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 .
Response to Amendment
The amendment to the claims filed 11 March 2026 has been entered. Claim(s) 1, 5-6, 8, 12-13, 15 and 19 is/are currently amended. Claim(s) 1-20 is/are pending.
Objections and/or Rejections Withdrawn
Objections to the claims, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) made in the prior Office action (mailed 17 December 2025, "Non-Final Rejection") that are not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Interpretation
As noted in the Non-Final Rejection, claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Since none of the pending claim use "means" or "step" for language, and no claim limitations have been otherwise identified as being interpreted under 35 U.S.C. 112(f), no feature and/or limitation of any pending claim is being interpreted to invoke 35 U.S.C. 112(f), consistent with Applicant's submission (Remarks, pg. 7).
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) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more.
Claims 1-14 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. Claims 15-20, instead of determining a minimum RMS value during the medical maneuver, recites determining an RMS value at the end of the medical maneuver, and similarly calculating a ratio with respect to the baseline RMS value.
The above 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, 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; determining an RMS value at the end of the medical maneuver encompasses the user mentally/manually calculating an RMS value for a time window ending at the end of the maneuver; calculating a ratio encompasses a user mentally/manually dividing one calculated value by another. 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 1-20 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) 1-3, 7-10, 14-17 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).
Regarding claims 1-3 and 7, Galiatsatos discloses and/or 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 (Methods, the univariate correlation between LVEDP and each PPG waveform feature was examined, indicating the calculated ratio(s) was at least stored for this 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 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/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 method 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 8-10 and 14, Galiatsatos discloses/suggests a computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a computing device to cause the 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/programs are stored), the operations 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 (Methods, the univariate correlation between LVEDP and each PPG waveform feature was examined, indicating the calculated ratio(s) was at least stored for this 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 computer program product 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 and/or 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/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 method 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 15-17 and 20, Galiatsatos discloses/suggests system comprising:
a processor, and a non-transitory computer-readable storage medium that stores program instructions executable by the processor to cause the processor to perform operations (Methods, analyses were conducted with scripts using various commercially available software programs, i.e., a computing device programmed to execute said scripts/software), the operations 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 an amplitude value of the biometrics data at the end of the Valsalva maneuver (Methods, calculating pulse amplitude of the last PPG cycle before release of the VM);
calculating a ratio between the amplitude value at the end of the Valsalva maneuver and the baseline amplitude value to generate an amplitude ratio (Methods, ratios of measures obtained during the VM to those obtained at baseline were calculated); and
storing the amplitude ratio (Methods, the univariate correlation between LVEDP and each PPG waveform feature was examined, indicating the calculated ratio(s) was at least stored for this subsequent analysis), wherein the amplitude ratio represents information pertaining to cardiac function including cardiac filling pressure of the user (Results, PAR is associated with LVEDP).
Galiatsatos does not disclose the baseline amplitude value and the amplitude value at the end of the Valsalva maneuver 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 system of Galiatsatos with the baseline amplitude value and the amplitude value at the end of the Valsalva maneuver being a baseline RMS value and an RMS value, respectively, such that the ratio therebetween is an RMS ratio, as disclosed and/or 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/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 method of Galiatsatos with outputting the 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).
Claim(s) 4, 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galiatsatos in view of Muehlsteff as applied to claim(s) 1, 8 and 15 above, and further in view of US 2015/0305674 A1 (previously cited, McPherson).
Regarding claims 4, 11 and 18, Galiatsatos discloses 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/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 (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]).
Claim(s) 5-6 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galiatsatos in view of Muehlsteff as applied to claim(s) 1 and 8 above, and further in view of US 2021/0169356 A1 (previously cited, Jang) and McPherson.
Regarding claims 5-6 and 12-13, Galiatsatos as modified discloses/suggests the limitations of claims 1 and 8, and further discloses/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 that 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/operations of Galiatsatos 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 and/or 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 method/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]).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galiatsatos in view of Muehlsteff as applied to claim(s) 15 above, and further in view of Jang.
Regarding claim 19, Galiatsatos as modified discloses/suggests the limitations of claim 15, as discussed above, and further discloses determining the amplitude value of the biometrics data at the end of the medical maneuver comprises modeling the biometrics data (Methods, plotting the PPG waveform along with the time course of the expiratory effort); and identifying the end of the medical maneuver prior based on the modeling the biometrics data (identifying the approximate time of the start and end of the VM). Galiatsatos does not disclose determining the amplitude value of the biometrics data at the end of the medical maneuver comprises selecting a time window covering a period of time before the end of the medical maneuver up until the end of the medical maneuver; and calculating the RMS value within the selected window.
Jang discloses a method of determining the RMS value of a PPG at the end of the medical maneuver including selecting a time window covering a period of time before the end of the medical maneuver up until the end of the medical maneuver (Fig. 3, Wn, Wm); and calculating the RMS value within the selected window (¶ [0063] calculating a function, e.g., RMS, value for each window, including a window of a last section of the pulse wave signal).
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 selecting a time window covering a period of time before the end of the medical maneuver up until the end of the medical maneuver; and calculating the RMS value within the selected window as disclosed/suggested by Jang in order to facilitate calculating an amplitude value at the end 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]).
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, "The independent claim 1 recites 'an ultraviolet (UV) light source configured to emit UV light towards a UV light zone at a UV light level,' 'a motion sensor device configured to sense movements of one or more individuals in the UV light zone,' and 'a controller in communication with the motion sensor device and the UV light source.' Applicant submits that even under the broadest reasonable interpretation, these features cannot be interpreted as human beings or being action performed in a human mind. Accordingly, because the claims concern a UV light source, a motion sensor device, and a controller, the claim cannot embrace a method of organizing human activity" (Remarks, pg. 9).
None of the pending claims, let alone independent claim 1, recite a UV light source, a motion sensor device, or a controller in communication with a motion sensor device and a UV light source. Further, the examiner has made no contention that the pending claims "embrace a method of organizing human activity."
Applicant contends "storing and outputting the minimum RMS ratio on a computer display for assessment of cardiac filling pressure of the user" 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. 9-10).
As noted above, the examiner has made no contention that the pending claims recite and/or directed to methods of organizing human activity. Rather, as discussed in the rejection(s) of record above, the 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). Further, 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/outputting limitation is identified as an additional limitation of the claim. As discussed above, 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 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.
In view of the above, the rejections under 35 U.S.C. 101 have been maintained.
With respect to the prior art rejections of the independent claims, Applicant contends Muehlsteff does not teach or suggest "determining the RMS value prior to performance of a medicial [sic] maneuver," or "calculating a ratio between the minimum RMS value and the baseline RMS value to generate a minimum RMS ratio," and thus "claims 1, 8 and 15 are allowable" (Remarks, pg. 11).
The examiner respectfully disagrees with Applicant's conclusion. With respect to features Applicant contends Muehlsteff does not teach, the examiner notes Muehlsteff is not relied upon as a disclosure of said features. Specifically, as discussed in the rejections of record above, the primary reference to Galiatsatos discloses determining a baseline amplitude value prior to performance of a Valsalva maneuver, determining a minimum amplitude value during the Valsalva maneuver or determining an amplitude value at the end of the Valsalva maneuver and calculating a ratio between the baseline and minimum (or end-maneuver) amplitude values. Galiatsatos merely does not disclose the amplitude values are RMS values. Rather, Galiatsatos appears to disclose 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 an amplitude value of an acquired PPG signal may be calculated/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) comparable to the disclosure of Galiatsatos. Muehlsteff further discloses an amplitude value of an acquired PPG can alternatively/additionally be calculated as an RMS value of the acquired PPG signal (¶ [0053]). Accordingly, Muehlsteff discloses an RMS value is a suitable, predictable alternative method for characterizing the amplitude of an acquired PPG than the amplitude calculation method apparently disclosed by Galiatsatos, and therefore would have been an obvious modification.
Applicant further submits the dependent claims are allowable at least based on their dependence on an allowable base claim as well as the additional features they recite (Remarks, pgs. 11-13). The examiner respectfully disagrees for at least the reasons discussed above.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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