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 office action is a response to applicant’s communication submitted August 3, 2026 in response to the February 3, 2026 requirement for restriction. This application is a national stage application of PCT/GB2022/050462, filed February 21, 2022, which claims benefit of foreign application GB2102379.1, filed February 19, 2021.
Claims 1-20 are pending in this application.
Election/Restrictions
Applicant’s provisional election with traverse of group I, claims 1-12 and 18-20, drawn to compounds according to formula (1a) or (1b), filed August 3, 2026, is acknowledged. Applicant’s arguments of record with respect to the aforementioned traversal are acknowledged and found to be not persuasive to remove the requirement for restriction. Specifically, Applicant argues that unity of invention exists in the present application because three similar groups of claims were allowed together in US patent 12673968. Firstly, a determination as to unity of invention is made independently in each application. Whether or not different groups of claims were examined together in a different application has no bearing on the merits of the present requirement for restriction. Secondly, the compounds described in the issued claims of ‘968 are narrower in scope than the compounds of formulae 1a and 1b in the present claims. Therefore the issues involved in the determination of unity of invention may differ from those in the present application, particularly whether the specific structure recited in the claims itself represents a special technical feature over the art. Thirdly, even in cases where similar issues are involved in examining a compound along with methods of making and using the compound, the non-elected groups would be eligible for rejoinder should the compounds of group I be found to be patentable. Therefore even if it is in the public interest to issue claims directed to a compound and to methods of making and using the compound in the same patent, it can still be practical to examine the claims directed to the compound separately and then rejoin the process claims if the compound is found to be allowable, without requiring the filing of several different applications.
The examiner further notes the election of the species
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. While these are species clearly pictured in dependent claim 12, they are not included in the scope of structures 1a and 1b in independent claim 1. Specifically the several provisos in claim 1 regarding the identities of the variables X and Y in claim 1 do not allow for X to be N while Y is CH, as explained further below in the section discussing 3 USC 112(d). In view of the fact that this species does appear in dependent claim 12, the reply will be treated as proper and claim 12 will be examined on the merits as it reads on the elected species herein, while all other claims which do not claims the elected species will be withdrawn from consideration.
Claims 1-11 and 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on August 3, 2026.
Claim 12 is examined on the merits herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Base claim 1, from which claim 12 depends, defines X as N, CH, CR7, or CR8, and Y as CH or N. However, claim 1 contains an additional proviso requiring that either X and Y are both N, or else X is CR8, and Y is presumably either CH or N. This does not allow, for example, X to be N while Y is CH, as is the case in the structures:
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. Therefore since claim 12 contains compounds which do not comply with either of these provisos, it fails to include all the limitations of the base claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US pre-grant publication 2019/0144905, cited in PTO-892) in view of Scott et al. (Reference included with PTO-892)
Claim 12 is examined as it reads on the elected species:
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. Chen et al. discloses the use of modified, amine masked nucleotides in a method of enzymatic nucleic acid synthesis. (p. 1 paragraph 11 – p. 2 paragraph 12) Various compounds falling within this scope include for example the compounds described in paragraph 92 bridging pp. 15-17. These compounds, which include substituted purine derivatives differ from the elected species in that they contain masked amino groups, for example azido, methylamino, and various amido groups. Furthermore these modified nucleobases are successfully incorporated into oligonucleotides using the enzyme terminal deoxynucleotide trasferase, or TdT. (See examples 1-6 on pp. 19-21) Therefore it is the case that TdT is seen to be tolerant of various non-naturally occurring nucleobase derivatives. This allows for the use of these nucleotides in reversibly terminated nucleic acid synthesis. (p. 5 paragraph 35)
Scott et al. discloses that it is useful to incorporate fluorine atoms into oligonucleotides, as an NMR label. (p. 11776 left column first and second paragraphs) This nucleotide was then enzymatically incorporated into an oligonucleotide by in vitro transcription using phage T7 RNA polymerase. (p. 11776 right column first paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to produce a 3’- aminooxy reversibly terminated derivative of the 2F-ATP labeled nucleotide described by Scott et al. One of ordinary skill in the art would have been motivated to do so in order to allow the incorporation of these nucleic acids into labeled oligonucleotides by reversibly terminated in vitro transcription and would have reasonably expected success in view of the finding by Chen that the template independent TdT enzyme is tolerant to purine bases having various non-natural substituents.
Therefore the invention taken as a whole is prima facie obvious.
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.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 11236377. (Cited in PTO-892, herein referred to as ‘377) in view of Chen et al. (US pre-grant publication 2019/0144905, cited in PTO-892) in view of Scott et al. (Reference included with PTO-892) Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 2 of ‘377 claims a method of synthesizing a nucleic acid by using terminal deoxynucleotidyl transferase (TdT) to add a 3’- blocked nucleotide to an initiator oligonucleotide and cleaving the 3’- blocking group. Claim 5 of ‘377 further specifies that the 3’- blocking group is selected from a number of options including 3’-O-aminoxy. While the claims of ‘377 do not specify the identity of the base on the 3’- blocked nucleotide being 2-fluoroadenine, as discussed previously under 35 USC 103, Chen discloses that TdT is capable of adding 3’-O- azidomethyl dNTPs having modified purine bases bearing nonstandard substituents, and Scott discloses that it is desirable to make oligonucleotides incorporating 2-Fluoro-adenosine nucleotides. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to make a 3’-O- blocked 2-Fluoro-ATP nucleotide identical to the elected structure in order to produce oligonucleotides incorporating this nucleotide as described by Scott.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 9/17/2026
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