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 with traverse of Group I, claims 19-27 and 35-43 in the reply filed on 4/13/2026 is acknowledged. The traversal is on the ground(s) that Applicant does not believe that it would constitute a substantial serious search and/or examination burden on the Office to search and examine Groups I and II together. This is not found persuasive because the kit of Group II is a materially distinct product from the method of Group I and requires elements such as multiple containers which would not be found in a search of the method of Group I.
The requirement is still deemed proper and is therefore made FINAL.
Claims 29-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/13/2026.
The instant application is a DIV of 16/065,167, now US Pat. No. 11,739,351.
Claims 19-27 and 35-43 are examined in the instant application.
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.
Claim 43 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,739,351. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant engineered cell encompasses identical structural limitations (i.e. SEQ ID NO: 30) as the engineered CHO cell allowed in ‘351.
It should be noted that while the instant application was filed as a DIV, in the parent application, 16/065,167, the restriction requirement mailed on 4/16/2021 restricted the instantly examined method from the allowed engineered cell. However, while the instant method is a proper divisional of the parent application, the instant engineered cell is interpreted to be obvious double patenting of the allowed engineered cell in ‘351.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-25 and 35-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
a method for genome editing in a Chinese Hamster Ovary (CHO) cell comprising:
(i) introducing into a CHO cell having a genome a heterologous system for introducing
single or double stranded brakes into a target nucleic acid sequence of the genome,
wherein the target nucleic acid sequence comprises at least one ERV (endogenous
retrovirus) element comprising:
SEQ ID No: 30, or
a sequence having more than 90% sequence identity with SEQ ID No: 30,
wherein the SEQ ID No: 30 or the sequence having more than 90% sequence identity
with SEQ ID No: 30 is altered to comprise
at least one deletion, at least one addition, at least one substitution or
combinations thereof resulting in an altered sequence, wherein the at least one
ERV element comprising the altered sequence does not encode a functional Gag
protein and further
(ii) introducing into the CHO cell,
(a) heterologous nucleic acid sequences encoding or activating one or more
proteins of one or more homologous recombination (HR) pathways, and/or
(b) heterologous nucleic acid sequences encoding one or more sequences or
proteins suppressing expression of the one or more proteins of one or more
of the HR pathways,
does not reasonably provide enablement for genetically editing any species of cell, other than CHO cells. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The breadth of the claimed invention encompasses genome editing any species of cell.
Whereas the nature of the invention is genetically modifying CHO cells, the breadth of the claimed invention is not supported by the instantly filed specification.
Claims 19 and 43 are directed to a genus of engineered cells from all sources and species comprising alterations of one or more genomic DNA residues located in said genome endogenous retrovirus (ERV) elements, wherein said genus is inadequately described in the disclosure.
The specification on pages 37-40 only disclose the successfully genetic editing of CHO cells using CRISPR/Cas9.
However, the claims encompass a genus of engineered cells with genomic alterations which may enhance/suppress the function of its ERVs. However, no specific function for such engineered cell is recited. Further, given the structural diversity of ERV’s in various cells, no structural limitations are provided for such ERV’s, in order to clarify as to where in the genome such additions, substitutions, deletions may occur and what structural features should be searched to find such ERV’s and what will be a reasonable alteration strategy to inactivate/activate each of said genus of ERV’s.
This is particularly important because the claims encompass any species of cells to comprise a genetic edit, however the art teaches that some cells are resistant to genetic editing particularly, CRISPR/Cas9 editing. For example, Tomasi et al. (2024, Scientific Reports, Vol. 14, pgs. 1-15) teaches that some cancer cells exhibit consistent resistance to genetic modification via CRISPR/Cas9 (see Abstract and Introduction). Thus the skilled artisan would find that practicing the claimed method on the cells of Tomasi as unpredictable.
The specification only teaches the preparation of CHO engineered cells, wherein some mammalian ERV elements thereof have been altered (i.e. a single species), which is not sufficient to fully enable the genus of cells encompassed for use in the claimed method.
Therefore, given the enormity of the scope of the claimed invention, one of skill in the art cannot reasonably practice the claimed method with a predicable degree of success and without an undue amount of experimentation. Thus limiting the claimed method to the scope set forth above is proper.
Conclusion
No claims are allowed. The claims are free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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