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, 3, 8, 10, 12-16, 18, 20, 26, 30, 31, 33-36 41 and 46) and of the species represented by Cutaneous T-cell lymphoma in the reply filed on 12/18/2025 is acknowledged. Claims 1, 3, 8, 10, 12-16, 18, 20, 26, 30, 31, 33-36 41 and 46 are pending and are examined.
Claim Rejections - 35 USC § 102
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.
Claims 1, 12-16, 18, 20, 30, 31, 33-36, 41 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis et al. (WO 2019133934-cited by Applicant).
Lewis et al. WO 2019/133934 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 and Kaposi sarcoma (table 5). 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 to10 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, 50 μg to 75 μg, 75 μg to 100 μg, 100 μg to 150 μg, 150 μg to 200 μg, 200 μg to 300 μg, 300 μg to 500 μg, 500 μg to 1 mg, or 1mg to 10 mg ([00281]).
Thus, in the broadest reasonable interpretation, the claims 1, 12-16, 18, 30, 31, 33-36, 41 and 46.
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.
Claim 3, 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis et al. (WO 2019133934-cited by Applicant).
The claims add the limitations that the treatment with extracellular vesicle comprising IL-12 results in a 10-100% of an objective response rate or a complete response.
The teachings of Lewis et al. were presented supra and they were silent about the amount of composition needed for a certain percentage of response or the stage that the intervention is needed.
The art at the time that the invention was filed was very mature in assessing the effectiveness of a cancer treatment.
With respect to the decision to first administer the composition comprising EV with IL-12, it is submitted that a skilled artisan would have desired to start the therapeutic administration as soon as possible.
It would have been obvious for a person of ordinary skill in the art to have used known parameters in assessment of the effectiveness of a treatment and determine the dosage and the administration regimen needed to attained a particular effective response percentage with respect to a complete response.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable 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).
The claims of the Patent are drawn to a composition comprising: an extracellular vesicle comprising a cell membrane bounding an enclosed volume, wherein the extracellular vesicle comprises a fusion protein comprising a prostaglandin F2 receptor negative regulator (PTGFRN) or a fragment thereof fused to an immunomodulating component which may be IL-12 and the extracellular vesicle is an exosome. The composition may also comprise an inhibitor of cytotoxic T-lymphocyte-associate protein 4 (CTLA-4), programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), lymphocyte-activated gene 3 (LAG3), T-cell immunoglobulin mucin-containing protein 3 (TIM-3), B and T lymphocyte attenuator (BTLA),or T cell immunoreceptor with Ig and ITIM domains (TIGIT).
The Patent does not claim a method of treatment. However, Lewis et al. (cited above) teaches using exosomes with the same components 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].
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 composition claimed in the Patent to treat CTCL with a reasonable expectation of success since very similar compositions disclosed in the Lewis et al. were disclosed in methods of treatment of CTCL and Kaposi sarcoma.
Claims 1, 12-16, 18, 31, 33-36, 41 and 46 are 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).
The claims of the Patent are drawn to a composition comprising: an extracellular vesicle comprising a fusion protein comprising a prostaglandin F2 receptor negative regulator (PTGFRN) or a fragment thereof sharing at least 90% sequence identity with either SEQ ID NO. 1 or SEQ ID NO. 2, fused to an immunomodulating component which may be IL-2 and an inhibitor for a negative checkpoint regulator or an inhibitor for a binding partner of a negative checkpoint regulator. The extracellular vesicle is an exosome comprising one or two immunomodulating components. The IL-12 cytokine may be expressed as a fusion protein displayed on a surface of the extracellular vesicle. The composition is used for treatment of cancer.
The Patent does not claim a method of treatment of CTCL. However, Lewis et al. (cited above) teaches using exosomes with the same components 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].
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 composition claimed in the Patent to treat CTCL with a reasonable expectation of success since very similar compositions disclosed in the Lewis et al. were disclosed in methods of treatment of CTCL and Kaposi sarcoma.
Claims 1, 12-16, 18, 31, 33-36, 41 and 46 are 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).
The Patent claims are drawn to an exosome comprising a fusion protein which is present on an exterior surface of the exosome, wherein the fusion protein comprises (i) an immunomodulating component and (ii) a prostaglandin F2 receptor negative regulator (PTGFRN) or a functional fragment thereof, and wherein the immunomodulating component comprises an interleukin-12 (IL12) and a pharmaceutical composition comprising it. The exosome may also comprise an inhibitor for a negative checkpoint regulator or an inhibitor for a binding partner of a negative checkpoint regulator. The Patent does not claim a method of treatment. However, Lewis et al. (cited above) teaches using exosomes with the same components 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].
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 composition claimed in the Patent to treat CTCL with a reasonable expectation of success since very similar compositions disclosed in the Lewis et al. were disclosed in methods of treatment of CTCL and Kaposi sarcoma.
Claims 1, 8, 10, 12-16, 18, 30, 31, 33-36, 41 and 46 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).
The claims of the copending Application are drawn to a method of treating a tumor in a subject comprising administering (i) a composition comprising an extracellular vesicle (EV) and a stimulator of interferon genes protein (STING) agonist in combination with (ii) an interleukin 12 (IL-12) moiety. The administering reduces the volume of the tumor by at least two fold, at least three fold, at least four fold, at least five fold, at least six fold, at least seven fold, at least nine fold, or at least ten fold compared to the tumor volume after administering either an extracellular vesicle comprising the STING agonist or the IL-12 moiety (“monotherapy”). The method further comprises administering an anti-cancer agent (a checkpoint inhibitor comprises an anti-PD-1 antibody, an anti-PD-L1 antibody, an anti-CTLA-4 antibody, an anti-LAG-3 antibody, or an anti-TIM-3 antibody). The EV is an exosome overexpressing a Prostaglandin F2 receptor negative regulator (PTGFRN) protein. The IL-12 is linked to the PTGFRN and the composition is the administered parenterally, orally, intravenously, intramuscularly, intra-tumorally, intraperitoneally, or via any other appropriate administration route.
The copending Application does not claim a method of treatment of CTCL. However, Lewis et al. (cited above) teaches using exosomes with the same components 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].
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 composition claimed in the copending Application to treat CTCL with a reasonable expectation of success since very similar compositions disclosed in the Lewis et al. were disclosed in methods of treatment of CTCL and Kaposi sarcoma.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647