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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/20/2025 has been entered.
Claims Pending
Applicant’s addition of claims 33-36, in the response filed 08/20/2025 and previous cancellation of claims 1-9, 11, 17, and 25-26 is acknowledged.
Claims 10, 12-16, 18-24, and 27-36 are the current claims hereby under examination.
Claim Objections - Withdrawn
Applicant’s amendments, filed 08/20/2025, have been fully considered, and the previous objection withdrawn.
Claim Interpretation - Withdrawn
Applicant’s amendments, filed 08/20/2025, have been fully considered, and the previous interpretation withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24, 29-32, and 35-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites the limitation “wherein the process further comprises predicting bioavailability of L-arginine based on the detection of NO”, which lacks sufficient detail within the applicant’s specification as to The applicant’s amended specification, filed 08/20/2025, states “It is also possible to accompany the management of a physiological function such as the monitoring of the bioavailability of L-arginine. Specifically, the natural precursor of NO in an organism is an amino acid called L-arginine. The human body can produce NO in response to an effort only within the limits of its store of L-arginine.”, which merely indicates “the monitoring of the bioavailability of L-arginine”, rather than an actual step of making a prediction on the bioavailability of L-arginine. The applicant does state a prediction step “Consequently, the device also makes it possible to predict the moment when the subject will no longer be able to manage his/her vasodilation” (amended specification, filed 08/20/2025), however, the applicant made no previous indication as to the manner in which a prediction is made or the existence of any thresholds. As such, the claim is rejected.
Claim 36 recites the limitation “determining that the subject will no longer be able to manage vasodilation when the monitored bioavailability of L-arginine falls below a specified threshold”, which is considered to be new matter, as the applicant made no previous indication as to “determining that the subject will no longer be able to manage vasodilation when the monitored bioavailability of L-arginine falls below a specified threshold”. The applicant’s amended specification, filed 08/20/2025, states “It is also possible to accompany the management of a physiological function such as the monitoring of the bioavailability of L-arginine. Specifically, the natural precursor of NO in an organism is an amino acid called L-arginine. The human body can produce NO in response to an effort only within the limits of its store of L-arginine.”, which merely indicates “the monitoring of the bioavailability of L-arginine”, rather than a tangible step of making a prediction on the bioavailability of L-arginine. The applicant does state a prediction step “Consequently, the device also makes it possible to predict the moment when the subject will no longer be able to manage his/her vasodilation” (amended specification, filed 08/20/2025), however, the applicant makes no indication as to the manner in which the prediction is made or any prior indication as to the existence of any specific thresholds of L-arginine. As such, the claim is rejected.
Claims 29-32 and 35-36 are dependent on claim 24, and as such are also rejected.
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 24, 29-32, and 35-36 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 24 recites the limitation “wherein the process further comprises predicting bioavailability of L-arginine based on the detection of NO”, as it is unclear as to the manner in which a prediction of bioavailability of L-arginine is performed based on the detection of NO. The applicant’s amended specification, filed 08/20/2025, states “It is also possible to accompany the management of a physiological function such as the monitoring of the bioavailability of L-arginine. Specifically, the natural precursor of NO in an organism is an amino acid called L-arginine. The human body can produce NO in response to an effort only within the limits of its store of L-arginine.”, where it is unclear as to the manner in which a prediction is made regarding bio-availability L-arginine. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as -monitoring bioavailability of L-arginine based on the detection of NO-.
Claim 29 recites the limitation “in which several sensing units includes the first sensing unit”, which fails to effectively define the metes and bounds of the claim as it is unclear as what “several sensing units” are being referred to, as the claim also recites “wherein the sensing element comprises a plurality of sensing units”. As such, it is unclear why the applicant has switched from stating “plurality of sensing units” to “several sensing units”. Are the several sensing units included among the plurality of sensing units, or are these referring to different sensing units. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as -in which the plurality of sensing units includes the first sensing unit-.
Claims 29-32 and 35-36 are dependent on claim 24, and as such are also rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 34 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 34 recites the limitation “with a first portion of the fibrous body positioned against the epidermis and a second portion folded back over the sensing element and covering the sensing element”, which is directed towards a human organism as the claim requires the existence of “the epidermis” as part of the claim itself. As such, the claim is rejected.
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 claims are generally directed towards a system, and more specifically a system for a device that is attached to the surface of the skin; able to measure the concentration of specific biomarkers found in the bodily fluid/liquid produced by the subject; the bodily fluids are moved through the device through the use of capillary forces to a sensor, where the biomarkers are specifically measured by an electrochemical sensor that is able to identify biomarker concentrations.
Claims 10, 12-14, 16, 18-20, 27-28, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Ionescu (US Pub. No. 20190110722) hereinafter Ionescu, and further in view of Liu (US Pub. No. 20170184564) hereinafter Liu, Heikenfeld (US Pub. No. 20180340903) hereinafter Heikenfeld, Heywood (US Pat. No. 10078054) hereinafter Heywood, and Arbault (US Pub. No. 20080294026) hereinafter Arbault.
Regarding Claim 10, Ionescu discloses A detection device for detecting (Abstract), in a subject, an amount produced by said subject in the course of a sequence of a predefined activity state (Par. 7-8), said device comprising:
a part intended to be positioned on an investigation zone of an epidermis of said subject (Par. 7 (skin)) and held thereon in a leaktight manner (Par. 93 (sealing elements)) in order to track, directly and continuously, the production of a biological liquid originating from the epidermis (Par. 7-8), wherein the sensing element (Fig. 3, sensing layer- 310) comprises two electrochemical sensors (Fig. 3, sensor – 316,318 (analyte sensors)) distributed in a first sensing unit (Fig. 3, sensor – 316) and a second sensing unit (Fig. 3, sensor – 318),
wherein the first sensing unit carries out the detection by means of a first electrochemical sensor (Sensor – 316),
wherein the second sensing unit carries out the detection by means of a second electrochemical sensor (sensor – 318),
a second part (Par. 25, (electronic circuit)) configured to send, owing to an energy generator (Par. 155 (energy source)) associated with said sensing element (Sensors- 316,318) (Par. 105), signals (Par. 25 (signals sent by circuit)),
wherein the sensing element provides the signal as a result of an electrochemical measurements by the first electrochemical sensor and the second electrochemical sensor taken using the biological liquid (Par. 105 (electrochemical measurements taken))(Sensor – 316,318), produced by the subject in the investigation zone (Abstract, Par. 105 (from the skin)), as electrolyte between two working electrodes positioned on an insulating planar support (Fig. 3, sensors – 316,318, sensing layer - 310) (positioned on the sensing substrate layer))(Par. 17 (substrate layer)) (Examiners Note: the electrochemical sensors are working electrodes).
Ionescu fails to explicitly disclose detecting an amount of NO, track the production of NO in a biological liquid originating from the epidermis, detection of NO, the reading of which enables the detection of the amount of NO produced during said sequence.
However, Liu teaches detecting an amount of NO (Par. 33), track the production of NO in a biological liquid originating from the epidermis (Par. 33, 36), detection of NO (Par. 33), the reading of which enables the detection of the amount of NO produced during said sequence (Par. 33, 36) (Par. 48, “The amount or level of current measured is proportional to the level or amount of nitric oxide in the sample.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu with that of Liu to include detecting an amount of NO, track the production of NO in a biological liquid originating from the epidermis, detection of NO, the reading of Ionescu of which enables the detection of the amount of NO produced during said sequence through substitution of analytes measured as would have yielded predictable results of provided capabilities to determine the existence of a disease in the subject (Liu (Par. 5) through the measurement of nitric oxide levels.
Modified Ionescu fails to explicitly disclose a first part.
However, Heikenfeld teaches a first part (Par. 29, “The device 200 includes sweat sample management components 230, 232, 234. Although the description herein focuses on sweat, other biofluid samples may be sensed by the device 200…” (sweat management component 232 and 234 are considered to be the first part)) (Par. 37, “Suitable materials for the sweat sample management components 230, 232, 234 include, without limitation…” “… hydrogels, superporous hydrogels or polymers, textiles, beads or powders, sponges, fiber mats, salts or desiccants, or other suitable material”) (Par. 36-37 (capillary forces)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu and Liu with that of Heikenfeld to include a first part through the combination of references as differing wicking materials are known in the art (Heikenfeld (Par. 37)) and it would have yielded the predictable result of providing a direct path for movement of sweat through capillary action (Heikenfeld (Par. 29,36,37)), which does not require energy for transport.
Modified Ionescu fails to explicitly disclose wherein the detection device comprises a fastening base made of a biocompatible and adhesive flexible material, the fastening base ensuring that the detection device is held on the epidermis.
However, Ionescu does teach in alternate embodiments wherein the detection device comprises a fastening base made of a biocompatible and adhesive flexible material, the fastening base ensuring that the detection device is held on the epidermis (Par. 34, “In certain embodiments, the biofluid collection and sensing device comprises a fixture module (e.g., one or more acrylate-based, biocompatible, and/or medical grade adhesives or tapes, e.g., one or more mechanically fastened straps) for disposing (e.g., affixing) the device on the body part (e.g., skin of a wearer) [e.g., wherein the fixture module includes a temporary (e.g., reversible) adhesive, is water-resistant, and has an external surface area of about 40 cm.sup.2 or less] (e.g., wherein the fixture module has an external surface area of about 5 cm.sup.2 or less).”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, and Heikenfeld with that of Ionescu to include wherein the detection device comprises a fastening base made of a biocompatible and adhesive flexible material, the fastening base ensuring that the detection device is held on the epidermis through the combination of embodiments as it would have yielded the predictable of aiding in the securement of the device while not causing an adverse reaction with the user (Ionescu (Par. 34)).
Modified Ionescu fails to explicitly disclose wherein a central part of the fastening base defines a recess where the first part of the device is positioned, the first part being attached to a sensing element.
However, Heikenfeld further teaches wherein a central part of the fastening base (Fig. 2, adhesive – 210) defines a recess (Fig. 2 (observable wicking space -280 in between both sides of adhesive 210)) where the first part (Fig. 2 (sample couplers 232 and 234 are considered to be the first part)) of the device is positioned (Fig. 2 (observable that sample collector 234 is in wicking space 280, which is between both sides of adhesive 210)), the first part being attached to a sensing element (Fig. 2, Par. 29, “The sample coupler 232 transports sweat across the sensor 220. The sample pump 230 moves excess or old sweat from the sample coupler 232.” (sample collector 232 is in direct contact with sensor -220)) (Par. 36-37 (capillary forces)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, and Heikenfeld with that of Heikenfeld to include wherein a central part of the fastening base of Ionescu defines a recess where the first part of the device is positioned, the first part being attached to a sensing element of Ionescu through the combination of references as it would have yielded the predictable result of providing a direct path for the movement of sweat through capillary action (Heikenfeld (Par. 29,36,37)), which does not require energy for transport.
Modified Ionescu fails to explicitly disclose detection of NO2-, the reading of which enables the detection of an amount of NO2- produced during said sequence.
However, Heywood teaches detection of NO2- (Claim 1 (nitrite concentration)), the reading of which enables the detection of an amount of NO2- produced during said sequence (Claim 1, 3 (nitrite concentration)) (Col. 3, lines 21-40) (Claim 12,15).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, and Heikenfeld with that of Heywood to include detection of NO2-, the reading of which enables the detection of an amount of NO2- produced during said sequence through the combination of references as NO and NO2- measurement are known variations in the art (Heywood (Abstract)) and it would have yielded the predictable result of providing additional health data to the user.
Modified Ionescu fails to explicitly disclose a second part including a converter coupled to a processor, the processor coupled to a radiocommunication system.
However, Ionescu highly suggests a second part (Par. 25, (electronic circuit)) including a converter coupled to a processor (Par. 100-101 (converter and electronic circuitry)), the processor coupled to a radiocommunication system (Par. 102, “for example, wearable device 100 can include a wireless communication element (e.g., antenna) for transmitting data and/or signals measured and/or calculated by device 100 to an external device (e.g., mobile device 110, the processor of a web-based server, or a personal computer). For example, user 120 may tag (e.g., scan) wearable device with a camera or with a wireless communication module (e.g. a Near Field Communications (NFC) module, e.g., a Wi-Fi module, e.g., a Bluetooth® module) of mobile device 110 to obtain communication parameters from the wearable device 110. The communication parameters can include information (e.g., a wireless network address) for interfacing with the wearable device 110 via a wireless network. The data can be transmitted via wireless Ethernet, Bluetooth®, or radio and received by a receiver of mobile device 110.”) (Par. 155, “Embodiments of the sensing device described herein may comprise electronic circuitry for local electronic processing of detected and/or produced electrical signals, and/or the sensing device may be designed for operation with a processor of a separate component (e.g., a wearable apparatus in which the sensing device is a plug-in or fixed module), and/or for transmission of signals and/or data to an external processor (e.g., via the wireless means described above). The sensing device and/or wearable apparatus may comprise an energy source (e.g., battery).”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ionescu, Liu, Heikenfeld, and Heywood with that of Ionescu to explicitly include a second part including a converter coupled to a processor, the processor coupled to a radiocommunication system through the combination of references as it would have yielded the predictable result of explicitly providing the exact circuitry for allowing for the analysis of measured data on external devices (Ionescu (Par. 102)).
Modified Ionescu fails to explicitly disclose wherein the working electrodes of at least one of the first electrochemical sensor and the second electrochemical sensor consist of metal deposits of platinum black.
However, Arbault teaches wherein the electrodes consist of metal deposits of platinum black (Par. 45).
Ionescu, Liu, Heikenfeld, Heywood, and Arbault are considered to be analogous art to the claimed invention as they are involved with the measurement of biological products with sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ionescu, Liu, Heikenfeld, and Heywood with that of Arbault to explicitly include wherein the working electrodes of at least one of the first electrochemical sensor and the second electrochemical sensor consist of metal deposits of platinum black through substitution of types of platinum (Ionescu (Par. 97 (platinum electrodes))) as it would have yielded the predictable result of increasing the sensitivity of the electrodes.
Regarding claim 12, modified Ionescu further discloses wherein a reference electrode is connected to the two working electrodes (Fig. 3, QRE – 320, Sensors –316, 318).
Regarding claim 13, modified Ionescu further discloses wherein the insulating planar support (Par. 17 (FD-SOI with microchannel)) comprises at least one microchannel (Par. 17 (FD-SOI with microchannel)) so as to guide the biological liquid to the electrochemical sensor (Par. 12 (microchannel leads to sensors)).
Regarding claim 14, modified Ionescu further discloses wherein the sensing element comprises a plurality of similar electrochemical sensors (Fig. 3, Sensing layer – 310, Sensors - 316, 318) (Par. 25), the signals of which are combined to improve the output signal (Par. 131 (plot result of two sensors)).
Regarding claim 16, modified Ionescu further discloses wherein the measurements are carried out in line with orifices provided in the planar support (Par. 17 (insulating support layer with microfluidic channels)), which is in line with the conductive patterns of the electrodes (Par. 118 (microfluidic layers direct biofluid through sensors)).
Regarding claim 18, modified Ionescu further discloses wherein the sensing element (sensing layer – 310) comprises a plurality of electrochemical sensors (sensor – 316, 318) distributed in a plurality of sensing units (Par. 105, sensors -316, 318) and in that each sensing unit is configured to detect at least one chemical species (Par. 106 (each sensor detects different biomarkers)).
Regarding claim 19, modified Ionescu further discloses wherein the insulating planar support comprises a plurality of microchannels (Par. 17 (microchannels in the substrate)), and wherein each channel comprises a sensing unit (Par. 118 (channels direct biofluid to sensors)).
Regarding claim 20, modified Ionescu fails to explicitly disclose the limitations of the claim.
However, Heikenfeld further teaches wherein the first part comprises a fibrous body in order to convey the biological liquid from the investigation zone to the sensing element by means of capillary forces (Par. 29, “The device 200 includes sweat sample management components 230, 232, 234. Although the description herein focuses on sweat, other biofluid samples may be sensed by the device 200…” (sweat management component 232 and 234 are considered to be the first part)) (Par. 37, “Suitable materials for the sweat sample management components 230, 232, 234 include, without limitation…” “… hydrogels, superporous hydrogels or polymers, textiles, beads or powders, sponges, fiber mats, salts or desiccants, or other suitable material”) (Fig. 2, Par. 29, “The sample coupler 232 transports sweat across the sensor 220. The sample pump 230 moves excess or old sweat from the sample coupler 232.” (sample collector 232 is in direct contact with sensor -220)) (Par. 36, (capillary forces)).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Heikenfeld to include to include wherein the first part comprises a fibrous body in order to convey the biological liquid from the investigation zone to the sensing element by means of capillary forces through the combination of references for the reasoning as indicated in claim 10 above.
Regarding claim 27, modified Ionescu further discloses wherein the biological liquid is sweat (Abstract).
Regarding claim 28, modified Ionescu further discloses wherein the sensing element (Fig. 3, sensing layer- 310) comprises a third electrochemical sensor distributed in a third sensing unit (Fig. 3, pH Sensor – 312) (Par. 106, “the surface of each of sensors 312, 314, 316, and 318 can be prepared and/or functionalized for the detection and/or quantification of a biomarker of interest”), wherein the third sensing unit carries out a detection by said third electrochemical sensor (Fig. 3, pH Sensor – 312) (Par. 106, “the surface of each of sensors 312, 314, 316, and 318 can be prepared and/or functionalized for the detection and/or quantification of a biomarker of interest”).
Modified Ionescu fails to explicitly disclose the third sensing unit carries out a detection of H2O2.
However, Ionescu does teach a detection of H2O2 (Par. 92, “The one or more biomarkers may include…” “…organic compounds: [e.g., vitamins (e.g., ascorbic acid), glucose, penicillin, and hydrogen peroxide], and/or other components”).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Ionescu to include the third sensing unit carries out a detection of H2O2 through the substitution of measurement targets as hydrogen peroxide is a known biomarker found in sweat used to monitor health (Ionescu (Par. 92)) and it would have yielded the predictable result of providing additional health data to the user.
Regarding claim 33, modified Ionescu fails to explicitly disclose wherein the fibrous body is attached to the sensing element and surmounts the sensing element.
However, Heikenfeld further teaches wherein the fibrous body is attached to the sensing element and surmounts the sensing element (Par. 29, “The device 200 includes sweat sample management components 230, 232, 234. Although the description herein focuses on sweat, other biofluid samples may be sensed by the device 200…” (sweat management component 230, 232 and 234 are considered to be the fibrous body)) (Fig. 2 (observable that component 230 is directly above sensor 220)) (Par. 37, “Suitable materials for the sweat sample management components 230, 232, 234 include, without limitation…” “… hydrogels, superporous hydrogels or polymers, textiles, beads or powders, sponges, fiber mats, salts or desiccants, or other suitable material”) (Fig. 2, Par. 29, “The sample coupler 232 transports sweat across the sensor 220. The sample pump 230 moves excess or old sweat from the sample coupler 232.” (sample collector 232 is in direct contact with sensor -220)) (Par. 36, (capillary forces)).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Heikenfeld to include wherein the fibrous body is attached to the sensing element and surmounts the sensing element through the combination of references for the reasoning as indicated in claim 10 above and it would have yielded the predictable result of improving sweat management (Heikenfeld (Par. 29, 36)).
Regarding claim 34, modified Ionescu fails to explicitly disclose the limitations of the claim..
However, Heikenfeld further teaches wherein the fibrous body sandwiches the sensing element (Par. 29, “The device 200 includes sweat sample management components 230, 232, 234. Although the description herein focuses on sweat, other biofluid samples may be sensed by the device 200…” (sweat management component 230, 232 and 234 are considered to be the fibrous body)) (Fig. 2 (observable that components 230, 232, and 234 sandwich sensor 220)), with a first portion of the fibrous body positioned against the epidermis (Fig. 2, (first portion is considered to be the lower part of the indicated fibrous body that includes component 234 and the part of component 232 below sensor 220)) and a second portion folded back over the sensing element and covering the sensing element (Fig. 2, (the second portion is considered to be the upper part of the indicated fibrous body that includes component 230 and the part of component 230 that is not directly below sensor 220)) (Par. 37, “Suitable materials for the sweat sample management components 230, 232, 234 include, without limitation…” “… hydrogels, superporous hydrogels or polymers, textiles, beads or powders, sponges, fiber mats, salts or desiccants, or other suitable material”) (Fig. 2, Par. 29, “The sample coupler 232 transports sweat across the sensor 220. The sample pump 230 moves excess or old sweat from the sample coupler 232.” (sample collector 232 is in direct contact with sensor -220)) (Par. 36, (capillary forces)).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Heikenfeld to include wherein the fibrous body sandwiches the sensing element, with a first portion of the fibrous body positioned against the epidermis and a second portion folded back over the sensing element and covering the sensing element through the combination of references for the reasoning as indicated in claim 10 above and it would have yielded the predictable result of improving sweat management (Heikenfeld (Par. 29, 36)).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ionescu in view of Liu, Heikenfeld, Heywood, and Arbault, as applied to claim 10 above, and further in view of Heinz (US Pub. No. 20190013746) hereinafter Heinz.
Ionescu, Liu, Heikenfeld, Heywood, and Arbault teach the device of claim 10 above.
Regarding claim 15, Modified Ionescu fails to explicitly disclose the limitations of the claim except the device as claimed in claim 10.
However, Heinz teaches wherein the pattern of the work electrodes relative to their support follows a Hilbert curve in order to improve the strength of the output signal per unit area of the support (Par. 51 (electrode arrangement is formed based on a Hilbert curve)).
Ionescu, Liu, Heikenfeld, Heywood, Arbault, and Heinz are considered to be analogous art to the claimed invention as they are involved with the measurement of biological products with sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the electrode arrangement of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with the teachings of Heinz to follow a Hilbert curve through the combination of references as it would have yielded the predictable result of creating a higher electrical field strength (Heinz (Par. 8)).
Claims 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ionescu in view of Liu, Heikenfeld, Heywood, and Arbault, as applied to claim 20 above, and further in view of Hammami (US Pub. No. 20200306701) hereinafter Hammami.
Ionescu, Liu, Heikenfeld, Heywood, and Arbault teach the device of claim 20 above.
Regarding claim 21, modified Ionescu fails to explicitly disclose the limitations of the claim.
However, Liu further teaches wherein the first part further comprises a membrane configured to filter the biological liquid at an inlet of the sensing element in order to avoid distorting the detection of NO by interfering elements contained in the biological liquid (Par. 17 (polyelectrolyte film that is semi-permeable to allow nitric oxide))(Par. 41 (the film covers detection regions and exposed parts of electrodes)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Liu to include wherein the first part further comprises a membrane configured to filter the biological liquid at an inlet of the sensing element in order to avoid distorting the detection of NO by interfering elements contained in the biological liquid through the combination of references as it would have yielded the predictable result of inhibiting unwanted anions that may inhibit the detection of nitric oxide (Liu (Par. 17)).
Modified Ionescu fails to explicitly teach that the filter is a eugenol membrane, as disclosed in the specification of the applicant.
However, Hammami teaches a eugenol membrane (Par. 82)
Ionescu, Liu, Heikenfeld, Heywood, Arbault, and Hammami are considered to be analogous art to the claimed invention as they utilize membrane structures.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Hammami to make the filter be composed of a Eugenol type membrane as it would have yielded predictable results of inhibiting the growth of bacteria in the area surrounding the device that is attached to the skin (Hammami (Par. 82)), and preventing bacteria from interfering with the device during use.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ionescu in view of Liu, Heikenfeld, Heywood, and Arbault as applied to claim 10 above, and further in view of Shekarriz (US Pub No. 20180028099) hereinafter Shekarriz.
Ionescu, Liu, Heikenfeld, Heywood, and Arbault teach the device of claim 10 above.
Regarding claim 22, Modified Ionescu fails to explicitly disclose the limitations of the claim. However, Shekarriz teaches wherein the second part (Fig. 1, electronics module -3) is positioned above the first part (Fig. 1, dermal strip -2) (Fig. 1 (observable that the electronics module is above the dermal strip)), the second part containing electronics for receiving the raw measurements from the electrochemical sensor (Par. 57 (circuity 27, which is part of electronics module 3 (Fig. 1), receives signals from detector 4)).
Ionescu, Liu, Heikenfeld, Heywood, Arbault, and Shekarriz are considered to be analogous art to the claimed invention as they are involved with the measurement of biological products with sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Shekarriz to include wherein the second part is positioned above the first part, the second part containing electronics for receiving the raw measurements from the electrochemical sensor through the combination of references as it would have yielded the predictable result of provide providing enhanced flexibility (Shekarriz (Par. 45)).
Modified Ionescu fails to explicitly disclose converting them into an NO concentration and ensuring the transmission of the signal possibly with other parameters linked to the environment.
However, Liu teaches converting them into an NO concentration and ensuring the transmission of the signal possibly with other parameters linked to the environment (Par. 33).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, Heikenfeld, Heywood, Arbault, and Shekarriz with that of Liu to include converting them into an NO concentration and ensuring the transmission of the signal possibly with other parameters linked to the environment through the combination of references as it would have yielded the predictable result of determining the presence of any types of diseases in the subject (Liu (Par. 5)).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ionescu in view of Liu, Heikenfeld, Heywood, and Arbault, as applied to claim 10 above, and further in view of Kraiter (US Pub No. 20180055373) hereinafter Kraiter.
Ionescu, Liu, Heikenfeld, Heywood, and Arbault teach the device of claim 10 above.
Regarding Claim 23, modified Ionescu fails to explicitly disclose the limitations of the claim.
However, Kraiter teaches wherein the device comprises a gyroscopic and/or accelerometric unit (Par. 5, accelerometer – 34) to detect the activity state of the subject and that the device is configured to carry out and transmit measurements at a frequency that is a function of the activity state of the subject (Par. 31 (activity and posture data)).
Ionescu, Liu, Heikenfeld, Heywood, Arbault, and Kraiter are considered to be analogous art to the claimed invention as they are involved with biological measurements with sensors.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Ionescu, Liu, Heikenfeld, Heywood, and Arbault with that of Kraiter to include wherein the device comprises a gyroscopic and/or accelerometric unit to detect the activity state of the subject and that the device is configured to carry out and transmit measurements at a frequency that is a function of the activity state of the subject through the combination of references as it would have yielded the predictable result of determining patient activity levels and posture (Kraiter (Par. 31)) so as to provide additional information that aids in the overall diagnosis of the patient (Kraiter (Par. 5)).
Prior Art overcome
The closest prior art of record includes Ionescu, Liu, Heikenfeld, Heywood, Arbault, Rogers (US Pub No. 20180064377) hereinafter Rogers, and Berner (US Pat. No. 6233471) hereinafter Berner
Regarding claim 24, Ionescu discloses A process for detecting (Par. 41), in a subject, an amount by said subject in the course of a sequence of a predefined activity state (Par. 7-8), wherein an investigation zone of an epidermis of said subject is chosen (Par. 7 (skin)), the production in a biological liquid originating from the epidermis is tracked therein, directly and continuously (Par. 7-8), by means of a device (Par. 7-8, abstract) positioned on said investigation zone and held thereon in a leak-tight manner (Par. 93 (sealing elements)),
wherein the sensing element (Fig. 3, sensing layer – 310) comprises two electrochemical sensors distributed in a first and second sensing units (sensors - 316, 318), wherein the first sensing unit carries out the detection by means of a first one of the two electrochemical sensors (sensor – 316),
wherein the second sensing unit carries out the detection by means of a second one of the two electrochemical sensors (sensor – 318),
wherein, owing to an energy generator (Par. 155 (energy source)) associated with said sensing element (Sensors- 316,318) (Par. 105), signals (Par. 25 (signals sent by circuit)) are sent by the first and second electrochemical sensors (Sensors- 316,318) (Par. 105), the reading of which signals enables the detection (Par. 25 (signals)) (Examiners Note: desired detection of NO and NO2- is not explicitly disclosed by Ionescu and is addressed below),
wherein the first and second electrochemical sensors provide the signals as a result of electrochemical measurements (Par. 105 (electrochemical measurements taken))(Sensors – 316, 318) taken using the biological liquid produced by the subject in the investigation zone (Abstract)(Par. 105 (from the skin)) as electrolyte between two working electrodes positioned on an insulating planar support (Fig. 3, sensors – 316,318, sensing layer - 310) (positioned on the sensing substrate layer))(Par. 17 (substrate layer)) (Examiners Note: the electrochemical sensors are working electrodes).
Ionescu fails to explicitly disclose detecting an amount of NO, the production of NO dissolved in a biological liquid originating from the epidermis is tracked, detection of NO.
However, Liu teaches detecting an amount of NO (Par. 33), the production of NO dissolved in a biological liquid originating from the epidermis is tracked (Par. 33, 36), detection of NO (Par. 33).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Ionescu with that of Liu to include detecting an amount of NO, the production of NO dissolved in a biological liquid originating from the epidermis is tracked, detection of NO through substitution of analytes measured as would have yielded predictable results of provided capabilities to determine the existence of a disease in the subject (Liu (Par. 5) through the measurement of nitric oxide levels.
Modified Ionescu fails to explicitly disclose comprising a first part, the first part being attached to a sensing element.
However, Heikenfeld teaches a first part (Par. 29, “The device 200 includes sweat sample management components 230, 232, 234. Although the description herein focuses on sweat, other biofluid samples may be sensed by the device 200…” (sweat management component 232 and 234 are considered to be the first part)) (Par. 37, “Suitable materials for the sweat sample management components 230, 232, 234 include, without limitation…” “… hydrogels, superporous hydrogels or polymers, textiles, beads or powders, sponges, fiber mats, salts or desiccants, or other suitable material”) the first part being attached to a sensing element (Fig. 2, Par. 29, “The sample coupler 232 transports sweat across the sensor 220. The sample pump 230 moves excess or old sweat from the sample coupler 232.” (sample collector 232 is in direct contact with sensor -220)) (Par. 36-37 (capillary forces)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Ionescu and Liu with that of Heikenfeld to include a first part, the first part being attached to a sensing element of Ionescu through the combination of references as differing wicking materials are known in the art (Heikenfeld (Par. 37)) and it would have yielded the predictable result of providing a direct path for movement of sweat through capillary action (Heikenfeld (Par. 29, 36, 37)), which does not require energy for transport.
Modified Ionescu fails to explicitly disclose detection of NO2-.
However, Heywood teaches detection of NO2- (Claim 1 (nitrite concentration)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Ionescu, Liu, and Heikenfeld with that of Heywood to include detection of NO2- through the combination of references as NO and NO2- measurement are known variations in the art (Heywood (Abstract)) and it would have yielded the predictable result of providing additional health data to the user.
Modified Ionescu fails to explicitly disclose the reading of which signals enables the desired detection (Examiners Note: interpreted as detection of NO).
However, Liu further teaches the reading of which signals enables the desired detection (Par. 33, 36) (Par. 48, “The amount or level of current measured is proportional to the level or amount of nitric oxide in the sample.”) (Examiners Note: detection of NO).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Ionescu, Liu, Heikenfeld, and Heywood with that of Liu to include the reading of which signals enables the desired detection (Examiners Note: of NO) through substitution of analytes measured as would have yielded predictable results of provided capabilities to determine the existence of a disease in the subject (Liu (Par. 5) through the measurement of nitric oxide levels.
Modified Ionescu fails to explicitly disclose the reading of which signals enables the desired detection (Examiners Note: interpreted as detection of NO2-).
However, Heywood further teaches the reading of which signals enables the desired detection (Examiners Note: interpreted as detection of NO2-) (Claim 1, 3 (nitrite concentration)) (Col. 3, lines 21-40) (Claim 12,15).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Ionescu, Liu, Heikenfeld, and Heywood with that of Heywood to include the reading of which signals enables the desired detection (Examiners Note: of NO2-) through the combination of references as NO and NO2- measurement are known variations in the art (Heywood (Abstract)) and it would have yielded the predictable result of providing additional health data to the user.
Modified Ionescu fails to explicitly disclose wherein the working electrodes of at least one of the first and second electrochemical sensors consist of metal deposits of platinum black.
However, Arbault teaches wherein the electrodes consist of metal deposits of platinum black (Par. 45).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Ionescu, Liu, Heikenfeld, and Heywood with that of Arbault to explicitly include wherein the working electrodes of at least one of the first and second electrochemical sensors consist of metal deposits of platinum black through substitution of types of platinum (Ionescu (Par. 97 (platinum electrodes))) as it would have yielded the predictable result of increasing the sensitivity of the electrodes.
However, the prior art of record fails to explicitly disclose an additional method step wherein the process further comprises predicting bioavailability of L-arginine based on the detection of NO. As such, independent claim 24 and dependent claims 29-32 and 35-36 have overcome the prior art.
Response to Arguments
Applicant's arguments filed 08/20/2025, regarding the 103 rejection have been fully considered and are deemed as not persuasive.
The applicant’s argument, that the prior art does not teach the added limitations to claim, have been fully considered and deemed as not persuasive. As the limitation was not previously addressed, the limitation has been addressed in the 103 rejection as indicated above.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case and as indicated above, Ionescu discloses a second electrochemical sensor (Ionescu (Sensor – 318)), but fails to explicitly disclose the detection of NO2-. However, Heywood teaches the detection of NO2- (Heywood (Claim 1 (nitrite concentration)). The motivation for this combination is that NO and NO2- measurement are known variations in the art (Heywood (Abstract)) and it would have yielded the predictable result of providing additional health data to the user.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant’s arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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, Jason Sims can be reached at (571) 272-7540. 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.
/ARI SINGH KANE PADDA/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791