DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 5 is objected to because of the following informalities: line 3 recites, “a user’s body” and should instead recite, “a body of the user” to refer back to the same user of claim 1. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: line 2 recites, “a user’s body” and should instead recite, “a body of the user” to refer back to the same user of claim 1. Appropriate correction is required.
Claims 15 and 30 recite the same limitation as claim 5 and are similarly objected to.
Claim 16 recites the same limitation as claim 6 and is similarly objected to.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-30 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 1-30 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below.
Regarding Claim 1:
Step 1: Claim 1 is drawn to a method.
Step 2A – Prong 1: Claim 1 is drawn to an abstract idea in the form of a method that, under its broadest reasonable interpretation, covers performance of the limitations in the mind and is directed to certain methods of organizing human activity. In particular, claim 1 recites limitations:
obtaining, via a sensor system of a wearable device, first heart rate waveforms at a first wearable device configuration, the first wearable device configuration corresponding with a first position of one or more sensors of the sensor system;
prompting, via a user interface of the wearable device, a user to change the wearable device configuration to a second wearable device configuration, the second wearable device configuration corresponding with a second position of one or more sensors of the sensor system;
obtaining, via the sensor system, second heart rate waveforms at the second wearable device configuration;
determining, based at least in part on the first heart rate waveforms and the second heart rate waveforms, whether to change a wearable device configuration or maintain a current wearable device configuration; and
prompting, via the user interface, the user either to change the wearable device configuration or maintain the current wearable device configuration
The bolded element is drawn to an abstract idea because it is a process that, under its broadest reasonable interpretation, is a mere step that is capable of being mentally performed or with pen and paper. For example, a skilled artisan is capable of mentally comparing several waveforms, and based on their quality, make a determination of whether to maintain a current wearable device configuration that provided one waveform or change a wearable device configuration that provided another waveform.
The underlined elements are directed to method of organizing human activity, regarded as an abstract idea of following rules or instructions, similar to In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018) and Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1004 (2010).
Step 2A – Prong 2: Claim 1 recites italicized limitations that are beyond the judicial exception but do not integrate the exception into a practical application of the exception because they are recited at a high level of generality to perform the abstract idea. The wearable device, sensor system and the user interface are recited at a high level of generality and are merely tools to perform an existing process(MPEP 2106.05(f)). Obtaining first heart rate waveforms at a first wearable device configuration and second heart rate waveforms at a second wearable device configuration is directed to data gathering- an insignificant, pre-solution activity, a necessary precursor for the recited judicial exception and does not integrate the judicial exception into a practical application. Accordingly, the additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The elements do not amount to significantly more than the judicial exception because these 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 (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). The wearable device and sensor system for obtaining heart rate information are well understood, routine and conventional as evidenced by Vu et al. (US 2023/0284978), teaching, “Many conventional wearables integrate sensor technology to provide health information such as heart rate.” ([0003]). User interfaces on wearable devices are well understood, routine and conventional as evidenced by Ku et al. (US 2016/0299580), teaching, “A band-type wearable electronic device, such as a conventional smart watch, provides a user interface” ([0007]). Obtaining first heart rate waveforms at a first wearable device configuration and second heart rate waveforms at a second wearable device configuration is directed to data gathering- an insignificant, pre-solution activity, a necessary precursor for the recited judicial exception and does not integrate the judicial exception into a practical application. See MPEP 2106.04(d)(2) and 2106.05(g) and CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011).
Regarding claims 11, 22 and 26
Claims 11, 22, and 26 are directed to apparatuses that recite corresponding limitations as recited in claim 1 and are therefore rejected under 35 U.S.C. 101 for the same reasons as indicated above.
Dependent claims 2-10, 12-21, 23-25 and 27-30 are directed to further limiting the abstract ideas (that is, the claims only recite limitations that further limit the mental process or organization of human activity), recite limitations directed to insignificant extra-solution activity, or further define the type of data gathered. 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 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.
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 6-7, 9, 11, 13, 16-17, 19, 22, 24, 26, 28, is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (US 2023/0058052) in view of Castaneda et al. (“A review on wearable photoplethysmography sensors and their potential future applications in health care.” International journal of biosensors & bioelectronics vol. 4,4 (2018): 195-202.).
Regarding claims 1 and 26, Al-Ali et al. discloses a method and one or more computer-readable non-transitory media having instructions for controlling one or more devices to perform a method stored thereon, the method comprising: obtaining, via a sensor system (“oximetry- or plethmosmograph-based and/or ECG physiological parameters” [0248]; “The physiological parameter measurement sensor or module 100 can be an optical sensor” [0250]) of a wearable device 10 (fig. 1E), first physiological waveforms (“physiological parameters, which can include, for example, pulse rate, respiration rate, oxygen saturation (SpO2), Pleth Variability Index (PVI), Perfusion Index (PI), Respiration from the pleth (RRp), hydration, glucose, blood pressure, and/or other parameters” [0250]; fig. 32) at a first wearable device configuration (“a first position or notch “n”.” [0422]), the first wearable device configuration corresponding with a first position of one or more sensors of the sensor system (“The signal data from the sensors shown in FIG. 32 was obtained from the device when the strap of the device was in a first position or notch “n”.” [0422]); prompting, via a user interface 4502 (fig. 35-39; [0427]) of the wearable device, a user to change the wearable device configuration to a second wearable device configuration (“notch “n−1”.” [0422]; “the device can be configured to, at step 4308 in FIG. 34, output an appropriate warning to the user and/or provide an instruction to the user to increase the tightness of the strap or decrease the size of the strap to increase the contact pressure between the body portion 4001 and 4001′ of the device and the user's skin.” [0424]), the second wearable device configuration corresponding with a second position of one or more sensors of the sensor system (“the signal data from the sensors shown in FIG. 33 was obtained from the same device and same user when the strap of the device was in a second, improved or more optimal position or notch “n−1”.” [0424]); obtaining, via the sensor system, second physiological waveforms ([0250]; fig. 33) at the second wearable device configuration; determining, based at least in part on the first physiological waveforms and the second physiological waveforms, whether to change a wearable device configuration or maintain a current wearable device configuration ([0423-0425]; fig. 34); and prompting, via the user interface, the user to either change the wearable device configuration or maintain the current wearable device configuration (“output an appropriate warning to the user and/or provide an instruction to the user to increase the tightness of the strap or decrease the size of the strap” [0424]; “output an appropriate message to the user to indicate to the user that an appropriate or optimal strap tension has been achieved and/or prompt the user to record or remember the wrist strap notch position or setting” [0425]).
Al-Ali et al. does not expressly disclose the first and second physiological waveforms are specifically heart rate waveforms. Castaneda et al. however teaches that photoplethysmography (PPG) sensors, which is disclosed by Al-Ali et al. to detect the waveforms shown in fig. 32-33 ([0248]), are known in the art for providing uncomplicated and inexpensive measurements for monitoring heart rate (abstract), the PPG signal comprising pulsatile components (AC) that depict the systolic and diastolic phases of cardiac activity, can be used to measure heart rate variability or variations between heartbeat time intervals such as Peak-to-Peak intervals (p. 5, fig. 2), regarded as the “pulse rate” physiological parameter disclosed by Al-Ali et al. ([0250]). This aligns with the applicant’s own disclosure of presenting an example heart rate waveform systolic and diastolic pulsatile components (fig. 7) provided by a PPG signal ([0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to regard the “pulse rate” of Al-Ali et al. as a “heart rate waveform” as PPG sensors provide pulsatile waveform signals used to depict cardiac activity as evidenced by Castaneda et al., such an interpretation to be known in the art.
Regarding claims 3 and 28, Al-Ali et al. discloses obtaining, via the sensor system, first through Nth heart rate waveforms at a first through Nth wearable device configurations, N being an integer greater than 2 ([0422-0424]; “This process can be repeated until the quality of the signal data is determined by the processor to be above a predefined threshold value” [0425]); selecting, based at least in part on the first through Nth heart rate waveforms, one of the first through Nth wearable device configurations ([0422]); and prompting, via the user interface, the user to change the wearable device configuration to a selected wearable device configuration (“output an appropriate warning to the user and/or provide an instruction to the user to increase the tightness of the strap or decrease the size of the strap” [0424]; “output an appropriate message to the user to indicate to the user that an appropriate or optimal strap tension has been achieved and/or prompt the user to record or remember the wrist strap notch position or setting” [0425]).
Regarding claim 6, Al-Ali et al. discloses obtaining sensor data at a current pressure being applied to a user’s body by the wearable device at the current wearable device configuration; and determining, based at least in part on the sensor data, whether to prompt the user to change the current pressure to another pressure (“the device can be configured to instruct a user to increase or decrease the level of tightness of the strap and then determine if the quality of the signal data has improved or degraded” [0422]; “the level of tightness of the strap and, accordingly, the level of contact pressure between the body portion 4001′ and the user's skin” [0423]).
Regarding claim 7, Al-Ali et al. discloses wherein determining whether to prompt the user to change the current pressure to another pressure involves determining whether the current pressure is within a desired pressure range (“the contact pressure between the body portion 4001′ and the user's skin is greater in the second position, resulting in higher quality signal data from the sensor(s)” [0423]).
Regarding claim 9, Al-Ali et al. does not expressly disclose prompting, via the user interface, the user to withdraw a hand used to change the wearable device configuration. However, given the wearable device changes configuration via a hand wound tension mechanism ([0417]) and given the user interface prompts the user that an appropriate or optimal strap tension has been achieved ([0425]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the user interface effectively prompts the user to withdraw the hand used to wind the tension mechanism when indicating an appropriate or optimal strap tension has been achieved, as the hand used to change the wearable device configuration is no longer needed when an appropriate or optimal strap tension has been achieved.
Regarding claims 11 and 22, Al-Ali et al. discloses a wearable device 10 (fig. 1E), comprising: a sensor system (“oximetry- or plethmosmograph-based and/or ECG physiological parameters” [0248]; “The physiological parameter measurement sensor or module 100 can be an optical sensor” [0250]) configured to obtain physiological waveforms (“physiological parameters, which can include, for example, pulse rate, respiration rate, oxygen saturation (SpO2), Pleth Variability Index (PVI), Perfusion Index (PI), Respiration from the pleth (RRp), hydration, glucose, blood pressure, and/or other parameters” [0250]” [0250]; fig. 32-33) from a user of the wearable device, the sensor system being adjustable according to a plurality of wearable device configurations ([0422]); a user interface system 4502 (fig. 35-39; [0427]); and a control system (“processor” [0424]) configured to: obtain, via the sensor system, first physiological waveforms (fig. 32) at a first wearable device configuration (“a first position or notch “n”.” [0422]), the first wearable device configuration corresponding with a first position of one or more sensors of the sensor system (“The signal data from the sensors shown in FIG. 32 was obtained from the device when the strap of the device was in a first position or notch “n”.” [0422]); control the user interface system 4502 (fig. 35-39; [0427]) to prompt the user to change the wearable device configuration to a second wearable device configuration (“notch “n−1”.” [0422]; “the device can be configured to, at step 4308 in FIG. 34, output an appropriate warning to the user and/or provide an instruction to the user to increase the tightness of the strap or decrease the size of the strap to increase the contact pressure between the body portion 4001 and 4001′ of the device and the user's skin.” [0424]), the second wearable device configuration corresponding with a second position of one or more sensors of the sensor system (“the signal data from the sensors shown in FIG. 33 was obtained from the same device and same user when the strap of the device was in a second, improved or more optimal position or notch “n−1”.” [0424]); obtain, via the sensor system, second physiological waveforms (fig. 33) at the second wearable device configuration; determine, based at least in part on the first physiological waveforms and the second physiological waveforms, whether to change a wearable device configuration or maintain a current wearable device configuration ([0423-0425]; fig. 34); and control the user interface system to prompt the user to either change the wearable device configuration or maintain the current wearable device configuration (“output an appropriate warning to the user and/or provide an instruction to the user to increase the tightness of the strap or decrease the size of the strap” [0424]; “output an appropriate message to the user to indicate to the user that an appropriate or optimal strap tension has been achieved and/or prompt the user to record or remember the wrist strap notch position or setting” [0425]).
Al-Ali et al. does not expressly disclose the first and second physiological waveforms are specifically heart rate waveforms. Castaneda et al. however teaches that photoplethysmography (PPG) sensors, which is disclosed by Al-Ali et al. to detect the waveforms shown in fig. 32-33 ([0248]), are known in the art for providing uncomplicated and inexpensive measurements for monitoring heart rate (abstract), the PPG signal comprising pulsatile components (AC) that depict the systolic and diastolic phases of cardiac activity, can be used to measure heart rate variability or variations between heartbeat time intervals such as Peak-to-Peak intervals (p. 5, fig. 2), regarded as the “pulse rate” physiological parameter disclosed by Al-Ali et al. ([0250]). This aligns with the applicant’s own disclosure of presenting an example heart rate waveform systolic and diastolic pulsatile components (fig. 7) provided by a PPG signal ([0032]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to regard the “pulse rate” of Al-Ali et al. as a “heart rate waveform” as PPG sensors provide pulsatile waveform signals used to depict cardiac activity as evidenced by Castaneda et al., such an interpretation to be known in the art.
Regarding claims 13, 24, Al-Ali et al. discloses the control system is further configured to: obtain, via the sensor system, first through Nth heart rate waveforms at a first through Nth wearable device configurations, N being an integer greater than 2 ([0422-0424]; “This process can be repeated until the quality of the signal data is determined by the processor to be above a predefined threshold value” [0425]); select, based at least in part on the first through Nth heart rate waveforms, one of the first through Nth wearable device configurations ([0422]); and control the user interface system to prompt the user to change the wearable device configuration to a selected wearable device configuration (“output an appropriate warning to the user and/or provide an instruction to the user to increase the tightness of the strap or decrease the size of the strap” [0424]; “output an appropriate message to the user to indicate to the user that an appropriate or optimal strap tension has been achieved and/or prompt the user to record or remember the wrist strap notch position or setting” [0425]).
Regarding claim 16, Al-Ali et al. discloses the control system is further configured to: obtain sensor data at a current pressure being applied to a user’s body by the wearable device at the current wearable device configuration; and determine, based at least in part on the sensor data, whether to prompt the user to change the current pressure to another pressure (“the device can be configured to instruct a user to increase or decrease the level of tightness of the strap and then determine if the quality of the signal data has improved or degraded” [0422]; “the level of tightness of the strap and, accordingly, the level of contact pressure between the body portion 4001′ and the user's skin” [0423]).
Regarding claim 17, Al-Ali et al. discloses wherein determining whether to prompt the user to change the current pressure to another pressure involves determining whether the current pressure is within a desired pressure range (“the contact pressure between the body portion 4001′ and the user's skin is greater in the second position, resulting in higher quality signal data from the sensor(s)” [0423]).
Regarding claim 19, Al-Ali et al. does not expressly disclose wherein the control system is further configured to control the user interface system to prompt the user to withdraw a hand used to change the wearable device configuration. However, given the wearable device changes configuration via a hand wound tension mechanism ([0417]) and given the user interface prompts the user that an appropriate or optimal strap tension has been achieved ([0425]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the user interface system effectively prompts the user to withdraw the hand used to wind the tension mechanism when indicating an appropriate or optimal strap tension has been achieved, as the hand used to change the wearable device configuration is no longer needed when an appropriate or optimal strap tension has been achieved.
Claim(s) 2, 12, 21, 23, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (US 2023/0058052) in view of Castaneda et al. (“A review on wearable photoplethysmography sensors and their potential future applications in health care.” International journal of biosensors & bioelectronics vol. 4,4 (2018): 195-202.) and further in view of Nadeau et al. (US 2021/0330209).
Regarding claims 2, 12, 23 and 27, Al-Ali et al. discloses comparing the quality of the first heart rate waveform and the second heart rate waveform ([0422-0423]) but does not expressly disclose determining a first signal-to-noise ratio (SNR) corresponding to the first heart rate waveforms; determining a second SNR corresponding to the second heart rate waveforms; and comparing the first SNR to the second SNR. Nadeau et al. teaches it is known in the art to determine and use signal-to-noise ratio as a quality/confidence metric to compare multiple signals ([0031]) in an analogous wristband device that detects PPG signals ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Ali et al. to try determining signal-to-noise ratios for the first heart rate waveforms and the second heart rate waveforms as a quality metric and to compare the two SNRs when comparing the signal data as taught by Nadeau et al. as SNRs are known metrics of quality when attempting to compare multiple signals, such a modification being reasonably predictable and would not have altered the overall operation of the device.
Regarding claim 21, Al-Ali et al. discloses the control system is further configured to: determine whether the quality of the first heart rate waveforms equals or exceeds a threshold (“if the quality of the signal data is above a predefined threshold value or, in some examples, at a predefined threshold value” [0425]); and responsive to determining that the quality of the signal exceeds the threshold, control the user interface system to prompt the user to maintain the current wearable device configuration (“output an appropriate message to the user to indicate to the user that an appropriate or optimal strap tension has been achieved and/or prompt the user to record or remember the wrist strap notch position or setting, as appropriate” [0425]). However Al-Ali et al. does not expressly disclose the quality of the signal is a first signal-to-noise ratio (SNR) corresponding to the first heart rate waveforms and the threshold is a SNR ratio. Nadeau et al. teaches it is known in the art to determine and use signal-to-noise ratio as a quality/confidence metric ([0031]) in an analogous wristband device that detects PPG signals ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Ali et al. to try determining signal-to-noise ratios for the first heart rate waveforms as a quality metric as taught by Nadeau et al. and compare the SNR to a SNR threshold as SNRs are known metrics of quality, such a modification being reasonably predictable and would not have altered the overall operation of the device.
Claim(s) 4-5, 8, 10, 14-15, 18, 20, 25, 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (US 2023/0058052) in view of Castaneda et al. (“A review on wearable photoplethysmography sensors and their potential future applications in health care.” International journal of biosensors & bioelectronics vol. 4,4 (2018): 195-202.) and further in view of Kitchens et al. (US 2022/0175258).
Regarding claims 4, 14, 25, 29, Al-Ali et al. does not expressly disclose the first heart rate waveforms and the second heart rate waveforms are obtained via a photoacoustic process. Kitchens et al. teaches that when comparing photoacoustic plethysmography (PAPG) sensing methods to PPG sensing methods, PAPG can at times be a better detector of heart rate waveforms than PPG, since PAPG sensing methods can distinguish artery heart rate waveforms from vein heart rate waveforms and other heart rate waveforms ([0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Ali to substitute photoacoustic plethysmography for the photoplethysmography for obtaining the first heart rate waveforms and the second heart rate waveforms as taught by Kitchens et al. as they may be more effective in depth-discrimination of cardiac signals, such a modification being reasonably predictable.
Regarding claims 5, 15, 30, Al-Ali et al. in view of Kitchens et al. disclose controlling a light source system of the wearable device to direct light to a target portion of a user’s body ([0063]); and obtaining, via a receiver system of the wearable device, acoustic signals corresponding to photoacoustic responses of the target portion of the user’s body to the light ([0064]).
Regarding claims 8 and 18, Al-Ali et al. does not expressly disclose wherein determining whether to prompt the user to change the current pressure to another pressure involves determining whether a blood vessel distension has been reduced at the current pressure. Kitchens et al. teaches that arterial distension is a known parameter ([0157-0158]) to determine using arterial distension sensors 1706, 1708 on a wearable device positioned around a wrist of a user at a current pressure ([0169]) and is commonly used in conjunction with photoacoustic plethysmography sensing, impedance plethysmography sensing ([0163]) and determining blood pressures ([0161]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Ali et al. to take into consideration blood vessel distension at the current pressure as taught by Kitchens et al. as it is a known parameter in wearable devices that is useful for determining physiological parameters, the quality of said signal at the current pressure being important to determine when choosing to prompt the user to change the current pressure to another pressure.
Regarding claims 10 and 20, Al-Ali et al. does not expressly disclose estimating blood pressure based, at least in part, on heart rate waveforms obtained by the sensor system. Kitchens et al. teaches blood pressure estimation based on depth-discriminated PAPG methods can be substantially more accurate than blood pressure estimation based on PPG-based methods ([0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Al-Ali et al. to substitute photoacoustic plethysmography for the photoplethysmography for obtaining the first heart rate waveforms and the second heart rate waveforms (see claim 4) and to further estimate blood pressure based at least in part on the said heart rate waveforms as taught by Kitchens et al. as it would provide a “substantially more accurate” estimation than otherwise ([0054]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796