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 .
Priority
This application is a continuation of 16996586 filed on 08/18/2020 now patented, which is a continuation of PCT/US2019/058641 filed on 10/29/2019. Applicants’ claim for the benefit of a prior- filed application parent provisional application 62752711 filed on 10/30/2018 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The Information Disclosure Statement filed 09/15/2023 and 12/04/2024 have been considered by the Examiner.
Status of Claims
Claims 1-4, 7-21, 29-35 are under examination.
Claims 5-6, 22-28, and 36-42 are cancelled.
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 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a composition of live mammalian cells formulated for oral delivery to an individual, the composition comprising (a) an enteric coating, (b) a matrix “about 1.0% to about 2%” methyl cellulose and “about 1.0% to about 2%” alginate gel, and (c) a plurality of live mammalian cells, wherein the plurality of live mammalian cells is suspended in the matrix. All claims fall within the “about 1.0% to about 2%” range because they are within 0.5% which would still be considered about 1%.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require methyl cellulose and alginate gel are present at a ratio of about 1:1.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the plurality of live mammalian cells comprises at least 10,000 cells.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require live mammalian cells comprise human cells.
Claims 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the live mammalian cells comprises non-human cells which can be canine cells, bovine cells, feline cells, porcine cells, equine cells, or ovine cells.
Claims 11 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because both require live mammalian cells comprises at least two types of cells.
Claims 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require plurality of live mammalian cells comprises multipotent cells.
Claims 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require mesenchymal stem cells, the mesenchymal stem cells are Type 2 mesenchymal stem cells.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable U.S. Patent No. 11707489.With regard to claim 15, upon reading claim 11 of U.S. Patent No. 11707489 a person of ordinary skill in the art would consult the specification of ’489 to determine suitable mesenchymal stem cells. Within the specification of ’489 one of ordinary skill in the art would find that Type I cells are suitable for use in the composition (column 1, lines 53-54).Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because both require the mesenchymal stem cells are Type 2 mesenchymal stem cells.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require wherein the plurality of live mammalian cells comprise immune cells.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable U.S. Patent No. 11707489.With regard to claim 18, upon reading claim 13 of U.S. Patent No. 11707489 a person of ordinary skill in the art would consult the specification of ’489 to determine suitable live mammalian immune cells. Within the specification of ’489 one of ordinary skill in the art would find that the immune cells comprise B cells, T cells, CD8+ T cells, CD4+ T cells, NK cells, dendritic cells, or macrophage cells suitable for use in the composition (column 1, lines 60-64).Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the composition preserves the viability of the plurality of live mammalian cells above about 80% viability for at least 14 days at 24ºC.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the matrix further comprises an extracellular matrix protein.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable U.S. Patent No. 11707489.With regard to claim 21, upon reading claim 15 of U.S. Patent No. 11707489 a person of ordinary skill in the art would consult the specification of ’489 to determine a suitable extracellular matrix protein. Within the specification of ’489 one of ordinary skill in the art would find that collagen is a suitable extracellular matrix protein (column 2, lines 15-16).Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a method of treating an inflammatory or autoimmune disorder in an individual comprising administering a dose of the composition to the alimentary canal of an individual.
Claim 30 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the individual is human.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the individual is a dog, a cow, a cat, a pig, a horse, or a sheep.
Claims 32- 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require the method of treating is for the gastrointestinal inflammatory or autoimmune disorder comprises Crohn's disease.
Claims 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 11707489. Although the claims at issue are not identical, they are not patentably distinct from each other because they both require a method of making a composition of live mammalian cells formulated for oral delivery, the method comprising admixing a plurality of live mammalian cells with a matrix comprising about 1.0% methyl cellulose and about 1.0%alginate gel to provide a cell-matrix, and applying an enteric coating to cell-matrix.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Catherine L McCormick whose telephone number is (703)756-5659. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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/C.L.M./Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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