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
Applicant’s election without traverse of Group II, claims 54-57 in the reply filed on September 9, 2026 is acknowledged.
Claims 1, 2, 5, 8, 10-12, 14, 18, 21, 28, 29, 31, 34, 42-44, 58, and 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 9, 2026.
Claim Objections
Claims 54 and 55 are objected to because of the following informalities: the claims are written as dependent claims. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over Getts (WO 2017/143346 A1) in view of Pearson (US 2019/0282707).
Getts teaches a pharmaceutical composition comprising TIMP-GLIA [Toleragenic Immune Modifying nanoParticles containing gliadin] comprising gliadin or TIMPs comprising another allergen for treatment of allergies (see entire document including title; abstract; paras. 0004, 0030, 0034, 0036, 0112, 0125-30). The particles “contain soluble antigen (e.g., gliadin) within their cores that are surrounded by a shell of poly(lactide-coglycolide) for tolerance induction in autoimmune disease and/or for the treatment of allergies” (para.0030). The method for preparing the particles comprise a double emulsion solvent evaporation process which claim 1 reads on (paras.0009, 0014, 0031; Fig. 2 and accompanying text ). The surfactant or emulsifier can be in an aqueous solution (para.0065). The pharmaceutical dosage forms may include excipients such as sucrose, sodium citrate and mannitol (para.0130) in instant claim 57.
Getts does not specifically teach encapsulating a peanut protein.
However Pearson teaches tolerizing immune modified particles for inducing antigen-specific tolerance and protective immune responses and for the treatment of allergies. Pearson specifically teaches peanut proteins as well as gliadin (paras. 0154, 0169, 0173, 0230; see entire document including title; abstract; claim 1).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine their teachings because both are drawn to tolerizing immune-modulating particles and Cour teaches peanut proteins are suitable for that application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 54-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 8 of U.S. Patent No. 11510996 in view of Pearson (US 2019/0282707).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a composition comprising an antigen encapsulated in a polymeric carrier particle prepared via a double emulsion solvent evaporation process. The difference is that the present claims recite the antigen as a peanut protein. However Pearson teaches tolerizing immune modified particles for inducing antigen-specific tolerance and protective immune responses and for the treatment of allergies. Pearson specifically teaches peanut proteins as well as gliadin (paras. 0154, 0169, 0173, 0230; see entire document including title; abstract; claim 1). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine their teachings because both are drawn to tolerizing immune-modulating particles and Cour teaches peanut proteins are suitable for that application.
Claims 54-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 9, and 11 of U.S. Patent No. 12502436 in view of Pearson (US 2019/0282707).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a composition comprising an antigen encapsulated in a polymeric carrier particle prepared via a double emulsion solvent evaporation process. The difference is that the present claims recite the antigen as a peanut protein. However Pearson teaches tolerizing immune modified particles for inducing antigen-specific tolerance and protective immune responses and for the treatment of allergies. Pearson specifically teaches peanut proteins as well as gliadin (paras. 0154, 0169, 0173, 0230; see entire document including title; abstract; claim 1). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine their teachings because both are drawn to tolerizing immune-modulating particles and Cour teaches peanut proteins are suitable for that application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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H. SARAH PARK
Primary Examiner
Art Unit 1614
/H. SARAH PARK/Primary Examiner, Art Unit 1614
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