DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant previously canceled claims 1-21. Applicant newly adds claims 22-41. Claims 22-41 are currently pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement filed May 22, 2024 has been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see Page 48, [00183]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for
patent published or deemed published under section 122(b), in which the patent or application, as the
case may be, names another inventor and was effectively filed before the effective filing date of the
claimed invention.
Claims 22- are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Haskins et al. (U.S. Patent Application Publication US 2012/0128646 A1, published May 24, 2012).
Regarding claim 22, Haskins teaches a composition comprising a plurality of complexes wherein each complex comprises a carrier, molecules of a major histocompatibility complex (MHC) conjugated to the carrier and molecules of a polynucleotide-peptide conjugate (Pages 2-5, [0010]-[0013], Page 7, [0024], Pages 7-8, [0026], Pages 8-9, [0035]-[0036], Page 23, [0216], Page 32, [0303], Page 33, [0317]-[0319], Pages 36-37, [0363]-[0364] and Page 41, [0412]). Haskins teaches the polynucleotide of the polynucleotide-peptide conjugate is attached to and uniquely identifies the peptide of the polynucleotide-peptide conjugate (i.e., probes; Pages 12-13, [0088], Page 30, [0282] and [0285, Page 15, [0123]-[0126], Pages 16-17, [0157], Page 17, [0161], Page 22, [0207]-[0208], Pages 23, [0219]-[0229] and Page 42, [0422]). Haskins teaches in each complex, the peptides of the polynucleotide-peptide conjugate molecules bind to the MHC molecules to form peptide-MHC complexes (Pages 2-5, [0010]-[0013], Page 7, [0024], Pages 7-8, [0026], Pages 8-9, [0035]-[0036], Page 23, [0216], Page 32, [0303], Page 33, [0317]-[0319], and Page 41, [0412]). Haskins teaches the peptides in the plurality of complexes form a library of candidates for binding to a T-cell receptor (TCR) (Page 20 , [0188], Page 24, [0226]-[0227], Page 25, [0235]-[0239] and Page 41, [0412]).
Regarding claim 23, Haskins teaches the carrier is a natural or synthetic polysaccharide (Pages 8-9, [0036]-[0037]).
Regarding claim 24, Haskins teaches the carrier is a dextran (Pages 36-37, [0364]).
Regarding claim 25, Haskins teaches the carrier is a bead or dendrimer (Pages 8-9, [0036]-[0037] and Page 10, [0062]).
Regarding claim 26, Haskins teaches the MHC molecules are directly conjugated to the carrier ((Pages 2-5, [0010]-[0013] and Page 38, [0383]).
Regarding claim 27, Haskins teaches the MHC molecules are indirectly conjugated to the carrier ((Pages 2-5, [0010]-[0013] and Page 38, [0383]).
Regarding claim 28, Haskins teaches the carrier comprises a streptavidin and the MHC is biotinylated, and the MHC molecules are conjugated to the carrier via biotin-streptavidin binding (Pages 42-43, [0421]-[0423], Page 38, [0383], Page 14, [0105] and Page 12, [0086]).
Regarding claim 29, Haskins teaches the carrier is fluorescently labeled (Page 14, [0105], Page 30, [0285] and Page 38, [0379] and [0383]).
Regarding claim 30, Haskins teaches the polynucleotide of the polynucleotide-peptide conjugate comprises a DNA encoding the peptide of the polynucleotide-peptide conjugate (Page 30, [0282], Pages 39-40, [0402] and Page 13, [0097]).
Regarding claim 31, Haskins teaches the polynucleotide of the polynucleotide-peptide conjugate is covalently attached to the peptide of the polynucleotide-peptide conjugate (Page 8, [0035], Page 14, [0106], Pages 42-43, [0423], Pages 12-13, [0088], Page 30, [0282] and [0285, Page 15, [0123]-[0126], Pages 16-17, [0157], Page 17, [0161], Page 22, [0207]-[0208], Pages 23, [0219]-[0229] and Page 42, [0422]).
Regarding claim 32, Haskins teaches the peptides in the plurality of complexes are synthetically produced peptides (Page 2, [0010], Page 9, [0037], Page 26, [0243] and Page 41, [0412]).
Regarding claim 33, Haskins teaches the peptides in the plurality of complexes are randomly generated peptides (Page 16, [0139], Page 25, [0237], Page 41, [0412] and Page 42, [0421]).
Regarding claim 34, Haskins teaches the peptides in the plurality of complexes comprise at least one antigen selected from the group consisting of an autoantigen, a cancer antigen, an infectious agent, a toxin, and an allergen.
Regarding claim 35, Haskins teaches the plurality of complexes comprises at least 100 different peptides (Page 30, [0284]-[0285]).
Regarding claim 36, Haskins teaches the MHC is a Class I MHC (Page 7, [0026].
Regarding claim 37, Haskins teaches the plurality of complexes is in a solution (Page 10, [0062], Page 29, [0271] and Page 30, [0287]).
Regarding claim 38, Haskins teaches the TCR (Page 16, [0140] and [0152] and Page 25, [0238]).
Regarding claim 39, Haskins teaches the TCR is a TCR on a T cell, an isolated TCR, a soluble TCR, or an immobilized TCR (Pages 2-3, [0010], Page 16, [0152], Page 17, [0162], Page 32, [0304] and Page 41, [0412]).
Regarding claim 40, Haskins teaches the TCR is on the T cell, and wherein the peptide-MHC complexes induce a T cell response upon binding to the T cell (Pages 2-3, [0010], Page 16, [0152], Page 17, [0162], Page 32, [0304], Page 41, [0412], Page 16, [0156] and Pages 31-32, [0302]-[0304]).
Regarding claim 41, Haskins teaches the T cell response is activation, induction of anergy, or death of the T cell (Abstract and Page 1, [0008]).
Haskins teaches each and every limitation of claims 22-41 and therefore Haskins anticipates claims 22-41.
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 22, 30-35, 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21, 23, 26, 31, 36-39, 43, 47 and 49 of U.S. Patent No. 11,092,601.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are slightly different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for screening a library of different candidate peptides and having a composition comprising a plurality of complexes comprising peptides in the plurality of complexes that form a library of candidates using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 22, 30-35, 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 16, 27-29 and 36 of U.S. Patent No. 11,231,419.
Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are slightly different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for screening a library of different candidate peptides and having a composition comprising a plurality of complexes comprising peptides in the plurality of complexes that form a library of candidates using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 22, 30-35, 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 16, 27-29 and 36 of U.S. Patent No. 11,913,952.
Although the claims at issue are not completely identical, they are not patentably distinct from each other because the preambles are identical as well as it appears that almost all of the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention having a composition comprising a plurality of complexes comprising peptides in the plurality of complexes that form a library of candidates using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
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/JESSICA D PARISI/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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