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 . 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 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.
Response to Amendment
This Office Action is responsive to the amendment filed 01/07/2026 (“Amendment”). Claims 30, 32-34, 37-46, 49, and 50 are currently under consideration. The Office acknowledges the amendments to claims 30, 37, 38, 40, 45, and 49, as well as the cancellation of claims 47 and 48 and the addition of new claim 50. Claims 31, 35, and 36 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 30 and 45 are objected to because of the following informalities:
Regarding claim 30, the recitation of “breath flow rate is disposed” should instead read –breath flow rate disposed--.
Further regarding claim 30, the recitation of “using flow rate” should instead read –using the flow rate--.
Regarding claim 45, the recitation of “potassium ferric ferrocyanide” should be changed to –potassium ferrocyanide--.
Appropriate correction is required.
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: “cooling device” in claims 30, 32-34, 37, and 49, and “temperature control unit” in claims 30, 32, 33, and 49.
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 (e.g. for “cooling device,” a Peltier device as described in the specification, and for “temperature control unit,” a sensor and microcontroller as shown in e.g. Fig. 9).
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 30, 32-34, 37-46, 49, and 50are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 30 and 49, there is insufficient antecedent basis for the recitations of “the mouthpiece unit.” Further, it is unclear whether this unit is distinct from the already-recited mouthpiece. For purposes of examination, it will be interpreted as the same mouthpiece.
Regarding claim 45, it is unclear how all of the elements can be recited in the alternative when the second element appears to depend from the first.
Claims 32-34, 37-46, 49, and 50 are rejected because they depend on rejected claims.
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 30, 32-34, 37-46, 49, and 50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 30, 32-34, 37-46, 49, and 50 are directed to a “device,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 30 recites (“sets forth” or “describes”) the abstract idea of a mental process and a mathematical concept, substantially as follows:
calculate the specific humidity upstream of the cooling device (ω(in,m)) in a direction of flow of breath using breath temperature measured by the breath temperature sensor (610), calculate the specific humidity at the exhaust ω(out,m)) using exhaust temperature T(breath,m) measured by the exit temperature sensor (710), and determine the amount of condensate collected in the device (1000) based on the specific humidity of breath, the specific humidity at the exhaust (18) and the breath flow rate V(breath,m) using flow rate measured by the flow sensor (620).
The calculating and determining steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see a printout of e.g. the temperature and flow rate data, they would be able to derive specific humidity therefrom, and determine an amount of condensate by applying a straightforward formula. There is nothing to suggest an undue level of complexity in the calculations and determinations. Therefore, a person would be able to perform the calculations mentally or with pen and paper.
The calculating and determining steps also involve the mathematical concepts of deriving values from other values based on formulas or lookup tables. These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 30 does not include additional elements that integrate the mental process or mathematical concept into a practical application. Therefore, the claim is “directed to” the mental process and mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a temperature control unit), and
add insignificant extra-solution activity (the pre-solution activity of: obtaining data using a breath temperature sensor, exit temperature sensor, flow sensor, and sensor unit, and using a cooling device and mouthpiece to facilitate breath condensate collection).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the determined amount of condensate is not outputted in any way such that a diagnostic benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 30 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the extra-solution activity (e.g. controlling temperature (claims 32-34), measuring a biomarker (claim 34), a surface for forming condensate (claims 37 and 38), sensor details (claims 39-43, 45, and 46), etc.),
further recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. means to analyse measurements (claim 44), etc.), and
further describe the abstract idea (e.g. determining a corrected amount of condensate based on a correction factor (claims 49 and 50), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
Claim 30, 32-34, 37-44, 49, and 50 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2020/0041485 (“Funch-Nielsen”) in view of US Patent Application Publication 2015/0370271 (“Raghunathan”) and US Patent Application Publication 2018/0195984 (“Isoya”).
Regarding claim 30, Funch-Nielsen discloses [a]n exhaled breath collection device (1000) (Abstract) comprising a sensor unit (100) configured to measure a biomarker in exhaled breath (¶¶s 0080, 0093, etc.), a cooling device (200) configured to reduce a temperature of exhaled breath (Abstract, ¶ 0085, etc.), a temperature control unit (¶¶s 0020, 0021, 0085 (static or dynamic temperature)), wherein the temperature control unit can, in use, control the cooling device (200) to reach a target temperature greater than 0 °C and less than or equal to 30 °C (¶¶s 0054, 0085, 0097, etc., 10 or 5 °C), a mouthpiece (300) configured to direct exhaled breath towards the cooling device (200)(¶¶s 0091, 0109, etc.), …, wherein the biomarker is hydrogen peroxide (H2O2) (¶¶s 0080, 0083, etc.), … .
Funch-Nielsen does not appear to explicitly teach a breath temperature sensor (610) configured to measure the breath temperature disposed downstream of the mouthpiece (300) unit in a direction of flow of breath and upstream of the cooling device (200) in a direction of flow of breath (although ¶ 0036 does describe using a temperature sensor to measure breath temperature); an exit temperature sensor (710) disposed at the device exhaust (18) to measure the temperature of breath leaving the device; and a flow sensor configured to measure the breath flow rate is disposed downstream of the mouthpiece (300) unit in a direction of flow of breath and upstream of the cooling device (200) in a direction of flow of breath (although ¶ 0116 does describe monitoring flow rate), wherein the temperature control unit is configured to calculate the specific humidity upstream of the cooling device (ω(in,m)) in a direction of flow of breath using breath temperature measured by the breath temperature sensor (610), calculate the specific humidity at the exhaust (ω(out,m)) using exhaust temperature (T(breath,m)) measured by the exit temperature sensor (710), and determine the amount of condensate collected in the device (1000) based on the specific humidity of breath, the specific humidity at the exhaust (18) and the breath flow rate (V(breath,m)) using flow rate measured by the flow sensor (620).
Raghunathan teaches calculating an amount of condensation by taking a difference in specific humidity between the inlet and outlet of a unit and accounting for flow rate through the unit (¶ 0038), while also measuring temperature (¶ 0029, etc.).
Isoya teaches a known relationship between temperature and specific humidity (¶ 0149).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate temperature sensors into Funch-Nielsen to measure breath and exhaust temperatures, and to incorporate a flow sensor as well, thereby measuring on both sides of the condensation area, as in Raghunathan, for the purpose of calculating the amount of condensation formed (Raghunathan: ¶ 0038) according to known relationships (Isoya: ¶ 0149), and for the purpose of ensuring a sufficient amount of condensation was obtained (Funch-Nielsen: ¶¶s 0039, 0115, etc.).
Regarding claim 32, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the temperature control unit is configured to control the cooling device (200) to cool down to the target temperature greater than 0 °C and less than or equal to 30 °C (Funch-Nielsen: ¶¶s 0054, 0085, 0097, etc., 10 or 5 °C, cooling the condensing zone).
Regarding claim 33, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the control unit is configured to control the cooling device (200) such that the temperature remains above 0 °C until the target temperature is reached (Funch-Nielsen teaches cooling the condensing zone e.g. down to 10 °C (¶¶s 0054, 0085, 0097, etc., 10 or 5 °C). Therefore, there is no reason for the temperature to ever reach below 0 °C, and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cool the device such that the temperature remains above 0 °C until the target temperature is reached, for the purpose of saving energy by not cooling more than necessary (Funch-Nielsen: ¶ 0085).
Regarding claim 34, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the cooling device (200) is configured to reduce the temperature of exhaled breath such that exhaled breath condensate is formed, and the sensor unit (100) is configured to measure the biomarker in the exhaled breath condensate (Funch-Nielsen: ¶ 0080).
Regarding claim 37, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches a condensation surface (21) configured to be cooled by the cooling device (200) and disposed to be exposed to exhaled breath introduced to the device (1000) (Funch-Nielsen: Abstract, ¶ 0085, etc.); wherein the condensation surface (21) is disposed in contact with the cooling device (200); or wherein the condensation surface (21) is a surface of the cooling device (200) (Funch-Nielsen: ¶¶s 0085, 0122, etc., a Peltier plate for cooling the cartridge – also see Fig. 1, a condensing zone that is kept cool by the cooling device).
Regarding claim 38, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the condensation surface (21) is disposed perpendicular to the direction of flow of exhaled breath through the mouthpiece (300) (Funch-Nielsen: Figs. 1, 1a, 1b, and 2, ¶ 0091, etc., the condensing zone is uppermost, such that fluid flows down into the sensing zone. This suggests that exhaled breath flows e.g. into the page, which means there is a vertical wall of the condensing zone that is perpendicular to the direction of flow of exhaled breath).
Regarding claim 39, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 37, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the sensor unit (100) is disposed such that exhaled breath condensate formed on the condensation surface (21) is deposited on the sensor unit (100) (Funch-Nielsen: ¶ 0093, Fig. 1a, condensing zone 12 leads to sensor element 19, working electrode 20, and ceramic sensor 21).
Regarding claims 40 and 41, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the sensor unit (100) comprises a biosensor (110), wherein the biosensor (110) is an electrochemical sensor (Funch-Nielsen: ¶¶s 0041, 0081, etc.); wherein the sensor unit (100) comprises an inert adsorption layer (140); or wherein the sensor unit (100) comprises an inert adsorption layer (140) configured to direct exhaled breath condensate to the biosensor (110), wherein the inert adsorption layer (140) comprises one or more porous polymers, or one or more porous ceramics (Funch-Nielsen: ¶ 0093, the working electrode 20 is housed as part of a ceramic sensor 21 – also see ¶¶s 0046, 0047, etc.). Note that based on claim interpretation, only one of the “wherein” clauses needs to be taught by the art, including e.g. the first clause. Nonetheless, for purposes of facilitating compact prosecution, others have also been found.
Regarding claim 42, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the exhaled breath collection device (1000) is configured such that the sensor unit (100) can be removed (Funch-Nielsen: ¶ 0086, the analytical elements can be incorporated into a removable section, while the collection elements can be reused. Also note, since the sensor unit is not molded with the rest of the device, it is removable for that reason as well).
Regarding claim 43, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches an electrical contact (16) configured to interface with a corresponding electrical contact (160) of the sensor unit (100) (Funch-Nielsen: ¶ 0093, corresponding elements on the apparatus housing enabling electrical connection with electrical contact pads 22, Fig. 1a).
Regarding claim 44, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches means to analyse the biomarker measurements taken by the sensor unit (100) (Funch-Nielsen: ¶¶s 0088, 0090, 0091, 0118-0120, etc., the device is a collection and analysis device that is able to perform calculations based on sensed data).
Regarding claim 49, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the temperature control unit is configured to determine a corrected amount of condensate based on the determined amount of condensate collected in the device (1000) and a correction factor (CF); wherein the correction factor (CF) is based on the ratio of the determined amount of condensate collected in the device to a standardised amount of condensate based on predetermined values of breath temperature downstream of the mouthpiece unit and upstream of the cooling device, breath flow rate downstream of the mouthpiece unit and upstream of the cooling device, temperature of the cooling device and exhaust breath temperature (it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a corrected amount of condensation based on the determined amount and a correction factor based on corrected sensor values (see e.g. ¶ 0149 of Isoya), for the purpose of accounting for device calibration and expected results).
Regarding claim 50, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 49, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the correction factor (CF) is defined by [the claimed equation] wherein A is the area of the condensation surface (21), k(overall,m) is the overall mass transfer coefficient; V(breath,m) is the breath flow rate using flow rate measured by the flow sensor (620); ω(in,m) is the specific humidity upstream of the cooling device (200); ω(out,m) is the specific humidity at the exhaust (18); T(breath,m) is the exhaust temperature; k(overall,s) is a predetermined standardised overall mass transfer coefficient; V(breath,s) is a predetermined standardised breath flow rate; ω(in,s) is a predetermined standardised upstream specific humidity; ω(out,s) is a predetermined standardised exhaust specific humidity; and T(breath,s) is a predetermined standardised exhaust temperature (it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine a corrected amount of condensation based on the determined amount and a correction factor based on corrected sensor values (see e.g. ¶ 0149 of Isoya), for the purpose of accounting for device calibration and expected results).
Claims 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Funch-Nielsen-Raghunathan-Isoya in view of US Patent Application Publication 2020/0232970 (“Haick”).
Regarding claims 45 and 46, Funch-Nielsen-Raghunathan-Isoya teaches all the features with respect to claim 30, as outlined above. Funch-Nielsen-Raghunathan-Isoya further teaches wherein the sensor unit (100) comprises an electrode (120) coated with an active agent dispersed in a [] polymer [matrix] (Funch-Nielsen:¶¶s 0041, 0051, 0081, etc.); wherein the active agent is potassium ferric ferrocyanide (Funch-Nielsen: ¶¶s 0082 and 0083); or wherein there is at least 0.1 nmol/cm2 of potassium ferric ferrocyanide on the surface of the electrode (120), but does not appear to explicitly teach that the polymer is a conductive polymer, or wherein the conductive polymer is poly(3,4-ethylenedioxythiophene)-poly(styrenesulfonate). Note that based on claim interpretation, only one of the “wherein” clauses needs to be taught by the art, including e.g. the second clause. Nonetheless, for purposes of facilitating compact prosecution, others have also been found.
Haick teaches using a PEDOT:PSS conducting polymer as the polymer matrix of a breath gas-sensing electrode (¶¶s 0032, 0114, 0117, 0119, 0120), where PEDOT:PSS is poly(3,4-ethylenedioxythiophene)-poly(styrenesulfonate) (¶ 0013).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the polymer matrix of the combination with PEDOT:PSS as in Haick, as a simple substitution of parts with predictable results (detecting breath gases – Haick: ¶ 0032), and for the purpose of using a material with enhanced resistivity towards external stimuli (Haick: ¶ 0005) and insensitivity to lateral strain (Haick: ¶ 0009).
Response to Arguments
Applicant’s arguments filed 01/07/2026 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 101, they are not persuasive. The Office has not relied on characterizing elements as well-understood or routine. Instead, the elements are described as being used in pre-solution data-gathering activity, e.g. involving forming a condensate to be measured. Applicant has presented no other or specific arguments. Thus, the rejections are maintained.
In response to the arguments and amendments regarding the rejections under 35 USC 102, they are persuasive. However, they are not persuasive in view of the further teachings of Raghunathan and Isoya, as outlined above.
Any reasoning at the international stage, found in e.g. an International Preliminary Report on Patentability, is not binding on the Office.
Further, the Office maintains that Funch-Nielsen teaches monitoring flow rate (e.g. via a flow sensor - ¶ 0116). And Raghunathan uses a formula that requires measuring mass flow rate of air. To make the formula work, mass flow rate must be detected. Creating flow with a fan is not the same as determining mass flow rate. I.e., both of these references teach (and suggest) a flow sensor.
Raghunathan also teaches determining specific humidity at the inlet and outlet of a unit, and this teaching would have been obvious to apply to Funch-Nielsen as outlined above. Raghunathan is analogous art because, even if from a different field, it seeks to solve the same problem (e.g., calculating an amount of condensation formed).
Isoya’s teachings on absolute humidity have not been cited by the Office, so Applicant’s related arguments are unclear. Isoya is analogous art because it seeks to solve the same problem (e.g., how to use relationships between temperature, humidity, etc. to determine physical quantities of a gas).
Applicant has presented a general argument and a bare allegation of patentability, without any specific analysis of which features are e.g. not taught by the prior art. Thus, all claims remain rejected in light of the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791