DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed January 10, 2025. Currently, claims 1-3, 9, 13, 17, 21, 31, 37, 49-52, 57-58, 66-68, 81-82 are pending.
Election/Restrictions
The response to the Election requirement filed June 24, 2026 has been considered. In view of the search and art, the election of species has been withdrawn.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim(s) 1-3, 9, 13, 17, 21, 31, 37, 49-52, 57-58, 66-68, 81-8is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Korlach et al. (US 2003/0044781, March 6, 2003).
Korlach teaches methods for sequencing a target nucleic acid molecules having a plurality of bases. Korlach teaches contacting nucleotide bases and measuring the temporal order of the base additions during polymerization (abstract). A primer is hybridized with a target sequence and polymerase is used to extend the oligonucleotide primer at an active site. A plurality of labelled nucleotide analogs are added with each distinguishable type of nucleotide being complementary to a different nucleotide in the target (abstract). The extended nucleic acid strand is analyzed for the nucleotide added. As seen in Figure 3, over time, different fluorescent signals are added and the sequence is deduced. Korlach teaches suitable means for removal, i.e. deactivation, of the fluorophore after it has been detected and identified includes photobleaching of the fluorophore or photochemical cleavage (para 66).
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With respect to Claims 2-3, Korlach teaches sequencing a target nucleic acid using a 3rd, 4th and more labeled nucleotide.
With respect to Claim 9, Korlach teaches the polymerase may be Sp6RNA polymerase, T4 DNA polymerase, and T7 DNA polymerase (para 42 and 65).
With respect to Claim 13, the primer may comprise ribonucleotides, deoxyribonucleotides (see Claim 13, for example).
With respect to Claim 17, Korlach does not teach using ddNTPs, theu the nucleotides are void of a terminating group.
With respect to Claim 21, Korlach teaches using four different labels, each with a different fluorescence emission spectrum (para 61).
With respect to Claim 31, Korlach teaches contacting the primer, polymerase, labeled nucleotides.
With respect to Claim 37, Korlach teaches nanofabrication is useful in limiting the reaction volume to reduce the level of background fluorescence (para 91).
With respect to Claim 49, Koralch teaches labels may be removed by photobleaching (para 66).
With respect to Claims 50 and 57-58, Korlach teaches labels added to the sequencing primer are removed after they have been detected, as shown in FIG. 2C. This preferably takes place before additional nucleotide analogs are incorporated into the oligonucleotide primer (para 56). Korlach contemplates both before and after and preferably removes label before an additional nucleotide is added, but also teaches that’s merely preferable.
With respect to Claim 51, teaches using photobleaching of the fluorophore or photochemical cleavage (para 66).
With respect to Claim 52, 67-68, Korlach teaches the fluorescence photon emission and photobleaching processes themselves are stochastic processes (para 103).
Duplicate Claim Warning
Applicant is advised that should claim 50 be found allowable, claim 57 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sundararajan et al. (US 2005/0026163, February 3, 2005) teaches sequencing nucleic acids by observing the uptake of nucleotides modified with bulky groups. The addition and cleavage of protecting groups was performed before additional nucleotides were added (para 44).
Lapidus et al. (US 9,657,344, May 23, 2017) teaches short cycle methods for sequencing polynucleotides. Figure 1 illustrates incorporation of labeled nucleotides and removing label, adding another nucleotide for sequencing.
Turner et al. (US 7,767,394, August 3, 2010) teaches methods of sequencing using detection of labeled nucleotides or labeled nucleic acid targets.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
August 26, 2026
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