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 Arguments
Applicant’s arguments, with respect to the rejection(s) of claim(s) 1, 4-7, and 16-20 under 35USC 103 and 112 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant's arguments filed 4/23/2026 have been fully considered but they are not persuasive regarding the 35USC101 rejections.
The Examiner notes that the new determining steps may still be construed as abstract ideas. The fact that the computer components do this does not take away from the ability for the limitations to be a mental process and/or mathematical concept. The argument that the synchronize step cannot be done in the mind is traversed since the mental process is recited at a high level of generality (e.g. is synchronizing just comparing two data points and making them more similar?). The argument of the calculations of the determining step being potentially mathematical concepts also makes the argument moot. Applicant argues that this function is a concrete technological operation though it appears to just be data processing. Clarification is requested on what the operation entails to the components of the claim. If calibration of the components occurs this would likely overcome the 101 rejection. However, just determining these values does not integrate the claim into practical application. Applicant further argues that the claim requires continuous and breath by breath analysis of the data. That does not appear to be commensurate with the scope of the claims currently. The arguments that the components in combination are not generic appears to be refuted by the Mault references which are relatively old use all the sensing devices in a similar manner as the claims currently. The applicant notes that the system “then subsequently operates using the calibrated wearable sensor alone”. This doesn’t appear to be included in the claims.
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, 4-7, and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1, the claim recites a system for monitoring respiration that performs a series of
steps or acts, including determining a first mass of carbon in exhaled carbon dioxide in breath,
determining a second mass of carbon in exhaled carbon dioxide in breath, and dynamically determining
the density of carbon dioxide for calculation of at least one of the first and second masses of carbon
based on sensed ambient temperature and pressure. Thus, the claim is directed to a machine, 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
steps of “determining, for a breath, a volume… based on the MCO2”, “synchronize, ..of carbon dioxide”, “correlate a volumetric change… the breath”, and “determine a density..exhaled VCO2” set forth judicial exceptions. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. Alternatively, these also could be construed as mathematical concepts (note the expressions are written out).
Next, the claim as a whole is analyzed to determine whether the claim recites additional
elements that integrate the judicial exception into a practical application. The additional elements are merely for generic data gathering/insignificant extra-solution activity or are a generic computing device is recited as performing the abstract idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of
elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
Besides the Abstract Idea, the claim recites additional steps of receiving a volume of air expelled during
a breath, receiving a concentration of carbon dioxide in the breath, receiving volumetric changes in the
chest and/or abdomen during the breath, and correlating a volumetric change in the chest and/or
abdomen with an amount of air expelled during the breath. Each of the receiving steps and the
correlating step are recited at a high level of generality such that it amounts to insignificant presolution
activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high
level of generality, there is no meaningful limitation, such as a particular or unconventional step that
distinguishes it from well-understood, routine, and conventional data gathering and comparing activity
engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established
that the mere physical or tangible nature of additional elements such as each of the receiving steps and
the correlating step do not automatically confer eligibility on a claim directed to an abstract idea (see,
e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike
the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but
taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Furthermore, the device recited in claim 1 is a generic device comprising generic components configured to perform the abstract idea. The recited spirometer, capnometer, and respiratory volume sensor are generic sensors configured to perform pre-solutional data gathering activity, and the computing device is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. It is noted that the Mault references teach utilizing the combined claimed structural components.
Independent claim 16 is similarly rejected and interpreted.
The dependent claims also fail to add something more to the abstract independent claim as they generally recite method steps pertaining to data gathering and the display of data. The receiving and correlating steps recited in the independent claim maintain a high level of generality even when considered in combination with the dependent claims.
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 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 ALEX M VALVIS whose telephone number is (571)272-4233. The examiner can normally be reached 9:00-5:00 M-F.
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ALEX M. VALVIS
Supervisory Patent Examiner
Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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