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 .
This Office action is responsive to the Reply of Office Action filed September 18, 2025. The Examiner acknowledges the cancellation of claims 3, 10-19 and 21. Claims 1-2, 4-9, 20 & 22 are currently pending.
Response to Arguments
Applicant's arguments filed September 18, 2025, regarding the previous rejection of claim 6 under 35 USC 112(b) have been fully considered and are persuasive. Therefore, the previous rejection of claim 6 under 35 USC 112(b) has been withdrawn. The rejection of claim 15 under 35 USC 112(b) is withdrawn as claim 15 has been canceled.
Regarding the previous rejection of claims 10-11, 13-19 and 21 under 35 USC 101, as claims 10-11, 13-19 and 21 have been canceled, the previous rejection of said claims under 35 USC 101 has been withdrawn.
Regarding the previous rejection of the claims under 35 USC 103 as being unpatentable over Mault in view of Hubbard and in further view of Williams and Suslick, Applicant argues that Williams fails to teach an internal cylinder or functionality attributed to the internal cylinder. Applicant further argues that Williams fails to provide any structural element which would function in accordance with that which the combination of the column and internal cylinder provides, and that the addition of the Suslick reference fails to remedy the deficiencies of Mault as modified by Hubbard and Williams. The Examiner respectfully disagrees with this argument because the Williams reference was not used to disclose the internal cylinder or the column as recited in the claims of the instant application. Instead, Williams was used to teach impingement of breath of a patient/user onto a sensor. Mault was used to disclose both the internal cylinder and column, as Mault teaches an analysis portion 100 that comprises an internal cylinder 110 (i.e., a flow tube) (see Mault, fig. 4, par 0048), wherein the internal cylinder is within a column (see Mault, fig. 4, wherein flow tube 110 is contained within a column) and exhaled breath flows through the internal cylinder into functional contact with a sensor and through said column (see Mault, par 0048, fig. 4, wherein breath flows through the internal cylinder 110 to the sensor 120). As noted in the prior Office Action, Mault as modified by Hubbard fails to teach that the internal cylinder focuses impingement of the exhaled breath onto a surface of the colorimetric sensor, which is why the Williams reference was used. Williams teaches a device for the detection of respiratory system lesions where a subject exhales their breath into a mouthpiece 6 that is connected to a conduit comprising a sensing element 8, wherein the stream of gas exhaled from the breath of the subject impinges upon the sensing element, as the stream of exhaled gas is perpendicular to the sensing element (see Williams, par 0010, 0039, 0056, fig. 3). Therefore, the combination of Mault as modified by Hubbard and Williams teaches an internal cylinder within a column that impinges breath onto a sensor, as recited in the claims, and the rejection of claim 8 over Mault, Hubbard, Williams, and Suslick is proper. See 35 USC 103 rejections below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: capture element in claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. As described in the specification, the capture element is a side arm and sample bag that the exhaled breath flows into.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-7, 9, 20 & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20020026937 --as previously cited--, hereinafter referenced as "Mault", in view of US Patent Application Publication 20040077965 --as previously cited--, hereinafter referenced as "Hubbard", and in further view of US Patent Application Publication 20120165693 –as previously cited--, hereinafter referenced as “Williams”.
With respect to claim 1, Mault teaches an apparatus 10 (see Mault, figs. 1 & 2) for measuring a respiratory gas in exhaled breath comprising:
a sample collection portion 104 (i.e., a mask) (see Mault, par 0048, figs. 3 & 4) capable of capturing exhaled breath to control the volume of exhaled breath passed through the device during a breath test (i.e., inhalation and exhalation gases are passed through the device) (see Mault, par 0040-0041);
and an analysis portion 100 (i.e., a gas meter, such as a nitric oxide meter) (see Mault, figs. 3 & 4) capable of receiving said exhaled breath from said sample collection portion (see Mault, par 0048), wherein the analysis portion 100 comprises an internal cylinder 110 (i.e., a flow tube) (see Mault, fig. 4, par 0048) which is within a column (see Mault, fig. 4, wherein flow tube 110 is contained within a column) wherein said exhaled breath flows through the internal cylinder into functional contact with a sensor and through said column (see Mault, par 0048, fig. 4, wherein breath flows through the internal cylinder 110 to the sensor 120).
Mault does not teach that the apparatus is used for measuring an ammonia concentration in exhaled breath, that the analysis portion comprises a colorimetric sensor comprising an active component on a substrate, wherein the colorimetric sensor changes color proportional to the ammonia concentration in the exhaled breath, nor that the internal cylinder focuses impingement of the exhaled breath onto a surface of the colorimetric sensor.
Hubbard teaches an apparatus (see Hubbard, fig. 1B) for measuring an ammonia concentration in exhaled breath (see Hubbard, par 0035), and a colorimetric sensor 6,7 (i.e., fiber optic ammonia sensors and a fiber optic instrument reader) comprising an active component on a substrate (i.e., a non-water soluble pH indicator dye incorporated into an ammonia permeable film) (see par 0036), wherein the colorimetric sensor changes color proportional to the ammonia concentration in the exhaled breath (see par 0036 & 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Mault to comprise a colorimetric sensor comprising an active component on a substrate wherein said colorimetric sensor changes color proportional to an ammonia concentration in said exhaled breath. Doing so improves the system of Mault by enabling the determination of gastric infections, such as that of H. pylori, and the determination of liver and kidney function due to the tight regulation of ammonia levels by those organs (see Hubbard, par 0002-0004 & 0009). Furthermore, using colorimetric sensors provides a simple, rapid, and non-invasive diagnostic test based on measuring ammonia in breath (see Hubbard, par 0013).
Mault as modified by Hubbard fails to teach the internal cylinder focuses impingement of the exhaled breath onto a surface of the colorimetric sensor.
Williams teaches a device for the detection of respiratory system lesions, wherein a subject exhales their breath into a mouthpiece 6 that is connected to a conduit 4 comprising a sensing element 8, wherein the stream of gas exhaled from the breath of the subject impinges upon the sensing element 8 (see Williams, par 0010, 0039, 0056, fig. 3). The stream of exhaled gas from the subject is perpendicular to the sensing element 8 (see Williams, fig. 3), and impinges upon the sensing element 8 as valves 34, 36 respectively close and open as the subject exhales, which ensures the perpendicular stream of breath of the subject impinges upon the sensing element 8 (see Williams, par 0010, 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mault in view of Hubbard such that the internal cylinder focuses impingement of the exhaled breath onto a surface of the colorimetric sensor because doing so ensures that analytes in the exhaled breath are effectively determined since the exhaled breath makes direct contact with the sensing element/sensor (see Williams, par 0012, 0034, 0039, 0056).
With respect to claim 2, Mault as modified by Hubbard and Williams teaches the apparatus for measuring ammonia concentration in exhaled breath of claim 1. Mault further teaches the sample collection portion 104 comprises a mouthpiece (i.e., a respiratory connector, such as a mask) (see Mault, par 0048, figs. 3 & 4) and an inlet tube 112 (i.e., a flow tube) attached to said mouthpiece (see Mault, par 0048).
With respect to claim 4, Mault as modified by Hubbard and Williams teaches the apparatus for measuring ammonia concentration in exhaled breath of claim 1. Mault further teaches a holder (i.e., the wall of an outer column within the analysis portion 100) capable of securing a sensor 120 in flow relationship with said internal cylinder (see Mault, fig. 4, par 0048).
With respect to claim 5, Mault as modified by Hubbard and Williams teaches the apparatus for measuring ammonia concentration in exhaled breath of claim 4. Mault further teaches that the sample collection portion 104 comprises an inlet tube 112 and said inlet tube 112 has a larger diameter than a diameter of said internal cylinder (see Mault, par 0048, fig. 4).
With respect to claim 6, Mault as modified by Hubbard and Williams teaches the apparatus for measuring ammonia concentration in exhaled breath of claim 1. Mault further teaches that the apparatus comprises a capture element that regulates a volume of said exhaled breath (i.e., a reservoir of respiratory gases that exhaled breath flows into once passing the analysis portion of the apparatus) (see Mault, par 0042).
With respect to claim 7, Mault as modified by Hubbard and Williams teaches the apparatus for measuring ammonia concentration in exhaled breath of claim 1. Mault further teaches that the apparatus comprises a pressure gauge (i.e., a pressure sensor) that can be used to control the flow rate of exhaled breath (see Mault, par 0076).
With respect to claim 9, Mault as modified by Hubbard and Williams teaches the apparatus for measuring ammonia concentration in exhaled breath of claim 1. Hubbard further teaches that the active component is selected from the group consisting of Berthelot’s reagent, Bromocresol Green, Bromophenol Blue, Bromocresol Purple, Titanium(IV) Oxide, and Hydroquinone (see Hubbard, par 0036 & figs. 2A-2D).
With respect to claim 20, Mault as modified by Hubbard and Williams teaches the apparatus for determining ammonia concentration in exhaled breath of claim 1. Mault further teaches the internal cylinder 110 is perpendicular to the sample collection portion 104 (see Mault fig. 4, par 0048).
With respect to claim 22, Mault as modified by Hubbard and Williams teaches the apparatus for determining ammonia concentration in exhaled breath of claim 1. Mault in view of Hubbard fail to teach the internal cylinder is perpendicular to a surface of the colorimetric sensor.
Williams teaches a device for the detection of respiratory system lesions, wherein a subject exhales their breath into a mouthpiece 6 that is connected to a conduit 4 comprising a sensing element 8, wherein the stream of gas exhaled from the breath of the subject impinges upon the sensing element 8 (see Williams, par 0010, 0039, 0056, fig. 3). The stream of exhaled gas from the subject is perpendicular to the sensing element 8 (see Williams, fig. 3), and impinges upon the sensing element 8 as valves 34, 36 respectively close and open as the subject exhales, which ensures the perpendicular stream of breath of the subject impinges upon the sensing element 8 (see Williams, par 0010, 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mault in view of Hubbard such that the internal cylinder is perpendicular to a surface of the colorimetric sensor because doing so permits the impingement of the exhaled breath of a subject/user upon the sensor which ensures that analytes in the exhaled breath are effectively determined since the exhaled breath makes direct contact with the sensing element/sensor (see Williams, par 0012, 0034, 0039, 0056).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mault in view of Hubbard and in further view of Williams, as applied to claims 1 & 10 above, and further in view of US Patent Application Publication 20050171449 --as previously recited--, hereinafter referenced as "Suslick".
With respect to claims 8, Mault as modified by Hubbard and Williams teaches the apparatus and method for measuring and determining ammonia concentration in exhaled breath of claims 1 & 10, wherein a sensor dye (i.e., active component) on a substrate is used to detect the ammonia concentration in exhaled breath of a user. However, Mault as modified by Hubbard and Williams fails to teach what the substrate is that comprises the dye (i.e., active component).
Suslick teaches a method and apparatus for detecting ammonia from exhaled breath that comprises a sensor plate that is a substrate with an array of dyes, wherein the substrate is any suitable material or materials, including chromatography paper (see Suslick, par 0031-0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method of Mault as modified by Hubbard and Williams such that the dye is on chromatography paper because Suslick teaches substrates that are used for affixing dyes when detecting ammonia concentrations from exhaled breath can include any suitable material, including chromatography paper (see Suslick, par 0032).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791