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’ election without traverse of Group I (Claims 1, 3, and 4), drawn to a vector in the reply filed on 05/12/2026 is acknowledged. Claims 5-20 are withdrawn from consideration, as being directed to a non-elected invention. Claims 1, 3, and 4 have been examined on the merits.
Priority
Acknowledgement is made that the instant application is a National Stage of International application No. PCT/JP2022/012427 (filed 03/17/2022). Acknowledgement is further made of Applicants’ claim for priority to Japanese applications JP2021-054970 (filed 03/29/2021) and JP2021-054930 (filed 03/29/2021). Copies of the foreign priority documents are present in the application file.
Response to Arguments
Applicants argue in the response to election filed 05/12/2026 that neither Samulski nor Liew et al teach a single vector comprising (a) the protelomerase-encoding sequence, (2) the paired recognition sequences, and (3) the target protein-encoding sequence and instead rely on a “multi-component” system. Additionally, applicants argue there is no reason to combine these elements into a single vector because the designs of Samulski and Liew et al allow the host cell to process any subsequently introduced target vector.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Liew et al discloses a method of stably expressing TelN. A person of ordinary skill in the art would have been motivated to modify the vector of Samulski by adding a TelN sequence following the CMV promoter, as disclosed by Liew et al, in order to stably express TelN and continuously produce specific, desired covalently closed hairpins.
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, 3, and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/076,287 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claim 1 of Application No. 19/076,287 is drawn to a double-stranded circular DNA vector (reads on claim 3) comprising a protelomerase gene sequence… an endonuclease gene sequence…a pair of protelomerase recognition sequences which are recognized by the protelomerase… at least one endonuclease recognition sequence… and a nucleic acid sequence of interest, wherein the protelomerase gene sequence, the endonuclease gene sequence, and the endonuclease recognition sequence are placed in a region between the pair of protelomerase recognition sequences… wherein the protelomerase gene sequence and the endonuclease gene sequence are placed under the control of a promoter which is capable of regulating their expression (reads on a nucleic acid sequence regulating expression of the protelomerase (claim 4)). Thus, the vector of Application No. 19/076,287 reads on a vector comprising a nucleic acid sequence encoding protelomerase; a pair of nucleic acid sequences recognized by the protelomerase; and a nucleic acid sequence located between the pair of nucleic acid sequences and encoding a protein (i.e. claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Samulski (WO2019246544A2) in view of Liew et al (Analytical Biochemistry, 2019).
Samulski discloses a double stranded plasmid comprising an EGFP sequence flanked by a telL sequence and a telR sequence (See Fig. 9 and ¶0132-0133). The vector of Samulski further comprises a CMV promoter sequence (See Fig. 9). The telRL sequence in the vector of Samulski is cut by TelN to produce two covalently closed hairpins (See ¶0081 and Fig. 8).
Regarding claims 1, 3, and 4: Samulski discloses a double stranded plasmid (reads on a double-stranded circular plasmid DNA vector) comprising an EGFP sequence (reads on a nucleic acid sequence encoding a protein) flanked by telL and telR sequences (reads on between a pair of nucleic acid sequences recognized by the protelomerase). Samulski discloses the telRL sequence is cut by TelN (reads on a protelomerase) to produce two covalently closed hairpins. The vector of Samulski further comprises a CMV promoter sequence.
Samulski does not disclose the vector further comprises a nucleic acid sequence encoding protelomerase.
Liew et al discloses a vector express TelN (reads on protelomerase) under control of a CMV promoter that can be used to stably express TelN in mammalian cells (reads on a nucleic acid sequence regulating expression of the protelomerase) (See Se. 2.4).
Given that Samulski discloses a vector comprising an EGFP flanked by tell and telR sequences that can be cleaved by TelN protelomerase to produce two covalently closed hairpins and further expressing a CMV promoter and Liew et al discloses a vector expressing TelN under control of a CMV promoter for stably expressing TelN in mammalian cell lines, it would have been prima facie obvious to a person of ordinary skill in the art to modify the vector of Samulski by adding a TelN sequence driven by the CMV promoter (reads on a nucleic acid sequence regulating expression of the protelomerase). One would have been motivated to modify the vector of Samulski by adding a TelN sequence driven by the CMV promoter in order to stably express TelN in mammalian cells allowing for continuous production of the covalently closed hairpins produced by the vector of Samulski. There is a reasonable expectation of success because inserting sequences into vectors in a known technique in the art and Liew et al teaches TelN can be stably expressed in mammalian cells under the control of a CMV promoter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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/MARISOL ANN O'NEILL/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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