the reference antibody comprises CDRs recited in the claim. Dependent claims 3-8 recite particular properties of the anti-latent TGF-beta 1 antibody. Note that the antibodies of claim 2 are not limited to the reference antibodies and that the reference antibodies do not have all of the properties in the dependent claims. At least for example, TBA0946 (corresponding to claim 2, part (1)) does not bind to human latent TGF-beta 1 (see claim 3). See at least Figure 1B. At least for example, TBA0946 was not tested with respect to plasma kallikrein and matrix metalloproteinases (see claims 7-8).
The specification does not disclose the identity of any epitope (linear or conformational) for any of the reference antibodies recited in claim 2. The genus of antibodies embraced by claim 2 is not adequately described. It is not known what epitope(s) must be bound. There is no structure/function correlation disclosed by the specification for this genus of antibodies, particularly for antibodies having all of the properties in dependent claims 3-8. The specification does not describe representative examples to support the scope of the claims.
The prior art recognized that a single protein can be bound by a very large and structurally diverse genus of antibodies (i.e., there is no common structural relationship even for
antibodies that bind to the same protein, epitope, or overlapping epitopes). For example,
Edwards et al. (2003, JMB 334:103-118) teaches that over 1,000 different antibodies to a single
protein can be generated, all with different sequences, and representative of almost the entire extensive heavy and light chain germline repertoire (42/49 functional heavy chain germlines and
33 of 70 V-lambda and V-kappa light chain germlines), and with extensive diversity in the
HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well.
The instant specification does not provide an adequate written description for the genus of
antibodies embraced by the claims
The claimed antibodies are not adequately described. Applicant is reminded that this is a written description and not an enablement rejection.
Applicant has traversed this rejection but provided no substantive argument as to why the antibodies of claims 2-8 are adequately described. The response does not address the lack of identified epitopes.
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 2-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13-17 of U.S. Patent No. 11,312,767. Although the claims at issue are not identical, they are not patentably distinct from each other because the antibodies in the issued claims include humanized and optimized antibodies of parent antibody TBA0947, corresponding to the reference antibody of instant claim 2, part (2). See at least Example 2 of the issued patent, particularly columns 57-58, with respect to claimed sequences SEQ ID NOS: 12-19 and CDRs of SEQ ID NOS: 20-43. Issued claims 15-16 meet the limitations of instant claim 4. Issued claim 17 meets the limitations of instant claim 5. Absent evidence to the contrary, these antibodies would bind the same epitope as the reference antibody in instant claim 2, part (2) and have the same binding characteristics as the parent (reference) antibody (i.e. instant claims 3-8).
Applicant has acknowledged this rejection but has not provided a properly executed terminal disclaimer.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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