Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The priority information in this application has been changed such that the instant application is a CIP of 17/351,040, which claims benefit of 63/041,727. Thus, the earliest effective filing date for which the instant claims may receive benefit is 06/19/20.
NEW GROUND OF REJECTION NECESSITATED BY THE AMENDMENT
3. 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.
4. 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.
5. 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.
6. 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.
7. Claims 1-3, 5, 7-9, 13, 17-18, and 21-31 are rejected under 35 U.S.C. 103 as being unpatentable over Lefkowitz et al. (US 2021/0301342; effective filing date at least 09/06/19) in view of Rezvani et al. (US 2018/0353544).
Regarding independent claim 1, Lefkowitz discloses a method comprising receiving a sample from a subject who has received a transplant or allograft, isolating recipient and donor derived nucleic acids from the sample, amplifying said nucleic acids, and without consideration of genotype information from said subject, detecting said nucleic acids by sequencing a panel of SNPs. See paragraphs 0014-0029, 0090, 0159, 0199-0249, and claims 11, 12, and 13.
Lefkowitz does not disclose application of the method to a subject having or suspected of having a hematologic cancer, who has received allogeneic cells, such as NK cells.
Rezvani discloses treating a subject having a hematologic cancer (e.g., leukemia) with NK cells, and that it is desirable to determine the status of such a transplantation. See abstract and paragraphs 0003, 0005-0009, 0015.
One of ordinary skill in the art would have been motivated to modify the method of Lefkowitz by applying it to a subject having or suspected of having a hematologic cancer such as leukemia, and who has accordingly been treated with allogeneic cells such as NK cells, because Rezvani disclosed this type of transplant or allograft in treating hematologic cancer, and that there was a need to determine transplantation outcome or success. Thus, there would have been suggestion with reasonable likelihood of success in using the method of Lefkowitz to determine transplantation outcome in cancer patients treated with NK cells. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed methods.
Regarding dependent claims 2-3, 5, 7-9, 13, 17-18, and 21-31, the further limitations would have merely involved straightforward, logical scientific reasoning, or routine optimization of known-important reaction parameters, which as well established in US patent practice does not support unobviousness (M.P.E.P. 2144.05).
CONCLUSION
8. No claims are free of the prior art.
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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08/20/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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