DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on January 20, 2026 were received and fully considered. No claims were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts for non-invasively assessing a disease state or abnormal condition of a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“...a method for interpreting a patient's multi-breath nitrogen washout (MBNW) data, the method comprising: determining five free parameters, wherein the free parameters comprise the FRC of the subject, the volume of the physiologic dead space, the heterogeneity of lung emptying as a function of lung volume, the heterogeneity of regional tidal volume throughout the lungs, and a reflection of structural asymmetry at the level of an acinus; and applying the five free parameters to the patient's MNBW data to determine functional lung capacities and ventilation heterogeneities.
These limitations describe a mathematical calculation. Moreover, the limitations also recite a mental process as the skilled artisan is capable of looking at obtained data (five free parameters) and making a mental assessment thereafter.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
Here, there are no additional limitations that integrate the identified judicial exception into a practical application. The absence of any additional limitations also means there is no need to analyze the claims under Step 2B, i.e., assessing whether additional limitations add significantly more to the identified judicial exception.
Dependent claims 2-6 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-6 are not patent eligible under 35 USC 101.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they were not persuasive. When considered as an ordered combination, Examiner maintains that the claims recite an abstract idea (mathematical calculation and/or mental process) that is (1) not integrated into a practical application; and (2) there are no additional limitations that amount to significantly more. In arguing patent eligibility, Applicant contends that the “claim’s focus... is the applied pulmonary diagnostic use of MBNW data interpreted through a physiologically meaningful parameter set to produce pulmonary function determinations” (see remarks, pg. 9). However, this is not persuasive as the purported improvement still appears to lie within the judicial exception itself1. Moreover, there are no additional (structural, applied therapy, etc.) limitations that would equate to significantly more than the current recited abstract idea. For at least these reasons, the 35 USC 101 rejections are maintained.
Applicant’s arguments filed with respect to the 35 USC 103 rejections were persuasive. Therefore, these rejections are withdrawn.
Conclusion
No claim is allowed.
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 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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 See MPEP 2106.05a, “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.”
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