Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1683) whose telephone number is (571)272-1113.
Election/Restrictions
3. Applicant’s election of Group II in the reply filed on 28 August 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The previous species election is withdrawn.
Claims 1-16 are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 August 2025.
Claims 17-25 are under prosecution.
Information Disclosure Statement
4. The Information Disclosure Statements filed 1 September 2021 and 6 December 2022 are acknowledged and have been considered.
Claim Objections
5. Claim 21 is objected to because of the following informalities: claim 21 contains the text “red ox” in line 1, which appears to be a typographical error. Appropriate correction is required.
Claim Interpretation
6. Claims 17-25 are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 17-24 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 (upon which claims 18-24 depend) is indefinite in the recitation “the redox molecule” in line 15 of the claim, which lacks antecedent basis in the previous recitation of “a plurality of redox molecules.”
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. Claims 17-19 and 22-25 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (U.S. Patent Application Publication No. US 2016/0061766 A1, published 3 March 2016) and Korlach et al (U.S. Patent Application Publication No. UU 2013/0109577 A1, published 2 May 2013) as evidenced by “DNA Helix” from Sciencedirect.com ([retrieved on 2025-12-22]. Retrieved from the Internet: <URL: https://www.sciencedirect.com/topics/neuroscience/dna-helix>).
Regarding claims 17 and 19, Hu et al teach a system (paragraph 0057) comprising a nucleic acid layer comprising a capture probe comprising a molecular recognition element configured to specifically bind to a target, in the form of the molecule comprising Ab1 of Figure 1A. Figure 1A further depicts a first polynucleotide conjugated to a conductive base, in the form of the thiolated DNA bound to the gold electrode, which is hybridized via the claimed second region to the claimed first region of the capture probe. Figure 1A also shows the ECPA probe (i.e., MB-DNA) having a redox label and conjugated to the claimed third polynucleotide, which is hybridized to the fourth polynucleotide, in the form of the molecule bearing Ab2, which is bound to the target protein (Example 1; also compare Figure 1A of Hu et al to Figure 1A of the instant Application). Hu et al also teach the system produces rapid quantitative results (Abstract). Thus, Hu et al teach the known techniques discussed above.
While Hu et al teach the system required proximity dependent hybridization (Abstract), Hu et al do not teach the claimed nucleotide distance or a plurality of redox labels.
However, Korlach et al teach systems comprising nucleic acids immobilized to conductive bases, in the form of electrodes (paragraph 0128) and nucleotides comprising multiple redox labels (paragraph 0069). Korlach et al further teach the redox labels are proximal to the electrode, in a range of about 1 to 50 nm (paragraph 0131). Sciencdriect.com teaches a single helical repeat of DNA is 10.5 base pairs, and has a length of 3.4 nm (Figure 6.8). Thus, having the redox molecules of the probe at about 1.7 nm from the conductive base corresponds to half a helical turn of DNA, which is about 5 base pairs (i.e., claims 17 and 19).
It is also noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where 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 Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
Korlach et al further teach the system allows multiple simultaneous real time detection (paragraph 0037). Thus, Korlach et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Hu et al and Korlach et al to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of producing rapid quantitative results as explicitly taught by Hu et al (Abstract) and the added advantage of allowing multiple simultaneous real-time detection as explicitly taught by Korlach et al (paragraph 0037). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in systems useful for electrochemical detection of analytes.
Regarding claim 18, the system of claim 17 is discussed above. Hu et al teach the redox molecule is methylene blue (paragraph 0010), as do Korlach et al (paragraph 0068).
Regarding claim 22, the system of claim 17 is discussed above, Hu et al teach thiolated DNA on the nucleic acid layer (Figures 2A-F and paragraph 0011). Korlach et al also teach thioesters for attaching nucleic acids to solid supports (paragraph 0128).
Regarding claim 23, the system of claim 17 is discussed above. Korlach et al teach 12 redox molecules on a nucleotide (paragraph 0069).
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where 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.
Therefore, the claimed range merely represents an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant reminded to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 24, the system of claim 17 is discussed above. Hu e al each the molecular recognition elements are antibodies or aptamers (paragraph 0023).
Regarding claim 25, Hu et al teach a system (paragraph 0057) comprising a nucleic acid layer comprising a capture probe comprising a molecular recognition element configured to specifically bind to a target, in the form of the molecule comprising Ab1 of Figure 1A. Figure 1A further depicts a first polynucleotide conjugated to a conductive base, in the form of the thiolated DNA bound to the gold electrode, which is hybridized via the claimed second region to the claimed first region of the capture probe. Figure 1A also shows the ECPA probe (i.e., MB-DNA) having a redox label and conjugated to the claimed third polynucleotide, which is hybridized to the fourth polynucleotide, in the form of the molecule bearing Ab2, which is bound to the target protein (Example 1; also compare Figure 1A of Hu et al to Figure 1A of the instant Application). Hu et al also teach probe/target solutions (paragraph 0010), and that the system produces rapid quantitative results (Abstract). Thus, Hu et al teach the known techniques discussed above.
While Hu et al teach the system required proximity dependent hybridization (Abstract), Hu et al do not teach the claimed chamber, nucleotide distance, or a plurality of redox labels.
However, Korlach et al teach systems comprising nucleic acids immobilized to conductive bases, in the form of electrodes (paragraph 0128) and nucleotides comprising multiple redox labels (paragraph 0069). Korlach et al further teach the redox labels are proximal to the electrode, in a range of about 1 to 50 nm (paragraph 0131). Sciencdriect.com teaches a single helical repeat of DNA is 10.5 base pairs, and has a length of 3.4 nm (Figure 6.8). Thus, having the redox molecules of the probe at about 1.7 nm from the conductive base corresponds to half a helical turn of DNA, which is about 5 base pairs (i.e., claims 17 and 19).
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where 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.
Therefore, the claimed range merely represents an obvious variant and/or routine optimization of the values of the cited prior art.
Korlach et al also teach electrodes in contact with fluids within a chamber (paragraph 0039); thus it would have been obvious to have the conductive base (i.e., electrode) within the chamber.
In addition, the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04. Thus it would have been obvious to have the conductive base (i.e., electrode) within the chamber.
Applicant reminded to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Korlach et al further teach the system allows multiple simultaneous real time detection (paragraph 0037). Thus, Korlach et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Hu et al and Korlach et al to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of producing rapid quantitative results as explicitly taught by Hu et al (Abstract) and the added advantage of allowing multiple simultaneous real-time detection as explicitly taught by Korlach et al (paragraph 0037). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in systems useful for electrochemical detection of analytes.
12. Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al (U.S. Patent Application Publication No. US 2016/0061766 A1, published 3 March 2016) and Korlach et al (U.S. Patent Application Publication No. UU 2013/0109577 A1, published 2 May 2013) as evidenced by “DNA Helix” from Sciencedirect.com ([retrieved on 2025-12-22]. Retrieved from the Internet: <URL: https://www.sciencedirect.com/topics/neuroscience/dna-helix>) as applied to claim 17 above, and further in view of Heeger et al (U.S. Patent Application Publication No. US 2007/0020641 A1, published 25 January 2007),
Regarding claims 20-21, the system of claim 17 is discussed above in Section 11.
Hu et al teach buffers and salts (e.g., NaClO4; paragraph 0058). Korlach et al also teach the use of buffers and sodium salts (paragraph 0132). Korlach et al further teach the redox labels are proximal to the electrode, in a range of about 1 to 50 nm (paragraph 0131). Sciencdriect.com teaches a single helical repeat of DNA is 10.5 base pairs, and has a length of 3.4 nm (Figure 6.8). Thus, having the redox molecules of the probe at about 1.7 nm from the conductive base corresponds to half a helical turn of DNA, which is about 5 base pairs.
Neither Hu nor Korlach et al teach the claimed salt concentrations.
However, Heeger et al teach systems comprising polynucleotide probes (i.e., oligonucleotides) immobilized to conductive bases, in the form of electrodes, wherein to probes comprise redox labels (paragraph 0025). Heeger et al further teach multiple redox labels (paragraph 0079), as well as buffers having 140 mM NaCl (i.e., 0.14M salt; paragraph 0134).
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where 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.
Therefore, the claimed ranges (i.e., base pairs and salt concentrations) merely represents an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant reminded to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Heeger et al teach the systems have the added advantage of being sensitive, selective and reusable (paragraph 0023). Thus, Heeger et al teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Heeger et al with Hu et al and Korlach et al to arrive at the instantly claimed system with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a system having the added advantage of being sensitive, selective, and reusable as explicitly taught by Heeger et al (paragraph 0023). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with Heeger et al with predictable results because the known techniques of the cited prior art with Heeger et al predictably result in systems useful for electrochemical detection of analytes.
Conclusion
13. No claim is allowed.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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, Anne Gussow can be reached at 571-272-6047. 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.
Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683