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 .
Claim Status
Claims 5 and 15 were canceled.
Claims 1-4, 6-14 and 16 are pending and under consideration.
Withdrawn Rejections
Objections of claims 2-3 and 10 are withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claims 1-4 and 6-16 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicant amended the claim 1 to recite specific species of microbiome strain, thereby obviating this rejection/objection.
Rejection of Claim(s) 1-16 under 35 U.S.C. 102(a)(1) as being anticipated by Beak et al (Journal of Translational Medicine (2022) 20:104) is withdrawn. Applicant filed declaration under 37 CFR 1.130(a) on 1/30/2026 and provided a persuasive argument “As explained in the Rule 130 Declaration, the potential prior art subject matter disclosed in Beak et al was obtained directly or indirectly from Mi-La CHO, Min-Jung PARK, and Joo-Yeon JHUN (the same person as JooYeon JHUN) who are the joint inventors of the instant application (i.e., a grace period disclosure by inventor or obtained from inventor according to 35 U.S.C. 102(b)(1)(A)). As such, Beak has been disqualified as prior art, and the rejections are rendered moot” (Applicant’s response filed 1/30/2026, page 9).
NEW - 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.
Claim(s) 1-3, 6-11, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (Frontiers in Immunology, December 2021, Volume 12, article 696074; PTO-892).
Regarding claim 1, 7-11 and 16, Kim teaches “Tacrolimus (Tac) is an immunosuppressant used in the treatment of systemic lupus erythematosus (SLE); however, it induces T cell subset imbalances by reducing regulatory T (Treg) cells. Lactobacillus acidophilus (LA) is reported to have therapeutic efficacy in immune-mediated diseases via T cell regulation.
Methods: This study investigated whether a combination therapy of LA and Tac improves the therapeutic efficacy of Tac by modulating T cell subset populations (corresponds to “the composition regulates immune cells” of claim 7) in an animal model of SLE. Eight-week-old MRL/lpr mice were orally administered with 5 mg/kg of Tac and/or 50 mg/kg of LA daily for 8 weeks. Cecal microbiota compositions, serum autoantibodies levels, the degree of proteinuria, histological changes in the kidney, and populations of various T cell subsets in the spleen were analyzed.
Results: Mice presented with significant gut dysbiosis, which were subsequently recovered by the combination treatment of Tac and LA. Double negative T cells in the peripheral blood and spleens of MRL/lpr mice were significantly decreased by the combination therapy. The combination treatment reduced serum levels of anti-dsDNA antibodies and Immunoglobulin G2a, and renal pathology scores were also markedly alleviated. The combination therapy induced Treg cells (corresponds to “increases the activity of immunoregulatory cells” of claim 10 and “increases the activity of Treg cell” of claim 11) and decreased T helper 17 (Th17) cells (corresponds to “suppresses activity of Th17” of claims 8-9) both in vitro and in vivo. In vitro treatment with LA induced the production of indoleamine-2,3-dioxygenase, programmed death-ligand 1, and interleukin-10 via the specific intracellular adhesion molecule-3 grabbing non-integrin homolog-related 3 receptor signals.
Conclusion: The present findings indicate that LA augments the therapeutic effect of Tac and modulates Th17/Treg balance in a murine model of SLE” (abstract). Tacrolimus is alternative name for FK506 of Formula I. Therefore, Kim teaches administering combination of Formula I and Lactobacillus acidophilus as recited by instant claim 1.
Regarding claim 2-3, limitation “for treating transplantation rejection” of claim 1 is expected result of the claimed method and does not change the active process step of claim 1. Because Kim teaches same active process step of instant claims and the same active process step of administering same compound Formula I and Lactobacillus acidophilus will have same expected result, claim 2-3 are also anticipated by Kim.
Regarding claim 6, claim 6 describes functional characteristics of the composition. Because Kim teaches same composition comprising same compound Formula I and Lactobacillus acidophilus, the composition of Kim will have same functional characteristics.
Regarding claim 14, Kim teaches “Cytokine quantification in the supernatants of the splenocytes obtained under the aforementioned conditions revealed that the levels of inflammatory IL-17 and regulatory IL-10 were significantly decreased and increased, respectively, in the Tac + LA treated cells compared to controls, and to the Tac- and LA-alone treated cells” (page 6, bridging paragraph).
Allowable Subject Matter
Claims 4 and 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 4 and 12-13 are objected to.
Claims 1-3, 6-11, 14 and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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