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. In the response filed 6/16/26, Applicants elected Group I, without traverse, drawn to the indicated species. Therefore, this restriction is deemed proper and is made FINAL.
B. Claims 1, 5, 8, 11-22 and 26-30 are pending. Claims 13-20, 29 and 30 are withdrawn as being drawn to non-elected inventions. Claims 1, 5, 8, 11, 12, 21, 22 and 26-28 are the subject of this Office Action.
2. Specification
A. According to 37 CFR 1.821(d) (MPEP § 2422), where the description or claims of a patent application discuss a sequence listing that is set forth in the "Sequence Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. Sequences appear on page 2, lines 9-32, of the specification, but are not identified by SEQ ID NO as required.
B. The listing of references on page 3 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.
C. 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 Objections
In claim 12, though not incorrect, it is suggested that the term “harboring” be replace with “comprising” in order to be more consistent with common claim language.
4. Claim Rejections - 35 USC § 103
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 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. Claims 1, 5, 12, 21, 22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (U.S. Patent No. 9,914,909) in view of Ackerman et al (U.S. Patent No. 12,378,305) in view of Shiku et al. (U.S. Patent No. 9,175,308).
Brown (City of Hope) teaches CARs comprising a ligand binding domain, spacer domain, transmembrane domain, costimulatory domain and a CD3zeta signaling domain (column 1, line 66 to column 2, line 12). The spacer domain is identical to instant SEQ ID NO:31 and the costimulatory domain is identical to instant SEQ ID NO:37 (see sequence comparisons below). Brown teaches these CARs can be expressed in immune cells (column 2, lines 25-27). Brown does not teach instant SEQ ID NO:4, 8 or 16, nor a scFv.
However, Ackerman does teach antibodies comprising SEQ ID NO:4 and 8 (see sequence comparisons below) as well as scFv (column 5, line 25; column 9, lines 55-56) for the treatment of HSV. Ackerman does not teach the transmembrane domain of instant SEQ ID NO:16
However, Shiku does teach CARs comprising the transmembrane domain of SEQ ID NO:16 (see below).
Therefore, it would have been obvious at the time of the instant invention to have substituted a ligand binding domain for HSV envelope glycoprotein D, as taught by Ackerman, for the ligand binding domain of Brown in order to target the glycoprotein, or any protein of interest, using the universal CAR of Brown. Similarly, it would have been obvious to have used any well-known spacer domain in the CAR of Brown.
SEQ ID NO:31
Patent No. 9914909
GENERAL INFORMATION
APPLICANT: CITY OF HOPE
TITLE OF INVENTION: COSTIMULATORY CHIMERIC ANTIGEN RECEPTOR T CELLS TARGETING
TITLE OF INVENTION: IL13R-ALPHA-2
FILE REFERENCE: 40056-0002WO1
CURRENT APPLICATION NUMBER: US/15/167,869
CURRENT FILING DATE: 2016-05-27
PRIOR APPLICATION NUMBER: PCT/US2015/051089
PRIOR FILING DATE: 2015-09-18
PRIOR APPLICATION NUMBER: 62/053,068
PRIOR FILING DATE: 2014-09-19
NUMBER OF SEQ ID NOS: 54
SEQ ID NO 20
LENGTH: 129
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
NAME/KEY: source
OTHER INFORMATION: /note="Description of Artificial Sequence: Synthetic
polypeptide"
Query Match 100.0%; Score 710; Length 129;
Best Local Similarity 100.0%;
Matches 129; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ESKYGPPCPPCPGGGSSGGGSGGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ESKYGPPCPPCPGGGSSGGGSGGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIA 60
Qy 61 VEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQ 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQ 120
Qy 121 KSLSLSLGK 129
|||||||||
Db 121 KSLSLSLGK 129
SEQ ID NO:34
Patent No. 9914909
GENERAL INFORMATION
APPLICANT: CITY OF HOPE
SEQ ID NO 28
LENGTH: 41
TYPE: PRT
ORGANISM: Homo sapiens
ALIGNMENT:
Query Match 100.0%; Score 231; Length 41;
Best Local Similarity 100.0%;
Matches 41; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RSKRSRGGHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 41
|||||||||||||||||||||||||||||||||||||||||
Db 1 RSKRSRGGHSDYMNMTPRRPGPTRKHYQPYAPPRDFAAYRS 41
SEQ ID NO:4
Patent No. 12378305GENERAL INFORMATION
APPLICANT: Trustees of Dartmouth College
APPLICANT: Duke University
TITLE OF INVENTION: COMPOSITIONS AND METHODS FOR PREVENTING OR AMELIORATING NEONATAL
TITLE OF INVENTION: HSV INFECTION
FILE REFERENCE: 029511-8077
CURRENT APPLICATION NUMBER: US/17/284,427
CURRENT FILING DATE: 2021-04-09
PRIOR APPLICATION NUMBER: 62/744,325
PRIOR FILING DATE: 2018-10-11
PRIOR APPLICATION NUMBER: PCT/US19/55685
PRIOR FILING DATE: 2019-10-10
NUMBER OF SEQ ID NOS: 19
SEQ ID NO 17
LENGTH: 108
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic polypeptide
Query Match 100.0%; Score 555; Length 108;
Best Local Similarity 100.0%;
Matches 108; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPGTLSLSPGERATLSCRASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIP 60
Qy 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPTFGGGTKVEIKR 108
||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPTFGGGTKVEIKR 108
SEQ ID NO:8
SEQ ID NO 16
LENGTH: 121
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic polypeptide
Query Match 100.0%; Score 635; Length 121;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVTLKQSGAEVKKPGSSVKVSCTASGGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKTDY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVTLKQSGAEVKKPGSSVKVSCTASGGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKTDY 60
Qy 61 AQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLVTV 120
SEQ ID NO:16
Patent No. 9175308
GENERAL INFORMATION
APPLICANT: MIE UNIVERSITY
APPLICANT: TAKARA BIO INC.
TITLE OF INVENTION: Chimeric antigen receptor comprising GITR cytoplasmic domain
FILE REFERENCE: 671198
CURRENT APPLICATION NUMBER: US/14/349,763
CURRENT FILING DATE: 2014-04-04
PRIOR APPLICATION NUMBER: JP 2011-222510
PRIOR FILING DATE: 2011-10-7
NUMBER OF SEQ ID NOS: 39
SEQ ID NO 24
LENGTH: 28
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: Human CD28 transmembrane domain
Query Match 100.0%; Score 141; Length 28;
Best Local Similarity 100.0%;
Matches 27; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FWVLVVVGGVLACYSLLVTVAFIIFWV 27
|||||||||||||||||||||||||||
Db 1 FWVLVVVGGVLACYSLLVTVAFIIFWV 27
B. Claims 1, 5, 12, 21, 22 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. in view of Lai et al. (U.S. Patent No. 8,252,906) in view of Shiku et al.
The teachings of Brown and Shiku are seen above. Neither teach SEQ ID NO:4 and 8. However, Lai does (see below).
Therefore, it would have been obvious at the time of the instant invention to have substituted a ligand binding domain for HSV envelope glycoprotein D, as taught by Lai, for the ligand binding domain of Brown in order to target the glycoprotein, or any protein of interest, using the universal CAR of Brown. Similarly, it would have been obvious to have used any well-known spacer domain in the CAR of Brown.
SEQ ID NO:4
Patent No. 8252906
GENERAL INFORMATION
APPLICANT: LAI, Jiann-Shiun
APPLICANT: CHAN, Woan-Eng
TITLE OF INVENTION: ANTI-HERPES SIMPLEX VIRUS ANTIBODIES AND METHODS OF USE THEREOF
FILE REFERENCE: 674232000120
CURRENT APPLICATION NUMBER: US/12/651,325
CURRENT FILING DATE: 2010-03-18
PRIOR APPLICATION NUMBER: 12/348,550
PRIOR FILING DATE: 2009-01-05
NUMBER OF SEQ ID NOS: 45
SEQ ID NO 2
LENGTH: 110
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 555; Length 110;
Best Local Similarity 100.0%;
Matches 108; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EIVLTQSPGTLSLSPGERATLSCRASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EIVLTQSPGTLSLSPGERATLSCRASQSVTSSQLAWYQQKPGQAPRLLISGASNRATGIP 60
Qy 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPTFGGGTKVEIKR 108
||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPTFGGGTKVEIKR 108
SEQ ID NO:8
SEQ ID NO 1
LENGTH: 124
TYPE: PRT
ORGANISM: Homo sapiens
Query Match 100.0%; Score 635; Length 124;
Best Local Similarity 100.0%;
Matches 120; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVTLKQSGAEVKKPGSSVKVSCTASGGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKTDY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3 QVTLKQSGAEVKKPGSSVKVSCTASGGTLRTYGVSWVRQAPGQGLEWLGRTIPLFGKTDY 62
Qy 61 AQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 63 AQKFQGRVTITADKSMDTSFMELTSLTSEDTAVYYCARDLTTLTSYNWWDLWGQGTLVTV 122
C. Claims 8 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. in view of either (1) Ackerman et al., or (2) Lai et al., each in view of Shiku et al. and each further in view of Trinh et al.
The teachings of Brown, Ackerman, Lai and Shiku are seen above. None teach a (GGGGS)3 linker. However, (GGGGS)n linkers were well known in the art at the time of the invention and Trinh teaches a (GGGGS)3 variation which produces “a significant increase in recombinant fusion antibody expression”.
5. Conclusion
A. Claims 1, 5, 8, 12, 21, 22, 27 and 28 are not allowable.
B. Claims 11 and 26 are objected to since sequences are free of the prior art. However, they are otherwise allowable.
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).
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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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