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 .
Applicant's reply to the previous Office action, dated March 31, 2026, has been received. By way of this submission, Applicant has amended claims 1 and 32, and cancelled claims 3-4, 16, 34-35, and 46.
Claims 1-2, 9-12, 14-15, 22-25, 29, 31-33, 39-42, 44-45, 53-55, and 59-60 are pending in the application. Claims 24-25 and 54-55 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed May 14, 2025.
Claims 1-2, 9-12, 14-15, 22-23, 29, 31-33, 39-42, 44-45, 53, and 59-60 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated October 2, 2025.
Terminal Disclaimer
The terminal disclaimer filed on March 31, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of patent application 17/907,115 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 9-12, 14-16, 22-23, 29, 31-34, 39-42, 44-46, 53, and 59-60 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claims 1-2, 9-12, 14-15, 22-23, 29, 31-33, 39-42, 44-45, 53, and 59-60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant argues that the claims as amended recite a step of exposing the fibroblasts and/or functional derivatives thereof to oxytocin, which renders the claims enabled.
Applicant's arguments have been considered fully but are not found to be persuasive.
The claims are drawn to methods of inhibiting one or more inflammatory cytokines and methods of treating inflammation, comprising the step of providing to the individual an effective amount of fibroblasts and/or functional derivatives thereof that reduce production of IL-17 from IL-17 producing cells, that reduce cellular response to IL-17, and/or that reduce generation of Thl7 cells, wherein prior to the providing step, the fibroblasts and/or functional derivatives thereof are exposed to oxytocin, and wherein the fibroblast derivatives are selected from the group consisting of soluble cytokines, metabolites, fatty acids, nucleic acids, ribosomes, apoptotic bodies, microvesicles, lysates, exosomes, and a combination thereof.
Applicant's specification describes fibroblasts that were cultured in the presence of 1 M oxytocin to activate the fibroblasts to suppress IL-17 production, or fibroblasts that are CD73+ and administered to a mouse model of collagen-induced arthritis. However, the claims broadly encompass fibroblasts or functional derivatives thereof, with the ability to reduce production of IL-17 in any context. Claim 31 indicates that the individual may have atherosclerosis, cancer, Graft-versus-host disease (GvHD), cystic fibrosis, depression, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel diseases, rheumatoid arthritis (RA), multiple sclerosis (MS), psoriasis, Crohn's disease, systemic lupus erythematosus (SLE), asthma, Behget's disease, hyper IgE syndrome, or a combination thereof.
Claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971). MPEP 2164.08(b).
As of the time of filing, fibroblasts were not generally considered as inhibitors of IL-17. For example, Schirmer (Blood. 2010 Sep 9;116(10):1715-25, cited previously) teaches that fibroblasts support interleukin-23 release from dendritic cells (Figure 1), which in turn upregulates secretion of IL-17 from T cells (Figure 5).
Applicant shows no data that exposure of a functional derivative to oxytocin results in a product that would reduce production of IL-17 from IL-17 producing cells, that reduce cellular response to IL-17, and/or reduce generation of Thl7 cells. For example, it is not readily apparent as to how a nucleic acid derived from a fibroblast would possess such a property. There is nothing in the specification that gives guidance as to which functional derivatives of fibroblasts would possess the required property and which would not, and there appears to be no way to discern which functional derivatives would possess said property without trial and error.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. MPEP 2164.08. Given the breadth of molecules that fall within the scope of functional derivative of fibroblasts, it would take undue experimentation to determine which embodiments are operative and which are not. For reasons stated above, this renders the claims nonenabled.
In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the full scope of the claimed invention.
This rejection is therefore maintained.
Claims 1-4, 9-12, 14-16, 22-23, 29, 31-35, 39-42, 44-46, 53, and 59-60 were previously 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.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claims 16 and 46 were previously 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.
Applicant's cancellation of claims 16 and 46 has rendered this rejection moot, and it is withdrawn.
Double Patenting
Claims 1-4, 12, 29, 32-35, 42, and 59 were previously provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, and 20 of copending Application No. 17/907,115 (reference application).
Applicant's filing of a terminal disclaimer to the conflicting '115 application has addressed this issue, and this rejection is hereby withdrawn.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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