DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 July 2026 has been entered.
Status of Claims
Claims 1, 8 and 15 are currently amended. Claims 5, 12 and 19 have been canceled. Claims 1-4, 6-11, 13-18 and 20 is/are pending.
Claim Interpretation
As noted in the prior Office action(s), no claim limitation is being interpreted to invoke 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-4, 6-11, 13-18 and 20 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 8, claim 1 and claims dependent thereon, the limitation "A computer-implemented method comprising […] assessing the cardiac filling pressure of the user based on the minimum RMS ratio" of claim 1 and the comparable limitations of claims 8 and 15 lack sufficient support in the application as filed. While Applicant discloses, "This ratio may be stored or outputted for aiding in a medical analysis (e.g., assessing cardiac filling pressure)" (e.g., ¶ 0019]) and/or the ratio "represents information pertaining to cardiac function" (claims 7, 14 and 20), there is no indication said analysis is performed/implemented by a computer or system as required/encompassed by the pending claims. Further, Applicant fails to sufficiently disclose an algorithm by which a computer/system may perform said assessment. Accordingly, each of claims 1, 8 and 15 (and claims dependent thereon) is directed to/encompasses new matter.
Regarding claim 15 and claims dependent thereon, the limitation "determining an RMS value of the biometrics data at an end of the medical maneuver by selecting a first time window during performance of the medical maneuver, calculating an average photoplethysmogram (PPG) value during the first time window, removing a direct current (DC) offset, squaring values above zero after removing the DC offset, summing the squared values, calculating a mean of the squared values, calculating a first RMS value during the first time window, advancing to a second time window, calculating a second RMS value in the second time window, and determining a minimum RMS value, of a plurality of RMS values calculated at respective plurality of time windows during performance of the medical maneuver" lacks sufficient support in the application as filed. The newly-added steps of claim 15 are disclosed as process for calculating a minimum RMS value during a Valsalva maneuver (e.g., original claims 5 and 12) rather than a process for "determining an RMS value of the biometrics data at an end of the medical maneuver" as required by claim 15. Applicant fails to disclose determining an RMS value of the biometrics data at an end of the medical maneuver through use of the claimed steps, such that claim 15 (and claims dependent thereon) are directed to/encompass new matter.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 15-18 and 20 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 15 and claims dependent thereon, the limitation "determining an RMS value of the biometrics data at an end of the medical maneuver by selecting a first time window during performance of the medical maneuver, calculating an average photoplethysmogram (PPG) value during the first time window, removing a direct current (DC) offset, squaring values above zero after removing the DC offset, summing the squared values, calculating a mean of the squared values, calculating a first RMS value during the first time window, advancing to a second time window, calculating a second RMS value in the second time window, and determining a minimum RMS value, of a plurality of RMS values calculated at respective plurality of time windows during performance of the medical maneuver" is indefinite. It is unclear how/in what manner "an RMS value of the biometrics data at an end of the medical maneuver" is calculated by performing the recited steps, as the steps identify a minimum RMS value throughout the maneuver, rather than an RMS value at any particular point within the maneuver.
For the purpose of this Office action, claim 15 (and claims dependent thereon) will be further discussed with the understanding the system is configured to determine a minimum RMS ratio (comparable to the limitations of claims 1 and 8), rather than a ratio based on an RMS value of the biometrics data at an end of the medical maneuver.
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) 1-4, 6-11, 13-18 and 20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1-4, 6-11, 13-18 and 20 recite the steps of determining a baseline RMS value prior to performance of a medical maneuver by a user; determining a minimum RMS value during the medical maneuver by calculating the RMS values for a plurality of time windows during the medical maneuver and identifying which of said RMS values is the lowest; and calculating a ratio between the minimum RMS value and the baseline RMS value.
These limitations cover mathematical calculations (e.g., algorithm/procedure for calculating RMS values, determination of a ratio, identifying the lowest among a plurality of numbers, etc.), and therefore fall within the mathematical concepts grouping of abstract ideas. Alternatively/Additionally, these limitations are a process that, under its broadest reasonable interpretation (BRI), covers performance of the limitations in the mind but for the recitation of generic computer components where present. For example, determining a baseline RMS value encompasses a user selecting any pre-maneuver segment of the biometric data and mentally and/or manually calculating an RMS value therefrom; determining a minimum RMS value during the medical maneuver encompasses the user mentally/manually calculating a plurality of RMS values for respective time windows during the maneuver and mentally/manually identifying the lowest of the calculated RMS values; calculating a ratio encompasses a user mentally/manually dividing one calculated value by another. Lastly, the step of assessing cardiac filling pressure of the user based on a calculated RMS ratio encompasses a user mentally/manually forming a judgment about cardiac filling pressure, in any manner he/she desires, for a calculated RMS ratio. If claim limitations, under their BRI, cover performance of the limitation in the mind, then the falls within the mental processes grouping of abstract ideas. Accordingly, the claim recites an abstract idea(s).
This judicial exception is not integrated into a practical application. The claims recite the additional limitations of receiving the biometric data, storing or outputting the calculated RMS ratio, and a computer or computer program for performing the abstract idea. The computer or computer program is recited at a high-level of generality (i.e., as a generic computer performing generic computer functions of performing calculations), such that it amounts no more than mere instructions to apply the exception using a generic computer component. The step of receiving the biometric data amounts to necessary data gathering, and is comparable to concepts identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), e.g., performing clinical tests on individuals to obtain input for an equation) and/or as a well-understood, routine and/or conventional computer function (see MPEP 2106.05(d), e.g., receiving or transmitting data over a network, storing and retrieving information in memory, etc.) The step of storing and outputting the calculated ratio amounts to necessary outputting (e.g., displaying, printing, transmitting, etc.) the calculated ratio, and is comparable to and/or encompasses concepts identified by the courts as insignificant extra-solution activity (see MPEP 2106.05(g), e.g., printing or downloading generated menus) and/or as a well-understood, routine and/or conventional computer function (see MPEP 2106.05(d), e.g., receiving or transmitting data over a network, storing and retrieving information in memory, etc.). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 1-4, 6-11, 13-18 and 20 are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer or computer program to perform the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component. Further, as discussed above, the steps of receiving the necessary data to the abstract idea and storing/outputting the result of performing the abstract idea are comparable to steps identified as well-understood, routine and/or conventional computer functions. Accordingly, even when considered in the combination, the additional elements merely invoke computers or machinery as a tool to perform the claimed mathematical calculations.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 1-4, 6-11, 13-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over "Usefulness of a Noninvasive Device to Identify Elevated Left Ventricular Filling Pressure Using Finger Photoplethysmography During a Valsalva Maneuver" (previously cited, Galiatsatos) in view of US 2021/0169406 A1 (previously cited, Muehlsteff), US 2021/0169356 A1 (previously cited, Jang) and US 2015/0305674 A1 (previously cited, McPherson).
Regarding claims 1-3 and 6-7, Galiatsatos discloses/suggests a computer-implemented method comprising:
receiving biometrics data for a user, the biometrics data including a photoplethysmogram (PPG) value and an expiratory pressure value (Methods, transduced signals from the mouth piece expiratory pressure sensor and the finger PPG probe were analyzed using an algorithm developed using Excel Software);
determining, based on the biometrics data, a baseline amplitude value prior to performance of a Valsalva maneuver by the user (Methods, calculating average pulse amplitude of the selected segment of PPG cycles during baseline);
determining a minimum amplitude value of the biometrics data during the Valsalva maneuver (Methods, calculating minimum PPG pulse amplitude during the VM);
calculating a ratio between the minimum amplitude value and the baseline amplitude value to generate a minimum amplitude ratio (Methods, ratios of measures obtained during the VM to those obtained at baseline were calculated); and
storing the minimum amplitude ratio and assessing the cardiac filling pressure of the user based on the minimum amplitude ratio (Methods, the univariate correlation between LVEDP and each PPG waveform feature was examined and/or calculating LVEDP based on the PPG waveform feature(s) using a model/equation, indicating the calculated ratio(s) was stored at least temporarily for subsequent analysis), wherein the minimum amplitude ratio represents information pertaining to cardiac function/cardiac filling pressure of the user (Results, MinPAR is strongly associated with LVEDP).
Galiatsatos does not disclose the baseline amplitude value and the minimum amplitude value are RMS values. Rather, Galiatsatos discloses the amplitude values represent the difference between a maximum of the PPG and a minimum of the PPG signal of a given pulse (e.g., Fig. 3).
Muehlsteff discloses amplitude of an acquired PPG signal may be defined as a difference between a maximum of the acquired PPG signal and a minimum of the acquired PPG signal (e.g. within a heart period), or alternatively may comprise a root mean squared amplitude of the acquired PPG signal (¶ [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Galiatsatos with the baseline amplitude value and the minimum amplitude value being a baseline RMS value and a minimum RMS value, respectively, such that the ratio therebetween is a minimum RMS ratio, as disclosed/suggested by Muehlsteff as a simple substitution of one suitable amplitude characteristic of the PPG signal for another to yield no more than predictable results. See MPEP 2143(I)(B).
Galiatsatos as modified further discloses and/or suggests iteratively calculating respective amplitude values for each of a plurality of PPG cycles during the performance of the Valsalva maneuver and identifying the minimum amplitude RMS value from the respective RMS values (Methods, calculating minimum PPG pulse amplitude during the VM, indicating each PPG pulse amplitude during the VM is calculated and the least/minimum PPG pulse amplitude identified therefrom). Galiatsatos does not disclose iteratively calculating respective RMS values at iterative time windows during performance of the medical maneuver, e.g., by selecting a first time window during performance of the medical maneuver; calculating an average photoplethysmogram (PPG) value during the selected first time window; removing a direct current (DC) off set; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating a first RMS value during the first time window; advancing to a second time window; calculating a second RMS value in the second time window; etc., and identifying the minimum RMS value from the respective RMS values by determining a minimum RMS value, of a plurality of RMS values calculated at respective plurality of time windows during performance of the Valsalva maneuver.
Jang discloses a method comprising iteratively calculating respective RMS values at iterative time windows during performance of a medical maneuver (e.g., Fig. 3; ¶¶ [0061]-[0064]) including: selecting a first time window during performance of the medical maneuver (W1); and calculating a first RMS during the first time window (¶ [0063] applying a predetermined function to the pulse wave signal within a window W1 of a first section of the pulse wave signal, the processor 120 may calculate a function value for the window W1 of the first section, wherein the predetermined function may obtain the RMS value of the window) by removing a DC offset (e.g., ¶ [0065] AC component of the pulse wave; Fig. 3, signal is symmetric around zero; etc.); squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values (Equation 1); advancing to a second time window (W2) (¶¶ [0063]-[0064] processor 120 may shift the window by a reference interval (UT) or window size (WS)); similarly calculating a second RMS value in the second time window (¶ [0063] calculating a function value for a window W2 of a second section, and in this manner, the processor 120 may calculate function values until a window of a last section of the pulse wave signal while sliding the window). Jang further discloses an extremum (e.g., maximum) in the RMS values can be identifying from the respective RMS values (Fig. 5; ¶ [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Galiatsatos with iteratively calculating respective RMS values at iterative time windows during performance of the medical maneuver, e.g., by selecting a first time window during performance of the medical maneuver; removing a DC offset; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating a first RMS value during the first time window; advancing to a second time window; calculating a second RMS value in the second time window; etc., as disclosed/suggested by Jang in order to facilitate calculating amplitude values during performance of the medical maneuver in a manner that does not require identifying individual PPG cycles and/or that can be accurately assessed in noisy environments (Jang, ¶ [0004]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Galiatsatos with identifying the minimum RMS value from the RMS values calculated for the respective plurality of time windows during performance of the medical maneuver, in order to facilitate deriving a ratio strongly associated with cardiac function (Galiatsatos, Results).
Galiatsatos as modified does not expressly disclose calculating the RMS value of each time window comprises calculating an average PPG value during the respective time window. While Jang (or Galiatsatos as modified thereby) does not expressly disclose DC offset is removed, as discussed above, Jang discloses the RMS value is determined for the AC component within each window (¶ [0065]), illustrating the waveform to be analyzed is symmetric around zero (e.g., Fig. 3), such that one of ordinary skill in the art would at once envisage that a DC component or offset has been removed from said signal. Alternatively/Additionally, McPherson discloses, prior to calculating an RMS value of PPG signal, the average of said PPG signal is calculated and subtracted from the PPG signal to remove a DC offset therefrom (e.g., claim 19; ¶ [0048]; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Galiatsatos with calculating the RMS value of each time window comprising calculating an average PPG value during the respective time window and removing a DC offset, e.g., based on the calculated average PPG value, as disclosed and/or suggested by McPherson in order to ready the PPG signal within the window for subsequent feature extraction (e.g., RMS value calculation) (McPherson, ¶ [0048]).
Galiatsatos as modified further discloses/suggests outputting data on a computer display for assessment of the cardiac filling pressure of the user (e.g., Discussion, noninvasively obtained LVEDP using the hand-held device; using a calculated LVEDP to guide therapy; etc.), but does not expressly disclose the calculated ratio is output on the computer display. However, Galiatsatos does disclose other non-invasive tests may aid in the assessment of LVEDP (e.g., Discussion, chest x-ray, echocardiogram, serum natriuretic peptide markers). Muehlsteff discloses outputting information resulting from a method on a computer display for assessment of the user, including an acquired PPG signal(s), characteristic(s) identified from the PPG signal(s), an assessment based on the PPG signal(s) and/or characteristic(s) thereof, etc. (e.g., ¶ [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Galiatsatos with outputting the minimum RMS ratio on the computer display as disclosed/suggested by Muehlsteff in order to further permit a clinician to utilize his/her judgement in assessing cardiac function/cardiac filling pressure based on said ratio individually and/or in combination with the results of other non-invasive tests may aid in such an assessment (Galiatsatos, Discussion).
Regarding claim 4, Galiatsatos discloses/suggests determining the baseline amplitude value comprises selecting a baseline time window prior to the performance of the Valsalva maneuver (Methods, identifying the approximate time of the starting and ending peak of a typical segment of cycles in during baseline) from which the baseline amplitude value is calculated (e.g., Methods, calculating average pulse amplitude of the selected segment of PPG cycles during baseline). Galiatsatos as modified discloses/suggests the baseline amplitude value calculated from said baseline time window comprises a baseline RMS value, as discussed above, but does not expressly disclose the particular steps by which said baseline RMS value is calculated, i.e., calculating an average PPG value during the selected baseline time window; removing a direct current (DC) offset; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating the baseline RMS value.
McPherson discloses a method of determining an RMS value of a PPG comprising calculating an average PPG value during a time window and removing a DC offset (claim 19, filtering and normalizing said plethysmographic waveform prior to a feature extracting step including removing DC offset by subtracting the average of the PPG waveform from the PPG waveform; ¶ [0048] processing the signal such that it is symmetrically periodic around zero, with all DC bias removed; etc.); squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating the RMS value (¶ [0048] waveform is ready for feature extraction after DC bias is removed; ¶¶ [0054]-[0056] calculating RMS of the waveform).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Galiatsatos with determining the baseline RMS value prior to performance of the Valsalva maneuver by the user by calculating an average PPG value during the selected baseline time window; removing a DC offset, e.g., by subtracting the calculated average PPG value; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating the baseline RMS value as disclosed/suggested by McPherson in order to facilitate calculating a baseline amplitude value in a manner that does not require identifying individual PPG cycles and/or to return a real number (i.e., RMS value) that can be used in further analysis, e.g., calculating ratios to limit intersubject variability (Galiatsatos, Methods), as an alternative amplitude metric (Muehlsteff, ¶ [0053]).
Regarding claims 8-10, 13-17 and 20, Galiatsatos discloses/suggests a system comprising:
a processor (i.e., computing device) and a computer program product comprising a non-transitory computer readable storage medium that stores program instructions executable by the processor to cause the processor/computing device to perform operations (Methods, analyses were conducted with scripts using various commercially available software programs, wherein the "computer readable storage medium" is the hardware component(s) on which said scripts or programs are stored), the operations comprising:
receiving biometrics data for a user, the biometrics data including a PPG value and an expiratory pressure value (Methods, transduced signals from the mouth piece expiratory pressure sensor and the finger PPG probe were analyzed using an algorithm developed using Excel Software);
determining, based on the biometrics data, a baseline amplitude value prior to performance of a Valsalva maneuver by the user (Methods, calculating average pulse amplitude of the selected segment of PPG cycles during baseline);
determining a minimum amplitude value of the biometrics data during the Valsalva maneuver (Methods, calculating minimum PPG pulse amplitude during the VM);
calculating a ratio between the minimum amplitude value and the baseline amplitude value to generate a minimum amplitude ratio (Methods, ratios of measures obtained during the VM to those obtained at baseline were calculated); and
storing the minimum amplitude ratio and assessing the cardiac filling pressure of the user based on the minimum amplitude ratio (Methods, the univariate correlation between LVEDP and each PPG waveform feature was examined and/or calculating LVEDP based on the PPG waveform feature(s) using a model/equation, indicating the calculated ratio(s) was stored at least temporarily for subsequent analysis), wherein the minimum amplitude ratio represents information pertaining to cardiac function, including cardiac filling pressure of the user (Results, MinPAR is strongly associated with LVEDP).
Galiatsatos does not disclose the baseline amplitude value and the minimum amplitude value are RMS values. Rather, Galiatsatos discloses the amplitude values represent the difference between a maximum of the PPG and a minimum of the PPG signal of a given pulse (e.g., Fig. 3).
Muehlsteff discloses amplitude of an acquired PPG signal may be defined as a difference between a maximum of the acquired PPG signal and a minimum of the acquired PPG signal (e.g. within a heart period), or alternatively may comprise a root mean squared amplitude of the acquired PPG signal (¶ [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Galiatsatos with the baseline amplitude value and the minimum amplitude value being a baseline RMS value and a minimum RMS value, respectively, such that the ratio therebetween is a minimum RMS ratio, as disclosed/suggested by Muehlsteff as a simple substitution of one suitable amplitude characteristic of the PPG signal for another to yield no more than predictable results. See MPEP 2143(I)(B).
Galiatsatos as modified further discloses and/or suggests iteratively calculating respective amplitude values for each of a plurality of PPG cycles during the performance of the Valsalva maneuver and identifying the minimum amplitude RMS value from the respective RMS values (Methods, calculating minimum PPG pulse amplitude during the VM, indicating each PPG pulse amplitude during the VM is calculated and the least/minimum PPG pulse amplitude identified therefrom). Galiatsatos does not disclose iteratively calculating respective RMS values at iterative time windows during performance of the medical maneuver, e.g., by selecting a first time window during performance of the medical maneuver; calculating an average photoplethysmogram (PPG) value during the selected first time window; removing a direct current (DC) off set; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating a first RMS value during the first time window; advancing to a second time window; calculating a second RMS value in the second time window; etc., and identifying the minimum RMS value from the respective RMS values by determining a minimum RMS value, of a plurality of RMS values calculated at respective plurality of time windows during performance of the Valsalva maneuver.
Jang discloses a method comprising iteratively calculating respective RMS values at iterative time windows during performance of a medical maneuver (e.g., Fig. 3; ¶¶ [0061]-[0064]) including: selecting a first time window during performance of the medical maneuver (W1); and calculating a first RMS during the first time window (¶ [0063] applying a predetermined function to the pulse wave signal within a window W1 of a first section of the pulse wave signal, the processor 120 may calculate a function value for the window W1 of the first section, wherein the predetermined function may obtain the RMS value of the window) by removing a DC offset (e.g., ¶ [0065] AC component of the pulse wave; Fig. 3, signal is symmetric around zero; etc.); squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values (Equation 1); advancing to a second time window (W2) (¶¶ [0063]-[0064] processor 120 may shift the window by a reference interval (UT) or window size (WS)); similarly calculating a second RMS value in the second time window (¶ [0063] calculating a function value for a window W2 of a second section, and in this manner, the processor 120 may calculate function values until a window of a last section of the pulse wave signal while sliding the window). Jang further discloses an extremum (e.g., maximum) in the RMS values can be identifying from the respective RMS values (Fig. 5; ¶ [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Galiatsatos with iteratively calculating respective RMS values at iterative time windows during performance of the medical maneuver, e.g., by selecting a first time window during performance of the medical maneuver; removing a DC offset; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating a first RMS value during the first time window; advancing to a second time window; calculating a second RMS value in the second time window; etc., as disclosed/suggested by Jang in order to facilitate calculating amplitude values during performance of the medical maneuver in a manner that does not require identifying individual PPG cycles and/or that can be accurately assessed in noisy environments (Jang, ¶ [0004]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Galiatsatos with identifying the minimum RMS value from the RMS values calculated for the respective plurality of time windows during performance of the medical maneuver, in order to facilitate deriving a ratio strongly associated with cardiac function (Galiatsatos, Results).
Galiatsatos as modified does not expressly disclose calculating the RMS value of each time window comprises calculating an average PPG value during the respective time window. While Jang (or Galiatsatos as modified thereby) does not expressly disclose DC offset is removed, as discussed above, Jang discloses the RMS value is determined for the AC component within each window (¶ [0065]), illustrating the waveform to be analyzed is symmetric around zero (e.g., Fig. 3), such that one of ordinary skill in the art would at once envisage that a DC component or offset has been removed from said signal. Alternatively/Additionally, McPherson discloses, prior to calculating an RMS value of PPG signal, the average of said PPG signal is calculated and subtracted from the PPG signal to remove a DC offset therefrom (e.g., claim 19; ¶ [0048]; etc.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Galiatsatos with calculating the RMS value of each time window comprising calculating an average PPG value during the respective time window and removing a DC offset, e.g., based on the calculated average PPG value, as disclosed and/or suggested by McPherson in order to ready the PPG signal within the window for subsequent feature extraction (e.g., RMS value calculation) (McPherson, ¶ [0048]).
Galiatsatos as modified further discloses/suggests outputting data on a computer display for assessment of the cardiac filling pressure of the user (e.g., Discussion, noninvasively obtained LVEDP using the hand-held device; using a calculated LVEDP to guide therapy; etc.). Galiatsatos does not expressly disclose the calculated ratio is output on the computer display. However, Galiatsatos does disclose other non-invasive tests may aid in the assessment of LVEDP (e.g., Discussion, chest x-ray, echocardiogram, serum natriuretic peptide markers). Muehlsteff discloses outputting information resulting from a method on a computer display for assessment of the user, including an acquired PPG signal(s), characteristic(s) identified from the PPG signal(s), an assessment based on the PPG signal(s) and/or characteristic(s) thereof, etc. (e.g., ¶ [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Galiatsatos with outputting the minimum RMS ratio on the computer display as taught/suggested by Muehlsteff in order to further permit a clinician to utilize his/her judgement in assessing cardiac function/cardiac filling pressure based on said ratio individually and/or in combination with the results of other non-invasive tests may aid in such an assessment (Galiatsatos, Discussion).
Regarding claims 11 and 18, Galiatsatos discloses/suggests determining the baseline amplitude value comprises selecting a baseline time window prior to the performance of the Valsalva maneuver (Methods, identifying the approximate time of the starting and ending peak of a typical segment of cycles in during baseline) from which the baseline amplitude value is calculated (e.g., Methods, calculating average pulse amplitude of the selected segment of PPG cycles during baseline). Galiatsatos as modified discloses/suggests the baseline amplitude value calculated from said baseline time window comprises a baseline RMS value, as discussed above, but does not expressly disclose the particular steps by which said baseline RMS value is calculated, i.e., calculating an average PPG value during the selected baseline time window; removing a direct current (DC) offset; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating the baseline RMS value.
McPherson discloses a method of determining an RMS value of a PPG comprising calculating an average PPG value during a time window and removing a DC offset (claim 19, filtering and normalizing said plethysmographic waveform prior to a feature extracting step including removing DC offset by subtracting the average of the PPG waveform from the PPG waveform; ¶ [0048] processing the signal such that it is symmetrically periodic around zero, with all DC bias removed; etc.); squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating the RMS value (¶ [0048] waveform is ready for feature extraction after DC bias is removed; ¶¶ [0054]-[0056] calculating RMS of the waveform).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the operations of Galiatsatos with determining the baseline RMS value prior to performance of the Valsalva maneuver by the user by calculating an average PPG value during the selected baseline time window; removing a DC offset, e.g., by subtracting the calculated average PPG value; squaring values above zero after removing the DC offset; summing the squared values; calculating a mean of the squared values; and calculating the baseline RMS value as disclosed/suggested by McPherson in order to facilitate calculating a baseline amplitude value in a manner that does not require identifying individual PPG cycles and/or to return a real number (i.e., RMS value) that can be used in further analysis, e.g., calculating ratios to limit intersubject variability (Galiatsatos, Methods), as an alternative amplitude metric (Muehlsteff, ¶ [0053]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to eligibility under 35 U.S.C. 101, Applicant contends "storing and outputting the minimum RMS ratio on a computer display for assessment of cardiac filling pressure of the user" and "assessing the cardiac filling pressure of the user based on the minimum RMS ratio" cannot be performed in the human mind and therefore are neither mental processes nor methods of organizing human activity. Applicant further contends "these features are unlike any method of organizing human behavior" (Remarks, pgs. 7-9).
Firstly, as noted in the prior Office action, the examiner has made no contention that the pending claims recite and/or are directed to methods of organizing human activity. Rather, the rejection states that pending claims recite limitations that fall within the mathematical concept(s) and/or mental processes grouping(s) of abstract ideas. Accordingly, the claim recites an abstract idea(s). Secondly, the examiner has not made any assertion that outputting a calculated RMS ratio on a computer display is one of the limitations that fall within the above-noted grouping(s). Rather, the storing and outputting limitation is identified as an additional limitation of the claim. However, said limitation merely adds insignificant extrasolution activity to the judicial exception(s), and is a well-understood, routine and/or conventional computer function. Even when considered in combination, the claim limitations, at best, appear to amount to mere instructions to apply an exception using a computer and/or merely invoke computers or machinery as a tool to perform an abstract idea, e.g., require the use of software to tailor information and provide it to the user on a generic computer. Lastly, Applicant's contention that "assessing the cardiac filling pressure of the user based on the minimum RMS ratio" cannot be practically performed in the mind is unpersuasive. All that is required of the limitation is that a user consider the ratio in any manner he/she desires in making a mental assessment (judgment, evaluation, etc.) of cardiac filling pressure. Further, the argument appears to contradict the specification as filed. Applicant discloses, "In some embodiments, the minimum RMS ratio may be presented on a display, output/stored to another device, included in a report or chart, etc.," thereby at least suggesting that a person (physician, clinician, etc.) is reading said display, report, chart, etc., and mentally/manually performing said assessment.
With respect to the prior art rejections, Applicant contends, "Jang does not teach or suggest determining a minimum function value, let alone teach or suggest determining a minimum RMS value from among iteratively determined RMS values, as presently recited in amended claims 1, 8, and 15" (Remarks, pgs. 10-11).
Jang alone is not relied on as a disclosure of determining a minimum RMS value from among iteratively determined RMS values. Rather, the rejection is based on a combination of references. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, the test for obviousness is not that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In the present case, the primary reference to Galiatsatos discloses determining a minimum amplitude value of the biometrics data during the Valsalva maneuver, wherein the amplitude value represents the difference between a maximum of the PPG and a minimum of the PPG signal of a given pulse. Muehlsteff discloses an amplitude value of a signal, such as a PPG signal, may be defined as a difference between a maximum of the acquired PPG signal and a minimum of a given pulse (e.g. within a heart period of the acquired PPG signal) (i.e., comparable to Galiatsatos) or alternatively may comprise a root mean squared amplitude (RMS) of the acquired PPG signal. Galiatsatos as modified by Muehlsteff in the rejection of record therefore discloses/suggests determining a minimum RMS value of the biometrics data during the Valsalva maneuver.
Jang (or Jang and McPherson) discloses/suggests a means/method by which to identify said minimum RMS value during the medical maneuver, e.g., by selecting a first time window during performance of the medical maneuver, calculating an average PPG value during the first time window, removing a DC offset, squaring values above zero after removing the DC offset, summing the squared values, calculating a mean of the squared values, calculating a first RMS value during the first time window, advancing to a second time window, and calculating a second RMS value in the second time window. Jain further discloses a characteristic point may be identified among the calculated RMS values, including an extremum thereof (e.g., ¶ 0048], ¶ [0077], etc.), and discloses the means and/or method enables identifying said characteristic point with high accuracy even in high noise environments (e.g., ¶ [0004]). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method/operations of Galiatsatos with determining a minimum RMS value of the biometrics data during the medical maneuver in the manner disclosed/suggested by Jang (or Jang and McPherson) in order to facilitate determining the minimum RMS value in a manner that does not require identifying individual PPG cycles and/or that can be accurately assessed in noisy environments.
Conclusion
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/Meredith Weare/Primary Examiner, Art Unit 3791
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