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
2. Claims 1-20 are pending and currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) for benefit of the earlier filing date of application, is acknowledged.
4. 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 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.
Claim Rejections - 35 USC § 102
5. 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.
6. Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bobilev et al. (US 20190322746, published on 10/24/2019).
Claims 1-20 are herein drawn to a method for treating mismatch repair deficient (MMRd) rectal cancer in a patient in need thereof comprising administering to the patient an effective amount of an anti-PD1 antibody or an antigen binding fragment thereof, wherein the anti-PD 1 antibody or antigen binding fragment comprises a heavy chain immunoglobulin variable domain (VH) and a light chain immunoglobulin variable domain (VL), wherein the VH comprises a VH-CDR1 sequence of SEQ ID NO: 5, a VH-CDR2 sequence of SEQ ID NO: 6, and a VH-CDR3 sequence of SEQ ID NO: 7 and the VL comprises a VL-CDR1 sequence of SEQ ID NO: 8, a VL-CDR2 sequence of SEQ ID NO: 9, and a VL-CDR3 sequence of SEQ ID NO: 10, and wherein the patient has not received a prior cancer therapy, wherein the VH comprises the sequence of SEQ ID NO: 3 and the VL comprises the sequence of SEQ ID NO: 1.
Bobilev et al. teach a method of treating cancer, the method comprising administering an anti-PD-1 antibody, wherein the anti-PD-1 antibody comprising VH set forth in SEQ ID NO: 17 and VL set forth in SEQ ID NO: 18; see [0243-0245]. Bobilev et al. teach the cancer is colorectal cancer; see [0053]. Bobilev et al. teach the colorectal cancer has a defective DNA mismatch repair (MMRd) system; see [0047-0048], [0053], [0210], [0216-0218].
It is well known that colorectal cancer includes rectal cancer and/or colon cancer.
SEQ ID NOs: 17-18 of Bobilev et al. are 100% identical with the instant claimed SEQ ID NOs: 3 and 1; see below sequence alignment 1.
For claim 3, Bobilev et al. teach the anti-PD-1 antibody comprising a heavy chain (HC) set forth in SEQ ID NO: 13 and a light chain (LC) set forth in SEQ ID NO: 14; see [0247-0248]. SEQ ID NOs: 13-14 of Bobilev et al. are 100% identical with the instant claimed SEQ ID NOs: 4 and 2; see below sequence alignment 2.
For claims 4-7, 9-10, 12 and 17-19, a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, MPEP 2111.04.
For claim 8, Bobilev et al. teach Lynch Syndrome; see [0209].
For claim 11, Bobilev et al. teach prior cancer therapy includes surgery, radiotherapy, chemotherapy, or immunotherapy; see [0083-0084].
For claim 13, Bobilev et al. teach the antibody fragments include Fab, F(ab')2, Fab', scFv, and Fv; see [0149].
For claim 14, Bobilev et al. teach that the anti-PD 1 antibody is administered intravenously; see claim 150.
For claims 15-16, Bobilev et al. teach dose and treatment schedules of anti-PD1 antibody; see claims 72-79.
For claim 20, Bobilev et al. teach that the MMRd is detected by an immunohistochemistry (IHC); see [0210].
Claim Rejections - 35 USC § 103
7. 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 of this title, 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.
8. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
9. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz et al. (US 20190023787, published on 01/24/2019) in view of Bobilev et al. (US 20190322746, published on 10/24/2019).
Claims 1-20 are herein drawn to a method for treating mismatch repair deficient (MMRd) rectal cancer in a patient in need thereof comprising administering to the patient an effective amount of an anti-PD1 antibody or an antigen binding fragment thereof, wherein the anti-PD 1 antibody or antigen binding fragment comprises a heavy chain immunoglobulin variable domain (VH) and a light chain immunoglobulin variable domain (VL), wherein the VH comprises a VH-CDR1 sequence of SEQ ID NO: 5, a VH-CDR2 sequence of SEQ ID NO: 6, and a VH-CDR3 sequence of SEQ ID NO: 7 and the VL comprises a VL-CDR1 sequence of SEQ ID NO: 8, a VL-CDR2 sequence of SEQ ID NO: 9, and a VL-CDR3 sequence of SEQ ID NO: 10, and wherein the patient has not received a prior cancer therapy, wherein the VH comprises the sequence of SEQ ID NO: 3 and the VL comprises the sequence of SEQ ID NO: 1.
Diaz et al. teach a method for treating colorectal cancer in a patient, wherein the patient has been determined to have a tumor that exhibits a mismatch repair (MMR) deficiency status, the method comprises administering an effective amount of an anti-PD-1 antibody to the patient; see entire document, e.g., Figures 1-2, Examples, claims 1-29.
For claims 4-7, 9-10, 12 and 17-19, a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, MPEP 2111.04.
Diaz et al. teach the colorectal cancer has Lynch Syndrome (instant claim 8); see [0011].
Diaz et al. teach that the prior cancer therapy drug was fluoropyrimidine, or oxaliplatin (instant claim 11); see claim 16.
Diaz et al. teach that the anti-PD-1 antibody is administered by intravenous infusion (instant claim 14); see claim 28.
Diaz et al. teach that the mismatch repair (MMR) deficiency status in the tumor is determined by immunohistochemistry (instant claim 20); see claims 6 and 20.
Diaz et al. do not teach the anti-PD1 antibody comprising the VH comprises the sequence of SEQ ID NO: 3 and the VL comprises the sequence of SEQ ID NO: 1.
However, these deficiencies are remedied by Bobilev et al.
Bobilev et al. teach a method of treating cancer, the method comprising administering an anti-PD-1 antibody, wherein the anti-PD-1 antibody comprising VH set forth in SEQ ID NO: 17 and VL set forth in SEQ ID NO: 18; see [0243-0245]. Bobilev et al. teach the cancer is colorectal cancer; see [0053].
SEQ ID NOs: 17-18 of Bobilev et al. are 100% identical with the instant claimed SEQ ID NOs: 3 and 1; see below sequence alignment 1.
Bobilev et al. teach the anti-PD-1 antibody comprising a heavy chain (HC) set forth in SEQ ID NO: 13 and a light chain (LC) set forth in SEQ ID NO: 14; see [0247-0248]. SEQ ID NOs: 13-14 of Bobilev et al. are 100% identical with the instant claimed SEQ ID NOs: 4 and 2; see below sequence alignment 2.
Bobilev et al. teach the antibody fragments include Fab, F(ab')2, Fab', scFv, and Fv (instant claim 13); see [0149].
Bobilev et al. teach dose and treatment schedules of anti-PD1 antibody (instant claims 15-16); see claims 72-79.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to treat colorectal cancer in a patient, wherein the patient has been determined to have a tumor that exhibits a mismatch repair (MMR) deficiency status, the method comprises administering an effective amount of an anti-PD-1 antibody to the patient, wherein the anti-PD-1 antibody comprising instant claimed SEQ ID NOs. One would have been motivated to do so because Diaz et al. teach a method for treating colorectal cancer in a patient, wherein the patient has been determined to have a tumor that exhibits a mismatch repair (MMR) deficiency status, the method comprises administering an effective amount of an anti-PD-1 antibody to the patient; Bobilev et al. teach a method of treating colorectal cancer, the method comprising administering an anti-PD-1 antibody, wherein the anti-PD-1 antibody comprising VH set forth in SEQ ID NO: 17 and VL set forth in SEQ ID NO: 18, SEQ ID NOs: 17-18 of Bobilev et al. are 100% identical with the instant claimed SEQ ID NOs: 3 and 1. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to substitute the anti-PD1 antibody of Diaz et al. for another anti-PD1 antibody of Bobilev et al., because simple substitution of the anti-PD1 antibody of Diaz et al. for another anti-PD1 antibody of Bobilev et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of the anti-PD1 antibody of Diaz et al. for another anti-PD1 antibody of Bobilev et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Conclusion
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 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, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YAN XIAO/Primary Examiner, Art Unit 1642
Sequence alignment 1
US-16-476-534-17
Filing date in PALM: 2019-07-08
Sequence 17, US/16476534
Publication No. US20190322746A1
GENERAL INFORMATION
APPLICANT: Tesaro, Inc.
TITLE OF INVENTION: METHODS OF TREATING CANCER WITH ANTI-TIM-3 ANTIBODIES
FILE REFERENCE: TSR-002WO
CURRENT APPLICATION NUMBER: US/16/476,534
CURRENT FILING DATE: 2019-07-08
PRIOR APPLICATION NUMBER: 62/444,354
PRIOR FILING DATE: 2017-01-09
PRIOR APPLICATION NUMBER: 62/582,272
PRIOR FILING DATE: 2017-09-06
NUMBER OF SEQ ID NOS: 26
SEQ ID NO 17
LENGTH: 116
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
Query Match 100.0%; Score 614; Length 116;
Best Local Similarity 100.0%;
Matches 116; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISGGGSYTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISGGGSYTYY 60
Qy 61 QDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCASPYYAMDYWGQGTTVTVSS 116
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCASPYYAMDYWGQGTTVTVSS 116
US-16-476-534-18
Filing date in PALM: 2019-07-08
Sequence 18, US/16476534
Publication No. US20190322746A1
GENERAL INFORMATION
APPLICANT: Tesaro, Inc.
TITLE OF INVENTION: METHODS OF TREATING CANCER WITH ANTI-TIM-3 ANTIBODIES
FILE REFERENCE: TSR-002WO
CURRENT APPLICATION NUMBER: US/16/476,534
CURRENT FILING DATE: 2019-07-08
PRIOR APPLICATION NUMBER: 62/444,354
PRIOR FILING DATE: 2017-01-09
PRIOR APPLICATION NUMBER: 62/582,272
PRIOR FILING DATE: 2017-09-06
NUMBER OF SEQ ID NOS: 26
SEQ ID NO 18
LENGTH: 107
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
Query Match 100.0%; Score 573; Length 107;
Best Local Similarity 100.0%;
Matches 107; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSFLSAYVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASTLHTGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQLTQSPSFLSAYVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASTLHTGVPS 60
Qy 61 RFSGSGSGTEFTLTISSLQPEDFATYYCQHYSSYPWTFGQGTKLEIK 107
|||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTEFTLTISSLQPEDFATYYCQHYSSYPWTFGQGTKLEIK 107
Sequence alignment 2
US-16-476-534-13
Filing date in PALM: 2019-07-08
Sequence 13, US/16476534
Publication No. US20190322746A1
GENERAL INFORMATION
APPLICANT: Tesaro, Inc.
TITLE OF INVENTION: METHODS OF TREATING CANCER WITH ANTI-TIM-3 ANTIBODIES
FILE REFERENCE: TSR-002WO
CURRENT APPLICATION NUMBER: US/16/476,534
CURRENT FILING DATE: 2019-07-08
PRIOR APPLICATION NUMBER: 62/444,354
PRIOR FILING DATE: 2017-01-09
PRIOR APPLICATION NUMBER: 62/582,272
PRIOR FILING DATE: 2017-09-06
NUMBER OF SEQ ID NOS: 26
SEQ ID NO 13
LENGTH: 443
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
Query Match 100.0%; Score 2360; Length 443;
Best Local Similarity 100.0%;
Matches 443; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISGGGSYTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYDMSWVRQAPGKGLEWVSTISGGGSYTYY 60
Qy 61 QDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCASPYYAMDYWGQGTTVTVSSASTK 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QDSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCASPYYAMDYWGQGTTVTVSSASTK 120
Qy 121 GPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 GPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYS 180
Qy 181 LSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFP 240
Qy 241 PKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVS 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVS 300
Qy 301 VLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVS 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 VLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVS 360
Qy 361 LTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFS 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFS 420
Qy 421 CSVMHEALHNHYTQKSLSLSLGK 443
|||||||||||||||||||||||
Db 421 CSVMHEALHNHYTQKSLSLSLGK 443
US-16-476-534-14
Filing date in PALM: 2019-07-08
Sequence 14, US/16476534
Publication No. US20190322746A1
GENERAL INFORMATION
APPLICANT: Tesaro, Inc.
TITLE OF INVENTION: METHODS OF TREATING CANCER WITH ANTI-TIM-3 ANTIBODIES
FILE REFERENCE: TSR-002WO
CURRENT APPLICATION NUMBER: US/16/476,534
CURRENT FILING DATE: 2019-07-08
PRIOR APPLICATION NUMBER: 62/444,354
PRIOR FILING DATE: 2017-01-09
PRIOR APPLICATION NUMBER: 62/582,272
PRIOR FILING DATE: 2017-09-06
NUMBER OF SEQ ID NOS: 26
SEQ ID NO 14
LENGTH: 214
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic Polypeptide
Query Match 100.0%; Score 1126; Length 214;
Best Local Similarity 100.0%;
Matches 214; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DIQLTQSPSFLSAYVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASTLHTGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQLTQSPSFLSAYVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASTLHTGVPS 60
Qy 61 RFSGSGSGTEFTLTISSLQPEDFATYYCQHYSSYPWTFGQGTKLEIKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGTEFTLTISSLQPEDFATYYCQHYSSYPWTFGQGTKLEIKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214