DETAILED ACTION
This action is in reply to papers filed 10/28/2025.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20220174921A1, Published 1/13/2022.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-18, in the reply filed on 10/28/2025 is acknowledged. The traversal is on the ground(s) that in view of amendments made to claim 19, wherein said claim has been amended such that it depends upon the subject matter of Group I, there is no undue burden in examining Groups I and II. These arguments are found persuasive. Accordingly, claims 1-20 are pending and examined herein.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly the claiming the subject matter which the applicant regards as his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 is drawn to a composition for evaluating a humanized T cell immune response between mouse, the composition comprising a first and second mouse cell. Claim 19 limits the first mouse cell to the mouse T cell of claim 1 “..that expresses (a) the chimeric human/mouse CD4 co-receptor and/or the chimeric human/mouse CD8 co-receptor comprising the chimeric human/mouse CD8α polypeptide and the chimeric human/mouse CD8β polypeptide, and (b) a T cell receptor comprising a humanized TCRα chain and a humanized TCRβ chain, wherein the humanized TCRα chain is encoded by a rearranged human TCR Vα/Jα sequence operably linked to the mouse TCRα constant region sequence, wherein the rearranged human TCR Vα/Jα sequence is formed by rearrangement of the at least one human Vα segment and the at least one human Jα segment, and wherein the humanized TCRβ chain is encoded by a rearranged human TCR Vβ/Dβ/Jβ sequence operably linked to the mouse TCRβ constant region sequence, wherein the rearranged human TCR Vβ/Dβ/Jβ sequence is formed by rearrangement of the at least one human Vβ segment, the at least one Dβ segment, and the at least one human Jβ segment…”. There is a lack of antecedent basis regarding this limitation as the mouse T cell of claim 1 does not recite this limitation.
Separately, claim 19 recites, inter alia, “the second mouse cell expresses the chimeric human/mouse MHC I polypeptide and a human or humanized β2 microglobulin.” There is a lack of antecedent basis regarding this limitation. This is because claim 19 does not recite the second cell comprising a human/mouse MHC I polypeptide. While claim 1 does recite this limitation, the second cell is not claimed as being the mouse T cell of claim 1. Claim 20 is included in this rejection as it depends on claim 19.
Clarification is requested.
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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11259510. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claims are drawn to a mouse T cell expressing a TCR protein comprising a human TCR variable domain specific for an antigen, the mouse T cell comprising in its genome
(a) a first nucleotide sequence encoding a chimeric human/mouse CD4 co-receptor that comprises D1, D2 and D3 domains of a human CD4 polypeptide and transmembrane and cytoplasmic domains of a mouse CD4 polypeptide; (b) a second nucleotide sequence encoding a chimeric human/mouse CD8α polypeptide and a third nucleotide sequence encoding a chimeric human/mouse CD8β polypeptide, wherein the chimeric human/mouse CD8α polypeptide comprises an IgV-like domain of a human CD8α polypeptide and transmembrane and cytoplasmic domains of a mouse CD8α polypeptide, wherein the chimeric human/mouse CD8β polypeptide comprises an IgV-like domain of a human CD8β polypeptide and transmembrane and cytoplasmic domains of mouse CD8β polypeptide; (c) a first nucleic acid sequence encoding a chimeric human/mouse MHC II α polypeptide and a second nucleic acid sequence encoding a chimeric human/mouse MHC II β polypeptide, wherein the chimeric human/mouse MHC II α polypeptide comprises an extracellular domain of an HLA class II α polypeptide and transmembrane and cytoplasmic domains of a mouse MHC II α polypeptide, wherein the chimeric human/mouse MHC IIβ polypeptide comprises an extracellular domain of an HLA class IIβ polypeptide and transmembrane and cytoplasmic domains of a mouse MHC II β polypeptide; (d) a third nucleic acid sequence encoding a chimeric human/mouse MHC I polypeptide, wherein the chimeric human/mouse MHC I polypeptide comprises an extracellular domain of an HLA class I polypeptide and transmembrane and cytoplasmic domains of a mouse MHC I polypeptide; and (e) a rearranged human TCR Vα/Jα sequence operably linked to a mouse TCRα constant region sequence that encodes a humanized TCRα chain comprising a human TCRα variable domain operably linked to a mouse TCRα constant domain, and a rearranged human TCR Vβ/Dβ/Jβ sequence operably linked to a mouse TCRβ constant region sequence that encodes a humanized TCRβ chain comprising a human TCRβ variable domain operably linked to a mouse TCRβ constant domain, and wherein the TCR protein comprises the humanized TCRα chain and the humanized TCRβ chain. Claim 18 is drawn to a non-human hybridoma expressing a TCR protein comprising a human TCR variable domain specific for an antigen, wherein the non-human hybridoma is produced from the mouse T cell of claim 1.
Claim 1 of U.S. Patent ‘510 is drawn to a genetically modified mouse comprising in its genome (a) a first nucleotide sequence encoding a chimeric human/mouse CD4 co-receptor that comprises D1, D2 and D3 domains of a human CD4 polypeptide and transmembrane and cytoplasmic domains of a mouse CD4 polypeptide; (b) a second nucleotide sequence encoding a chimeric human/mouse CD8α polypeptide and a third nucleotide sequence encoding a chimeric human/mouse CD8β polypeptide, wherein the chimeric human/mouse CD8α polypeptide comprises an IgV-like domain of a human CD8α polypeptide and transmembrane and cytoplasmic domains of a mouse CD8α polypeptide, wherein the chimeric human/mouse CD8β polypeptide comprises an IgV-like domain of a human CD8β polypeptide and transmembrane and cytoplasmic domains of a mouse CD8β polypeptide; (c) a first nucleic acid sequence encoding a chimeric human/mouse MHC II α polypeptide and a second nucleic acid sequence encoding a chimeric human/mouse MHC II β polypeptide, wherein the chimeric human/mouse MHC II α polypeptide comprises α1 and α2 domains of a human HLA class II α polypeptide and transmembrane and cytoplasmic domains of a mouse MHC II α polypeptide,
wherein the chimeric human/mouse MHC II β polypeptide comprises β1 and β2 domains of a human HLA class II β polypeptide and transmembrane and cytoplasmic domains of a mouse MHC II β polypeptide; (d) a third nucleic acid sequence encoding a chimeric human/mouse MHC I polypeptide, wherein the chimeric human/mouse MHC I polypeptide comprises α1, α2, and α3 domains of a human HLA class I polypeptide and transmembrane and cytoplasmic domains of a mouse MHC I polypeptide; and (e) an unrearranged T cell receptor (TCR) α variable region sequence comprising at least one human Vα segment and at least one human Jα segment, wherein the unrearranged T cell receptor (TCR) α variable region sequence is operably linked to a mouse TCRα constant region sequence; and an unrearranged TCRβ variable region sequence comprising at least one human Vβ segment, at least one human Dβ segment, and at least one human Jβ segment, wherein the unrearranged TCRβ variable region sequence is operably linked to a mouse TCRβ constant region sequence, wherein the mouse expresses:
(A) the chimeric human/mouse CD4 co-receptor, (B) a chimeric human/mouse CD8 co-receptor comprising the chimeric human/mouse CD8α polypeptide and the chimeric human/mouse CD8β polypeptide, (C) a chimeric human/mouse MHC II complex comprising the chimeric human/mouse MHC II_α polypeptide and the chimeric human/mouse MHC II β polypeptide, wherein the chimeric human/mouse MHC II complex is capable of binding the chimeric human/mouse CD4 co-receptor, (D) the chimeric human/mouse MHC I polypeptide, wherein the chimeric human/mouse MHC I polypeptide is capable of binding the chimeric human/mouse CD8 co-receptor, and (E) a T cell receptor comprising a humanized TCRα chain and a humanized TCRβ chain, wherein the humanized TCRα chain is encoded by a rearranged human Vα/Jα sequence operably linked to the mouse TCRα constant region sequence, wherein the rearranged human Vα/Jα sequence is formed by rearrangement of the at least one human Vα segment and the at least one human Jα segment, wherein the humanized TCRβ chain is encoded by a rearranged human Vβ/Dβ/Jβ sequence operably linked to the mouse TCRβ constant region sequence, wherein the rearranged human Vβ/Dβ/Jβ sequence is formed by rearrangement of the at least one human Vβ segment, the at least one Dβ segment, and the at least one human Jβ segment.
Application claims and patented claims are not patentably distinct as it would have been prima facie obvious to isolate the mouse T cell, as set forth in the instant application, from the genetically modified mouse of the patented claims.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632