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 .
Response to Amendment
In the amendment filed on 05/04/2026 Applicant amended claims 1, 8, 10, 15, 16, 18, 26, 41, and 46. Claims 1, 3, 8, 10, 12-16, 18, 20, 26, 30, 31, 33-36, 41, and 46 are pending and are examined.
Withdrawn claim rejections
Claim Rejections - 35 USC § 102
The rejection of claims 1, 12-16, 18, 20, 30, 31, 33-36, 41 and 46 under 35 U.S.C. 102(a)(1) as being anticipated by Lewis et al. (WO 2019133934) is withdrawn in view of the amendments to the claims.
New and Maintained claim rejections
Claim Rejections - 35 USC § 103
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.
Claims 1, 3, 8, 10, 12-16, 18, 20, 30, 31, 33-36, 41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (WO 2019133934).
The claims are drawn to a method of treating cutaneous T-cell lymphoma (CTCL), in a subject in need thereof comprising administering an extracellular vesicle (EV) comprising Interleukin-12 (IL-12), wherein the IL-12 comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 2, 3 or 4, wherein the EV is administered at a therapeutically effective amount, and wherein the therapeutically effective amount exhibits less systemic toxicity in the subject compared to the administration of the same dose of recombinant IL-12. The CTCL is a stage IA-IIB and the administration results in at least 10% complete response or at least 20% objective response rate. The EV further comprises a scaffold moiety (Scaffold X) with has the IL-12 linked to it. The scaffold moiety may be prostaglandin F2 receptor negative regulator (the PTGFRN protein). The EV may be an exosome and may be administered parenterally, orally, intravenously, intramuscularly, intra-tumorally, intranasally, subcutaneously, or intraperitoneally. The method may further comprise an anti-neoplastic agent, which may be an immune checkpoint inhibitor. The therapeutically effective amount may be 0.3-12 µg in one or more doses (once about every week, once about every other week, once about every three weeks, once about every four weeks, once about every 10 to 18 days, once about every 12 to about 16 days, once about every 14 to about 21 days, once about every 10 to 14 days, or once about every 14 to about 18 days).
Lewis et al. discloses a composition comprising an extracellular vesicle which comprises a first immunomodulating component which may be IL-12 either p35 or p70 , and further comprises PTGFRN (Example 10; claims 33-36, 39-41, 57). The exosomes may be used for treating various cancers by administering to the subject a therapeutically effective amount of the composition, wherein the composition is capable of up-regulating an immune response in the subject, thereby enhancing the tumor targeting of the subject's immune system [0038]. The extracellular vesicle comprises an immunomodulating component that is chemically conjugated, with or without use of a linker ([00251]). Within the cancers to be treated are Cutaneous T-Cell Lymphoma. The composition may be administered orally, pulmonarily, intranasally, parenterally (intravenously, intra-arterially, intramuscularly, or intraperitoneally) ([0125]). Doses of extracellular vesicles are administered at intervals such as once daily, every other day, once weekly, twice weekly, once monthly or twice monthly ([00283]). The dosage of the extracellular vesicles is between 1ng to 10 ng, 10 ng to 100 ng, 100 ng to 1 μg, 1 μg to 5 μg, 5 μg to 10 μg, 10 μg to 50 μg ([00281]). The method is used for treating cancer by administering to the subject a therapeutically effective amount of the composition, wherein the composition is capable of up-regulating an immune response in the subject, thereby enhancing the tumor targeting of the subject's immune system ([0038]).
It would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have considered the teachings of Lewis et al. and successfully perform a method of treating cutaneous T-cell lymphoma (CTCL), in a subject in need thereof comprising administering an extracellular vesicle (EV) comprising Interleukin-12 (IL-12), wherein the IL-12 comprises an amino acid sequence having at least 90% sequence identity to SEQ ID NO: 2, 3 or 4, wherein the EV is administered at a therapeutically effective amount, and wherein the therapeutically effective amount exhibits less systemic toxicity in the subject compared to the administration of the same dose of recombinant IL-12. This is because Lewis et al. used the method for treating cancers and even mentioned the treatment of CTCL. All a skilled artisan would have to do is perform a routine experimentation of dosages, within the limits set up by Lewis et al. and arrive to the instant Invention.
On page 6 of the Remarks Applicant argues: “Lewis does not disclose a method of treating cutaneous T-cell lymphoma in a subject need thereof comprising administering an extracellular vesicle (EV) comprising IL-12, wherein the EV is administered at a therapeutically effective amount, and wherein the therapeutically effective amount exhibits less systemic toxicity in the subject compared to the administration of the same dose of recombinant IL-12, as presently claimed.”
The arguments were carefully considered but not found persuasive because Lewis teaches that the he exosomes may be used for treating various cancers by administering to the subject a therapeutically effective amount of the composition, wherein the composition is capable of up-regulating an immune response in the subject, thereby enhancing the tumor targeting of the subject's immune system. Since the composition is the same, all what a person of ordinary skill in the art had to do is routinely experiment with the taught dosage until the desired effect had been achieved.
A person of ordinary skill in the art is always motivated to pursue the known
options within her or his technical grasp. If this leads to the anticipated success, it is
likely the product not of innovation but of ordinary skill and common sense.
Double Patenting
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 12-16, 18, 31, 33-36, 41 and 46 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims over claims 1, 2, 4, 6, 7, 9 and 17-19 of U.S. Patent No. 10,723,782 in view of Lewis et al. (WO 2019133934-cited by Applicant) for reasons of record.
Claims 1, 12-16, 18, 31, 33-36, 41 and 46 remain rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1-7 and 14 of U.S.
Patent No. 12,030,924 in view of Lewis et al. (WO 2019133934-cited by Applicant) for reasons of record.
Claims 1, 12-16, 18, 31, 33-36, 41 and 46 remain rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 5-10, 12-14 and 19-20
of U.S. Patent No. 12,331,100 in view of Lewis et al. (WO 2019133934-cited by
Applicant) for reasons of record.
Claims 1, 8, 10, 12-16, 18, 30, 31, 33-36, 41 and 46 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23, 27, 31 and 42-52 of copending Application No. 17/763,973 in view of Lewis et al. (cited above) for reasons of record.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/ Primary Examiner, Art Unit 1647
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