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 .
DETAILED ACTION
This Final Office Action is responsive to the communication received 4/20/2026.
Claims 1-20 are pending.
Claims 1-20 are under examination in this Office Action.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn.
Double Patenting - Maintained
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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Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of U.S. Patent Number 11492613.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 1 is drawn to a method of generating a cell library for screening a desired variant of a target gene, the method comprising: (1) obtaining a first plurality of mammalian cells each of which comprises at a genomic locus a first recombination site recognized by a serine integrase, and (2) introducing into the first plurality of mammalian cells a library of nucleic acid constructs, each of the nucleic acid constructs comprising: (i) a second recombination site recognized by the serine integrase, (ii) a polynucleotide encoding a variant of the target gene, wherein at least one of the nucleic acid constructs comprises a desired variant of the target gene, thereby generating a second plurality of mammalian cells comprising the library of nucleic acid constructs; (3) expressing in each of the second plurality of mammalian cells the serine integrase, and (4) maintaining the second plurality of mammalian cells expressing the serine integrase under conditions that facilitate recombination between the first and the second recombination sites mediated by the serine integrase, thereby generating a cell library comprising a third plurality of mammalian cells each of which comprises a variant of the target gene at the genomic locus and claim 1 in U.S. Patent Number 11492613 is drawn to a method of screening for a desired variant of a target site-specific recombinase, the method comprising: (1) obtaining a first plurality of mammalian cells each of which comprises at a genomic locus (i) a first recombination site recognized by a serine integrase, wherein the serine integrase is different from the target site-specific recombinase and (ii) a first promoter and a second promoter; (2) generating a cell library by (i) introducing into the first plurality of mammalian cells a library of nucleic acid constructs, each of the nucleic acid constructs comprising: (a) a second recombination site recognized by the serine integrase (b) a polynucleotide encoding a variant of the target site-specific recombinase, and (c) a first selectable marker, thereby generating a second plurality of mammalian cells comprising the library of nucleic acid constructs, wherein at least one of the nucleic acid constructs comprises a polynucleotide encoding the desired variant of the target site-specific recombinase, (ii) expressing in each of the second plurality of mammalian cells the serine integrase, and (iii) maintaining the second plurality of mammalian cells expressing the serine integrase under conditions that facilitate recombination between the first and the second recombination sites mediated by the serine integrase, thereby generating a cell library comprising a third plurality of mammalian cells each of which comprises a variant of the target site-specific recombinase at the genomic locus, wherein the first promoter drives the expression of the variant of the target site-specific recombinase and the second promoter drives the expression of the first selectable marker; (3) selecting, from the cell library, a mammalian cell expressing the desired variant of the target site-specific recombinase by (i) introducing a selection construct to each mammalian cell of the cell library, wherein the selection construct comprises (a) a third recombination site, (b) a fourth recombination site, and (c) a second selectable marker, wherein at least one of the third and the fourth recombination sites are not recombined by the target site-specific recombinase but are recombined by the desired variant of the target site-specific recombinase, and wherein the second selectable marker is not expressed in the absence of a recombination between the third and the fourth recombination sites in the mammalian cell, and (ii) maintaining the cell library with the selection construct under conditions that facilitate recombination between the third and the fourth recombination sites mediated by the desired variant of the target site-specific recombinase, and (iii) detecting expression or the lack of expression of the second selectable marker that indicates the recombination between the third and the fourth recombination sites in the mammalian cell, and (4) generating from the mammalian cell selected in step (3) a polynucleotide encoding the desired variant of the target site-specific recombinase.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11492613.
Claims 1-20 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of U.S. Patent Number 12291706.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 1 is drawn to a method of generating a cell library for screening a desired variant of a target gene, the method comprising: (1) obtaining a first plurality of mammalian cells each of which comprises at a genomic locus a first recombination site recognized by a serine integrase, and (2) introducing into the first plurality of mammalian cells a library of nucleic acid constructs, each of the nucleic acid constructs comprising: (i) a second recombination site recognized by the serine integrase, (ii) a polynucleotide encoding a variant of the target gene, wherein at least one of the nucleic acid constructs comprises a desired variant of the target gene, thereby generating a second plurality of mammalian cells comprising the library of nucleic acid constructs; (3) expressing in each of the second plurality of mammalian cells the serine integrase, and (4) maintaining the second plurality of mammalian cells expressing the serine integrase under conditions that facilitate recombination between the first and the second recombination sites mediated by the serine integrase, thereby generating a cell library comprising a third plurality of mammalian cells each of which comprises a variant of the target gene at the genomic locus and claim 1 in U.S. Patent Number 12291706 is drawn to a method of generating a mammalian cell library for screening a desired variant of a target gene, the method comprising: (1) obtaining a first plurality of mammalian cells each of which comprises at genomic locus Hipp11 (H11) an attP site recognized by a Bxb1 integrase; (2) introducing into the first plurality of mammalian cells a library of nucleic acid constructs wherein at least one of the nucleic acid constructs comprises the desired variant of the target gene, each of the nucleic acid constructs comprising: a) an attB site recognized by the Bxb1 integrase, and b) a variant of a target gene, thereby generating a second plurality of mammalian cells comprising the library of nucleic acid constructs, wherein at least one of the second plurality of mammalian cells comprises the desired variant of the target gene: (3) expressing in each of the second plurality of mammalian cells the Bxb1 integrase encoded by the polynucleotide sequence of SEQ ID NO: 1 wherein the Bxb1 coding sequence is operably linked to an expression control sequence; and (4) maintaining the second plurality of mammalian cells under conditions that facilitate recombination between the attP and the attB sites mediated by the Bxb1 integrase to integrate the variants of the target gene at the genomic locus H11, thereby generating the mammalian cell library comprising a third plurality of mammalian cells each of which comprises a variant of the target gene at the genomic locus H11 wherein integration of the variants of the target gene at the genomic locus H11 does not involve a unidirectional recombinase other than the Bxb1 integrase.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 12291706.
Discussion and Answer to Argument
Applicant requested the double patenting rejection(s) be held in abeyance (Reply, starting on page 3). Applicants have filed Terminal Disclaimers on 4/20/2026, however on 4/30/2026 both Terminal Disclaimers were disapproved. Thus, the above double patenting rejection(s) is/are maintained for the reasons of record.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
Prosecution Insights