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 .
Status of the Claims
Claim 7 is cancelled by Applicant. Claims 1-6, 8-10, and 16-26 are pending and examined herein.
Priority
This application, filed 05/09/2022, claims priority to provisional application 63/185,647, filed 05/07/2021. This priority is acknowledged for claims 1-6, 8-10, 15, and 18-26 which are treated as having an effective filing date of 05/09/2021. However, this priority is not acknowledged for claims 16 and 17 for the inclusion of a hormone or an opioid as an antigen, which is not disclosed in the priority document. Therefore, claims 16 and 17 are treated as having an effective filing date of 05/09/2022.
Amended Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, and 18-26 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0134880 A1, “APPARATUS AND METHOD FOR DETECTING ONE OR MORE ANALYTES” (published 02/23/2011, referred to herein as Kurkina) in view of Krivitsky et al., “Antigen-Dissociation from Antibody-Modified Nanotransistor Sensor Arrays as a Direct Biomarker Detection Method in Unprocessed Biosamples” NanoLett (published 08/31/2016, referred to herein as Krivitsky) as evidenced by Light et al., “Conductivity and Resistivity of Water from the Melting to Critical Points” Anal. Chem (published 10/01/1987).
Regarding claims 1 and 23, Kurkina teaches a method for detecting an analyte (para. 0002, lines 1-3) with a sensor comprising a substrate (para. 002, line 6) and a sensor medium comprising a plurality of carbon nanostructures (para. 002, lines 6-8 and para. 0020, lines 1-6) that are enriched for superconducting character (para. 0020, lines 1-5) and the nanostructures being functionalized by the attachment of an antibody (para. 0087, lines 1-6. Para. 0090, lines 1-3) to detect an analyte. Kurkina teaches the sensor is connected to electronic circuitry (para. 0002, lines 5-9) to measure a change in the sensor medium (para. 0019, lines 3-7). Kurkina teaches exposing the sensor to the sample in 10mM potassium phosphate buffer (para. 0098, lines 3-5).
However, Kurkina does not teach washing the sensor with a liquid of known ionic strength then measuring the output of the sensor (claims 1 and 23). Kurkina does not teach that the ionic strength of the liquid is less than that of the fluid sample (claims 2 and 24). Kurkina does not teach that the liquid is purified water (claims 3 and 25 with a resistivity greater than or equal to 18.2 MΩcm (claims 4 and 26).
Regarding claims 1, 2, 23, and 24, Krivitsky teaches a method of detecting an analyte using a FET-based sensor by washing the sensor with low ionic strength buffer after analyte binding (Figure 1. p. 6275, col. 1, para. 1, lines 16-21). Krivitsky teaches that this washing process “enhances the portability of the sensing platform and reduces to minimum the required volume of tested sample, as it allows the direct detection of untreated biosamples” (abstract, lines 20-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method for analyte detection taught by Kurkina by including the wash with low ionic strength solution as taught by Krivitsky. Doing so would provide the advantage of analyte detection, for example amyloid beta peptide (Kurkina para. 0090) and insulin (Kurkina para. 0092), directly in untreated biosamples. An artisan would be motivated to make this change because, as taught by Krivitsky, this reduces the time-consuming process of biosample manipulation and reduces to minimum the required volume of the tested sample which is “of great importance in near-future point-of-care medical applications” (Krivitsky, p. 6280, col. 1, para. 2, lines 30-38). An artisan would have a reasonable expectation of success because the device and analyte-detection mechanism used by Krivitsky, i.e. FET-based analyte detection with antibodies attached to nanostructures, is similar to those described by Kurkina.
Regarding claims 3 and 25, Krivitsky teaches washing the device with a low ionic strength solution to overcome “the detrimental Debye screening limitation of nanowire-based biosensors” (abstract, lines 9-15) but does not teach using a solution of purified water. However, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the ionic strength of the buffer in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, 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. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed buffer with an ionic strength of 0, i.e. purified water, was anything other than routine, that the properties of the purified water from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Wu et al., “The Effect of Ionic Strength on the Sensing Performance of Liquid-Gated Biosensors” (published 07/25/2017, referred to herein as Wu). Wu teaches the use of a range of buffers with varying ionic strengths correlates with electrical response after analyte detection in FET-based sensors using antibodies (Figure 5a, p. 244, col. 2, para. 1, lines 1-12). Wu teaches that lowering the ionic strength of the buffer results in a longer Debye length (Figure 5b) and increased response (Figure 5a). Wu teaches that there is a trade-off between response and the chemical stability of the antibody-antigen binding when lowering the ionic strength of the buffer (p. 245, col. 1, para. 1, lines 6-16). However, an artisan would be motivated to lower the ionic strength to 0 by using purified water to test if their antibody-antigen binding would still be functional in order to maximize the Debye length and the signal generated by the device.
Regarding claims 4 and 26, the resistivity of purified water, i.e. water with an ionic strength of 0, as described regarding claims 3 and 25 above, is an inherent property of purified water and is 18.2 MΩcm, as evidenced by Light et al., “Conductivity and Resistivity of Water from the Melting to Critical Points” Anal. Chem (published 10/01/1987) (Table II, p. 2327, col. 1, para. 1, lines 7-10).
Regarding claim 5, Kurkina teaches that the agent is connected to the nanostructure by covalent bond (para. 0086, lines 5-11).
Regarding claim 18, Kurkina teaches that the sensor is incorporated with a field effect transistor circuit (para. 0120, lines 6-8) and the liquid functions as a liquid gate (para. 0012, lines 1-5).
Regarding claim 19, Kurkina teaches that the device includes a plurality of sensors, i.e. is functionalized for detecting a plurality of analytes (para. 0017, lines 1-9).
Regarding claim 20 and 21, Kurkina teaches the covalent attachment (para. 0086, lines 5-11) of a plurality of different agents, i.e. different receptors specific to a different analytes, to the nanostructure (para. 0083, lines 6-11).
Regarding claim 22, Kurkina teaches that the device comprises forming a static liquid reservoir with the nanostructure and agent (para. 0008, lines 4-7).
Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kurkina in view of Krivitsky as applied to claims 1 and 2 above, and further in view of Li et al., “High-Quality, Highly Concentrated Semiconducting Single-Wall Carbon Nanotubes for Use in Field Effect Transistors and Biosensors” ACSNano (published 07/22/2013, referred to herein as Li).
Regarding claim 6, Kurkina teaches the use of single-wall carbon nanotubes with semiconducting character (para. 0020, lines 1-5).
However, Kurkina does not specifically teach single-wall carbon nanotubes enriched for semiconducting content of at least 90%.
Li teaches a method of using a biosensor with ~93% semiconducting single-wall carbon nanotubes (Abstract, lines 3-8). Cheng teaches a biosensor made with these semiconducting single-wall carbon nanotubes has a detection limit “several orders of magnitude lower than the values previously reported” with non-enriched devices (p. 6836, col. 2, para. 1, lines 10-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by the combined teachings of Kurkina and Krivitsky by using the single-wall carbon nanotubes enriched for semiconducting content taught by Li in order to provide the advantage of increasing the sensitivity of the device. An artisan would have a reasonable expectation of success because Kurkina teaches the use of single-wall carbon nanotubes with semiconducting character for the detection of analytes.
Regarding claim 8, Kurkina teaches that the nanostructures are single-wall carbon nanotubes (para. 0020, lines 1-5).
Regarding claim 9, Kurkina teaches the measurement of complex impedance, i.e. of magnitude and phase for each pair of electrodes (para. 0018, lines 1-6).
Regarding claim 10, Kurkina teaches the measurement of an insulin antigen with an anti-insulin antibody (para. 0092, lines 1-2).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kurkina in view of Krivitsky and Li as applied to claims 1-10 above, and further in view of Wharton et al., “Detection of 30 Fentanyl Analogs by Commercial Immunoassay Kits” (published 01/04/2021, referred to herein as Wharton).
Regarding claims 16 and 17, Kurkina teaches the detection of biological analytes with antibodies (para. 0090, line 2. Para. 0092, lines 1-2).
However, Kurkina does not teach the detection of an opioid (claim 16), such as norfentanyl (claim 17).
Wharton teaches the use of antibodies (p. 111, col. 2, para. 2, lines 1-5) to detect norfentanyl (Figure 1. P. 113, col. 2, para. 4, lines 9-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the antibodies taught by Kurkina with the antibodies for detecting norfentanyl taught by Wharton. Doing so would provide the advantage of enabling the use of the device taught by Kurkina to detect norfentanyl. An artisan would have been motivated to make this substitution because norfentanyl is a dangerous analogue of fentanyl and its detection is important for the protection of the public. An artisan would have had a reasonable expectation of success because the antibodies used in Kurkina and Wharton are both used for the detection of biological analytes in immunoassays.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on page 8 on the rejection under 35 U.S.C. 103 of claims 1-5 and 18-26, Applicant argues that the washing step taught by Krivitsky cannot be used to modify the method taught by Kurkina because the method of Krivitsky further goes on to do dynamic measurement of the system with this use of a reference device, whereas Applicant asserts that the claimed method requires a steady-state measurement without a reference device.
This argument is not persuasive. 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., the steady-state measurement) is not recited in the rejected claims. 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). In this case, the claimed step of “after washing the sensor, measuring an output of the sensor” is considered to encompass any measurement step after the addition of the wash liquid, which may or may not include a reference device. This is not considered to limit the claimed invention to only one method of “measuring”, such as steady-state measurement. Further, even if the claim did limit the invention to steady-state measurement, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, although Krivitsky teaches a method using dynamic measurement after the wash, Krivitsky teaches that “washing of the sensing devices with the ‘sensing buffer’ results in the fast removal of unbound, or loosely bound, nonspecific chemical species” (p. 6273, col. 2, para. 1, lines 4-6) which would motivate an artisan to use this wash step whether measuring the steady-state or dynamics of a sensing device since removal of non-specific chemical species would improve the signal from the sensing device.
Further regarding the remarks on page 8, Applicant argues that the claimed carbon-based device of the claimed method functions differently than the SiNW device of Krivitsky and that the inventor have discovered that the dynamic measurement method of Krivitsky is inoperable with the claimed carbon-based device.
This argument is not persuasive. The device of Krivitsky is not relied upon for the rejection of claim 1 under 35 U.S.C. 103; rather, only the teaching of the wash step is incorporated from Kravitisky to modify the method of Kurkina is relied upon. Kurkina does teach a carbon-based nanostructure device, as claimed, and further teaches the use of other inorganic nanowires for the device (para. 0020, lines 1-11) evidencing the overlap in methods that can be used by both carbon nanowire and inorganic nanowire devices. Further, even though the SiNW device of Krivitsky is not relied upon for the rejection under 35 U.S.C. 103 of claim 1, Applicant's arguments, i.e. the assertion that the method of Krivitsky is inoperable in the carbon-nanostructure-based device used in the claims, fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Conclusion
THIS ACTION IS MADE FINAL. 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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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 April 28, 2026
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