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 .
1. Formal Matters
A. Applicant’s election of Group I, drawn to the indicated species, in the reply filed on 6/23/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Therefore, this restriction is deemed proper and is made FINAL.
B. Claims 1, 2, 5, 8, 11, 13, 16, 19, 20, 24, 26-28, 30, 32, 33 and 35-38 are pending. Claims 32, 33 and 35-37 are withdrawn as being drawn to a non-elected invention. Claims 1, 2, 5, 8, 11, 13, 16, 19, 20, 24, 26-28, 30 and 38 are the subject of this Office Action.
2. Specification
A. The listing of references on pages 75-76 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
B. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware
3. Claim Rejections - 35 USC § 112(a) – written description
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.
Claims 11, 13, 16, 20, 24 and 27 are rejected under 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. They recite nucleic acids and CARs in terms of “variant” and those “substantially as set out in” a recited sequence. Therefore, these nucleic acids would have one or more nucleic acid substitutions, deletions, insertions and/or additions to said polynucleotides and would encode for a protein with one or more amino acid substitutions, deletions, insertions and/or additions to the protein encoded for by the claimed SEQ ID NOs.
Other than encoding a CAR, or the CAR, itself, the specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. The specification and claims do not provide any guidance as to what changes should be made in order to retain the desired function. Structural features that could distinguish compounds in the genus from others in the nucleic acid or protein class are missing from the disclosure. No common structural attributes identify the members of the genus.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, the wild-type SEQ ID NOs, alone, are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
4. 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.
(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 1, 2, 5, 8, 11, 13, 16, 24, 26, 27, 28, 30 and 38 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Yang et al. (WO 2020/156335 – cited on the IDS filed 10/19/23; machine translation references below). Claim 1 is drawn to a nucleic acid construct comprising a promoter linked to a nucleotide encoding a TCR V-beta CAR.
Yang teaches nucleic acids (paragraph [0146] of the machine translation) encoding a CAR which binds to a TCR Vb region (Abstract; paragraph [0006] of the machine translation), meeting claims 1 and 28. Promoters are generally taught ([0116]), as is the T7RNA polymerase promoter ([0147]). It is noted that, in addition to meeting part (i) of claim 2, that this promoter would meet the limitation of part (iii) since it is a “variant” of SEQ ID NO:3.
Regarding claim 5, the Vbeta regions recited in Table 1 are optional.
Regarding claim 8, Vbeta 8 is taught in Example 2.
Regarding claim 11, Yang meets this limitation due to the recitation of “variant thereof”
Regarding claim 13, Yang teaches a CD8a hinge and transmembrane region (paragraph [0023]), a CD3z intracellular region ([0022]). Though optional, Yang meets a “variant” of SEQ ID NO:14 and 15.
Claim 16 is also met by Yang in view of “variant thereof”.
Claim 24 is also met by Yang in view of “variant thereof”. See also paragraph [0116]).
Claim 26 is met by paragraph [0116].
Claim 27 is also met by Yang in view of “variant thereof”.
Claims 30 and 38 are met by paragraph [0121].
5. Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
A. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. in view of Rosenberg et al. (U.S. Patent No. 8,465,743). The teachings of Yang are seen above under 35 USC 102. Yang teaches CD8a hinge and TM domains, but does not teach SEQ ID NO:14. However, Rosenberg does teach the use of SEQ ID NO:14 in the production of a CAR (column 6, lines 53-55).
SEQ ID NO:14
Sequence 3, US/13499349
Patent No. 8465743
GENERAL INFORMATION
APPLICANT: ROSENBERG, Steven A.
APPLICANT: CHINNASAMY, Dhanalakshmi
TITLE OF INVENTION: ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-2 CHIMERIC
TITLE OF INVENTION: ANTIGEN RECEPTORS AND USE OF SAME FOR THE TREATMENT OF CANCER
FILE REFERENCE: 709935
CURRENT APPLICATION NUMBER: US/13/499,349
CURRENT FILING DATE: 2012-03-30
PRIOR APPLICATION NUMBER: PCT/US10/48701
PRIOR FILING DATE: 2010-09-14
PRIOR APPLICATION NUMBER: US 61/247,625
PRIOR FILING DATE: 2009-10-01
SEQ ID NO 3
LENGTH: 83
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 452; Length 83;
Best Local Similarity 100.0%;
Matches 83; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FVPVFLPAKPTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 FVPVFLPAKPTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWA 60
Qy 61 PLAGTCGVLLLSLVITLYCNHRN 83
|||||||||||||||||||||||
Db 61 PLAGTCGVLLLSLVITLYCNHRN 83
B. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. in view of Sadelain et al. (U.S. Patent No. 7,446,190) in view of Orentas et al. (U.S. Patent No. 9,868,774). The teachings of Yang are seen above under 35 USC 102. Yang teaches a CD28 signaling domain, 4-1BB and CD3z, but does not teach SEQ ID NO:16, 18 or 20, respectively. However, Sadelain does teach the use of the CD28 of SEQ ID NO:16 and the CD3z of 20 in the production of a TCRs (e.g. Abstract, Examples 7-9). Neither Yang nor Orentas teach SEQ ID NO:18. However, Orentas does teach the use of SEQ ID NO:18 (4-1BB) in the production of CARs.
SEQ ID NO:16
Patent No. 7446190
GENERAL INFORMATION
APPLICANT: Sadelain, Michel
APPLICANT: Brentjens, Renier
APPLICANT: Maher, John
TITLE OF INVENTION: Chimeric T Cell Receptors
FILE REFERENCE: MSK.P-058
CURRENT APPLICATION NUMBER: US/10/448,256C
CURRENT FILING DATE: 2003-05-28
PRIOR APPLICATION NUMBER: 60/383,872
PRIOR FILING DATE: 2002-05-28
SEQ ID NO 9
LENGTH: 41
TYPE: PRT
ORGANISM: homo sapiens
Query Match 100.0%; Score 227; Length 41;
Best Local Similarity 100.0%;
Matches 41; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 41
|||||||||||||||||||||||||||||||||||||||||
Db 1 RSKRSRLLHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 41
SEQ ID NO:18
Patent No. 9868774
GENERAL INFORMATION
APPLICANT: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE
APPLICANT: SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
TITLE OF INVENTION: ANTI-CD22 CHIMERIC ANTIGEN RECEPTORS
FILE REFERENCE: 716166
CURRENT APPLICATION NUMBER: US/14/352,530
CURRENT FILING DATE: 2014-04-17
PRIOR APPLICATION NUMBER: US 61/549,516
PRIOR FILING DATE: 2011-10-20
PRIOR APPLICATION NUMBER: PCT/US2012/061025
PRIOR FILING DATE: 2012-10-19
SEQ ID NO 13
LENGTH: 47
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 100.0%; Score 255; Length 47;
Best Local Similarity 100.0%;
Matches 47; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RFSVVKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCEL 47
|||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RFSVVKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCEL 47
SEQ ID NO:20
Patent No. 7446190
GENERAL INFORMATION
APPLICANT: Sadelain, Michel, et al.
SEQ ID NO 14
LENGTH: 112
TYPE: PRT
ORGANISM: homo sapiens
Query Match 100.0%; Score 593; Length 112;
Best Local Similarity 100.0%;
Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYN 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYN 60
Qy 61 ELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR 112
||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR 112
C. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. in view of either Sadelain et al. or Orentas et al. The teachings of all are seen in the above rejection. Since claim 16 is written in the alternative (i.e. (i) or (ii) or (iii)), the rejection can be made over either secondary reference.
D. Claims 19 and 20 in view of Ma et al. (US2019/0345217 - cited on the IDS filed 10/19/23). The teachings of Yang are seen above regarding 35 USC 102. Yang does not teach suicide genes. However, Ma teach CARs comprising suicide genes including, but not limited to, caspase 9 gene (paragraph [0040]).
6. Prior Art of Interest Not Relied Upon
A. Pule et al. (US 2019/0209612; cited on the PCT/ISA/210 and IDS filed 10/19/23) teaches CARs, but does not teach any more than Yang et al. (WO 2020/156335).
B. EP 3 919 515 A1 is provided herewith as the English equivalent to WO 2020/156335.
C. Oh teaches “single variable domains from the T cell receptor β chain function as mono- and bifunctional CARs and TCRs”, but does not teach more than the prior art of record.
7. Conclusion
A. No claim is allowable.
B. SEQ ID NO:12, 13, 31, 32, 34, 35 and 36 are free of the prior art.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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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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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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