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
Receipt is acknowledged of applicant's amendment filed on 3/23/26. Claims 12-14 are new. Claims 1-14 are currently pending and an action on the merits is as follows.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of calculating information corresponding to an amount of ventilation and correcting each signal.
The limitation of calculating information corresponding to an amount of ventilation and correcting each signal, as drafted, are processes that, under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a controller”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, communications interface and output language, “calculating” and “correcting” in the context of this claim encompasses the user manually integrating the waveform or calculating a correction. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a detector which involves mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the controller and display device are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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 1-14 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. It is unclear what is meant by correcting the signals such that the absolute values of the first and second signal are “balanced” It is not clear if this means that the inspiration signal and the expiration signal are balanced in relation to each other per breath or per a certain length of the signal as a whole. It seems from the specification that the signal is integrated in order to determine a volume and those values are corrected to be as close as possible to each other but that is not clear from the actual claim language. It is also unclear if the statement that the volume is proportional to a square of flow is just a statement of fact about the physical reality of patient airflow or if this is a particular transfer function used.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gavriely et al. US 2012/0215126 in view of Korten et al. US 4,972,842.
Regarding claims 1 and 9, Gavriely discloses a respiratory measurement method comprising:
acquiring respiration signals by a detector attached to a human body, the respiration signals being based on respiratory sound sensed by the detector ([¶43] the acoustic transducer collects respiration signals);
extracting, from the acquired respiration signals, a first signal indicating an inspiratory phase and a second signal indicating an expiratory phase ([¶13,59] the sound signals represent inspiration and exhalation); and
calculating information corresponding to an amount of ventilation by respiration on a basis of the extracted first signal and second signal ([¶58-60] the combined data is used to determine volume changes),
outputting the information corresponding to the amount of ventilation ([¶49] the determinations are output)
wherein the calculating includes correcting each signal of the respiration signals, such that, for a plurality of respirations, an integrated value of respective absolute values of the first signals among the respiration signals is balanced with an integrated value of respective absolute values of the second signals among the respiration signals ([¶60,64] a correction factor is determined to balance the expiration and inhalation signals integrated values)
wherein a volume of the respiratory sound is proportional to a square of flow velocity of respiration ([¶64] the correction factor can be exponential or logarithmic. It is noted that the limitation seems to be a statement of the fact as to how the volume relates to the velocity so it is presumed until proven otherwise this is just the relationship of the physical properties of breathing).
Gavriely does not specifically disclose a display device. Korten teaches a similar system also analyzing respiratory flow signals that has a display device ([C6 L1-20]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Macklem with the teachings of Korten in order to easily output the determinations. Similarly, Korten provides the additional advantage of calibrating the spirometry system in order to ensure the pneumotach and the phonospirometer are calibrated.
Regarding claim 2, Macklem discloses the information corresponding to the amount of ventilation includes waveform information ([FIG.4,11]).
Regarding claim 3, Macklem discloses the information corresponding to the amount of ventilation includes biological information obtained through calculation ([¶60,64]).
Regarding claim 4, Macklem does not specifically disclose converting the second signal to a negative value; performing correction by multiplying the second signal among the respiration signals by a correction coefficient; and calculating the information corresponding to the amount of ventilation by integrating the respiration signals wherein the first signal is a positive value ([¶60,64,69-70] the decrease in the signal is negative and used as part of the correction factor calculation).
Regarding claim 5, Korten teaches the correction coefficient is a value obtained by dividing an integrated value of an absolute value of the first signal among the respiration signals by an integrated value of an absolute value of the second signal among the respiration signals ([C13 L35 – C14 L18] the injected or inhaled volume is divided by the integrated value).
Regarding claim 6 Gavriely discloses updating the correction coefficient every time predetermined conditions are satisfied ([¶19] the calibration factor is updated).
Regarding claim 7, Gavriely discloses the correction coefficient is set to be a predetermined value ([¶60] the correction factor can be static or dynamically updated).
Regarding claim 8 and 11, Korten teaches acquiring a biological signal different from the information corresponding to the amount of ventilation from a biological signal detector, outputting the calculated information corresponding to the amount of ventilation, wherein the outputting includes outputting the biological signal along with the information corresponding to the amount of ventilation ([FIG.1] ECG signals are also determined).
Regarding claims 12-14, Gavriely discloses outputting waveform information ([FIG12]) but does not disclose the display device. Korten teaches a display device ([C6 L1-20]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gavriely in view of Korten further in view of Lehrman et al. US 7789837.
Regarding claim 10, Gavriely discloses the detector includes: a storage that stores the acquired respiration signals (the device uses a computer system that inherently has some storage). Gavriely does not specifically disclose a transmitter that transmits the respiration signals stored in the storage to the controller in a wireless manner. Lehrman teaches a similar device for tracking respiratory parameters that uses wireless transmission ([C6 L29-40] the collar wirelessly transmits to a base station). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Gavriely with the teachings of Lehrman in order to have the base station separate from where the person sleeps.
Response to Arguments
Applicant's arguments filed 3/23/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 101 rejection, specifically the technical improvement, Examiner respectfully disagrees. It is unclear how the calculating the correction such that an integrated value of respective absolute values of the first and second signals are balanced provides an advantage of making the device more portable so the patient can move more freely. Additionally, prior art like Gavriely and Macklem disclose correcting the inhalation and expiration signals so the flow values are balance so this does not appear to be an improvement in the art.
Regarding Applicant’s arguments that the claims as a whole integrate the judicial exception into a practical application, Examiner respectfully disagrees. The additional elements of the detector, controller and display and generally recited computer elements. The detector performs pre-solutional data collection and the display preforms post-solutional output. These elements merely link the abstract idea to a technical field of use but does not add significantly more in order transform the claims into a practical application.
Applicant’s arguments, see pgs. 15-18, filed 3/23/26, with respect to the rejection(s) of claim(s) 1-11 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gavriely.
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.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791