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 10-15 and 25-30) in the reply filed on 10/13/2025 is acknowledged. Applicant’s election of “anti-CD28” and “cancer” is acknowledged.
Claims 9, 24 have been canceled, claims 1-8, 16-23 and 31-51 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 10-15 and 25-30 have been considered on the merits.
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 and 25-29 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Perica et al. (2014, Nanomedicine: Nanotechnology, Biology, and Medicine; IDS ref. #3 filed 10/1/2024)
Regarding claims 10-12 and 25-27, Perica et al. teach nanoscale iron-dextran artificial antigen presenting cells (aAPC) comprising biotinylated MHC-Ig dimer and biotinylated anti-CD28 antibody (p.120, Methods). The iron-dextran particles are paramagnetic having 50-100 nm in diameter (Abstract; Fig. 1). Perica et al. also teach iron-dextran beads having 4.5 mm (i.e. 4500 nm) diameter (i.e. micro-aAPC) (p.120, 2nd col.; Micro-aAPC synthesis). It is noted that the term “bead” in claim 25 is interpreted the same as “particle” taught by Perica et al. The biotin labeled on the aAPC is considered to meet the reporting moiety of claim 25. Perica et al. teach that the MHC-Ig dimers were loaded with peptide (p.120, Preparation of MHC-Ig dimers).
Claims 10 and 25 disclose that the adaptive aAPC is (b) capable of loading one or more antigen peptides through binding with the MHC or HLA prior to contacting T cells. This limitation does not require any particular structure other than the presence of HMC or HLA on the aAPC as it is directed to a product-by-process limitation that is not required by the claimed product because it is disclosed as the claimed product “is capable of” loading the antigen(s). Thus, this (b) of claim 10 or claim 25 is interpreted as an intended use of the claimed product to load one or more antigen peptides but the structure of the product does not require the presence of one or more antigen peptides. Rather, the product taught by Perica et al. is capable of loading one or more antigen peptide as the product is intended to present one or more antigen peptides. Therefore, this limitation does not provide patentable weight in determining patentability of the claimed product.
Regarding claims 14-15 and 28-29, as the limitation (b) of claim 10 and 25, respectively, does not provide any structure to the claimed product, and thus, the limitation of claim 14-15 or 28-29 dependent on the one or more peptides of claims 10 and 25 does not either. Therefore, the limitations of claims 14-15 or 28-29 do not provide any weight in determining patentability of the claimed product of claim 10 or 25.
Regarding the term “adaptive” in the claim 10, 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.
The term “adaptive detection bead” of claim 25 only provides a structure that the product is a bead as “adaptive detection” is interpreted as intended purpose of the product.
Thus, the reference anticipates the claimed invention.
Claim(s) 10-15 and 25-30 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Schneck et al. (US 2016/0051698 A1).
Regarding claims 10 and 13, Schneck et al. 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 (para. 74). 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 is (b) capable of loading one or more antigen peptides through binding with the MHC or HLA prior to contacting T cells. This limitation does not require any particular structure other than the presence of HMC or HLA on the aAPC as it is directed to a product-by-process limitation that is not required by the claimed product because it is disclosed as the claimed product “is capable of” loading the antigen(s). Thus, this (b) of claim 10 is interpreted as an intended use of the claimed product to possibly load one or more antigen peptides. Therefore, this limitation does not provide patentable weight in determining patentability of the claimed product.
Claim 14 discloses the limitation directed to the (b) of claim 10, and claim 15 limits the one or more peptides of claim 14. As discussed above, the (b) limitation of claim 10 does not provide any structure to the claimed product, and thus, the limitation of claim 14 or 15 does not either. Therefore, the limitations of claims 14-15 do not provide any weight in determining patentability of the claimed product of claim 10.
Even if the one or more antigen being loaded to the aAPC via binding to MHC considered to provide a structural limitation, the structure to be considered would be the product comprising one or more antigen, not the process of the product-by-process limitation. Schneck et al. teach that a variety of antigens can be bound to antigen presenting complexes. The nature of the antigens depends on the type of antigen presenting complex that is used. For example, peptide antigens can be bound to MHC class I and class II peptide binding clefts (para. 154).
Regarding claim 11, Schneck et al. teach that the non-aAPC comprises at least one MHC class I molecular complex (para. 22 and 44) or MHC class II complex (para. 45).
Regarding claim 12, Schneck et al. teach that the MHC complex is a chimeric Ig dimer loaded with specific peptide (MHC-Ig) (paras. 70, 240-241).
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. Schneck et al. teach that nanoparticles bearing fluorescently labeled MHC-Ig dimer (para. 331), and this teaching would meet the limitation. The term “adaptive detection bead” of claim 25 only provides a structure that the product is a bead as “adaptive detection” is interpreted as intended purpose of the product.
Regarding claims 26-27, Schneck et al. teach that the non-aAPC comprises at least one MHC class I molecular complex (para. 22 and 44) or MHC class II complex (para. 45). Schneck et al. teach that the MHC complex is a chimeric Ig dimer loaded with specific peptide (MHC-Ig) (paras. 70, 240-241).
Regarding claims 28-29, claim 28 discloses the limitation directed to the (b) of claim 25, and claim 29 limits the one or more peptides of claim 28. As discussed above, the (b) limitation of claim 25 does not provide any structure to the claimed product, and thus, the limitation of claim 28 or 29 does not either. Therefore, the limitations of claims 28-29 do not provide any weight in determining patentability of the claimed product of claim 25. Again, even if the one or more antigen being loaded to the adaptive detection bead via binding to MHC is considered to provide a structural limitation, the structure to be considered would be the product comprising one or more antigen, not the process of the product-by-process limitation. Schneck et al. teach that a variety of antigens can be bound to antigen presenting complexes. The nature of the antigens depends on the type of antigen presenting complex that is used. For example, peptide antigens can be bound to MHC class I and class II peptide binding clefts (para. 154).
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 Perica et al. (supra) in view of Green et al. (US 20140370099A1).
Perica et al. teach the subject matter of claims 10-15 and 25-29 as discussed above, and thus, render them obvious.
Regarding claim 30 directed to the reporting moiety being fluorescent agent, Perica et al. do not particularly teach the limitation.
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 Perica et al. 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.
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. (US 2014/0370099A1). 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).
Thus, the claims of the ‘668 patent in view of Green et al. 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). 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).
Thus, the claims of the ‘595 patent in view of Green et al. 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). 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).
Thus, the claims of the ‘412 patent in view of Green et al. 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631