DETAILED ACTION
Applicant' s arguments, filed 05/13/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/21/2024, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 8-16 are the current claims hereby under examination.
Examiner’s Note: All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2024/0180435 A1.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-10 and 12-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “a display” and “an output device … comprising one or more of … a visual display” it is unclear if the display and the visual display of the output device are the same as, related to, or different from each other. For the purposes of this examination, the visual display of the output device is interpreted as the same display of the device.
Claims 9-10 and 12-16 are rejected by virtue of their dependence on claim 8. Claim 11 clarifies the relationship between the two displays and is thus not rejected by virtue of its dependency.
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 8-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 8-16 are directed to a method of processing pulse wave signals using a computational algorithm, which is an abstract idea. Claims 8-16 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 8 is as follows:
Step 1: Claim 8 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] calculating a blood pressure value based on the acquired pulse wave
[B1] generating pulse wave reproduction information, the pulse wave reproduction information being dynamic information reproducing pulse wave intervals of the acquired pulse wave at a time of calculation of the blood pressure value
[C1] stores the blood pressure value and the pulse wave reproduction information
[D1] displays the blood pressure value
[E1] outputs the pulse wave reproduction information
[F1] output the pulse wave reproduction information acquired at the time of calculation of the blood pressure value when the blood pressure value stored is displayed
These elements [A1]-[F1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] acquiring at least a pulse wave
[B2] a control unit including a processor
[C2] a non-transitory computer readable storage medium
[D2] a display
[E2] an output device comprising one or more of a loudspeaker, a visual display, a vibration generating device, or a device that generates a palpable sensory effect
These elements [A2]-[E2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2] and [E2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [B2]-[D2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “acquiring at least a pulse wave” does not qualify as significantly more because this limitation merely describes the receipt of data and does not incorporate any sensor device as part of the claimed invention. Also, the recitation “acquiring at least a pulse wave” is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than a conventional blood pressure cuff. Such blood pressure sensors are conventional as evidenced by:
US Patent Application Publication Number US 20020147404 A1 hereinafter Kato teaches that wrist blood pressure monitors which use cuffs to collect pulse wave signals are conventional (Paragraphs 0007-0008)
US Patent Application Publication Number US 20200000350 A1 hereinafter Lin teaches that sphygmomanometers are conventional and utilize inflating and deflating cuffs to obtain pulse wave signals (Paragraph 0004)
Further, the elements [B2]-[D2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Additionally the element [E2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception. In particular, each of the types of output devices are well-known and conventionally included in computing devices such as smartphones which include displays, speakers, and vibration generating devices which produce a palpable effect. Additionally, theses elements are well-known as evidenced by Applicant’s lack of a particular description of their structures and/or operation in the specification.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 9-16 depend from claim 9, and recite the same abstract idea as claim 9. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claims 10-11: the output device comprises the visual display;
Claim 12: the output device includes the vibration generating device; and
Claim 13: a sensor.
Claim 14: a cuff member
Claim 16: a second non-transitory computer readable medium
Each of these claim’s limitations does not integrate the exception into a practical application. In particular, the elements of claims 10-14 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the sensor and the sensor being a cuff member are routine and conventional blood pressure sensors as evidenced by Kato and Lin (as provided above with respect to the rejection of claim 1).
Also, the limitations from claims 10-12 and 16 are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display and vibration output) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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.
Claims 8-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chang US Patent Application Publication Number US 2009/0062664 A1 hereinafter Chang in view of Inoue US Patent Application Publication number US 2011/0130667 A1 hereinafter Inoue.
Regarding claim 8, Chang teaches a blood pressure measurement device (Abstract) comprising:
a control unit including a processor (Paragraph 0029: the central processing unit), the control unit:
acquiring at least a pulse wave (Paragraph 0092: the cuff inflates and the device detects heart pulses);
calculating a blood pressure value based on the acquired pulse wave (Paragraphs 0031 and 0092: the measured blood pressure);
generating pulse wave reproduction information, the pulse wave reproduction information being dynamic information reproducing pulse wave intervals of the acquired pulse wave at a time of calculation of the blood pressure value (Paragraph 0030: the heart rate value; Paragraphs 0085 and 0092: the device detects heart pulses and beeps for each one detected and displays the cuff pressure);
a non-transitory computer readable storage medium that stores the blood pressure value and the pulse wave reproduction information (Paragraphs 0029: the storage component; previous measurements may be compared so the measured data is recorded; various data regarding blood pressure measurement is stored; Paragraphs 0087 and 0093: the determined blood pressure, heart rate, and measurement state, and other related data is stored);
a display that displays the blood pressure value transmitted from the non-transitory computer readable medium (Paragraph 0061: the display unit; Paragraphs 0085 and 0087: the blood pressure is measured, displayed, and saved to a memory either in the device or a removable memory); and
an output device that outputs the pulse wave reproduction information, the output device comprising one or more of a loudspeaker, a visual display, a vibration generating device, or a device that generates a palpable sensory effect (Paragraph 0061: the display unit, speaker, and/or flashing indicators; Paragraph 0068: the output of a heart rate value; Paragraphs 0085 and 0092: the beeping with each pulse, and display of the measured cuff pressure, or pulse signal),
wherein the output device is configured to output the pulse wave reproduction information acquired at the time of calculation of the blood pressure value (Paragraphs 0085, 0092 and 0068: the heartbeat indicator and the device may beep with each measured heartbeat and may display the measured cuff pressure, or pulse signal. These operations occur with blood pressure measurement; Paragraphs 0030-0031: both current and previous data may be displayed including heart rate values and data regarding blood pressure measurement.)
Chang fails to explicitly disclose the device comprising: an output device that outputs the pulse wave reproduction information transmitted from the non-transitory computer readable medium; and wherein the output device is configured to output the pulse wave reproduction information acquired at the time of calculation of the blood pressure value when the blood pressure value stored in the non-transitory computer readable storage medium is displayed to the display unit.
Inoue teaches a blood pressure information display device for calculating a blood pressure value based on a pulse wave amplitude through the oscillometric method (Abstract). Thus, Inoue falls within the same field of endeavor as Applicant’s invention.
Inoue teaches an output device that outputs the pulse wave reproduction information transmitted from the non-transitory computer readable medium; and wherein the output device is configured to output the pulse wave reproduction information acquired at the time of calculation of the blood pressure value when the blood pressure value stored in the non-transitory computer readable storage medium is displayed to the display unit (Paragraphs 0012-0013 and 0086-0087, 0092-0093 and 0123: the received sensor data is recorded to memory then processed. The display includes blood pressure, and pulse wave related information which may be the pulse waveform along the time axis).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of Chang to store and display the pulse wave information over time with the blood pressure information as taught by Inoue because displaying the pulse wave information allows the user to see if the timing between pulses is irregular or if the pulses themselves have irregular varying amplitude. Such data provides additional context to the user’s condition that is not provided by blood pressure and heart rate alone.
Regarding claim 9, Chang in view of Inoue teaches the blood pressure measurement device according to claim 8. Modified Chang further teaches the device wherein the control unit further detects an arrhythmia when present in the pulse wave acquired (Paragraph 0068: arrhythmia detection),
An obvious variation of Chang would be to configure the device wherein the output device outputs the pulse wave reproduction information only when the blood pressure value calculated based on the pulse wave at a time of detection of the arrhythmia is displayed to the display unit. Such a variation would be obvious because Chang teaches the detection of arrhythmia (Paragraph 0068) and the output of pulse reproduction information (Paragraphs 0092 and 0068), but appears to be directed towards always presenting the pulse reproduction information when blood pressure is being determined. An obvious variation of such a presentation of the pulse reproduction information would be to only display it when arrhythmia is detected because there are a finite number of identified, predictable solutions, with a reasonable expectation of success. Thus it would be obvious to try configuring the device to only present the pulse reproduction information (the flashing of the heartbeat indicator and/or the beeping) only when arrhythmia is detected. There are a finite number of predictable solutions including presenting the indicators all the time when detecting pulses, not presenting them at all, presenting them only when no issues are detected, presenting them when any issue is detected, and presenting them when only certain issues are detected. The claim is directed towards presenting the indicators when only certain issues (only arrhythmia) are detected which is considered an obvious variation of Chang because such a configuration would be obvious to try and does not produce a surprising technical effect.
Regarding claim 10, Chang in view of Inoue teaches the blood pressure measurement device according to claim 9. Modified Chang further teaches the device wherein the output device comprises the visual display and outputs information indicating presence of the arrhythmia when the blood pressure value calculated based on the pulse wave at the time of detection of the arrhythmia is displayed to the display unit (Paragraph 0068: the measurement error indicator turns on when arrhythmia is detected during blood pressure determination; Fig. 6 references 614, 616, and 626).
Regarding claim 11, Chang in view of Inoue teaches the blood pressure measurement device according to claim 8. Modified Chang further teaches the device wherein the display serves as the visual display of the output device, and the pulse wave reproduction information is output to the display at least as a moving image (Fig. 6 reference 628; Paragraphs 0068, 0085, and 0092: the heartbeat indicator is present on the display and the display may be the output unit. The cuff pressure is also displayed).
Regarding claim 13, Chang in view of Inoue teaches the blood pressure measurement device according to claim 8. Modified Chang further teaches the device further comprising a sensor that detects at least the pulse wave (Paragraphs 0070 and 0085: the cuff pressure sensor which is processed to determine blood pressure and heart rate).
Regarding claim 14, Chang in view of Inoue teaches the blood pressure measurement device according to claim 13. Modified Chang further teaches the device wherein the sensor is a component of a cuff member (Paragraph 0060: the main body, cuff, and associated hose; Fig. 5A references 502 and 504; Paragraph 0070: the pressure sensor).
Regarding claim 15, Chang in view of Inoue teaches the blood pressure measurement device according to claim 13. Modified Chang further teaches the device wherein the control unit acquires the pulse wave via the sensor (Paragraph 0092: the detection of heart pulses; Paragraphs 0085 and 0070: the pressure sensor is used to determine heart rate and blood pressure and thus provides the input for pulse detection).
Regarding claim 16, Chang in view of Inoue teaches the blood pressure measurement device according to claim 13. Modified Chang further teaches the device wherein the control unit acquires the pulse wave from a second non-transitory computer readable medium (Paragraphs 0071, 0078, 0084, 0087, 0089 and 0095-0097: the system may have both an embedded and removable memory and may interface with removable memory to store measurements and access previous data.).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Chang US Patent Application Publication Number US 2009/0062664 A1 hereinafter Chang in view of Inoue US Patent Application Publication number US 2011/0130667 A1 hereinafter Inoue as applied to claim 8 above and further in view of Brumfield US Patent Application Publication Number US 2014/0364750 A1 hereinafter Brumfield further in view of Thomson US Patent Application Publication Number US 2015/0018660 A1 hereinafter Thomson
Regarding claim 12, Chang in view of Inoue teaches the blood pressure measurement device according to claim 11. Modified Chang further teaches the device, wherein the pulse wave reproduction information is output as blinking of an icon (Paragraphs 0092 and 0068: the heartbeat indicator and the device may beep with each measured heartbeat. The name of the heartbeat indicator in combination with the teachings of paragraphs 0068, 0079, 0084-0085, and 0091 drawn towards the optional beeping when each heartbeat is detected is considered sufficient to at least suggest that the heartbeat indicator on the display may be configured to flash with each detected heartbeat to indicate its detection)
Modified Chang fails to further teach the device the output device includes the vibration generating device, and the pulse wave reproduction information is output: the blinking icon is in synchronization with peak positions of an amplitude of the pulse wave and as vibration pf the vibration generating device in synchronization with the peak positions of the amplitude of the pulse wave.
Brumfield teaches a method for identifying cardiac bradiacardia behavior may include acquiring pulse volume wave data from a sensor associated with a patient, and calculating metrics associated with peaks detected therein (Abstract). Thus, Brumfield is reasonably pertinent to the problem at hand.
Brumfield teaches that blood pressure cuffs may be used to capture pulse waveforms (Paragraph 0020). Brumfield further teaches that pulse waves may be identified by their peaks and the peaks used for timing purposes (Paragraphs 0051-0056).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the device of modified Chang to detect pulse waves by their peaks as taught by Brumfield and to synchronize the heartbeat indicator and beeping with those peaks as the peaks serve as the peaks are used to determine when a pulse wave is detected because utilizing the peaks of pulse waves to detect the pulse wave and determine timing metrics provides a consistent metric for determinations of arrhythmia and pulse rate metrics which may improve accuracy since the timing of each wave is determined in a consistent manner.
Chang in view of Inoue further in view of Brumfield fails to teach device the output device includes the vibration generating device, and the pulse wave reproduction information is output: as vibration pf the vibration generating device in synchronization with the peak positions of the amplitude of the pulse wave.
Thomson teaches devices, systems, and methods for measuring and monitoring biometric or physiological parameters in a user-friendly and convenient manner (Abstract). Thus, Thomson falls within the same field of endeavor as Applicant’s invention.
Thomson teaches a tactile feedback mechanism for providing feedback to the user (Paragraph 0329).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate a tactile feedback mechanism as taught by Thomson into the device of Chang in view of Inoue in view of Brumfield because such a mechanism provides an additional avenue to provide feedback to the user and may be more convenient than the visual and/or auditory feedback taught by Chang in some instances. Furthermore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to configure the vibration feedback mechanism to pulse in synchronization with the heartbeat similar to the visual heartbeat indicator and auditory beeping of Chang because such a vibration mechanism would provide the user with an additional way of tracking when heartbeats are detected and may be more user-friendly than the beeping and/or visual display taught by Chang in some circumstances.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In particular, the amended language has changed the interpretation of the claims and Inoue is now relied upon for the teachings of displaying dynamic pulse wave reproduction information when such is displayed from the memory of the device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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