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 .
Status of Application, Amendments and/or Claims
The amendment of 17 July 2026 has been entered in full. Claims 1, 3, 9, and 12 are amended. Claims 2, 7, 8, 10, 11, 16, 18-21, 23-28, 32-37, 39, 41-47 are cancelled. Claims 48 and 49 are added.
It is noted that Applicant elected the examination of Group V, claims 1-3, 7-9, and 12, drawn to a method of regulating immune responses or resisting tumors comprising administering an antibody that recognizes and binds to ITPRIPL1, in the reply filed on 02 February 2026. Therefore, claims 4-6, 13-15, 17, 22, 29-31, 38, and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02 February 2026.
Claims 1, 3, 9, 12, 48, and 49 are under consideration in the instant application as they read upon the elected invention of administering an antibody that recognizes and binds to ITPRIPL1.
Drawings
The replacement drawings were received on 17 July 2026. These drawings are acceptable.
Withdrawn Objections and/or Rejections
1. The objections to the drawings as set forth at pages 3-4 of the previous Office Action of 22 April 2026 are withdrawn in view of the submission of replacement drawings (17 July 2026).
2. The Sequence Listing Requirement deficiencies set forth at pages 4-7 of the previous Office Action of 22 April 2026 are withdrawn in view of the amended instant specification and drawings (17 July 2026).
3. The objections to the specification as set forth at page 7 of the previous Office Action of 22 April 2026 are withdrawn in view of the amended instant specification and drawings (17 July 2026).
4. The objections of claims 1-3, 7-9, and 12 as set forth at pages 7-8 of the previous Office Action of 22 April 2026 are withdrawn in view of the amended and cancelled claims (17 July 2026).
5. The rejections of claims 1-3, 7-9, and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at pages 8-9 of the previous Office Action of 22 April 2026 are withdrawn in view of the amended and cancelled claims (17 July 2026).
6. The rejection of claims 1-3, 7-9, and 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), first paragraph (scope of enablement), as set forth at pages 18-26 of the previous Office Action of 22 April 2026 is withdrawn in view of the amended and cancelled claims (17 July 2026).
7. The rejection of claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mootha et al. (WO 2021/173712; published 02 September 2021; priority to 24 February 2020) as set forth at pages 27-28 of the previous Office Action of 22 April 2026 is withdrawn in view of the amended and cancelled claims (17 July 2026). Specifically, Mootha et al. does not teach a method of treating ITPRIPL1-overexpressing tumors comprising administering an anti-ITPRIPL1 antibody.
Please note that any previous rejections over claims 2, 7, and 8 are hereby withdrawn in response to Applicant’s cancellation of these claims.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
8. The Examiner acknowledges that Applicant submitted a ST.26 sequence listing XML file, statements, and specification amendments directed to such on 17 July 2026.
Applicant then filed a ST.25 ASCII sequence text file (and CRF) on 22 July 2026. The new ST.25 sequence listing is correct because the instant 371 application has a filing date before 01 July 2022. In view of the most recent ST.25 sequence listing on file, the application has the following deficiencies that must be corrected:
8a. Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
8b. Specific deficiency – The "Sequence Listing" has not been entered into the application because the amendment does not direct entry of either the "Sequence Listing" (as required by 37 CFR 1.825(a)(2) or 1.825(b)(2)) or contain the required Incorporation by Reference paragraph into the application.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
8c. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. The incorporation by reference statement in the amendment of 17 July 2026 refers to the sequence listing XML file name, creation date, and size. This paragraph must be updated to reflect the ASCII text file submitted on 22 July 2026.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
8d. Specific deficiency – The "Sequence Listing" has not been entered into the application because the required statement of no new matter is missing. See 37 CFR 1.825(a)(4) or 1.825(b)(5).
Required response – Applicant must provide:
A proper statement of no new matter.
Claim Objections
9. Claims 1, 3, 48, and 49 are objected to because of the following informalities:
9a. Claims 1 and 3 recite non-elected groups of inventions.
9b. Claims 48 and 49 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.
Appropriate correction is required.
Maintained Claim Rejections - 35 USC § 112(a)
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.
10. Claims 1, 3, 9, and 12 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. The basis for this rejection is set forth for claims 1-3, 7-9, and 12 at pages 9-18 of the previous Office Action of 22 April 2026.
Claim 1 is directed to a method of treating inositol 1,4,5-triphosphate receptor interacting protein-like 1 (ITPRIPL1)-overexpressing tumors, comprising administering a regulator of ITPRIPL1, wherein the regulator is used to block ITPRIPL1 on tumor cells from binding to CD3ε on T cells and decrease the expression or function of the ITPRIPL1 gene or protein of the tumor cells; wherein the regulator comprises an antibody that recognizes and binds to ITPRIPL1, wherein the antibody is capable of binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen.
Claim 3 recites that the antibody that recognizes and binds to ITPRIPL1 is a polyclonal antibody, a monoclonal antibody, a single-stranded antibody, an antigen binding domain, a bispecific antibody, a multi-specific antibody, or an antigen binding portion in a chimeric antigen receptor.
Claim 12 recites a method of treating ITPRIPL1-overexpressing tumors, comprising administering an antibody that recognizes and binds to ITPRIPL1, wherein the antibody recognizes and binds to the extracellular domain of the ITPRIPL1 protein, wherein the antibody blocks ITPRIPL1 on tumor cells from binding to the CD3ε on T cells; wherein the antibody is capable of binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen.
(i) At the middle of page 18 of the Response of 17 July 2026, Applicant argues that consistent with the current written-description guidance reflected in MPEP §2163, the present claims include more than a target-antigen/binding affinity definition. Applicant submits that for the antibody embodiments, amended claims 1 and 12 require (i) recognition and binding of ITPRIPL1, (ii) binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen, and (iii) blocking of the IRPRIPL1/CD3ε interaction at the tumor cell/T cell interface. Applicant states that the claimed antibodies are not solely defined by a desired result of binding ITPRIPL1, but by a specific disclosed epitope/region and by a disclosed functional mechanism. Applicant asserts that the specification provides sufficient written description for this mechanism. Applicant points out that the specification describes the construction and expression of ITPRIPL1 and the extracellular domain/receptor binding domain portions thereof, and provides experimental results showing the interaction between ITPRIPL1 and CD3ε, including co-immunoprecipitation and colocalization assays. Applicant indicates that the specification further describes experiments using tumor cells and immune cells, including results showing that ITPRIPL1 expression affects PBMC-mediated tumor cell killing and that blocking ITPRIPL1 can enhance anti-tumor immune activity. Applicant concludes that a person of ordinary skill in the art would understand that Applicant was in possession of the claimed ITPRIPL1/CD3ε blocking therapeutic approach in the context of ITPRIPL1-overexpressing tumors.
At page 19 of the Response of 17 July 2026, Applicant reiterates that the amended claims include both functional and structural limitations. Amended claims 1 and 12 require that the antibody recognizes and binds to ITPRIPL1 and is capable of binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen. Applicant argues that the specification discloses the ITPRIPL1 extracellular-domain antigen, representative anti-ITPRIPL1 antibodies, antibody binding to ITPRIPL1-expressing cells, and antibody-mediated blocking of the ITPRIPL1/CD3e interaction. Applicant states that the antibody embodiments are not defined merely by broad target binding; they are limited by the recited ITPRIPL1 antigen sequence and the disclosed blocking mechanism. Applicant asserts that the instant claims are distinguishable from claims that merely attempt to cover all antibodies binding to a target without corresponding structural or mechanical limitations. Applicant contends that here, the claims are limited by the disease context, namely, ITPRIPL1-overexpressing tumors; by the functional mechanism, namely, blocking ITPRIPL1 on tumor cells from binding to CD3ε on T cells; and for antibody embodiments, by binding to the recited ITPRIPL1 antigen sequence.
Applicant’s arguments have been fully considered but are not found to be persuasive. Specifically, the instant claims only recite administration of an antibody that (i) recognizes and binds to ITPRIPL1, (ii) blocks ITPRIPL1 on tumor cells from binding to CD3ε on T cells; (iii) binds to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen; and (iv) treats ITPRIPL1-overexpressing tumors. The teachings of the specification are not adequate written description of an entire genus of antibodies that (i) recognize and bind to ITPRIPL1, (ii) block ITPRIPL1 on tumor cells from binding to CD3ε on T cells; (iii) bind to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen; and (iv) treat ITPRIPL1-overexpressing tumors.
In the instant case, the only factors present in the method claims are (i) a structural characteristic of an antibody and (ii) functional characteristics of recognizing and binding to ITPRIPL1, blocking ITPRIPL1 on tumor cells from binding to CD3ε on T cells, binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen, and treating ITPRIPL1-overexpressing tumors. There is no other identification of any particular sequence or structure of the antibody in the instant claims. There is also no identification of any particular sequence or structure that must be conserved in order to provide the required functions of recognizing and binding to ITPRIPL1, blocking ITPRIPL1 on tumor cells from binding to CD3ε on T cells, binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen, and treating ITPRIPL1-overexpressing tumors.
As discussed in the previous Office Action of 22 April 2026, the description of two monoclonal anti-ITPRIPL1 antibodies, termed “13B7A6H3” and “18B12D1A6” that neutralize ITPRIPL1 in the instant specification, is not adequate written description of an entire genus of antibodies that recognize/bind to ITPRIPL1, block ITPRIPL1 on tumor cells from binding to CD3ε on T cells, bind to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen, and treat ITPRIPL1-overexpressing tumors. Applicant is reminded that generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one or two species within the genus (Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)). A patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017) at page 1358). An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” (Amgen page 1361).
Contrary to Applicant’s arguments, the instant claims are attempting to claim administration of every antibody that would achieve a desired result, i.e., recognizing/binding to ITPRIPL1, blocking ITPRIPL1 on tumor cells from binding to CD3ε on T cells, binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen, and treating ITPRIPL1-overexpressing tumors, whereas the specification does not describe representative examples to support the full scope of the claims. Applicant is reminded that "when a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the same result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)). However, in the instant case, the specification does not disclose the generation of a genus of antibodies that (i) recognize and bind to ITPRIPL1, (ii) block ITPRIPL1 on tumor cells from binding to CD3ε on T cells; (iii) bind to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen; and (iv) treat ITPRIPL1-overexpressing tumors. Therefore, the specification does not provide adequate written description of an entire genus of antibodies that achieve a desired result, i.e., recognizing/binding to ITPRIPL1, blocking ITPRIPL1 on tumor cells from binding to CD3ε on T cells; binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen; and treating ITPRIPL1-overexpressing tumors. In the instant application, the skilled artisan cannot envision the detailed chemical structure of the antibodies of the encompassed method claims, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation.
Hundreds of unique antibody structures may bind a single antigen (see Lloyd et al. and Edwards et al., cited at pages 15-16 of the previous Office Action) and one species or small group of related species cannot be representative of all the antibodies that bind to the same epitope. Given the unpredictability of the structures of the large number of antibodies that could bind to ITPRIPL1 encompassed by the claims, the instant specification does not describe representative examples to support the full scope of the claims. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Applicant is reminded of the decision in Amgen Inc. v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), wherein the court discussed whether an antibody is adequately described by describing a newly characterized antigen. Specifically, the court referred to the decision in Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir. 2011). In that case, the patentee claimed a genus of antibodies containing a human variable region that has particularly desirable therapeutic properties: high affinity, neutralizing activity, and A2 specificity. Despite the fact that the specification disclosed human TNF-α protein, the court ruled that that the generic antibody claims at issue were invalid for lack of written description, despite the disclosure of the structures of more than one species of antibody encompassed in the genus. The fact pattern is similar in the instant case. Specifically, in the instant case, the structure of the ITPRIPL1 protein is provided by the amino acid sequence of SEQ ID NOs: 20 and 72 (for example), as well as antigenic amino acid sequences of SEQ ID NOs: 49 and 1, while specific structures for antibodies that recognize/bind to ITPRIPL1, block ITPRIPL1 on tumor cells from binding to CD3ε on T cells, bind to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1 in an ITPRIPL1 antigen; and treat ITPRIPL1-overexpressing tumors are not. As in the court case, the instant claims recite a genus of antibodies that have a desirable therapeutic property, i.e., recognizing/binding to ITPRIPL1, blocking ITPRIPL1 on tumor cells from binding to CD3ε on T cells; binding to an amino acid sequence as set forth in SEQ ID NO: 49 or SEQ ID NO: 1; and treating ITPRIPL1-overexpressing tumors. Following the finding in Centocor, the instant claims are found to lack adequate written description.
The court in Amgen v. Sanofi further compares the requirements of enablement and written description, stating that:
“We cannot say that this particular context, involving a “newly characterized antigen” and a functional genus claim to corresponding antibodies, is one in which the underlying science establishes that a finding of “make and use” (routine or conventional production) actually does equate to the required description of the claimed products. For us to draw such a conclusion, and transform a factual issue into a legally required inference, we would have to declare a contested scientific proposition to be so settled as to be entitled to judicial notice. That we cannot do.”
The court indicated that it has been hotly disputed whether or not knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. Citing Centocor again, the court provides an analogy for the antibody-antigen relationship as not quite a lock and key relationship but rather providing a lock and then searching for a key on a ring with a million keys on it. The court concludes that the “newly characterized antigen” test flouts basic legal principles of the written description requirement, reasoning that section 112 requires a written description of the invention, whereas the newly characterized antigen test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The court urges that such constricts the “quid pro quo” of the patent system where one describes an invention in order to obtain a patent.
Accordingly, since the instant fact pattern fits the “newly characterized antigen” scenario, wherein the specification describes the structure of the target/antigen but not the structure of the genus of antibodies, the claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Only administration of an isolated antibody that binds and inhibits ITPRIPL1, wherein the antibody comprises (i) the six CDR amino acid sequences of SEQ ID NOs: 26-29, KV, and 31; (ii) the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 24 and the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 25; (iii) the six CDR amino acid sequences of SEQ ID NOs: 36-39, KV, and 41; or (iv) the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 34 and the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 35 (as recited in instant claims 48 and 49), but not the full breadth of claims, meets the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
(ii) At the middle of page 19 of the Response, Applicant states that the regulator recited in amended claim 1 is not an unlimited class of unrelated agents. Rather, claim 1 expressly limits the regulator to specific categories disclosed in the specification: a gene editing system that enables knockout or mutation of the ITPRIPL1 gene, an RNA molecule that reduces the expression level of the ITPRIPL1 gene, or an antibody that recognizes and binds to ITPRIPL1. Applicant indicates that the specification describes CRISPR/Cas9-based ITPRIPL1 gene-editing embodiments, RNA-based ITPRIPL1 expression-reducing embodiments, and anti-ITPRIPL1 antibody embodiments. Applicant submits that these regulator categories are all directed to the same disclosed target, ITPRIPL1, and to the same therapeutic rationale of reducing or blocking ITPRIPL1 mediated immune suppression in ITPRIPL1-overexpressing tumors.
Applicant’s arguments have been fully considered but are not found to be persuasive. Applicant is arguing limitations that are directed to inventions encompassing Groups I and II in the Restriction of 02 December 2025. These inventions were not considered in the previous Office Action of 22 April 2026. Applicant is reminded that the examined invention of the instant application is Group V, drawn to a method of regulating immune responses or resisting tumors comprising administering an antibody that recognizes and binds to ITPRIPL1. Election was made without traverse in the reply filed on 02 February 2026. The instant claim set is only under consideration as it reads upon the elected invention of administering an antibody that recognizes and binds to ITPRIPL1. The Examiner’s response to Applicant’s arguments directed to the antibody embodiment are set forth directly above in (i).
Conclusion
Claims 1, 3, 9, and 12 are rejected. Claims 48 and 49 are objected.
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 BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
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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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BEB
Art Unit 1647
08 October 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
