DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. According to the Amendment, filed 22 February 2026, the status of the claims is as follows:
Claims 1, 2, 4-9, and 12-18 are currently amended;
Claim 11 is as originally filed;
Claim 10 is previously presented; and
Claim 3 is cancelled.
Response to Arguments
3. In the prior Office Action, p. 16, mailed 21 October 2025, claims 4 and 5 were indicated as allowable if rewritten in independent form including all of the limitations of the base claim. Applicant amended claim 1 to include the allowable subject matter of claims 4 and 5, and intervening claim 3. Thus, the rejection of claims 1-3, 6-10, 12, and 16-18 under 35 U.S.C. 103 as being unpatentable over Toshiyuki, Japanese Patent No. 2012-202874 A, in view of Killard et al., U.S. Patent Application Publication No. 2015/0260706 A1, and further in view of Chang et al., U.S. Patent Application Publication No. 2007/0048181 A1, is withdrawn. However, upon further consideration, a new ground(s) of rejection is discussed below.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. 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.
7. Claims 1, 2, 4-10, 12, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Toshiyuki, Japanese Patent No. 2012-202874 A (“Toshiyuki”), in view of Killard et al., U.S. Patent Application Publication No. 2015/0260706 A1 (“Killard”), and further in view of Chang et al., U.S. Patent Application Publication No. 2007/0048181 A1 (“Chang”), and further in view of LeBoeuf et al., U.S. Patent Application Publication No. 2008/0220535 A1 (“LeBoeuf”).
As to Claim 1, Toshiyuki teaches the following:
A breath analyzer (“breath component measuring apparatus”) 10 (see “The present invention relates to an expiratory component measuring apparatus and an expiratory component measuring method, and more particularly to an expiratory component measuring apparatus and an expiratory component measuring method for detecting the concentration of ammonia contained in human exhaled breath.” in para. [0001]; and see “FIG. 1 is a diagram schematically showing a configuration of an exhalation component measuring apparatus 10 according to the present embodiment.” in para. [0024]; and see figs. 1 and 2), comprising:
an input (“elongated cylindrical exhalation introduction tube”) 26 that receives a breath sample (see “As shown in FIG. 2, the detection unit 20 includes an elongated cylindrical exhalation introduction tube 26 in which a mouthpiece 26 a for injecting exhalation by a subject is formed.” in para. [0025]);
a first sensor (“ammonia sensor”) 22 that contacts the breath sample (see “The ammonia sensor 22 is a sensor that detects ammonia gas contained in the gas flowing in the exhalation introduction pipe 26.” in para. [0026]), …;
a second sensor (“carbon dioxide sensor”) 24 that contacts the breath sample (see “The oxygen sensor 24 is a sensor that detects oxygen in the gas flowing in the exhalation-introducing pipe 26.” in para. [0027]; and see “However, instead of the oxygen sensor 24, a carbon dioxide sensor that detects the concentration of carbon dioxide is used. The concentration may be detected to determine the presence or absence of H. pylori in the same manner as described above. Hereinafter, a specific example in which the determination is made by detecting the concentration of carbon dioxide instead of the concentration of oxygen will be described.” in para. [0054]), …;
a processor (“CPU (Central Processing Unit)”, not labeled) (see “For example, a CPU (Central Processing Unit) and a ROM (Read Only Memory) And a computer having a RAM (Random Access Memory). That is, for example, the ROM is used as a storage medium storing a program for executing the ammonia concentration calculation process and the determination process executed by the calculation determination unit 40, and the CPU stores the program stored in the ROM as a work piece.” in para. [0031]); and
an electrical circuit (“calculation determination unit”) 40, wherein the electrical circuit 40 operably connects the first 22 and second 24 sensors to the processor (see “The ammonia sensor 22 and the oxygen sensor 24 of the detection unit 20 are connected to the calculation determination unit 40.” in para. [0029]), wherein the processor detects resistivity in the electrical circuit 40 and uses the resistivity to calculate a total concentration of ammonia and a total concentration of 12CO2 and 13CO2 in the breath sample (see “Similarly to the first embodiment, the concentration [Am] pre of ammonia and the concentration [CO2] pre of carbon dioxide are detected and acquired from the breath of the subject before drinking urea and sodium bicarbonate. Then, after the subject was swallowed by urea and then sodium bicarbonate was swallowed by the subject, the concentration of ammonia [Am] post and the concentration of carbon dioxide [CO2] post were detected from the subject's breath.” in para. [0057]).
Toshiyuki does not teach the following:
… wherein the first sensor comprises a first conductive polymer and a conductive material, wherein the first conductive polymer contacts the conductive material, wherein the first conductive polymer has a resistivity that increases in response to increased concentration of ammonia; ….
However, Killard teaches the following:
a sensor (“sensor”) 160 comprises a conductive polymer (“sensing film 162 comprises a polyaniline nanoparticle film”) 162 and a conductive material (“electrical connector”) 164, wherein the conductive polymer 162 contacts the conductive material 164, wherein the first conductive polymer 162 has a resistivity that increases in response to increased concentration of ammonia (see “The sensing and measuring means 150 comprises a sensing chamber 151 housing a sensor 160. The sensor is an ammonia sensor. The sensor 160 is a conducting polymer sensor. The sensing and measuring means 150 is configured to measure change in conductivity or impedance of the conducting polymer sensor 160 on exposure to ammonia in a breath sample.” in para. [0066]; and see “In more detail, the sensor 160 is a conducting polymer polyanailine sensor which includes a substrate 161 and a sensing film 162. The sensing film 162 comprises a polyaniline nanoparticle film. The sensor 160 further includes an electrical connector 164. The sensor 160 of the exemplary arrangement is based on the inkjet printed deposition of polyaniline nanoparticles as described in patent applications including EP 2004840 and US 20100008831.” in para. [0067]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Toshiyuki’s “ammonia sensor 22” to Killard’s “sensor 160” to have a “polyaniline nanoparticle film” and an “electrical connector”, because to this is a simple substitution of one known element, i.e.Toshiyuki’s “ammonia sensor 22”, for another, i.e. Killard’s “sensor 160”, to obtain predictable results, i.e. monitoring ammonia levels in breath.
Toshiyuki in view of Killard do not teach the following:
… wherein the second sensor comprises a second conductive polymer and a conductive material, wherein the second conductive polymer contacts the conductive material of the second sensor, wherein the second conductive polymer has a resistivity that increases in response to increased concentration of 12CO2 and 13CO2, wherein the second conductive polymer comprises sulfonated polyaniline blended with polyethylene oxide and/or doped polypyrrole; …
However, Chang teaches the following:
a sensor (“sensor”) 102 comprises a conductive polymer (“functionalization material or layer”) 120 and a conductive material (“conductive elements or contacts”) 110 (see “One or more conductive elements or contacts 110, 112 may be disposed over the substrate and electrically connected to conducting channel 106 comprising a nanostructure material.” in para. [0067]; and see “In an exemplary embodiment of a carbon dioxide (CO.sub.2) sensor (see schematic of FIG. 1), sensitivity to CO.sub.2 may be achieved using a suitable functionalization material or layer 120 (which may be continuous or discontinuous). The functionalization layer may perform two main functions: 1) to selectively recognize carbon dioxide molecules and 2) upon the binding of CO.sub.2 to generate an amplified signal that is transferred to the carbon nanotube transducer. In the presence of water, carbon dioxide forms carbonic acid which dissociates and alters the pH of the functionalization layer, thus protonating the electron donating groups and making the NTFET more p-type. Basic inorganic compounds (e.g., sodium carbonate), pH-sensitive polymers, such as polyaniline, poly(ethyleneimine), poly(o-phenylenediamine), poly(3-methylthiophene), and polypyrrole, as well as aromatic compounds (benzylamine, naphthalenemethylamine, antracene amine, pyrene amine, etc.) may be used to functionalize NTFETs for CO.sub.2 sensing. The functionalization layer may be constructed using polymeric materials such as polyethylene glycol, poly(vinyl alcohol) and polysaccharides, including various starches as well as their components amylose and amylopectin.” in para. [0090]), wherein the conductive polymer contacts the conductive material of the sensor 102 (see “FIG. 1. shows an exemplary electronic sensing device 100 having aspects of the invention, for detecting an analyte 101 (e.g. CO.sub.2, H.sub.2 or NO, and the like), comprising a nanostructure sensor 102. Sensor 102 comprises a substrate 104, and a conducting (e.g., semiconducting) channel or layer 106 comprising a nanostructure material, such as a nanotube or network of nanotubes, disposed on the substrate.” in para. [0065]), wherein the conductive polymer 120 has a resistivity that increases in response to increased concentration of 12CO2 and 13CO2, wherein the second conductive polymer comprises sulfonated polyaniline blended with polyethylene oxide or doped polypyrrole (see “Such materials may be included in sensors such as are describe herein without departing from the spirit of the invention. TABLE-US-00001 TABLE 1 Examples of alternative recognition materials V.sub.2O.sub.5 WO.sub.3 Polyacrylic acid Polyurethane resin Poly(acrylic acid-co-isooctylacrylate) Polycarbazole poly(ethylene imine), "PEI" poly(sulfone) poly(4-vinylphenol) poly(vinyl acetate) poly(alkyl methacrylate) poly(vinyl alcohol) poly(a-methylstyrene) poly(vinyl butyral) poly(caprolactone) polyacrylamide poly(carbonate bisphenol A) polyacrylonitrile poly(dimethylsiloxane) polyaniline poly(ethylene glycol) polybutadiene poly(ethylene oxide) polycarbonate poly(ethylenimine) polyethylene poly(methyl vinyl ether-co-maleic polyoxyethylene anhydride) poly(N-vinylpyrrolidone) polypyrrole poly(propylene) polytetrafluoroethylene poly(styrene) polythiophene polyvinyl-methyl-amine Polyvinyl pyridine polyaminostyrene chitosan chitosan HCL polyallylamine polyallylamine HCL poly(diallylamine) poly(diallylamine) HCL poly(entylene-co-vinyl acetate), .about.82% poly-(m-aminobenzene ethylene sulfonic acid), "PABS" poly(styrene-co-allyl alcohol), .about.5.7% poly(vinyl chloride-co- hydroxyl vinyl acetate), .about.10% vinyl acetate poly(styrene-co-maleic anhydride), .about.50% poly(vinylidene chloride- styrene co-acrylonitrile), .about.80% vinylidene chloride” in para. [0095]), wherein the conductive material of the first sensor or the second sensor comprises a plurality of electrodes (“One or more conductive elements or contacts”) 110, 112 (see “One or more conductive elements or contacts 110, 112 may be disposed over the substrate and electrically connected to conducting channel 106 comprising a nanostructure material. Elements 110, 112 may comprise metal electrodes in contact with conducting channel 106. In the alternative, a conductive or semi-conducting material (not shown) may be interposed between contacts 110, 112 and conducting channel 106. Contacts 110, 112 may comprise source and drain electrodes, respectively, upon application of a source-drain voltage V.sub.sd.” in para. [0067]), and …
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Toshiyuki’s “carbon dioxide sensor 24” to Chang’s “sensor 102” to have a “functionalization material or layer 120” and a “conductive elements or contacts 110”, because to this is a simple substitution of one known element, i.e. Toshiyuki’s “carbon dioxide sensor 24”, for another, i.e. Chang’s “sensor 102”, to obtain predictable results, i.e. monitoring carbon dioxide levels in breath.
Toshiyuki in view of Killard, and further in view of Chang, do not teach the following:
wherein the plurality of electrodes comprise wires arranged in a spiral configuration or in a rectangular configuration.
However, LeBoeuf teaches the following:
a plurality of electrodes (“photocatalytic electrodes”) 908 comprise wires (“contact layer”) 906 arranged in a spiral configuration or in a rectangular configuration (“rectangular geometries”, not labeled) (see “A top-view of the photoelectrocatalytic sensor 800 is shown as 900 in FIG. 9. Only the photoelectrocatalytic films 908, the contact layers 906, and the support layer 902 are shown for simplicity. Note that exemplary rectangular geometries are drawn for the photocatalytic electrodes, but other shapes, such as circles, squares, triangles and/or other shapes may be used in other embodiments. Moreover, although contact layers 906 are shown on top of the photoelectrocatalytic films 908, these contacts can be placed at the edges, the center, the corners and/or virtually anywhere along the photoelectrocatalytic film surface in other embodiments. Enough space should be left between the contacts to allow detection of absorbed analytes near the surface of the photoelectrocatalytic films 908. Also, although only two contacts per photocatalytic film are shown, three or more contacts may also be employed in other embodiments.” in para. [0108]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Toshiyuki in view Chang’s plurality of electrodes (“One or more conductive elements or contacts”) 110, 112 to include LeBoeuf’s wires (“contact layer”) 906 arranged in a spiral configuration or in a rectangular configuration (“rectangular geometries”, not labeled) because it would be a simple substitution of one known configuration, i.e. Chang’s “One or more conductive elements or contacts 110, 112”, for another, i.e. LeBoeuf’s “rectangular geometries” for electrodes, to obtain the same or similar predictive result, i.e. monitoring carbon dioxide levels in breath.
As to Claim 2, Chang teaches the following:
wherein the sulfonated polyaniline is synthesized from an emeraldine form of polyaniline polymer (see para. [0095]).
As to Claims 4 and 5, LeBoeuf teaches the following:
wherein the plurality of electrodes comprise wires arranged only in the spiral configuration or only in the rectangular configuration (see “A top-view of the photoelectrocatalytic sensor 800 is shown as 900 in FIG. 9. Only the photoelectrocatalytic films 908, the contact layers 906, and the support layer 902 are shown for simplicity. Note that exemplary rectangular geometries are drawn for the photocatalytic electrodes, but other shapes, such as circles, squares, triangles and/or other shapes may be used in other embodiments.” in para. [0108]).
As to Claim 6, Toshiyuki teaches the following:
wherein the breath analyzer is in wireless communication with a remote device (“display part”) 50 (see “A display unit 50 is connected to the calculation determination unit 40. The determination result of the microorganism determination unit 44 is output to the display unit 50 and displayed on the display unit 50.” in para. [0030], and fig. 1).
As to Claim 7, Toshiyuki teaches the following:
wherein the breath analyzer has two separate channels (not labeled, see separate portions of “mouthpiece 26” that distribute exhalation flow to “ammonia sensor 22” and “carbon dioxide sensor 24” in fig. 2), the breath sample being configured to travel from the input 26, through the separate channels, to each of the first 22 and second 24 sensors (see “As shown in FIG. 2, the detection unit 20 includes an elongated cylindrical exhalation introduction tube 26 in which a mouthpiece 26 a for injecting exhalation by a subject is formed. Each of the ammonia sensor 22 that detects and outputs the concentration of ammonia in the exhalation of the subject and the oxygen sensor 24 that detects and outputs the concentration of oxygen in the exhalation of the subject include: It is provided oppositely so as to be equivalent to the exhalation. A suction fan 28 that is driven to suck the breath of the subject is provided in the state of being supported by the rod 30 inside the breath introduction pipe 26 and closer to the mouthpiece 26 a than the ammonia sensor 22 and the oxygen sensor 24.” in para. [0025]).
As to Claim 8, Chang teaches the following:
wherein a ratio of polyethylene oxide to sulfonated polyaniline is from 10%-30% by weight (see para. [0095]).
As to Claim 9, Chang teaches the following:
wherein the ratio of polyethylene oxide to sulfonated polyaniline is about 30% by weight (see para. [0095]).
As to Claim 10, Toshiyuki teaches the following:
A method of detecting H. Pylori in a digestive tract of a subject (see “The present invention relates to an expiratory component measuring apparatus and an expiratory component measuring method, and more particularly to an expiratory component measuring apparatus and an expiratory component measuring method for detecting the concentration of ammonia contained in human exhaled breath.” in para. [0001]), the method comprising:
collecting a baseline breath sample from a subject (see “Here, before breathing urea and sodium bicarbonate, exhaled air that is blown by the subject through the mouthpiece 26a is normal exhalation, that is, gas from the alveoli (hereinafter also referred to as alveolar-derived gas). Thus, gas from the stomach (hereinafter also referred to as stomach-derived gas) is not included. Accordingly, the ammonia concentration and the oxygen concentration obtained in step 100 are the concentrations of ammonia and oxygen in the alveolar gas.” in para. [0037]) using the breath analyzer 10 according to claim 1 (see discussion of claim 1 above);
determining a total amount of ammonia and a total amount of 12CO2 and 13CO2 present in the baseline breath sample using the breath analyzer 10 (see para. [0037]);
allowing the subject to ingest a meal containing a predetermined amount of 13C -labeled or unlabeled urea (see “Next, the subject is allowed to drink (orally administer) a solution or solid substance (tablet or the like) containing urea of a predetermined concentration. If H. pylori is present in the stomach of the subject, a reaction shown in the following formula (1) is generated by an enzyme called urease of H. pylori, and ammonia is generated.” in para. [0038]);
collecting a post-urea ingestion breath sample from the subject using the breath analyzer (see “In this state, the subject is infused through the mouthpiece 26a of the detection unit 20 for a predetermined appropriate time. The exhaled breath exhaled from the subject at this time is a mixture of alveolar gas and gas derived from gas because the stomach is filled with gas.” in para. [0041]);
determining a total amount of ammonia and a total amount of 12CO2 and 13CO2 present in the post-urea ingestion breath sample using the breath analyzer 10 (see “When the predetermined appropriate time has elapsed since the subject started to breathe, step 102 in FIG. 3 is performed to obtain a detection signal indicating the concentration of ammonia from the ammonia sensor 22, and A detection signal indicating the concentration of oxygen is acquired from the oxygen sensor 24. The concentration value indicated by the detection signal from the ammonia sensor 22 acquired here is a storage means (in the above-mentioned RAM, which is predetermined as the concentration [Am] post of exhaled ammonia after oral administration of urea and sodium bicarbonate. And the concentration value indicated by the detection signal output from the oxygen sensor 24 obtained in the same manner is stored in the storage means as the oxygen concentration [O2] post after oral administration of urea and sodium bicarbonate.” in para. [0042]); and
designating a presence of H. Pylori in the digestive tract of the subject if the total amount of ammonia and the total amount of 12CO2 and 13CO2 present in the post-urea ingestion breath sample exceeds the total amount of ammonia and the total amount of 12CO2 and 13CO2 present in the baseline breath sample by a predetermined value (see “In step 106, the presence / absence of a microorganism having urease activity (herein, H. pylori) is determined based on the calculated ammonia concentration [Am] stomach in the stomach. Specifically, when the ammonia concentration [Am] stomach is a concentration equal to or higher than a predetermined threshold, it is determined that H. pylori is present in the stomach of the subject. It is determined that H. pylori is not present in the examiner's stomach.” in para. [0049]).
As to Claim 12, Toshiyuki teaches the following:
wherein collecting the baseline breath sample from the subject and collecting the post-urea ingestion breath sample from the subject comprises collecting both the baseline breath sample and the post-urea ingestion breath sample from a single subject and from a single portable breath analyzer 10, the single portable breath analyzer being the breath analyzer 10 according to claim 1 (see para. [0024] and [0037]-[0049]).
As to Claim 16, Chang teaches the following:
wherein the doped polypyrrole comprises polypyrrole doped with 3-Aminobenzenesulfonic acid (see para. [0095]).
As to Claim 17, Chang teaches the following:
wherein the doped polypyrrole comprises polypyrrole doped with 4-Dodecylbenzenesulfonic acid (see para. [0095]).
As to Claim 18, Chang teaches the following:
wherein the doped polypyrrole comprises polypyrrole doped with 4-hydroxybenzenesulfonic acid (see para. [0095]).
Allowable Subject Matter
4. Claims 11 and 13-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
5. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 11, neither Toshiyuki, Killard, Chang, LeBoeuf nor the prior art of record teaches the method of base claim 10, including the following, in combination with all other limitations of the base claim:
designating an absence of H. Pylori in the digestive tract of the subject if the total amount of ammonia and the total amount of 12CO2 and 13CO2 present in the post-urea ingestion breath sample does not exceed the total amount of ammonia and the total amount of 12CO2 and 13CO2 present in the baseline breath sample by the predetermined value.
As to Claims 13-15, neither Toshiyuki, Killard, Chang, LeBoeuf, nor the prior art of record teaches the method of base claim 1, including the following, in combination with all other limitations of the base claim:
(i) comparing the measured resistivity of the baseline breath sample to the measured resistivity of the post-urea breath sample;
(j) calculating the difference between the resistivity of the first sensor of the baseline breath sample and the measured resistivity of the first sensor of the post-urea breath sample;
(k) calculating the difference between the resistivity of the second sensor of the baseline breath sample and the measured resistivity of the second sensor of the post-urea breath sample;
(l) expressing the difference in resistivity of the first sensor in ppb of NH3 and the difference in resistivity of the second sensor in ppm of CO2 and 13CO2; and
(m) displaying a final result as positive for H. Pylori when the difference between post-urea and baseline measured resistivity of the first and second sensors is a positive number and as negative for H. Pylori when the difference between post-urea and baseline resistivity of the first and second sensors is zero or a negative number.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 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 M 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.
/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 05/05/2026
Prosecution Insights