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 .
Election/Restrictions
Applicants’ election without traverse of Group 1, and the species of concurrent administration of the treatment for dysbiosis and the treatment comprising administration of a therapeutically effective amount of a composition comprising fibroblasts (claim 1), inhibition of inflammation (claim 9), fibroblasts that express the CD73 cell surface marker (claim 10), an abnormality in the host/treatment subject microbiome (claim 29) and treating stroke with the composition comprising the fibroblasts (claim 39), in the reply filed on Sep. 11, 2025 is acknowledged. Applicants did not indicate explicitly whether the election was with or without traverse. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1, 3, 8, 10, 29 and 39 have been amended. Claims 4-7, 11-28, 30-38, 40-88 have been canceled. No claims have been added. Claims 1-3, 8-10, 29 and 39 are examined on the merits herewith. The restriction requirement is deemed proper and is made final.
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 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.
Claim(s) 1-3, 8-10, 29 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Heeron et al. (WO 2019/108756 A1, filed on Nov. 29, 2018), cited in Applicants’ IDS and corresponding PCT application.
O’Heeron et al. disclose a method of treating dysbiosis, a method of normalizing the microbiome, in a subject in need thereof, by treating the dysbiosis by administering (i) a therapeutically effective amount of a composition comprising a probiotic (Lactobacillus reuteri) and/or a prebiotic and (ii) a therapeutically effective amount of a composition comprising a co-culture of Treg cells (regulatory T cells) and fibroblasts (the fibroblast-based treatment). As fibroblasts are cells, the fibroblast-based treatment is a fibroblast-based cellular treatment. The fibroblasts induce generation of Treg cells and expand the Treg cell population. Thus, the fibroblasts have regenerative activity. Treg cells act to regulate the immune system, thereby inhibiting inflammation, and decrease the autoimmune response, and a Treg cell deficiency results in gut microbial dysbiosis and autoimmunity. See paragraphs 129, 130, 133-135, 137 -140 and 154. See claims 1, 3, 8 and 9. The fibroblasts express the cell surface markers CD73 and CD105; see paragraphs 255, 276, 356. See claim 10. Dysbiosis is an abnormality in the microbiome of the host, an imbalance of the normal flora; see claim 29. Many diseases can be treated by the combination Treg cell-fibroblast composition, including the liver diseases of cirrhosis, non-alcoholic fatty liver disease and non-alcoholic steatohepatits (NASH), which are fatal if they are not treated; see paragraph 151. See claim 39.
Regarding claim 2, the reference does not disclose verbatim that the subject suffering from dysbiosis is identified and that the dysbiosis is assessed. Yet, as discussed above, the reference discloses treating dysbiosis in a subject in need thereof, by administering to this subject the needed therapeutic compositions, one comprising a probiotic and one comprising the combination of Treg cells and fibroblasts. It would have been routine and conventional and obvious to the artisan of ordinary skill at the time that the invention was filed, in a disease treatment method, to identify the subject to be treated and then to assess his disease, the various aspects of his disease. This claim does not distinguish the invention over the reference.
The reference does not use the exact same words that Applicants do to describe the treatment method, but the reference discloses the same subject matter. In view of the foregoing, a holding of obviousness is required.
In claim 39, the elected species of treating stroke with the combination Treg cell-fibroblast composition is not disclosed by the reference.
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/ROSANNE KOSSON/Primary Examiner, Art Unit 1759 2025-09-24