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 .
Response to Amendment
The amendment filed April 14, 2026 has been entered.
Examiner acknowledges Applicant’s cancellation of claim 15.
Applicant’s newly submitted drawings obviate the previous drawing objection.
A new claim objection is presented.
Applicant’s amendments necessitate new grounds of rejection under 35 U.S.C. 112(b).
Applicant’s amendments and arguments are insufficient to overcome the rejection of the claims under 35 U.S.C. 101.
Claims 1-14 and 16-24 are pending.
Response to Arguments
Applicant's arguments filed April 14, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
“In one aspect, the claims recite techniques that resolve a technical problem of existing clinical methods that are unable to reliably detect or predict exacerbations of airways disease such as asthma and chronic obstructive pulmonary disease (COPD). Existing methods and systems do not account for (i) bronchodilator responsiveness, (ii) diurnal variation, and (iii) individual baseline lung function in an integrated way. In another aspect, the method claims relate to the use of a non-linear time series regression model calibrated to individual physiological parameters. The calibration to individual physiological state implements a specific technical solution, which involves more than data analysis.”
Applicant alleges “techniques” involved in the claims are intended to address a technical problem; however, Applicant does not demonstrate how such techniques are not abstract evaluations implemented via generic computer components, nor how such techniques are an improvement on existing methods besides accounting for factors in additional mental considerations. Applicant does not identify additional elements in the claim which could allow the judicial exception to amount to significantly more. Accordingly, the claims are directed to no more than abstract analysis of data gathered from requisite data-gathering components considered well-known in the art.
Regarding Applicant’s argument:
“The claimed method produces a specific, clinically actionable outcome that directly informs patient management and treatment intervention. In one example, the outcome includes diagnosis or prediction of a respiratory exacerbation. As amended herein, the claims specify a particular technical implementation that includes modelling bronchodilator responsiveness as a decaying exponential function (step (b)) and computing a corrected lung function value by subtracting both the bronchodilator response and diurnal variation components from an instantaneous measurement (step (d)). These steps cannot be reasonably characterized as mere generic calculations.”
Forming a diagnosis or prediction is the end-result of evaluation steps carried out on gathered data, which is an abstract idea. Additionally, while the claimed evaluation steps are novel (see lack of prior art rejections applied), such novelty does not preclude the judicial exception from being abstract. See Synopsys, Inc. v. Mentor Graphics Corp.:
Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a new abstract idea is still an abstract idea”) (emphasis in original).
Regarding Applicant’s argument:
“Amended claim 17 integrates computations into a specific hardware system comprising an electronic handheld spirometer and an inhaler adherence monitor. The electronic handheld spirometer can continuously capture real-time PEFR/FEV1 measurements. The inhaler adherence monitor provides the historical timepoints of bronchodilator inhalation. The system produces the bronchodilator timing data and processes it in a defined way. This is not mere data gathering.”
Each component aside from generic computer components are directed to well-understood, routine, and conventional components whose sole use in the judicial exception is extra-solution data-gathering (see Step 2B of rejection under 35 U.S.C. 101 including Applicant’s description of an “inhaler adherence monitor” as well-known in the art). As per MPEP 2106.05.I.A:
“ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d))…”
Regarding Applicant’s argument:
“Even under Step 2B, the claims recite an inventive concept that amounts to significantly more than the abstract idea. The combination of (i) a mode-based reference value computation (e.g., highest modal value by kernel density estimation), (ii) non-linear time series regression for bronchodilator responsiveness modelled as a decaying exponential, (iii) regression-based diurnal variation estimation, and (iv) a corrected parameter value subtracting both effects, represents an unconventional technical approach not previously applied to respiratory exacerbation monitoring. As provided in the Specification, this combination produces results that are significantly superior with respect to existing systems. In one example, FIG. 8 shows that elevated diurnal variation amplitude measured up to 10 days before physician diagnosis can provide a clinically significant early-warning capability not achievable with previous methods.”
Each of the claimed points listed is an abstract idea of evaluation, whereby the end-result of such evaluation arises from the judicial exception after requisite data-gathering. When looking to additional elements which may provide a technical improvement, the additional elements even in combination amount to no than requisite data-gathering components and generic computer components for implementing steps of the abstract idea.
Examiner further notes, that each independent claim remains broad in reciting steps taken to analyze a “parameter” indicating lung function of the individual, whereby Applicant’s alleged improvement upon previous systems is not clearly demonstrated considering what “the parameter” may encompass in each independent claim.
Regarding Applicant’s argument:
“The Office Action asserts that “[no] limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.” Applicant respectfully disagrees. The continuous monitoring of PEFR/FEV1 at sufficient temporal resolution to estimate diurnal variation (requiring multiple measurements per day over extended periods), combined with real-time tracking of each bronchodilator inhalation event and the fitting of a non-linear regression model to this continuous dataset, cannot feasibly be performable manually (i.e., using pen-and-paper to note continuous measurements over prolonged periods of time). The computational complexity, the continuous real-time data integration, and the volume of data involved require a computer as a practical matter.”
The human mind is capable of monitoring a parameter at “multiple measurements per day over extended periods.” For example, an individual is capable of reading the latest scores for several sporting events and making judgements or evaluations thereon. The “real-time tracking” of each bronchodilator inhalation event is not performed by the human mind, but by the additional element of an inhaler adherence monitor, whereby such a step is directed to limitations of the data gathered. Evaluations (e.g., non-linear regression) on such data, when performed on generic computer components, are admittedly faster and provide more up-to-date output than performing such evaluations by pen-and-paper or mental practice; however, see citation of Bancorps in the rejection of the claims under 35 U.S.C. 101, provided again below for convenience:
"Indeed, humans routinely processed large amounts of data by hand before the advent of computers. As our reviewing court has explained, ‘the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.’” Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
Examiner further notes that the claims do not require evaluations to be completed within a requisite time span, only that a prediction of exacerbation occurs based on gathered data and an instantaneous value (i.e., one currently-measured value) of a parameter.
Claim Objections
Claim 1 is objected to because of the following informalities:
“non -linear” in point b) should read as “non-linear.”
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 1, 17, and dependent claims thereof 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.
Re. Claims 1 and 17: Claim 1 recites the phrase “the value of the lung function.” It is unclear what phrase in the claim establishes antecedent basis for the identified phrase above. Examiner requests clarification if the intended antecedent basis for the identified phrase is “a reference value for a parameter indicating expiratory lung function of the individual” recited on lines 3-4 of claim 1 along with appropriate amendment to establish clear antecedent basis.
Claim 17 possesses similar limitations pertaining to the issue above.
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 1-14, and 16-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites steps or instructions for ascertaining and processing data to measure a blood pressure of a mammal subject, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 1 recites a computer-implemented method comprising the steps of:
a) computing a reference value for a parameter indicating expiratory lung function of the individual, the reference value consisting the highest modal value with the highest density in a distribution of the measured values of the parameter determined after a predetermined time duration subsequent to the timepoint at which the individual last inhaled a bronchodilator;
b) estimating the responsiveness of the individual to the bronchodilator by modelling the change in the measured values of the parameter using a non-linear time series regression model, the regression model comprising at least two or more of the following: the decay rate of the bronchodilator,
the rate of absorption of the bronchodilator,
the bronchodilator responsiveness,
dependence of bronchodilator response on current lung function; and
one or more timepoints at which the bronchodilator was previously inhaled, wherein the responsiveness of the individual to the bronchodilator is modelled as a decaying exponential function, and wherein the value of the lung function measured is taken into account;
c) estimating the phase and amplitude of diurnal variation of the parameter using a regression analysis model and the measured values of the parameter;
d) determining a corrected value of the measured parameter by subtracting corrected terms from the responsiveness estimated in step (b), and the phase and amplitude of the diurnal variation estimated in step (c) from an instantaneous value of the measured parameter;
e) diagnosing an exacerbation if the corrected value of the parameter drops below a predetermined threshold relative to the reference value computed in step (a), for a predefined number of instances; and
f) predicting an exacerbation from the reference value computed in step (a), responsiveness estimated in step (b), the phase and amplitude of the diurnal variation estimated in step (c), the corrected value estimated in step (d), and one or more historical timepoints of inhalation of the bronchodilator.
Each limitation identified above recites at least one step or instruction grouped as a mental process; therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
Points a) through f) are purely evaluation steps carried out on observed or received data.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice. For instance, while the claim requires evaluation of regression and regression analysis models, evaluation of such models may be carried out by hand. Further, such evaluations do not necessarily require a computer to perform such calculations. Improving the efficiency by which such evaluations are carried solely by implementation on a computer does not alter patent eligibility. See Bancorps:
"Indeed, humans routinely processed large amounts of data by hand before the advent of computers. As our reviewing court has explained, ‘the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.’” Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation of regression models) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
Independent claim 17 recites a system to diagnose and predict an exacerbation for an individual, the system comprising:
a computing device;
a non-transitory memory means;
at least one electronic handheld spirometer;
and an inhaler adherence monitor;
Each of the above elements is identified as an additional element (see bolded portions above), and not an abstract idea. See consideration of additional elements under Step 2A, Prong Two and Step 2B. The steps or instructions carried out by the non-transitory memory means are mutatis mutandis identical to those recited in the computer-implemented method claim of independent claim 1; see analysis of independent claim 1.
The dependent claims 2-14, 16, and 18-24 merely include limitations that either further define the abstract idea or extra-solution activity thereof (e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process) and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 1 does not positively recite any additional elements aside from generic computer components implied by the preamble (“A computer implemented method”). Claim 1 analyzes data of an individual having taken a pharmaceutical (i.e., a bronchodilator), which is a quality of the data analyzed extra-solution to the abstract idea steps claimed.
Independent claim 17 recites the following additional elements:
a computing device;
a non-transitory memory means;
at least one electronic handheld spirometer;
and an inhaler adherence monitor;
Such additional elements are generically recited elements which do not improve the functioning of a computer or any other technology or technical field. The claim recites merely acquiring data from known devices (i.e., one electronic handheld spirometer and inhaler adherence monitor), having no operative connection to the computing device executing instructions of the non-transitory memory means besides communication of obtained data. Thus, the functions of the one electronic handheld spirometer and inhaler adherence monitor are insignificant, extra-solution activity in the form of mere data gathering. Mere data-gathering does not constitute an integration into a practical application. Although the sensors may imply particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
Furthermore, computing device executing instructions of the non-transitory memory means is recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., computing device as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Examiner notes that an improvement in an abstract idea is not an improvement in technology (see MPEP 2106.05(a).III). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Dependent claims 2-14, 16, and 18-24 do not recite additional elements to the abstract idea, and merely recite limitations that either further define the abstract idea or extra-solution activity thereof.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 does not positively recite any additional elements, as per analysis under Step 2A, Prong One.
Independent claim 17 recites the following additional elements:
a computing device;
a non-transitory memory means;
at least one electronic handheld spirometer;
and an inhaler adherence monitor;
As per page 19 of Applicant’s Specification, a generically-recited a computing device is stated to be “be a personal computer, a portable device such as a tablet computer, a laptop, a smart phone, connected medical device or any operating system based connected portable device,” and that the “memory means has a plurality of instructions stored thereon which configures the computing device…” Thus, both the additional elements of a computing device and memory means are encompassed by a generic computer.
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed electronic handheld spirometer and inhaler adherence monitor.
The most detail regarding the electronic handheld spirometer is on page 2 of the Specification: “In this test, spirometric measurements such as FEV1 or PEFR are first assessed using a lab spirometer.” Applicant provides no detail regarding the structure and operation of the electronic handheld spirometer
Similarly, the most detail regarding an inhaler adherence monitor are on pages 7, 13, and 18 of the Specification, which describe only the operation and operative coupling of the inhaler adherence monitor to other components of the system, and which also provides no detail regarding the structure and operation of the inhaler adherence monitor. In page 2 of Remarks dated April 14, 2026, Applicant admits “…the inhaler adherence monitor is well-known in the art as a device that can measure the times at which the bronchodilator was used or activated by an individual (see, e.g., pages 7 and 13 of the PCT publication).” Thus, such a component is considered well-understood, routine, and conventional.
No special programming or algorithms is indicated for how such sensors operate. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the medical technology industry or medical technology arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers and sensor components with their already available basic functions to use as tools in executing the claimed process.
Dependent claims 2-14, 16, and 18-24 merely recite steps which further define the abstract idea and data/data-processing steps. Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing of sensor data). That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
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 JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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