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 .
Claim Status
Currently, claims 1-2, 4-8 are pending in the instant application. Claim 3 has been canceled. This action is written in response to applicant' s correspondence submitted 07/06/2026. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is FINAL.
Sequence Disclosure
The amendment to the specification and sequence listing filed 07/09/2026 has been entered.
Withdrawn Rejections
The rejection of claims 1-8 under 35 USC 112(b) is withdrawn in view of the amendment to the claims.
The rejection of claims 5-7 under 35 USC 112(d) is withdrawn in view of the amendment to the claims.
Maintained Rejections
Claim Rejections - 35 USC § 102
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.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGinnis (US6635419 B1). This rejection was previously presented and is reiterated below.
With regard to claim 1-4 and 8, McGinnis teaches a method for determining a sequence of one or more nucleotides in a target polynucleotide. McGinnis teaches a target specific primer is contacted with a polynucleotide sample for the primer to anneal to the complementary region and form a target-primer hybrid. McGinnis teaches the primer comprises a target binding segment and a mobility reducing moiety that does not significantly bind the target (claim 3). McGinnis teaches the primer extension products are separated by electrophoresis (See column 3, lines 33-54). McGinnis teaches the target is double stranded nucleic acid (see column 7, lines 15-18). McGinnis teaches the primers contain a target binding site and a mobility reducing moiety. McGinnis teaches a first primer and a second primer and teaches the second primer comprises the mobility reducing moiety which is longer than the first primer(see ex 1) (claim 2 and 4). McGinnis teaches the mobility reducing agent is a non-polynucleotide polymer that can be branched (see column 10, lines 60-64) (claim 8). McGinnis teaches the mobility reducing agent comprise amino acids (see column 11, lines 2-5). McGinnis teaches adding the mobility reducing agent to the 5’ end (see column 11, lines 29-31). Amino acids are both mobility reducing agents and a reaction stop, as evidence by the instant specification. The specification exemplifies a reaction stop compound includes an amino acid residue (see para 21) and a mobility reduction site is an amino acid residue (see para 22). While McGinnis does not explicitly state the mobility reducing agents include a stop compound, the specification teaches the stop compound and mobility reduction site comprise the same compounds (See para 21 and 22), as such the mobility reducing agents of McGinnis encompass both a mobility reducer and a stop agent, as defined by the instant specification.
With regard to claim 5 and 7, McGinnis teaches fluorescently labeled nucleotides and radioactive isotopes (see column 9, lines 3-15). McGinnis teaches ddNTP fluorescently labeled. McGinnis teaches direct labels include radioisotopes labels (see column 8, lines 31-32).
Response to Arguments
The response traverses the rejection on page 10-11 of the remarks mailed 07/09/2026. The response asserts that McGinnis does not disclose a reaction stop site located on a 5’ side of a target recognition site in a second primer. This response has been reviewed but not found persuasive. As addressed in the rejection above, McGinnis teaches the mobility reducing agent is a non-polynucleotide polymer that can be branched (see column 10, lines 60-64) (claim 8). McGinnis teaches the mobility reducing agent comprise amino acids (see column 11, lines 2-5). McGinnis teaches adding the mobility reducing agent to the 5’ end (see column 11, lines 29-31). Amino acids are both mobility reducing agents and a reaction stop, as evidence by the instant specification. The specification exemplifies a reaction stop compound includes an amino acid residue (see para 21) and a mobility reduction site is an amino acid residue (see para 22). While McGinnis does not explicitly state the mobility reducing agents include a stop compound, the specification teaches the stop compound and mobility reduction site comprise the same compounds (See para 21 and 22), as such the mobility reducing agents of McGinnis encompass both a mobility reducer and a stop agent, as defined by the instant specification. For these reasons and reasons of record this rejection is maintained.
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.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over McGinnis (US6635419 B1, cited on IDS) in view of Ju (Analytical Biochem, 1995, 231, pp 131-140).
McGinnis teaches a method of sequencing double stranded DNA using a first primer and a second primer, wherein the second primer comprises a mobility compound and a stop reaction site. McGinnis does not teach a primer comprising a fluorescent label.
However using fluorescently labeled primers in sequencing reactions was known in the art. Ju teaches using fluorescence energy transfer dye labeled primers in DNA sequencing and analysis. Ju teaches the fluorescently labeled primers provide better results and higher sensitivity. Ju teaches higher quality sequencing data can be obtained with much less template DNA (see pg. 137, 1st column).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to apply fluorescently labeled primers in the method of McGinnis for the expected benefit of better results, higher sensitivity and higher quality sequencing data with less template DNA as known in the art taught and taught by Ju.
Response to Arguments
The response traverses the rejection on page 11 of the remarks mailed 07/09/2026. The response asserts that McGinnis does not teach a reaction stop site located on a 5’ side of a target recognition site in a second primer and Ju does not cure the deficiencies of McGinnis. This response has been reviewed but not found persuasive. As addressed above, McGinnis does teach a stop site on a 5’ side of the target recognition site of the second primer. McGinnis teaches adding the mobility reducing agent to the 5’ end (see column 11, lines 29-31). The mobility reducing agent is also a reaction stop site and therefore McGinnis teaches this embodiment. Ju was not cited to teach this embodiment but to render obvious a fluorescently labeled primer in the method of McGinnis. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. 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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
