DETAILED ACTION
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. Applicant's preliminary amendment filed on 11/16/2025 is acknowledged.
Claims 2-22 are pending.
3. Claim 22 is object to because of apparently redundant recitations of “pembrolizumab” and “MK-3475,” which refer to the same product. Appropriate correction or clarification is required.
4. 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.
5. Claims 7, 16 and 21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 7 is indefinite, because the purpose of the “testing” is unknown, and it is unknown how the results of “measuring” are interpreted or utilized.
(ii) Claim 16 is indefinite in the recitation of “a second composition,” because the composition of the “composition” is not defined.
(iii) Claim 21 is indefinite in the recitation of “CCRY,” because it is unknown what the abbreviation stands for.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. The following is a quotation 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.
7. Claim 21 is rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treating a tumor comprising administering an inhibitor of LAG-3, PD-L1, or B7H3, does not reasonably provide enablement for a method of treating a tumor comprising administering an inhibitor of CD137, CD134, OX-40, CD40, B7.1, or generically recited “KIR.” The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to make and use the invention commensurate with the scope of the claims without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
A person of skill in the art would be aware that CD137, CD134, OX-40, and CD40 are activators of immune response, B7.1 acts as an activator or an inhibitor, and the genus of “KIR” molecules contains both activatory and inhibitory members. Therefore, administration of inhibitors of these molecules would almost certainly exacerbate rather than treat cancer. Accordingly, a skilled artisan would reasonably conclude that experimentation to that effect would be improper and undue.
8. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
9. Claims 2-6 and 8-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11612426.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of US ‘426. The latter are directed to methods of treating a tumor comprising intratumorally administering a CTLA-4 inhibitor, a PD-1 inhibitor, and GM-CSF, and ablating the tumor using cryoablation and RF-EMB type ablation (claim 1).
The composition is injected in a single dose or in more than one dose (claim 8), comprises the CTLA-4 inhibitor at a concentration of approximately 0.5 to 10 mg/ml, the PD-1 inhibitor at a concentration of approximately 0.5 to 20 mg/ml, and the GM-CSF at a concentration of approximately 10 to 500 μg/ml (claim 9), and further comprises a cytokine selected from IL-6, IL-4, TNF, IFNγ, and IFNα (claim 12), and an inhibitor of LAG-3 or PD-L1 (claim 13), wherein the CTLA-4 inhibitor is ipilimumab or tremelimumab and the PD-1 inhibitor is pembrolizumab, nivolumab, pidilizumab, or MEDI 4736 (claim 14). The method further comprises administering subcutaneously a second cytokine (claim 7). Accordingly, US ‘426 claims anticipate instant claims 2-4, 8-10, 13, 15, and 18-22.
The limitations of instant claim 14 are inherent in US ‘426 claims, and the limitations of instant claims 5-6, 11-12, and 16-18 would be at once envisaged by a skilled artisan, or obvious to a skilled artisan, in view of US ‘426 claims.
Claim 7 is not presently included in the rejection because its scope is unknown, but could be included, if appropriate, once the scope is clarified.
10. Claims 2-6 and 8-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11497544 (cited on IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or obvious over the claims of each of US ‘544. The latter are directed to methods of treating a tumor comprising intratumorally administering a composition comprising a CTLA-4 inhibitor, a PD-1 inhibitor, and GM-CSF, and ablating the tumor using cryoablation and RF-EMB type ablation (claim 11), thereby anticipating instant claims 2-4 and 13.
The limitations of instant claim 14 are inherent in US ‘544 claims, and the limitations of instant claims 5-6, 8-12, and 15-22 would be at once envisaged by a skilled artisan, or obvious to a skilled artisan, in view of US ‘544 claims.
In particular, claim 19 is included in the rejection, because the recited concentration ranges are very broad, and it is within the skill in the art to optimize result-effective variables. Claims 20-22 are included because, for example, IFNα, PD-L1 inhibitory antibodies, and ipilimumab and nivolumab are approved for cancer treatment.
Claim 7 is not presently included in the rejection because its scope is unknown, but could be included, if appropriate, once the scope is clarified.
11. Conclusion: no claim is allowed.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644