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
Acknowledgement is made of Applicants’ claim for benefit of U.S. Provisional Application No. 63/393,451 (filed 07/29/2022).
Claim Objections
Claims 2-8 and 13 are objected to because of the following informalities:
Regarding claims 4, 8: These claims recite, “…wherein said degenerative condition is associated with fibrosis one more organ…”; there is an ‘of’ missing after ‘fibrosis’.
Regarding claims 2-8: These claims recite, “…one more organ systems”; there is an ‘or’ missing after ‘one’.
Regarding claim 13: This claim recites, “…results in cells expression pluripotency markers”; this should recite, “…results in cells’ expression of pluripotency markers” or, alternatively, “…results in cells .
Appropriate correction is required.
Claim Interpretation
The following comments are made to establish broadest reasonable interpretation for the record.
Regarding claim 12: This claim recites the limitation, “…wherein said dedifferentiation is accomplished by introduction into cells proteins capable of inducing dedifferentiation.” Lacking guidance from the instant disclosure in the form of drawings or working examples, the broadest reasonable interpretation of the term introduction into cells proteins includes intracellular delivery of both proteins and nucleic acids encoding proteins.
Duplicate Claim Warning
Applicant is advised that should claim 4 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-20 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.
Regarding claim 1: This claim is directed to a method of treating a degenerative condition. Thus, claim 1 provides for a method a treatment; however, it does not set forth any steps involving administering/delivering said cells to a subject, and so it is unclear the specific process Applicants intend to encompass. A person of ordinary skill in the art would not be able to determine how the steps recited in the method of claim 1 result in the treatment of a degenerative condition. Is the regenerative cell obtained in step c) administered to a subject? How exactly is the degenerative condition treated? It appears the claim is, at best, lacking an essential step (administeration or delivery of the cells).
Regarding claims 2-20: These claims depend from claim 1, inherit its deficiencies, and are likewise rejected for indefiniteness.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 9-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kimbrel, et al. (US 2014/0072537).
Kimbrel, et al. teaches methods for obtaining mesenchymal stromal cells and methods of treating a pathology using such cells (Abstract).
Regarding claim 1: Kimbrel, et al. teaches a method of generating mesenchymal stem cells (MSCs), comprising generating hemangioblasts from induced pluripotent stem cells (iPSCs) using exogenously added factors, before differentiating the hemangioblasts into MSCs (pars. 0106-0107). The MSCs can be used in the treatment of graft-versus-host disease, myocardial infarction and inflammatory and autoimmune disorders (par. 0092). This reads on:
the method of treating a degenerative condition comprising the steps of obtaining a pluripotent stem cell, inducing expression in said pluripotent stem cell of one or more factors capable of promoting differentiation into desired cell lineage, and differentiating said stem cell into a regenerative cell limitations recited in claim 1;
the wherein said degenerative condition is associated with loss of function of one or more organ systems limitation recited in claim 2;
the wherein said degenerative condition is associated with deterioration of function of one or more organ systems limitation recited in claim 3;
the wherein said degenerative condition is associated with inflammation occurring in one or more organ systems limitation recited in claim 5;
the wherein said degenerative condition is associated with autoimmune attack against one or more organ systems limitation recited in claim 6;
the limitations recited in a) – k) in claim 9; and
the wherein said pluripotent stem cell is an inducible pluripotent stem cell limitation recited in claim 10.
Regarding claims 11-12, 20: Following the above discussion, Kimbrel, et al. teaches the iPSCs may be generated by reprogramming a somatic cell, e.g., a fibroblast, with reprogramming factors comprising OCT4, SOX2, and NANOG, wherein the factors are introduced into the cell via method known in the art, e.g., a vector comprising a nucleic acid which encodes the factors, or exogenous factors added to culture media and introduced into cells through coupling to cell entry peptides, lipofection, electroporation (pars. 0096-0097); this reads on the wherein said pluripotent stem cell is generated by dedifferentiation limitation recited in claim 11, the wherein said dedifferentiation is accomplished by introduction into cells proteins capable of inducing dedifferentiation limitation recited in claim 12, and the wherein said proteins capable of inducing dedifferentiation comprise OCT4, NANOG, SOX-2 limitations recited in claim 20.
Regarding claims 13-19: Following the above discussion, Kimbrel, et al. teaches the pluripotent cells may express markers such as TRA-1-60, hTERT, TRA-1-81, SSEA4, OCT4, SOX2 (pars. 0083, 0087); this reads on the wherein said dedifferentiation results in the expression of pluripotency markers limitation recited in claim 13, as well as the respective pluripotency marker limitations recited in claims 14-19.
Claims 1-13 and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Angel, et al. (WO 2021/222389).
Angel, et al. teaches cell-based therapies based on mesenchymal stem cells (Abstract).
Regarding claim 1: Angel, et al. teaches a method of making a composition comprising a therapeutic cell, comprising reprogramming an induced pluripotent stem cell (iPSC) into a mesenchymal stem cell (MSC) (pg. 2; par. 1); the composition can be used to treat amyotrophic lateral sclerosis (ALS), spinal cord injury, degenerative disc disease, coronary artery disease, multiple sclerosis (MS), idiopathic pulmonary fibrosis (IPF), Crohn's disease (pg. 39; par. 4). This reads on:
the method of treating a degenerative condition comprising the steps of obtaining a pluripotent stem cell, inducing expression in said pluripotent stem cell of one or more factors capable of promoting differentiation into desired cell lineage, and differentiating said stem cell into a regenerative cell limitations recited in claim 1;
the wherein said degenerative condition is associated with loss of function of one or more organ systems limitation recited in claim 2;
the wherein said degenerative condition is associated with deterioration of function of one or more organ systems limitation recited in claim 3;
the wherein said degenerative condition is associated with fibrosis of one or more organ systems limitation recited in claim 4 and 8;
the wherein said degenerative condition is associated with inflammation occurring in one or more organ systems limitation recited in claim 5;
the wherein said degenerative condition is associated with autoimmune attack against one or more organ systems limitation recited in claim 6;
the wherein said degenerative condition is associated with denervation of one or more organ systems limitation recited in claim 7;
the limitations recited in a) – k) in claim 9; and
the wherein said pluripotent stem cell is an inducible pluripotent stem cell limitation recited in claim 10.
Regarding claim 11: Following the above discussion, Angel, et al. teaches the iPSCs may be generated by dedifferentiating a mature cell, e.g., a fibroblast (pg. 8, par. 3); this reads on the wherein said pluripotent stem cell is generated by dedifferentiation limitation recited in claim 11.
Regarding claims 12, 20: Following the above discussion, Angel, et al. teaches dedifferentiation can be done via transfection with reprogramming factors OCT4, SOX2, NANOG (pg. 20; par. 2); this reads on the wherein said dedifferentiation is accomplished by introduction into cells proteins capable of inducing dedifferentiation limitation recited in claim 12, as well as the wherein said proteins capable of inducing dedifferentiation comprising OCT4, NANOG, SOX-2 limitations recited in claim 20.
Regarding claim 13: Following the above discussion, Angel, et al. teaches an embodiment wherein iPSC generation is assessed via pluripotency assays, e.g., gene expression profiles (pg. 9; par. 3); this reads on the wherein said dedifferentiation results in cells expression pluripotency markers limitation recited in claim 13.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Angel, et al. (WO 2021/222389) in view of Rieck and Rezania (US 2017/0362572).
The teachings of Angel, et al. are set forth above; claims 1-13 and 20 are anticipated by Angel, et al.
Rieck and Rezania (hereinafter Rieck) teaches methods of differentiating pancreatic endocrine cells into pancreatic beta cells (Abstract).
Regarding claims 14-19: Following the above discussion, Angel, et al. does not explicitly teach which markers comprise the gene expression profile.
However, Rieck teaches pluripotent stem cell markers include OCT4, SOX2, SSEA-4, hTERT, TRA-1-60, TRA-1-81 (par. 0091); this reads on the pluripotency marker limitations recited in claims 14-19.
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method of Angel, et al. by using the pluripotency markers taught by Rieck. This conclusion of obvious is based on the ‘teaching, suggestion, or motivation rationale’; one would be motivated to do so because Rieck teaches OCT4, SOX2, SSEA-4, hTERT, TRA-1-60, TRA-1-81 as appropriate stem cell markers, and Angel, et al. discloses use of a gene expression profile in order to assess pluripotency. Further, as evidenced by both the Angel, et al. and Rieck disclosures, analyzing gene expression is a well-known technique in the art; thus, a person skilled in the art would have more than a reasonable expectation of success.
This renders obvious the limitations recited in the instant 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 1-3, 5-7, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, and 8-9 of copending Application No. 18/785, 305 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-3, 5-7, 9-11: Copending claims 1-2, 4, and 8-9 teach a method comprising culturing a dedifferentiated induced pluripotent stem cell in a decellularized bone matrix to generate a mesenchymal stem cell useful for the treatment of orthopedic conditions such as bone fracture, osteoarthritis, rheumatoid arthritis, cartilage degeneration, torn meniscus, degenerative joint disease; this reads on the limitations recited in instant claims 1-3, 5-7, and 9-11.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-7, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 12-17 of copending Application No. 18/493,694 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-3, 5-7, 9: Copending claims 1-7 and 12-17 teach a method of inhibiting or reversing epilepsy by administrating a regenerative cell, wherein the regenerative cell is a mesenchymal stem cell generated from a method comprising differentiating the pluripotent stem cell in the presence of a SMAD-2/3 pathway inhibitor to obtain the mesenchymal stem cell; this reads on the limitations recited in instant claims 1-3, 5-7, and 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA PRONZATI whose telephone number is (571)270-5725. The examiner can normally be reached Monday - Friday 9:00a - 5:00p ET.
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/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633