DETAILED ACTION
In view of the appeal brief filed on 04/06/2026, PROSECUTION IS HEREBY REOPENED. The examiner withdraws the finality of the previous Office action and modifies rejections established in the previous Office action as set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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 .
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.
Claim(s) 178, 180, 182-183 and 185-194 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. (US 2015/0377868) (Cooper) in view of Fleischer et al. (US 2014/0202232) (Fleischer) and Atsalakis (US 2019/0120821).
Regarding claim 178, Cooper teaches a method of conditioning a gas sample, the gas sample having a humidity and comprising one or more input analytes, wherein Cooper teaches a breath analysis system for analyzing constituents of a patient's breath and a method comprising providing an analysis cartridge and collecting a breath sample on a filter assembly (par [0086], [0094]). Cooper states that “the analysis cartridge 14 are used by the clinician and patient to capture certain components of the patient's breath.” (Fig. 1, par [0094]).
Cooper teaches a. providing the gas sample to a gas sample receiver, wherein the gas sample receiver comprises one of a removable cartridge or a capsule. Cooper teaches an analysis cartridge 14 having a breath chamber 30 with a breath entry opening, breath exit opening, and breath path P1 therebetween (par [0095]). Cooper further teaches that, after the breath has been collected, “the user removes the analysis cartridge 14 from the handle assembly 12,” thereby teaching that the analysis cartridge is removable (par [0109]).
Cooper teaches wherein the removable cartridge or the capsule comprises one or more frits and wherein the gas sample passes through the one or more of the one or more frits. Cooper teaches that filter assembly 19 of analysis cartridge 14 includes “two filters or frit plates 26 (sometimes referred to together as a frit stack)” (par [0096]). Cooper further teaches that the frit plates are “sufficiently porous so that the breath can pass therethrough” and that, when a patient blows through breath chamber 30, breath passes through the frit plates (par [0097], [0108]).
Cooper teaches wherein the removable cartridge or the capsule comprises one or more conditioning materials … and wherein the gas sample passes through the one or more conditioning materials in a layered configuration. Cooper teaches a substrate space 27 between the first and second frit plates 26, with silica substrate 28 disposed between the frit plates. Cooper expressly teaches forming the assembly by placing the first frit in the opening, dosing silica onto the first frit, and pressing the second frit onto the silica “to create a frit stack” (par [0097]-[0098]). Thus, Cooper teaches a layered arrangement of first frit → silica substrate → second frit, through which the breath sample travels.
Cooper does not explicitly teach that the silica conditioning material comprises a permanganate salt on silica or that the material both adjusts humidity and chemically converts the gas sample.
However, Fleischer teaches a breath-analysis converter containing precisely such a material. Fleischer teaches that its breath converter has grids at both ends with filter elements arranged therebetween and that the converter comprises “silica gel which is partially impregnated with KMnO4” (par [0020]). Fleischer further teaches that the KMnO₄ converts nitrogen monoxide in exhaled air to measurable nitrogen dioxide and that the silica gel simultaneously removes excess breath moisture (par [0020]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to modify the silica substrate disposed between Cooper's frit plates to comprise the KMnO₄-impregnated silica gel taught by Fleischer. One of ordinary skill in the art would have been motivated to make the combination to improve Cooper's breath-analysis cartridge by simultaneously conditioning the humidity of the breath sample and converting a difficult-to-measure breath analyte into a more readily measurable analyte. Fleischer expressly teaches that conversion of NO to NO₂ permits the analyte to be more readily measured and that dehumidification avoids excessive moisture loading of the sensor (par [0002], [0020]).
The resulting modified Cooper cartridge would therefore comprise a layered configuration including a first frit, KMnO₄-on-silica conditioning material, and a second frit, with the breath sample passing through the frits and the conditioning material.
Fleischer teaches b. adjusting the humidity of the gas sample and chemically converting the gas sample using the permanganate salt on the silica. Fleischer expressly teaches that the converter comprises silica gel partially impregnated with KMnO₄, wherein “the main function is conversion, caused by the KMnO4, of nitrogen monoxide NO of the exhaled air into nitrogen dioxide NO2 measurable by the sensor,” while “[t]he second function is to remove excess breath moisture using the silica gel” (par [0020]). Thus, the same KMnO₄-on-silica conditioning material both chemically converts the gas sample and adjusts its humidity.
Cooper in view of Fleischer does not explicitly teach:
c. providing the gas sample to a tube comprising one or more of a perfluorosulfonic acid, a perflurocarboxylic acid, or a humidity exchange material; and
d. adjusting the humidity of the gas sample to conditions equal to or about equal to ambient humidity.
However, Atsalakis teaches these limitations. Atsalakis teaches a breath-analysis device in which the dehumidifying means is a Nafion® tube, wherein “[t]he exhaled breath is dried as it passes through a series of one or more Nafion® tubes … and reaches the humidity of ambient air” (par [0065]). Atsalakis further explains that reducing exhaled breath to ambient humidity is beneficial because humidity differences otherwise adversely affect sensor measurements (par [0019]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to further modify the Cooper/Fleischer breath-analysis system by providing the conditioned breath sample, after the KMnO₄-on-silica converter, through the Nafion® tube taught by Atsalakis before measurement. One of ordinary skill in the art would have been motivated to make the combination to further improve the accuracy of breath analysis by bringing the conditioned breath sample to ambient humidity before measurement, as expressly taught by Atsalakis (par [0019], [0065]).
Fleischer teaches e. detecting or measuring one or more readout analytes, wherein detecting or measuring the one or more readout analytes follows step (a) and step (b). Fleischer teaches delivering the breath through converter 11 and thereafter delivering the converted respiratory air to sensors located in measuring chamber 18 (par [0018]-[0019]). Fleischer specifically teaches that NO in the exhaled breath is converted by KMnO₄ to NO₂, which is thereafter measurable by the sensor (par [0020]). Thus, NO₂ corresponds to the claimed readout analyte and is measured after the gas passes through and is chemically converted by the conditioning material.
Fleischer teaches wherein the detecting or measuring one or more readout analytes is performed by a chemoreceptive sensor or a chemiresistive sensor. Fleischer teaches a sensor system configured to detect a target gas component after conversion by the converter (par [0006]); such a sensor corresponds to a chemoreceptive sensor because it responds to and detects the chemical gas component being measured. Further, Atsalakis expressly teaches that breath-analyte sensors may comprise a metal oxide semiconductor sensor (par [0055]), which likewise corresponds to a chemoreceptive sensor because it senses a chemical species in the gas sample.
Regarding claim 180, Cooper further teaches “wherein one or more frits comprises one or more of … a porous polypropylene.”.
Cooper teaches that the filter assembly includes “two filters or frit plates 26” and that the frit plates are sufficiently porous to permit breath to pass therethrough. Cooper further teaches that the frit plates are formed from packed spherical plastic material and that the spheres may be made from materials including polypropylene (par [0097]).
Specifically, Cooper states that the spherical or roundish shape of the packed material “creates the voids or pores necessary for breath to get through,” and that the spheres may be made from “polyethylene, polypropylene, etc.”
Thus, Cooper teaches a frit comprising porous polypropylene, as recited in claim 180.
Regarding claim 182, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches wherein the cartridge or the capsule comprises one or more humidity stabilizing materials.
Cooper teaches that analysis cartridge 14 includes a frit stack having silica substrate 28 disposed between frit plates 26 (par [0096]-[0098]).
Fleischer teaches using silica gel partially impregnated with KMnO₄ in a breath converter and expressly teaches that “[t]he second function is to remove excess breath moisture using the silica gel” (par [0020]). Thus, the silica gel corresponds to a humidity stabilizing material because it stabilizes/controls the humidity of the breath sample by removing excess moisture.
As discussed with respect to claim 178, it would have been obvious to modify Cooper's silica-containing cartridge to use the KMnO₄-impregnated silica gel of Fleischer to provide simultaneous chemical conversion and humidity conditioning of the breath sample.
Regarding claim 183, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches wherein the adjusting the humidity of the gas sample in step (b) is a result of the gas sample passing through the one or more conditioning materials.
Fleischer teaches that respiratory air is delivered through converter 11 before being provided to the downstream sensors. Fleischer further teaches that the converter comprises silica gel partially impregnated with KMnO₄, wherein the KMnO₄ converts NO to NO₂ and the silica gel “remove[s] excess breath moisture.”
Thus, the humidity adjustment results from the breath sample passing through the KMnO₄-on-silica conditioning material, as recited in claim 183.
Regarding claim 185, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches “wherein step (a) and step (b) occur substantially simultaneously.”
Fleischer teaches passing the breath sample through converter 11 containing silica gel partially impregnated with KMnO₄, wherein the same material performs two functions: the KMnO₄ converts NO in the exhaled air to NO₂, while the silica gel removes excess breath moisture (par [0020]).
Thus, as the breath passes through the KMnO₄-on-silica conditioning material, the gas is both chemically converted and humidity-conditioned during the same passage through the converter. Therefore, providing the gas sample through the conditioning material and performing the humidity/chemical conditioning occur substantially simultaneously, as recited in claim 185.
Regarding claim 186, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches “wherein the adjusting the humidity of the gas sample in step (b) decreases the humidity of the gas sample.”
Fleischer expressly teaches that the silica gel of the KMnO₄-on-silica converter has the function “to remove excess breath moisture.” Thus, Fleischer teaches decreasing the humidity of the breath sample during step (b) (par [0020]).
Regarding claim 187, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches “wherein the gas sample passes through the tube in step (c).”
Atsalakis expressly teaches a dehumidifying means comprising a Nafion® tube and states that “[t]he exhaled breath is dried as it passes through a series of one or more Nafion® tubes” along the primary and/or secondary pathways (par [0065]).
Thus, Atsalakis teaches the gas sample passing through the humidity-exchange tube recited in step (c).
Regarding claim 188, Cooper in view of Fleischer and Atsalakis teaches claim 187 as set forth above. The combination further teaches “wherein the adjusting the humidity of the gas sample to conditions equal to or about equal to ambient humidity in step (d) is a result of passing through the tube.”
Atsalakis expressly teaches that the Nafion® tube dries the exhaled human breath and that the breath, as it passes through the one or more Nafion® tubes, “reaches the humidity of ambient air” (par [0065]).
Thus, the adjustment of the breath sample to ambient humidity results from passage through the Nafion® tube, as recited in claim 188.
Regarding claim 189, Cooper in view of Fleischer and Atsalakis teaches claim 188 as set forth above. The combination further teaches “wherein the adjusting the humidity of the gas sample comprises adjusting the humidity so that the difference between the relative humidity of the sample and the relative humidity of ambient conditions is less than 20%RH.”
Atsalakis teaches that the exhaled breath passing through the Nafion® tube “reaches the humidity of ambient air.” Atsalakis further explains that the purpose is to reduce exhaled-breath humidity to ambient levels so that inhaled and exhaled breath have the same humidity for accurate measurement.
Because a gas sample having the humidity of ambient air has a relative-humidity difference of approximately 0% RH from ambient conditions, Atsalakis teaches a difference that is necessarily less than 20% RH, as recited in claim 189.
Regarding claim 190, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches “wherein the one or more input analytes comprises a first input analyte, and wherein the one or more readout analytes comprises a first readout analyte,” and “before step (e), altering the first input analyte chemically, thereby providing the first readout analyte.”
Fleischer teaches that the input analyte is nitrogen monoxide (NO) in exhaled breath and that the KMnO₄ of the converter chemically converts the NO into nitrogen dioxide (NO₂), which is thereafter measurable by the sensor. Thus, NO corresponds to the first input analyte and NO₂ corresponds to the first readout analyte, wherein the first input analyte is chemically altered before detection to provide the first readout analyte (par [0020]).
Regarding claim 191, Cooper in view of Fleischer and Atsalakis teaches claim 190 as set forth above. The combination further teaches “wherein step (f) comprises one or more of oxidizing the first input analyte.”
Fleischer expressly teaches that the KMnO₄ converts nitrogen monoxide (NO) in the exhaled air into nitrogen dioxide (NO₂). Fleischer further characterizes this conversion as oxidation, explaining that in the asthma application “NO is oxidized to NO₂” (par [0002], [0020]).
Thus, Fleischer teaches oxidizing the first input analyte, as recited in claim 191.
Regarding claim 192, Cooper in view of Fleischer and Atsalakis teaches claim 190 as set forth above. The combination further teaches “wherein step (f) precedes or follows any of steps (a), (b), (c), or (d).”
As discussed above, Fleischer teaches chemically converting NO to NO₂ in the KMnO₄-on-silica converter. In the combined method, this chemical alteration occurs before the conditioned gas sample is subsequently provided to the Nafion® tube of Atsalakis and adjusted to ambient humidity. Atsalakis teaches that the exhaled breath passes through the Nafion® tube and reaches the humidity of ambient air.
Thus, the chemical alteration of step (f) precedes at least steps (c) and (d), as recited in claim 192.
Regarding claim 193, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches “wherein the gas sample is a breath sample from a human or an animal.”
Cooper expressly teaches a breath-analysis system for analyzing constituents in a patient's breath and teaches that a user blows through the mouthpiece and breath chamber to provide a predetermined volume of exhaled breath (par [0094], [0109]).
Fleischer likewise expressly teaches nitrogen oxide measurement in human breath (par [0017]).
Regarding claim 194, Cooper in view of Fleischer and Atsalakis teaches claim 178 as set forth above. The combination further teaches “wherein the gas sample is provided by a pump, diffusion, or a vacuum.”
Atsalakis expressly teaches that its breath-analysis device “may comprise a pump to draw a sample of exhaled breath along the secondary pathway,” wherein the pump provides a constant flow rate through the pathway and across the sensors (par [0020]). Atsalakis further teaches a pump “for drawing exhaled breath through the secondary pathway” and explains that the pump draws a sample of exhaled breath through the pathway (par [0072]).
Thus, Atsalakis teaches providing the gas sample by a pump, as recited in claim 194.
Response to Arguments
Applicant’s arguments with respect to claim(s) 178 have been considered but are moot in view of new ground of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797
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