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 .
Appeal Brief
In view of the appeal brief filed on February 17th, 2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683
Notice of New Examiner
The Examiner would like to note for the Applicant that this case has been
transferred to a new examiner for continued examination. Any further communications on this case may be directed to the contact information included in the conclusion of this
office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later- filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. V. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. EP21382725.6, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. This prior-filed application does not include description related to a partially closed linear deoxyribonucleic acid (DNA) product, or wherein the double stranded DNA molecule generated by step (a) of the method is not purified prior to step (b). Thus, the priority date of claims 8 and 9 is July 29, 2022.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on February 23rd, 2026; April 23rd, 2026; and June 25th, 2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Previous Objections and Rejections
The previous Reply filed November 17th, 2025 is acknowledged. Regarding the most recent Office Action mailed September 16th, 2025:
The rejection set forth under 35 U.S.C. 103 is withdrawn in view of further considerations. New grounds of rejection are set forth below.
Claim Summary
Claims 1-15 are pending. Claims 1-7 and 10-15 are withdrawn from consideration as being drawn to non-elected inventions. Claims 8 and 9 are under examination and discussed in this Office action.
Drawings - New - Necessitated by Further Considerations
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
A statement from Applicant that there is no intention to have color drawings will result in acceptance of the drawings; otherwise, the conditions set forth above must be met in order for the color drawings to be accepted.
Specification - New - Necessitated by Further Considerations
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 12 of the instant specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of terms such as Qubit and FlashScribe, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation - New - Necessitated by Further Considerations
It is noted that the examined claims recite “a partially closed linear DNA product”. There is no well-known, art accepted meaning for a partially closed linear DNA product. Turning to the specification, the most direct description of a partially closed linear DNA product appears to be a linear DNA product ligated to a hairpin adapter on one end and a linear adapter on the other end (Figures 17 and 18; Page 81, paragraph 4). This interpretation will be applied for examination purposes.
Claim Rejections - 35 USC § 103 - New - Necessitated by Further Considerations
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Turner (US 20140295498 A1; cited on the IDS filed July 1st, 2025), in view of Pham (US 20190360043 A1; cited on the IDS filed February 23rd, 2026).
Regarding instant claim 8, Turner teaches a method for producing a closed linear deoxyribonucleic acid (DNA) product, wherein the method comprises: (a) amplifying a DNA template molecule comprising at least one endonuclease target sequence to generate a double-stranded DNA molecule, wherein the DNA template molecule is amplified by rolling circle amplification (Page 16, paragraphs [0138]-[0139]; Figure 4); (b) contacting the double-stranded DNA molecule with an endonuclease, a ligase and first and second adaptor molecules to form a single contiguous aqueous volume (Page 16, paragraphs [0139]-[0140]; Figure 4); and (c) incubating the single contiguous aqueous volume to generate the closed linear DNA product, wherein the closed linear DNA product comprises a linear double-stranded region, wherein the linear double-stranded region comprises a portion of the double-stranded DNA molecule (Page 16, paragraphs [0139]-[0140]; Figure 4), and wherein the first adaptor molecule is ligated to a first end of the linear double-stranded region and the second adaptor molecule is ligated to a second end of the linear double-stranded region (Page 16, paragraphs [0139]-[0140]; Figure 4), and wherein the linear double-stranded region is closed at the second end by the second adaptor molecule (Page 16, paragraphs [0139]-[0140]; Figure 4).
The above embodiment of Turner does not explicitly state that these steps are occurring such that there is no purification step between steps (a) and (b). However, Turner later teaches that for previously described embodiments, the various steps of the method can be performed concurrently and various steps can be performed in a single reaction mixture containing all necessary reagents (Page 18, paragraph [0152]). Therefore, it would be obvious to not have a purification step between steps (a) and (b). Turner does not teach wherein the method produces a partially closed linear DNA product. Turner also does not teach wherein the first adaptor molecule is a nucleic acid molecule that comprises one or more nuclease-resistant nucleotides
Given the earlier claim interpretation, Pham, in the same field of endeavor, teaches on using a combination of a strand-linking adapter and a linear adapter ligated to a linear DNA product, produced a partially closed linear DNA product (Page 5, paragraph [0072]; Figure 1, part 110). Pham also teaches on the addition of modified nucleotides to any adapter, including exonuclease resistant nucleotides (Page 5, paragraph [0073]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the adapters of Turner with the adapters and modified nucleotides of Pham. Since both Turner and Pham are in the same field of endeavor (e.g. formation of linear DNA products via adapters), one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to use the adapters of Pham in place of the adapters of Turner because this amounts to simple substitution of one known element for another to obtain predictable results (see MPEP 2141(III)). One of ordinary skill in the art would have been motivated to add modified nucleotides to an adapter to prevent degradation by exonucleases (Pham, Page 10, paragraph [0108]).
Regarding instant claim 9, Turner, in view of Pham, teaches the method of claim 8. Pham further teaches wherein the one or more nuclease-resistant nucleotides are one or more phosphorothioated nucleotides (Page 2, paragraph [0030]; Page 5, paragraph [0073]; Page 10, paragraph [0108]: thiophosphate linkages).
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 8 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19306828 in view of Turner (US 20140295498 A1; cited on the IDS filed July 1st, 2025) and Pham (US 20190360043 A1; cited on the IDS filed February 23rd, 2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘828 application and the instant application claim a partially double-stranded DNA portion closed at one end and open at the other with one or more nuclease-resistant nucleotides (instant claim 8, reference claim 1), and both claim the nuclease-resistant nucleotides are phosphorothioated nucleotides (instant claim 9, reference claim 4. While the instant claims are directed to a method, the method can reasonably produce the product of the ‘828 application.
The reference claims do not teach on a method of producing the product. However, Turner and Pham teach the method limitations as discussed in the above 103 rejections, obviating these variations to the claims of the ‘828 application. Pham further obviates the addition of modified nucleotides to any adapter (Page 5, paragraph [0073]), reasonably teaching that the open end region may have the one or more nuclease-resistant nucleotides as indicated in the ‘828 application, regardless of which end is open in the instant case and the ‘828 application. Any additional limitations of the claims of copending Application No. 19306828 are encompassed by the open claim language "comprising" found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights