DETAILED ACTION
Applicant’s amendment and response received on 1/5/26 has been entered. Claims 1-20 have been canceled. Claims 21-30 are currently pending in this application.
Applicant’s election of Group II, claims 21-25, is acknowledged. As applicant has not provided any arguments traversing the grounds for restriction, the election of Group II is considered to have been made without traverse. As such, claims 26-30 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/5/26.
Claims 21-25 are currently under examination. The present application is being examined under the pre-AIA first to invent provisions. An action on the merits follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/28/23 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement has been considered by the examiner, and an initialed and signed copy of the 1449 is attached to this communication.
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.
Claim 23 is 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 23 depends on claim 21 and recites the limitation wherein the isolated preparation of cells, “is administered to the subject in advance of the tissue”. However, claim 21 recites that the method comprises, “administering to a subject having transplanted tissue an isolated preparation” of cells. Thus, independent claim 21, upon which claim 23 depends, clearly recites that the subject already has transplanted tissue prior to the administration of the cells. As such, the limitation of claim 23 which recites that the cells are administered in advance of the tissue, conflicts with the limitations of claim 21. Therefore, the metes and bounds of claim 23 cannot be determined.
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 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-10 of U.S. Patent No. 8,455,245, hereafter referred to as the ‘245 patent, in view of U.S. Patent Application No. 2007/0292872 (2007), hereafter referred to as Sylvester et al., with an effective filing date of at least 2/10/2006.
The ‘245 patent claims are drawn to products comprising a substantially pure preparation of immunomodulatory dermal mesenchymal stem cells characterized by expression of ABCB5, where the ABCB5+ dermal cells comprises at least 95% of the isolated substantially pure preparation, and where the cells are formulated in a sterile isotonic buffer (‘245 claim 2). The ‘245 patent claims also recite said cell preparations in an injection vial, ampoule, or infusion bag or unit dosage of ABCB5+ dermal mesenchymal stem cells, and further recite specific dosages of the cells including 1X10-7-1X10-10, or 1X10-8.5-1X10-9 dermal mesenchymal stem cells (‘256 claims 4-6). In addition, the ‘245 patent claims further recite instructions for administering the stem cells to a subject (‘245 claim 7). In particular, claim 7 recites that the cells are to be administered to a subject that has undergone or is about to undergo an organ transplant, or a subject having an autoimmune disease, a liver disease, a neurodegenerative disease, or a cardiovascular disease.
While the ‘245 patent claims are product claims, not method claims as currently recited in the instant claims, the products for in vivo administration recited in the ‘245 patent claims are identical to those used in the instant methods of administration of the cells to a subject with a tissue or organ transplant as set forth in instant claims 21 and 24. The ‘245 patent claims further specifically recite that the ABCB5+ dermal mesenchymal stem cells to be administered to a subject are immunomodulatory, and recite specific instructions for the administration of the ABCB5+ dermal mesenchymal stem cells to a subject that has undergone or is about to undergo an organ transplant. Note that administration of the cells to a subject “about to undergo” an organ transplant reads on administration of the cells “in advance” of the organ transplant.
The specification of the ‘245 patent also clearly teaches the use of the cells for these specific purposes, including where the ABCB5+ dermal mesenchymal stem cells are administered to the subject with a transplant, such as an allogeneic heart, lung, liver, or kidney transplant, to prolong allograft survival and treat graft-versus- host disease. Note that MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for ODP rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. The court in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Further, at the time of filing, the prior art teaches methods of administering mesenchymal stem cells before, at the same time, or after the transplantation of an allograft such as an organ in order to prevent or treat GVHD and/or prolong allograft survival (Sylvester et al., paragraphs 7 and 90). Sylvester et al. further teaches where the transplant organ is a heart, liver, lung, or kidney et al., (Sylvester et al., paragraph 92). Therefore, in view of the specific instructions in the ‘245 patent claims to administer a product which is a substantially pure preparation of immunomodulatory dermal mesenchymal stem cells characterized by expression of ABCB5, where the ABCB5+ dermal mesenchymal stem cells comprises at least 95% of the isolated substantially pure preparation, to a subject who has undergone or is about to undergo an organ transplant, the detailed disclosure in the ‘245 patent specification for uses for the ABCB5+ dermal mesenchymal stem cells which include methods administering the ABCB5+ dermal mesenchymal stem cells to a subject which has or will have a transplanted tissue or organ, and the teachings of Sylvester for similar methods of administering mesenchymal stem cells to a subject with a transplant and particularly an allograft such as an allogenic heart, liver, kidney, or lung transplant in order to prolong allograft survival and/or treat graft versus host disease, it would have been obvious to the skilled artisan to practice the methods described in the instructions recited in the ‘245 patent product claims, and as disclosed in Sylvester et al., with a reasonable expectation of success. As such, the ‘245 patent claims in view of Sylvester et al. render obvious the instant method claims obvious.
Additional Comments
The claims are free of the prior art of record. The closest prior art of record is Frank et al. (2003) J. Biol. Chem., Vol. 278 (47) 47156-47165. Frank et al. teaches the isolation of a purified population of ABCB5+ cells from a human epidermal melanocyte culture derived from samples of human foreskin using a MiniMACS microbead antibody purification technique which utilizes an anti-ABCB5 antibody (Frank et al., pages 47156-47157). Frank et al. also teaches further purification of these cells based on the stem cell marker CD 133 resulting in a purified population of ABCB5+ CD 133+ population of cells which Frank et al. characterize as ABCB5+ skin progenitor cells (Frank et al., pages 47157-47158, and 47164). However, the cells obtained by Frank et al. are epidermal stem/progenitor cells, not dermal cells.
No claims are allowed.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634