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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 28, 2026 has been entered.
Response to Amendment
The Amendment filed July 28, 2026 has been entered. Claims 18-20 and 24 remain pending in the application.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 18-20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Luna et al. (US 2014/0094675 A1) (hereinafter – Luna) in view of Pantelopoulos et al. (US 2017/0209053 A1) (hereinafter – Pantelopoulos) in further view of Ferber et al. (US 2016/0242700 A1) (hereinafter – Ferber).
Regarding claim 18, Luna discloses A method of calibrating a wearable blood-pressure monitoring device, the method comprising (Abstract and entire document):
receiving a plurality of pulse observations from a plurality of bio-impedance sensors disposed on the wearable blood-pressure monitoring device, the blood-pressure monitoring device configured to be arranged on a bodily region of a wearer (FIG. 2 and Para. [0022], “According to various embodiments, a heart rate signal can include (or can be based on) a pulse wave.” And para. [0018], “As used herein, the term "sensor" can refer, for example, to a combination of one or more driver electrodes and one or more sink electrodes for determining one or more bioimpedance-related values and/or signals, according to some embodiments.” FIG. 1A and [0017], “Diagram 100 depicts an array 100 of electrodes 110 coupled to a physiological information generator 120 that is configured to generate data representing one or more physiological characteristics associated with a user that is wearing or carrying array 101.”),
wherein the plurality of bio-impedance sensors is connected to a controller via a wired or wireless connection (FIG. 1A and [0017], “Diagram 100 depicts an array 100 of electrodes 110 coupled to a physiological information generator 120 that is configured to generate data representing one or more physiological characteristics associated with a user that is wearing or carrying array 101.” Each sensor pair is coupled to the controller, generator 120. See further, “Electrodes 110 can include any suitable structure for transferring signals and picking up signals, regardless of whether the signals are electrical, magnetic, optical, pressure-based, physical, acoustic, etc., according to various embodiments. According to some embodiments, electrodes 110 of array 101 are configured to couple capacitively to a target location. In some embodiments, array 101 and physiological information generator 120 are disposed in a wearable device, such as a wearable data-capable band 170, which may include a housing that encapsulates, or substantially encapsulates, array 101 of electrodes 110. In operations, physiological information generator 120 can determine the bioelectric impedance ("bioimpedance") of one or more types of tissues of a wearer to identify, measure, and monitor physiological characteristics.” And para. [0018], “As used herein, the term "sensor" can refer, for example, to a combination of one or more driver electrodes and one or more sink electrodes for determining one or more bioimpedance-related values and/or signals, according to some embodiments.”);
capturing signals from different combinations of sensors of the plurality of bio-impedance sensors placed along the radial and ulnar arteries of the wearer (Para. [0019], “In some embodiments, sensor selector 122 can be configured to determine (periodically or aperiodically) whether the subset of electrodes 110a and 110b are optimal electrodes 110 for acquiring a sufficient representation of the one or more physiological characteristics from the second signal.” See also para. [0018], “In various examples, the target location can be adjacent to or can include blood vessel 102. Examples of blood vessel 102 include a radial artery, an ulnar artery, or any other blood vessel. Array 101 is not limited to being disposed adjacent blood vessel 102 in an arm, but can be disposed on any portion of a user's person (e.g., on an ankle, ear lobe, around a finger or on a fingertip, etc.).” sensors are arranged along the radial and ulnar arteries. Every sensor that occupies at least a portion of an artery is arranged along the artery as the sensor is more than one dimensional),
wherein each of the different combinations of sensor comprised a first bio-impedance sensor and a second bio-impedance sensor of the plurality of bio-impedance sensors ([0018]; [0024], combinations of sensors in subset 105 and subsets 109a, 109b, 109c; subset 105 is two different combinations of sensors used to determine the bioimpedance, 110d-110e is one sensor and 110c-110d is also one sensor, using 110d twice, as part of two different sensors, comparing the bioimpedance between the two groups, that equals a sensor. See also [0024], where 109a is defined as “a subset” and not as a single sensor. Again, bioimpedance is determined between each subset of sensors 109a, 109b and 109c, the best and most accurate data is chosen and that subset is selected.);
measuring bio-impedance between the first bio-impedance sensor and the second bio-impedance sensor of each of the different combinations of sensors (impedance is measured between each of 109a, 109b, 109c combinations and 110d-110e/110c-110d; using 110d twice);
using the captured signals to generate a plurality of parameters for each heart beat of the wearer (FIG. 2 and Para. [0022], “Physiological characteristic determinator 126 is configured to receive the physiological-related signal component of the second signal and is further configured to process (e.g., digitally) the signal data including one or more physiological characteristics to derive physiological signals, such as either a heart rate ("HR") signal or a respiration signal, or both. For example, physiological characteristic determinator 126 is configured to amplify and/or filter the physiological-related component signals (e.g., at different frequency ranges) to extract certain physiological signals. According to various embodiments, a heart rate signal can include (or can be based on) a pulse wave. A pulse wave includes systolic components based on an initial pulse wave portion generated by a contracting heart, and diastolic components based on a reflected wave portion generated by the reflection of the initial pulse wave portion from other limbs.” Which covers pulse amplitude as the parameter and the pulse wave is continuous to cover multiple heart beats.),
determining a subset of sensors of the plurality of bio-impedance sensors that provide data actionable for a determination of at least one physiological parameter of the wearer selected from the group consisting of pulse wave velocity, pulse pressure, pulse slope, pulse arrival time, and pulse amplitude (FIG. 1A and [0018], discussing sensor selector. See also FIG. 2 and Para. [0022], “Physiological characteristic determinator 126 is configured to receive the physiological-related signal component of the second signal and is further configured to process (e.g., digitally) the signal data including one or more physiological characteristics to derive physiological signals, such as either a heart rate ("HR") signal or a respiration signal, or both. For example, physiological characteristic determinator 126 is configured to amplify and/or filter the physiological-related component signals (e.g., at different frequency ranges) to extract certain physiological signals. According to various embodiments, a heart rate signal can include (or can be based on) a pulse wave. A pulse wave includes systolic components based on an initial pulse wave portion generated by a contracting heart, and diastolic components based on a reflected wave portion generated by the reflection of the initial pulse wave portion from other limbs.” Which covers pulse amplitude);
adjusting the at least one parameter of the plurality of the bio-impedance sensors to control or localize a sensing coverage area of the plurality of bio-impedance sensors or observations to identify a signal of interest (Para. [0019], “While electrodes 110a and 110b may be displaced from the target location, other electrodes are displaced to a position previously occupied by electrodes 110a and 110b (i.e., adjacent to the target location).” And “Note that each electrode 110 can be configured as either a driver or a sink electrode. Thus, electrode 110b is not limited to being a driver electrode and can be configured as a sink electrode in some implementations. As used herein, the term "sensor" can refer, for example, to a combination of one or more driver electrodes and one or more sink electrodes for determining one or more bioimpedance-related values and/or signals, according to some embodiments.” Thus when changed to sink or driver electrode, parameters are changed, if selected or unselected then parameters are also changed and controls the sensing coverage area.); and
Luna fails to disclose wherein the plurality of parameters are selected from the heart beat's diastolic phase which represents a peak of the signal, the heart beat's systolic phase which represents a foot of the signal, a point of change in the peak of the signal, a point of change in the foot of the signal, a point in the slope between the peak of the signal and the foot of the signal, and a inflection point resulting from a pressure pulse;
generating an average of a selection of the plurality of parameters for a selection of heart beats; and
wherein the adjusting at least one parameter of the bio-impedance sensor comprises one or more of changing a frequency of excitation current, performing a frequency sweep, changing a current level injected into the plurality of bio-impedance sensors, and changing the wavelength of optical excitation; and
measuring a pulse wave velocity as a phase shift between two signals of the captured signals of the plurality of bio-impedance sensors.
However, in the same field of endeavor, Pantelopoulos teaches wherein the plurality of parameters are selected from the heart beat's diastolic phase which represents a peak of the signal, the heart beat's systolic phase which represents a foot of the signal, a point of change in the peak of the signal, a point of change in the foot of the signal, a point in the slope between the peak of the signal and the foot of the signal, and a inflection point resulting from a pressure pulse ([0093], “For example, in the case of using ECG and PPG, in order to accurately measure the arrival of a pulse, one or more data processing techniques are applied for detecting various features of the pulse wave such as the foot, peak, maximum, 1.sup.st derivative, or 2nd derivative.” Including peak and foot and derivatives indicating points of change and slope. See also [0086], “Other morphological features of PPG, PCG, BCG or ultrasound graph may be used in some implementations for estimating PTT. For instance, as illustrated here for PPG data, the second peak, the inflection points, the left foot, ⅓, ½, or ⅔ from the left foot to the left peak, features of first and second derivative, and combinations thereof may be used in the proximal wave and distal wave to estimate PTT.”);
generating an average of a selection of the plurality of parameters for a selection of heart beats ([0093], “In some implementations, multiple heart beats can be averaged to generate a smooth template which can then be cross-correlated with the PPG signal to reliably measure multiple PTT intervals. These intervals can then be combined together using a computation that is robust to outliers such a median.” See also [0094])); and
wherein the adjusting at least one parameter of the bio-impedance sensor comprises one or more of changing a frequency of excitation current, performing a frequency sweep, changing a current level injected into the plurality of bio-impedance sensors, and changing the wavelength of optical excitation (FIG. 18A-18F and para. [0228], “The intensity of the light source may be modified (e.g., through a light source intensity control module) to maintain a desirable reflected signal intensity. For example, the light source intensity may be reduced to avoid saturation of the output signal from the light detector. As another example, the light source intensity may be increased to maintain the output signal from the light detector within a desired range of output values. Notably, active control of the system may be achieved through linear or nonlinear control methods such as proportional-integral-derivative (PID) control, fixed step control, predictive control, neural networks, hysteresis, and the like, and may also employ information derived from other sensors in the device such as motion, galvanic skin response, etc.”); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Luna to include wherein the plurality of parameters are selected from the heart beat's diastolic phase which represents a peak of the signal, the heart beat's systolic phase which represents a foot of the signal, a point of change in the peak of the signal, a point of change in the foot of the signal, a point in the slope between the peak of the signal and the foot of the signal, and a inflection point resulting from a pressure pulse; generating an average of a selection of the plurality of parameters for a selection of heart beats; wherein the adjusting at least one parameter of the bio-impedance sensor comprises one or more of changing a frequency of excitation current, performing a frequency sweep, changing a current level injected into the plurality of bio-impedance sensors, and changing the wavelength of optical excitation as taught by Pantelopoulos in order to maintain desired values (Para. [0228], “The intensity of the light source may be modified (e.g., through a light source intensity control module) to maintain a desirable reflected signal intensity. For example, the light source intensity may be reduced to avoid saturation of the output signal from the light detector. As another example, the light source intensity may be increased to maintain the output signal from the light detector within a desired range of output values. Notably, active control of the system may be achieved through linear or nonlinear control methods such as proportional-integral-derivative (PID) control, fixed step control, predictive control, neural networks, hysteresis, and the like, and may also employ information derived from other sensors in the device such as motion, galvanic skin response, etc.”).
Luna as modified fails to disclose measuring a pulse wave velocity as a phase shift between bio-impedance signals respectively associated with two of the different combinations of sensors of the plurality of bio-impedance sensors.
However, in the same field of endeavor, Ferber teaches measuring a pulse wave velocity as a phase shift between bio-impedance signals respectively associated with two of the different combinations of sensors of the plurality of bio-impedance sensors (Para. [0249], “In some embodiments, if two LEDs at the same wavelength are positioned at different locations of the same artery, a phase shift may be obtained between the measured PPG signals, e.g., due to blood flow. This may facilitate calculation of pulse wave velocity (PWV) and/or pulse transit time (PTT), both of which may be included in a feature vector, and/or otherwise provided to the empirical blood pressure model used to calculate arterial blood pressure values.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Luna as modified to include measuring a pulse wave velocity as a phase shift between bio-impedance signals respectively associated with two of the different combinations of sensors of the plurality of bio-impedance sensors as taught by Ferber in order to provide higher quality data (Para. [0240], “The wave selection rules 1438 define attributes and/or functions for selecting (or, "extracting") high quality waves from a set of waves of a signal. The high quality waves may form a subset of waves.”).
Regarding claim 19, Luna as modified teaches The method of claim 18, Luna further discloses wherein the determining comprises evaluating at least one of signal strength and a location of a sensor of the plurality of bio-impedance sensors (Para. [0018], “Sensor selector 122 is configured to determine which one or more subsets of electrodes 110 (out of a number of subsets of electrodes 110) are adjacent to a target location. As used herein, the term "target location" can, for example, refer to a region in space from which a physiological characteristic can be determined. A target region can be adjacent to a source of the physiological characteristic, such as blood vessel 102, with which an impedance signal can be captured and analyzed to identify one or more physiological characteristics.”).
Regarding claim 20, Luna as modified teaches The method of claim 19, Luna as modified fails to disclose wherein the determining further comprises measuring peak- to-peak amplitude of bio-impedance.
However, in the same field of endeavor, Ferber teaches wherein the determining further comprises measuring peak- to-peak amplitude of bio-impedance (Para. [0016], “In some embodiments, the measurement values include any of wave peak locations or amplitudes, or wave valley locations or amplitudes.” See also para. [0094], “The output signal of the energy receiver 206 may be an electric current or an electric voltage, of which the amplitude may be related to the amount of the energy detected.” Thus peak-to-peak analysis can be performed on bio-impedance measurements.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Luna as modified to include wherein the determining further comprises measuring peak- to-peak amplitude of bio-impedance as taught by Ferber in order to provide higher quality data (Para. [0240], “The wave selection rules 1438 define attributes and/or functions for selecting (or, "extracting") high quality waves from a set of waves of a signal. The high quality waves may form a subset of waves.”).
Regarding claim 24, Luna as modified teaches The method of claim 18, Luna further discloses further comprising deactivating the bio-impedance sensors of the plurality of bio-impedance sensors that are not in the selected subset of bio- impedance sensors (Para. [0018], “Sensor selector 122 is configured to determine which one or more subsets of electrodes 110 (out of a number of subsets of electrodes 110) are adjacent to a target location” and “Sensor selector 122 operates to either drive a first signal via a selected subset to a target location, or receive a second signal from the target location, or both.” So once the region is discovered, only the electrodes at that region are activated and the others are deactivated.).
Response to Arguments
Applicant's arguments filed July 28, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding claim 18, the arguments are not persuasive. The arguments state that Luna fails to disclose different combinations of sensors and acquiring bioimpedance between the different combinations of sensors. However, as shown in FIG. 1A, for example look at subset 105, this is two different combinations of sensors used to determine the bioimpedance, 110d-110e is one sensor and 110c-110d is also one sensor, using 110d twice, as part of two different sensors, comparing the bioimpedance between the two groups, that equals a sensor. See also [0024], where 109a is defined as “a subset” and not as a single sensor. Again, bioimpedance is determined between each subset of sensors 109a, 109b and 109c, the best and most accurate data is chosen and that subset is selected. Thus the arguments are not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Pantelopoulos teaches in [0228] the benefit of desirable signal intensity.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). See [0023] – [0024] of Pantelopoulos discussing the interchangeability of the different types of sensors. The interpretation of the data between different types of sensors is well understood. See the present application, [00021] and [00024] describing a person having ordinary skill in the art understanding well, how to interpret the different types of sensor data. Thus, the references are properly combined. The arguments regarding Ferber are similar in that the argument is there is no interchange between impedance sensors and PPG sensors. For the same reasons as discussed with reference to Pantelopoulos, the arguments are not persuasive. Additionally, In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combination of the references is used to teach the pulse wave velocity between the different combinations of the bioimpedance sensors. Luna teaches the bioimpedance sensors and the different combinations. Pantelopoulos and Ferber teach the data manipulation techniques on the different types of data to produce the PWV of the different combination of bioimpedance sensors as disclosed by Luna. Thus, the arguments are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hadley (US-20160120411-A1); BREEN (US-20170000360-A1); and Giovangrandi (US-20150359452-A1) all teach using different combinations of sensors for optimal calculations of pulse wave velocity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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