FINAL ACTION
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 .
Amendments and Status of the Claims
2. This action is in response to papers filed 6 May 2026 in which claims 17 and 21 were amended, no claims were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
Any previous rejections not reiterated below are withdrawn in view of the amendments.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections.
3. Claims 17-25 are under prosecution.
Claim Interpretation
4. As noted in the previous Office Action, 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 § 103
5. 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.
6. 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.
7. 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. US 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.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
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 is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
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 is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
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.
8. 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 7.
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 is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record, and that the Response above should not be construed as an invitation to file an after final declaration.
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.
Response to Arguments
9. Applicant's arguments filed 6 May 2026 (hereafter the “Remarks”) have been fully considered but they are not persuasive for the reasons discussed above.
A. Page 8 of the Remarks refers to the previous objections and indefiniteness rejections, which are withdrawn in view of the amendments,.
B. Pages 8-9 of the Remarks cite case law but do not present specific arguments regarding the rejection.
C. Applicant’s arguments on pages 9-11 of the Remarks refer to Figure 1fo Korlach et al. .
However, it is noted that the rejection does not rely upon Figure 1 of Korlach et al. . Rather, as noted above, the rejection merely relies upon Korlach et al. for the claimed nucleotide distance and a plurality of redox labels.
In addition, Figure 1 of Korlach is describes and “an embodiment” of the invention therein (paragraph 0021), and therefore is non-limiting.
D. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., estimation of reactions and quantitative measurement) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various unclaimed uses argued by Applicant (quantitative detection) fail to define additional structural elements of the claimed system. Because the cited prior art teaches the structural elements of the claims, the claims are obvious. See MPEP § 2114.
E. Applicant argues on pages 10-11 of the Remarks that the claimed plurality of redox molecules and separation are not taught by the cited prior art.
However, as noted in the rejections above, Korlach et al. clearly teach nucleotides comprising multiple redox labels; i.e., “ 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 redox moieties comprise the redox label on a nucleotide analog (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).
F. Applicant’s arguments on page 11 of the Remarks again rely on the non-limiting (and not relied upon) Figure 1 of Korlach et al. , and refer to intended uses of the claimed system.
In addition, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Specifically, it is Figure 1A of Hu et al. that 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). Thus, the nucleic acid layer of Hu et al. already includes a redox label; Korlach et al. is merely relied upon for multiple redox moieties (i.e., molecules) on a nucleotide within the probe of Hu et al.
G. Applicant agues quantifiable readouts on pages 11-12 of the Remarks, which is already addressed above.
H. In response to Applicant's argument on pages 12-13 that the references fail to show certain features of the invention, it is reiterated that the features upon which Applicant relies (i.e., use as a point of care system) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.
In addition, the various unclaimed uses argued by Applicant (use as a point of care system) fail to define additional structural elements of the claimed system. Because the cited prior art teaches the structural elements of the claims, the claims are obvious.
I. Applicant argues on page 13 of the Remarks that Hu et al. is a static system and Korlach et al. is a dynamic system that renders Hu et al. inoperable.
However, the cleavage of the redox molecules allegedly taught by Korlach et al. again refers to an intended use, and the rejection does not rely upon this method step. Rather, Korlach et al. is merely relied upon for having multiple redox molecules on the redox labeled probe already taught by Hu et al. Thus, the modification does not render Hu et al. inoperable.
J. In response to Applicant’s argument on pages 13-14 of the Remarks that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation for combining the references is clearly articulated above.
In addition, it is also noted that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See Ex parte Smith (USPQ2d, slip op. at 20 (Bd. Pat. App. & Interf. June 25, 2007).
K. Applicant’s remaining arguments rely on alleged deficiencies previously addressed, which are unpersuasive for the reasons discussed above. Therefore, the claims remained rejected based on the prior art citations presented in the rejections.
Conclusion
10. No claim is allowed.
11. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
12. 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.
13. 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.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights