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 .
Response to Amendment
The amendment filed on March 16, 2026 was considered by the examiner. Claims 1 and 3-24 are pending in the application.
Claim Objections
Claim 22 is objected to because of the following informalities:
in claim 22, line 4: “substrate” should be inserted before “material”.
Appropriate correction is required.
Drawings
The drawings are objected to because Figs. 1, 10, 13, 16-17, and 19-20 contain photographs; however, photographs are not the only practicable medium to show the depicted elements, see 37 C.F.R. 1.84(b)(1).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 7, 12-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Eichler (German Patent Document DE 102010014008A1 – citing to translation from Espacenet.com, cited in prior action), hereinafter Eichler, and in view of Ghoreishizadeh et al. (“An Integrated Platform for Differential Electrochemical and ISFET Sensing”, 2016 IEEE International Symposium on Circuits and Systems (ISCAS), IEEE, 22 May 2016, 2875-2878 – cited by Applicant), hereinafter Ghoreishizadeh.
Regarding Claim 1, Eichler teaches a device for isolating analytes contained in the breath condensation of a flow channel (see abstract and Figs. 1-2). Eichler teaches an electrochemical sensor for monitoring a presence of an analyte in a breath of a subject (see abstract and ¶[0055]-[0056] the sensor 8; Figs. 1-2), comprising:
a support comprising a porous substrate material (¶[0014]-[0021], ¶[0025]-[0026], and ¶[0055]-[0056] the support structure 8.3, the support structure may comprise a hydrogel), wherein the support serves as a supporting material mechanically stabilizing the electrochemical sensor (see Fig. 2, the support structure 8.3 is the main supporting structure of the sensor 8, so it would mechanically stabilize the sensor 8);
at least two electrodes (¶[0056] the sensor 8 comprises at least the electrodes 8.1/8.2; Fig. 2), which are applied directly onto one side of the porous substrate and/or integrated into the porous substrate material (¶[0018]-[0019] and ¶[0034] the electrodes 8.1/8.2 and the support structure 8.3 are formed of a composite of the electrodes and the at least one support structure; Fig. 2);
wherein a salt is immobilized in the support (¶[0035] the support structure can be functionalized for analysis, such as via a buffer salt),
such that upon exhaling onto the electrochemical sensor a differential measurement at said at least two electrodes (¶[0024] the analysis of the analytes may be amperometrically or potentiometrically, which would be a differential measurement between current/voltage) allows for monitoring the presence of the analyte in the breath of said subject (¶[0009]-[0010], ¶[0024], ¶[0028], and ¶[0035]-[0036] the quantitative and/or qualitative detection of the analytes, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal); and
wherein the electrochemical sensor is capable of a continuous monitoring of the analyte during a single or multiple exhaling and inhaling cycles (¶[0029], ¶[0056], and ¶[0061] the sensor 8 is at least temporarily fluid permeable so that fluid may flow therethrough, the additional flow paths (i.e., the path 4, the valve 5, etc.) are not part of the claimed sensor, the sensor 8 as described would be capable to have fluid through therethrough for a single exhale and inhale cycle, no structure is present in the sensor 8 itself to limit such fluid flow, ¶[0027]-[0030] the sensor 8 is detailed to work over time, but is only designed to have breath flow therethrough (via the valves) when measurements are desired, but the sensor 8 itself could still work for at least a single exhale/inhale cycle, there is no indication how many cycles would cause the sensor 8 to be so swollen so as to reduce permeability completely),
wherein the support is continuously air-permeable such that the breath may at least partially flow through an entirety of the electrochemical sensor and a breathing through the electrochemical sensor itself is possible (¶[0014]-[0021] and ¶[0029] the support structure 8.3 and the electrodes 8.1/8.2 are fluid permeable so exhalation can flow through, the sensor provides continuous fluid permeability while air flowing through; see Figs. 1-2, the sensor 8 is air permeable within the fluid flow channel 7.1), and
wherein the porous substrate material of the support is hygroscopic such that a liquid portion of the breath is captured to allow for dissolution of the salt immobilized in the support (¶[0020] the water storing layer for storing breath condensate with the support structure 8.3, such that the support structure 8.3 is hygroscopic, ¶[0025]-[0026] the water storing may be implemented via hydrogels, which are hygroscopic and are porous, ¶[0035] the support structure can be functionalized for analysis, such as via a buffer salt; Fig. 2).
Eichler teaches that at least two electrodes are utilized for an amperometric or potentiometric analyte detection, but not specifically the electrode structure including that the at least two working electrodes comprise an analyte-sensitive sensing electrode and an analyte-insensitive blank electrode, as well as at least one counter electrode and/or reference electrode.
Ghoreishizadeh teaches a four electrode sensor array for electrochemical sensing (see abstract), in which the standard biomolecule measurement electrode array (i.e., the analyte sensitive working electrode, reference electrode, and counter electrode) is modified with an additional working electrode (the analyte insensitive working electrode) to duplicate the background current without the detected analyte, so that the background current would be removed and only the current related to the concentration of the analyte remains (see pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the four electrode modality of Ghoreishizadeh to measure and remove background current (noise) as the electrode modality for the amperometric or potentiometric analyte detection of Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) removing the background current (noise) from the analyte measurement signal will make the sensor less susceptible to noise and the analyte concentration determined more accurate.
Regarding Claim 3, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. Eichler further teaches that the at least two working electrodes and the at least one counter electrode and/or reference electrode are integrated into the support (¶[0018]-[0019] and ¶[0034] the electrodes 8.1/8.2 and the support structure 8.3 are formed of a composite of the electrodes and the at least one support structure; Fig. 2).
Regarding Claim 4, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. Eichler further teaches the analyte is selected from the group consisting of hydrogen peroxide, glucose, lactate, proteins, pathogens, genetic materials, hormones, hydrocarbons, aldehydes, sulfides, ammonia, ethanol, acetone, isoprene, ethane, carbonyl sulfides, carbon dioxides, carbon monoxide, nitrogen monoxide and volatile organic compounds (VOCs) (¶[0012] the analyte for the lung, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal). These would at least correspond to proteins, pathogens, genetic materials, and hormones.
Regarding Claim 5, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches the sensing electrode is supplemented with or coated with the analyte-sensitive material or the porous substrate in vicinity to the sensing electrode comprises the analyte-sensitive material, wherein the analyte-sensitive material is a catalyst for an electrochemical reaction (see Eichler ¶[0024] the analysis of the analytes may be amperometrically or potentiometrically, which would be a differential measurement between current/voltage, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal; see Ghoreishizadeh pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the enzyme coated, analyte sensitive working electrode).
Regarding Claim 7, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. Eichler further teaches the salt immobilized in the support is hydrophilic to an extent that the humidity of human exhaled breath is sufficient to form a conductive electrolyte and to keep the porous substrate material wet (¶[0020] the water storing layer for storing breath condensate with the support structure 8.3, such that the support structure 8.3 is hygroscopic, ¶[0025]-[0026] the water storing may be implemented via hydrogels, which are hydrophilic, ¶[0035] the support structure can be functionalized for analysis, such as via a buffer salt).
Regarding Claim 12, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. Eichler further teaches (¶[0008] and ¶[0047] the sensor may be utilized with a pneumotachograph device, ¶[0002] which may include a filter extension; Fig. 1).
Regarding Claim 13, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches a method for an on-site or clinical monitoring of the presence of the analyte in the breath of the subject (see abstract and Figs. 1-2) comprising:
providing the electrochemical sensor according to claim 1 (see above claim 1 mapping of Eichler in view of Ghoreishizadeh),
positioning said electrochemical sensor in a respiratory flow of said subject (see Eichler abstract, ¶[0009], and Figs. 1-2, the sensor 8 positioned within the expiratory flow channel 7), and
employing a differential measurement by detecting a differential electrochemical signal at the at least two working electrodes in order to monitor the presence of the analyte (see Eichler ¶[0009]-[0010], ¶[0024], ¶[0028], and ¶[0035]-[0036] the quantitative and/or qualitative detection of the analytes, ¶[0024] the analysis of the analytes may be amperometrically or potentiometrically, which would be a differential measurement between current/voltage, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal; see Ghoreishizadeh abstract and pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the standard biomolecule measurement electrode array (working electrode, reference electrode, and counter electrode) is modified with an additional working electrode to duplicate the background current without the detected analyte, so that the background current would be removed and only the current related to the concentration of the analyte remains).
Regarding Claim 14, Eichler in view of Ghoreishizadeh teaches the method of claim 13 as stated above. Eichler further teaches the presence of the analyte is monitored continuously during a single or multiple exhaling and inhaling cycles (¶[0054] the device is utilized in accordance with a respiratory cycle, the sensor would necessarily need at least one cycle in order to receive exhalation and make a measurement) and/or wherein different segments of the differential electrochemical signal are used in order to quantify the presence of the analyte in different regions of a lung and/or airways (¶[0012] the analyte is monitored from the lung).
Regarding Claim 15, Eichler in view of Ghoreishizadeh teaches the method of claim 13 as stated above. The modified Eichler further teaches a signal detected at the analyte-insensitive blank electrode is used for a background correction of non-specific interferences of a signal detected at said analyte-sensitive sensing electrode (see Ghoreishizadeh abstract and pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the standard biomolecule measurement electrode array (working electrode, reference electrode, and counter electrode) is modified with an additional working electrode to duplicate the background current without the detected analyte, so that the background current would be removed and only the current related to the concentration of the analyte remains).
Regarding Claim 16, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. Eichler further teaches the support is selected from the group consisting of a cellulose based material, a ceramic, a hydrogel and hydrophilic polymer (¶[0020] the water storing layer for storing breath condensate with the support structure 8.3, such that the support structure 8.3 is hygroscopic, ¶[0025]-[0026] the water storing may be implemented via hydrogels, ¶[0037] the support structure may comprise filter materials, plastics, ceramics, etc.).
Regarding Claim 17, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches the analyte-sensitive material is selected from the group consisting of metal, metal oxide or semiconducting micro- or nanoparticles, enzymes, selective membranes and conductive polymers (see Eichler ¶[0024] the analysis of the analytes may be amperometrically or potentiometrically, which would be a differential measurement between current/voltage, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal; see Ghoreishizadeh pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the enzyme coated, analyte sensitive working electrode).
Regarding Claim 19, Eichler in view of Ghoreishizadeh teaches the method of claim 15 as stated above. The modified Eichler further teaches the background correction method is able to compensate current variations caused by a respiratory movement and environmental conditions (see Ghoreishizadeh abstract and pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the standard biomolecule measurement electrode array (working electrode, reference electrode, and counter electrode) is modified with an additional working electrode to duplicate the background current without the detected analyte, so that the background current would be removed and only the current related to the concentration of the analyte remains). Here, as the background electric current is removed, it would include the background current caused by respiratory movement and/or environmental conditions, and therefore would be included in the background current removed so that only the analyte current signal remains.
Regarding Claim 20, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches the sensing electrode comprises an analyte-sensitive receptor, which causes an electrically measurable signal change in dependence of the analyte concentration (see Eichler ¶[0024] the analysis of the analytes may be amperometrically or potentiometrically, which would be a differential measurement between current/voltage, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal; see Ghoreishizadeh pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the enzyme coated, analyte sensitive working electrode).
Regarding Claim 21, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches the salt immobilized in the support is a buffer salt mixture (¶[0035] the support structure can be functionalized for analysis, such as via a buffer salt) or is selected from the group consisting of potassium chloride, sodium chloride, sodium acetate, ammonium acetate, and monosodium phosphate.
Claims 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Eichler in view of Ghoreishizadeh as applied to claim 1 above, and in view of Wiedemair et al. (US Patent Application 2014/0021065 – corresponding to WO 2012/067511, cited by Applicant), hereinafter Wiedemair.
Regarding Claim 6, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches the sensing electrode comprises a metal or metal micro/nanoparticles or a mediator, as an analyte-sensitive material (see Ghoreishizadeh pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the enzyme coated, analyte sensitive working electrode, with nano-structures).
Eichler contemplates the sensing of various analytes (see ¶[0012]); however, the modified Eichler does not specifically teach that the analyte is hydrogen peroxide.
Wiedemair teaches a microfabricated device for the measurement of hydrogen peroxide, as well as other biomarkers, in a gaseous mixture (see abstract), specifically from the breath of a user (see ¶[0003]-[0011]; Figs. 1-3). Wiedemair teaches an electrochemical sensor for monitoring a presence of an analyte in a breath of a subject (see abstract and ¶[0003]-[0011], the hydrogen peroxide is the analyte), comprising:
a support comprising a porous substrate material (¶[0013]-[0016] and ¶[0051] the membrane 15 with the hygroscopic additive, such as salt, the membrane may be microporous; Figs. 1-3),
at least two working electrodes (¶[0012], ¶[0024]-[0025], and ¶[0051] the working electrode (WE), in which there may be more than one WE, which would be at least two WE; Figs. 1-3),
as well as at least one counter electrode and/or reference electrode (¶[0025] and ¶[0051] the counter electrode (CE) and the reference electrode (RE); Figs. 1-3),
which are applied onto and/or integrated into said porous substrate material (¶[0051] the membrane 15 next to the micro-fabricated chip 13 which contains the electrodes; Figs. 1-3),
characterized in that the at least two working electrodes comprise an analyte-sensitive sensing electrode (¶[0012], ¶[0024]-[0025], and ¶[0051] the WE is implemented such that the hydrogen peroxide gathers on the electrode surface due to coatings, enzymes, metals, nano-/micro-particles, so that a concentration dependent current signal is generated) and
wherein a salt is immobilized in said support (¶[0013]-[0016] and ¶[0051] the membrane 14/15 with the hygroscopic additive, such as salt; Figs. 1-3),
such that upon exhaling onto the electrochemical sensor a differential electrochemical measurement at said at least two working electrodes allows for monitoring the presence of the analyte in the breath of said subject (abstract and ¶[0003]-[0011] the monitoring for the presence of hydrogen peroxide in the breath of a subject, ¶[0012], ¶[0024]-[0025], and ¶[0051] there may be two WE that utilize a different measurement technique, such as redox cycling); and
wherein the support is air-permeable such that the breath may at least partially flow through the electrochemical sensor and hygroscopic such that a liquid portion of the breath is captured to allow for dissolution of the salt immobilized in said support (¶[0013]-[0016] and ¶[0051] the membrane 15 with the hygroscopic additive, such as salt, the membrane may be microporous, and may also be configured for attracting and keeping the hydrogen peroxide, here, as the breath would flow through the membrane 15, this would be considered that air is at least partially flowing through the electrochemical sensor; Figs. 1-3).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the analyte sensing of hydrogen peroxide as taught in Wiedemair with the electrodes and nanostructure of the modified Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Eichler contemplates sensing various analytes and Wiedemair teaches one such analyte; and/or (3) monitoring for hydrogen peroxide in the lungs tells of lung health and other health conditions (i.e., aspiration) useful for a medical professional in treating the patient.
Regarding Claim 9, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler is silent regarding the specific types of electrodes utilized.
Wiedemair teaches a microfabricated device for the measurement of hydrogen peroxide, as well as other biomarkers, in a gaseous mixture (see abstract), specifically from the breath of a user (see ¶[0003]-[0011]; Figs. 1-3). Wiedemair teaches an electrochemical sensor for monitoring a presence of an analyte in a breath of a subject (see abstract and ¶[0003]-[0011], the hydrogen peroxide is the analyte), comprising:
a support comprising a porous substrate material (¶[0013]-[0016] and ¶[0051] the membrane 15 with the hygroscopic additive, such as salt, the membrane may be microporous; Figs. 1-3),
at least two working electrodes (¶[0012], ¶[0024]-[0025], and ¶[0051] the working electrode (WE), in which there may be more than one WE, which would be at least two WE, ¶[0012], ¶[0024]-[0025], ¶[0051], and ¶[0058] the WE may comprise a platinum electrode; Figs. 1-3),
as well as at least one counter electrode and/or reference electrode (¶[0025] and ¶[0051] the counter electrode (CE) and the reference electrode (RE), ¶[0025] the Ag/AgCl reference electrode; Figs. 1-3),
which are applied onto and/or integrated into said porous substrate material (¶[0051] the membrane 15 next to the micro-fabricated chip 13 which contains the electrodes; Figs. 1-3),
characterized in that the at least two working electrodes comprise an analyte-sensitive sensing electrode (¶[0012], ¶[0024]-[0025], and ¶[0051] the WE is implemented such that the hydrogen peroxide gathers on the electrode surface due to coatings, enzymes, metals, nano-/micro-particles, so that a concentration dependent current signal is generated).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the platinum working electrode as taught in Wiedemair as the working electrodes of the modified Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Eichler requires working electrodes and Wiedemair teaches one such working electrode; and/or (3) the platinum electrode would provide efficient detection of certain analytes, such as hydrogen peroxide (see Wiedemair ¶[0024]).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the Ag/AgCl reference electrode as taught in Wiedemair as the reference electrodes of the modified Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) Eichler requires a reference electrode and Wiedemair teaches one such reference electrode; and/or (3) Ag/AgCl reference electrodes provide stable potential and have long-term stability, at a low cost.
Claims 8, 10-11, 18, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Eichler in view of Ghoreishizadeh as applied to claim 1 above, and in view of Güder et al. (US Patent Application Publication 2017/0356899 – cited in prior action), hereinafter Güder.
Regarding Claim 8, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches the electrochemical sensor comprises the at least two working electrodes (see Ghoreishizadeh abstract and pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the standard biomolecule measurement electrode array (working electrode, reference electrode, and counter electrode) is modified with an additional working electrode to duplicate the background current without the detected analyte, so that the background current would be removed and only the current related to the concentration of the analyte remains).
The modified Eichler does not specifically teach at least one additional working electrode targeted at the detection of the one or more analytes.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, in which the solubility of the salt may be increased, in which the salt may be potassium chloride (see ¶[0090]-[0091]). Güder further teaches that multiple sensors (i.e., multiple electrode pairs) may be utilized to detect the same gas, such as at different locations, so as to achieve spatial resolution (see ¶[0040] and ¶[0098]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize additional sensing (working) electrodes in the modified Eichler as taught by the multiple sensors (electrodes pairs) of Güder because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the additional working electrodes would be capable to provide spatial resolution of the gas composition which would provide additional useful information to the wearer and/or a medical professional.
Regarding Claim 10, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler further teaches that a structured pattern of a hydrophobic material is applied onto the porous substrate material, wherein the structured pattern may include different compartments inside an electrochemical cell (see Eichler ¶[0037]-[0038] the three dimensional support structure, ¶[0034] multiple support structures may be utilized between the electrodes) in which one working electrode of the at least two working electrodes is sensitized for the analyte by coating and/or functionalization (see Eichler ¶[0024] the analysis of the analytes may be amperometrically or potentiometrically, which would be a differential measurement between current/voltage, ¶[0036] the functional groups are used biologically for determining the analyte enzymatically or immunologically, to generate an electrochemically measurable signal; see Ghoreishizadeh pg. 2875 § II. Differential Sensing Platform, A. Differential sensor array, the enzyme coated, analyte sensitive working electrode).
The modified Eichler does not specifically teach that the electrochemical cell includes hydrophobic material compartments.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, in which the solubility of the salt may be increased, in which the salt may be potassium chloride (see ¶[0090]-[0091]). Güder further teaches that the sensor (electrode pair) may be encapsulated or between layers of a hydrophobic material (see ¶[0100]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the hydrophobic encapsulation of Güder with the electrodes of the modified Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Eichler teaches the electrodes may be within support structures for fixed positioning and Güder teaches on such fixed call modality.
Regarding Claim 11, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. Eichler generally teaches that the electrochemical sensor may be utilized with a pneumotachograph device, including a processor (see ¶[0049]), but the modified Eichler does not specifically teach that the electrochemical sensor additionally comprises a processing unit configured for the reading of electrically measurable signals of said at least two working electrodes and processing of said signals to monitor the presence of the analyte and/or the electrochemical sensor additionally comprises a communication interface for receiving and/or transmitting data to a mobile device.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, in which the solubility of the salt may be increased, in which the salt may be potassium chloride (see ¶[0090]-[0091]). Güder further teaches the use of a microcontroller for analyzing the data from the sensors and transmitting the data using a wireless communications system to an external device, such as a smartphone (see ¶[0036], ¶[0046], ¶[0051], ¶[0073], and ¶[0129]; Fig. 14A).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the microcontroller and/or wireless communication system of Güder with the modified device of Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the modified Eichler teaches to monitor signals and Güder teaches a suitable device (microcontroller) to manipulate those signals; and/or (3) the usage of a communication interface for receiving and/or transmitting data to a mobile device allows for easy readout of the data/signals to a user and/or medical professional.
Regarding Claim 18, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler is silent regarding that the salt is potassium chloride.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, in which the solubility of the salt may be increased, in which the salt may be potassium chloride (see ¶[0090]-[0091]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the potassium chloride salt of Güder as the salt of the modified device of Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Eichler requires a salt and Güder teaches one such salt.
Regarding Claim 22, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler is silent regarding that the salt is immobilized in the support by applying a solution containing the salt on the porous material.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, such as via dipping the substrate in an aqueous salt solution (see ¶[0090]-[0091]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the aqueous salt solution modality of Güder as the salt application modality of the modified device of Eichler because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the modified Eichler requires a salt application modality and Güder teaches one such modality.
Regarding Claim 23, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler is silent regarding that the porous substrate material is cellulose based.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, in which the solubility of the salt may be increased, in which the salt may be potassium chloride (see ¶[0090]-[0091]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the hygroscopic porous substrate, such as cellulose paper, of Güder with the modified device of Eichler because (1) it is the simple substitution of one know element for another with predictable results; and/or (2) the modified Eichler requires a substrate material and Güder teaches on such substrate material; and/or (3) the cellulose paper is inherently porous, which allows gases to easily penetrate and interact with the bulk of the material of the sensor, cellulose has a high surface area which increases sensitivity, cellulose paper is chemically inert to most gases, and cellulose fibers themselves are not electronically conductive (see Güder ¶[0083]).
Regarding Claim 24, Eichler in view of Ghoreishizadeh teaches the device of claim 1 as stated above. The modified Eichler is silent regarding that the porous substrate material is paper.
Güder teaches a method/system for detecting a gas or vapor utilizing a sensor comprising an electrode pair (see abstract), in which the electrodes are built on top of or into hygroscopic porous substrates, such as cellulose paper (see ¶[0012] and ¶[0082]-[0084]), in which salt additives may be incorporated into the substrate, in which the solubility of the salt may be increased, in which the salt may be potassium chloride (see ¶[0090]-[0091]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the hygroscopic porous substrate, such as cellulose paper, of Güder with the modified device of Eichler because (1) it is the simple substitution of one know element for another with predictable results; and/or (2) the modified Eichler requires a substrate material and Güder teaches on such substrate material; and/or (3) the cellulose paper is inherently porous, which allows gases to easily penetrate and interact with the bulk of the material of the sensor, cellulose has a high surface area which increases sensitivity, cellulose paper is chemically inert to most gases, and cellulose fibers themselves are not electronically conductive (see Güder ¶[0083]).
Response to Arguments
Applicant’s arguments, drawings
Applicant’s arguments, see pg. 11, filed March 16, 2026, with respect to the objections of Figs. 1, 10, 13, 16-17, and 19-20 under 37 C.F.R. 1.84(b)(1) have been fully considered and are NOT persuasive. It appears as if there are supposed to be amended drawings; however, no amending drawings were received in the reply filed on March 16, 2026.
Applicant’s arguments, claim objections
Applicant’s arguments, see pg. 11, filed March 16, 2026, with respect to the objection of claim 3 have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 12, filed March 16, 2026, with respect to the rejection of claim 21 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 12-, filed March 16, 2026, with respect to the rejections of claims 1 and 3-21 under 35 U.S.C. § 103 have been fully considered and are NOT persuasive. The Applicant first argues that, with respect to Feature A, Eichler does not disclose the electrodes disposed onto one side of the porous substrate. The examiner respectfully disagrees. Claim 1 as amended requires the electrodes “which are applied directly onto one side of the porous substrate and/or integrated into the porous substrate material” (emphasis added). As the limitation has an “and/or”, the element of “one side of the porous substrate” is not required to be taught, as Eichler teaches “integrated into the porous substrate material (¶[0018]-[0019] and ¶[0034] the electrodes 8.1/8.2 and the support structure 8.3 are formed of a composite of the electrodes and the at least one support structure; Fig. 2). Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, with respect to Feature B, the porous substrate material is itself hygroscopic, which is not taught by Eichler. The examiner respectfully disagrees. The claim requires “a support comprising a porous substrate material”. As Eichler teaches that the support (i.e., the support structure 8.3) may comprise a porous substrate material (i.e., the hydrogel, see ¶[0025]-[0026]), Eichler teaches the element as presently claimed. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, with respect to Feature C, the support structure 8.3 is temporarily fluid-permeable, and not capable of continuous monitoring. The examiner respectfully disagrees. The claim does not require continuous monitoring; rather, the claim requires that the sensor (i.e., the sensor 8) “is capable of a continuous monitoring of the analyte during a single or multiple exhaling and inhaling cycles” (emphasis added). As described above, the sensor 8 is capable of at least a continuous single exhaling and inhaling cycle (¶[0029], ¶[0056], and ¶[0061] the sensor 8 is at least temporarily fluid permeable so that fluid may flow therethrough, the additional flow paths (i.e., the path 4, the valve 5, etc.) are not part of the claimed sensor, the sensor 8 as described would be capable to have fluid through therethrough for a single exhale and inhale cycle, no structure is present in the sensor 8 itself to limit such fluid flow, ¶[0027]-[0030] the sensor 8 is detailed to work over time, but is only designed to have breath flow therethrough (via the valves) when measurements are desired, but the sensor 8 itself could still work for at least a single exhale/inhale cycle, there is no indication how many cycles would cause the sensor 8 to be so swollen so as to reduce permeability completely). The Applicant also argues the usage of the valve 5 to direct exhaled air to the sensor 8. The claim only requires the sensor (i.e., the sensor 8) is capable of continuous analyte monitoring. The valve 5 is not needed for this claim element. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, with respect to Feature D, Eichler teaches absolute measurement methods, and does not teach the difference between two signals as required by the claim. The examiner respectfully disagrees. For example, potentiometric analyte detection involves measuring the potential difference between electrodes (see for example “Potentiometry”, ScienceDirect, accessed on 05/27/2026, accessed at https://www.sciencedirect.com/topics/medicine-and-dentistry/potentiometry). Such a measurement would be considered a differential measurement as currently recited in the present claim. Any additional details, such as recited in the specification, are not presently recited in the claim. Furthermore, the at least two working electrodes is taught by the combination of Eichler in view of Ghoreishizadeh. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, further with respect to Feature D, Eichler in view of Ghoreishizadeh does not teach the claim elements and a PHOSITA would not be motivated to combine Eichler with Ghoreishizadeh. The examiner respectfully disagrees. As explained above, as presently recited, Eichler teaches a differential measurement. Furthermore, the examiner maintains that such a combination would have been obvious because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) removing the background current (noise) from the analyte measurement signal will make the sensor less susceptible to noise and the analyte concentration determined more accurate. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, with respect to Features A-D, the additional combinations in view of Wiedemair and Güder in the dependent claims do not teach the Features A-D. The examiner respectfully disagrees. As claim 1, including Features A-D, is taught by Eichler in view of Ghoreishizadeh, the additional references of Wiedemair and Güder are not necessary to teach the Features of A-D. Therefore, Applicant’s arguments are not persuasive.
Next, Applicant argues that, the references do not teach the elements as recited in claims 22-24. The new rejections above of Eichler in view of Ghoreishizadeh and Güder to claims 22-24 were necessitated by Applicant’s amendment filed on March 16, 2026; therefore, Applicant’s arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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