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 .
Claim Objections
Claims 2, 9, and 16 are objected to because of the following informalities:
Claim 2 refers to “a reference Parameter D value”; a “Parameter D” has not been defined in the claims nor is this a standard term in the art. Per the disclosure, this refers to a curve shape or rate of increase. The claims should contain some definition or explanation of what a “Parameter D” is when using this non-standard term. This is also found in claims 9 and 16.
Claim 2 calls for “predicting a survival for the subject”; this appears to have grammatical issues as the more standard description would be a survival of a subject. The same is found in claims 9 and 16.
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 4, 5, 11, 12, 18, and 19 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 4 now refers to “the predicted survival for the subject”; there is still no antecedent basis for any term relating to survival of the subject in claim 4 or claim 1. It still appears that claim 4 should depend from claim 2, and for the purposes of examination will again be treated as such, but correction is still required. The same issue is found in claims 11 and 18.
Claim 5 defines that the method of claim 1 “further comprises” comparing all three metrics to their threshold values and determining a presence or absence of obstruction based on all three comparisons. Claim 1 already calls for comparing metrics to thresholds and determining a presence or absence of obstruction. It is unclear if the additional steps further comprised as part of claim 5 are to be performed in addition to those of claim 1, or if the intent is to further refine the steps as defined in claim 1. For the purposes of examination the claim will be treated as the latter but correction is required. The same issue is found in claims 12 and 19.
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, 2, 4-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a process, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a process comprising obtaining expiratory volume measurement and airflow measurements using a spirometer; generating a volume-time curve and a flow-volume curve based on the measurements; generating “spirometry metrics” based on the curves by applying a first function to the volume-time curve to estimate a function that approximates the obtained data by minimizing a sum of absolute deviation and including Least Absolute Residuals and determining a metric of a shape of the volume-time curve from the estimated function that describes a rate of volume increase, applying second and/or third functions to the flow-volume curve to determine metrics of a transition point and/or a transition distance associated with the flow-volume curve; comparing each of the metrics to a corresponding threshold value; and determining a presence or absence of airflow obstruction based on the comparisons.
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely indicate performing calculations (claims 2, 5, 6, 7), and generating additional information (claim 4)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and evaluating data to reach a conclusion; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on generating curves from inputted data, applying functions to the curves, and finding metrics describing features of the curves
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of metrics as compared to thresholds to evaluate a condition – a judgment or opinion regarding airflow obstruction.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 16 recites a spirometer as apparently providing the data. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim (the performance of the method is wholly disembodied), effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, and the additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of obtaining airflow measurements using a spirometer, as indicated above, are merely the insignificant extrasolution activity of data gathering, which is merely simply appending well-understood, routine, and conventional activities previously known to the industry of airflow monitoring, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional; see also A61B5/087 and A61B5/091, and, for example, US 2999495, US 3154068, US 3577984, which disclose conventional spirometry devices used to measure both flow and volume).
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Claims 8, 9, 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a system, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 8 recites a system comprising data processors, and a non-transitory computer-readable storage medium with instructions configured to cause the processors to: obtain expiratory volume measurement and airflow measurements using a spirometer; generate a volume-time curve and a flow-volume curve based on the measurements; generate “spirometry metrics” based on the curves by applying a first function to the volume-time curve to estimate a function that approximates the obtained data by minimizing a sum of absolute deviation and including Least Absolute Residuals and determine a metric of a shape of the volume-time curve from the estimated function that describes a rate of volume increase, apply second and/or third functions to the flow-volume curve to determine metrics of a transition point and/or a transition distance associated with the flow-volume curve; compare each of the metrics to a corresponding threshold value; and determine a presence or absence of airflow obstruction based on the comparisons.
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely indicate performing calculations (claims 9, 12-14), and generating additional information (claim 11)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and evaluating data to reach a conclusion; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on generating curves from inputted data, applying functions to the curves, and finding metrics describing features of the curves
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of metrics as compared to thresholds to evaluate a condition – a judgment or opinion regarding airflow obstruction.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 16 recites a spirometer as apparently providing the data and processors and instructions which perform the abstract idea. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of obtaining airflow measurements using a spirometer, as indicated above, are merely the insignificant extrasolution activity of data gathering, which is merely simply appending well-understood, routine, and conventional activities previously known to the industry of airflow monitoring, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional; see also A61B5/087 and A61B5/091, and, for example, US 2999495, US 3154068, US 3577984, which disclose conventional spirometry devices used to measure flow and volume). It is further noted that the spirometer is not positively recited as being part of the claimed system.
The additional elements of processors and instructions, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but, rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Claims 15, 16, 18-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a manufacture, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 15 recites a non-transitory machine readable storage medium embodying a computer program comprising instructions configured to cause processors to: obtain expiratory volume measurement and airflow measurements using a spirometer; generate a volume-time curve and a flow-volume curve based on the measurements; generate “spirometry metrics” based on the curves by applying a first function to the volume-time curve to estimate a function that approximates the obtained data by minimizing a sum of absolute deviation and including Least Absolute Residuals and determine a metric of a shape of the volume-time curve from the estimated function that describes a rate of volume increase, apply second and/or third functions to the flow-volume curve to determine metrics of a transition point and/or a transition distance associated with the flow-volume curve; compare each of the metrics to a corresponding threshold value; and determine a presence or absence of airflow obstruction based on the comparisons.
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely indicate performing calculations (claims 16, 19-21), and generating additional information (claim 18)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and evaluating data to reach a conclusion; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on generating curves from inputted data, applying functions to the curves, and finding metrics describing features of the curves
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of metrics as compared to thresholds to evaluate a condition – a judgment or opinion regarding airflow obstruction.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 16 recites a spirometer as apparently providing the data and processors, storage medium, and instructions which perform the abstract idea. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no medical disease or condition, much less a treatment or prophylaxis for one), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of obtaining airflow measurements using a spirometer, as indicated above, are merely the insignificant extrasolution activity of data gathering, which is merely simply appending well-understood, routine, and conventional activities previously known to the industry of airflow monitoring, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional; see also A61B5/087 and A61B5/091, and, for example, US 2999495, US 3154068, US 3577984, which disclose conventional spirometry devices used to measure flow and volume). It is further noted that the spirometer is not positively recited as being part of the claimed product.
The additional elements of a storage medium, processors, and instructions, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but, rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Response to Arguments
Applicant's arguments filed 12 November 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant asserts that the amendments have resolved all issues in all the claims “as discussed and agreed upon in the Examiner Interview”; as that interview only included discussion of and amendments to claim 1, this assertion is false. See the Interview Summary Record and Appendix filed 31 October 2025. As noted above, several 112 issues remain.
Regarding the rejections under 101, Applicant argues that the references to use of a spirometer, never positively recited as part of any of the claimed inventions and used only for the insignificant extrasolution activity of data gathering, is somehow not more than data gathering even though it is recited explicitly as being used only for “obtaining, using a spirometer, data”. Applicant argues that the recited spirometer, which, again, is not even positively part of any of the claims as presented, is used for measurements of both volume and flow that are “not as well known or routinely implemented in the field as may be assumed”. It should be noted that spirometers which measure both volume and flow have been known for decades – see, for example, US 3154068 to Reinert, patented 1964, which sets forth “Another object of the invention is to provide a spirometer which will offer all known functions of previous spirometers, and at the same time provide an electrical readout of both volume changes and flow changes.” (column 1, lines 37-40). See also US 3577984 to Levy, 1971, “An electronic spirometer is disclosed for measuring a plurality of airflow and air volume parameters of a patient.” (abstract); US 3608546 to Shinn, 1971, “The transducer generates a pneumatic pressure signal proportional to airflow rate breathed therethrough and the integrator integrates the flow rate to obtain the volume of air breathed through the transducer over a period of time.” (abstract); US 3797479 to Graham, 1974, “Another object of the invention is to provide a new and improved spirometer of the above character which also provides recording outputs for absolute values of the instantaneous computed flow and volume which can be connected to conventional XY recorder or storage oscilloscope to directly display a flow-volume loop.” (column 1, lines 41-47).
It is entirely unclear what “technical complexity” might be involved in “real-time volume and flow data” capture, as any measure of a physiological parameter is a real-time measurement of that point in time; Applicant makes reference to “calibration, sensor accuracy, and data resolution” and “a high degree of fidelity”, none of which are reflected in the claims’ generic use of a nonspecific spirometer to acquire nonspecific volume and airflow measurements, similarly asserting that “conventional” spirometers only measure parameters such as FEV1 or FVC despite the existence of numerous devices which explicitly measure both flow and volume over time is unpersuasive.
Applicant attempts to argue that the recited “obtaining, using a spirometer, data corresponding to one or more expiratory airflow measurements for a subject, wherein the obtaining includes collecting volume measurements and flow measurements” is somehow more than the mere necessary collecting of data required for all uses of the recited judicial exception based on “deliberate, non-trivial selection and processing of data points”, which would be part of the judicial exception itself, not the acquiring of the data, such that this is entirely unpersuasive.
Applicant further argues that the invention as claimed provides a technical improvement of improving the field of spirometry as a whole “by identifying at least an additional 9.5% of subjects with COPD” “that are not detected using traditional spirometry measures”. It should be noted that the technical improvement must be provided by an additional element, not the judicial exception itself, such that “the novel metrics of the claimed method” cannot be considered as providing an improvement. Further, diagnosis or identification of COPD has not been claimed; at best some dependent claims call for determining that an obstruction is associated with COPD, but does not recite “identifying” COPD at any point, such that this assertion is not reflected in the claims as presented and thus moot.
Applicant concludes by asserting that “the additional elements and the claim as a whole integrate the alleged judicial exceptions into a practical application under Step 2A Prong Two”; as the only additional elements are generic computing components used to provide a technological environment for execution of the judicial exception itself, and a spirometer never positively recited as part of the claimed invention which is used only for the extrasolution of data gathering, this assertion is entirely unpersuasive, and the claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2013/0165811 to Decramer also discloses fitting two linear segments to a flow-volume curve, but finds the angle between the segments rather than the location of intersection (transition point); US 2013/0303932 to Helfenbein teaches evaluating a slope (rate of increase) and shape of a volume-time curve for evaluating lung function; US 3650466 to Talonn teaches finding a slope (rate of increase) of a volume-time curve
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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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/KAREN E TOTH/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791