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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The priority date is January 13, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 12, 2023 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Drawings
The drawings were received on July 12, 2023. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities:
From page 31 -43, Paragraphs are numbered “00100 to 00124”, but should read “0100 – 0124”. Appropriate correction is required.
Claims 2, 4, 6-9, 11-12, and 15-34 are cancelled. Claims 1, 3, 5, 10, 13-14 are pending and under examination.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3, 5, 10, 13, and 14 are rejected under 35 U.S.C. 102 unpatentable as being anticipated by Keselowsky et. al. (US 20130287729-A1; 7/12/2023 IDS, US Patent Publication doc. #1).
Instant claims recite method of promoting immune tolerance to an antigen, comprising introducing directly into at least one lymph node of the subject:(a) a therapeutically effective amount of a composition comprising an antigen associated with an autoimmune disease or disorder, wherein said antigen is selected from the group consisting of: chromogranin A (CgA); NRP-V7; insulin; GAD65; GAD67;carboxypeptidase H; insulinoma associated antigen-2 (IA-2); insulinoma associated antigen-2 beta (IA-2P); imogen 38; islet-specific glucose-6-phosphatase catalytic subunit-related protein (IGRP); ZnT8; islet amyloid polypeptide (TAPP); Tetraspanin-7 (Tspan;7); P4Hb; GRP78; Urocortin-3; and MHC antigen class I and class II molecules selected from Eu and EO; in combination with (b) a carrier comprising an immune modulatory agent wherein an immune response to said antigen is inhibited or suppressed in the subject, and wherein said immune modulatory agent is rapamycin, everolimus, temsirolimus, or sirolimus, andwherein said carrier is a biodegradable and/or biocompatible microparticle.
Keselowsky ‘729 teaches, “the present invention provides therapeutic compositions that induce immune tolerance in an antigen-specific manner. In preferred embodiments, the composition comprises microparticles that target immune cells of interest, wherein the microparticle is made of biocompatible material, is surface-conjugated with ligands targeting the immune cells of interest, and encapsulates therein a therapeutic agent and an antigen” (Detailed Disclosure [para. 0025]); Furthermore, Keselowsky ‘729 teaches that the “auto-antigens triggering type 1 diabetes include, but are not limited to, the 65 kDa isoform of glutamic acid decarboxylase (GAD), insulin, phosphatase-related 1A-2 molecule, epitopes of pancreatic beta cells and islet cells” (Detailed Disclosure [para. 0038]); and “the microparticles of the present invention generate both MHC-II-directed, as well as MHC-I-directed immune responses through cross-presentation” (Detailed Disclosure [para. 0041]) (as in instant claim 1a); “the microparticles are loaded with one or more therapeutic agents such as immunomodulatory factors (e.g., rapamycin)” (Brief Summary [para. 0007]); “Immunomodulatory agents include, but are not limited to, rapamycin (Antigen-Specific Tolerogenic Compositions” [para. 0033]) (as in instant claim 1b). Furthermore, the microparticle phagocytosable by dendritic cells has a diameter in the range of 0.5 um-10.0um (Antigen-Specific Tolerogenic Compositions)” [para. 0044] (as in instant claim 3); “bio-degradable polymeric materials including, but not limited to, hydrogels, collagen, alginate, poly(glycolide) (PGA), poly(L-lactide) (PLA), poly(lactide-co-glycolide) (PLGA), polyethylene glycol (PEG), polyesters, polyanhydrides, polyorthoesters, polyamides; non-polymeric biodegradable ceramic materials including, but not limited to, calcium phosphate, hydroxyapatite, tricalcium phosphate; and combinations thereof. In a preferred embodiment, microparticles are fabricated from poly(lactic-co-glycolic acid) (PLGA) (Antigen-Specific Tolerogenic Compositions [para. 0028]) (as in instant claim 5).
Additionally, Keselowski ‘729 teaches, “The microparticles and therapeutic compositions of the present invention may be delivered to tissues, e.g., skin, muscle, organ, etc or other localized sites, e.g. lymph nodes (Formulations and Administration [para. 0085])” (as in instant claim 10); “ the present invention is useful to treat immune disorders and autoimmune diseases including, but not limited to, type 1 diabetes, rheumatoid arthritis, Crohn's disease, chronic inflammatory bowel diseases, multiple sclerosis (MS), oophoritis, graft-versus-host and transplant rejection (Treatment of Immune Disorders and/or Autoimmune Diseases [para. 0067])” (as in instant claim 13 and 14).”
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alpa Amin whose telephone number is (571)272-0562. The examiner can normally be reached 8:30 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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