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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 February 2026 has been entered.
This action is responsive to the “PRELIMINARY AMENDMENT” filed 10 February 2026 and the “SUPPLEMENTAL PRELIMINARY AMENDMENT” filed 25 March 2026. The Examiner acknowledges the amendments to claims 1, 70, and 73-76 in the corresponding remarks filed 10 February 2026 and the amendments to claims 1, 70-72, and 74-78 in the corresponding remarks filed 25 March 2026. Claims 1-2, 6, 8, 11-13, 15, 17, 21, 27, 29, 32, 36-37, 60, 63, and 70-78 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “1708” [¶0599]; “3603” [¶0680, wherein the Examiner notes that based on the context of the cited paragraph and Figs. 37A-C, this reference character should read “3703”].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “120” [Fig. 1]; “411” [Figs. 4A-B]; “511” [Figs. 5A, 5C]; “514” [Fig. 5C]; “893.2” [Fig. 8Q]; “1703” [Figs. 17B-F]; “1906” [Figs. 19I-L]; “1907” [Fig. 19J]; “3703” [Fig. 37B]; “4204” [Fig. 42A].
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 1 [representative of all independent claims] recites a judicial exception [“determine the measured response signals”, “provide an output based on the measured response signals”, “perform an analysis at least in part using the measured response signals”] at Step 2A Prong 1, which is considered to be a judicial exception of an abstract idea that may be performed in the mind or by hand by merely observing known or previously collected data and drawing mental conclusions therefrom. However, the Examiner further notes that claim(s) 1 recites limitations directed towards additional elements [see limitations a)-c) directed towards a substrate, at least one signal generator, and at least one sensor; as well as limitations directed towards “at least some of the plurality of microstructures are arranged in a plurality of pairs of rows, each pair of rows being two rows of spaces apart plate microstructures having planar electrodes in opposition…”, “including a plurality of electrical microstructure connections connecting the plurality of microstructures…”, “wherein: i) response signals are independently measured for different pairs of rows of microstructures on the substrate; and ii) the stimulatory signal is independently applied for different pairs of rows of microstructures on the substrate”] that is/are considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 6, 8, 11, 17, 21, 27, 29, 32, 36-37, 60, 63, and 70-78 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pushpala (US-20150257685-A1, previously presented), hereinafter Pushpala ‘685 [previously referred to as “Pushpala II”].
Regarding claim 1, Pushpala ‘685 teaches
A system for performing measurements on a biological subject, the system including:
a) a substrate [microsensor 116 (Pushpala ‘685 Fig. 2A)] including a plurality of microstructures configured to breach a stratum corneum of the subject [The microsensor 116 of the microsensor patch no preferably comprises an array of filaments 117… the array of filaments 117 is configured to penetrate the user's stratum corneum (i.e., an outer skin layer) (Pushpala ‘685 ¶0035)];
b) at least one signal generator operatively connected to at least one of the plurality of microstructures to apply a stimulatory signal [Preferably, sensed analytes result in a signal (e.g., voltage, current, resistance, capacitance, impedance, gravimetric, etc.) detectable by the electronics subsystem 120 in communication with the microsensor 116 (Pushpala ‘685 ¶0036); The electronics subsystem 120 functions to receive analog signals from the microsensor 116 and to convert them into digital signals to be processed by a microprocessor 113 of the electronics subsystem 120 (Pushpala ‘685 ¶0043); In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113… an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)];
c) at least one sensor operatively connected to at least one of the plurality of microstructures, the at least one sensor being configured to measure response signals from the at least one of the plurality of microstructures [Pushpala ‘685 ¶0055]; and
d) one or more electronic processing devices configured to:
i) determine the measured response signals [The microprocessor 113 preferably includes memory and/or is coupled to a storage module 127 (e.g., flash storage)… The microprocessor 113 functions to process received signals, enable power distribution, enable impedance monitoring, and enable data transmission from the electronics subsystem 120, in relation to other portions of the electronics subsystem 120 described below; however, the microprocessor 113 can alternatively or additionally be configured to perform any other suitable function (Pushpala ‘685 ¶0044)]; and
ii) at least one of:
(1) provide an output based on the measured response signals [Pushpala ‘685 ¶0044];
(2) perform an analysis at least in part using the measured response signals; and
(3) store data at least partially indicative of the measured response signals [Pushpala ‘685 ¶0044];
wherein at least some of the plurality of microstructures are arranged in a plurality of pairs of rows, each pair of rows being two rows of spaced apart plate microstructures having planar electrodes in opposition [In one variation, as shown in FIG. 2C, the array of filaments 117 of the microsensor 116 is configured as a first working electrode 11 (corresponding to a first subarray of filaments), a second working electrode 12 (corresponding to a second subarray of filaments), a counter electrode 13 (corresponding to a third subarray of filaments), and a reference electrode 14 (corresponding to a fourth subarray of filaments)… Furthermore, in the specific example, each subarray has a square footprint, and the subarrays are configured in a 2.times.2 arrangement to define a larger square footprint. However, the array of filaments 117 can be configured as one or more of: a working electrode, a counter electrode, and a reference electrode in any other suitable manner, and can furthermore have any other suitable morphology(ies) and/or configuration relative to each other (Pushpala ‘685 ¶0039, Figs. 1B, 2C, emphasis applied), wherein as Fig. 1B depicts rows of subarrays of filaments and as ¶0039 notes that any configuration of working electrodes and reference electrodes of subarrays of filaments relative to one another may be employed, Pushpala is considered to anticipate a configuration of a plurality of pairs of rows as claimed], wherein the plurality of pairs of rows including at least one pair of rows where the two rows of spaced apart plate microstructures have a first spacing and at least one pair of rows where the two rows of spaced apart plate microstructures have a second spacing which is different to the first spacing [wherein the Examiner notes that based on the cited portion of Pushpala ‘685 ¶0039, Figs. 1B, 2C, and the analysis of the cited portions above, the reference electrode is considered to be differently spaced from each working electrode; see also Pushpala Fig. 7, wherein the reference electrode 14 (which may be considered to define a row of filaments based on the analysis above) is considered to be differently spaced from working electrodes 11 and (which may be considered to define a row of filaments based on the analysis), respectively, thus defining the first pair and the second pair being spaced apart as claimed], including a plurality of electrical microstructure connections connecting the plurality of microstructures, wherein one single electrical microstructure connection connects the plurality of microstructures in a single row [the signal conditioning module 122 comprises a multiplexer 22 in communication with the microsensor 116 (Pushpala ‘685 ¶0045), wherein as depicted in Fig. 2C, the multiplexer 22 is separately connected to each electrode (defining a row of filaments)], and wherein
i) response signals are independently measured for different pairs of rows of microstructures on the substrate [In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113. In one variation, wherein the microsensor 116 comprises a first working electrode 11, a second working electrode 12, a counter electrode 13, and a reference electrode, the impedance detection module 126 can be configured to detect impedance from two of the first working electrode 11, the second working electrode 12, the counter electrode 13, and the reference electrode 14, examples of which are shown in FIG. 7. In a specific example, an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)]; and
ii) the stimulatory signal is independently applied for different pairs of rows of microstructures on the substrate [Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers (Pushpala ‘685 ¶0040); Pushpala ‘685 ¶0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows];
wherein the measured response and stimulatory signals include electrical signals [Pushpala ‘685 ¶0055], and the substrate includes electrical housing connections to allow the electrical signals to be applied to and/or received from respective microstructures [Pushpala Fig. 2C], and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row [the electronics components can be fully integrated into the electronics subsystem 120 and configured to communicate with the microsensor 116, or the electronics components can be split between the microsensor and the electronics subsystem 120. The microsensor 116 can, however, comprise any other suitable architecture or configuration (Pushpala ‘685 ¶0036); the electronics subsystem 120 can additionally or alternatively include any other suitable modules configured to facilitate signal reception, signal processing, and data transfer in an efficient manner (Pushpala ‘685 ¶0043), wherein the claimed “electrical housing connections” are considered to refer to the connectors 315 (“In the example of FIGS. 3B and 3C, four connectors 315 are provided which are connected to respective microstructures 312 via connections 313 to allow stimulation signals and response signals to be applied to and measured from two sets of respective microstructures” Applicant’s Specification ¶0484 and further depicted in Figs. 3B-C), which are merely considered to define the connection (“the act of connecting : the state of being connected” based on https://www.merriam-webster.com/dictionary/connection, as opposed to any particular connective structure) between the connections 313 (which as depicted in Figs. 3B-C define a connective structure) and monitoring device 320, but are not defined by any particular structure, such that the respective connections between the subarrays of array 117 (working electrodes 11 and 12, counter electrode 13, and reference electrode 14) and multiplexer 22 as connected to the multiplexer 22 are considered to define “electrical housing connections” based on a structure defined by the electronics subsystem 120 (Pushpala ‘685 ¶¶0036, 0043)].
Regarding claim 2, Pushpala ‘685 teaches
The system according to claim 1, wherein the one or more processing devices are configured to at least one of:
a) control the at least one signal generator to cause a measurement to be performed [Pushpala ‘685 ¶0055]; and
b) control the at least one signal generator in accordance with the measured response signals.
Regarding claim 6, Pushpala ‘685 teaches
The system according to claim 2, wherein the system includes one or more switches for selectively connecting at least one of the at least one sensor and at least one signal generator to one or more of the plurality of microstructures [The multiplexer 22 can also comprise a switch 75, as shown in FIG. 5C, that allows altering of potentials within the analog front end 23 (Pushpala ‘685 ¶0047)], and wherein the one or more processing devices are configured to control the switches to at least one of:
a) allow at least one measurement to be performed [Pushpala ‘685 ¶0047]; and,
b) control which microstructures of the plurality of microstructures are used to produce response signals / apply stimulation.
Regarding claim 8, Pushpala ‘685 teaches
The system according to claim 1, wherein the measured response signals are indicative of at least one of:
a) fluid levels [the impedance detection module 126 can thus provide signals that indicate that the microsensor patch 110 is properly coupled to the user (e.g., interfacing with interstitial fluid and experiencing an .about.80% moisture environment) (Pushpala ‘685 ¶0054)];
b) a visualization;
c) a mapping;
d) mechanical properties;
e) forces;
f) pressures;
g) muscle movement;
h) blood pulse wave;
i) an analyte presence, absence, level or concentration [the array of filaments 117 of the microsensor 116 is configured to sense at least one of biomarkers, cell count, hormone levels, alcohol content, gases (e.g. carbon dioxide, oxygen, etc.), drug concentrations/metabolism, pH and analytes within a user's body fluid (Pushpala ‘685 ¶0037); Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers, or the same analyte/biomarker (Pushpala ‘685 ¶0040)];
j) a blood oxygen saturation [Pushpala ‘685 ¶0037];
k) a tissue inflammation state;
l) a bioimpedance [Pushpala ‘685 ¶0055];
m) a biocapacitance [Preferably, sensed analytes result in a signal (e.g., voltage, current, resistance, capacitance, impedance, gravimetric, etc.) detectable by the electronics subsystem 120 in communication with the microsensor 116 (Pushpala ‘685 ¶0036)];
n) a bioconductance [Pushpala ‘685 ¶0036]; and,
o) electrical signals within the subject’s body [Pushpala ‘685 ¶0055].
Regarding claim 11, Pushpala ‘685 teaches
The system according to claim 1, wherein the plurality of microstructures are at least partially tapered and have a substantially rounded rectangular cross sectional shape [A filament 118 of the array of filaments can comprise one or more of: a substrate core, the substrate core including a base end coupled to the substrate, a columnar protrusion having a proximal portion coupled to the base end and a distal portion, and a tip region coupled to the distal portion of the columnar protrusion and that facilitates access to the body fluid of the user (Pushpala ‘685 ¶0042), wherein as depicted in at least Pushpala Figs. 3B, 3D-3G, the filament 118 is formed as claimed].
Regarding claim 17, Pushpala ‘685 teaches
The system according to claim 1, wherein at least some of the plurality of microstructures include an electrode that is configured to at least one of:
a) extends over a length of a distal portion of the microstructure [Furthermore, any configuration of subarrays of the array of filaments 117 can additionally or alternatively be configured as one or more of: a working electrode, a counter electrode (i.e., auxiliary electrode), and a reference electrode, for instance, in a two-electrode cell, a three-electrode cell, or a more-than-three-electrode cell (Pushpala ‘685 ¶0039); A filament 118 of the array of filaments can comprise one or more of:… a conductive layer, isolated to the tip region of the substrate core and isolated away from the base end and the columnar protrusion as an active region that enables transmission of electronic signals generated upon detection of an analyte; an insulating layer ensheathing the columnar protrusion and base end of the substrate core and exposing a portion of the conductive layer, thereby defining a boundary of the active region (Pushpala ‘685 ¶0042)];
b) extends over a length of a portion of the microstructure spaced from a tip;
c) is positioned proximate a distal end of the microstructure;
d) is positioned proximate a tip of the microstructure;
e) extends over at least 25% of a length of the microstructure;
(f) is configured to be positioned in a viable epidermis of the subject in use; and,
(g) has a surface area of less than 200,000 µm².
Regarding claim 21, Pushpala ‘685 teaches
The system according to claim 1, wherein at least some of the plurality of microstructures include an insulating layer extending over at least one of:
a) part of a surface of the microstructure [Pushpala ‘685 ¶0042];
b) a proximal end of the microstructure [Pushpala ‘685 ¶0042];
c) at least half of a length of the microstructure;
d) 90 µm of a proximal end of the microstructure; and,
e) at least part of a tip portion of the microstructure.
Regarding claim 27, Pushpala ‘685 teaches
The system according to claim 1, wherein at least one of:
a) one or more of the plurality of microstructures are configured to interact with one or more analytes of interest such that the response signal is dependent on a presence, absence, level or concentration of analytes of interest [Pushpala ‘685 ¶¶0037, 0040]; and,
b) a coating on one or more of the plurality of microstructures is configured to interact with analytes to change electrical and/or optical properties of the coating, thereby allowing the analytes to be detected [a selective coating superficial to the intermediate protective layer, having a distribution of molecules that respond to presence of the analyte, superficial to the sensing layer (Pushpala ‘685 ¶0042)]].
Regarding claim 29, Pushpala ‘685 teaches
The system according to claim 1, wherein at least one of:
a) the plurality of microstructures include a material including at least one of:
i) a bioactive material [Pushpala ‘685 ¶0042];
ii) a reagent for reacting with analytes in the subject;
iii) a binding agent for binding with analytes of interest;
iv) a material for binding one or more analytes of interest;
v) a probe for selectively targeting analytes of interest;
vi) an insulator [Pushpala ‘685 ¶0042];
vii) a material to reduce biofouling;
viii) a material to attract at least one substance to the microstructures;
ix) a material to repel or exclude at least one substance from the microstructures [insulating layer (Pushpala ‘685 ¶0042)];
x) a material to attract at least some analytes to the microstructures; and,
xi) a material to repel or exclude at least some analytes from the microstructures [insulating layer (Pushpala ‘685 ¶0042)];
b) different microstructures of the plurality of microstructures are at least one of:
i) differentially responsive to analytes [Pushpala ‘685 ¶¶0037, 0040, 0042];
ii) responsive to different analytes [Pushpala ‘685 ¶¶0037, 0040, 0042];
iii) responsive to different combination of analytes; and,
iv) responsive to different levels or concentrations of analytes; and,
c) at least some of the plurality of microstructures at least one of:
i) attract at least one substance to the microstructures;
ii) repel or excludes at least one substance from the microstructures [insulating layer (Pushpala ‘685 ¶0042)];
iii) attract at least one analyte to the microstructures; and,
iv) repel or excludes at least one analyte from the microstructures [insulating layer (Pushpala ‘685 ¶0042)].
Regarding claim 32, Pushpala ‘685 teaches
The system according to claim 1, wherein at least some of the plurality of microstructures are at least partially coated with a coating and wherein at least one of:
a) at least some microstructures are uncoated;
b) at least some microstructures are porous with an internal coating;
c) at least some microstructures are partially coated [a sensing layer, in communication with the active region, characterized by reversible redox behavior for transduction of an ionic concentration of the analyte into an electronic signal; an intermediate selective layer superficial to the conductive layer and deeper than the sensing layer, relative to a most distal point of the tip region of the filament, that facilitates detection of the analyte; an intermediate protective layer, superficial to the intermediate selective layer, including a functional compound that promotes generation of a protective barrier; and a selective coating superficial to the intermediate protective layer, having a distribution of molecules that respond to presence of the analyte, superficial to the sensing layer (Pushpala ‘685 ¶0042)];
d) different microstructures have different coatings;
e) different parts of microstructures include different coatings [Pushpala ‘685 ¶0042];
f) at least some microstructures include multiple coatings [Pushpala ‘685 ¶0042]; and,
g) at least some of the microstructures are coated with a selectively dissolvable coating.
Regarding claim 36, Pushpala ‘685 teaches
The system according to claim 32, wherein the coating at least one of:
a) interacts with analytes [Pushpala ‘685 ¶0042];
b) undergoes a change in properties upon exposure to analytes;
c) undergoes a shape change to selectively anchor microstructures;
d) modifies surface properties to at least one of:
i) increase hydrophilicity;
ii) increase hydrophobicity; and,
iii) minimize biofouling;
e) attracts at least one substance to the plurality of microstructures;
f) repels or excludes at least one substance from the plurality of microstructures [Pushpala ‘685 ¶0042];
g) provides a physical structure to at least one of:
i) facilitate penetration of a barrier;
ii) strengthen the plurality of microstructures; and,
iii) anchor the plurality of microstructures in the subject;
h) dissolves to at least one of:
i) expose the microstructure;
ii) expose a further coating; and,
iii) expose a material;
i) provides stimulation to the subject;
j) contains a material [Pushpala ‘685 ¶0042];
k) selectively releases a material;
l) acts as a barrier to preclude at least one substance from the plurality of microstructures [Pushpala ‘685 ¶0042]; and,
m) includes at least one of:
i) polyethylene;
ii) polyethylene glycol;
iii) polyethylene oxide;
iv) zwitterions;
v) peptides;
vi) hydrogels; and,
vii) self-assembled monolayer.
Regarding claim 37, Pushpala ‘685 teaches
The system according to claim 1, wherein the system includes an actuator configured to apply a force to the substrate to at least one of pierce and penetrate the stratum corneum and wherein:
a) the actuator is at least one of:
i) an electromagnetic actuator;
ii) a vibratory motor [The patch applicator 180 preferably accelerates the a portion of the housing with the microsensor 116 toward skin of the user, thereby causing the microsensor 116 to penetrate skin of the user and sensing regions of the microsensor to access interstitial fluid of the user. However, the patch applicator 180 can additionally or alternatively facilitate coupling of the microsensor 116 to the user using one or more of: skin stretching, skin permeabilization, skin abrasion, vibration, and/or any other suitable mechanism, variations of which are shown in FIGS. 14A-14C. In a first variation, as shown in FIG. 15A, the patch applicator 180' can be incorporated into a first housing portion 191 of a housing 190 of the system 100 and can comprise an elastic pin 181 (e.g., spring-loaded pin) configured to complement a recess of a second housing portion 196. In this variation, a normal force applied to a broad surface of the second housing portion 196 initially causes the elastic pin 181 to retract, and rebounding of the elastic pin 181 into the recess of the second housing portion 196 biases and accelerates the microsensor 116 into the skin of the user (Pushpala ‘685 ¶0084)];
iii) a piezoelectric actuator; and,
iv) a mechanical actuator [Pushpala ‘685 ¶0084]; and,
b) the actuator is configured to apply at least one of:
i) a biasing force [Pushpala ‘685 ¶0084];
ii) a vibratory force [Pushpala ‘685 ¶0084]; and,
iii) a single continuous force.
Regarding claim 60, Pushpala ‘685 teaches
The system according to claim 1, wherein the system includes a monitoring device and a patch including the substrate and plurality of microstructures [microsensor patch 110 (Pushpala ‘685 ¶0030)] and wherein at least one of:
a) the monitoring device is at least one of:
i) inductively coupled to the patch;
ii) attached to the patch [In variations, the transmitting unit 130 includes an antenna 132, a radio 134 coupling the antenna to the microprocessor 113, and can additionally or alternatively include a linking interface 136 (e.g., wireless or wired interface, as described in further detail below) (Pushpala ‘685 ¶0060); The linking interface 136 functions to transmit an output of at least one element of the microsensor patch no/transmitting unit 130 assembly to a mobile computing device 150. Additionally, the linking interface 136 can function to transmit and output of at least one element of the microsensor patch no and transmitting unit 130 assembly to another element external to the microsensor patch no and transmitting unit 130. Preferably, the linking interface 136 is a wireless interface; however, the linking interface 136 can alternatively be a wired connection (Pushpala ‘685 ¶0065)]; and,
iii) brought into contact with the patch when a reading is to be performed; and,
b) the monitoring device is configured to at least one of:
i) cause a measurement to be performed;
ii) at least partially analyse measurements [the software module can be a cloud-computing-based application that performs data analysis, calculations, and other actions remotely from the mobile computing device 150… the software module can include any number of software components executable on any mobile computing device 150, computing device, and/or server and can be configured to perform any other function or combination of functions (Pushpala ‘685 ¶0078)];
iii) control stimulation applied to at least one microstructure;
iv) generate an output i[Pushpala ‘685 ¶0078];
v) provide an output indicative of an indicator [The notification 166 preferably contains information relevant to a body chemistry status of the user. The notification 166 can additionally include an explicit directive for the user to perform a certain action (e.g., eat, rest, or exercise) that affects the body chemistry of the user. Therefore, the notification 166 preferably systematically and repeatedly analyzes a body chemistry status of the user based on at least one analyte parameter of the user and provides and alert and/or advice to manage and monitor a user's body chemistry substantially in real time (Pushpala ‘685 ¶0080)];
vi) provide a recommendation based on the indicator [Pushpala ‘685 ¶0080]; and,
vii) cause an action to be performed [Pushpala ‘685 ¶¶0078, 0080].
Regarding claim 63, Pushpala ‘685 teaches
The system according to claim 1, wherein the system includes:
a) a wearable monitoring device that is configured to perform the measurements [The housing 190 supports the microsensor 116 and the electronics subsystem 120, and functions to facilitate robust coupling of the microsensor patch 110 to the user in a manner that allows the user to wear the microsensor patch no for a sufficient period of time (e.g., one week, one month, etc.) (Pushpala ‘685 ¶0068)]; and,
b) a processing system that is configured to:
i) receive subject data derived from the measured response signals [Pushpala ‘685 ¶¶0060, 0065]; and,
ii) analyse the subject data to generate at least one indicator, the at least one indicator being at least partially indicative of a health status associated with the subject [Pushpala ‘685 ¶¶0078, 0080].
Regarding claim 70, Pushpala ‘685 teaches
A method for performing measurements on a biological subject, the method including:
a) using a substrate [microsensor 116 (Pushpala ‘685 Fig. 2A)] including a plurality of microstructures to breach a stratum corneum of the subject [The microsensor 116 of the microsensor patch no preferably comprises an array of filaments 117… the array of filaments 117 is configured to penetrate the user's stratum corneum (i.e., an outer skin layer) (Pushpala ‘685 ¶0035)];
b) using at least one signal generator operatively connected to at least one of the plurality of microstructures to apply a stimulatory signal [Preferably, sensed analytes result in a signal (e.g., voltage, current, resistance, capacitance, impedance, gravimetric, etc.) detectable by the electronics subsystem 120 in communication with the microsensor 116 (Pushpala ‘685 ¶0036); The electronics subsystem 120 functions to receive analog signals from the microsensor 116 and to convert them into digital signals to be processed by a microprocessor 113 of the electronics subsystem 120 (Pushpala ‘685 ¶0043); In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113… an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)];
c) using at least one sensor operatively connected to at least one of the plurality of microstructures, the at least one sensor being configured to measure response signals from the at least one of the plurality of microstructures [Pushpala ‘685 ¶0055]; and
d) in one or more electronic processing devices:
i) determining the measured response signals [The microprocessor 113 preferably includes memory and/or is coupled to a storage module 127 (e.g., flash storage)… The microprocessor 113 functions to process received signals, enable power distribution, enable impedance monitoring, and enable data transmission from the electronics subsystem 120, in relation to other portions of the electronics subsystem 120 described below; however, the microprocessor 113 can alternatively or additionally be configured to perform any other suitable function (Pushpala ‘685 ¶0044)]; and
ii) at least one of:
(1) providing an output based on the measured response signals [Pushpala ‘685 ¶0044];
(2) performing an analysis at least in part using the measured response signals; and
(3) storing data at least partially indicative of the measured response signals [Pushpala ‘685 ¶0044];
wherein at least some of the plurality of microstructures are arranged in a plurality of pairs of rows, each pair of rows being two rows of spaced apart plate microstructures having planar electrodes in opposition [In one variation, as shown in FIG. 2C, the array of filaments 117 of the microsensor 116 is configured as a first working electrode 11 (corresponding to a first subarray of filaments), a second working electrode 12 (corresponding to a second subarray of filaments), a counter electrode 13 (corresponding to a third subarray of filaments), and a reference electrode 14 (corresponding to a fourth subarray of filaments)… Furthermore, in the specific example, each subarray has a square footprint, and the subarrays are configured in a 2.times.2 arrangement to define a larger square footprint. However, the array of filaments 117 can be configured as one or more of: a working electrode, a counter electrode, and a reference electrode in any other suitable manner, and can furthermore have any other suitable morphology(ies) and/or configuration relative to each other (Pushpala ‘685 ¶0039, Figs. 1B, 2C, emphasis applied), wherein as Fig. 1B depicts rows of subarrays of filaments and as ¶0039 notes that any configuration of working electrodes and reference electrodes of subarrays of filaments relative to one another may be employed, Pushpala is considered to anticipate a configuration of a plurality of pairs of rows as claimed], wherein the plurality of pairs of rows including at least one pair of rows where the two rows of spaced apart plate microstructures have a first spacing and at least one pair of rows where the two rows of spaced apart plate microstructures have a second spacing which is different to the first spacing [wherein the Examiner notes that based on the cited portion of Pushpala ‘685 ¶0039, Figs. 1B, 2C, and the analysis of the cited portions above, the reference electrode is considered to be differently spaced from each working electrode; see also Pushpala Fig. 7, wherein the reference electrode 14 (which may be considered to define a row of filaments based on the analysis above) is considered to be differently spaced from working electrodes 11 and (which may be considered to define a row of filaments based on the analysis), respectively, thus defining the first pair and the second pair being spaced apart as claimed], including a plurality of electrical microstructure connections connecting the plurality of microstructures, wherein one single electrical microstructure connection connects the plurality of microstructures in a single row [the signal conditioning module 122 comprises a multiplexer 22 in communication with the microsensor 116 (Pushpala ‘685 ¶0045), wherein as depicted in Fig. 2C, the multiplexer 22 is separately connected to each electrode (defining a row of filaments)], and wherein:
i) response signals are independently measured for different pairs of rows of microstructures in a group on the substrate [In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113. In one variation, wherein the microsensor 116 comprises a first working electrode 11, a second working electrode 12, a counter electrode 13, and a reference electrode, the impedance detection module 126 can be configured to detect impedance from two of the first working electrode 11, the second working electrode 12, the counter electrode 13, and the reference electrode 14, examples of which are shown in FIG. 7. In a specific example, an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)]; and
ii) the stimulatory signal is independently applied for different pairs of rows of microstructures in a group on the substrate [Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers (Pushpala ‘685 ¶0040); Pushpala ‘685 ¶0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows];
wherein the measured response and stimulatory signals include electrical signals [Pushpala ‘685 ¶0055], and the substrate includes electrical housing connections to allow the electrical signals to be applied to and/or received from respective microstructures, and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row [Pushpala ‘685 Fig. 2C], and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row [the electronics components can be fully integrated into the electronics subsystem 120 and configured to communicate with the microsensor 116, or the electronics components can be split between the microsensor and the electronics subsystem 120. The microsensor 116 can, however, comprise any other suitable architecture or configuration (Pushpala ‘685 ¶0036); the electronics subsystem 120 can additionally or alternatively include any other suitable modules configured to facilitate signal reception, signal processing, and data transfer in an efficient manner (Pushpala ‘685 ¶0043), wherein the claimed “electrical housing connections” are considered to refer to the connectors 315 (“In the example of FIGS. 3B and 3C, four connectors 315 are provided which are connected to respective microstructures 312 via connections 313 to allow stimulation signals and response signals to be applied to and measured from two sets of respective microstructures” Applicant’s Specification ¶0484 and further depicted in Figs. 3B-C), which are merely considered to define the connection (“the act of connecting : the state of being connected” based on https://www.merriam-webster.com/dictionary/connection, as opposed to any particular connective structure) between the connections 313 (which as depicted in Figs. 3B-C define a connective structure) and monitoring device 320, but are not defined by any particular structure, such that the respective connections between the subarrays of array 117 (working electrodes 11 and 12, counter electrode 13, and reference electrode 14) and multiplexer 22 as connected to the multiplexer 22 are considered to define “electrical housing connections” based on a structure defined by the electronics subsystem 120 (Pushpala ‘685 ¶¶0036, 0043)].
Regarding claim 71, Pushpala ‘685 teaches
The system according to claim 1, wherein each pairs of rows is provided with respective electrical microstructure connections, and thereby different pairs of rows are interrogated and/or stimulated independently [Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers (Pushpala ‘685 ¶0040); Pushpala ‘685 ¶0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows].
Regarding claim 72, Pushpala ‘685 teaches
The method according to claim 70, wherein each pairs of rows is provided with respective electrical microstructure connections, and thereby different pairs of rows are interrogated and/or stimulated independently [Pushpala ‘685 ¶¶0040, 0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows].
Regarding claim 73, Pushpala ‘685 teaches
The system according to claim 1, wherein the one or more sensors are connected to different groups of plate microstructures to allow different measured response signals to be measured from different groups of microstructures [Pushpala ‘685 ¶¶0040, 0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different groups of microstructures].
Regarding claim 74, Pushpala ‘685 teaches
The system according to claim 1, wherein the electrical microstructure connections are conductive tracks provided on the substrate [Pushpala ‘685 Fig. 2C].
Regarding claim 75, Pushpala ‘685 teaches
The system according to claim 1, wherein the electrical microstructure connections include multiple stimulation and response connections allowing different measurements to be performed via different electrical connections [Pushpala ‘685 ¶0055].
Regarding claim 76, Pushpala ‘685 teaches
The system according to claim 1, wherein an insulating layer is provided on the electrical microstructure connections so that the electrical microstructure connections do not make electrical contact with skin of the biological subject [Pushpala ‘685 ¶0042, wherein as noted in ¶0042, the conductive layer is isolated to the tip region as the active region that enables transmission of electronic signals].
Regarding claim 77, Pushpala ‘685 teaches
A system for performing measurements on a biological subject, the system including:
a) a substrate [microsensor 116 (Pushpala ‘685 Fig. 2A)] including a plurality of microstructures configured to breach a stratum corneum of the subject [The microsensor 116 of the microsensor patch no preferably comprises an array of filaments 117… the array of filaments 117 is configured to penetrate the user's stratum corneum (i.e., an outer skin layer) (Pushpala ‘685 ¶0035)];
b) at least one signal generator operatively connected to at least one of the plurality of microstructures to apply a stimulatory signal [Preferably, sensed analytes result in a signal (e.g., voltage, current, resistance, capacitance, impedance, gravimetric, etc.) detectable by the electronics subsystem 120 in communication with the microsensor 116 (Pushpala ‘685 ¶0036); The electronics subsystem 120 functions to receive analog signals from the microsensor 116 and to convert them into digital signals to be processed by a microprocessor 113 of the electronics subsystem 120 (Pushpala ‘685 ¶0043); In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113… an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)];
c) at least one sensor operatively connected to at least one of the plurality of-microstructures, the at least one sensor being configured to measure response signals from the at least one of the plurality of microstructures [Pushpala ‘685 ¶0055]; and
d) one or more electronic processing devices configured to:
i) determine the measured response signals [The microprocessor 113 preferably includes memory and/or is coupled to a storage module 127 (e.g., flash storage)… The microprocessor 113 functions to process received signals, enable power distribution, enable impedance monitoring, and enable data transmission from the electronics subsystem 120, in relation to other portions of the electronics subsystem 120 described below; however, the microprocessor 113 can alternatively or additionally be configured to perform any other suitable function (Pushpala ‘685 ¶0044)]; and
ii) at least one of:
(1) provide an output based on the measured response signals [Pushpala ‘685 ¶0044];
(2) perform an analysis at least in part using the measured response signals; and
(3) store data at least partially indicative of the measured response signals [Pushpala ‘685 ¶0044];
wherein at least some of the plurality of microstructures are arranged in a plurality of pairs of rows, each pair of rows being two rows of spaced apart plate microstructures having planar electrodes in opposition [In one variation, as shown in FIG. 2C, the array of filaments 117 of the microsensor 116 is configured as a first working electrode 11 (corresponding to a first subarray of filaments), a second working electrode 12 (corresponding to a second subarray of filaments), a counter electrode 13 (corresponding to a third subarray of filaments), and a reference electrode 14 (corresponding to a fourth subarray of filaments)… Furthermore, in the specific example, each subarray has a square footprint, and the subarrays are configured in a 2.times.2 arrangement to define a larger square footprint. However, the array of filaments 117 can be configured as one or more of: a working electrode, a counter electrode, and a reference electrode in any other suitable manner, and can furthermore have any other suitable morphology(ies) and/or configuration relative to each other (Pushpala ‘685 ¶0039, Figs. 1B, 2C, emphasis applied), wherein as Fig. 1B depicts rows of subarrays of filaments and as ¶0039 notes that any configuration of working electrodes and reference electrodes of subarrays of filaments relative to one another may be employed, Pushpala is considered to anticipate a configuration of a plurality of pairs of rows as claimed], wherein spacings between the two rows within a pair of rows are smaller than spacings between different pairs of rows [wherein the Examiner notes that based on the cited portion of Pushpala ‘685 ¶0039, Figs. 1B, 2C, and the analysis of the cited portions above, the reference electrode is considered to be differently spaced from each working electrode; see also Pushpala Fig. 7, wherein the reference electrode 14 (which may be considered to define a row of filaments based on the analysis above) is considered to be differently spaced from working electrodes 11 and (which may be considered to define a row of filaments based on the analysis), respectively, thus defining the different spacings as claimed], including a plurality of electrical microstructure connections connecting the plurality of microstructures, wherein one single electrical microstructure connection connects the plurality of microstructures in a single row [the signal conditioning module 122 comprises a multiplexer 22 in communication with the microsensor 116 (Pushpala ‘685 ¶0045), wherein as depicted in Fig. 2C, the multiplexer 22 is separately connected to each electrode (defining a row of filaments)], and wherein:
i) response signals are independently measured for different pairs of rows of microstructures on the substrate [In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113. In one variation, wherein the microsensor 116 comprises a first working electrode 11, a second working electrode 12, a counter electrode 13, and a reference electrode, the impedance detection module 126 can be configured to detect impedance from two of the first working electrode 11, the second working electrode 12, the counter electrode 13, and the reference electrode 14, examples of which are shown in FIG. 7. In a specific example, an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)]; and
ii) the stimulatory signal is independently applied for different pairs of rows of microstructures on the substrate [Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers (Pushpala ‘685 ¶0040); Pushpala ‘685 ¶0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows];
wherein the measured response and stimulatory signals include electrical signals [Pushpala ‘685 ¶0055], and the substrate includes electrical housing connections to allow the electrical signals to be applied to and/or received from respective microstructures [Pushpala ‘685 Fig. 2C], and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row [the electronics components can be fully integrated into the electronics subsystem 120 and configured to communicate with the microsensor 116, or the electronics components can be split between the microsensor and the electronics subsystem 120. The microsensor 116 can, however, comprise any other suitable architecture or configuration (Pushpala ‘685 ¶0036); the electronics subsystem 120 can additionally or alternatively include any other suitable modules configured to facilitate signal reception, signal processing, and data transfer in an efficient manner (Pushpala ‘685 ¶0043), wherein the claimed “electrical housing connections” are considered to refer to the connectors 315 (“In the example of FIGS. 3B and 3C, four connectors 315 are provided which are connected to respective microstructures 312 via connections 313 to allow stimulation signals and response signals to be applied to and measured from two sets of respective microstructures” Applicant’s Specification ¶0484 and further depicted in Figs. 3B-C), which are merely considered to define the connection (“the act of connecting : the state of being connected” based on https://www.merriam-webster.com/dictionary/connection, as opposed to any particular connective structure) between the connections 313 (which as depicted in Figs. 3B-C define a connective structure) and monitoring device 320, but are not defined by any particular structure, such that the respective connections between the subarrays of array 117 (working electrodes 11 and 12, counter electrode 13, and reference electrode 14) and multiplexer 22 as connected to the multiplexer 22 are considered to define “electrical housing connections” based on a structure defined by the electronics subsystem 120 (Pushpala ‘685 ¶¶0036, 0043)].
Regarding claim 78, Pushpala ‘685 teaches
A method for performing measurements on a biological subject, the method including:
a) using a substrate [microsensor 116 (Pushpala ‘685 Fig. 2A)] including a plurality of microstructures to breach a stratum corneum of the subject [The microsensor 116 of the microsensor patch no preferably comprises an array of filaments 117… the array of filaments 117 is configured to penetrate the user's stratum corneum (i.e., an outer skin layer) (Pushpala ‘685 ¶0035)];
b) using at least one signal generator operatively connected to at least one of the plurality of microstructures to apply a stimulatory signal [Preferably, sensed analytes result in a signal (e.g., voltage, current, resistance, capacitance, impedance, gravimetric, etc.) detectable by the electronics subsystem 120 in communication with the microsensor 116 (Pushpala ‘685 ¶0036); The electronics subsystem 120 functions to receive analog signals from the microsensor 116 and to convert them into digital signals to be processed by a microprocessor 113 of the electronics subsystem 120 (Pushpala ‘685 ¶0043); In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113… an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)];
c) using at least one sensor operatively connected to at least one of the plurality of microstructures, the at least one sensor being configured to measure response signals from the at least one of the plurality of microstructures [Pushpala ‘685 ¶0055]; and
d) in one or more electronic processing devices:
i) determining the measured response signals [The microprocessor 113 preferably includes memory and/or is coupled to a storage module 127 (e.g., flash storage)… The microprocessor 113 functions to process received signals, enable power distribution, enable impedance monitoring, and enable data transmission from the electronics subsystem 120, in relation to other portions of the electronics subsystem 120 described below; however, the microprocessor 113 can alternatively or additionally be configured to perform any other suitable function (Pushpala ‘685 ¶0044)]; and
ii) at least one of:
(1) providing an output based on the measured response signals [Pushpala ‘685 ¶0044];
(2) performing an analysis at least in part using the measured response signals; and
(3) storing data at least partially indicative of the measured response signals [Pushpala ‘685 ¶0044];
wherein at least some of the plurality of microstructures are arranged in a plurality of pairs of rows, each pair of rows being two rows of spaced apart plate microstructures having planar electrodes in opposition [In one variation, as shown in FIG. 2C, the array of filaments 117 of the microsensor 116 is configured as a first working electrode 11 (corresponding to a first subarray of filaments), a second working electrode 12 (corresponding to a second subarray of filaments), a counter electrode 13 (corresponding to a third subarray of filaments), and a reference electrode 14 (corresponding to a fourth subarray of filaments)… Furthermore, in the specific example, each subarray has a square footprint, and the subarrays are configured in a 2.times.2 arrangement to define a larger square footprint. However, the array of filaments 117 can be configured as one or more of: a working electrode, a counter electrode, and a reference electrode in any other suitable manner, and can furthermore have any other suitable morphology(ies) and/or configuration relative to each other (Pushpala ‘685 ¶0039, Figs. 1B, 2C, emphasis applied), wherein as Fig. 1B depicts rows of subarrays of filaments and as ¶0039 notes that any configuration of working electrodes and reference electrodes of subarrays of filaments relative to one another may be employed, Pushpala is considered to anticipate a configuration of a plurality of pairs of rows as claimed], wherein spacings between the two rows within a pair of rows are smaller than spacings between different pairs of rows [wherein the Examiner notes that based on the cited portion of Pushpala ‘685 ¶0039, Figs. 1B, 2C, and the analysis of the cited portions above, the reference electrode is considered to be differently spaced from each working electrode; see also Pushpala Fig. 7, wherein the reference electrode 14 (which may be considered to define a row of filaments based on the analysis above) is considered to be differently spaced from working electrodes 11 and (which may be considered to define a row of filaments based on the analysis), respectively, thus defining the different spacings as claimed], including a plurality of electrical microstructure connections connecting the plurality of microstructures, wherein one single electrical microstructure connection connects the plurality of microstructures in a single row [the signal conditioning module 122 comprises a multiplexer 22 in communication with the microsensor 116 (Pushpala ‘685 ¶0045), wherein as depicted in Fig. 2C, the multiplexer 22 is separately connected to each electrode (defining a row of filaments)], and wherein:
i) response signals are independently measured for different pairs of rows of microstructures in a group on the substrate [In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113. In one variation, wherein the microsensor 116 comprises a first working electrode 11, a second working electrode 12, a counter electrode 13, and a reference electrode, the impedance detection module 126 can be configured to detect impedance from two of the first working electrode 11, the second working electrode 12, the counter electrode 13, and the reference electrode 14, examples of which are shown in FIG. 7. In a specific example, an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)]; and
ii) the stimulatory signal is independently applied for different pairs of rows of microstructures in a group on the substrate [Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers (Pushpala ‘685 ¶0040); Pushpala ‘685 ¶0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows];
wherein the measured response and stimulatory signals include electrical signals [Pushpala ‘685 ¶0055], and the substrate includes electrical housing connections to allow the electrical signals to be applied to and/or received from respective microstructures [Pushpala Fig. 2C], and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row [the electronics components can be fully integrated into the electronics subsystem 120 and configured to communicate with the microsensor 116, or the electronics components can be split between the microsensor and the electronics subsystem 120. The microsensor 116 can, however, comprise any other suitable architecture or configuration (Pushpala ‘685 ¶0036); the electronics subsystem 120 can additionally or alternatively include any other suitable modules configured to facilitate signal reception, signal processing, and data transfer in an efficient manner (Pushpala ‘685 ¶0043), wherein the claimed “electrical housing connections” are considered to refer to the connectors 315 (“In the example of FIGS. 3B and 3C, four connectors 315 are provided which are connected to respective microstructures 312 via connections 313 to allow stimulation signals and response signals to be applied to and measured from two sets of respective microstructures” Applicant’s Specification ¶0484 and further depicted in Figs. 3B-C), which are merely considered to define the connection (“the act of connecting : the state of being connected” based on https://www.merriam-webster.com/dictionary/connection, as opposed to any particular connective structure) between the connections 313 (which as depicted in Figs. 3B-C define a connective structure) and monitoring device 320, but are not defined by any particular structure, such that the respective connections between the subarrays of array 117 (working electrodes 11 and 12, counter electrode 13, and reference electrode 14) and multiplexer 22 as connected to the multiplexer 22 are considered to define “electrical housing connections” based on a structure defined by the electronics subsystem 120 (Pushpala ‘685 ¶¶0036, 0043)].
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) 12-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pushpala ‘685, as applied to claim 1 above, in further view of Pushpala (US-20140259652-A1, previously presented), hereinafter Pushpala ‘652 [previously referred to as “Pushpala I”].
Regarding claim 12, Pushpala ‘685 teaches
The system according to claim 1.
However, while Pushpala ‘685 depicts structures similar to the anchor microstructures as claimed in Pushpala ‘685 Figs. 3E-F, Pushpala fails to explicitly disclose wherein the plurality of microstructures include anchor microstructures used to anchor the substrate to the subject, and wherein the anchor microstructures are configured to at least one of: a) undergo a shape change; b) undergo a shape change in response to at least one of substances in the subject and applied stimulation; c) swell; d) swell in response to at least one of substances in the subject and applied stimulation; e) include anchoring structures; f) have a length greater than at least some of the plurality of microstructures other than the anchor microstructures; g) are rougher than at least some of the plurality of microstructures other than the anchor microstructures; h) have a higher surface friction than at least some of the plurality of microstructures other than the anchor microstructures; i) are blunter than at least some of the plurality of microstructures other than the anchor microstructures; j) are fatter than at least some of the plurality of microstructures other than the anchor microstructures; and, k) enter the dermis of the subject.
Pushpala ‘652 discloses a system for performing measurements on a biological subject, wherein Pushpala ‘652 discloses microstructures that include anchor microstructures used to anchor the substrate to the subject [In a third example of the solid filament 120, the solid filament 120 can comprise two regions--a barbed tip region 123 including a barb configured to penetrate a user's skin and promote skin adherence, and a second region 122 coupled to the barbed tip region, as shown in FIG. 3F (Pushpala ‘652 ¶0038)], and wherein the anchor microstructures are configured to at least one of: include anchoring structures [Pushpala ‘652 ¶0038, Fig. 3F]; are fatter than at least some of the plurality of microstructures other than the anchor microstructures [Pushpala ‘652 ¶0038, Fig. 3F]; and enter the dermis of the subject [Pushpala ‘652 ¶0038, Fig. 3F].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pushpala ‘685 to employ wherein the plurality of microstructures include anchor microstructures used to anchor the substrate to the subject, and wherein the anchor microstructures are configured to at least one of: a) undergo a shape change; b) undergo a shape change in response to at least one of substances in the subject and applied stimulation; c) swell; d) swell in response to at least one of substances in the subject and applied stimulation; e) include anchoring structures; f) have a length greater than at least some of the plurality of microstructures other than the anchor microstructures; g) are rougher than at least some of the plurality of microstructures other than the anchor microstructures; h) have a higher surface friction than at least some of the plurality of microstructures other than the anchor microstructures; i) are blunter than at least some of the plurality of microstructures other than the anchor microstructures; j) are fatter than at least some of the plurality of microstructures other than the anchor microstructures; and, k) enter the dermis of the subject, so as to promote skin adherence of the microstructures.
Regarding claim 13, Pushpala ‘685 teaches
The system according to claim 1, wherein the plurality of microstructures are applied to skin of the subject, and wherein:
a) at least some of the plurality of microstructures are configured to at least one of:
i) penetrate the stratum corneum [Pushpala ‘685 ¶0035];
ii) enter a viable epidermis but not a dermis of the subject; and,
iii) enter the dermis of the subject.
However, Pushpala ‘685 fails to explicitly disclose b) at least some of the plurality of microstructures have at least one of: i) a length that is less than 2500 µm; ii) a maximum width that is less than 2500 µm; and iii) thickness that is at least one of: (1) less than the width; and, (2) less than 300 µm.
Pushpala ‘652 discloses microstructures wherein the plurality of microstructures are applied to skin of the subject, and wherein: at least some of the plurality of microstructures have: a length that is less than 2500 µm [each filament 120 in the array of filaments 110 has a length of 250-350 microns, which allows appropriate levels of detection, coupling to a user, and comfort experienced by the user. In variations of the specific example, a filament 120 in the array of filaments 120 can have a length from 0-100 m, or more specifically, a length from 150-500 µm (Pushpala ‘652 ¶0024)]; a maximum width that is less than 2500 pm [In a specific example, the substrate 130 is composed of…a thickness from 500-1500 µm (Pushpala ‘652 ¶0027, Figures 2A-F)]; and a thickness that is less than the width [In a specific example, the substrate 130 is composed of…a thickness from 500-1500 µm (Pushpala ‘652 ¶0027, Figures 2A-F); the solid filament 120 can have a profile tapering continuously to at least one point (e.g., pyramid or conical shaped with one or more pointed tips), and can have straight or curved edges (Pushpala ‘652 ¶0038, Figures 1-3), wherein the filament 120 being pyramidal or conical is considered to teach the substrate 130 having a length, width, and thickness, wherein since the width can be composed of a thickness of 500-1500 µm, the thickness of the substrate 130 is considered to similarly comprise the same range, such that the thickness can be considered to be less than the width since the width is described as having a range].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pushpala ‘685 to employ wherein b) at least some of the plurality of microstructures have at least one of: i) a length that is less than 2500 µm; ii) a maximum width that is less than 2500 µm; and iii) thickness that is at least one of: (1) less than the width; and, (2) less than 300 µm, as this modification would amount to mere simple substitution of one known element [microstructures of Pushpala ‘685] for another [microstructures of Pushpala ‘652] with similar expected results [penetrate skin and allow for analyte detection] [MPEP § 2143(I)(B)].
Regarding claim 15, Pushpala ‘685 teaches
The system according to claim 1.
However, Pushpala ‘685 fails to explicitly disclose wherein at least some of the plurality of microstructures include at least one of: a) a shoulder that is configured to abut against the stratum corneum to control a depth of penetration; and, b) a shaft extending from a shoulder to a tip, the shaft being configured to control a position of the tip in the subject.
Pushpala ‘652 discloses microstructures, wherein at least some of the plurality of microstructures include: a shaft extending from a shoulder to a tip, the shaft being configured to control a position of the tip in the subject [Having filaments 120 of different lengths can additionally or alternatively function to allow measurement of different ions/analytes at different depths of penetration (e.g., a filament with a first length may sense one analyte at a first depth, and a filament with a second length may sense another analyte at a second depth). The array of filaments 110 can also comprise filaments 120 of different geometries (e.g., height, diameter) to facilitate sensing of analytes/ions at lower or higher concentrations (Pushpala ‘652 ¶0023), wherein as seen in Figure 2E, the substrate 130 can be considered to read on the claimed shaft, wherein the depth of the filament is affected by the length of substrate 130, wherein the raised portion (shoulder) of element 140 upon which the substrates 130 (shaft) are positioned on in Figure 2E is considered to read on the shaft extending from a shoulder].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Pushpala ‘685 to employ wherein at least some of the plurality of microstructures include at least one of: a) a shoulder that is configured to abut against the stratum corneum to control a depth of penetration; and, b) a shaft extending from a shoulder to a tip, the shaft being configured to control a position of the tip in the subject, so as to control the depth of penetration of the microstructure.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 20-21, filed 10 February 2026, with respect to previously presented claim interpretations under § 112(f) have been fully considered and are persuasive. The claim interpretations under § 112(f) have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 21-24, filed 10 February 2026, and Applicant’s Remarks p. 21-24, filed 25 March 2026, with respect to the rejection(s) of claim(s) 1, 70, and 77-78 under Pushpala (US-20140259652-A1, previously presented) [referred to as Pushpala I in Applicant’s Remarks] have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pushpala (US-20150257685-A1, previously presented) [referred to as Pushpala II in Applicant’s Remarks].
The Applicant asserts that Pushpala I does not disclose or anticipate the amendment to claim 1, which requires “each pair of rows being two rows of spaces apart plate microstructures having planar electrodes in opposition… i) response signals are independently measured for different pairs of rows of microstructures on the substrate; and ii) the stimulatory signal is independently applied for different pairs of rows of microstructures on the substrate”, as the Applicant notes that Pushpala I [Fig. 1B] merely teaches a single array that functions as a single electrode and fails to teach or suggest independently measuring between the different pairs of rows as claimed. The Applicant additionally notes that it would require an inventive leap to perform a measurement at one spacing and an independent measurement at a different spacing based on the teachings of Pushpala I. The Examiner notes that Applicant’s arguments with respect to claim(s) 1 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. Previously presented Pushpala II, hereinafter referred to as Pushpala ‘685 in the response to arguments [and wherein Pushpala I is hereinafter referred to as Pushpala ‘652 in the response to arguments], is considered to anticipate claim 1, wherein Pushpala ‘685 teaches the argued subject matter regarding pairs of rows of microstructures [In one variation, as shown in FIG. 2C, the array of filaments 117 of the microsensor 116 is configured as a first working electrode 11 (corresponding to a first subarray of filaments), a second working electrode 12 (corresponding to a second subarray of filaments), a counter electrode 13 (corresponding to a third subarray of filaments), and a reference electrode 14 (corresponding to a fourth subarray of filaments)… Furthermore, in the specific example, each subarray has a square footprint, and the subarrays are configured in a 2.times.2 arrangement to define a larger square footprint. However, the array of filaments 117 can be configured as one or more of: a working electrode, a counter electrode, and a reference electrode in any other suitable manner, and can furthermore have any other suitable morphology(ies) and/or configuration relative to each other (Pushpala ‘685 ¶0039, Figs. 1B, 2C, emphasis applied), wherein as Fig. 1B depicts rows of subarrays of filaments and as ¶0039 notes that any configuration of working electrodes and reference electrodes of subarrays of filaments relative to one another may be employed, Pushpala ‘685 is considered to anticipate a configuration of a plurality of pairs of rows as claimed], wherein the spacings between each pair are different [wherein the Examiner notes that based on the cited portion of Pushpala ‘685 ¶0039, Figs. 1B, 2C, and the analysis of the cited portions above, the reference electrode is considered to be differently spaced from each working electrode; see also Pushpala ‘685 Fig. 7, wherein the reference electrode 14 (which may be considered to define a row of filaments based on the analysis above) is considered to be differently spaced from working electrodes 11 and (which may be considered to define a row of filaments based on the analysis), respectively, thus defining the first pair and the second pair being spaced apart as claimed]. Pushpala ‘685 further teaches wherein i) response signals are independently measured for different pairs of rows of microstructures on the substrate [In generating the impedance signal, the impedance detection module 126 can be configured to detect impedance between two electrodes of the array of filaments 117 in response to an applied voltage provided in cooperation with the power management module 126 and the microprocessor 113. In one variation, wherein the microsensor 116 comprises a first working electrode 11, a second working electrode 12, a counter electrode 13, and a reference electrode, the impedance detection module 126 can be configured to detect impedance from two of the first working electrode 11, the second working electrode 12, the counter electrode 13, and the reference electrode 14, examples of which are shown in FIG. 7. In a specific example, an applied signal can be injected into the system in a working electrode and detected in the reference electrode 14. However in other configurations of the microsensor 116, the impedance detection module 126 can be configured to detect impedance from electrodes of the microsensor 116 in any other suitable manner (Pushpala ‘685 ¶0055)]; and ii) the stimulatory signal is independently applied for different pairs of rows of microstructures on the substrate [Multiple subarrays of the array of filaments can then be configured to sense different analytes/biomarkers (Pushpala ‘685 ¶0040); Pushpala ‘685 ¶0055, wherein as the impedance detection module 126 is configured to detect impedance between two electrodes, as different electrodes (defined by subarrays of the array of filaments) may be configured to sense different analytes/biomarkers, the stimulatory signal is considered to be applied independently for different pairs of rows].
The Applicant asserts clarifies that claim 1 is directed to having pairs of rows functioning independently as illustrated in Applicant’s Fig. 3C and the connections thereto, wherein the Applicant notes that claim 1 requires “each pair of rows being two rows of spaced apart plate microstructures having planar electrodes in opposition, wherein the plurality of pairs of rows including at least one pair of rows where the two rows of spaced apart plate microstructures have a first spacing and at least one pair of rows where the two rows of spaced apart plate microstructures have a second spacing which is different to the first spacing, including a plurality of electrical microstructure connections connecting the plurality of microstructures, wherein one single electrical microstructure connection connects the plurality of microstructures in a single row, and wherein: i) response signals are independently measured for different pairs of rows of microstructures on the substrate; and ii) the stimulatory signal is independently applied for different pairs of rows of microstructures on the substrate; wherein the measured response and stimulatory signals include electrical signals, and the substrate includes electrical housing connections to allow the electrical signals to be applied to and/or received from respective microstructures, and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row”, as the Applicant notes that Pushpala I [Fig. 1B] merely teaches a single array that functions as a single electrode and has one electrical connection to each of the arrays, such that Pushpala I fails to teach or suggest independently the different electrical connections and pairs of rows as claimed. The Applicant additionally notes that it would require an inventive leap to obtain the different electrical connections and pairs of rows as claimed based on the teachings of Pushpala I. The Examiner notes that Applicant’s arguments with respect to claim(s) 1 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. Previously presented Pushpala II, hereinafter referred to as Pushpala ‘685 in the response to arguments [and wherein Pushpala I is hereinafter referred to as Pushpala ‘652 in the response to arguments], is considered to anticipate claim 1, wherein Pushpala ‘685 teaches the argued subject matter regarding a plurality of electrical microstructure connections connecting the plurality of microstructures, wherein one single electrical microstructure connection connects the plurality of microstructures in a single row [the signal conditioning module 122 comprises a multiplexer 22 in communication with the microsensor 116 (Pushpala ‘685 ¶0045), wherein as depicted in Fig. 2C, the multiplexer 22 is separately connected to each electrode (defining a row of filaments)], and wherein the substrate includes electrical housing connections to allow the electrical signals to be applied to and/or received from respective microstructures, and wherein the electrical housing connections include a single electrical housing connection connected to a single electrical microstructure connection per the single row [the electronics components can be fully integrated into the electronics subsystem 120 and configured to communicate with the microsensor 116, or the electronics components can be split between the microsensor and the electronics subsystem 120. The microsensor 116 can, however, comprise any other suitable architecture or configuration (Pushpala ‘685 ¶0036); the electronics subsystem 120 can additionally or alternatively include any other suitable modules configured to facilitate signal reception, signal processing, and data transfer in an efficient manner (Pushpala ‘685 ¶0043), wherein the claimed “electrical housing connections” are considered to refer to the connectors 315 (“In the example of FIGS. 3B and 3C, four connectors 315 are provided which are connected to respective microstructures 312 via connections 313 to allow stimulation signals and response signals to be applied to and measured from two sets of respective microstructures” Applicant’s Specification ¶0484 and further depicted in Figs. 3B-C), which are merely considered to define the connection (“the act of connecting : the state of being connected” based on https://www.merriam-webster.com/dictionary/connection, as opposed to any particular connective structure) between the connections 313 (which as depicted in Figs. 3B-C define a connective structure) and monitoring device 320, but are not defined by any particular structure, such that the respective connections between the subarrays of array 117 (working electrodes 11 and 12, counter electrode 13, and reference electrode 14) and multiplexer 22 as connected to the multiplexer 22 are considered to define “electrical housing connections” based on a structure defined by the electronics subsystem 120 (Pushpala ‘685 ¶¶0036, 0043)].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Huang (US-20130225956-A1) discloses systems for detecting a concentration of a target molecule, wherein the system comprises microstructures arranged in rows [the plurality of microneedles 20 are arranged on the substrate 10 in the form of an array and are electrically connected to the substrate 10 for detecting the concentration of a target molecule through an electrochemical method, such as electrochemical impedance (EIS), cyclic voltammetry, or amperometry. According to the present invention, the plurality of microneedles may be fixed on the substrate individually (as shown in FIG. 1B), or may be group in row needles and fixed on the substrate (as shown in FIG. 2A) (Huang ¶0033, Fig. 2A)]
Hantash (US-20070142885-A1) discloses systems for applying an electrical stimulation, wherein the system comprises microstructures arranged in rows [A preferred embodiment of the wiring pattern is shown in FIG. 3A. In FIG. 3A, the RF source 110 has two output terminals. One of the output terminals is labeled with a plus sign (active) and the other with a minus sign (return) to indicate two poles of the RF source 110. Alternate interleaved rows of the array are wired to either the plus or the minus electrode through the common wiring buses 111 and 112. Thus, two interleaved arrays of regularly spaced needles 115 are formed. One array includes all of the negative polarity needles 116 (return electrodes) and the other includes all of the positive polarity needles 117 (active electrodes). In FIG. 3, the negative needles 116 are open and the positive needles 117 are shaded (Hantash ¶0049, Fig. 3A)]
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
Prosecution Insights