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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) June 9,2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended independent claim 1 to recite a charged biomolecule colliding with a nanoelectrode, and argued that the combination of Panday et al., in view of Umehara et al., as cited in the previous Office Action does not meet the amended claim. As detailed below, the claims now stand rejected as being unpatentable over the combination of McKelvey et al., in view of Umehara et al. Because reference to McKelvey et al., is newly cited, the Examiner will not argue the merits of its teachings here but will instead rely on the rejection detailed below. Therefore, based on the teachings of the prior art, the Examiner contends that the limitations of the instant claims are taught by the references cited below, thus the claims are not in condition for allowance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 1, 2, and 4, is/are rejected under 35 U.S.C. 103 as being unpatentable over McKelvey et al., (Current Opinion in Electrochemistry 2017, 6:4-9) in view of Umehara et al., (PNAS vol 106, No. 12, March 24, 2009).
Regarding claim 1, McKelvey et al., teach measurement of electrochemical behavior of single entities comprising providing an external solution (sample solution, page 4 right column second full paragraph), contacting the sample with a nanopipette having a nanoelectrode in the barrel of the nanopipette (figure 1), and measuring a transient electrical potential change induced by a nanoparticle colliding with the nanoelectrode (page 4 right column last paragraph – page 5 first paragraph, figure 1). McKelvey et al., do not teach detecting an individual charged biomolecule.
Umehara et al., teach label-free biosensing wherein the surface charge of proteins are detected utilizing a nanopipette (Abstract, Sensing the Specific Binding of Cancer Biomarker Proteins to the Immobilized lgG Molecules, page 4613, Discussion, pages 4613-4614). Umehara et al., teach that it is advantageous to utilize a nanopipette to detect surface charges on biomolecules as a means of providing a sensing mechanism that is fast, compact, and easily multiplexed biosensing platform compared to optical methods (Discussion, page4614, right column second full paragraph). Umehara et al., also teach that the nanopipette being suitable for detecting proteins related to various cancers (Sensing the Specific Binding of Cancer Biomarker Proteins to the Immobilized lgG Molecules, page 4613).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McKelvey et al., wherein the nanopipette sensor is utilized to detect biomolecules in order to provide a fast, complex, and easily multiplexed biosensing platform for detecting cancer-related proteins as taught by Umehara et al.
Regarding claim 2, McKelvey et al., do not teach detecting a protein having a molecular weight ranging from 5kDa to 500kDa.
Umehara et al., teach label-free biosensing wherein the surface charge of proteins are detected utilizing a nanopipette (Abstract, Sensing the Specific Binding of Cancer Biomarker Proteins to the Immobilized lgG Molecules, page 4613, Discussion, pages 4613-4614) wherein VEGF (molecular weight ranges from 38 to 44kDa) is detected(Sensing the Specific Binding of Cancer Biomarker Proteins to the Immobilized lgG Molecules, page 4613). Umehara et al., teach that it is advantageous to detect VEGF as a means of detecting proteins related to colorectal cancer (Sensing the Specific Binding of Cancer Biomarker Proteins to the Immobilized lgG Molecules, page 4613).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McKelvey et al., wherein VEGF having a molecular weight ranging from 38 to 44 kDa is detected in order to detect proteins related to colorectal cancer as taught by Umehara et al.
Regarding claim 4, McKelvey et al., teach electrodes made of carbon (Multifunctional nanopipettes page 5 left column first full paragraph).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKelvey et al., (Current Opinion in Electrochemistry 2017, 6:4-9) in view of Umehara et al., (PNAS vol 106, No. 12, March 24, 2009) as applied to claim 1 above, and further in view of Karhanek et al., (US 2015/0198559).
Regarding claim 3, McKelvey et al., in view of Umehara et al., do not teach obtaining a sample from a subject and diluting the sample.
Karhanek et al., teach a nanopipette biosensor for detecting analytes wherein a sample is obtained from a subject, and diluted prior to detection (paragraphs 0014, 0046, 0078). Karhanek et al, teach that it is advantageous to obtain a sample from a subject as a means of performing sensitive, real-time, and cost-effective proteome analysis in a clinical setting (paragraph 0031).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McKelvey et al., in view of Umehara et al., wherein a sample is obtained from a subject and diluted as a means of performing sensitive, real-time, and cost-effective proteome analysis in a clinical setting as taught by Karhanek et al.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McKelvey et al., (Current Opinion in Electrochemistry 2017, 6:4-9) in view of Umehara et al., (PNAS vol 106, No. 12, March 24, 2009) as applied to claim 1 above, and further in view of Panday et al., (ACS Nano 2016, 10, 11237-11248.
Regarding claim 6, McKelvey et al., in view of Umehara et al., do not teach a nanoelectrode having a surface area of 0.02-0.30 µm2.
Panday et al., teach ionic current and potential detection of nanoparticles by a multifunctional nanopipette comprising a nanoelectrode having a surface area ranging from 0.30 µm2 to 1.33 µm2 (Multifunctional Nanopipette Fabrication and Characterization, page 11240 left column). Panday et al., teach that it is advantageous to provide a surface area ranging from 0.30 µm2 to 1.33 µm2 as a means of generating a more robust sensing mechanism (Multifunctional Nanopipette Fabrication and Characterization, page 11240 left column).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McKelvey et al., in view of Umehara et al., wherein the nanoelectrode has a surface area ranging from 0.30 µm2 to 1.33 µm2 in order to provide a more robust sensing mechanism as taught by Panday et al.
Regarding claim 7, McKelvey et al., in view of Umehara et al., do not teach a double barrel nanopipette sensor.
Panday et al., teach ionic current and potential detection of nanoparticles by a multifunctional nanopipette comprising a double barrel nanopipette sensor having first and second compartments, and a double barrel nanopipette connecting the first and second compartments wherein one barrel is filled with a carbon nanoelectrode and the other barrel having a nanopore (Introduction page 11238, left column, Figure 1). Panday et al., teach that it is advantageous to provide a double barrel nanopipette as a means of providing multimode detection for single molecules and nanoparticles (Introduction page 11238, left column, Figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McKelvey et al., in view of Umehara et al., to provide a double barrel nanopipette in order to provide multimode detection for single molecules and nanoparticles as taught by Panday et al.
Regarding claim 8, McKelvey et al., in view of Umehara et al., do not teach a nanopore having a diameter of 10 to 90 nm.
Panday et al., teach ionic current and potential detection of nanoparticles by a multifunctional nanopipette comprising a double barrel nanopipette wherein the nanopipette has a nanopore has a diameter of 77 nm (Multifunctional Nanopipette Fabrication and Characterization, page 11239). The Examiner is reading this combination as combining prior art elements according to known methods to yield predictable results which would have been obvious to one of ordinary skill in the art. Reference to Panday et al., teach utilizing nanopipettes of various diameters, thus one of ordinary skill in the art would have found it obvious to select a diameter ranging from 10 to 90 nm based on the size of the particles to be detected. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify McKelvey et al., in view of Umehara et al., wherein the nanopore has a diameter ranging from 10 to 90 nm as combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 9, McKelvey et al., teach translocation of charged molecules (Multifunctional nanoparticles page 6 right column first full paragraph).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAN A GERIDO whose telephone number is (571)270-3714. The examiner can normally be reached Mon-Fri 10-6.
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/DWAN A GERIDO/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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