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 .
Election/Restrictions
Applicant’s election of Invention II, claims 16-24, in the reply filed on 10/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-15 and 25-29 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 16-24 are currently under examination.
Claim Objections
Claim 17 is objected to because of the following informalities:
In Claim 17, “determining based on the measured pressure evolution a heath state of lungs”, should read -determining, based on the measured pressure evolution, a heath state of lungs- (Examiner's Note: Insertion of commas)
In Claim 22, “lung biomarker” (line 1), should read -the lung biomarker-
Appropriate correction is required.
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 16-24 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation “A method for pulmonary monitoring, the method comprising: non-flow measurement of pressure evolution from an individual holding an inhaled breath.” This is a “use” claim that is indefinite, as the applicant fails to effectively define the metes and bounds of the claim. The applicant merely recites the use, without providing further detail as to how the use is practiced, and as such the claim indefinite. For examination purposes, this will be interpreted as if the above limitation did include sufficient detail.
Claims 17-24 are dependent on claim 16, and as such are also rejected.
Claim 18 recites the limitation “wherein the health state of the lungs of the individual is the abnormal lung function”, which fails to effectively define the metes and bounds of the claim as it is unclear as to the health states of the lungs. For example, claim 17, which claim 18 is dependent on, recites “wherein the health state of the lungs of the individual includes normal lung function and abnormal lung function”, which indicates that the health state includes both normal lung function and abnormal lung function. However, claim 18 recites “the health state of the lungs of the individual is the abnormal lung function”, which indicates that the health state is the abnormal lung function and appears to contradict the previous claim. Was this meant to be a conditional limitation that states “wherein when the health state…”? As such the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as -determining that the health state of the lungs of the individual includes the abnormal lung function-. (Examiner's Note: It appears that the applicant may have intended for this to be a conditional limitation, however, due to this lack of clarity, it will not be treated as a conditional limitation.)
Claim 18 recites the limitation “determining between different types of the abnormal lung function”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what different types of abnormal lung function are being referred to. What are the different types? How are the different types determined? As such the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, the different types of abnormal lung function will be interpreted as disease states (Par. 14 of applicant’s spec.).
Claim 20 recites the limitation “wherein the individual holds their breath for as long as possible”, which fails to effectively define the metes and bounds of the claim as it is unclear as to how long is considered to be “as long as possible”. As such the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any amount of time (Par. 13 of applicant’s spec.).
Claim 21 recites the limitation “the recorded pressure measurements” in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -the pressure measurement- (Examiner's Note: There is no previous “recording” step).
Claim 23 recites the limitation “wherein the lung biomarker is a biomarker of disease manifestation”, which fails to effectively define the metes and bounds of the claim as it is unclear what the applicant considers to be “a biomarker of disease manifestation”. As such the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as any of the three different types of lung biomarkers (Par. 38, 39, 44, and 53 of applicant’s spec.).
Claim 24 recites the limitation “wherein the measured pressure evolution of the fixed volume of air is a measurement of non-flow lung properties” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this will be interpreted as -wherein the measured pressure evolution is a measurement of non-flow lung properties-.
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 16-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because single "use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. Therefore, the claim is rejected as it does not fall under a statutory category of 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The claims are generally directed towards a method of measuring a non-flow measurement of an individual holding their breath.
Claim(s) 16 and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (“Quantitative surface wave method for measuring local viscoelasticity of lungs”, 2009) hereinafter Zhang, and further in view of Zhang et al. (“Assessment of interstitial lung disease using lung ultrasound surface wave elastography”, 2017) hereinafter Zhang 2.
Regarding claim 16, Zhang teaches A method for pulmonary monitoring (Abstract (viscoelasticity measurement of lungs)), the method comprising:
non-flow measurement of pressure evolution from an individual (Abstract (viscoelasticity measurement of lungs)) (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”) (Examiner's Note: the non-flow measurement of pressure evolution is interpreted as a measurement of viscoelasticity).
Zhang fails to explicitly disclose an individual holding an inhaled breath.
However, Zhang 2 teaches an individual holding an inhaled breath (Abstract (Full inspiration breath hold for patients)) (Page 3, col. 1, “Bilateral measurements are made on the lung. The lung testing is performed with full inspiration breath hold”).
Zhang and Zhang 2 are considered to be analogous art to the claimed invention as they are involved with the measurement of respiration parameters.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Zhang with that of Zhang 2 to include an individual holding an inhaled breath through the substitution of experimental participants as it would yielded the predictable result of assessing individuals suffering from lung diseases (Zhang 2 (Abstract)).
Regarding claim 20, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Zhang 2 further teaches wherein the individual holds their breath for as long as possible (Zhang 2 (Abstract (Full inspiration breath hold)) (Page 3, col. 1, “Bilateral measurements are made on the lung. The lung testing is performed with full inspiration breath hold”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Zhang and Zhang 2 with that of Zhang 2 to include wherein the individual holds their breath for as long as possible for the reasoning as indicated in claim 16 above.
Regarding claim 21, modified Zhang further discloses analyzing a decrease of pressure over time from the recorded pressure measurements with rheological models to generate a lung biomarker (Zhang (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”(viscoelasticity measurement))).
Regarding claim 22, modified Zhang further discloses wherein lung biomarker includes at least one of an indication of peak pressure, an indication of asymptotic pressure, an indication of fractional relaxation, an indication of degrees of non-linearity, an indication of a time-constant, or an indication of solid versus fluid proportional response (Zhang (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”(viscoelasticity measurement))).
Regarding claim 23, modified Zhang further discloses wherein the lung biomarker is a biomarker of disease manifestation (Zhang (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”(viscoelasticity measurement))).
Regarding claim 24, modified Zhang further discloses wherein the measured pressure evolution of the fixed volume of air is a measurement of non-flow lung properties (Zhang (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”(viscoelasticity measurement))), the non-flow properties being viscoelasticity defined as the time (viscous) and stretch (elastic) dependency of lung function (Zhang (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”(viscoelasticity measurement))).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Zhang 2 as applied to claim 16 above, and further in view of Adam (US Pub. No. 20160106341) hereinafter Adam.
Zhang and Zhang 2 teach the method of claim 16 above.
Regarding claim 17, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Zhang does disclose determining based on the measured pressure evolution a health state of lungs of the individual (Zhang (Abstract (viscoelasticity measurement of lungs)) (Page 3, Col. 1, Fig. 5, “The wave speed dispersion with frequency can be estimated by measuring the wave speed at different frequencies. Fig. 5 shows the wave speed dispersion of the lung from 100 Hz to 400 Hz at 3 mm Hg pressure. The shear elasticity μ1 and shear viscosity μ2 can be estimated from the wave speed dispersion with…”))(Examiner's Note: the non-flow measurement of pressure evolution is interpreted as a measurement of viscoelasticity).
However, Adam teaches determining based on the measured pressure evolution a heath state of lungs of the individual (Par. 113, “Determining other respiratory parameters may also be performed in step 620…”), and wherein the health state of the lungs of the individual includes normal lung function and abnormal lung function (Par. 114, “Furthermore, the respiratory parameter determined in step 620 from the respiratory measurements may be a diagnosis or any qualitative measure of respiratory health (e.g., health, obstructive respiratory disease, restrictive respiratory disease, mixed defect, pulmonary vascular disorder, chest wall disorder, neuromuscular disorder, interstitial lung disease, pneumonitis, asthma, chronic bronchitis, emphysema).”).
Zhang, Zhang 2, and Adam are considered to be analogous art to the claimed invention as they are involved with the measurement of respiration parameters.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Zhang and Zhang 2 with that of Adam include determining based on the measured pressure evolution of Zhang a heath state of lungs of the individual of Zhang 2, and wherein the health state of the lungs of the individual includes normal lung function and abnormal lung function through the combination of references as differing lung states are known in the art (Adam (Par. 114)) and it would have yielded the predictable result of providing additional information regarding the respiratory health of the user.
Regarding claim 18, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Adam further teaches wherein the health state of the lungs of the individual is the abnormal lung function, the method further comprising: determining between different types of the abnormal lung function (Adam (Par. 113, “Determining other respiratory parameters may also be performed in step 620…”) (Par. 114, “Furthermore, the respiratory parameter determined in step 620 from the respiratory measurements may be a diagnosis or any qualitative measure of respiratory health (e.g., health, obstructive respiratory disease, restrictive respiratory disease, mixed defect, pulmonary vascular disorder, chest wall disorder, neuromuscular disorder, interstitial lung disease, pneumonitis, asthma, chronic bronchitis, emphysema).”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Zhang, Zhang 2, and Adam with that of Adam include wherein the health state of the lungs of the individual is the abnormal lung function, the method further comprising: determining between different types of the abnormal lung function through the combination of references as differing lung states are known in the art (Adam (Par. 114)) and it would have yielded the predictable result of assessing different respiratory disorders for a patient.
Regarding claim 19, modified Zhang fails to explicitly disclose the limitations of the claim.
However, Adam further teaches continuously monitoring the abnormal lung function for disease progression (Adam (Par. 111 (real time))(Par. 113, “Determining other respiratory parameters may also be performed in step 620…”) (Par. 114, “Furthermore, the respiratory parameter determined in step 620 from the respiratory measurements may be a diagnosis or any qualitative measure of respiratory health (e.g., health, obstructive respiratory disease, restrictive respiratory disease, mixed defect, pulmonary vascular disorder, chest wall disorder, neuromuscular disorder, interstitial lung disease, pneumonitis, asthma, chronic bronchitis, emphysema).”)(Par. 115 (routine)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Zhang, Zhang 2, and Adam with that of Adam include continuously monitoring the abnormal lung function for disease progression through the combination of references as it would have yielded the predictable result of providing a real time assessment of the patient condition (Adam (Par. 111)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571) 272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARI S PADDA/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791