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
The species election without traverse filed June 23, 2026, is acknowledged and has been entered. Applicant has elected to the species of elects the chimeric antigen receptor shown in SEQ ID NO: 11 which binds the claudin 18.2 antigen.
Claims 59-78 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements have been considered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 59-66, 68-69, 74 and 77-78 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 59 recites a “use” of a cell therapy product without any steps so the claim is not directed to a process. The dependent claims also do not require any steps. See MPEP 2173.05(q).
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 59-66, 68-69, 74 and 77-78 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.
The claims are indefinite for reciting the “use” of cells without any steps. Accordingly, one of skill in the art could not determine the scope of how the cells are to be “used”.
Therefore, the claims fail to delineate the metes and bounds of the subject matter that Applicant regards as the invention with the requisite clarity and particularity to permit the skilled artisan to know or determine infringing subject matter.
Claims 59-66, 68-69, 74 and 77-78 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, these claims recite broad limitations and then the language “preferably” and/or “more preferably” with narrower limitations (see e.g., claims 59, 61, 63, 64, 66, 67, 68, 70-73 and 78), so it is unclear how or when the narrow limitation further limits the claim.
Accordingly, due to the ambiguity that results from a broad limitation followed by a narrow limitation used in this claim, the claims fail to delineate the metes and bounds of the subject matter regarded as the invention with the clarity and particularity necessary to satisfy the requirement set forth under 35 U.S.C. § 112, second paragraph, so as to permit the skilled artisan to know or determine infringing subject matter.
It is suggested that the limitations referred to by “preferably” and/or “more preferably” be removed from the claims to obviate the rejection.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 74-75 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). “[A] sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For example, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875 (Fed. Cir. 2011).
The teachings of the specification and the claimed invention:
The nature and scope of the claimed invention at issue is methods that recite a genus of chimeric antigen receptors that bind to claudin 18.2 antigen comprising an antigen binding domain defined by 90% percent identity or more to SEQ ID Nos 7, 9 or 11.
Notably, because of the percent identity language, multiple amino acids in the antibody antigen binding domain in the CDRs can be modified.
The instant specification discloses an antibody that binds claudin 18.2 antigen that has the 6 CDRs comprising: HCDR1 shown in SEQ ID NO:1, HCDR2 shown in SEQ ID NO:2, HCDR3 shown in SEQ ID NO:3, LCDR1 shown in SEQ ID NO:4, LCDR2 shown in SEQ ID NO:5, LCDR3 shown in SEQ ID NO: 6, but the claims also recite a heavy chain variable region comprising an amino acid that has more than 90% sequence identity with SEQ ID NO:7 and a light chain variable region comprising an amino acid that has more than 90% sequence identity with SEQ ID NO:9 or a chimeric antigen receptor comprising an amino acid sequence that has more than 90% sequence identity with SEQ ID NO: 11 where these CDRs are not required.
The instant specification has not disclosed any CDR modifications that can be made in the disclosed antibody that binds claudin 18.2 antigen that retains the function of this antibody.
State of the Art
It is well established in the art that conventional antibodies have a large repertoire of distinct structures and that a huge variety of antibodies can be made to bind to a single antigen where some antibodies bind different epitopes on the antigen and some bind overlapping or the same epitope which allows them to compete for binding. For example, Lloyd et al (Protein Engineering, Design & Selection, 22:159-168, 2009) teach that hundreds of functional antibody fragments can be isolated from an antibody library that bind to the same antigen wherein these antibodies have distinct heavy and light chain sequences and can bind different epitopes on the antigen (see, e.g., Discussion). Similarly, Edwards et al (J Mol Biol, 14;334(1):103-118, 2003), found that over 1000 antibodies, all different in amino acid sequence, were generated to a single protein with 568 different amino acid sequences identified for the V(H) CDR3 domains of these antibodies (see Abstract).
It is also known in the antibody art that the formation of an intact antigen-binding site in a conventional antibody usually requires the association of the complete heavy and light chain variable regions of a given antibody, each of which comprises three CDRs (or hypervariable regions) that provide the majority of the contact residues for the binding of the antibody to its target epitope. See Almagro et al, (Frontiers in Immunology (2018) 8: 1751, pages 1-19), (“The IgG Molecule” (page 3) and Figure 1). Sela-Culang (Frontiers in Immunology (2013) 4: 302, pages 1-13) further teaches, “A major focus in analyzing the structural basis for [antigen] recognition has been in identifying the exact boundaries of the CDRs in a given [antibody]. It is a common practice to identify paratopes through the identification of CDRs” (page 3, left column, “CDRs Identification”).
Although the prior art teaches some understanding of the structural basis of antigen-antibody recognition, it is aptly noted that the art is characterized by a high level of unpredictability, since the skilled artisan still cannot accurately and reliably predict the consequences of amino acid substitutions, insertions, and deletions in the antigen-binding domains. Ni (The Protein Journal (2024) 43: 683-696) teaches, “Mutations, even one mutation, introduced in the CDRs through [somatic hypermutation] can change the binding properties and repertoire of antibodies. However, how just one-point mutation can dramatically change the recognition profiles of the antibody is still unclear” (Introduction). Furthermore, while affinity maturation techniques can result in differences in the CDRs of the antibody compared to its parental antibody, those techniques involve trial-and-error testing and the changes that maintain or improve affinity are not predictable a priori (Almagro, pages 3 and 6-7).
Therefore, it is expected that all 6 CDRs of a conventional antibody needs to be grafted into antibody framework regions to retain the requisite specificity and functionality of the parent antibody and that it cannot be known what other antigens any particular moiety will bind other than the one tested.
Claim Analysis
The instant claims are described above.
A skilled artisan in the art would recognize that the specificity of an antibody is dependent upon six specific CDR sequences. In the instant case, the antibody binds claudin 18.2 antigen and comprises HCDR1 shown in SEQ ID NO:1, HCDR2 shown in SEQ ID NO:2, HCDR3 shown in SEQ ID NO:3, LCDR1 shown in SEQ ID NO:4, LCDR2 shown in SEQ ID NO:5, LCDR3 shown in SEQ ID NO: 6, so it comprises six specific CDR sequences that are required for binding to claudin 18.2 antigen. The instant specification does not disclose which of these CDR residues can be modified to obtain the antigen binding domains defined by 90% percent identity or more to SEQ ID Nos 7, 9 or 11
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genera. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
It is suggested that the rejection could be obviated canceling the reference to percent identity in these claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 59-78 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Li et al (WO 2019/114762 A1) as evidenced by the translation attached as Exhibit 1 (the translation is cited below as evidence of the disclosure of WO 2019/114762 A1).
With respect to claims 59-67, 74-75 and 78, Li et al disclose methods of treating gastric cancer in a patient insensitive or resistant to prior therapy (encompassed by the claims because the claims recite wherein the previous treatment comprises treatment with an anti-PD-1 antibody and/or an anti-PD-L1 antibody, preferably), a patient with relapse after treatment or a patient with a refractory cancer (all encompassed by a patient who has failed a previous treatment of the cancer) by administering a therapeutically effective amount of T cells (at least part of the patients respond to therapy as set forth in claim 78) expressing a chimeric antigen receptor comprising SEQ ID NO:16 that binds claudin 18.2 for one or more cycles (SEQ ID NO:16 is 100% identical to instant SEQ ID NO:11 and comprises SEQ ID Nos:1-7 and 9) (see entire document, e.g., ¶ [0022]-[0037], [0049], [0061]-[0065]and [0084]-[0089] and alignment).
ID BGL13543 standard; protein; 473 AA.
AC BGL13543;
DT 25-JUL-2019 (first entry)
DE CLD18A2 targeting chimeric antigen receptor, SEQ ID 16.
KW CD28 protein; CD3 zeta protein; CD8 alpha protein; CLD18A2 protein;
KW T cell surface glycoprotein CD28; T-cell CD3 glycoprotein zeta chain;
KW T-cell surface CD8 alpha chain; antibody; cancer;
KW chimeric antigen receptor; cytostatic; immunotherapy; radiotherapy.
OS Homo sapiens.
OS Synthetic.
OS Unidentified.
CC PN WO2019114762-A1.
CC PD 20-JUN-2019.
CC PF 12-DEC-2018; 2018WO-CN120679.
PR 12-DEC-2017; 2017CN-11320333.
CC PA (CARS-) CARSGEN THERAPEUTICS CO LTD.
CC PA (SHAN-) SHANGHAI CANCER INST.
CC PI Li Z, Zhou M;
DR WPI; 2019-51779T/53.
CC PT Treating tumor e.g. colon cancer, rectal cancer, and renal cell
CC PT carcinoma, by administering immune effector cell in combination with
CC PT tumor local radiation therapy to individual with tumor.
CC PS Claim 13; SEQ ID NO 16; 70pp; Chinese.
CC The present invention relates to a method for treating a tumor. The
CC method involves administering immune effector cell in combination with
CC tumor local radiation therapy, wherein the clearance of lymphocytes is
CC not performed on the individual, and the immune effector cells comprise a
CC receptor that recognizes tumor antigen. The receptor recognizing the
CC tumor antigen is preferably a chimeric antigen receptor selected from the
CC sequences of SEQ ID 11-26 (see BGL13538-BGL13553) containing an antibody
CC of SEQ ID 2 (see BGL13529) which recognizes the tumor antigen. The method
CC of the invention is useful for preparing a medicament for treating a
CC tumor.
SQ Sequence 473 AA;
Query Match 100.0%; Score 2529; Length 473;
Best Local Similarity 100.0%;
Matches 473; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQESGPGLIKPSQTLSLTCTVSGGSISSGYNWHWIRQPPGKGLEWIGYIHYTGSTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQESGPGLIKPSQTLSLTCTVSGGSISSGYNWHWIRQPPGKGLEWIGYIHYTGSTNY 60
Qy 61 NPALRSRVTISVDTSKNQFSLKLSSVTAADTAIYYCARIYNGNSFPYWGQGTTVTVSSGG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NPALRSRVTISVDTSKNQFSLKLSSVTAADTAIYYCARIYNGNSFPYWGQGTTVTVSSGG 120
Qy 121 GGSGGGGSGGGGSDIVMTQSPDSLAVSLGERATINCKSSQSLFNSGNQKNYLTWYQQKPG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGSGGGGSGGGGSDIVMTQSPDSLAVSLGERATINCKSSQSLFNSGNQKNYLTWYQQKPG 180
Qy 181 QPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQNAYSFPYTFGGG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQNAYSFPYTFGGG 240
Qy 241 TKLEIKRTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDFWVLVVVG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 TKLEIKRTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDFWVLVVVG 300
Qy 301 GVLACYSLLVTVAFIIFWVRSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GVLACYSLLVTVAFIIFWVRSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 360
Qy 361 RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPQRRKNPQEGLY 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPQRRKNPQEGLY 420
Qy 421 NELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR 473
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 NELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR 473
With respect to claims 68-69, Li et al disclose that the chimeric antigen receptor comprises an antigen-binding domain specifically binding to a tumor antigen, a transmembrane region of CD28 or CD8, and CD3ζ (see e.g., ¶ [0014]-[0020]).
With respect to claim 70, it is noted that the claim does not recite a specific number of cells and Li et al disclose administering a therapeutically effective amount of the immune T cells to increase the number of anti-tumor cells in the patient (see ¶ [0061]) which is encompassed by an amount not exceeding the number of claim 70, absent a showing otherwise.
With respect to claims 71-73, it is noted that the claims recite pretreatment before administration, but the claims are not limited to any particular pretreatment and Li et al disclose treating the cancer before administering the T cells of the invention (see ¶ [0024], [0065] and [0098]) (pretreatment).
With respect to claim 76, Li et al disclose determining tumor size to determine the amount of cell therapy to administer (see ¶ [0061])
With respect to claim 77, Li et al disclose it is possible that a cytokine storm can occur after treatment with adoptive immune cells such that it is apparent that the methods include patients that do no show severe CRS (see¶ [0004]).
Therefore, Li et al is deemed to anticipate the instant claims absent a showing otherwise.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 59-78 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 US Patent 12,186,343 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
The claims of the patent are drawn to:
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1207
1128
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PNG
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690
648
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.
Accordingly, the claimed invention in the patent recites methods of treating any patients with gastric cancer by administering T cells that express a CAR comprising the amino acid sequence of SEQ ID NO:24 which is 100% identical to the instant SEQ ID NO:11. Since the claims recite treating any patients with gastric cancer, one of skill in the art would at once envisage that those patients include those that have failed other treatments because one of skill in the art knows that some patients fails first line treatments. Therefore, the claimed invention in the patent is so substantially similar that for the most part, the claimed subject matter of the patent anticipates the claimed subject matter of the instant application and any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent because it is common in the art to administer additional therapies to patients that have failed another cancer treatment.
RESULT 1
US-16-979-102-24
(NOTE: this sequence has 1 duplicate in the database searched)
Sequence 24, US/16979102
Patent No. 12186343
GENERAL INFORMATION
APPLICANT: CARSGEN THERAPEUTICS CO., LTD.
APPLICANT: SHANGHAI CANCER INSTITUTE
TITLE OF INVENTION: Method And Composition For Treating Tumors
FILE REFERENCE: P2020-1815
CURRENT APPLICATION NUMBER: US/16/979,102
CURRENT FILING DATE: 2020-11-17
PRIOR APPLICATION NUMBER: CN2018101965240
PRIOR FILING DATE: 2018-03-09
PRIOR APPLICATION NUMBER: CN201810806560.4
PRIOR FILING DATE: 2018-07-20
PRIOR APPLICATION NUMBER: CN2018110395941
PRIOR FILING DATE: 2018-09-06
PRIOR APPLICATION NUMBER: CN2018114950120
PRIOR FILING DATE: 2018-12-07
NUMBER OF SEQ ID NOS: 68
SEQ ID NO 24
LENGTH: 473
TYPE: PRT
ORGANISM: Artificial sequence
FEATURE:
OTHER INFORMATION: Synthesized polypeptide
Query Match 100.0%; Score 2529; Length 473;
Best Local Similarity 100.0%;
Matches 473; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQESGPGLIKPSQTLSLTCTVSGGSISSGYNWHWIRQPPGKGLEWIGYIHYTGSTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQESGPGLIKPSQTLSLTCTVSGGSISSGYNWHWIRQPPGKGLEWIGYIHYTGSTNY 60
Qy 61 NPALRSRVTISVDTSKNQFSLKLSSVTAADTAIYYCARIYNGNSFPYWGQGTTVTVSSGG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NPALRSRVTISVDTSKNQFSLKLSSVTAADTAIYYCARIYNGNSFPYWGQGTTVTVSSGG 120
Qy 121 GGSGGGGSGGGGSDIVMTQSPDSLAVSLGERATINCKSSQSLFNSGNQKNYLTWYQQKPG 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GGSGGGGSGGGGSDIVMTQSPDSLAVSLGERATINCKSSQSLFNSGNQKNYLTWYQQKPG 180
Qy 181 QPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQNAYSFPYTFGGG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 QPPKLLIYWASTRESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQNAYSFPYTFGGG 240
Qy 241 TKLEIKRTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDFWVLVVVG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 TKLEIKRTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDFWVLVVVG 300
Qy 301 GVLACYSLLVTVAFIIFWVRSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GVLACYSLLVTVAFIIFWVRSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 360
Qy 361 RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPQRRKNPQEGLY 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPQRRKNPQEGLY 420
Qy 421 NELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR 473
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 NELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR 473
Conclusion
No claims are allowed. The prior art Zhan et al (JCO, 37(15):3 pages, 2019, IDS) as evidenced by NCT03159819 (Attached as Exhibit 2) discloses methods for treating a cancer in a patient who has failed in previous treatment of the cancer by using a cell therapy product, wherein the cell therapy product comprises an immune effector cell expressing an exogenous receptor, wherein the antigen binding domain of the exogenous receptor specifically recognizes a tumor antigen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The Examiner works a flexible schedule and can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
September 18, 2026
Prosecution Insights