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
Status of Application/Amendment/Claims
Applicant's response filed 07/06/2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 03/04/2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With entry of the amendment filed on 07/06/2026, claims 1, 9, 10, 12, 15, 23-27 and 30-33 are pending in the application. Claims 25 is rejoined and new claims 30-33 ae within the scope of the elected invention and are rejoined.
SEQ ID Nos. 7, 9, 10 and 13 are free of the prior art and are not obvious in view of the prior art as hairpin adapters as in claim 1.
The 112(a) and Double-Patenting rejection against co-pending Application No. 17,796,596 (App596) is withdrawn in response to claim amendments.
Withdrawn Rejections
Any rejection not reiterated in this Office Action is hereby withdrawn.
New 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. See 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);and, 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 9, 10, 12, 15, 23-27 and 30-33 are provisionally rejected under the judicially created doctrine of double patenting over claims 1-29 of co-pending Application No. 19,551,392 (App392). This is a provisional double patenting rejection since the conflicting claims have not yet been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter. Claims 1-29 of App392 are drawn to a closed linear DNA with modifications of the hairpin adaptors as instantly claimed and is not patentably distinct from the instantly claimed closed linear DNA.
This is a provisional obviousness-type double patenting rejection.
Reasons for Indication of Claims Free of the Prior Art
Claims 1, 9, 10, 12, 15, 23-27 and 30-33 are not found in the prior or made obvious by the prior art. Metzker et al. (WO 2015/157747 of record cited on IDS filed 09/06/2022) teach a closed linear DNA molecule comprising hairpin loops at each end of a double stranded sequence as claimed. Metzker discloses that "[m]odified nucleotides may be substituted to alter the stability of the double-stranded stem region." See paragraph [00065] and does not teach or suggest the presently claimed clDNA with modified nucleotides located in each single stranded loop of the hairpin. It would
The prior art of Serantes et al., Heinrich et al. and Walters et al (of record 892 03/04/2026) teach double stranded DNA molecules with hairpin adapter sequences attached at the ends. The prior art of Metzker et al. does not make it obvious to modify the hairpin adaptors.
Furthermore, the claimed clDNA has the advantage of increased expression of an encoded product as shown in Figs 6 and 8 (Examples 2 and Table 3). The prior art does not teach or make obvious modifying the single stranded hairpin adaptors with the claimed nucleotides wherein the clDNA has increased expression of encoded proteins.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636
