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 .
Response to Remarks
Applicants’ arguments, filed on 02/13/2026, have been approved and entered.
They have been fully considered. Rejections and/or objections not reiterated from
previous office actions are hereby withdrawn. The following rejections and/or objections
are either newly applied or reiterated. They constitute the complete set presently
being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 is vague and indefinite because it is unclear what is the moiety “X1” in Formula (IB) because the claim does not define said “X1” .
Claim 19 recites the limitation " Z² is a second reactive group which is orthogonally reactive with the first reactive group Z¹”. There is insufficient antecedent basis for the limitation “the first reactive group Z¹" in the claim, because Z1 is an oligonucleotide not a reactive group.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ju et al. WO 2019/178893.
Ju et al. discloses nucleotide for sequencing having a structure identical to the instant compound of Formulas (IA) and (IB) comprising a nucleobase comprising adenine, guanine, cytosine, thymine, uracil, hypoxanthic or analog thereof which is viewed as the nucleobase W; a cleavable linker comprising an SS(DTM), an azo, an SS-azo, an allyl, a 2-nitrobenzyl, an azidomethyl, or azidomethyl derivative which is viewed as L1 or Q1-X1-Q2 ; said cleavable linker is linked to a Blocker which can be a nucleotide or oligonucleotide comprising 2-50 monomer units of abasic sugars or modified nucleosides or a combination thereof which is viewed as Z1 (see pages 49-51).
Ju et al. discloses nucleotide analogues having different reactive groups, wherein the reactive groups can be anchors that comprise biotin, TCO, DBCO and tetrazine and the labeled anchor binding molecules comprise streptavidin, tetrazine, azido and TCO respectively. Ju et al. provides wherein the anchor binding molecules are labeled with fluorescent organic dyes or quantum dots, wherein the fluorescent organic dye label is selected from a group of dyes comprising fluoresceins, rhodamines, cyanines, ATTO or Dyomics dyes. Ju et al. also provides wherein the anchors comprise anchor clusters. (see for example [0173], [0189], [0209], [355-356], Figures 42-51, 129, 145).
With regards to claims 19, Ju et al. does not specifically teach that the oligonucleotides are incorporated on a solid support comprising a plurality of nascent nucleic acid copy strands. However, the use of compounds disclosed in Ju et al. for sequencing and in particular sequencing by synthesis is common in the field (see Ju et al. [0005], [0186], [0207], [258] and Figures).
Therefore, one of ordinary skill in the art seeking to solve the stated problem, according to the circumstances, would have been motivated to modify the primary reference in the manner of the claims, without exercising inventive skill, to achieve the expected benefits, optimizations and/or expanded applications as this is well known practice in the art.
MPEP states wherein the “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Alter, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Routine optimization is not considered inventive and no evidence has been presented that the selection of a specific oligonucleotide modification or nucleic acid sequence was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art.
Claims 6-9, 11-13, and 15 are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEZIA RILEY/Primary Examiner, Art Unit 1681 26 March 2026
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