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 .
Claims 1-42 are pending as originally filed, and are considered herein.
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 9 and 18 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 9 is rejected. Claim 9 refers to “Dryvax”, which is a registered trademark. Because the composition of such is not constant, but is owned by the holder of the trademark, the metes and bounds of the composition are not clear.
Claim 9 recites “Dryvax” and “New York City Board of Health” vaccinia viruses. As best the Examiner can determine, these are the same virus. Thus, it would lead to confusion as to why both are claimed, in a Markush, where the equivalence is not indicated.
Claim 18 is rejected. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation at least 16 hours, and the claim also recites “at least 20 hours or at least 24 hours” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-63 of U.S. Patent No. 11,655,455. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claim 1 of the patent is the same as present claim, but lists an MOI of 0.001 to less than 1, incubation for 6-96 hours, and does not state the cells are not lysed due to the low MOI. However, in the art, a low MOI is considered to be less than 1, 6-96 hours is enough time to express the protein, and the low MOI not causing rupture is assumed to occur, as the structure is present. Claims 20-21 list other low MOI embodiments. Claim 39 teaches a method which produces the same, through the incubation, low MOI of 0.001-10 hours, for 6-48 hours, similar to Claim 1 being infringing, and here the steps result in the CAVES. Claim 47 is to a pharmaceutical composition, with similar embodiments infringing for similar reasons.
Claim 2: Claims 2 and 48-49 teach infringing embodiments.
Claim 3: e.g., Claims 3 and 50 teach infringing viruses, e.g., poxvirus.
Claim 4: e.g., Claims 4 and 58 teach infringing viruses, e.g., parvovirus.
Claim 5: e.g., Claims 5-6, 8-9, 22, 27, 32, 36, 53, 55, 57, 59 and 62-63 teach vaccinia virus.
Claim 6: e.g., Claims 1, 18, 19, 39, 47, 58-59, and 62-63 teach incubations infringing 2 or more hours.
Claim 7: e.g., Claims 6, 55, and 62 teach TK+ vaccinia.
Claim 8: e.g., Claims 8, 57 and 59 teach A34R mutation for EEV production.
Claim 9: e.g., Claim 9, 22, and 63 teaches infringing vaccinia viruses.
Claim 10: e.g., Claim 10 teaches the same cells.
Claim 11: e.g., Claims 2, 10-14, 46, and 48-49 teach infringing cell types.
Claim 12: e.g., Claims 10 and 12 teach MSCs.
Claim 13: e.g., Claims 11, 13-14 teach adipose stromal stem cells.
Claim 14: e.g., Claim 14 teaches infringing embodiments.
Claim 15: e.g., Claim 15, 51, and 59-60 teach the same treatment/modification for enhancing immunosuppressive/immunopriviledged properties and optional enhancing of amplification of the virus in the cell.
Claim 16: e.g., Claim 16 teraches the oncogene/tumor suppressor engineering of the cell.
Claim 17: e.g., Claim 17 teaches the same engineering to express the same Markush.
Claim 18: e.g., Claim 18 teaches the same 16/20/24 hours minimum.
Claim 19: e.g., Claims 19 and 29 teach up to 48 hours.
Claim 20: e.g., Claims 9, 22, and 63 teach infringing embodiments.
Claim 21: e.g., Claim 23 teaches SEQ ID NO: 71.
Claim 22: As shown above, the compositions so-made are claimed, and results from the methods.
Claim 23-24: e.g., Claim 26 teaches therapeutic products that treat tumors, including reprogramming blood vessels of the tumor, and T-cell infiltration into the tumor microenvironment.
Claim 25: e.g., Claim 27 teaches the same deletions/insertions in the same regions, where the virus attenuated.
Claim 26: e.g., Claim 28 teaches the same method of treatment of a subject with a solid tumor or hematologic malignancy (cancers), with administration of the CAVES.
Claim 27: e.g., Claim 29 teaches systemic administration.
Claim 29: e.g., Claim 31 teaches IV.
Claim 30: e.g., Claim 32 teaches vaccinia.
Claim 31: e.g., Claim 33 teaches the same cancers.
Claim 32: e.g., Claim 35 teaches allogeneic cells.
Claim 33: e.g., Claim 36 teaches a stem cell and vaccinia virus.
Claim 34: Claim 10 teaches neural stem cells.
Claim 35: e.g., Claim 37 teaches a second anticancer agent/treatment.
Claim 36: e.g., Claim 38 teaches checkpoint inhibitors, CAR-T or TIL cells.
Claim 37: Similar to the analysis above, Claim 38 teaches infringing embodiments for a method of producting cell-assisted viral expression system, with oncovirus incubation with carrier cells, and low MOI and up to 48 hours incubation, , recovering and storing.
Claim 38: e.g., Claim 48 parallels Claim 38 to infringe with the same steps of providing and administering.
Claim 39: e.g., Claim 41 teaches systemic administration.
Claim 40: e.g., Claims 43 and 45 teach infringing expression modifications.
Claim 41: e.g., Claims 47-57 teach the pharmaceutical compositions with vehicle.
Claim 42: e.g., Claim 50 teaches the same Markush of oncolytic viruses.
Thus, considering the patent, the invention is obvious. The Artisan would make it, and expect success, as it is claimed subject matter.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638