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 .
Detailed Action
This action is in response to the papers filed July 21, 2026.
Amendments
Applicant's response and amendments, filed July 21, 2026, is acknowledged. Applicant has cancelled Claims 2-4, 21, and 28-36, and amended Claims 13 and 22.
Claims 1, 5-20, and 22-27 are pending and under examination.
Priority
This application is a 371 of PCT/US2020/064415 filed on December 11, 2020. Applicant’s claim for the benefit of a prior-filed application provisional application 62/951,309 filed on December 20, 2019 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
Applicant has filed an Information Disclosure Statement on July 21, 2026 that has been considered.
The signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 101
1. The prior rejection of Claims 29 and 32-36 under 35 U.S.C. 101 is withdrawn in light of Applicant’s cancellation of the claim(s).
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.
2. The prior rejections of Claims 29 and 32-36 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is/are withdrawn in light of Applicant’s cancellation of the claim(s).
3. The prior rejection of Claims 13, 16, 22, 25, and 27 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in light of Applicant’s argument that the instant claims comply with the written description requirement of USPTO materials dated September 17, 2020 (see "Antibodies and the written description requirement of 35 U.S.C. l 12(a); presented by Supervisory Patent Examiner Daniel Kolker at a Biotechnology/Chemical/Pharmaceutical Customer Partnership Conference hosted by the USPTO September 17, 2020; "USPTO materials").
Upon review of the USPTO training materials, the Examiner concurs that the instant claims appear to follow the fact-pattern of, at least, Example 2, whereby it was concluded that the Example 2 claim complies with the description requirement, as the function (binding to antigen X) is correlated to a structure recited in the claim (the sequences in the CDRs). One skilled in the art would be able to immediately envision other antibodies which have different framework and constant regions yet which retain binding as claimed.
4. Claims 13-16, 22-25, and 27 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.
Claims 13 and 22 have been amended to recite a chimeric antigen receptor that binds to human GPC3.
The term “human” in Claims 13 and 22 is a relative term which renders the claim indefinite. The term “human GPC3” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)).
GenBank evidences that there are at least six structurally different Glypican-3 (GPC3) human isoforms composed of 486, 526, 549, 564, 580, and 603 amino acids.
GenBank XP_011856704.1 (Mandrill monkey, GPC3; 2015) is considered relevant prior art for having taught a GPC3 polypeptide that is 100% identical to a human GPC3 polypeptide composed of 526 amino acids.
The claims fail to recite, and the specification fails to disclose, which amino acid(s) must be present in the GPC3 protein to objectively identify it as being “human”, as opposed to which amino acid(s) may be absent, yet still be objectively identified as being “human”.
If there are multiple, structurally distinct GPC3 polypeptides from which to reference the ability of the claimed chimeric antigen receptor is to bind, then the claim may be indefinite because it is unclear which GPC3 polypeptide, and its corresponding amino acid sequence, is to be referenced in order to determine infringement.
Appropriate correction is required.
The instant claims as a whole do not apprise one of ordinary skill in the art of its scope and, therefore, does not serve the notice function required by 35 U.S.C. 112, second paragraph, by providing clear warning to others as to what constitutes infringement of the patent.
Dependent claims are included in the basis of the rejection because they do not correct the primary deficiencies of the independent claim.
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.
5. The prior rejection of Claims 29 and 32-36 on the ground of nonstatutory double patenting as being unpatentable over claims 15-24 of U.S. Patent No. 12,264,190 is withdrawn in light of Applicant’s cancellation of the claim(s).
6. The prior rejection of Claims 29 and 32-35 on the ground of nonstatutory double patenting as being unpatentable over claims 15-24 of U.S. Patent No. 12,264,190, as applied to Claims 1, 5-20, and 22-27 above, and in further view of Li et al (Redirecting T Cells to Glypican-3 with 4-1BB Zeta Chimeric Antigen Receptors Results in Th1 Polarization and Potent Antitumor Activity, Human Gene Therapy 28(5): 437-448, 2017) is withdrawn in light of Applicant’s cancellation of the claim(s).
7. The prior rejection of Claim 36 on the ground of nonstatutory double patenting as being unpatentable over claims 15-24 of U.S. Patent No. 12,264,190 in view of Li et al (2017), as applied to Claims 1, 5-20, 22-27, 29, and 32-36 above, and in further view of Norelli et al (Clinical pharmacology of CAR-T cells: Linking cellular pharmacodynamics to pharmacokinetics and antitumor effects, Biochimica et Biophys. Acta 1865: 90-100, 2016) is withdrawn in light of Applicant’s cancellation of the claim(s).
8. Claims 1, 5-20, and 22-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-24 of U.S. Patent No. 12,264,190.
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘190 claims a host cell comprising anti-GPC3 chimeric antigen receptor comprising a VH domain comprising SEQ ID NO:27 and a VL domain comprising SEQ ID NO:28,
wherein the anti-GPC3 antigen binding domain is an scFv comprising the amino acid sequence of SEQ ID NO:1,
wherein the anti-GPC3 chimeric antigen receptor comprises the amino acid sequence of SEQ ID NO:25 or SEQ ID NO:47, and
wherein the host cell is a T, NK, CTL, or a Treg cell.
‘190 SEQ ID NO:1, 25, and 47 comprise the amino acid sequences of instantly recited SEQ ID NO:27 and SEQ ID NO:28, and thus also comprise the VH CDR1, CDR2, and CDR3 motifs of SEQ ID NOs: 37, 38, and 39, respectively, and the VL CDR1, CDR2, and CDR3 motifs of SEQ ID NOs: 40, 41, and 42, respectively.
Instant SEQ ID NO:3 differs from ‘190 SEQ ID NO:25 and SEQ ID NO:47 by the presence of a GVHS motif, for example.
However, the specification fails to disclose an element of criticality for the presence and/or absence of the GVHS motif.
The "mere existence of differences between the prior art and an invention does not establish the invention's nonobviousness." Dann v. Johnston, 425 U.S. 219, 230, 189 USPQ 257, 261 (1976). The gap between the prior art and the claimed invention may not be "so great as to render the [claim] nonobvious to one reasonably skilled in the art."Id.
While ‘190 does not claim an isolated nucleic acid encoding said anti-GPC3 chimeric antigen receptor, those of ordinary skill in the art have long-recognized that nucleic acid molecular biology is required to design synthesize and express chimeric antigen receptors from the artisan’s host cell.
Thus, the instant claims are considered to be anticipated by and/or obvious variants of the ‘190 patented claims.
Response to Arguments
Applicant argues that the anti-GPC3 CAR of ‘190 further comprises a TGFbetaRII DN armoring molecule.
Applicant’s argument(s) has been fully considered, but is not persuasive.
As a first matter, instant claims recite, e.g. a “cell comprising an anti-GPC3 chimeric antigen receptor…” and as “anti-GPC3 chimeric antigen receptor comprising…”. The term "comprising" is open-ended and allows for additional, unrecited elements in the claims. MPEP 2111.03 specifically sets forth that the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). Instant claims fail to exclude or otherwise prohibit a TGFbetaRII DN armoring molecule from the claimed anti-GPC3 CAR(s) and/or the claimed cells comprising the claimed anti-GPC3 CAR(s).
As a second matter, it is axiomatic that the anti-GPC3 chimeric antigen receptor(s) of ‘190 comprise the VH CDR1-3 and VL CDR1-3 sequences of the instantly claimed anti-GPC3 chimeric antigen receptor(s),
Thus, the anti-GPC3 CAR(s) of ‘190, and cells comprising said CAR(s), anticipate, and are encompassed by, the instantly recited genus of anti-GPC3 CAR(s), and cells comprising said CAR(s).
Conclusion
9. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KEVIN K. HILL whose telephone number is (571)272-8036. The examiner can normally be reached 12pm-8pm EST.
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, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN K. HILL
Examiner
Art Unit 1638
/KEVIN K HILL/Primary Examiner, Art Unit 1638
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