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 .
2. Applicant’s amendment filed on 07/21/2025 is acknowledged.
3. Claims 19-36 are pending and under consideration for their full scope.
4. Applicant’s IDS document filed on 04/10/2024 has been considered.
5. The instant application is not properly a divisional application resulting from the restriction requirement mailed in 16/495,552.
6. 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.
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7. Claims 19-24, 26-27, 29-34 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent 11,946,074 (PTO-892; Reference A). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-7 of U.S. Patent 11,946,074 are directed to:
A method of identifying a hybridoma cell that secretes a monoclonal antibody among a heterogeneous population of hybridoma cells, the method comprising: (a) providing the hybridoma cells having been prepared by fusing B lineage cells with immortalized cells having expressed on their outer plasma membrane surfaces an Anchor, wherein said Anchor comprises i) an extracellular region comprising an antibody or fragment thereof capable of binding a selected Linker to form a first complex, and ii) a transmembrane amino acid sequence that immobilizes the Anchor on the outer plasma membrane surfaces, wherein said Anchor cannot bind said monoclonal antibody; (b) contacting the hybridoma cells of (a) with an effective amount of said Linker, wherein said Linker is a soluble antibody or antibody fragment comprising a variable domain that binds and forms a second complex with a conserved domain of the monoclonal antibody, wherein the contacting permits the monoclonal antibody to be linked to the surface of the hybridoma cell that secretes it upon formation of said first and second complexes; and (c) identifying the existence, antigen specificity, antigen binding affinity, titer, amount, or biological activity of the monoclonal antibody secreted by the hybridoma cells and bound thereto by said first and second immune complexes formed by Anchor-Linker-monoclonal antibody of claim 1; further comprising isolating the hybridoma cells at any time after step (a) of claim 2; wherein (b) further comprises contacting the hybridoma cells with an excess concentration of the Linker, wherein the excess increases the specificity of the binding between the Linker of the first complex on the cell surface of the hybridoma and the monoclonal antibody secreted by the hybridoma cell, relative to the binding of the monoclonal antibody to other hybridoma cells that do not secrete it, by binding excess unbound antibodies of claim 3; wherein (a) further comprises contacting the cells with a competitor antibody of the same species or type as the secreted monoclonal antibody, the competitor antibody having a different or non-specific antigen binding specificity, wherein the presence of the competitor antibody increases the specificity of the binding between the Linker of the first complex on the hybridoma surface and the monoclonal antibody secreted by the hybridoma, relative to the binding of that monoclonal antibody to a hybridoma cell that does not secrete it, by binding excess unbound Linker of claim 4; further comprising contacting the hybridoma cells with a detectably labelled antigen to which the monoclonal antibody specifically binds in a third complex; and forming cells to which are bound a multi-part complex formed by the first complex Anchor-Linker, the Linker also bound to the secreted monoclonal antibody, which is bound to the antigen; and wherein step (c) comprises identifying a hybridoma cell that secretes a monoclonal antibody specific for a selected antigen by identifying or quantifying the detectable label associated with the cell-bound multi-part complex of claim 5; wherein the monoclonal antibody is a human antibody; the Anchor molecule comprises an scFv specific for a selected non-human-originated Linker; and the Linker is an antihuman-Ig antibody or an antibody binding fragment of an anti-human-Ig antibody of claim 6; and wherein the immortalized cell line is LCX-BGS strain 03.06.17 designated by ATCC Accession No. PTA-124062.
The hybridoma cell and LCX-BGS strain 03.06.17 designated by ATCC Accession No. PTA-124062 of US Patent 11,946,074 are encompassed by the instant recitation of ”an immortilized cell that secretes an antibody” of claims 19-36 and “recombinant mammalian cells” of claims 27 and 34.
The reference teachings anticipate the claimed invention.
8. Claims 19, 28, 30 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent 11,946,074 (PTO-892; Reference A) in view of Kim et al. (PTO-892; Reference U).
Claims 1-7 of U.S. Patent 11,946,074 has been discussed supra.
The claimed invention differs from the prior art in the recitation of “wherein the recombinant mammalian cells are 293T cells or CHO cells” of claims 28 and 35.
The art of Kim et al. teaches that Rrecombinant Chinese hamster ovary cells (rCHO) cells have been the most commonly used mammalian host for large-scale commercial production of therapeutic proteins. Recent advances in cell culture technology for rCHO cells have achieved significant improvement in protein production leading to titer of more than 10 g/L to meet the huge demand from market needs. This achievement is associated with progression in the establishment of high and stable producer and the optimization of culture process including media development. (In particular, abstract).
It would have been obvious to one of ordinary skill in the art to use CHO cells in the method of U.S. Patent 11,946,074 because CHO cells are the most commonly used mammalian host for production of therapeutic proteins.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
9. 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 claiming the subject matter which the applicant regards as his invention.
10. Claims 28 and 35 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.
Claims 28 and 35 recites the limitation "the recombinant mammalian cells" in lines 1-2 of each claim. There is insufficient antecedent basis for this limitation in each of claims 28 and 35 because claims 19 and 30 upon which they depend, respectively, do not recite the term “recombinant mammalian cells.”
Correction is required.
11. No claim is allowed.
12. Claim 25 is objected to for dependence upon rejected claim 19.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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November 15, 2025
/Nora M Rooney/
Primary Examiner, Art Unit 1641