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 .
Applicant's response filed 2/26/2026 has been fully considered. The following rejections
and/or objections are either reiterated or newly applied. Examiner agrees with Applicant that the claims from the Preliminary Amendment filed 6/27/2022 were examined in the Office Action dated 8/26/2025, as evidenced by the "Disposition of Claims" on page 2 and "Status of Claims" on page 3 of the Office Action. Examiner thanks Applicant for understanding of the clerical error on page 2 under Status item 1 as being responsive to communications filed on 12/22/2021 (Remarks 2/26/2026 page 3).
Status of Claims
Claims 1, 4-5, 7-11, 15, 17, 18, 20-24, 26, 27, 29, 30, 32, and 33 are pending and examined on the merits.
Claims 2-3, 6, 12-14, 16, 19, 25, 28, and 31 are cancelled.
Priority
The instant application is a 371 national stage entry of PCT/SE2020/050657 filed on 6/24/2020, and claims the benefit of priority to Application No. SE1950781-3 filed on 6/25/2019. Thus, the effective filing date of the claims is 6/25/2019.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Information Disclosure Statement
The IDS filed on 3/3/2026 has been entered and considered. A signed copy of the corresponding 1449 form has been included with this Office action.
Specification
The objection to the specification is withdrawn in view of Applicant's claim amendments filed on 2/26/2026.
Claim Objections
The objection to claims 1 and 33 withdrawn in view of Applicant's claim amendments filed on 2/26/2026.
Withdrawn Rejections
35 USC § 112(a)
The rejection of claim 26 under 35 USC 112(b) withdrawn in view of Applicant's claim amendments filed on 2/26/2026.
35 USC § 112(b)
The rejection of claims 1-3, 17, 20, 24, 26, and 32 under 35 USC 112(b) withdrawn in view of Applicant's claim amendments filed on 2/26/2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-5, 7-11, 15, 17, 18, 20-24, 26, 27, 29, 30, and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1: “identifying an unidentified substance from a set of preselected substances during breath analysis of a human breath sample in a measuring cell using non-dispersive spectroscopy in a preselected wavelength range” provides an evaluation (identifying a substance using analysis methods) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“determining an absorption comparative value representing a comparison of at least the absorption in the first wavelength band and the absorption in the second wavelength band” provides a mathematical calculation (determining a comparative value between the first and second wavelength bands requires solving a difference) that is considered a mathematical concept, which is an abstract idea.
“determining a total absorption value representing a total absorption in at least the combined first wavelength band and the second wavelength band” provides a mathematical calculation (determining total value requires summing values) that is considered a mathematical concept, which is an abstract idea.
“comparing the absorption comparative value and the total absorption value with tabulated data for the preselected set of substances arranged with corresponding values” provides a comparison (assessing similarities or differences between items) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
“identifying the unidentified substance as the substance from the set of preselected substances representing the best match in terms of the absorption comparative values and the total absorption values” provides a comparison (determining a best match for identification) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 5: “identifying the reception of a human breath sample by means of peak detection of at least one tracer gas” provides an evaluation (identifying a breath sample and determining concentrations) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 8: “identifying the reception of a human breath sample by means of peak detection of at least one tracer gas and determining a tracer gas concentration value” provides an evaluation (identifying a breath sample) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 20: “determining an absorption comparative value and a total absorption value, and comparing this value to the total absorption value of the first and second wavelength bands” (interpretation from “Claim Rejections - 35 USC § 112”) provides a mathematical calculation (determining a comparative value between the first and second wavelength bands requires solving a difference and determining total value requires summing values) that is considered a mathematical concept, which is an abstract idea.
“identifying the unidentified substance as the substance from the set of preselected substances representing the best match in terms of the absorption comparative values and the total absorption values” provides a comparison (assessing similarities or differences between items and determining a best match for identification) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 24: “identifying the reception of a human breath sample by means of peak detection of at least one tracer gas” (interpretation from “Claim Rejections - 35 USC § 112”) provides an evaluation (identifying a breath sample) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 32: “determining the absorption comparative value representing the difference between the first and second, and second and third, wavelength bands” (interpretation from “Claim Rejections - 35 USC § 112”) provides a mathematical calculation (determining comparative values between wavelength bands and a value representing total absorption requires solving a difference and a sum, respectively) that is considered a mathematical concept, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas.
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claim 1: “recording at least a first signal from a first infrared detector and a second signal from a second infrared detector” provides insignificant extra-solution activities (recording data are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“the first infrared detector is provided with a first interference filter with a transition wavelength” provides insignificant extra-solution activities (providing and applying interference filters is a pre-solution activity involving sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 5: “determining a tracer gas concentration value and a step of determining a breath concentration value of the identified substance wherein the tracer gas concentration value is utilized” provides insignificant extra-solution activities (measuring a concentration value is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 7: “if the identified substance is not ethanol, an error indication is issued” provides insignificant extra-solution activities (outputting data are post-solution activities involving data manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 8: “a subset from the set of preselected substances has been predefine” provides insignificant extra-solution activities (defining a subset is a kind of input which is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“determining a breath concentration value of the identified substance wherein the tracer gas concentration value is utilized” provides insignificant extra-solution activities (measuring a concentration value is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 17: “recording a first signal from a first infrared detector provided with a first interference filter with a first characterizing transition wavelength, recording a second signal from a second infrared detector provided with a second interference filter with a second characterizing transition wavelength, and recording a third signal from a third infrared detector” provides insignificant extra-solution activities (recording data are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 18: “selecting ethyl alcohol as a specific target substance, selecting methyl alcohol, acetone, isopropyl alcohol, and 1-propanol as potential interfering substances, and selecting the selection of interferences filters, as well as the numbers of filters and detectors” provides insignificant extra-solution activities (selecting inputs is a kind of data input that are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 24: “determining a tracer gas concentration value, and wherein the control unit is configured to determine breath concentration value of the identified substance using the tracer gas concentration value” provides insignificant extra-solution activities (measuring a concentration value is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 26: “issuing a notification of an error at a display connected to the control unit” (interpretation from “Claim Rejections - 35 USC § 112”) provides insignificant extra-solution activities (outputting data are post-solution activities involving data manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 27: “the control unit performs the determination of a breath concentration value of the identified substance” provides insignificant extra-solution activities (measuring a concentration value is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 32: “record a first signal from a first infrared detector, a second signal from a second infrared detector and a third signal from a third infrared detector” (interpretation from “Claim Rejections - 35 USC § 112”) provides insignificant extra-solution activities (recording data are pre-solution activities involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
The steps for inputting, measuring, recording, and outputting data, and providing and applying interference filters are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre- and post-solution activities involving data gathering, data manipulation, and sample manipulation steps (see MPEP 2106.04(d)(2)).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The limitations for inputting, measuring, recording, and outputting data are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are well-understood, routine, and conventional. Specifically, for providing and applying interference filters, these steps are shown to be well-understood, routine, and conventional as evidenced by:
Jacquinot, Pierre. (Reports on progress in physics 23.1 (1960): 267-312), page 4 paragraph 2 "In reality, all the techniques of spectroscopy involve the phenomena of interference, In the prism the dispersion of light is due to the fact that different wavelengths are subject to different optical retardations in the prism material, and the resulting interference is constructive only in the directions given by the elementary laws of the prism" and page 6 figure 1 shows "The Fabry-Perot interferometer", and page 6 last paragraph "For a given value of A the F.P. acts as a wavelength filter";
Gat, Nahum. (Wavelet Applications VII 4056 (2000): 50-64), page 4 paragraph 3 "A number of interferometers have been used as ETF [electronically tunable filters] in similar applications. These devices produce an extremely high spectral resolution and may be more appropriate for gas/plume detection task"; and
Dinh et al. ( Sensors and Actuators B: Chemical 231 (2016): 529-538), page 3 col 2 paragraph 2 "The use of a NDIR sensor for a certain gas is subject to interference from other gases that can absorb IR light [16], [17], [18]. Multi-gas NDIR analyzers are mostly affected by such interference. Multi-optical filters have been widely applied to the multi-gas NDIR sensor [16], [19], [20], [21], [22], [23], [24]".
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1, 4-5, 7-11, 15, 17, 18, 20-24, 26, 27, 29, 30, and 32 are not patent eligible.
Response to Arguments under 35 USC § 101
Applicant’s arguments filed 2/26/2026 are fully considered but they are not persuasive.
Applicant asserts that "The inclusion of this additional structure (filter/detectors) integrates the judicial exception into a practical application" and that "the process of manipulating a beam of light using a filter is in no way a concept that can be practically performed in the human mind, nor is such a process merely a mathematical relationship" (Remarks 2/26/2026 pages 5-6). Examiner notes above that the amendments to claim 1 which provide an interference filter are additional elements that are considered to be well-understood, routine, and conventional as evidenced by Pierre Jacquinot, Nahum Gat, and Dinh et al. (see section "Claim Rejections - 35 USC 101" for specific citations). As such, the Examiner also notes that MPEP 2106(I) states that if the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). In the “search for an ‘inventive concept’” (the second part of the Alice/Mayo test), the additional elements identified do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception because providing and applying interference filters to a detector (sample manipulation steps) are all well-understood, routine, and conventional techniques that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Therefore, combining insignificant extra-solution activities with any of the identified judicial exceptions would not result in patent eligible subject matter because integrating well-understood, routine, and conventional techniques does not yield “significantly more” to a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon.
Therefore, the rejection of independent claims 1, 20, and 33 under 35 USC 101 is maintained. All other claims depend from these independent claims; therefore, their rejection is likewise maintained.
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.
Claims 1, 4-5, 7, 10, 11, 15, 17, and 18 rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US-5721430) in view of Kluczynski et al. (US-20130334419) and Cable et al. (US-20170074640).
Regarding claim 1, Wong teaches a method of identifying an unidentified substance from a set of preselected substances during gas sample analysis in a measuring cell using non-dispersive spectroscopy in a preselected wavelength range (Abstract "The disclosed infrared detector assemblies can be used in traditional NDIR [non-dispersive infrared] gas sensors having an active source or in passive infrared analysis gas sensors", Page 17 col 2 line 66 "The present invention is directed toward an infrared gas sensor for detecting the concentration of one or more predetermined gases using a novel infrared gas analysis technique referred to as passive infrared analysis (PIA).", and Page 19 col 5 line 35 "Furthermore, in the PIA technique employed in the infrared gas sensor of the present invention, the space between the passive infrared source, for example a certain portion of a wall, and the detector assembly becomes the sample chamber.")
Wong also teaches recording at least a first signal from a first infrared detector and a second signal from a second infrared detector, wherein the first signal represents the absorption in a first wavelength band in the preselected wavelength range and the second signal represents the absorption in a second wavelength band in the preselected wavelength range, wherein the first and second wavelength bands are separated by a preselected transition wavelength (Abstract "a first [and second] interference bandpass filter mounted on the top side of the substrate so that the first [and second] filter covers the aperture above the first [and second] detector and the first [and second] filter is interposed between the port and the first [and second] detector, the first [and second] interference bandpass filter designed to pass incident radiation at a first [and second] spectral band" and Page 24 col 16 line 57 "The CWL [center wavelength] and FWHM [full width at half maximum] of bandpass filters F.sub.1, F.sub.2 and F.sub.3 are set as described in connection with FIGS. 1-3").
Wong does not explicitly teach analysis of a human breath sample, determining absorption values of the first and second wavelength recordings, determining a total absorption of the first and second wavelength bands, comparing these values to tabulated data, identifying a substance representing the best match in terms of absorption values, or an optical filter that is capable of both transmitting and reflecting infrared radiation with a specified transition wavelength.
However, Kluczynski teaches analysis of a human breath sample (Para.0014 "The aim of the invention is to make the determination of trace amounts of alcohol vapor in breath possible, particularly the remote determination of alcohol vapor without interruption of the current activity of the person tested.").
However, Cable teaches determining absorption values of the first and second wavelength recordings, determining a total absorption of the first and second wavelength bands, comparing these values to tabulated data, and identifying a substance representing the best match in terms of absorption values (Para.0132 "Examples of methods to align data include autocorrelation, cross-correlation, difference calculations, similarity calculations and related techniques, all of which can be used with the present invention. The data may consist of an array or vector of integer values, real values, binary values or other data storage types in memory" and Para.0147 "The calculation of the sum of the signals from detector A and detector B can be accomplished using an analog circuit comprising an operational amplifier used in a summing configuration.").
Cable also teaches high- and low-pass interference filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match.").
Cable also suggests optical filters capable of transmitting or reflecting specified wavelengths at a particular threshold (para.0196 " It is known that interferometers and optical filters can have sensitivity to polarization. Thus, it is possible for an interferometer to have different path lengths for different polarization states or for optical filters to have different reflectivity or transmission for different polarization states, which would generate an error in the alignment between any two sweeps. In order to facilitate proper alignment from different VCL sources or other wavelength swept sources, it can be beneficial to align the polarization states of the VCL sources or other sources to be similar" and para.0205 "Multiple level transitions can occur, for example from an etalon, a Fabry-Perot filter, an interferometer, multiple Bragg gratings, or an optical filter with several notch or bandpass regions, for example, or thresholded signals thereof to make a digital signal").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong as taught by Kluczynski in order to analyze breath samples using NDIR (para.0012 "it is proposed to use carbon dioxide as a tracer gas to determine the amounts of other gases in the exhaled air measuring both gas components simultaneously using NDIR spectroscopy"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with gas analysis using infrared sensing methods.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong and Kluczynski as taught by Cable in order to compare signals for a match (para.0132 "Similar metrics, such as SSD [sum of squared differences], can be applied to find the offset with the best match. Both the direct comparison of signals and the comparison of counted values are considered part of a correspondence match of the present invention."). One skilled in the art would have a reasonable expectation of success because both methods can utilize infrared laser spectroscopy for analyzing a gaseous sample.
Regarding claim 4, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. Kluczynski also teaches spectroscopy in the wavelength range of 3.3 to 3.6 um (Para.0058 "As alluded to above the 3-4 um wavelength band have many broad absorption features due to various hydrocarbons. This also includes broadband absorption contributions from ethanol vapor itself").
Regarding claim 5, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. Kluczynski also teaches a step of identifying the reception of a human breath sample by means of peak detection of at least one tracer gas and determining a tracer gas concentration value and a step of determining a breath concentration value of the identified substance wherein the tracer gas concentration value is utilized (Para.0052 "The apparatus may include means to measure a known concentration of a tracer gas such as water vapor or carbon dioxide from the exhaled breath in order to determine the length of the absorption column and the dilution of the sample of exhaled air in the measuring space. If the absorption features of ethanol and the tracer gas is close in wavelength both ethanol and the tracer gas can be measured using one laser, as shown in FIG. 2a. The absolute concentration of ethanol in the exhaled breath can then be determined using the measured concentration of ethanol and the tracer gas.").
Regarding claim 7, Wong in view of Kluczynski and Cable teach the methods of Claims 1 and 5, on which this claim depends. Kluczynski also teaches if the identified substance is not ethanol, an error indication is issued (Abstract "the information about the level of the ethanol content is provided to a suitable display or device").
Regarding claim 10, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. Kluczynski also teaches the absorption comparative value is a ratio between the absorption in the first wavelength band and the absorption in the second wavelength band (Para.0060 "After removing the constant offset from both the ethanol and the tracer gas signals and taking the ratio we obtain the final formula for the ethanol concentration in exhaled breath").
Regarding claim 11, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. Kluczynski also teaches the total absorption is the sum of the absorption in the first wavelength band and the second wavelength band normalized with the tracer gas concentration value (Para.0059 " As we can see the above procedure enables us to normalize the ethanol absorption signal against both the total transmission T and the broadband absorption in the region of the "plateau" absorption T.sub..alpha.(c) at 403 and the changes in the light intensity from the source").
Regarding claim 15, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. Kluczynski also teaches the preselected transition wavelength, At, is between 3.3 and 3.6 um (Para.0058 "As alluded to above the 3-4 um wavelength band have many broad absorption features due to various hydrocarbons. This also includes broadband absorption contributions from ethanol vapor itself").
Regarding claim 17, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. Wong also teaches a first, second, and third infrared detector (Abstract "a first, a second and a third thermopile detector fabricated on the bottom side of the substrate, the hot junctions of each thermopile detector positioned over one of the apertures in the substrate so as to receive radiation transmitted through the aperture, and the cold junctions of each thermopile detector positioned over the substrate").
Wong also teaches the first signal represents the absorption in a first wavelength band, the second signal represents the absorption in a second wavelength band, and the third signal represents the absorption in a third wavelength band in the preselected wavelength range (Abstract "a first [second and third] interference bandpass filter mounted on the top side of the substrate so that the first [second and third] filter covers the aperture above the first [second and third] detector and the first [second and third] filter is interposed between the port and the first [second and third] detector, the first [second and third] interference bandpass filter designed to pass incident radiation at a first [second and third] spectral band").
Wong also teaches the first and second wavelength bands are separated by a preselected first transition wavelength corresponding to the first transition wavelength associated with the first interference filter, and the second and third wavelength bands are separated by a preselected second transition wavelength corresponding to the second transition wavelength associated with the second interference filter (Page 24 col 16 line 57 "The CWL [center wavelength] and FWHM [full width at half maximum] of bandpass filters F.sub.1, F.sub.2 and F.sub.3 are set as described in connection with FIGS. 1-3").
Regarding claim 18, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends. While Kluczynski does not specifically call out “selecting ethyl alcohol as a specific target substance, selecting methyl alcohol, acetone, isopropyl alcohol, and 1-propanol as potential interfering substances, and selecting the selection of interferences filters, as well as the numbers of filters and detectors, to separate wavelengths associated with the specific target substance from wavelengths associated with the identified potential interfering substances”, the wavelength band of 3-4 um is adjacent to the spectroscopic characteristic absorption of the O-H group contained in the listed compounds, which Kluczynski does teach (Para.0058 "As alluded to above the 3-4 um wavelength band have many broad absorption features due to various hydrocarbons. This also includes broadband absorption contributions from ethanol vapor itself"). Additionally, Kluczynski also teaches measuring a background signal (which can be interpreted as an interfering filter) that is recorded and removed from the measured target spectrum (Para.0020 "It is also advantageous that immediately before the measurement the background signal, which contains the absorption signal from other atmospheric gases, the characteristics of the used light source and any distortion of the received light signal in the used receiving means, is recorded and removed from the measured spectrum").
Claims 8 and 9 rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US-5721430) in view of Kluczynski et al. (US-20130334419) and Cable et al. (US-20170074640) as applied to claims 1, 4-5, 7, 10, 11, 15, 17, and 18 above, and further in view of Blackley et al. (US-20160371590).
Wong et al. in view of Kluczynski et al. and Cable et al. are applied to claims 1-5, 7, 10, 11, 15, 17, and 18.
Regarding claim 8, Wong in view of Kluczynski and Cable teach the methods of Claim 1, on which this claim depends.
Kluczynski also teaches a step of identifying the reception of a human breath sample by means of peak detection of at least one tracer gas and determining a tracer gas concentration value (Para.0052 "The apparatus may include means to measure a known concentration of a tracer gas such as water vapor or carbon dioxide from the exhaled breath in order to determine the length of the absorption column and the dilution of the sample of exhaled air in the measuring space. If the absorption features of ethanol and the tracer gas is close in wavelength both ethanol and the tracer gas can be measured using one laser, as shown in FIG. 2a. The absolute concentration of ethanol in the exhaled breath can then be determined using the measured concentration of ethanol and the tracer gas.").
Wong, Kluczynski, nor Cable explicitly teach a subset from the set of preselected substances has been predefined and the method further includes the step of determining a breath concentration value of the identified substance wherein the tracer gas concentration value is utilized is performed only if the identified substance is one of the substances in the subset.
However, while the specific differential of not determining a breath concentration value unless the identified substance is one of a subset is not found in the art for this particular device/application, Blackley does describe identification and subsequent determination of several characteristics of the detected substance including concentration (Para.0228 "The sensor can be further configured to detect one or more of, an identification of the one or more constituents a type of one or more constituents, a mixture of one or more constituents, a temperature, a color, a concentration, a quantity, a toxicity, a pH, a vapor density, or a particle size.").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong, Kluczynski, and Cable as taught by Blackley in order to determine blood alcohol level of the sampled individual (para.0239 "The analysis result can relate to at least one of a medical condition, a personal characteristic, a genetic characteristic, a disease type, a disease symptom, a vital measurement, a wellness indicator, or a spirometric measurement. For example, the analysis result can relate to a blood alcohol level"). One skilled in the art would have a reasonable expectation of success because these methods use sampled air for detection and identification of analytes using spectrometry.
Regarding claim 9, Wong in view of Kluczynski, Cable, and Blackley teach the methods of Claims 1 and 8, on which this claim depends.
Kluczynski also teaches the predefined subset comprises substances for which regulations defining a maximum allowed concentration in breath or blood exists (Para.0014 "The aim of the invention is to make the determination of trace amounts of alcohol vapor in breath possible, particularly the remote determination of alcohol vapor without interruption of the current activity of the person tested.", alcohol being a regulated substance which has a maximum allowed concentration in breath or blood, as evidenced by Jones (Jones, A. W. "Physiological aspects of breath-alcohol measurement." Alcohol Drugs Driving 6.2 (1990): 1-25.), page 3 paragraph 2 "In European countries. such as Great Britain (1985). The Netherlands (1987). Austria (1986). France (1985). Norway (1988). and Sweden (1989). the alcohol element of the offense of driving under the influence of alcohol is now defined as a certain concentration present in a sample of end-expiratory breath.").
Claims 20-24, 26, 29, 30, and 32 rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US-5721430) in view of Kluczynski et al. (US-20130334419), Yi et al. (US-20070279633), and Cable et al. (US-20170074640).
Regarding claim 20, Wong teaches an apparatus for non-dispersive gas analysis operating in a preselected wavelength range of an unidentified substance (Abstract "The disclosed infrared detector assemblies can be used in traditional NDIR [non-dispersive infrared] gas sensors having an active source or in passive infrared analysis gas sensors", Page 17 col 2 line 66 "The present invention is directed toward an infrared gas sensor for detecting the concentration of one or more predetermined gases using a novel infrared gas analysis technique referred to as passive infrared analysis (PIA).", and Page 19 col 5 line 35 "Furthermore, in the PIA technique employed in the infrared gas sensor of the present invention, the space between the passive infrared source, for example a certain portion of a wall, and the detector assembly becomes the sample chamber.")
Wong also teaches a measuring cell comprising non-dispersive infrared elements (Page 19 col 5 line 35 "Furthermore, in the PIA technique employed in the infrared gas sensor of the present invention, the space between the passive infrared source, for example a certain portion of a wall, and the detector assembly becomes the sample chamber.")
Wong also teaches a source configured to transmit an infrared beam (Abstract "The disclosed infrared detector assemblies can be used in traditional NDIR gas sensors having an active source").
Wong also teaches multiple interference filters arranged in the optical path of the measuring cell for detection by multiple detectors (Abstract "a first, a second and a third thermopile detector fabricated on the bottom side of the substrate, the hot junctions of each thermopile detector positioned over one of the apertures in the substrate so as to receive radiation transmitted through the aperture, and the cold junctions of each thermopile detector positioned over the substrate" and Abstract "a first [and second] interference bandpass filter mounted on the top side of the substrate so that the first [and second] filter covers the aperture above the first [and second] detector and the first [and second] filter is interposed between the port and the first [and second] detector, the first [and second] interference bandpass filter designed to pass incident radiation at a first [and second] spectral band").
Wong does not explicitly teach analysis of a human breath sample, detection of wavelengths in the wavelength range between 3.3 and 3.6 um, two or more concave mirrors to control the infrared beam, a control unit for determining absorption values of the first and second wavelength recordings, determining a total absorption of the first and second wavelength bands, comparing these values to tabulated data, identifying a substance representing the best match in terms of absorption values, or an optical filter that is capable of both transmitting and reflecting infrared radiation with a specified transition wavelength.
However, Kluczynski teaches analysis of a human breath sample (Para.0014 "The aim of the invention is to make the determination of trace amounts of alcohol vapor in breath possible, particularly the remote determination of alcohol vapor without interruption of the current activity of the person tested.").
Kluczynski also teaches detection of wavelengths in the wavelength range between 3.3 and 3.6 um (Para.0058 "As alluded to above the 3-4 um wavelength band have many broad absorption features due to various hydrocarbons. This also includes broadband absorption contributions from ethanol vapor itself").
However, Yi teaches two or more concave mirrors to control the infrared beam (Para.0035 "Particularly, the method proposed by Martin relates to an optical gas sensor cell structure comprising three concave reflection surfaces and applying the White's cell concept of setting the focus of reflected light on or adjacent to the opposite reflection surface.").
However, Cable teaches a control unit for determining absorption values of the first and second wavelength recordings (Para.0176 "One more specific embodiment of the present invention comprises a digital filter implemented in an FPGA, ASIC, DSP, processor, microcontroller, or any other digital processing unit.").
Cable also teaches determining a total absorption of the first and second wavelength bands, comparing these values to tabulated data, and identifying a substance representing the best match in terms of absorption values (Para.0132 "Examples of methods to align data include autocorrelation, cross-correlation, difference calculations, similarity calculations and related techniques, all of which can be used with the present invention. The data may consist of an array or vector of integer values, real values, binary values or other data storage types in memory" and Para.0147 "The calculation of the sum of the signals from detector A and detector B can be accomplished using an analog circuit comprising an operational amplifier used in a summing configuration.").
Cable also teaches high- and low-pass interference filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match.").
Cable also suggests optical filters capable of transmitting or reflecting specified wavelengths at a particular threshold (para.0196 " It is known that interferometers and optical filters can have sensitivity to polarization. Thus, it is possible for an interferometer to have different path lengths for different polarization states or for optical filters to have different reflectivity or transmission for different polarization states, which would generate an error in the alignment between any two sweeps. In order to facilitate proper alignment from different VCL sources or other wavelength swept sources, it can be beneficial to align the polarization states of the VCL sources or other sources to be similar" and para.0205 "Multiple level transitions can occur, for example from an etalon, a Fabry-Perot filter, an interferometer, multiple Bragg gratings, or an optical filter with several notch or bandpass regions, for example, or thresholded signals thereof to make a digital signal").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong as taught by Kluczynski in order to analyze breath samples using NDIR (para.0012 "it is proposed to use carbon dioxide as a tracer gas to determine the amounts of other gases in the exhaled air measuring both gas components simultaneously using NDIR spectroscopy"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with gas analysis using infrared sensing methods.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong and Kluczynski as taught by Yi in order to lengthen the path of the light sample so that small amounts of gases may be analyzed (para.0035 "This method has an advantage of simply providing a relatively long optical path compared with other methods." and para.0012 "and the length of optical path can extend to analyze even a small amount of gases on the optical path"). One skilled in the art would have a reasonable expectation of success because these methods employ mirrors for the measurement of light transmitted through gases to determine concentration.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong, Kluczynski, and Yi as taught by Cable in order to compare signals for a match (para.0132 "Similar metrics, such as SSD [sum of squared differences], can be applied to find the offset with the best match. Both the direct comparison of signals and the comparison of counted values are considered part of a correspondence match of the present invention."). One skilled in the art would have a reasonable expectation of success because both methods can utilize infrared laser spectroscopy for analyzing a gaseous sample.
Regarding claims 21, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claim 20, on which this claim depends. Wong also teaches the preselected transition wavelength is the characteristic transition wavelength of the first interference filter (Abstract "a first interference bandpass filter mounted on the top side of the substrate so that the first filter covers the aperture above the first detector and the first filter is interposed between the port and the first detector, the first interference bandpass filter designed to pass incident radiation at a first spectral band", as the transition wavelength can be set as the first interference filter).
Regarding claims 22 and 23, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claim 21, on which these claims depend. Cable also teaches high- and low-pass interference filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match.").
Regarding claim 24, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claim 20, on which this claim depends. Kluczynski also teaches identifying the reception of a human breath sample by means of peak detection of at least one tracer gas and determining a tracer gas concentration value and a step of determining a breath concentration value of the identified substance wherein the tracer gas concentration value is utilized (Para.0052 "The apparatus may include means to measure a known concentration of a tracer gas such as water vapor or carbon dioxide from the exhaled breath in order to determine the length of the absorption column and the dilution of the sample of exhaled air in the measuring space. If the absorption features of ethanol and the tracer gas is close in wavelength both ethanol and the tracer gas can be measured using one laser, as shown in FIG. 2a. The absolute concentration of ethanol in the exhaled breath can then be determined using the measured concentration of ethanol and the tracer gas.").
Regarding claim 26, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claim 20, on which this claim depends. Kluczynski also teaches if the identified substance is not ethanol, an error indication is issued (Abstract "the information about the level of the ethanol content is provided to a suitable display or device").
Regarding claim 29, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claim 20, on which this claim depends. Kluczynski also teaches the absorption comparative value is a ratio between the absorption in the first wavelength band and the absorption in the second wavelength band (Para.0060 "After removing the constant offset from both the ethanol and the tracer gas signals and taking the ratio we obtain the final formula for the ethanol concentration in exhaled breath").
Regarding claim 30, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claims 20 and 24, on which this claim depends. Kluczynski also teaches the total absorption is the sum of the absorption in the first wavelength band and the second wavelength band normalized with the tracer gas concentration value (Para.0059 " As we can see the above procedure enables us to normalize the ethanol absorption signal against both the total transmission T and the broadband absorption in the region of the "plateau" absorption T.sub..alpha.(c) at 403 and the changes in the light intensity from the source").
Regarding claim 32, Wong in view of Kluczynski and Cable teach the methods of Claim 20, on which this claim depends. Wong also teaches a first, second, and third infrared detector (Abstract "a first, a second and a third thermopile detector fabricated on the bottom side of the substrate, the hot junctions of each thermopile detector positioned over one of the apertures in the substrate so as to receive radiation transmitted through the aperture, and the cold junctions of each thermopile detector positioned over the substrate").
Wong also teaches the first signal represents the absorption in a first wavelength band, the second signal represents the absorption in a second wavelength band, and the third signal represents the absorption in a third wavelength band in the preselected wavelength range (Abstract "a first [second and third] interference bandpass filter mounted on the top side of the substrate so that the first [second and third] filter covers the aperture above the first [second and third] detector and the first [second and third] filter is interposed between the port and the first [second and third] detector, the first [second and third] interference bandpass filter designed to pass incident radiation at a first [second and third] spectral band").
Wong also teaches the first and second wavelength bands are separated by a preselected first transition wavelength corresponding to the first transition wavelength associated with the first interference filter, and the second and third wavelength bands are separated by a preselected second transition wavelength corresponding to the second transition wavelength associated with the second interference filter (Page 24 col 16 line 57 "The CWL [center wavelength] and FWHM [full width at half maximum] of bandpass filters F.sub.1, F.sub.2 and F.sub.3 are set as described in connection with FIGS. 1-3").
Cable teaches determining absorption values of the various wavelength recordings and determining a total absorption of the wavelength bands (Para.0132 "Examples of methods to align data include autocorrelation, cross-correlation, difference calculations, similarity calculations and related techniques, all of which can be used with the present invention. The data may consist of an array or vector of integer values, real values, binary values or other data storage types in memory" and Para.0147 "The calculation of the sum of the signals from detector A and detector B can be accomplished using an analog circuit comprising an operational amplifier used in a summing configuration.").
Claim27 rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US-5721430) in view of Kluczynski et al. (US-20130334419), Yi et al. (US-20070279633), and Cable et al. (US-20170074640) as applied to claims 20-24, 26, 29, 30, and 32 above, and further in view of Blackley et al. (US-20160371590).
Wong et al. in view of Kluczynski et al., Yi et al., and Cable et al. are applied to claims 20-24, 26, 29, 30, and 32.
Regarding claim 27, Wong in view of Kluczynski, Yi, and Cable teach the methods of Claim 20, on which this claim depends.
Wong, Kluczynski, Yi, nor Cable explicitly teach a subset from the set of preselected substances has been predefined and the method further includes the step of determining a breath concentration value of the identified substance wherein the tracer gas concentration value is utilized is performed only if the identified substance is one of the substances in the subset.
However, while the specific differential of not determining a breath concentration value unless the identified substance is one of a subset is not found in the art for this particular device/application, Blackley does describe identification and subsequent determination of several characteristics of the detected substance including concentration (Para.0228 "The sensor can be further configured to detect one or more of, an identification of the one or more constituents a type of one or more constituents, a mixture of one or more constituents, a temperature, a color, a concentration, a quantity, a toxicity, a pH, a vapor density, or a particle size.").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong, Kluczynski, and Cable as taught by Blackley in order to determine blood alcohol level of the sampled individual (para.0239 "The analysis result can relate to at least one of a medical condition, a personal characteristic, a genetic characteristic, a disease type, a disease symptom, a vital measurement, a wellness indicator, or a spirometric measurement. For example, the analysis result can relate to a blood alcohol level"). One skilled in the art would have a reasonable expectation of success because these methods use sampled air for detection and identification of analytes using spectrometry.
Claim 33 rejected under 35 U.S.C. 103 as being unpatentable over Wong et al. (US-5721430) in view of Kluczynski et al. (US-20130334419), Yi et al. (US-20070279633), and Cable et al. (US-20170074640).
Regarding claim 33, Wong teaches an apparatus for non-dispersive gas analysis operating in a preselected wavelength range of an unidentified substance (Abstract "The disclosed infrared detector assemblies can be used in traditional NDIR [non-dispersive infrared] gas sensors having an active source or in passive infrared analysis gas sensors" and Page 17 col 2 line 66 "The present invention is directed toward an infrared gas sensor for detecting the concentration of one or more predetermined gases using a novel infrared gas analysis technique referred to as passive infrared analysis (PIA).").
Wong also teaches a measuring cell comprising non-dispersive infrared elements (Page 19 col 5 line 35 "Furthermore, in the PIA technique employed in the infrared gas sensor of the present invention, the space between the passive infrared source, for example a certain portion of a wall, and the detector assembly becomes the sample chamber.")
Wong also teaches a source configured to transmit an infrared beam (Abstract "The disclosed infrared detector assemblies can be used in traditional NDIR gas sensors having an active source").
Wong also teaches multiple interference filters arranged in the optical path of the measuring cell for detection by multiple detectors (Abstract "a first, a second and a third thermopile detector fabricated on the bottom side of the substrate, the hot junctions of each thermopile detector positioned over one of the apertures in the substrate so as to receive radiation transmitted through the aperture, and the cold junctions of each thermopile detector positioned over the substrate" and Abstract "a first [and second] interference bandpass filter mounted on the top side of the substrate so that the first [and second] filter covers the aperture above the first [and second] detector and the first [and second] filter is interposed between the port and the first [and second] detector, the first [and second] interference bandpass filter designed to pass incident radiation at a first [and second] spectral band").
Wong also teaches the first and second wavelength bands are separated by a preselected first transition wavelength corresponding to the first transition wavelength associated with the first interference filter, and the second and third wavelength bands are separated by a preselected second transition wavelength corresponding to the second transition wavelength associated with the second interference filter (Page 24 col 16 line 57 "The CWL [center wavelength] and FWHM [full width at half maximum] of bandpass filters F.sub.1, F.sub.2 and F.sub.3 are set as described in connection with FIGS. 1-3").
Wong also teaches the first signal represents the absorption in a first wavelength band, the second signal represents the absorption in a second wavelength band, and the third signal represents the absorption in a third wavelength band in the preselected wavelength range (Abstract "a first [second and third] interference bandpass filter mounted on the top side of the substrate so that the first [second and third] filter covers the aperture above the first [second and third] detector and the first [second and third] filter is interposed between the port and the first [second and third] detector, the first [second and third] interference bandpass filter designed to pass incident radiation at a first [second and third] spectral band").
Wong does not explicitly teach analysis of a human breath sample, detection of wavelengths in the wavelength range between 3.3 and 3.6 um, two or more concave mirrors to control the infrared beam, nor an optical filter that is capable of both transmitting and reflecting infrared radiation with a specified transition wavelength.
However, Kluczynski teaches analysis of a human breath sample (Para.0014 "The aim of the invention is to make the determination of trace amounts of alcohol vapor in breath possible, particularly the remote determination of alcohol vapor without interruption of the current activity of the person tested.").
Kluczynski also teaches detection of wavelengths in the wavelength range between 3.3 and 3.6 um (Para.0058 "As alluded to above the 3-4 um wavelength band have many broad absorption features due to various hydrocarbons. This also includes broadband absorption contributions from ethanol vapor itself").
However, Yi teaches two or more concave mirrors to control the infrared beam (Para.0035 "Particularly, the method proposed by Martin relates to an optical gas sensor cell structure comprising three concave reflection surfaces and applying the White's cell concept of setting the focus of reflected light on or adjacent to the opposite reflection surface.").
However, Cable teaches high- and low-pass interference filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."), and also suggests optical filters capable of transmitting or reflecting specified wavelengths at a particular threshold (para.0196 " It is known that interferometers and optical filters can have sensitivity to polarization. Thus, it is possible for an interferometer to have different path lengths for different polarization states or for optical filters to have different reflectivity or transmission for different polarization states, which would generate an error in the alignment between any two sweeps. In order to facilitate proper alignment from different VCL sources or other wavelength swept sources, it can be beneficial to align the polarization states of the VCL sources or other sources to be similar" and para.0205 "Multiple level transitions can occur, for example from an etalon, a Fabry-Perot filter, an interferometer, multiple Bragg gratings, or an optical filter with several notch or bandpass regions, for example, or thresholded signals thereof to make a digital signal").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong as taught by Kluczynski in order to analyze breath samples using NDIR (para.0012 "it is proposed to use carbon dioxide as a tracer gas to determine the amounts of other gases in the exhaled air measuring both gas components simultaneously using NDIR spectroscopy"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with gas analysis using infrared sensing methods.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong and Kluczynski as taught by Yi in order to lengthen the path of the light sample so that small amounts of gases may be analyzed (para.0035 "This method has an advantage of simply providing a relatively long optical path compared with other methods." and para.0012 "and the length of optical path can extend to analyze even a small amount of gases on the optical path"). One skilled in the art would have a reasonable expectation of success because these methods employ mirrors for the measurement of light transmitted through gases to determine concentration.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Wong, Kluczynski, and Yi as taught by Cable in order to compare signals for a match (para.0132 "Similar metrics, such as SSD [sum of squared differences], can be applied to find the offset with the best match. Both the direct comparison of signals and the comparison of counted values are considered part of a correspondence match of the present invention."). One skilled in the art would have a reasonable expectation of success because both methods can utilize infrared laser spectroscopy for analyzing a gaseous sample.
Response to Arguments under 35 USC § 103
Applicant’s arguments filed 2/26/2026 are fully considered but they are not persuasive.
Applicant asserts "that the method called for in amended claim 1 is [n]either anticipated by, [n]or rendered obvious by, Wong, Kluczynski or Cable, whether these references are taken alone or in combination with one another" (Remarks 2/26/2026 page 8). Specifically, Applicant asserts that Wong, Kluczynski, and Cable "taken alone or in combination with one another fail to teach or suggest an optical filter that is capable of both transmitting and reflecting infrared radiation with a specified transition wavelength, as is now required by amended claim 1" (Remarks 2/26/2026 pages 9-10). Examiner notes the following as evidence to the contrary: para.0054 "In various optional aspects an arrangement with optical filters well known in the art can be used for separating the wavelength channels" suggests an optical filter capable of both transmitting and reflecting infrared radiation with a specified wavelength; and Cable suggests optical filters capable of transmitting or reflecting specified wavelengths at a particular threshold (para.0196 " It is known that interferometers and optical filters can have sensitivity to polarization. Thus, it is possible for an interferometer to have different path lengths for different polarization states or for optical filters to have different reflectivity or transmission for different polarization states, which would generate an error in the alignment between any two sweeps. In order to facilitate proper alignment from different VCL sources or other wavelength swept sources, it can be beneficial to align the polarization states of the VCL sources or other sources to be similar" and para.0205 "Multiple level transitions can occur, for example from an etalon, a Fabry-Perot filter, an interferometer, multiple Bragg gratings, or an optical filter with several notch or bandpass regions, for example, or thresholded signals thereof to make a digital signal").
All other arguments from Applicant are concerned with the other cited references (Blackley and Yi) not remedying the alleged deficiencies of Wong, Kluczynski, and Cable (Remarks 2/26/2026 pages 10-12). Examiner notes that the independent claims have been shown to be obvious and therefore unpatentable over Wong in view of Kluczynski and Cable, and further the previous rejections of the dependent claims are maintained.
Therefore, the rejection of claims 1, 20, and 33 under 35 USC 103 is maintained. All other claims depend from these independent claims; therefore, their rejection is likewise maintained.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, 13, and 27 of U.S. Patent No. 9823237 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve a breath sample inlet, a measuring cell, an infrared light source, at least two mirrors, multiple detectors, and interference filters.
While US-9823237 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11499914 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both a measuring cell, infrared light source, concave mirrors, multiple detectors, multiple interference filters specifically targeting wavelengths between 2.7 - 4.25 um wavelength, and bandpass filters.
While US-11499914 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11747274 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve a similar multiple concave mirror device for elongating the light path and focusing it on multiple detectors for sensing gases using an emitted infrared light source.
While US-11747274 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12140536 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve non-dispersive infrared sensors for measuring the concentration of a gas.
While US-12140536 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of US-20230051132 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve sampling exhaled breath, a measuring unit, a control unit, peak and tracer determination for calculating concentration of a substance.
While US-20230051132 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US-20230286466 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve sampling exhaled breath, identifying a substance then determining its concentration.
While US-20230286466 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Claims 1-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of US-20240310276 in view of Cable et al. (US-20170074640). Although the claims at issue are not identical, they are not patentably distinct from each other because both involve the same multiple concave mirror device for elongating the light path and focusing it on multiple detectors for sensing gases using an emitted infrared light source.
While US-20240310276 does not explicitly teach transmitting and reflecting radiation with a specified wavelength, it would have been obvious to one of ordinary skill in the art to modify these methods, with those taught by Cable as described above for claims 1, 20, and 33 of the instant application, in order to filter subsets of data using high or low pass filtering (Para.0140 "The further processing may include subselection of data, high pass filtering, low pass filtering, or any other mathematical processing of the data performed before the correspondence match."). One skilled in the art would have a reasonable expectation of success because both methods are capable of utilizing infrared laser spectroscopy for analyzing a gaseous sample.
Response to Arguments under Double Patenting
Applicant’s arguments filed 2/26/2026 are fully considered but they are not persuasive.
Applicant asserts "that none of the claims identified by the Examiner in the '237 Patent, the '914 Patent, the '274 Patent, the '536 Patent, the '132 Publication, the '466 Publication or the '276 Publication call for an optical interference filter that is capable of both transmitting and reflecting infrared radiation with a specified transition wavelength, as is now required by the independent claims of the instant patent application" (Remarks 2/26/2026 page 12). Examiner notes that the combination of any of the Patents or Publications with Cable would render the claims rejected on the ground of nonstatutory double patenting.
Therefore, the rejection of claims 1, 20, and 33 under nonstatutory double patenting is maintained. All other claims depend from these independent claims; therefore, their rejection is likewise maintained.
Conclusion
No claims are allowed.
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 TH REE-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 finaI action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert A. Player whose telephone number is (571)272-6350. The examiner can normally be reached Mon-Fri, 8am-5pm.
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, Larry D. Riggs can be reached on 571-270-3062. 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.
/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
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