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 .
Response to Arguments
Applicant's arguments below filed 6/15/2026 have been fully considered but they are not persuasive | moot in view of the new grounds of rejection.
The Applicant asserts on pages 11-12 of the Remarks:
“Burnam is directed to calibrating a blood pressure. See Burnam, Abstract. At portions cited in the Office Action, Burnam describes that "PPG device 120 may determine a current blood pressure of user 105 while height and/or position of PPG device 120 relative to the ground and/or heart of the user is also determined." Id., [0089]. However, the mere fact that "position of [the] PPG device" is determined does not teach or suggest that the system in Burnam actually determines a position of the body part. In other words, Burnam does not teach or suggest actually determining a position of the body part of the user. Much less, Burnam does not teach or suggest using "a comparison between the additional PPG morphology and the first PPG morphology associated with the first PPG data of the reference PPG data, the second PPG morphology associated with the second PPG data of the reference PPG data, or both" to determine a position of a body part. In other words, even if the system in Burnam actually determines the height and/or position of the PPG device 120, which applicant does not concede, cited portions of Burnam do not teach or suggest that the position of the body part/PPG device 120 is determined based on a comparison of a PPG morphology with PPG morphologies of "reference" PPG data, as recited in independent claim 1.
In this regard, cited portions of Burnam do not teach or suggest "determining a position of the body part of the user during the additional time interval based at least in part on a comparison between the additional PPG morphology and the first PPG morphology associated with the first PPG data of the reference PPG data, the second PPG morphology associated with the second PPG data of the reference PPG data, or both," as recited in independent claim 1.”
In response the examiner respectfully asserts that as recited above in the remarks paragraph [0089] of Burnam discloses “height and/or position of PPG device 120 relative to the ground and/or heart of the user is also determined”. Additionally paragraph [0048] of Burnam discloses “The PPG device may be a wearable device”. Therefore by determining a height and/or position of the PPG device a height or position of the body part the PPG device is being worn on is determined. As cited below Burnam discloses determining the height with the blood pressure. The height is required for the calibration function. Additionally [0088] of Burnam discloses “The calibration factor may then be determined by linearly or non-linearly associating the baseline blood pressure, the first blood pressure, the second blood pressure, and the respective positions of PPG device 120”. Therefore by determining the linear or non-linear association between baseline blood pressure, the first blood pressure, the second blood pressure, and the respective positions of PPG device the position of the device is determined based on the linear or non-linear association Additionally as cited below in [0058] “The trained machine learning model may correlate the PPG device 120 height with the current blood pressure”. As cited below the blood pressure is determined based on the PPG waveform. Therefore one with ordinary skill in the art would find it obvious to determine the height [position] of the PPG device [body part of the user] during the additional time interval based at least in part on a comparison between the additional PPG morphology and the first PPG morphology associated with the first PPG data of the reference PPG data, the second PPG morphology associated with the second PPG data of the reference PPG data, or both. In conclusion the examiner finds the arguments to be not persuasive.
The Applicant asserts on page 12 of the Remarks:
“Second, Burnam, alone or in any combination, does not teach or suggest "determining a blood pressure metric for the user during the additional time interval based at least in part on the additional PPG data, the determined position of the body part, and the calibration function," as recited in independent claim 1. Burnam further describes that "the height and/or position of the PPG device 120 may be determined when the PPG device 120 determines the respective one or more current blood pressure[s]." Id (emphasis added). However, the mere fact that "the respective one or more current blood pressure[s]" is determined does not teach or suggest that the system in Burnam actually determines the blood pressure "based at least in part on the additional PPG data, the determined position of the body part, and the calibration function," as recited in independent claim 1 (emphasis added). In other words, Burnam does not teach or suggest first determining a position of the user's body part, and subsequently using the determined position to determine the user's blood pressure. In this regard, cited portions of Burnam do not teach or suggest "determining a blood pressure metric for the user during the additional time interval based at least in part on the additional PPG data, the determined position of the body part, and the calibration function," as recited in independent claim 1.”
In response the examiner respectfully asserts that as cited below Burnam discloses determining a current blood pressure and the height and/or position of the device. Burnam also discloses that the blood pressure may be determined by analysis of the PPG waveform and that the blood pressure may be modified based on the calibration factor. Additionally [0088] of Burnam discloses “The calibration factor may then be determined by linearly or non-linearly associating the baseline blood pressure, the first blood pressure, the second blood pressure, and the respective positions of PPG device 120”. Because blood pressure is determined by analysis of the PPG waveform, the PPG waveform would also have an association with the positions of PPG device. Therefore a blood pressure metric for the user during the additional time interval can be determined based at least in part on the additional PPG data, the determined position of the body part, and the calibration function. In conclusion the examiner finds the arguments to be not persuasive.
The Applicant asserts on pages 12-13 of the Remarks:
“Third, Burnam, does not teach or suggest "the reference PPG data compris[es] first PPG data acquired during a first time interval that the body part is in a first position that is at approximately a level of a heart of the user, and second PPG data acquired during a second time interval that the body part is in a second position that is above or below the level of the heart of the user," as recited in independent claim 1 (emphasis added). Rather, Burnam further describes "measuring a baseline blood pressure of a user based on PPG device 120 being level with the user's heart." Id., [0089]. However, the mere fact that "baseline blood pressure" is based on being level with the user's heart does not teach or suggest that the baseline blood pressure in Burnam actually includes "first PPG data acquired during a first time interval that the body part is in a first position that is at approximately a level of a heart of the user, and second PPG data acquired during a second time interval that the body part is in a second position that is above or below the level of the heart of the user," as recited in independent claim 1 (emphasis added). Rather, Burnam describes generally measuring baseline blood pressure based on the PPG device being level with the user's heart. In this regard, cited portions of Burnam do not teach or suggest "the reference PPG data compris[es] first PPG data acquired during a first time interval that the body part is in a first position that is at approximately a level of a heart of the user, and second PPG data acquired during a second time interval that the body part is in a second position that is above or below the level of the heart of the user," as recited in independent claim 1.”
In response the examiner respectfully asserts that paragraph [0088] of Burnam discloses “The calibration factor may be determined by first: measuring a baseline blood pressure of a user based on PPG device 120 being level with the user's heart, measuring a first blood pressure of the user based on PPG device 120 being at a first position relative to the user's heart, and measuring a second blood pressure of the user based on PPG device 120 being at a second position relative to the user's heart”. Paragraph [0088] of Burnam then discloses that that the calibration factor is based on the baseline blood pressure, the first blood pressure, the second blood pressure, and the respective positions of PPG device 120. The positions are shown in Figs. 1B-1D and 3A-3C of Burnam including positions above and below the heart. Claim 1 of the current application claims that the reference data is used to determine a calibration function. Therefore the baseline blood pressure level with the user's heart, the first blood pressure at a first position relative to the user's heart, and the second blood pressure at a second position relative to the user's heart of Burnam can be interpreted as the reference PPG data comprising first PPG data acquired during a first time interval that the body part is in a first position that is at approximately a level of a heart of the user, and second PPG data acquired during a second time interval that the body part is in a second position that is above or below the level of the heart of the user. In conclusion the examiner finds the arguments to be not persuasive.
In light of the examiners remarks above the arguments regarding the dependent claims are also found to be not persuasive.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-6, 12, 14-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burnam (US 20240382160).
Regarding claims 1 and 15, Burnam discloses a method for calibrating blood pressure measurements performed by a wearable device ([0005] – “methods and systems are disclosed for calibrating a blood pressure measuring device”, [0028] – “the blood pressure measuring device may be a photoplethysmography (PPG) device”, [0048] – “The PPG device may be a wearable device”), comprising: [claim 1]
a system for calibrating blood pressure measurements performed (Abstract – “Techniques and systems for calibrating a blood pressure measuring device”), comprising: [claim 15]
a wearable device ([0048] – “The PPG device may be a wearable device”) configured to: [claim 15]
one or more processors communicatively coupled with the wearable device, a user device associated with the wearable device, or both, wherein the one or more processors are individually or collectively configured to ([0099] – “The one or more processors may be configured to perform such processes by having access to instructions (e.g., software or computer-readable code) that, when executed by the one or more processors, cause the one or more processors to perform the processes. The instructions may be stored in a memory of the computer system”, [0007] – “the at least one processor configured to: receive a blood pressure sensed using the PPG device”, [0048] – “The PPG device may be a wearable device”): [claim 15]
acquiring, during a calibration procedure, reference photoplethysmography (PPG) data from a body part of a user using the wearable device (Figs. 3A-3C, paragraph [0088] discloses a calibration factor being determined based on PPG signals at three different positions, Fig. 3A-3C show the three positions with the PPG device 120 being a wearable device placed on the wrist of the user, the PPG data acquired at the three positions for calibration is interpreted as the reference PPG data), the reference PPG data comprising first PPG data acquired during a first time interval that the body part is in a first position that is at approximately a level of a heart of the user (Fig. 3A, [0084] – “user 105 may operate PPG device 120 while user 105 holds PPG device 120 level with the user's heart in order to determine a first calibration blood pressure, as shown in FIG. 3A”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”), and second PPG data acquired during a second time interval that the body part is in a second position that is above or below the level of the heart of the user (Fig. 3B, [0084] – “As shown in FIG. 3B, the user may operate PPG device 120 at a second time to determine a second calibration blood pressure at a second position of PPG device 120 (e.g., above the user's heart)”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”), wherein the first PPG data and the second PPG data are associated with a first PPG morphology and a second PPG morphology, respectively ([0048] – “Blood pressure may be determined by analysis of the PPG waveform”, as cited above paragraph [0084] discloses a first calibration blood pressure and a second calibration blood pressure therefore there would be a first and second PPG waveform/morphology);
determining, as part of the calibration procedure and based on the reference PPG data, a first blood pressure metric and a second blood pressure metric associated with the first position and the second position, respectively ([0084] – “user 105 may operate PPG device 120 while user 105 holds PPG device 120 level with the user's heart in order to determine a first calibration blood pressure, as shown in FIG. 3A…As shown in FIG. 3B, the user may operate PPG device 120 at a second time to determine a second calibration blood pressure at a second position of PPG device 120”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”);
determining, as part of the calibration procedure, a calibration function associated with blood pressure metrics determined according to PPG data collected at a plurality of positions based at least in part on a comparison between the first blood pressure metric and the second blood pressure metric ([0029] – “the baseline value while the user's arm is level with the heart…a calibration factor may be determined based on the baseline blood pressure and one or more blood pressure measured at various locations and/or heights relative to the heart”, [0029] – “the calibration factor may be based on a linear or non-linear relationship”);
acquiring additional PPG data from the body part of the user using the wearable device during an additional time interval, the additional PPG data associated with an additional PPG morphology ([0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105 while the height and/or position of PPG device 120 relative to the ground and/or heart of user 105 is also determined”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”);
determining a position of the body part of the user during the additional time interval […] ([0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105 while the height and/or position of PPG device 120 relative to the ground and/or heart of user 105 is also determined”);
determining a blood pressure metric for the user during the additional time interval based at least in part on the additional PPG data, the determined position of the body part, and the calibration function ([0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105 while the height and/or position of PPG device 120 relative to the ground and/or heart of user 105 is also determined”, [0090] – “The one or more current blood pressure may be modified based on the calibration factor and the corresponding height and/or positions of PPG device 120”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”); and
transmitting an instruction to cause a user interface associated with the wearable device, a user device, or both, to display a notification of the blood pressure metric ([0071] – “The calibrated current blood pressure may be provided via a display”, therefore an instruction was transmitted, Fig. 6 shows computer 600 including display 610, [0101] discloses “computer 600 may be configured as PPG device 120…Computer 600 also may include a central processing unit (“CPU”) 602, in the form of one or more processors, for executing program instructions”, therefore there would instructions to cause the display to display the calibrated current blood pressure).
Burnam does not explicitly teach determining a position of the body part of the user during the additional time interval based at least in part on a comparison between the additional PPG morphology and the first PPG morphology associated with the first PPG data of the reference PPG data, the second PPG morphology associated with the second PPG data of the reference PPG data, or both. However Burnam discloses [0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105 while the height and/or position of PPG device 120 relative to the ground and/or heart of user 105 is also determined”, [0058] – “The trained machine learning model may correlate the PPG device 120 height with the current blood pressure”, [0048] – “A PPG device may operate by measuring the “pulse transit time,” which is converted to a respective blood pressure…Blood pressure may be determined by analysis of the PPG waveform”, and paragraph [0096] discloses the machine learning model nay be trained using the environments of Figs. 3A-3C. Additionally for clarification [0088] discloses “The calibration factor may then be determined by linearly or non-linearly associating the baseline blood pressure, the first blood pressure, the second blood pressure, and the respective positions of PPG device 120”. Therefore Burnam discloses a linear or non-linear relationship between the reference blood pressures and the reference positions and Burnam also discloses the blood pressure is determined based on the PPG waveform. Therefore one with ordinary skill in the art would find it obvious to use the correlation determined by the trained machine learning model to determine the height of PPG device relative to the ground and/or heart of user which would be based on a comparison between the current blood pressure and the first blood pressure, the second blood pressure, or both. The blood pressure is determined based on the pulse transit time which is determined from the PPG waveform therefore it would be obvious to compare the PPG waveforms as it is the measured data and not estimated or calculated data. One would have motivation to use the machine learned model to determine the position because a trained machine learned model can provide accurate results of a positioning relative to the heart position.
Regarding claims 4 and 18, Burnam discloses all the elements of the claimed invention as cited in claims 1 and 15.
Burnam further discloses wherein the second PPG data is collected during the second time interval that the body part is in the second position that is above the level of the heart of the user (Fig. 3B, [0084] – “As shown in FIG. 3B, the user may operate PPG device 120 at a second time to determine a second calibration blood pressure at a second position of PPG device 120 (e.g., above the user's heart)”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”), wherein acquiring the reference PPG data during the calibration procedure further comprises:
acquiring third PPG data that is acquired from the body part of the user during a third time interval that the body part is in a third position that is below the level of the heart of the user, wherein the third PPG data is associated with a third PPG morphology (Fig. 3C, [0084] – “As shown in FIG. 3C, the user may operate PPG device 120 at a third time to determine a third calibration blood pressure at a third position of PPG device 120 (e.g., below the user's heart)”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”), and wherein the blood pressure metric is determined based at least in part on a comparison between the additional PPG morphology and the third PPG morphology ([0058] – “The trained machine learning model may correlate the PPG device 120 height with the current blood pressure. Using this correlation, the machine learning model may use the calibration factor to calibrate the current blood pressure.”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”, paragraph [0096] discloses the machine learning model may be trained using the environments of Figs. 3A-3C therefore the additional PPG waveform is compared to the third PPG waveform).
Regarding claims 5 and 19, Burnam discloses all the elements of the claimed invention as cited in claims 1 and 15.
Burnam further discloses wherein the body part comprises a hand or a finger of an arm of the user ([0048] – “The PPG device may be a wearable device, e.g., a watch, a band, a strap, etc”, Figs. 3A-3C shows the PPG device 120 worn on the wrist), the method further comprising:
receiving a user input indicating a length of the arm of the user, a height of the user, or both ([0055] – “a machine learning model that is trained based on a calibration factor and/or applies a calibration factor may receive, as an input, additional user information. The additional user information may include…a user demographic (e.g., an age, a gender, a body weight, a body mass index (BMI), a height, an arm length”), wherein determining the calibration function, determining the blood pressure metric, or both, is based at least in part on the length of the arm of the user, an estimation of the length of the arm of the user performed based on the height of the user, or both ([0080] – “The machine learning model may be configured to output calibrated blood pressure”, [0059] – “The machine learning model output may be individualized to a user 105. The individualization may be based on data from a user's or a plurality of users' user height, a user medical conditions, or a user PPG device height relative to a user heart”).
Regarding claims 6 and 20, Burnam discloses all the elements of the claimed invention as cited in claims 1 and 15.
Burnam further discloses wherein determining the blood pressure metric for the additional time interval (Fig. 4, steps 404 and 406) comprises:
determining an initial blood pressure metric based at least in part on the additional PPG data collected during the additional time interval ([0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105”, [0048] – “Blood pressure may be determined by analysis of the PPG waveform”); and
adjusting the initial blood pressure metric to determine the blood pressure metric based at least in part on the determined position of the body part and the calibration function ([0090] – “The one or more current blood pressure may be modified based on the calibration factor and the corresponding height and/or positions of PPG device 120”).
Regarding claim 12, Burnam discloses all the elements of the claimed invention as cited in claim 1.
Burnam further discloses determining, as part of the calibration procedure and based at least in part on the reference PPG data, a first pulse transmit time associated with a first heartbeat observed at the body part in the first position (Fig. 3A, [0084] – “user 105 may operate PPG device 120 while user 105 holds PPG device 120 level with the user's heart in order to determine a first calibration blood pressure, as shown in FIG. 3A”, [0048] – “A PPG device may operate by measuring the “pulse transit time,” which is converted to a respective blood pressure”), and a second pulse transmit time associated with a second heartbeat observed at the body part in the second position (Fig. 3B, [0084] – “As shown in FIG. 3B, the user may operate PPG device 120 at a second time to determine a second calibration blood pressure at a second position of PPG device 120 (e.g., above the user's heart)”, [0048] – “A PPG device may operate by measuring the “pulse transit time,” which is converted to a respective blood pressure”), wherein the first blood pressure metric and the second blood pressure metric are based at least in part on the first pulse transmit time and the second pulse transmit time, respectively ([0048] – “A PPG device may operate by measuring the “pulse transit time,” which is converted to a respective blood pressure”, Fig. 3A, [0084] – “user 105 holds PPG device 120 level with the user's heart in order to determine a first calibration blood pressure”, Fig. 3B, [0084] – “a second calibration blood pressure at a second position of PPG device 120 (e.g., above the user's heart)”); and
determining, based at least in part on the additional PPG data, an additional pulse transmit time associated with an additional heartbeat observed at the body part during the additional time interval ([0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105 while the height and/or position of PPG device 120 relative to the ground and/or heart of user 105 is also determined”, [0048] – “A PPG device may operate by measuring the “pulse transit time,” which is converted to a respective blood pressure”),
Burnam does not explicitly teach wherein the position of the body part of the user during the additional time interval is further based on a comparison of the additional pulse transmit time with the first pulse transmit time, the second pulse transmit time, or both. However Burnam discloses [0089] – “At step 404, PPG device 120 may determine a current blood pressure of user 105 while the height and/or position of PPG device 120 relative to the ground and/or heart of user 105 is also determined”, [0058] – “The trained machine learning model may correlate the PPG device 120 height with the current blood pressure”, [0048] – “A PPG device may operate by measuring the “pulse transit time,” which is converted to a respective blood pressure…Blood pressure may be determined by analysis of the PPG waveform”, and paragraph [0096] discloses the machine learning model may be trained using the environments of Figs. 3A-3C. Therefore one with ordinary skill in the art would find it obvious to use the correlation determined by the trained machine learning model to determine the height of PPG device relative to the heart of user which would be based on a comparison between the current blood pressure and the first blood pressure, the second blood pressure, or both. Because the blood pressure is determined based on the pulse transit time which is determined from the PPG waveform it would be obvious to compare the pulse transit time as it is the measurement used to calculate the blood pressure. One would have motivation to use the machine learned model to determine the position because a trained machine learned model can provide accurate results while avoiding noisy data that may come from sensor data.
Regarding claim 14, Burnam discloses all the elements of the claimed invention as cited in claim 1.
Burnam further discloses wherein the wearable device comprises a wearable ring device, and wherein the body part comprises a finger of the user, or wherein the wearable device comprises a wrist-worn wearable device, and wherein the body part comprises a wrist of the user ([0048] – “The PPG device may be a wearable device, e.g., a watch, a band, a strap, etc”, Figs. 3A-3C shows the PPG device 120 worn on the wrist).
Claims 2, 3, 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Burnam (US 20240382160) hereinafter referred to as Burnam US2024 as applied to claims 1 and 15 above, and further in view of Burnam (WO 2024173061) hereinafter referred to as Burnam WO2024.
Regarding claims 2 and 16, Burnam US2024 discloses all the elements of the claimed invention as cited in claims 1 and 15.
Conversely Burnam US2024 does not explicitly teach wherein the first blood pressure metric associated with the first position that is at approximately the level of the heart of the user is used as a reference blood pressure metric, the method further comprising:
adjusting the second blood pressure metric by an amount to match to the reference blood pressure metric, wherein determining the calibration function is based at least in part on the amount that the second blood pressure metric is adjusted by to match the reference blood pressure metric.
However Burnam WO2024 discloses wherein the first blood pressure metric associated with the first position that is at approximately the level of the heart of the user is used as a reference blood pressure metric ([0022] – “a reference point from which any change is compared (e.g., the arm extended outward relative to the body and at heart level)”, [0060] – “At step 402, a first blood pressure may be detected while the arm with the calibrated smart device 220 (hereinafter referred to as the “arm”) is held at a base level at position 545 (e.g., heart-level) (as shown in diagram 540 of FIG.5A). This pressure may be denoted as BP0”, in light of the disclosure and equations in paragraphs [0060]-[0064] BPA has not been defined therefore it is interpreted that BPA is equivalent to BP0 and is used as a reference blood pressure), the method further comprising:
adjusting the second blood pressure metric by an amount to match to the reference blood pressure metric, wherein determining the calibration function is based at least in part on the amount that the second blood pressure metric is adjusted by to match the reference blood pressure metric ([0060]-[0064], in light of the disclosure and equations in paragraphs [0060]-[0064] BPA has not been defined therefore it is interpreted that BPA is equivalent to BP0, the equations in paragraphs [0061], [0063], and [0064] solve for a vector of gravity in the up direction and the down direction which is interpreted as the calibration factor and then solve for the true blood pressure in the up direction and down direction using the vector of gravity, when the vector of gravity equation is plugged into the equation for
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The disclosure of Burnam WO2024 is an analogous art considering it is in the field of a wearable device to measure blood pressure and a method to calibrate the device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burnam US2024 to incorporate the adjustment of the second blood pressure metric by an amount to match to the reference blood pressure metric of Burnam WO2024 to achieve the same results. One would have motivation to combine because it would provide a blood pressure equivalent to the pressure provided by the heart.
Regarding claims 3 and 17, Burnam US2024 discloses all the elements of the claimed invention as cited in claims 1 and 15.
Conversely Burnam US2024 does not explicitly teach wherein the first blood pressure metric associated with the first position that is at approximately the level of the heart of the user is used as a reference blood pressure metric, and wherein the calibration function comprises an algorithm or mathematical operation used to adjust blood pressure metrics collected at positions other than the first position relative to the reference blood pressure metric.
However Burnam WO2024 discloses wherein the first blood pressure metric associated with the first position that is at approximately the level of the heart of the user is used as a reference blood pressure metric, and wherein the calibration function comprises an algorithm or mathematical operation used to adjust blood pressure metrics collected at positions other than the first position relative to the reference blood pressure metric ([0022] – “a reference point from which any change is compared (e.g., the arm extended outward relative to the body and at heart level)”, [0060]-[0064], in light of the disclosure and equations in paragraphs [0060]-[0064] BPA has not been defined therefore it is interpreted that BPA is equivalent to BP0, the equations in paragraphs [0061], [0063], and [0064] solve for a vector of gravity in the up direction and the down direction which is interpreted as the calibration factor and then solve for the true blood pressure in the up direction and down direction using the vector of gravity, when the vector of gravity equation is plugged into the equation for
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,
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is equal to BPA, this is also true for
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.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burnam US2024 to incorporate the adjustment of the blood pressure metrics by an amount to match to the reference blood pressure metric of Burnam WO2024 to achieve the same results. One would have motivation to combine because it would provide a blood pressure equivalent to the pressure provided by the heart.
Claims 9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Burnam (US 20240382160) hereinafter referred to as Burnam US2024 as applied to claim 1 above, and further in view of Colburn (US 20210378529).
Regarding claim 9, Burnam US2024 discloses all the elements of the claimed invention as cited in claim 1.
Conversely Burnam US2024 does not teach transmitting one or more signals to the wearable device, the user device, or both, wherein the one or more signals are configured to cause the user interface to display a set of instructions for performing the calibration procedure, wherein the set of instructions displayed by the user interface comprise a first instruction for the user to maintain the body part in the first position for the first time interval, and a second instruction for the user to maintain the body part in the second position for the second time interval.
However Colburn discloses transmitting one or more signals to the wearable device, the user device, or both, wherein the one or more signals are configured to cause the user interface to display a set of instructions for performing the calibration procedure ([0013] – “the calibration processing element outputs instructions on a display indicating steps for a user-assisted calibration”, [0244] –“ the techniques presented herein could be applied to current ECG-capable smartwatches”, smartwatches a user interface to display information), wherein the set of instructions displayed by the user interface comprise a first instruction for the user to maintain the body part in the first position for the first time interval, and a second instruction for the user to maintain the body part in the second position for the second time interval ([0248] – “After an initial 5-minute period of rest to acquire baseline readings (with both arms at heart level), the participants were asked to raise or lower their non-dominant arm to the designated armrest, located 25 cm above or below heart level, to cause a Ph perturbation. The participant was instructed to rest at the new position for 1 minute”).
The disclosure of Colburn is an analogous art considering it is in the field of a wearable device to measure blood pressure and a method to calibrate the device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burnam US2024 to incorporate the displayed instructions to perform calibration of Colburn to achieve the same results. One would have motivation to combine because it would allow one to correctly perform blood pressure monitory in a home setting.
Regarding claim 13, Burnam US2024 discloses all the elements of the claimed invention as cited in claim 1.
Conversely Burnam US2024 does not teach wherein each of the first PPG data, the second PPG data, and the additional PPG data are associated with a plurality of wavelengths, and wherein the first PPG morphology, the second PPG morphology, and the additional PPG morphology are associated with PPG features of the plurality of wavelengths.
However Colburn discloses wherein each of the first PPG data, the second PPG data, and the additional PPG data are associated with a plurality of wavelengths, and wherein the first PPG morphology, the second PPG morphology, and the additional PPG morphology are associated with PPG features of the plurality of wavelengths ([0085] – “the single plethysmographic sensor has multiple LEDs of different wavelengths. The pulse wave velocity can be estimated empirically based on the signals generated from the photodetector when excited by the different LEDs”, [0248] – “After an initial 5-minute period of rest to acquire baseline readings (with both arms at heart level), the participants were asked to raise or lower their non-dominant arm to the designated armrest, located 25 cm above or below heart level, to cause a Ph perturbation. The participant was instructed to rest at the new position for 1 minute”, therefore one with ordinary skill in the art would find it obvious to use the PPG sensor having multiple LEDs of different wavelengths each time a measurement is taken).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burnam US2024 to incorporate the multiple wavelength PPG data of Colburn to achieve the same results. One would have motivation to combine because it allows the sensor to provide data at different depths and therefore providing more accuracy in the PPG signal.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Burnam (US 20240382160) hereinafter referred to as Burnam US2024 as applied to claim 1 above, and further in view of Xiao (WO 2024098785) machine translation.
Regarding claim 11, Burnam US2024 discloses all the elements of the claimed invention as cited in claim 1.
Conversely Burnam US2024 does not teach receiving, via the user interface, an indication of a relative position of the body part of the user during the additional time interval, wherein the position is determined based at least in part on the indication of the relative position.
However Xiao discloses receiving, via the user interface, an indication of a relative position of the body part of the user during the additional time interval, wherein the position is determined based at least in part on the indication of the relative position ([0216] – “watch 20 instructs the user to assume a pre-calibration posture and instructs the user to manually measure the height difference between watch 20 and the user's heart in that posture, and instructs the user to input the height difference in watch 10, as shown in Figure 20”, one with ordinary skill in the art would find it obvious to provide an input of a position for any measurement).
The disclosure of Xiao is an analogous art considering it is in the field of a wearable device to measure blood pressure and a method to calibrate the device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Burnam US2024 to incorporate the input of a position of Xiao to achieve the same results. One would have motivation to combine because the user knows the positioning of their heart and therefore can provide a more accurate position of the device relative to the heart.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 7, as recited in the rejection of claim 1 Burnam US2024 teaches a trained machine learning model that may correlate the PPG device height with the current blood pressure and that the blood pressure is determined based on analysis of a PPG signal. Therefore it would be obvious for one with ordinary skill in the art to use the machine learning model to determine the position of the device based on a comparison of a PPG signal with previous PPG signals. However Burnam US2024 does not teach a machine learning model to extract features from each PPG data to be compared to features in the calibration PPG data to determine the position of the body part. It would not have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the method of calibrating the wearable device of Burnam US2024 to include the machine learning model to extract features of the PPG signals and comparing the features of a PPG signal to features of the PPG data collected for calibration. Thus the combination of elements is found to distinguish over the prior art collectively.
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 8, as recited in the rejection of claim 1 Burnam US2024 teaches a trained machine learning model that may correlate the PPG device height with the current blood pressure and that the blood pressure is determined based on analysis of a PPG signal. Therefore it would be obvious for one with ordinary skill in the art to use the machine learning model to determine the position of the device based on a comparison of a PPG signal with previous PPG signals. However Burnam US2024 does not teach determining the position of the body part based on a comparison between respective sets of PPG features associated with a PPG signal and the reference PPG signals. The PPG features include “a relative timing between systolic peaks and diastolic peaks, an amplitude of systolic peaks, an amplitude of diastolic peaks, a shape of a first derivative of the first PPG data, the second PPG data, the additional PPG data, or any combination thereof, a shape of a second derivative of the first PPG data, the second PPG data, the additional PPG data, or any combination thereof, a timing between peaks of the first derivative or the second derivative, or any combination thereof”. It would not have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the method of calibrating the wearable device of Burnam US2024 to include a comparison of a relative timing between systolic peaks and diastolic peaks, an amplitude of systolic peaks, an amplitude of diastolic peaks, a shape of a first derivative of the first PPG data, the second PPG data, the additional PPG data, or any combination thereof, a shape of a second derivative of the first PPG data, the second PPG data, the additional PPG data, or any combination thereof, a timing between peaks of the first derivative or the second derivative, or any combination thereof between PPG signals to determine a position of the body part. Thus the combination of elements is found to distinguish over the prior art collectively.
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 10, as recited in the rejection of claim 9 Colburn teaches instructions displayed to perform calibration of the blood pressure device. Colburn also teaches that the user is instructed to place their arm in multiple positions to calibrate the device. However Colburn does not teach a motion sensor to confirm that the user manipulated the body part in accordance with the instructions displayed and the calibration function is determined based on the confirmation. It would not have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the method of calibrating the wearable device of Burnam US2024, as modified by Colburn, to include a motion sensor to confirm that the user manipulated the body part in accordance with the instructions displayed and the calibration function is determined based on the confirmation. Thus the combination of elements is found to distinguish over the prior art collectively.
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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/R.C.L./Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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