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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice of Amendment
In response to the amendment(s) filed on 12/1/25, amended claim(s) 1 and 9-10 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 1-7 and 9-10 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, Claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “measuring, with a plurality of measurements at predefined time frequency, a first set of parameters that define a pulmonary function of a patient by means of a forced oscillation technique (FOT),” (Examiner’s Note: these “measurements” are derived (i.e., generated mentally) as evidenced by the paragraph that bridges pages 5-6 of Applicant’s specification as originally filed), “simultaneously measuring a second set of parameters indicative of the respiratory pattern, represented by at least one or more of the following: tidal volume (VT), mean inspiratory (Ti) and expiratory times (Te), respiratory frequency (RR), respiratory duty cycle (Ti*RR), mean inspiratory (Vt/Ti) and expiratory flow (Vt/Te) and a minute ventilation (Ve),” (Examiner’s Note: these “measurements” are derived (i.e., generated mentally) as evidenced by the paragraph that bridges pages 5-6 of Applicant’s specification as originally filed), “eliminating the measurements containing abnormal values in at least one parameter of each of the first and the second sets of parameters, by step of comparing each measurement with a corresponding median value, calculated from measurements available within a predetermined time window, including the current and past measurements,” “calculating trends of the first set of parameters and the second set of parameters in a predefined time period by calculation of an N order polynomial regression model,” “identifying an impending exacerbation by comparing parameters describing said trends of the first set of parameters and the second set of parameters by comparing at least one coefficient (β) of the N order polynomial regressions with predefined thresholds,” “wherein for the first and second sets of parameters a deterioration trend of a pathology is assessed according to whether all of polynomial regression coefficient (β), a corresponding p-value and corresponding coefficient (r2) of at least one of the deterioration trend or the pathology are above or below a predefined threshold and depending on this assessment, assigning a value 1 or 0 to a corresponding trend parameter (MIp),” “predicting an exacerbation by performing a weighted sum of said corresponding trend parameter,” and “providing, to a viewer device, an alert identifying a presence of recurrences of chronic obstructive pulmonary disease, wherein said alert provides a notification for a medical personnel to contact the patient to verify a state of health of the patient and to adjust a course of treatment.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. There are no additional elements recited in the claim. Further, many of the features claimed are derived from other work as evidenced by pages 4-6 of Applicant’s specification as originally filed. Therefore, there are not elements that are significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Independent claims 9 and 10 also fail to recite patent-eligible subject matter for similar, if not the same, reasoning as that of claim 1. Dependent claim(s) 2-7 fail to cure the deficiencies of independent claim(s) 1 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or generic computer structure. Thus, claim(s) 1-7 and 9-10 is/are rejected under 35 U.S.C. 101.
Allowable Subject Matter
Claim(s) 1-7 and 9-10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) and 35 U.S.C. 101, set forth in this Office action.
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 12/1/25.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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