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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in China on 08/28/2024, 09/30/2024, 01/27/2025, 02/0/2025 and 05/30/2025. It is noted, however, that applicant has not filed a certified copy of the applications: Application No. 20241195305.2, filed on 08/28/2024, 202411388891.2, filed on 09/30/2024, 2025101127573.9, filed on 01/27/2025, 202510130736.9, filed on 02/05/2025 and 202510717116.5, filed on 05/30/2025 as required by 37 CFR 1.55.
Status of the Claims
Claims 36, 45-50, 52, 54-56, 59 and 65-71 are pending; claims 36, 45-50, 52, 54, 55-56, 59, 65-70 are amended, claim 71 is newly recited, claims 37-44, 51, 53, 57, 58 and 60-64 are canceled. Claims 36, 45-50, 52, 54-56, 59 and 65-71 are examined below.
Information Disclosure Statement
Previously it was indicated that two references were lined through in information disclosure statement (IDS) entered 11/19/2025 (referring to non-patent literature citation nos. 9 and 15), however, the IDS is reconsidered, the references are present. IDS entered 11/19/2025 is considered, initialed and is attached hereto.
Withdrawn Objections/Rejections
The previous objection to the specification is withdrawn in response to Applicant’s amendment to the specification (title).
The previous rejection of claims under 35 U.S.C. 112(a), regarding the written description requirement, is withdrawn in response to amendments to the claims.
Claim Objections
Claims 45-48, 50, 52 and 54-56 are objected to because of the following informalities:
Claims 45-48, 50, 52, 54-56, each recite language at the preamble that is “The antigen-binding protein according to claim…”, it is suggested that Applicant amend “according to” to “of claim…” in order to improve clarity of the record so that it’s clear that all the limitations of the earlier claim from which the claim depends from, are included, and further so that all claims throughout the claim set rely on consistent claim language.
Claim 50 recites scFv, this is the first instance of this abbreviation. It is suggested that abbreviations be accompanied at their first recitation with the full terminology in order to improve clarity of the record.
Claim 56 recites “wherein the antigen-binding protein comprises a light chain”, it appears that there is a typographical error and that the claim should recite “wherein the second antigen-binding domain comprises a light chain…”, as the sequence recited appears to correspond to with earlier sequences recited describing the variable light chain region. See also the prior claim specific to the first antigen-binding domain recites the word “first”, further suggesting that claim 56 was intended as recited “second”.
Appropriate correction is required.
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 36, 45-50, 52, 54-56, 59 and 65-71 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.
Claim 36 recites “as set forth in SEQ ID NO:…” (see throughout the claim). The recited language “as set forth in” is indefinite claim language because it is not readily clear from this language if the claim is intended as communicating that the CDR is the sequence recited therewith, or rather if “as set forth in” is intended as any sequence “set forth in” the recited sequence (i.e., any combination of amino acid residues recited within the claimed sequences, meaning smaller sequences including therein). It is suggested that Applicant amend the recited language in order to recite each CDR as … “amino acid sequence of SEQ ID NO: …” in order to improve clarity of the record so that it’s clear that each of the recited sequences corresponds with the associated CDR sequence.
This similarly applies to claims 45-49, 52, 54-56, 65 and 66 (see for example, claim 66 as amended omits “having” the sequence “as set forth in” and now recites “comprising the sequence as set forth in”).
Claim 70 recites “wherein simultaneous binding of TL1A and integrin α4β7 by the antigen-binding protein results in enhanced internalization of integrin α4β7 from the surface of immune cells relative to binding of integrin α4β7 alone”, the claim is indefinite because the claim is recited as a dependent claim limitation and as such, suggests that the claim further limits the product of claim 36 in some additional way. However, the recited limitation appears to read as a natural consequence that follows as a result of the use of the product of claim 36 (the use of the product to bind TL1A and integrin α4β7 in immune cells). The claim language is indefinite because it is not readily clear what additional structure/structural feature the recited language is intended as communicating. For the same reasons, the claim is addressed simultaneously under 35 U.S.C. 112(d).
Claim 71 recites “wherein the composition comprises a pharmaceutically acceptable carrier”, the recited language is indefinite because the claims (and the specification) fail to specify what would or would not be considered “pharmaceutically acceptable”. There is no specified standard by which a carrier is considered to be “pharmaceutically acceptable”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 70 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As indicated above, claim 70 recites “wherein simultaneous binding of TL1A and integrin α4β7 by the antigen-binding protein results in enhanced internalization of integrin α4β7 from the surface of immune cells relative to binding of integrin α4β7 alone”, the claim fails to clearly impart any particular additional limitation, such as an additional structural element/feature to the claimed product of claim 36. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 36, 45-50, 52, 54-56, 59 and 66-71 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-14 of copending Application No. 19/312,502 (reference application) in view of Arch et al., US PG Pub No. 2015/0132311A1 (previously cited), Spyre Therapeutics, Corporate Overview, (2023), https://s26.q4cdn.com/935390172/files/doc_presentation/2023/09/SPYRE-Corporate-Overview-Sept-2023.pdf, (56 pages) (previously cited), Ma et al., Bispecific Antibodies: From Research to Clinical Application, Frontiers in Immunology, 12 (Article 626616), (2021), 19 pages (previously cited) and Fox et al., US PG Pub No. 2012/0282249A1.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Copending 19/312,502 recites (see at copending claim 1) an antigen-binding protein binding TNF-like protein A (TL1A) that is a monoclonal antibody having heavy chain SEQ ID NO: 339 and light chain SEQ ID NO: 340, and each SEQ ID NO: 339 contains heavy chain CDR SEQ ID Nos. 2, 6, and 15 of the present claim (see also as at instant claim 67) first antigen binding domain, SEQ ID NO: 340 contains light chain CDR SEQ ID Nos. 42-44 of the present claim first antigen binding domain. Copending at claims 12-14 recites the antigen binding protein for treating TL1A-mediated disease that is inflammatory bowel disease.
SEQ ID NO. 339 of the copending application also addresses claimed VH of the first antigen binding domain comprising SEQ ID NO. 379 (see referring to the sequences in claims 45, 54, 65, 66), SEQ ID NO. 340 of the copending also addresses VL comprising SEQ ID NO. 380 (referring to the sequence in claims 46, 54, 65, 66)
The copending application is teaching an antigen binding protein that reads on the claimed first antigen binding domain, however fails to teach the antigen binding protein comprising a second antigen binding domain that specifically binds α4β7, second antigen binding domain comprising HCDR1-3 SEQ ID Nos. 332-334 and LCDR1-3 SEQ ID Nos. 336-338 (sequences specific of vedolizumab).
Arch et al. teach treating disease/disorders mediated by TL1A by use of antibody or antigen binding fragment (para [0155]), see for example disease including inflammatory bowel disease (para [0156]). Arch et al. suggest creating bispecific or polyvalent antibodies (antigen-binding protein) that bind specifically to TL1A and to another molecule (para [0729]). Arch comprise scFv fragments (paras [0612] and [0729]).
See Spyre teaching their aim to transform the treatment of IBD (inflammatory bowel disease), Spyre teach for example, at page 5 programs directed to what they call rational therapeutic combinations (combination products, see page 11), specifically suggesting the combination of α4β7 and TL1A (see second from bottom of the list). See at page 39, Spyre teach blockade of α4β7 prevents circulating T cell from entering inflammatory gut tissue, and neutralization of TLA1 suppresses inflammation within the gut tissue and block immune cell activation.
Ma et al. teach compared to monoclonal antibodies, bispecific antibodies offer more advantages, including superior cytotoxic effect, and lower rate of resistance due to the matched targeting of two different antigens (page 1, introduction paragraph). See further, page 4, last paragraph, Ma et al. also teach because bispecific antibodies have two binding sites directed at different antigens or recognize two different epitopes of one antigen simultaneously, the functioning pathways are quite flexible. See also page 6, col. 2, para 3, Ma teach bispecific antibodies are widely used in both diagnosis and therapy, that these antibodies are not limited to treatment of tumors, but also other diseases (see also Figure 2, showing various possible structures of bispecific antibodies).
Fox et al. is art describing the sequence of the monoclonal antibody, vedolizumab (see throughout, particularly, para [0037], Figure 3, [0068]). Vedolizumab is an art recognized, known and available antibody that specifically binds α4β7, such antibodies of Fox recognized for formulations/methods of treating inflammatory bowel disease.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the TL1A antibody of the copending to provide the antibody as a bispecific antibody that binds TL1A and also α4β7, one having ordinary skill motivated to modify because it was known in the art the TL1A specific treatments for bowel disease be provided as bispecific antibodies (Arch), and because Spyre specifically teach the targeted combination of TLA1 and α4β7 as desirable therapeutic treatment for IBD (blockade of α4β7 prevents circulating T cell from entering inflammatory gut tissue, and neutralization of TLA1 suppresses inflammation within the gut tissue and block immune cell activation). Further, one would be motivated to provide the combination as a bispecific antibody as in Arch and Ma because compared to monoclonal antibodies, bispecific antibodies offer more advantages, including superior cytotoxic effect, and lower rate of resistance due to the matched targeting of two different antigens (Ma et al.).
Further, when modifying to provide the antibody as a bispecific having antigen binding to TL1A and α4β7, one would be motivated to rely on anti- α4β7 that is vedolizumab (Fox), as an obvious matter of applying a known antibody for its intended purpose, specifically choosing from a finite list of known suitable alternatives for binding α4β7, the antibody vedolizumab is specifically recognized (Fox) as an antibody, known and available in the prior art, for binding α4β7. One having ordinary skill in the art would have a reasonable expectation of success using a known antibody that binds α4β7 to target α4β7.
Regarding claims 59 and 71 (directed at a composition), copending application similarly teaches providing as a pharmaceutical composition (see at copending claims 11-14).
Regarding claims 68-69, the combination of the cited art is addressing a bispecific antibody having the structure as claimed, see further Arch et al. further describing the bispecific nature of the antibody, including linking VH to VL using a flexible linker (paras [0555], [0729]).
Regarding claim 70, see as discussed previously above, the limitations of claim 70 fail to impart further structural feature/element to the claimed antigen binding protein. The antigen binding protein of the cited prior art is structurally the same as that presently claimed, and as such is expected similarly capable of the intended results recited at claim 70 when used (in methods of using), this further supported by the combined cited art above (referring to Spyre).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Allowable subject matter was discussed by interview 8/11/2026 (see attached interview, referring to Examiner proposed amendments to the claims to place the application in better condition for allowance pending terminal disclaimer addressing non-statutory double patenting rejection as indicated in detail above).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677
