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 .
Election/Restrictions
Applicant’s election without traverse of the species of antibody clone M3, encompassing CDR sequences of SEQ ID NOs: 87-92, respectively, or SEQ ID NOs: 93-98, respectively; VH sequences of SEQ ID NOs: 85, 99-102, and 183-197; and VL sequences of SEQ ID NOs: 86, 103-105, and 198-201 for search and examination filed in the reply on 01/12/2026 is acknowledged. Claims 1, 5-7, 10-23, and 48 read on the elected species.
Claim 1 is allowable. The election requirement, as set forth in the Office action mailed on 01/12/2026, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the election requirement of species as listed in the office action of 01/12/2026 is partially withdrawn. Claim 3, directed to the non-elected TIP-1 antibody species, remains withdrawn from further consideration pursuant to the election requirement because it does not require all the limitations of an allowable claim. Claims 1, 5-7, 10-23, and 48 are currently pending and under examination.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
Application claims priority to U.S. Provisional Application No. 63/021,215, filed May 7, 2020, and subsequently filed provisional applications. However, review of the priority applications indicates that the earliest provisional application providing support under 35 U.S.C. 112(a) for the presently elected M3 antibody species, including the recited M3 CDR and VH/VL sequences, is U.S. Provisional Application No. 62/706,131, filed August 3, 2020. Accordingly, for purposes of examination of claims 1, 5-7, 10-23, and 48 insofar as they read on the elected species M3, the earliest effective filing date supported by the priority applications is August 3, 2020. The May 7, 2020 provisional filing date is not accorded to the elected M3 subject matter because that provisional application does not provide adequate support for the claimed M3 species.
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.
1. Claim 22 is 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 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 22 broadly encompasses a CAR comprising any anti-binding domain that specifically binds GPC3, without limiting the binding domain to the disclosed M3 sequences or other structurally defined antibodies. Although the Specification discloses particular anti-GPC3 antibodies, including M3 and various humanized M3 VH/VL sequences, and constructs particular scFv molecules therefrom (Table 1, and Tables 7-8), the Specification does not disclose a representative number of structurally diverse GPC3-binding antigen-binding domains commensurate with the full scope of the claim, nor does it identify structural features common to the claimed genus that correlate with the recited GPC3-binding function. Accordingly, the disclosure does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full genus of CARs containing any antigen-binding domain capable of specifically binding GPC3 at the time of filing.
2. Claims 17, 22, and 48 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 17, the Specification states generally that anti-TAA antibodies may be used to treat inflammatory disease (paragraph 0551, pg. 27), but does not identify a particular inflammatory disease shown to be responsive to anti-GPC3 treatment, provide an inflammatory-disease working example, or establish a GPC3-mediated therapeutic mechanism for such diseases. In contrast, the disclosed biological rationale for GPC3 is principally directed to its tumor-associated expression and use as a cancer therapeutic target (paragraph 0006, pg. 1).
Considering the Wands factors, the claim encompasses a broad and heterogeneous class of inflammatory diseases; therapeutic response in this field is unpredictable; the Specification provides little direction regarding which inflammatory diseases would respond to GPC3 targeting, appropriate patient populations, or disease-specific treatment conditions; and no working example demonstrates treatment of an inflammatory disease with the claimed antibody. Although skilled artisans possess substantial knowledge of antibody therapeutics, determining which inflammatory diseases, if any, are treatable using the claimed anti-GPC3 composition would require substantial disease-by-disease experimentation. Accordingly, the Specification does not enable the claimed inflammatory disease treatment scope without undue experimentation.
Regarding claim 22 and applying the Wands factors, the breadth of the claim is substantial because it encompasses structurally diverse antigen-binding domains defined principally by the functional requirement of specifically binding GPC3; the nature of antibody-antigen recognition is relatively unpredictable; and the Specification provides working examples primarily for particular disclosed anti-GPC3 antibodies, humanized variants, and scFv constructs rather than the full functional genus. The examples describe production, binding assays, humanization, and construction of selected scFvs, but provide limited guidance for predicting which additional, structurally distinct antigen-binding domains will specifically bind GPC3 and function in the claimed CAR. Although the level of skill in the art is high and routine CAR construction techniques were known, practicing the full scope would require generating and screening potentially numerous candidate binding domains to determine which satisfy the claimed function. The quantity of experimentation, limited guidance and examples relative to claim breadth, and unpredictability of the art therefore weigh in favor of undue experimentation.
Claim 48 depends from claim 17 but fails to rectify the deficiencies of claim 17.
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 19 and 23 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.
Regarding claim 19, the claim recites “the bispecific antibody or antigen-binding fragment thereof.” However, no “bispecific antibody” is previously introduced or otherwise identified in claim 19. There is insufficient antecedent basis for this limitation in the claim, and it is therefore unclear which bispecific antibody is required by the claim.
Regarding claim 23, claim 22 recites an extracellular domain comprising “at least one antigen binding domain,” thereby permitting more than one antigen-binding domain, while claim 23 subsequently refers to “the antigen binding domain.” Therefore, it is unclear where more than one antigen-binding domain is present, whether each antigen-binding domain or only at least one antigen-binding domain is required to comprise the recited CDR sequences.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 22 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (US 20160215261).
Li teaches a nucleic acid encoding a chimeric antigen receptor targeting GPC3, wherein the CAR comprises an extracellular binding domain containing a GPC3-specific scFv, a transmembrane region, and an intracellular signaling domain (Abstract). Li further discloses that the transmembrane region may comprise a CD8 or CD28 transmembrane region together with a hinge region, and that the intracellular signaling domain may comprise CD3ζ, CD28, CD137, CD134, or combinations thereof (paragraph 0006, pg. 1). Li also provides specific nucleic acid sequences encoding the disclosed GPC3-targeting CARs (Table 5, pg. 12).
Accordingly, Li discloses each limitation of claim 22, namely, an isolated polynucleotide encoding a CAR comprising an extracellular antigen-binding domain that specifically binds GPC3, a hinge region, a transmembrane region, and an intracellular signaling domain. Claim 22 therefore is anticipated by Li. The present claim recites that same generic GPC3-CAR architecture.
Allowable Subject Matter
Claims 1, 5-7, and 10-21 are allowable over the prior art of record. A search of the elected M3 species and the remaining non-elected species encompassed by claim 1 did not identify prior art that anticipates or renders obvious the recited GPC3-binding CDR combinations. Therefore, claim 1 distinguishes over the prior art, and claims 5-7, and 10-21 retain the patentable limitations of claim 1.
Conclusion
Claims 17, 19, 22-23, and 48 are rejected. Claims 1, 5-7, 10-16, 18, and 20-21 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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