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 .
Applicant’s amendment and response filed on 4/9/2026 has been received and entered into the case.
Claims 9 and 24 have been canceled, claims 1-8, 16-23 and 31-51 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 10-15 and 25-30 have been considered on the merits. All arguments have been considered.
The claim rejection under 35 USC 102 and 103 based on Perica et al. has been withdrawn due to the instant amendment.
The claim rejection under 35 USC 102 based on Schneck et al. (US2016/0051698A1) has been withdrawn due to the instant amendment.
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.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Schneck939 (US10,098,939; IDS ref.).
Regarding claims 10 and 13, Schneck939 teach an artificial antigen presenting cell (aAPC) comprising biocompatible iron-dextran paramagnetic beads having 50-100 nm in diameter (nano-aAPC), and comprises peptide-MHC complex and anti-CD28 signals (col. 3, lines 22-26).
Regarding the term “adaptive” in the claims, the term does not provide any particular structure and thus, it does not limit the claimed product. Rather it is considered as a intended result or characteristics of the claimed product.
Claim 10 discloses that the adaptive aAPC having MHC or HLA wherein (b) the MHC or HLA conjugated to the surface of the paramagnetic particle is not loaded with a peptide, such that the MHC or HLA is capable of loading one or more antigen peptides through binding with the MHC or HLA prior to contacting T cells.
Schneck939 teach that the aAPC can be used to screen for neo-epitopes that induce a T cell response in a variety of cancers or in a particular patient’s cancer, and a peptide library is synthesized, and MHC bearing aAPC are depositied in multi-well plates and passively loaded with peptide (col. 20, lines 48-50 and col. 21, lines 4-6). This teaching is understood such that the MHC bearing aAPC which is not loaded with a peptide is loaded with various different peptides in the library. Therefore, Schneck939’s teaching would meet the aAPC with conjugated MHC that is not loaded with a peptide as disclosed in claim 10.
Regarding claim 11, Schneck939 teach that the non-aAPC comprises at least one MHC class I molecular complex or MHC class II complex (col. 10, lines 3-4).
Regarding claim 12, Schneck939 teach that the MHC complex is a chimeric Ig dimer (MHC-Ig dimer) (col. 3, lines 23-24; col. 27, lines 22-27).
The loading of peptide from the library using multi-well plates taught by Schneck939 would meet the limitation of claim 14 as one or more peptides can be loaded individually from the mixture of 10,000 or more distinct antigens (i.e. peptide library). The source of peptides taught by Schneck939 being a variety of cancers or a particular patient’s cancer would meet the limitation of claim 15 directed to the one or more peptides isolated from a tumor cell.
Thus, the reference anticipates the claimed invention.
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.
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) 10-15 and 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneck939 (supra) in view of Green et al. (US 20140370099A1; of record).
Schneck939 anticipate the subject matter of claims 10-15 and thus, render them obvious (see above).
Regarding claims 25 and 30, the limitations of claim 25 are identical to claim 10 except (c) that the magnetic particle, i.e. adaptive detection bead, is labeled with a reporting moiety which is a fluorescent agent. As discussed above, Schneck939 teach the subject matter of claims 10-15, thus, Schneck939 teach the limitation of claim 25 but they do not teach the mangnetic particle being labeled with a reporting moiety (step (c) of claim 25) or the reporting moiety being fluorescent agent (claim 30).
Green et al. teach aAPCs comprising MHC-IgG dimer labeled fluorescently (para. 25 and 120).
It would have been obvious to a person skilled in the art to fluorescently label the aAPC of Schneck939 as taught by Green et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because Green et al. teach that MHC-Ig dimer can be labeled fluorescently, and it is known in the art that fluorescence dye can be used as an alternative to biotin for detection of a molecule. Furthermore, while Schneck939 do not particularly disclose that the MHC-Ig dimer is fluorescently labeled, however, they teach that for the reagents they utilized fluorescently labeled monoclonal antibodies (col. 27, lines 19-21).
Regarding claims 26-29, the limitations of these claims are identical to claims 11-14 and Schneck939 teach the limitations as discussed above. Therefore, Schneck939 in view of Green et al. which meet the subject matter of claim 25 would meet the limitations of claims 26-29 based on the teachings of Schneck939 discussed above.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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 10-15 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,435,668 in view of Green et al. (supra) and Schneck939 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘668 patent disclose nano-scale artificial antigen presenting cells, nano-aAPCs comprising paramagnetic particle having a mean diameter of 50-500 nm and a costimulatory molecules that is an anti-CD28 antibody, and MHC antigen presenting complex comprising MHC class I peptide bound to a peptide antigen. The product used in the method of the ‘668 patent is substantially similar, if not identical, to the product of the instant application. While the claims of the ‘668 patent do not particularly teach MHC-Ig dimer or the reporting moiety including fluorescent agent, however, it is well known in the art that fluorescently labeled MHC artificial antigen presenting cell according to Green et al. (para. 25, 77).
Regarding the new limitation directed to the MHC conjugated to the paramagnetic particle not loaded with a peptide, the claims of the ‘668 patent disclose that MHC class I peptide binding cleft has a peptide antigen bound thereto. However, it is known in the art that the nano-aAPC of the ‘668 patent can be prepared without loading a peptide, and the loading can be done at any time when desired. For example, Schneck939 teach the loading of a peptide onto nano-aAPCs (col. 20, lines 48-50 and col. 21, lines 4-6). Thus, while the claims of the ‘668 patent disclose nano-aAPCs bound to a desired peptide onto MHC I complex, however, the nano-aAPCs that are not bound to a peptide is a prerequisite product required for loading a desired peptide. Thus, the nano-aAPC without peptide bound is obvious product based on the teachings discussed above.
Thus, the claims of the ‘668 patent in view of Green et al. and Schneck939 render the claims of the instant application obvious.
Claims 10-15 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,939,595 in view of Green et al. (supra) and Schneck939 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘595 patent disclose nano-scale artificial antigen presenting cells, nano-aAPCs comprising paramagnetic particle having a mean diameter of 50-500 nm and a costimulatory molecules that is an anti-CD28 antibody, and MHC antigen presenting complex comprising MHC class II peptide bound to a peptide antigen. The product used in the method of the ‘595 patent is substantially similar, if not identical, to the product of the instant application. While the claims of the ‘595 patent do not particularly teach MHC-Ig dimer or the reporting moiety including fluorescent agent, however, it is well known in the art that fluorescently labeled MHC artificial antigen presenting cell according to Green et al. (para. 25, 60, 77).
Regarding the new limitation directed to the MHC conjugated to the paramagnetic particle not loaded with a peptide, the claims of the ‘595 patent disclose that MHC class I peptide binding cleft has a peptide antigen bound thereto. However, it is known in the art that the nano-aAPC of the ‘595 patent can be prepared without loading a peptide, and the loading can be done at any time when desired. For example, Schneck939 teach the loading of a peptide onto nano-aAPCs (col. 20, lines 48-50 and col. 21, lines 4-6). Thus, while the claims of the ‘595 patent disclose nano-aAPCs bound to a desired peptide onto MHC I complex, however, the nano-aAPCs that are not bound to a peptide is a prerequisite product required for loading a desired peptide. Thus, the nano-aAPC without peptide bound is obvious product based on the teachings discussed above.
Thus, the claims of the ‘595 patent in view of Green et al. and Schneck939 render the claims of the instant application obvious.
Claims 10-15 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-27 of U.S. Patent No. 10,987,412 in view of Green et al. (supra) and Schneck939 (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘412 patent disclose a paramagnetic nanoparticle having a mean diameter of 10-500 nm and a costimulatory molecules that is an anti-CD28 antibody, and MHC Class-I antigen presenting complex comprising HLA-peptide antigen-presenting complex. The product used in the method of the ‘412 patent is substantially similar, if not identical, to the product of the instant application. While the claims of the ‘412 patent do not particularly teach MHC-Ig dimer or the reporting moiety including fluorescent agent, however, it is well known in the art that fluorescently labeled MHC artificial antigen presenting cell according to Green et al. (para. 25, 77).
Regarding the new limitation directed to the MHC conjugated to the paramagnetic particle not loaded with a peptide, the claims of the ‘412 patent disclose that MHC class I peptide binding cleft has a peptide antigen bound thereto. However, it is known in the art that the nano-aAPC of the ‘412 patent can be prepared without loading a peptide, and the loading can be done at any time when desired. For example, Schneck939 teach the loading of a peptide onto nano-aAPCs (col. 20, lines 48-50 and col. 21, lines 4-6). Thus, while the claims of the ‘412 patent disclose nano-aAPCs bound to a desired peptide onto MHC I complex, however, the nano-aAPCs that are not bound to a peptide is a prerequisite product required for loading a desired peptide. Thus, the nano-aAPC without peptide bound is obvious product based on the teachings discussed above.
Thus, the claims of the ‘412 patent in view of Green et al. and Schneck939 render the claims of the instant application obvious.
Claims 10-15 and 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-12, 19-20 and 64-65 of copending Application No. 18/698,673 (reference application) in view of Green et al. (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘673 application disclose an artificial antigen presenting cell (aAPC) comprising a particle having a MHC class I and class II molecule conjugated to the surface thereof, and the aAPC comprises a costimulatory ligand conjugated to the surface thereof including an anti-CD28 antibody. The MHC-class I molecule comprises a Kb-Ig dimer.
Regarding the aAPC having a MHC not being loaded with a peptide, the claims of the ‘673 application do not require a peptide being loaded to the MHC of the aAPC. Thus, the claims of the ‘673 application in view of Green et al. would meet the limitation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to the claim rejection(s) of claim(s) 10-15 and 25-30 have been fully considered and are persuasive in view of the instant amendment. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schneck939 as cited in the claim rejections above.
Applicant has requested to hold the double patenting rejections in abeyance until identification of allowable subject matter. Therefore, the double patenting rejections are maintained. It is noted that the double patenting rejections have been updated to address the instant amendment.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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