DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 3-24-26.
Claims 1, 5-13, 18-31, 36, 68, 71 are pending in the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 3-24-26 has been entered.
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, 5-13, 18-31, 36, 68, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 33, 34, 38, 41, 50, 54, 57, 59, 61, 69, 73 of copending Application No. 18/728,735 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to plasmids comprising double-stranded DNA molecules comprising in 5' to 3' direction of the top strand a first inverted terminal repeat (ITR), wherein a first and a second restriction site for nicking endonuclease are arranged on opposite strands within proximity of the nucleotides from ITR closing base pairs of the first ITR wherein nicking results in a top strand 5' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; or a bottom strand 3' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; and. an expression cassette; and a second ITR, wherein a third and a fourth restriction site for nicking endonuclease are arranged on opposite strands in proximity to the nucleotides from ITR closing base pairs of the second ITR wherein nicking results in a top strand 3' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second viral ITR; or a bottom strand 5' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second ITR, which plasmid optionally further comprises a fifth and sixth restriction site for nicking endonucleases.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-13, 18-31, 36, 68, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 10, 12, 13, 18, 20, 24-28, 30, 31, 36, 37, 41, 42, 45, 51-53, 55-57, 60-65, 68, 69, 74, 75, 85-87, 89, 91, 93, 94, 95, 97, 98, 100--106 of copending Application No. 18/018,151 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to plasmids comprising double-stranded DNA molecules comprising in 5' to 3' direction of the top strand a first inverted terminal repeat (ITR), wherein a first and a second restriction site for nicking endonuclease are arranged on opposite strands within proximity of the nucleotides from ITR closing base pairs of the first ITR wherein nicking results in a top strand 5' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; or a bottom strand 3' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; and. an expression cassette; and a second ITR, wherein a third and a fourth restriction site for nicking endonuclease are arranged on opposite strands in proximity to the nucleotides from ITR closing base pairs of the second ITR wherein nicking results in a top strand 3' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second viral ITR; or a bottom strand 5' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second ITR, which plasmid optionally further comprises a fifth and sixth restriction site for nicking endonucleases.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-13, 18-31, 36, 68, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-49 of copending Application No. 19/156,797 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to plasmids or kits comprising double-stranded DNA molecules comprising in 5' to 3' direction of the top strand a first inverted terminal repeat (ITR), wherein a first and a second restriction site for nicking endonuclease are arranged on opposite strands within proximity of the nucleotides from ITR closing base pairs of the first ITR wherein nicking results in a top strand 5' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; or a bottom strand 3' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; and. an expression cassette; and a second ITR, wherein a third and a fourth restriction site for nicking endonuclease are arranged on opposite strands in proximity to the nucleotides from ITR closing base pairs of the second ITR wherein nicking results in a top strand 3' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second viral ITR; or a bottom strand 5' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second ITR, which plasmids or kits optionally further comprise a fifth and sixth restriction site for nicking endonucleases.
Claims 1, 5-13, 18-31, 36, 68, 71 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 70, 72 of copending Application No. 18/556,251 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to plasmids or kits comprising double-stranded DNA molecules comprising in 5' to 3' direction of the top strand a first inverted terminal repeat (ITR), wherein a first and a second restriction site for nicking endonuclease are arranged on opposite strands within proximity of the nucleotides from ITR closing base pairs of the first ITR wherein nicking results in a top strand 5' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; or a bottom strand 3' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; and. an expression cassette; and a second ITR, wherein a third and a fourth restriction site for nicking endonuclease are arranged on opposite strands in proximity to the nucleotides from ITR closing base pairs of the second ITR wherein nicking results in a top strand 3' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second viral ITR; or a bottom strand 5' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second ITR, which plasmids or kits optionally further comprise a fifth and sixth restriction site for nicking endonucleases.
Claims 1, 5-13, 18-31, 36, 68, 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 11,634,742. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising double-stranded DNA molecules comprising in 5' to 3' direction of the top strand a first inverted terminal repeat (ITR), wherein a first and a second restriction site for nicking endonuclease are arranged on opposite strands within proximity of the nucleotides from ITR closing base pairs of the first ITR wherein nicking results in a top strand 5' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; or a bottom strand 3' single strand DNA overhang comprising the first ITR or a functional fragment thereof upon separation of the top from the bottom strand of the first ITR; and. an expression cassette; and a second ITR, wherein a third and a fourth restriction site for nicking endonuclease are arranged on opposite strands in proximity to the nucleotides from ITR closing base pairs of the second ITR wherein nicking results in a top strand 3' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second viral ITR; or a bottom strand 5' single strand DNA overhang comprising the second ITR or a functional fragment thereof upon separation of the top from the bottom strand of the second ITR, which compositions optionally further comprise a fifth and sixth restriction site for nicking endonucleases.
Conclusion
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Jane Zara
4-7-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
Prosecution Insights