CTFR 17/930,412 CTFR 99472 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Pursuant to the amendment dated 03/13/2026, claims 1 and 10 were amended. Claims 1-17 are pending in the instant application and are examined on the merits herein. Priority The instant application is a PCT Patent Application No. PCT/EP2021/078390 filed on 10/14/2021 and claims foreign priority to EPO 20201865.1 filed on 10/14/2020. Withdrawn Rejections Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 1-3, 6 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 1 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 1, 4, and 5 under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025) and Narayanan et al. (Nucleic Acids Research, published 04/19/2004, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 1 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 1 and 7 under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025) and Ravan et al. (Analytical Biochemistry, published 10/09/2013, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 1 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 1 and 9 under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025) and Gui et al. (JACS, published 07/11/2007, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 1 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 10-12, 16, and 17 under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 10 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 13 and 14 under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025) as applied to claim 10 above, and further in view of Narayanan et al. (Nucleic Acids Research, published 04/19/2004, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 10 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Applicant’s amendment, filed on 03/13/2026, with respect to the rejection of claim 15 under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025) as applied to claim 10 above, and further in view of Gui et al. (JACS, published 07/11/2007, see PTO-892 dated 12/16/2025), has been fully considered and is persuasive. Applicant has amended independent claim 10 to limit the aqueous solution to consist of a nucleic acid compound and sodium chloride and Apartsin does not exemplify an aqueous solution consisting of a nucleic acid compound and sodium chloride. The rejection is hereby withdrawn . Rejections Necessitated by Amendment The following are new ground(s) necessitated by Applicants' amendment, filed on 03/13/2026, wherein instant independent claims 1 and 10 were amended to alter the breadth and scope of the claim, and wherein the remaining pending claims 2-9 and 11-17 depend from said independent claims 1 and 10. 12-256 AIA New Grounds of Rejection Claim Rejections - 35 USC § 112(d) 07-36 AIA 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. 07-36-01 AIA Claim 8 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. Claim 8 excludes a phosphate ion or 2-[4-(2-hydroxyethyl)-1-piperazinyl]-ethanesulfonic acid. However, claim 8 depends from claim 1 which limits the aqueous solution’s solute to consist of a nucleic acid compound and sodium chloride. Therefore, the aqueous solution must necessarily not contain a phosphate ion or 2-[4-(2-hydroxyethyl)-1-piperazinyl]-ethanesulfonic acid . 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 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-3, 6-8, 10-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025), Ghosh et al. (J Phys. Chem. B, published 12/30/2015, see PTO-892) and Ravan et al. (Analytical Biochemistry, published 10/09/2013, see PTO-892 dated 12/16/2025) . Apartsin is drawn to the study of multifunctional hybrids of single-walled carbon nanotubes with nucleic acids (title). Apartsin exemplifies a 5’-pyrene conjugated oligonucleotide noncovalently binding to a SWCNT (Figure 1, page 1456). The figure shows that the nucleic acid compound and the linker structure are bonded to each other via the phosphate group. The 5’-pyrene conjugated oligonucleotide are incubated with the SWCNT in aqueous solution of 10 mM Tris-HCl, 1 mM Na 2 EDTA, 0.1 M NaCl, pH 7.5. The SWCNT meets the limitation of a “sensor element” as specified in instant claim 1 to include “graphene, graphene oxide, a carbon nanotube, or graphite”. Regarding instant claim 6, the aqueous solution does not contain an organic solvent. Regarding instant claim 8, the aqueous solution does not contain a phosphate ion or 2- [4-(2-hydroxyethyl)-1-piperazinyl]-ethanesulfonic acid. PNG media_image1.png 574 1101 media_image1.png Greyscale Apartsin Figure 1 (page 1456). Apartsin does not teach a solution that is limited only to nucleic acid and sodium chloride. Apartsin does not teach a sodium chloride at concentration of 150 mM or more. Apartsin does not teach a reagent kit. Ghosh is drawn to the study of salt concentration dependent nucleobase distribution in a single-stranded DNA-single walled carbon nanotube hybrid with molecular dynamis (Title). Ghosh teaches that the absorption of nucleobases on the surface of a SWCNT depends strongly on the ionic strength of the medium. Ghosh showed using atomistic molecular dynamics that at low salt concentration ssDNA wraps on the surface of SWCNT through hydrophobic π−π stacking between the DNA bases and the sp 2 -hybridized carbon atoms of the carbon nanotube. At high salt concentration, however, the DNA molecule adopts a partially folded structure and the ssDNA−SWCNT wrapping gets weakened significantly due to the self-stacking of the DNA bases (abstract). Ghosh teaches that the noncovalent and hydrophobic binding interactions between ssDNA and SWCNT are governed by the distributions of nucleobases which are distinctly different at the two concentrations of salt under study. At low salt concentration, the flexible ssDNA prefers to wrap around the rigid SWCNT prior to the neutralization of the negatively charged phosphate backbone of the ssDNA and thus overcoming the electrostatic repulsion between the phosphate moieties. When excess amount of salt accumulates round the ssDNA in aqueous solution it adopts a more compact/folded state where the nucleobases prefer to undergo self-stacking and thus forcing the bases to distance themselves from the binding sites on the SWCNT surface. Ghosh compares an 18 mM NaCl, which corresponds to the charge neutralized system, and 150 mM NaCl, which corresponds to the physiological concentration of NaCl inside living cells (page 464). Ghosh teaches that the layer of Na+ around the DNA strand is thicker at a higher concentration of salt. Therefore, the cations are probably more efficient in screening the electrostatic repulsion between the negatively charged phosphate backbone at a higher ionic strength of the medium (page 463-464). Ravan is drawn to the study of strategies for optimizing DNA hybridization on surfaces. Ravan teaches that several strategies have been applied to control the loading of the oligonucleotide probes on surfaces. The most important strategy includes changing the ionic strength of the immobilization solution. The kinetics of probe immobilization on the gold surface depends strongly on the solution ionic strength. In solutions with high ionic strength, many more probe molecules adsorbed to the surface in a short time. At a low ionic strength, electrostatic repulsions between probes heavily suppress the adsorption of DNA strands on the surface, while at a high ionic strength, the repulsions between the probes are efficiently screened by the salt ions, allowing many more probes to adsorb to the surface. Therefore, adjusting the solution ionic strength can effectively control the surface probe density. It would have been prima facie obvious to combine the teachings of Apartsin, Ghosh, and Ravan before the effective filing date of the claimed invention by modifying the aqueous solution utilized in the method of immobilizing nucleic acid to a SWCNT taught by Apartsin to be an aqueous solution comprising 150 mM NaCl and nucleic acid only as taught by Ghosh and Ravan to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the aqueous solution taught Apartsin to consist only of sodium chloride and nucleic acid because Ghosh studies the interaction of nucleic acids binding to CNT in a 150 mM NaCl solution and Ravan teaches that increased ionic strength can increase the nucleic acid density on the surface. One of ordinary skill in the art would have a reasonable expectation of success because Ghosh teaches a 150 mM NaCl only solution and Ravan teaches that increased ionic strength results in a higher nucleic acid density. It would have been prima facie obvious before the effective filing date of the claimed invention to prepare a kit based on the combined prior art of Apartsin, Ghosh, and Ravan to arrive at the claimed invention. It would have been prima facie obvious to one of ordinary skill in the art to prepare a kit based on the prior art because the grouping together of various objects or compositions directed to a common purpose (i.e. forming a kit) when all the individual objects or compositions are prima facie obvious over the prior art does not make the kit patentable. The idea of preparing a kit based on a prima facie obvious composition flows logically from the perspective of providing organization, convenience and quality control. See In re Ngai , 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) . 07-22-aia AIA Claim s 4-5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025), Ghosh et al. (J Phys. Chem. B, published 12/30/2015, see PTO-892) and Ravan et al. (Analytical Biochemistry, published 10/09/2013, see PTO-892 dated 12/16/2025) as applied to claim s 1 and 10 above, and further in view of Narayanan et al. (Nucleic Acids Research, published 04/19/2004, see PTO-892 dated 12/16/2025) . Claim 1 is rejected as discussed above. The combined teachings of Apartsin, Ghosh and Ravan are discussed above. The combined teachings of Apartsin, Ghosh and Ravan do not teach the linker structure that is represented by formula 1 or formula 2 as cited in instant claim 4. combined teachings of Apartsin, Ghosh and Ravan do not teach the compound that is represented by formula 3 or formula 4 as cited in instant claim 5. Narayanan is drawn to the study of oligonucleotides with molecular caps as fidelity-enhancing elements (FEE) at the 5’- and 3’- terminal residues (title). Narayanan exemplifies formula 6 and formula 8 (Scheme 4, compound 13 and compound 14). Narayanan teaches that pyrenylmethyl-substituted oligonucleotides 13 and 14 were believed to have the advantage of a more flexible linker between the hydroxypyrrolidine ring and the pyrene moiety, because the rotation of the bond between the nitrogen atom of the pyrrolidine ring and the pyrenyl ring system is not restricted by an amide resonance. Also, their tertiary amino group may be protonated at physiological pH, favoring duplex formation electrostatically (right column, page 2904). Narayanan further teaches that compounds 13 and 14 had higher melting temperatures than any of the caps tested and observed an increase in the base-pairing fidelity (page 2906, left column). Narayanan teaches that the advantage of non-nucleosidic FEEs over other strategies, such as introducing artificial mismatches (39) or lengthening the probe, is that they are orthogonal in their binding properties, meaning that they do not offer additional binding sites for related sequences and thus do not encourage cross-hybridization (right column, page 2910). It would have been prima facie obvious to combine the combined teachings of Apartsin, Ghosh and Ravan and the teachings of Narayanan before the effective filing date of the claimed invention by substituting the linker of the oligonucleotide taught by Apartsin to be the pyrenylmethyl to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to substitute the linker taught by Apartsin to be pyrenylmethyl because Narayanan teaches that the linker is more flexible and showed that the compounds 13 and 14 had an increase in base-paring fidelity. One of ordinary skill in the art would have a reasonable expectation of success because Narayanan exemplified the compounds of instant formula 8 and Apartsin showed that a 5’-pyrene conjugated oligonucleotide can noncovalently bind to a SWCNT . 07-22-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Apartsin et al. (ACS Appl. Mater. Interfaces, published 01/03/2014, see PTO-892 dated 12/16/2025), Ghosh et al. (J Phys. Chem. B, published 12/30/2015, see PTO-892) and Ravan et al. (Analytical Biochemistry, published 10/09/2013, see PTO-892 dated 12/16/2025) as applied to claim s 1 and 10 above, and further in view of Gui et al. (JACS, published 10/31/2007, see PTO-892 dated 12/16/2025) . Claim 1 is rejected as discussed above. The combined teachings of Apartsin, Ghosh and Ravan are discussed above. The combined teachings of Apartsin, Ghosh and Ravan are silent on a washing step. Gui is drawn to the study of DNA sensing by field-effect transistors based on networks of carbon nanotubes. Gui teaches a method for immobilizing oligonucleotides onto SWCNT network transistors (SNFETs) by immersing the SNFET in a 1 µM oligonucleotide in Tris-EDTA buffer solution (10 mM tris-HCl/1.0mM EDTA/0.10M NaCl) for 16-24 hours followed by a standard rinsing with the Tris-EDTA buffer to remove the weakly bound DNA molecules (left column, page 14428). It would have been prima facie obvious to combine the combined teachings of Apartsin, Ghosh and Ravan and the teachings Gui before the effective filing date of the claimed invention by adding a wash step with an aqueous buffer as taught by Gui to the method of preparing SWCNT with nucleic acids taught by the combined teachings of Apartsin, Ghosh and Ravan are to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to add a wash step with an aqueous buffer to the method taught by the combined teachings of Apartsin, Ghosh and Ravan are because Gui teaches that a wash step would remove weakly bound DNA molecules. One of ordinary skill in the art would have a reasonable expectation of success because teaches that a wash step would remove weakly bound DNA molecules and teaches the use of the same aqueous solution buffer used to incubate the oligonucleotides with the SNFETs. Response to Arguments Applicant's arguments filed 03/13/2026 have been fully considered in so much as they apply to the amended claims but they are not persuasive. Applicant argues that Apartsin does not teach a solution containing solute that consists of NaCl and nucleic acid. The applicant draws attention to the instant figure 6 that shows that the immobilized amount nucleic acid is higher in the absence of a phosphate group or HEPES and argues that none of the cited references in the office action dated 12/16/2025 taught that phosphate groups inhibit immobilization density. The argument is not persuasive. In the new rejection, Ghosh investigates a sodium chloride only solution at two concentrations including 150 mM NaCl and teaches that when an excess amount of salt accumulates round the ssDNA in aqueous solution it adopts a more compact/folded state where the nucleobases prefer to undergo self-stacking and thus forcing the bases to distance themselves from the binding sites on the SWCNT surface. This would reasonably lead to a higher capacity for nucleic acid binding which is further supported by Raven that teaches that solutions with high ionic strength have more probes absorbed to the surface. Conclusion No claims are allowed. 07-40 AIA 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. 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Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693 /SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693 Application/Control Number: 17/930,412 Page 2 Art Unit: 1693 Application/Control Number: 17/930,412 Page 3 Art Unit: 1693 Application/Control Number: 17/930,412 Page 4 Art Unit: 1693 Application/Control Number: 17/930,412 Page 5 Art Unit: 1693 Application/Control Number: 17/930,412 Page 6 Art Unit: 1693 Application/Control Number: 17/930,412 Page 7 Art Unit: 1693 Application/Control Number: 17/930,412 Page 8 Art Unit: 1693 Application/Control Number: 17/930,412 Page 9 Art Unit: 1693 Application/Control Number: 17/930,412 Page 10 Art Unit: 1693 Application/Control Number: 17/930,412 Page 11 Art Unit: 1693 Application/Control Number: 17/930,412 Page 12 Art Unit: 1693 Application/Control Number: 17/930,412 Page 13 Art Unit: 1693 Application/Control Number: 17/930,412 Page 14 Art Unit: 1693 Application/Control Number: 17/930,412 Page 15 Art Unit: 1693
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