Office Action Predictor
Application No. 17/935,082

LABELED NUCLEOTIDE COMPOSITIONS AND METHODS FOR NUCLEIC ACID SEQUENCING

Non-Final OA §102§103§112§DP
Filed
Sep 23, 2022
Examiner
TURPIN, ZACHARY MARK
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Quantum-Si Incorporated
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds
3y 5m
To Grant

Examiner Intelligence

0%
Career Allow Rate
0 granted / 10 resolved
Without
With
+0.0%
Interview Lift
avg trend
3y 5m
Avg Prosecution
62 pending
72
Total Applications
career history

Statute-Specific Performance

§101
9.1%
-30.9% vs TC avg
§103
30.6%
-9.4% vs TC avg
§102
19.8%
-20.2% vs TC avg
§112
25.5%
-14.5% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§102 §103 §112 §DP
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 Claims 1-16 are pending in the present application. Claims 1-16 are under examination. Effective Filing Date The present application, filed on September 23, 2022, is a Continuation of U.S. Application No: 15/600,979, filed on May 22, 2017, now abandoned, which claims the benefit of U.S. Provisional Application No: 62/426,144, filed November 23, 2016, and U.S. Provisional Application No: 62/339,790, filed on May 20, 2016. Therefore, the priority date of the present application is determined to be May 20, 2016. Drawings The drawings filed on September 23, 2022 are acceptable. 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. Claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Claim 10 recites the claim terms “TEG”, “TEMPO-TEG”, “trolox-TEG”, and “monosaccharide-TEG”. The terms “TEMPO”, “trolox”, and “TEG” are acronyms, the meanings of which are subject to change over time, and are not defined in the specification. It is unclear what chemical structure(s) are encompassed by these claim terms. 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 1-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cherkasov et al., US 2010/0029494 A1, published February 4, 2010. Regarding claim 1, Cherkasov et al. teach fluorescently labeled (i.e. luminescently labeled) nucleotides comprising one or more signal giving marker units (i.e. labels) connected to one or more nucleotide polyphosphates via a nucleic acid. (Cherkasov et al., figures 1 and 7 and paragraph 0014). Regarding “luminescent labels”, the specification provides examples of suitable luminescent labels comprising “Cy®3” (page 4, line 31-page 5, line 12). Cherkasov et al. teaches that “Cy®3” is a suitable fluorescent label for a labeled nucleotide (“nucleoside polyphosphate”) (Cherkasov et al., figure 48). As such, Cherkasov et al. teach “luminescently” labeled nucleotides. It is noted that the instant specification does not provide an explicit definition of “protecting element” but provides for embodiments wherein “the protecting element is an oligonucleotide” (page 63, lines 1-2). As such, the broadest reasonable interpretation of the claim term “protecting element” encompasses embodiments wherein the protecting element is the nucleic acid itself. Therefore, Cherkasov et al. teaches all of the presently claimed structural limitations. PNG media_image1.png 620 423 media_image1.png Greyscale PNG media_image2.png 533 407 media_image2.png Greyscale PNG media_image3.png 465 412 media_image3.png Greyscale Regarding claim 2, Cherkasov et al. teach the nucleic acid through which the luminescent label is connected to the nucleoside polyphosphate is single stranded (Cherkasov et al., figure 48) (see above). Regarding claim 3, Cherkasov et al. teach the nucleic acid through which the luminescent label is connected to the nucleoside polyphosphate is double stranded (Cherkasov et al., figure 7) (see above). Regarding claim 4, Cherkasov et al. teach a first oligonucleotide strand comprising the luminescent label and a second oligonucleotide strand comprising the nucleoside polyphosphate, wherein the two oligonucleotides are annealed to each other (Cherkasov et al., figure 7) (see above). Cherkasov et al. further teaches that the position of the linkers through which the label is attached can be at one end of the oligonucleotide (as shown in figures 7 and 48) or can be in the middle of the sequence (i.e. an internal position having one or more nucleotides on either side) (Cherkasov et al., paragraph 0650-0653). Regarding claim 5, Cherkasov et al. teach the labeled nucleotide comprises a poly-T linker (i.e. a plurality of thymidine nucleotides) (Cherkasov et al., Figure 48). Regarding claim 6, Cherkasov et al. teach the linker can be linear (Cherkasov et al., figure 1) or branched (Cherkasov et al., figure 6). PNG media_image4.png 630 392 media_image4.png Greyscale Regarding claim 7, Cherkasov et al. teaches the marker is coupled to the nucleoside polyphosphate through a nucleic acid (i.e. a protecting element comprising energy absorbing modifications; nucleobases). In particular, Cherkasov et al. teaches a linker comprising polyT homopolymer (Cherkasov et al., figure 48). Regarding claim 8, Cherkasov et al. teaches the oligonucleotides can be further modified with FRET pairs or a fluorescent-dye/quencher molecule pair (i.e. a triplet state quencher) (Cherkasov et al., paragraph 0652). Regarding claim 9, Cherkasov et al. teaches the labeled nucleotide comprises a dendrimer (i.e. a dendron modification) (Cherkasov et al., figure 8), and that nucleic acids (i.e. energy absorbing modifications) can be coupled to said dendrimer (Cherkasov et al., paragraph 0095). Regarding claim 10, Cherkasov et al. teaches the labeled nucleotide comprises a linker component that comprises a water-soluble polymer such as a polysaccharide (i.e. comprising disaccharides) (Cherkasov et al., paragraph 0282). Regarding claim 11, Cherkasov et al. teaches that oligonucleotides comprising hairpin structures (stemloops) can be incorporated in the labeled nucleotides in place of the polyT oligonucleotide depicted in figure 48 (Cherkasov et al., Figure 48 and paragraph 0649). Regarding claims 13 and 14, Cherkasov et al. teaches third and fourth oligonucleotide strands are annealed to at least one of the first and second oligonucleotide strands (Cherkasov et al., figure 7, see above) 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 1, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cherkasov et al., US 2010/0029494 A1, published February 4, 2010 in view of Gaylord et al., US 2011/0256549 A1, published October 20, 2011. This rejection under 103 is directed to the embodiment of energy-absorbing modification comprises “a glycerol dendrimer” as recited in claim 10. Claims 1 and 7 are included in this rejection under 103 because claim 10 depends from claims 1 and 7. Claims 1 and 7 are rejected under U.S.C. 102(a)(1) above, and are summarized below. Regarding claim 1, Cherkasov et al. teach fluorescently labeled (i.e. luminescently labeled) nucleotides comprising one or more signal giving marker units (i.e. labels) connected to one or more nucleotide polyphosphates via a nucleic acid. (Cherkasov et al., figures 1 and 7 and paragraph 0014). Regarding “luminescent labels”, the specification provides examples of suitable luminescent labels comprising “Cy®3” (page 4, line 31-page 5, line 12) (i.e. Cy3 is a “luminescent label”). Cherkasov et al. teaches that “Cy®3” is a suitable fluorescent label for a labeled nucleotide (“nucleoside polyphosphate”) (Cherkasov et al., figure 48). As such, Cherkasov et al. teach “luminescently” labeled nucleotides. It is noted that the instant specification does not provide an explicit definition of “protecting element” but provides for embodiments wherein “the protecting element is an oligonucleotide” (page 63, lines 1-2). As such, the broadest reasonable interpretation of the claim term “protecting element” encompasses embodiments wherein the protecting element is the nucleic acid itself. Therefore, Cherkasov et al. teaches all of the presently claimed structural limitations. PNG media_image1.png 620 423 media_image1.png Greyscale PNG media_image2.png 533 407 media_image2.png Greyscale PNG media_image3.png 465 412 media_image3.png Greyscale Regarding claim 7, Cherkasov et al. teach the marker is coupled to the nucleoside polyphosphate through a nucleic acid (i.e. a protecting element comprising energy absorbing modifications; nucleobases). In particular, Cherkasov et al. teaches a linker comprising polyT homopolymer (Cherkasov et al., figure 48). Regarding claim 10, Cherkasov et al. teaches the labeled nucleotide comprises a linker component that comprises a water-soluble polymer such as a polysaccharide (i.e. comprising disaccharides) (Cherkasov et al., paragraph 0282). Cherkasov et al. further teaches the labeled nucleotide comprises a dendrimer (i.e. a dendron modification) (Cherkasov et al., figure 8), and that nucleic acids (i.e. energy absorbing modifications) can be coupled to said dendrimer (Cherkasov et al., paragraph 0095). Cherkasov et al. does not teach that the labeled nucleotide comprises a glycerol dendrimer. However, Gaylord et al. teach conjugated polymer “CP” labels comprising glycerol dendrimers (Gaylord et al., paragraph 0228) are useful for amplifying the detection sensitivity in nucleic acid diagnostics (Gaylord et al., paragraph 0003-0004) and specifically contemplates the usefulness of such labels in nucleic acid sequencing (Gaylord, paragraph 0197). Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the luminescently labeled nucleotide comprising a dendrimeric linker, taught by Cherkasov et al. by swapping the dendrimer taught by Cherkasov et al. with the glycerol dendrimer taught by Gaylord et al., because of the teaching of Gaylord et al. that conjugated polymers comprising glycerol dendrimers have the advantage of improving detection sensitivity of biological signals (i.e. labeled nucleotides) (Gaylord et al,. paragraph 0003) by acting as light harvesting structures (Gaylord et al., paragraph 0172) (i.e. comprise energy-absorbing modifications). The ordinary artisan would have been motivated to modify the dendrimer component of the labeled nucleotide taught by Cherkasov et al. with the specific glycerol dendrimer taught by Gaylord et al., because of the teaching of Gaylord et al. that said dendrimers are useful in nucleic acid sequencing (Gaylord et al., paragraph 0197) as signal enhancers that can absorb more energy than conventional organic dyes (Gaylord et al., paragraph 0172). The ordinary artisan would have had a reasonable expectation of success because Gaylord teaches glycerol dendrimers are exemplary conjugated polymers that are useful for enhancing detectable signals in biological assays, including nucleic acid sequencing. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Cherkasov et al., US 2010/0029494 A1, published February 4, 2010 in view of Wegener et al., US 2009/0233302 A1, published September 17, 2009, Sebo et al., US 2015/0050659 A1, published February 19, 2015, and Sorge et al., US 2009/0117540 A1, published May 7, 2009. Regarding claim 1, Cherkasov et al. teaches fluorescently labeled (i.e. luminescently labeled) nucleotides comprising one or more signal giving marker units (i.e. labels) connected to one or more nucleotide polyphosphates via a nucleic acid. (Cherkasov et al., figures 1 and 7 and paragraph 0014). Regarding “luminescent labels”, the specification provides examples of suitable luminescent labels comprising “Cy®3” (page 4, line 31-page 5, line 12). Cherkasov et al. teaches that “Cy®3” is a suitable fluorescent label for a labeled nucleotide (“nucleoside polyphosphate”) (Cherkasov et al., figure 48). As such, Cherkasov et al. teach “luminescently” labeled nucleotides. It is noted that the instant specification does not provide an explicit definition of “protecting element” but provides for embodiments wherein “the protecting element is an oligonucleotide” (page 63, lines 1-2). As such, the broadest reasonable interpretation of the claim term “protecting element” encompasses embodiments wherein the protecting element is the nucleic acid itself. Therefore, Cherkasov et al. teaches all of the presently claimed structural limitations. PNG media_image1.png 620 423 media_image1.png Greyscale PNG media_image2.png 533 407 media_image2.png Greyscale PNG media_image3.png 465 412 media_image3.png Greyscale Regarding claim 11, Cherkasov et al. teaches that oligonucleotides comprising hairpin structures (stemloops) can be incorporated in the labeled nucleotides in place of the polyT oligonucleotide depicted in figure 48 (Cherkasov et al., Figure 48 and paragraph 0649). Regarding claim 12, Cherkasov et al. teaches that the position of the linkers through which the label is attached can be at one end of the oligonucleotide (as shown in figures 7 and 48) or can be in the middle of the sequence (i.e. an internal position having one or more nucleotides on either side) (Cherkasov et al., paragraph 0650-0653). Therefore, Cherkasov et al. teaches that the oligonucleotide linker may be a homopolymer (i.e. oligo-T) or a hairpin structure labeled at the middle of the sequence (i.e. in the loop of the hairpin loop) or at a terminus of the sequence comprising hairpin structures (i.e. the hairpin is unlabeled). Cherkasov et al. does not explicitly teach that the “oligonucleotides comprising hairpin structures used for the synthesis of nuc-macromolecules” (Cherkasov et al., paragraph 0649) are arranged as required by claim 12 (at least one label is attached at a loop that is separated from the one or more nucleotides by one or more unlabeled stem loops). However, Wegener et al. teach labeled nucleic acid reaction components comprising structural components that maintain damaging labeling components sufficiently distal from the reactant portion of the molecule (Wegener, Abstract). In particular, Wegener et al. teach labeled nucleoside polyphosphates wherein a fluorescent label is separated from the nucleoside polyphosphate by a DNA linker wherein the label is attached at the loop of a stem loop (Wegener, figure 4C and paragraph 38). Wegener et al. teaches nucleic acid linker structures advantageously provides ease of synthesis using conventional DNA synthesis and dye coupling techniques and allows for control of linker length, rigidity, and the stability of the protecting hairpin structure (Wegener et al., paragraph 0038). Sebo et al. teach labeled nucleic action reaction components (nucleotides) for single molecule real time nucleic acid sequencing wherein the label and the nucleotide are separated in space by a linker comprising a bulky “shield element” that protects the reaction components (a polymerase and the nucleotide) from photodamage from to the fluorescent label (Sebo et al., abstract). Sebo et al. primarily utilize proteinaceous or polymeric (i.e. PEG-containing) shield element, but further teach that the exact structure of the shield elements is not critical, so long as the structures are large enough to limit contacts between the label(s) and the reaction components that are sensitive to photodamage (proteins, nucleoside polyphosphates) (Sebo et al., paragraph 0173-0175). Finally, Sorge et al. teach bulky nucleic acid structures comprising multiple hairpin structures that are useful as degradable linkers between a fluorescent label and a nucleotide sequence of interest in a labeled nucleic acid probe (Sorge et al., paragraph 0022 and figure 3G). Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the labeled macromolecular nucleoside polyphosphates taught by Cherkasov et al., comprising DNA linkers/”core components” (as seen in Cherkasov et al., figures 7 and 48) to comprise bulky shield elements, as taught by Sebo et al. to further protect the polymerase from label-induced photodamage. Because of the teachings of Sebo et al. that the exact nature of the bulky shield elements is not critical, and the teaching and Wegener et al. that DNA linkers between the label and nucleotide are advantageously easier to produce and optimize, it would likewise have been obvious to utilize bulky DNA structures to further separate the nucleotide component from the label component. Sorge provides structures of bulky DNA secondary structures including a “cloverleaf” structure comprising multiple hairpins (Sorge et al., figure 3G). The ordinary artisan would have been motivated to use modify the labeled nucleotides taught by Cherkasov et al. to further comprise bulky DNA shield elements with multiple hairpin structures, such as those taught by Sorge et al. because of the teachings of Sebo et al. that bulky shield elements protect polymerases from label-induced damage in real time single-molecule sequencing (Sebo et al., paragraph 003-004 and 0010) and the teachings of Wegener et al. that DNA linkers (i.e. protecting elements/shield elements) are easier to manufacture and optimize (Wegener et al., paragraph 0038). The ordinary artisan would have been reasonably confident that the bulky DNA structures taught by Sebo et al., Wegener et al., and Sorge et al. would have successfully functioned as shield elements in the modular labeled nucleotide structures taught by Cherkasov et al. because each of Cherkasov et al., (Cherkasov et al., paragraph 0041) Sebo et al., (Sebo et al., Abstract) and Wegener et al., (Wegener et al., paragraph 0035) teach that labeled nucleotides comprising long linkers and bulky protecting groups are useful as labeled nucleotides in DNA sequencing applications. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cherkasov et al., US 2010/0029494 A1, published February 4, 2010 in view of Buckhout-White et al., US 2015/0293022 A1, published October 15, 2015. Regarding claims 1, 4, 13, and 14, upon which claim 15 depends, Cherkasov et al. teaches all of the recited structural elements of these claims (see the 102(a)(1) rejection above). Regarding claim 15, Cherkasov et al. does not teach that the oligonucleotide strands form a Holliday junction. However, Buckhout-White et al. teach nanoscale nucleic acid antennae that absorb energy produced by fluorescent label(s) (Buckhout-White et al., paragraph 0003 and paragraph 0026). Of the structures tested, Buckhout-White et al. teach that the Holliday junction exhibits the strongest antenna effect (Buckhout-White et al., paragraph 0045). Buckhout-White et al. further teach that these “nanoscale antennas” absorb light energy and direct the energy in a particular direction (Buckhout-White et al., paragraph 0026). Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have modified the multi-stranded labeled-nucleotide:nucleic acid assembly structure taught by Cherkasov et al. (see Cherkasov et al., figure 7 or 37) such that the nucleic acid strands are arranged in a Holliday junction such as those taught by Buckhout-White et al. The ordinary artisan would have been motivated to modify the labeled nucleotides of Cherkasov et al. with a reasonable expectation of success because of the teaching of Buckhout-White et al. that the Holliday junction structure absorbs light energy (i.e. is a protecting element) and directs the energy in a particular direction (i.e. away from the labeled nucleotide/polymerase). Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Cherkasov et al., US 2010/0029494 A1, published February 4, 2010 in view of Sebo et al., US 2015/0050659 A1, published February 19, 2015. Regarding claim 16, Sebo et al. teach a method of determining the sequence of a template nucleic acid (Sebo et al., abstract) comprising exposing a template, primer, and polymerase complex in a target volume to luminescently labeled nucleotides, directing a series of pulses of excitation radiation toward the target volume, detecting emitted photons during sequential incorporation into the primer, and identifying the sequence by determining the retention time of the labeled nucleotide during incorporation (i.e. determining timing of the emitted photons) (Sebo et al., paragraphs 0069-0071). Sebo et al. teach labeled nucleotides comprising shield elements that prevent the fluorescent label from contacting (and damaging) the polymerase or other reaction components (Sebo et al., paragraphs 0072-0073). Sebo et al. primarily utilize proteinaceous or polymeric (i.e. PEG-containing) shield elements, but further teach that the exact structure of the shield elements is not critical, so long as the structures are large enough to limit contacts between the label(s) and the reaction components that are sensitive to photodamage (proteins, nucleoside polyphosphates) (Sebo et al., paragraph 0173-0175). Cherkasov et al. teach fluorescently labeled (i.e. luminescently labeled) nucleotides comprising one or more signal giving marker units (i.e. labels) connected to one or more nucleotide polyphosphates via a nucleic acid. (Cherkasov et al., figures 1 and 7 and paragraph 0014). Regarding “luminescent labels”, the specification provides examples of suitable luminescent labels comprising “Cy®3” (page 4, line 31-page 5, line 12). Cherkasov et al. teaches that “Cy®3” is a suitable fluorescent label for a labeled nucleotide (“nucleoside polyphosphate”) (Cherkasov et al., figure 48). As such, Cherkasov et al. teach “luminescently” labeled nucleotides. It is noted that the instant specification does not provide an explicit definition of “protecting element” but provides for embodiments wherein “the protecting element is an oligonucleotide” (page 63, lines 1-2). As such, the broadest reasonable interpretation of the claim term “protecting element” encompasses embodiments wherein the protecting element is the nucleic acid itself. Finally, Cherkasov et al. teach the labeled nucleotides are useful in sequencing by synthesis methods, including single-molecule-sequencing (Cherkasov et al., paragraph 0041). Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention for one of ordinary skill in the art to have substituted the labeled nucleotides taught by Cherkasov et al. into the single-molecule, real-time sequencing methods taught by Sebo et al. with a reasonable expectation of success. The ordinary artisan would have been motivated to make said substitution because of the teaching of Cherkasov et al. that he use of nucleic acid chains modified with nuc-macromolecules is especially advantageous if the nuc-macromolecule participates as part of a polymer chain in an enzymatic reaction or is in the immediate proximity of the nucleotide participating in the reaction. The influence of a macromolecular marker component on the enzyme is greatly reduced by the long linker of the nuc-macromolecules, so that the modified nucleotide components can take part in the enzymatic reactions. (Cherkasov et al., paragraph 0329). 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 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,174,363 B2 (herein referred to as ‘363). Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to methods of sequencing nucleic acids comprising detecting the incorporation of luminescently labeled nucleotides. Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,001,875 B2 (herein referred to as ‘875). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘875 anticipate the present claim. Claim 1 of ‘875 recites a method of determining the sequence of a template nucleic acid comprising exposing a complex in a target volume… directing a series of pulses towards a target volume… detecting emitted photons from luminescently labeled nucleotides, and identifying the sequence based on properties of the observed luminescent signals. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,613,772 B2 (herein referred to as ‘772). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘772 anticipate the present claims. Claim 1 of ‘772 recites a labeled nucleotide comprising a nucleoside polyphosphate connected to a nucleic acid comprising a FRET label that comprises at least three (i.e. one or more) luminescent molecules (i.e. a luminescently labeled nucleotide). Conclusion No claim is allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Each of the following references were cited in the prosecution of the parent case 15/600,979 but are not relied upon in this office action. It is further noted that the present claims are identical to the claims in the parent case received on May 22, 2017. Korlach et al. US 2010/0152424 A1 and 61/069247 Perfect et al. US 2010/0034750 A1 Park et al. US 2010/0093553 A1 Kamtekar et al. US 2014/0094375 A1 Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY MARK TURPIN whose telephone number is (703)756-5917. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm. 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, Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Z.M.T./Examiner, Art Unit 1682 /WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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Prosecution Timeline

Sep 23, 2022
Application Filed
Aug 05, 2025
Non-Final Rejection — §102, §103, §112
Apr 01, 2026
Response after Non-Final Action

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