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 Claims
Claims 1-12 have been amended. Claims 13-15 have been added. 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 it first recites “multiple subsensors” and that “two or more subsensors” with “each” subsensor being functionalized with a single selective agent, exposing “all” of the subsensors to a solution, measuring photocurrent of “each” of the subsensors and then using measurements from “two or more subsensors” and the inconsistency of terminology is confusing as to which subsensors are being used for what. For example, if the method only incorporates two subsensors – and these two subsensors are both functionalized with a single selective agent of a different type, then are photocurrent measurements from these two subsensors used to deduce a concentration? Or are there intended to be other subsensors present and functionalized that are not being used to deduce the concentration? Clarification is requested.
Claims 3 and 12 are confusing because it recites “subset of two or more” and since a set usually includes at least two, it unclear how a subset could be created from the potentially two subsensors of claim 1.
Claim 3 is confusing because it recites that the two or more subsensors are sensitized with a same selective agent but claim 1 has already recited that different subsensors are functionalized with different selective agents. Therefore it is unclear which subsensors are functionalized with what.
Claim 4 is unclear because it recites “a majority of the two or more” and if the method includes two subsensors, and “majority” is generally defined as more than half, then what is the majority of two subsensors that are being functionalized with a same agent?
Claims 8-9 are confusing because it recites that 1 or more of the 2 or more subsensors are left functionalized but claim 1 has recited that each subsensor is functionalized with a single selective agent and thus is it unclear which subsensor is intended to be left unfunctionalized.
Claim 15 is indefinite because it recites “a set of one or more of the two or more subsensors” and it is unclear what is encompassed by this initial set given that a set is usually defined as more than one? Is the subsensor itself including a set of sensors? The claim then goes on to claim “a second set of one or more of the two or more subsensors” and again, if there are only two subsensors present in the method then what exactly is comprised in the claimed sets? As such, it is confusing which of the subsensors are responsible for the protein concentration determination. Furthermore, it is unclear what is meant by “sensitive to a second protein but not the first in combination”. For further prosecution, the claim will be interpreted as having each of the two subsensors functionalized with a selective agent and using both subsensors to determine the concentration.
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) 1-15 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”).
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 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). One skilled in the art would have had a reasonable expectation of success in deducing analyte concentration as taught by Byrne within the method of Black since Black teaches that analyte concentration can be determined and Byrne teaches the benefits of determining analyte concentration
Regarding claim 2, Black teaches the method wherein the different types of selective agent that the first of the two or more 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 two or more 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 two or more subsensors in combination (Byrne, paragraph 0094).
Regarding claim 4, Black in view of Byrne teach the method wherein the majority of the two or more 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 two or more 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 one or more of the two or more subsensors are 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 two or more 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 two or more subsensors functionalized with different selective agents are used in combination to separate out signals from two or more proteins (paragraph 0069).
Regarding claim 11, Black in view of Byrne teach the method further comprising separating measurement signals from multiple proteins (Black, paragraphs 0069-0070). While the references do not explicitly teach determining the concentration of a first protein to which the sensor is exposed by comparing a measurement from one of the two or more subsensors functionalized with an antibody selective for both the first protein and a second protein to a measurement from one of the two or more subsensors functionalized with an antibody selective to the second protein but not the first, Byrne teaches that monoclonal and polyclonal antibodies can be used (paragraph 0065) and thus it would be obvious to one having ordinary skill in the art that the references could be modified with different monoclonal and polyclonal antibodies for monospecific or bispecific binding on the subsensors that can determine concentrations of different analytes.
Regarding claim 12, Black in view of Byrne teach the method wherein the subset of the two or more 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 two or more 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).
Regarding claim 15, Black in view of Byrne teach the method further comprising determining the concentration of a first protein in the solution of interest by using photocurrent measurements from a set of one or more of the two or more subsensors functionalized with a selective agent which is sensitive to the first protein and a second set of one or more of the two or more subsensors functionalized with a selective agent which is sensitive to a second protein but not the first in combination (Black, paragraphs 0076-0077 and Byrne, paragraph 0094 and 0133).
Response to Arguments
Applicant’s arguments filed 11/17/2025 have been considered but are not found to be persuasive. Applicant argues that neither Black or Byrne teach using measurements from the two or more subsensors in combination to deduce a concentration of a particular material since the teachings by Black that different subsections can be functionalized to be sensitive to different biomarkers and Byrne that polyclonal antibodies can be used – does not disclose the teachings of the claimed device.
Firstly, Examiner did not rely on Byrne for its teachings of polyclonal antibodies to teach functionalizing two more more subsensors where each subsensor is functionalized with a solution containing a single selective agent – this limitation is taught at paragraph 0069 of Black teaching that individual nanowires of a group can be functionalized for the same biomarker but different groups of nanowires as a whole can be sensitive to different biomarkers.
Byrne teaches that when more than one active sensor is present on the chip, all the sensors can be configured to detect the same or different analyte (paragraph 0027) and more specifically, active sensors together with the reference sensor can be used 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). When taken in combination with the teachings of Black that multiple subsensors are exposed to a particular material than the first of the multiple subsensors is functionalized for (paragraphs 0069-0070), at least one other of the multiple subsensors not being functionalized for the particular material (paragraphs 0076-0077), and measurements from the multiple subsensors being used in combination to detect the particular material (paragraphs 0076-0077), it would be obvious 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).
For further clarification (see 112b rejections above) and to distinguish from the teachings of Black in view of Byrne, Examiner recommends clarifying structural configuration, placement, or orientation of the claimed subsensors/sets of subsensors/etc. to make clear what sensors are incorporated in the sets on the device and how their varying functionalization is utilized for concentration determination.
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 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