DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 18,20-23 and 25-39 are currently pending in the Application with claims 29-37 currently withdrawn. Claims 18,20-23 and 25-26 and 38-39 are examined on the merits below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 18, 20-23, 25-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edelson (US20050084966A1), and further in view of Blazar (WO2005086781A2).
The instant claims are directed to T regulatory (“Treg” cells) with enhanced function. The claimed the T regulatory cells are “obtained” through a variety of manipulations through in-vitro culture systems and constitutes a product by process limitation. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113).
In reply to the previously applied rejection of Edelson the Applicant has introduced the limitation that the population of T cells with regulatory activity comprises a dose of 1x10E5 to 1x10E7 cells per kilogram of body weight. Considering a 100kg individual for simplicity, this correlates to 1x10E7 to 1x10E9 cells per individual on an estimated basis. As described previously the disclosure of Edelson provides that T regulatory cells may be prepared from CD4+ T cells. The Treg of the invention are described as obtained through a process in which CD4+ T cells are incubated in-vitro with dendritic cells which have been exposed to autologous apoptotic disease effector cells (0008). The Treg cells thus produced may be utilized for administration back into a subject for the purpose of improving an immunological state and are therefore “enhanced” in function with respect to improving an immunological state (0008). For example CD3+ T cells which are exposed to dendritic cells (DC) which have been fed apoptotic cells have increased CTLA-4 expression as indicated in figure 13(b) of Edelson. The cells additionally provide for “enhanced” IL-10 and TGF-beta cytokine production after treatment with the method of Edelson. Both the increased expression of CTLA-4 and the increased production of IL-10 and TGF-beta are described as useful for the beneficial suppression of a subject’s immune system (0087-0088). T regulatory cells of the invention may likewise be administered to the same donor subject for the purposes of treating a disease such as autoimmune disorders for example (0087). The disclosure of Edelson does not particularly describe the particular dose of T regulatory cells that may be administered to the subject. However the disclosure of Blazar likewise comprehensively describes the utilization of T regulatory cells for suppression of autoimmune disease responses (abstract, title). The disclosure of Blazar likewise indicates that T regulatory cells of the invention mediate their effects through the production of inhibitory cytokines such as TGF-beta and IL-10 (p2, 17-24). The disclosure further provides that ex-vivo methods of the invention provide for Treg with “enhanced suppressive activity” (p8, 4-10). Importantly appropriate doses of the modified cells of the invention are described as falling within the range of 1x10E6 to 1x10E12 cells. Additional sub-dosing ranges are contemplated. It would be therefore obvious to utilize the particular dosage range of T regulatory cells with enhanced function of Edelson as previously contemplated by the disclosure of Blazar for instance.
Therefore cells which may cause autoimmune disease or transplant rejection can in embodiments be utilized as apoptotic source material which is subsequently utilized for the purposes of producing T regulatory cells in-vitro from subject CD4+ T cells for instance (0086-0087). The in-vitro produced enhanced function T regulatory cells of the invention may be utilized to treat a variety of autoimmune disease for example graft versus host disease and tissue rejection.
Response to Arguments Claim Rejections – 35 USC § 101
Applicant’s amendment to the instant claim 18 have obviated the previous basis of rejection and therefore it is removed.
Response to Arguments Claim Rejections – 35 USC § 102
Applicant’s amendment to the claim 18 has obviated the previously applied rejection of record and therefore this rejection is removed. New obviousness based rejection necessitated by amendment is provided above.
Allowable Subject Matter
Claim 38 and 39 are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/BRIAN HARTNETT/ Examiner, Art Unit 1644
/JANET L ANDRES/ Supervisory Patent Examiner, Art Unit 1671