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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/28/2026 has been entered.
Status of Claims
Claims 1-4, 7-13 and 15 have been amended. Claims 1-15 are pending and have been examined.
Claim Rejections - 35 USC § 112
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.
Claims 1-15 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 1 is indefinite because at line 4 the claim recites “different types of selective agent are used for different ones of the multiple subsensors” and at line 3 the claim has said that “each” of the subsensors is functionalized but it is unclear if all or some of the different ones of the multiple subsensors are functionalized with a different selective agent.
Claims 3-4 states that a subset of the multiple subsensors are sensitized with a same selective agent which is confusing because claim 1 has stated that different types of selective agents are used for different ones of the multiple subsensors.
**Regarding the indefinite rejections, clarity could be provided by including additional structural language about the sensor device, for example, applicant’s specification at paragraph 0030 states that the sensor is subdivided into multiple subsensors, each subsensor comprising a plurality of nanowires, which would then allow clarity for dependent claims stating that different subsets of subsensors are functionalized with the same or different selective agents.
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.
Claim(s) 1-10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (US 2017/0052182, Pub Date: 02/23/2017, IDS, hereinafter “Black”) in view of Byrne et al. (US 2018/0299403, Pub Date: 10/18/2018, hereinafter “Byrne”) and Glezer et al. (US 2003/0113713, Pub Date: 06/19/2003, hereinafter “Glezer”).
Regarding claim 1, Black teaches a method for analyzing data from a sensor device with multiple subsensors (paragraphs 0007-0010), the method comprising 1) functionalizing two or more subsensors where each subsensor is functionalized with a solution containing a single selective agent and different types of selective agent are used for different subsensors (paragraphs 0013, 0069-0079 and 0076-0077), 2) exposing all of the subsensors of the sensor device to a solution of interest (paragraph 0007), 3) measuring photocurrent of each of these subsensors (paragraph 0016), 4) using measurement from the two or more subsensors in combination to detect a particular material (paragraphs 0076-0077).
While Black teaches that in some instances, the amount of biomarker can be quantified using the biosensor (paragraph 0048), the reference fails to explicitly teach that measurements from different ones of the multiple subsensors are used in combination to detect a concentration of the particular material.
Byrne teaches throughout the publication devices and systems for detection and quantification of analytes of interest utilizing multiple sensors and one or more reference sensors to detect the desired analyte (paragraph 0005). More specifically, Byrne teaches the use of the active sensors together with the reference sensor to obtain the analyte concentration (paragraph 0094). Byrne teaches that utilizing multiple sensors provides analysis with built in redundancy by providing increased quantitative information through the use of raw data or computational algorithm to compute total quantity (paragraph 0133).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the detection method of Black, further quantitative analysis to determine analyte concentration using both active and reference sensors as taught by Byrne because it would have been desirable to provide increased quantitation information (Byrne, paragraph 0133).
While Black in view of Byrne teach the use of a functionalized sensor and a reference sensor to deduce quantitative information, the reference does not explicitly teach the use of multiple different functionalized sensors. Glezer teaches throughout the publication, multiplexed test measurements having a plurality of assay domains (abstract). More specifically, Glezer teaches measuring potentially cross-reacting analytes in different domains within the same well such that a first and second analyte are measured using a first domain selective for the first analyte and a second domain selective for the second analyte. Furthermore, the measurement of both analytes allows for the mathematical deconvolution of signals based on concentrations of the analytes and then using the determined information for measurement of the first or second analyte (see paragraph 0018).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the methods of Black in view of Byrne to incorporate the use of multiple analyte measurements on different assay sites as taught by Glezer in order to deduce further information about a desired analyte in the assay system.
Regarding claim 2, Black teaches the method wherein the different types of selective agent that the first of the multiple subsensors is functionalized for includes a protein (paragraph 0010).
Regarding claim 3, Black in view of Byrne teach the method wherein a subset of the multiple subsensors in different locations on the sensor device are sensitized with a same selective agent (Byrne, paragraph 0027) and the method further comprises verifying results of the method based on measurements of the subset of the multiple subsensors in combination (Byrne, paragraph 0094).
Regarding claim 4, Black in view of Byrne teach the method wherein the majority of the multiple subsensors are sensitized with the same selective agent (Byrne, paragraph 0027).
Regarding claim 5, Black teaches the method wherein the different types of selective agent includes an antibody (paragraph 0013).
Regarding claim 6, Black in view of Byrne teach the method wherein the selective agent is an aptamer (Byrne, paragraph 0061).
Regarding claim 7, Black in view of Byrne teach the method further comprising determining homogeneity of samples based on results of measurements from the multiple subsensors (Black, paragraph 0007, determining sample makeup regarding biomarkers presence, absence or quantity can illustrate the sample makeup and thus homogeneity of the samples).
Regarding claim 8, Black teaches the method wherein the sensor device further includes a subsensor that is left unfunctionalized and are utilized as a control subsensor (paragraph 0076).
Regarding claim 9, Black in view of Byrne teaches the method wherein one or more of the multiple subsensors are coated with a material to prevent functionalization (Byrne, paragraph 0088, reference sensor comprises a passivation layer).
Regarding claim 10, Black teaches the method wherein different ones of the multiple subsensors functionalized with different selective agents are used in combination to separate out signals from two or more proteins (paragraph 0069).
Regarding claim 12, Black in view of Byrne teach the method wherein the subset of the multiple subsensors in different locations on the sensor device that are sensitized with a same selective agent form an easily recognizable pattern on the sensor (Black, paragraphs 0069-0070, nanowires grouped into sections; Byrne, paragraph 0027, same analyte of interest measured).
Regarding claim 13, Black in view of Byrne teach the method wherein the multiple subsensors are electrically isolated from each other (Black, paragraph 0015).
Regarding claim 14, Black in view of Byrne teaches the method wherein step 4) is used to deduce the concentration of more than one protein (Black, paragraphs 0076-0077 and Byrne, paragraph 0094 and 0133).
Allowable Subject Matter
Claims 11 and 15 are free of the prior art.
Response to Arguments
Applicant’s arguments filed 04/28/2026 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims. As described above, Glezer at paragraph 0018 cures the deficiencies of Black in view of Byrne in teaching the use of at least two spaces functionalized for different analytes and using the combined measured information to determine information about a single one of the different analytes.
Additionally, as noted in the indefinite rejection section, Examiner recommends providing clarity to the independent claim by including additional structural language about the sensor device, for example, applicant’s specification at paragraph 0030 states that the sensor is subdivided into multiple subsensors, each subsensor comprising a plurality of nanowires, which would then allow clarity for dependent claims stating that different subsets of subsensors are functionalized with the same or different selective agents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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