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 .
Applicant's response to the previous Office action, dated January 7, 2026, has been received. By way of this submission, Applicant has amended claims 18-19, 22-24, and 27-30.
Claims 14, 18-19, and 21-36 are pending in the application. Claims 14 and 34 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed July 11, 2024.
Claims 18-19, 21-33 and 35-36 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated August 7, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 7, 2026 was filed after the mailing date of the first Office action on the merits on November 13, 2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim Rejections - 35 USC § 103
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.
Claims 18-19, 21-23, 27-33 and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Kadiyala (US20180221503A1) as evidenced by Rescigno (Semin Immunol. 2015 Mar;27(2):119-24).
Applicant argues that Kadiyala does not teach every limitation of the claims as amended; specifically, Kadiyala does not teach the specific combination of features recited in the claims. Applicant asserts that a person having ordinary skill in the art would not have been motivated to select a personalized neoantigenic construct as a payload for the phagocytosable particle, or a core with a largest dimension in the range of 0.5 micrometers to 2.5 micrometers. Applicant further argues that Kadiyala does not teach the additional steps of the claimed method. Applicant further argues that the claimed method produces unexpectantly superior results that could not have been predicted from the teachings of Kadiyala.
Applicant's arguments have been considered fully but are not found to be persuasive.
Kadiyala teaches that the payload of the particle may be a tumor specific antigen such as a neoantigen (para. 0094 and 0164). As neoantigens are specific to each individualized cancer, this would therefore be a personalized neoantigenic construct.
Kadiyala further teaches that the above composition may be used to prime T cells isolated from the subject ex vivo (i.e., in vitro), and then reinfusued to the patient (para. 0413 and 0427). Kadiyala also teaches a combination of the above adoptive immumotherapy with the particle and the active immunotherapy of administering the claimed particle (para. 0413 and 0059).
With regards to Applicant's assertion that Kadiyala does not teach a core with a largest dimension in the range of 0.5 micrometers to 2.5 micrometers, Kadiyala further teaches that the nanoparticle may have a dimension of less than 1 micrometer (para. 0234). Applicant's claim 31 recites that the particle has a largest dimension in the range of 0.5 micrometers to 2.0 micrometers. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05.
It is also noted that Applicant's specification at page 40 teaches that dendritic cells are capable of phagocytosis of such particles.
Kadiyala further teaches that the nanoparticle may comprise a core of superparamagntic iron oxide (para. 0382). Kadiyala further teaches that the nanoparticle may comprise polystyrene (para. 0242). This is in express motivation to use such materials in assembling the claimed particle.
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed. In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). MPEP 2123(II).
There is no requirement that an "express, written motivation to combine must appear in prior art references before a finding of obviousness." Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). Any judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). MPEP 2145(X)(A).
If there is an unexpected criticality in using the specifically claimed components of the invention, this must be demonstrated with evidence. Applicant has not met this standard. It is also noted that independent claim 18 does not rely on any particular tumor-specific antigen or core material.
Kadiyala also teaches that the above nanoparticle is useful in causing dendritic cells to enhance antigen presentation (para. 0423). This is the same result as what has occurred with Applicant's invention. As such, the results cannot be said to be unexpected.
This rejection is therefore maintained.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kadiyala as applied to claims 18 and 23 above, and further in view of Shukla (J Immunol Methods. 2018 Sep:460:5 1-62, cited in IDS).
Applicant argues that Shukla does not remedy the alleged deficiencies of Kadiyala. This is not persuasive, for reasons described supra.
This rejection is therefore maintained.
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 18-19, 21-33 and 35-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51, 59-64, 69-71, and 73-76 of copending Application No. 18/999,139 in view of Kadiyala and Shukla.
Applicant argues that the disclosure of the '139 application does not remedy the alleged deficiencies of Kadiyala. This is not persuasive, for reasons described supra.
This rejection is therefore maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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/PETER JOHANSEN/Examiner, Art Unit 1644