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 .
Election/Restrictions
Applicant’s election with traverse of Group is acknowledged. Examiner also acknowledges the cancellation of claims 2-4, 9, 10, and 13-15, of which encompassed previously identified Group II. As all the claims corresponding to previously identified Group II were cancelled, applicant’s arguments are moot. Claims 1, 5-8, 11, 12, 16, and 17 are treated on the merits. Please see below for more detail.
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy (EP21162254.3 filed on March 12, 2021) has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 11, 2023 has been considered by the examiner.
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, 5-8, 11, 12, 16, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims 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 method for extracting respiratory information from a bio-impedance signal. 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 extracting respiratory information from a bio- impedance signal, the method comprising the steps of… filtering the bio-impedance signal using a Savitzky-Golay low-pass filter to provide first respiratory information representing a respiratory effort signal, wherein the Savitzky-Golay low-pass filter incorporates a 3rd degree polynomial fit, wherein the Savitzky-Golay low-pass filter is applied on subsets of data points of the bio-impedance signal which are filtered using a frame length in the interval of 1.3 - 1.7 seconds; and differentiating the respiratory effort signal with a Savitzky-Golay first derivative kernel to provide second respiratory information representing a respiratory flow signal, wherein the Savitzky-Golay first derivative kernel incorporates a 2nd degree polynomial fit, and wherein the Savitzky-Golay first derivative kernel is applied on subsets of datapoints of the respiratory effort signal which are filtered using a frame length in the interval of 0.5 - 1.5 seconds…”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
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.
For this part of the 101 analysis, the following additional limitations are considered:
“providing a bio-impedance signal of a subject”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception fail to integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to widely-understood, routine, and conventional techniques for obtaining a bio-impedance signal. Examiner takes official notice that using electrodes to derive respiratory effort signals, while not positively claims, is widely known in impedance pneumography. Please see prior art cited in the current office action for example teachings.
Dependent claims 5-8, 11, 12, 16, and 17 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1, 5-8, 11, 12, 16, and 17 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-8, 11, 12, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Seppa et al. (Assessment of Pulmonary Flow Using Impedance Pneumography, IEEE Transactions on Biomedical Engineering, Vol. 57, No. 9, September 2010) (hereinafter “Seppa”) in view of Rahman et al. (US PG Pub. No. 2021/0386318 A1) (hereinafter “Rahman”).
With respect to claim 1, Seppa teaches a method for extracting respiratory information from a bio-impedance signal (abstract “impedance pneumography… for measurement of continuous pulmonary flow and volume signals instead of only the respiration rate… or tidal volume”), the method comprising the steps of: providing a bio-impedance signal of a subject (pg. 2278, right column, “C. Lead Configurations… tetrapolar impedance measurement, four electrodes are used… the measured impedance value Z is obtained”); filtering the bio-impedance signal using a Savitzky-Golay low-pass filter to provide first respiratory information representing a respiratory effort signal (pg. 2279, right column, “E. Signal Processing.. applied a Savitzky-Golay (S-G) smoothing filter… advantage of preserving the high-frequency content of the signal…conditioned volume-related impedance signal… turned into a flow-related one by differentiating it over time with an S-G filter”), wherein the Savitzky-Golay low-pass filter is applied on subsets of data points of the bio-impedance signal (pg. 2279, right column, “E. Signal Processing... applied a Savitzky-Golay (S-G) smoothing filter…conditioned volume-related impedance signal) which are filtered using a frame length (pg. 2279, right column, E. Signal Processing “differentiating over time… frame size”); and differentiating the respiratory effort signal with a Savitzky-Golay (pg. 2279, right column, “E. Signal Processing… differentiating it over time with an S-G filter”).
However, Seppa does not explicitly teach wherein the Savitzky-Golay low-pass filter incorporates a 3rd degree polynomial fit, using a frame length in the interval of 1.3 - 1.7 seconds, and differentiating the respiratory effort signal with a Savitzky-Golay first derivative kernel to provide second respiratory information representing a respiratory flow signal, wherein the Savitzky-Golay first derivative kernel incorporates a 2nd degree polynomial fit, and wherein the Savitzky-Golay first derivative kernel is applied on subsets of datapoints of the respiratory effort signal which are filtered using a frame length in the interval of 0.5 - 1.5 seconds.
Rahman the Savitzky-Golay low-pass filter incorporates a 3rd degree polynomial fit (par.0063 “using a third-order Savitzky-Golay filter”), and differentiating the respiratory effort signal with a Savitzky-Golay first derivative kernel to provide second respiratory information representing a respiratory flow signal (par.0036, 0063), wherein the Savitzky-Golay first derivative kernel incorporates a 2nd degree polynomial fit (par.0036, 0063).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Seppa to incorporate S-G filtering with low-order polynomials in the manner recited for the purpose of smoothing noise-infused data while offering the advantage of preserving peaks, as evidence by Rahman (par.0036, 0063). Additionally, PHOSITA would have had predictable success modifying Seppa to select temporal windows within the recited claim range (a frame length in the interval of 1.3 – 1.7 seconds, using a frame length in the interval of 0.5 - 1.5 seconds, etc.) as a result-effective variable, optimized to preserve respiratory frequencies while attenuating higher-frequency noise. Furthermore, it would have been further obvious to PHOSITA to select window length within the claimed ranges since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 5, Seppa teaches a step of filtering the respiratory effort signal using a high-pass filter to obtain a baseline filtered respiratory effort signal (pg. 2279, right column, E. Signal Processing “high-pass filter was applied to remove baseline fluctuations and drift”).
With respect to claim 6, Seppa teaches wherein the high-pass filter has a cutoff frequency in the interval of 0.001 - 0.1 Hz (pg. 2279, right column, E. Signal Processing).
With respect to claim 7, Seppa teaches wherein the Savitzky-Golay filter or filters are adaptively updated based on an instantaneous respiratory frequency (pg. 2279, right column, E. Signal Processing).
With respect to claim 8, Seppa teaches wherein the instantaneous respiratory frequency is estimated from the bio-impedance signal, wherein the method incorporates the steps of detecting a breath-by-breath breathing rate, BR, from the bio-impedance, BI, signal performing a moving average of the resulting BR-signal with non-overlapping time windows of frame lengths in the interval of 15 - 30 seconds, which resulting BR- signal is denoted as ABR-signal, and applying a multiplier M so that at any point in time along the BI-signal, the adaptive frame length of the Savitzky-Golay smoothing filter is equal to M*(1/ABR), thus resulting in an adaptively smoothed bio-impedance, ASBI, signal, wherein said M is a value selected in the interval of 0.10 - 0.30 (pg. 2279, right column, E. Signal Processing).
With respect to claim 11, Seppa teaches a computer program comprising instructions which, when executed by a computing device, cause the computing device to carry out the method according to claim 1 (pg. 2278 “laptop computer”).
With respect to claim 12, Seppa teaches a program readable storage medium storing the computer program according to claim 11 (pg. 2278 “laptop computer”, of which is it implied that the computer utilizes program, executable code, etc. to perform the signal processing).
With respect to claim 16, Seppa teaches wherein the high-pass filter has a cutoff frequency in the interval of 0.01 - 0.05 Hz (pg. 2279, right column, E. Signal Processing).
With respect to claim 17, Seppa and Rahman do not explicitly teach wherein the Savitzky-Golay first derivative kernel is applied on subsets of datapoints of the respiratory effort signal which are filtered using a frame length in the interval of 0.8 - 1.2 seconds. However, further modification to incorporate this feature would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
No claim is allowed.
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
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