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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8, 11 and 13) in the reply filed on 7/17/2026 is acknowledged.
Claims 15-16 and 20-31 have been canceled, claims 9-10, 12, 14, 17-19 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-8, 11 and 13 have been considered on the merits.
Claim Objections
Claim 8 is objected to because of the following informalities: Claim 8 discloses “a stimulation with IL-2”. It would be more appropriate as “a step of stimulating the NK cells with IL-2” instead. Appropriate correction is required.
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 6-7 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.
Claim 6 discloses a table showing the structure of the compound belonging to Formula IIa. It is not clear what term term “Ex” in the table intends to point out. Does this term “Ex” provides any meaning to the compound or limiting the structure? Clarification is required.
The table of Claim 6 discloses one last item with “Ex” being “L598”. It is not clear what subject matter this “L598” intends to point out and it is vague whether it is required for the claimed method. Furthermore, there is no particular structure shown in the box other than “Br”. Clarification is required.
Claim 7 discloses the compound of Formula Ia, however, the structure of the Formula shown in the claim appears to belong to Formula II or IIa. Clarification is required. For search purpose, the claim is examined as the compound of claim 7 is further limiting the formula IIa of claim 5 instead.
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.
Claim(s) 1-8, 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinganis et al. (WO2021/108867A1; IDS ref.) in view of Tremblay et al. (WO2019/036815; IDS ref.).
Tinganis et al. teach a method for activating leukocytes using a PTP1B inhibitor and a PTPN2 inhibitor for immunotherapy (p.3-4), and the leukocytes for the method include Natural Killer (NK) cells (p.4, lines 11-12). Tinganis et al. teach that a PTP1B inhibitor reduces phosphatase activity of PTP1B (p.34).
Tinganis et al. do not particularly teach the compound of structural Formula I, Formula II or pharmaceutically acceptable salts thereof (Claims 1-7).
Tremblay et al. teach an ex vivo method of treating an isolated primary cell with an effective amount of a compound of structural Formula I (para. 74). The compounds of Formula I or II are inhibitors of the PTPN1 (PTP1B) and PTPN2 (CT-PTP) (para. 5). The compounds taught by Tremblay et al. are identical to the claimed inhibitors having Formula I and II (para. 11 and para. 89) of claim 1.
Regarding the “effective amount” of the compound as claimed, while Tinganis et al. do not particularly teach the limitation, however, one skilled in the art would use the amount of the PTP1B inhibitor sufficient to inhibit the enzyme. Furthermore, the effective amount is for stimulating NK cells, and there is no particular amount claimed. As the inhibition of the phosphatase by PTP1B inhibitor would necessarily result in the activation of NK cells, and Trembley et al. teach the effective amount of a compound for stimulating leukocytes including NK cells. Thus, the combined teachings of the cited references would meet the “effective amount”.
Regarding claims 2-4, Tremblay et al. teach the Formula Ia (para. 75), Formula Ib (para. 76), structures of claim 4 (para. 77).
Regarding the Formula IIa of claim 5, the compounds listed in claim 6, or the formula of claim 7, Tremblay et al. teach the compound of Formula II (para. 90, the second structure), which is identical to Ex4 of claim 6 and claim 7.
Thus, it would have been obvious to a person skilled in the art to use the compounds of Formula I or II taught by Tremblay et al. as the PTP1B inhibitor in the method of Tinganis et al. with a reasonable expectation of success. Particularly, Tinganis et al. teach that the PTP1B inhibitor can be small molecules (p.18, lines 28-29; p.34, lines 6-11), and one skilled in the art would recognize that the inhibitor of PTP1B taught by Trembley et al. would be suitable for the purpose.
Regarding claim 8 directed to an additional step of activating with IL-2, Tiganis et al. teach that a composition comprising the cytotoxic leukocytes (e.g., CDS+ T cells, NK cells, etc) and a PTP1 B inhibitor and/or a PTPN2 inhibitor may further include the cancer specific antigen and/or one or more cytokines to enhance cell killing (such as IL-2 or IFNy) (p.52, lines 7-10).
Regarding claim 11 directed to the NK cells being isolated from a human subject, while Tinganis et al. do not particularly disclose “human” NK cells, however, they teach the lymphocytes can be isolated from an allogenic donor with HLA matched (p.31, lines 5-8), and this teaching indicates that the NK cells can be isolated from a human subject. As the method of Tinaganis et al. utilize NK cells isolated from a donor for the inhibition, this teaching would meet the “ex vivo” method as claimed.
Regarding claim 13 directed to the isolated NK cell further comprising a CAR, Tinganis et al. teach that the leukocytes (preferably T cells or NK cells) may also be genetically engineered to express anti-tumor T cell receptors or chimeric antigen receptors (CARs) (p.4, lines 14-16).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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, JAMES SCHULTZ can be reached at 571-272-0763. 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.
/TAEYOON KIM/ Primary Examiner, Art Unit 1631
Prosecution Insights