CTNF 18/773,900 CTNF 100547 Detailed Action Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Abstract The abstract of the disclosure is objected to because the first line of the submitted abstract contains a typographical error. The current recitation “methos” should read “method”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Drawings 06-22 AIA The drawings are objected to because Figures 5-6 fail to include units on the y-axis. The lack of units make it unclear what data is being represented . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 07-29 AIA The disclosure is objected to because of the following informalities: the specification fails to provide a clear description as to what units are missing from the y-axis of the graphs displayed in Figures 5 and 6 . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding Claims 1 and 17, the limitation “the peripheral of the user” lacks proper antecedent basis. This limitation is being interpreted to mean “a peripheral of the user”. Regarding Claim 4, the limitation “the calculated feature values” lacks proper antecedent basis. This limitation is being interpreted to mean “the calculated pulse wave feature values”. Claims not explicitly rejected above are rejected due to their dependence on the above claims. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of Claim 9 follows. STEP 1 Regarding Claim 1, the claim recites a series of steps or acts, including obtaining, by a first sensor that includes a first light-emitting device and at least one light-receiving device, a first photoplethysmographic signal of a capillary of a finger of a user; obtaining, by a second sensor that includes a second light-emitting device and the at least one light-receiving device, a second photoplethysmographic signal of an arteriole of the finger of the user, the second light-emitting device being disposed farther away from the at least one light-receiving device than the first-light emitting device; estimating, by at least one processor, a pulse wave transmission time based on the first and second photoplethysmographic signals; and estimating, by the at least one processor, a peripheral hemodynamic state of the peripheral of the user based on the estimated pulse wave transmission time. Thus, the claim is directed to a process, which is one of the statutory categories of invention. STEP 2A, PRONG ONE The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of estimating, by the at least one processor, a peripheral hemodynamic state of the peripheral of the user based on the estimated pulse wave transmission time set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea. STEP 2A, PRONG TWO Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 fails to recite any application of estimating, by the at least one processor, a peripheral hemodynamic state of the peripheral of the user based on the estimated pulse wave transmission time in a manner that imposes a meaningful limitation on the Abstract Idea. The Abstract Idea alone does not provide an improvement to the technological field, the method does not affect a particular treatment or effect a particular change based on an estimated peripheral hemodynamic state of the peripheral of the user, nor does the method use a particular machine to perform the Abstract Idea. STEP 2B Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, Claim 1 recites additional steps of obtaining a first photoplethysmographic signal of a capillary of a finer, obtaining a second photoplethysmographic signal of an arteriole of a finger, and estimating a pulse wave transmission time based on the first and second photoplethysmographic signals. The obtaining and estimating steps are recited at a high level of generality such that they amount to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Additionally, the recited processor is a generic computer device configured to use mathematical concepts to estimate a pulse wave transmission time as well as perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and estimating steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter. Regarding Claim 17, the claim recites a method containing similar steps disclosed in Claim 1 above. Dependent Claims 2-16 and 18-20 fail to add something more to the abstract independent claims as they generally recite steps pertaining to data gathering and processing. Regarding Claims 2-4, 6-7, 9-10, 15-16, and 18-20, “processor” is recited at a high level of generality that it amounts to a generic computer. Regarding Claims 2 and 4, the steps of estimating a blood pressure index and calculating pulse wave feature values as well as a blood pressure index are mere pre-solution data gathering. Regarding Claims 5 and 8, the steps of measuring the pulse wave transmission time are mere pre-solution data gathering. Regarding Claims 6-7, the steps of estimating a quality of sleep and determining a sleep state of a user amount to insignificant extra-solution activity. Regarding Claim 9, the step of estimating a peripheral blood circulation disorder amounts to insignificant extra-solution activity. Regarding Claims 11-12 and 18-19, the steps of estimating a pulse wave transmission time are mere pre-solution data gathering. Regarding Claim 16, the step of determining whether the user is in a resting state amounts to insignificant extra-solution activity. The obtaining and estimating steps recited in the independent claims, Claims 1 and 17, maintain a high level of generality even when considered in combination with the dependent claims. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-5, 8 and 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over He'677 (U.S. Publication Number 20160302677) in view of Ferber et. al.'040 (U.S. Publication Number 20180085040) . Regarding Claim 1, He'677 discloses a method for estimating a peripheral hemodynamic state of a user (Paragraph [0069] - the device 100 can also include a computing device 115 that can be configured to compute the biometric parameters, including, for example, blood pressure, respiratory rate, blood oxygen, stroke volume, cardiac output, and temperature), the method comprising: obtaining, by a first sensor that includes a first light-emitting device and at least one light-receiving device, a first photoplethysmographic signal (Paragraph [0054] - the PPG data can be measured at the wrist using one or more optical sensors); obtaining, by a second sensor that includes a second light-emitting device and the at least one light-receiving device, a second photoplethysmographic signal (Paragraph [0054] - PPG data obtained at the second location…Light from the optical sensors (i.e., the light sources such as LEDs of the optical sensors) is directed toward the skin of the subject, and the reflected light (which is modulated by blood volume changes underneath the skin) is measured using one or more photo-detectors (e.g., photodiodes)); estimating, by at least one processor, a pulse wave transmission time based on the first and second photoplethysmographic signals (Paragraph [0056] - PTT from MoCG (or BCG) and PPG data measured at substantially the same location on a human body (e.g., the wrist). This includes identifying, from the PPG data, a time point (e.g., the time points 109) at which a pulse wave arrives at the location, identifying, from the BCG data, a time point (e.g., the time points 108) at which the pulse originated at a different location on the body (e.g., the heart) from the MoCG data, and determining the PTT 113 as a difference between the two identified time points); and estimating, by the at least one processor, a peripheral hemodynamic state of the peripheral of the user based on the estimated pulse wave transmission time (Paragraph [0110] - Such changes in MPTT in turn affects the blood pressure calculation, in particular if the blood pressure is calculated using an MPTT value determined at a significant height deviation from the calibration point). He’677 discloses a measurement device positioned on a wrist of a user (Paragraph [0054] - The time of arrival of the pulse at a second location (e.g., the wrist) can be determined from PPG data obtained at the second location. For example, the PPG data can be measured at the wrist using one or more optical sensors), but fails to disclose photoplethysmographic signal of a capillary of a finger of a user, photoplethysmographic signal of an arteriole of the finger of the user, the second light-emitting device being disposed farther away from the at least one light-receiving device than the first-light emitting device, and a pulse wave transmission time. Ferber et. al.'040 teaches obtaining measurements from capillaries and arteries in a finger (Paragraph [0277] - For example, this may be the difference in time between the onset of the R-wave on ECG, and the pulse wave peak on the finger; Paragraph [0411] - When using a sensor system for measurement of a state (e.g., through arterial tissue) of a user, it may be important to measure the state of tissue at a specific measuring area, because signal shape received through a specific tissue (e.g., arterial tissue) is largely different from signal shape received through tissue of other types (e.g., capillary tissue and venous tissue). It will be appreciated that measuring an inappropriate tissue may cause inaccurate measurement). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He’677 to include obtaining measurements in different locations such as arteries and capillaries in a finger of a user in order to account for different blood behaviors occurring between these regions and types of vessels at this portion of the body of a user as seen in Ferber et. al.’040. Ferber et. al.’040 also teaches a device comprising light emitting devices positioned at different distances from light receiving elements (Paragraph [0420] - At the first measuring area (starting on the left of FIG. 30D), energy transmitted by LED 1 (at any number of wavelengths) is reflected by tissue of a user to photodiode B…Similarly, at the third measuring area, energy transmitted by LED 3 is reflected by the tissue of the user and received by PDB). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of He’677 to include a light receiving device obtaining measurements from light emitting devices at various distances in order to create larger measurement areas as seen in Ferber et. al.’040 (Paragraph [0422] - This creates a larger measuring area to enable tracking of any number of arteries and/or any number of veins even if the arter(ies) and/or vein(s) do not necessarily travel laterally up the user's wrist). Ferber et. al.’040 further teaches a method of obtaining pulse wave velocity (PWV) based on pulse transit time (PTT) (Paragraph [0399] - by measuring a pulse transit time (PTT.sub.m) based on two signal patterns obtained from at least two pairs of the energy transmitters and energy receivers, it is possible to obtain a pulse wave velocity (PWV) by dividing a distance between the two measuring areas (e.g., measuring points)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He’677 to include calculating a pulse wave velocity based on pulse transit time in order to assist in calculating blood pressure metrics occurring in different vessels of a user’s finger as seen in Ferber et. al.’040 (Paragraph [0285] - 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; Paragraph [0399] - The pulse wave velocity (PWV) may be used to obtain blood metrics including, but not limited to, blood pressure or other blood metric). Regarding Claim 17, the sections of He’677 in view of Ferber et. al.’040 cited above disclose a method comprising the elements set forth in the claim. Regarding Claim 2, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses estimating, by the at least one processor, a peripheral blood pressure index of the user based on the first and second photoplethysmographic signals (Paragraph [0124] - In addition to using the PPG data and accelerometer data (e.g., MoCG data) discussed above to determine certain vital signs (e.g., blood pressure (BP), HR, HRV, respiratory rate, blood oxygen levels, SV, and cardiac output (CO)) of the wearer of the device, a processor (e.g., a processor of the computing device 115 (shown in FIG. 1B), or of an external computing device to which the PPG data and the MoCG data is transmitted) can be programmed to use this data to detect or predict certain health-related conditions). Regarding Claim 3, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses wherein the estimating of the peripheral hemodynamic state is based on the estimated pulse wave transmission time and the estimated peripheral blood pressure index (Paragraph [0121] - The operations of the process 1250 also includes computing a calibration metric as a function of (i) the hydrostatic difference in blood pressure, and (ii) the difference between the first PTT and the second PTT (1258). For example, the calibration metric k can be determined substantially as described above with reference to FIG. 12B. The computed calibration metric can then be determined to adjust a blood pressure value to compensate for hydrostatic differences). Regarding Claim 4, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 2 above. He’677 further discloses calculating, by the at least one processor, pulse wave feature values from the first and second photoplethysmographic signals (Paragraph [0053] - FIG. 1A illustrates pulse transit time (PTT) calculation using an example BCG plot 102, and a photoplethysmogram (PPG) plot); and calculating, by the at least one processor, the peripheral blood pressure index of the user from the calculated feature values (Paragraph [0098] - The operations also include computing MPTT as a difference between the first and second time points (730). The MPTT represents a time taken by the pulse pressure wave to travel from the second body part to the first body part of the subject can then be used in computing various parameters such as blood pressure or arterial stiffness). Regarding Claim 5, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses continuously or intermittently measuring the pulse wave transmission time of the user a plurality of times while the user is sleeping to estimate the pulse wave transmission time (Paragraph [0115] - The second MPTT value can be automatically obtained when the subject is horizontal (e.g., sleeping or otherwise lying down)). Regarding Claim 8, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses continuously or intermittently measuring the pulse wave transmission time of the user a plurality of times over a period of one day or longer to estimate the pulse wave transmission time (Paragraph [0090] - FIG. 9 shows an example of the representative segment 904 of the PPG data used in determining the MPTT. The representative segment 904 in this example is calculated by averaging across multiple segments 906 of equal duration. The MoCG data is then analyzed using the representative segment (706) to calculate candidate MPTT values. The representative segment can be calculated, for example, by averaging across multiple segments of equal duration arranged on the same time grid as a representative PPG signal; Paragraph [0251] - The application can include one or more user interfaces that allow the user to review the variations over the course of a particular time period (e.g., a day, overnight, a week, or a month)). Regarding Claim 10, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses determining, by an acceleration sensor, whether the wrist of the user is positioned at a height of a heart of the user (Paragraph [0089] - During any time period, the motion sensor or sensors (e.g., the accelerometers) collect three sets of MoCG data along three orthogonal axes, x, y, and z, or along polar coordinates; Paragraph [0119] - The configuration of the subject and/or the arm can be determined, for example, based on information from one or more motion sensors); estimating, by the at least one processor, the pulse wave transmission time when the wrist is determined to be positioned at the height of the heart (Paragraph [0118] - The PTT can be measured when the wrist of the subject is at a first height. For example, the first PTT can be obtained when the subject is in a horizontal position such that the first height is substantially equal to the vertical height of the heart of the subject); and estimating, by the at least one processor, the peripheral hemodynamic state based on the pulse wave transmission time estimated at a time when the wrist is determined to be positioned at the height of the heart (Paragraph [0110] - The plot 1200 is divided into multiple regions, each showing the MPTT in a particular configuration of the subject. For example, the regions 1212 and 1216 show the variations in MPTT over time when the subject holds up the arm on which the device is disposed. The regions 1214 and 1218 show variations in the MPTT when the arm is lowered. Similarly, the regions 1220 and 1224 illustrate variations when the subject is lying down, and the regions 1222 and 1226 illustrate variations when then subject is standing up. Such changes in MPTT in turn affects the blood pressure calculation, in particular if the blood pressure is calculated using an MPTT value determined at a significant height deviation from the calibration point). Regarding Claim 11, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses wherein the estimating of the pulse wave transmission time includes estimating first and second pulse wave transmission times, the first pulse wave transmission time being a pulse wave transmission time when the wrist of the user is positioned at a first height, the second pulse wave transmission time being a pulse wave transmission time when the wrist of the user is positioned at a second height, and the second height being different from the first height (Paragraph [0118] - The PTT can be measured when the wrist of the subject is at a first height. For example, the first PTT can be obtained when the subject is in a horizontal position such that the first height is substantially equal to the vertical height of the heart of the subject; Paragraph [0119] - The operations of the process 1250 also includes obtaining a second PTT measurement, wherein the second PTT is measured when the wrist of the subject is at a second height (1254). For example, the second PTT can be obtained when the subject is in a vertical position). Regarding Claim 12, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 11 above. He’677 further discloses estimating the peripheral hemodynamic state based on first and second peripheral hemodynamic states, the first peripheral hemodynamic state being a state estimated based on the first pulse wave transmission time, and the second peripheral hemodynamic state being a state estimated based on the second pulse wave transmission time (Paragraph [0121] - The operations of the process 1250 also includes computing a calibration metric as a function of (i) the hydrostatic difference in blood pressure, and (ii) the difference between the first PTT and the second PTT (1258)). Regarding Claim 13, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 12 above. He’677 further discloses wherein the first height and the second height are at least one of: a height of the wrist when the user is in a sitting posture and holds a hand at a height of a chest of the user (Paragraph [0067] - For example, the user may be asked to hold the device 100 at or near chest level to equalize hydrostatic pressure effects and sense chest vibrations that are used in computing a calibration point. This way, a delay between a chest vibration and the time of arrival of a pulse wave at the wrist (if the device 100 is worn on the wrist) can be used to calibrate for blood pressure for a scenario where there is no height difference between the heart and the measuring point), a height of the wrist when the user is in a sitting posture and holds the hand at a height of a head of the user, and a height of the wrist when the user is in a sitting posture and holds the hand at a height of an abdomen of the user (Paragraph [0111] - For example, the first set of calculations can be performed with the device held at the level of the heart, and a second set of calculations can be performed with the device held at a level different from the level of the heart (e.g., higher than or lower than the level of the heart). The difference in pressure can then be related to the difference in the heights of the two levels). Regarding Claim 14, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 12 above. He’677 further discloses wherein the first height and the second height are a combination of: a height of the wrist when the user is in a supine posture on a flat surface and holds a hand at a height of a chest of the user (Paragraph [0067] - For example, the user may be asked to hold the device 100 at or near chest level to equalize hydrostatic pressure effects and sense chest vibrations that are used in computing a calibration point. This way, a delay between a chest vibration and the time of arrival of a pulse wave at the wrist (if the device 100 is worn on the wrist) can be used to calibrate for blood pressure for a scenario where there is no height difference between the heart and the measuring point); and a height of the wrist when the user is in the supine posture and holds the hand at a height of the flat surface (Paragraph [0111] - For example, the first set of calculations can be performed with the device held at the level of the heart, and a second set of calculations can be performed with the device held at a level different from the level of the heart (e.g., higher than or lower than the level of the heart). The difference in pressure can then be related to the difference in the heights of the two levels). Regarding Claim 15, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 12 above. He’677 further discloses obtaining an amount of change of each of the first height and the second height (Paragraph [0110] - Such changes in MPTT in turn affects the blood pressure calculation, in particular if the blood pressure is calculated using an MPTT value determined at a significant height deviation from the calibration point); and estimating, by the at least one processor, the peripheral hemodynamic state based on the pulse wave transmission time and the amount of change of each of the first height and the second height (Paragraph [0110] - The plot 1200 is divided into multiple regions, each showing the MPTT in a particular configuration of the subject. For example, the regions 1212 and 1216 show the variations in MPTT over time when the subject holds up the arm on which the device is disposed. The regions 1214 and 1218 show variations in the MPTT when the arm is lowered. Similarly, the regions 1220 and 1224 illustrate variations when the subject is lying down, and the regions 1222 and 1226 illustrate variations when then subject is standing up. Such changes in MPTT in turn affects the blood pressure calculation, in particular if the blood pressure is calculated using an MPTT value determined at a significant height deviation from the calibration point). Regarding Claim 16, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 1 above. He’677 further discloses determining, by the at least one processor, whether the user is in a resting state (Paragraph [0118] - In some implementations, the first PTT can be automatically obtained when the subject is lying in a horizontal position (e.g., when sleeping at night). The horizontal configuration can be determined based on information obtained by one or more motion sensors, such as accelerometers and/or gyroscopes disposed in the device 100); and estimating, by the at least one processor, the peripheral hemodynamic state based on the pulse wave transmission time when the user is in the resting state (Paragraph [0110] - The plot 1200 is divided into multiple regions, each showing the MPTT in a particular configuration of the subject. For example, the regions 1212 and 1216 show the variations in MPTT over time when the subject holds up the arm on which the device is disposed. The regions 1214 and 1218 show variations in the MPTT when the arm is lowered. Similarly, the regions 1220 and 1224 illustrate variations when the subject is lying down, and the regions 1222 and 1226 illustrate variations when then subject is standing up. Such changes in MPTT in turn affects the blood pressure calculation, in particular if the blood pressure is calculated using an MPTT value determined at a significant height deviation from the calibration point). Regarding Claim 18, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 17 above. He’677 further discloses determining, by an acceleration sensor, whether the wrist of the user is positioned at a height of a heart of the use (Paragraph [0089] - During any time period, the motion sensor or sensors (e.g., the accelerometers) collect three sets of MoCG data along three orthogonal axes, x, y, and z, or along polar coordinates; Paragraph [0119] - The configuration of the subject and/or the arm can be determined, for example, based on information from one or more motion sensors); estimating, by the at least one processor, the pulse wave transmission time when the wrist is determined to be positioned at the height of the heart (Paragraph [0118] - The PTT can be measured when the wrist of the subject is at a first height. For example, the first PTT can be obtained when the subject is in a horizontal position such that the first height is substantially equal to the vertical height of the heart of the subject); and estimating, by the at least one processor, the peripheral hemodynamic state based on the pulse wave transmission time estimated at a time when the wrist is determined to be positioned at the height of the heart (Paragraph [0110] - The plot 1200 is divided into multiple regions, each showing the MPTT in a particular configuration of the subject. For example, the regions 1212 and 1216 show the variations in MPTT over time when the subject holds up the arm on which the device is disposed. The regions 1214 and 1218 show variations in the MPTT when the arm is lowered. Similarly, the regions 1220 and 1224 illustrate variations when the subject is lying down, and the regions 1222 and 1226 illustrate variations when then subject is standing up. Such changes in MPTT in turn affects the blood pressure calculation, in particular if the blood pressure is calculated using an MPTT value determined at a significant height deviation from the calibration point). Regarding Claim 19, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 17 above. He’677 further discloses wherein the estimating of the pulse wave transmission time includes estimating, by the at least one processor, first and second pulse wave transmission times, the first pulse wave transmission time being a pulse wave transmission time when the wrist of the user is positioned at a first height, the second pulse wave transmission time being a pulse wave transmission time when the wrist of the user is positioned at a second height, and the second height being different from the first height (Paragraph [0118] - The PTT can be measured when the wrist of the subject is at a first height. For example, the first PTT can be obtained when the subject is in a horizontal position such that the first height is substantially equal to the vertical height of the heart of the subject; Paragraph [0119] - The operations of the process 1250 also includes obtaining a second PTT measurement, wherein the second PTT is measured when the wrist of the subject is at a second height (1254). For example, the second PTT can be obtained when the subject is in a vertical position). Regarding Claim 20, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 12 above. He’677 further discloses estimating, by the at least one processor, the peripheral hemodynamic state based on first and second peripheral hemodynamic states, the first peripheral hemodynamic state being a state estimated based on the first pulse wave transmission time, and the second peripheral hemodynamic state being a state estimated based on the second pulse wave transmission time (Paragraph [0121] - The operations of the process 1250 also includes computing a calibration metric as a function of (i) the hydrostatic difference in blood pressure, and (ii) the difference between the first PTT and the second PTT (1258)) . 07-22-aia AIA Claim s 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over He'677 (U.S. Publication Number 20160302677) in view of Ferber et. al.'040 (U.S. Publication Number 20180085040) as applied to Claim 5 above, and further in view of Laharnar et. al.'2020 (Overnight Pulse Wave Analysis to Assess Autonomic Changes During Sleep in Insomnia Patients and Healthy Sleepers) . Regarding Claim 6, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 5 above. He’677 further discloses estimating, by the at least one processor, the peripheral hemodynamic state from a change in the pulse wave transmission time measured while the user is sleeping (Paragraph [0118] - FIG. 12C is a flowchart of an example process 1250 for determining a metric that quantifies how variations in MPTT due to hydrostatic differences affect blood pressure calculation…In some implementations, the first PTT can be automatically obtained when the subject is lying in a horizontal position (e.g., when sleeping at night)) as well as identifying sleep quality (Paragraph [0143] - Once the processor has confirmed during which of the identified SRPs the wearer was sleeping, the data collected during those periods can be analyzed to provide detailed information about the wearer's sleep and to deduce the sleep quality). Laharnar et. al.'2020 teaches (Pages 7-8 - Our PSG recording and pulse wave analysis supported the notion of a physiological hyperarousal in insomniacs as previously demonstrated in terms of electroencephalographic features of disturbed sleep and elevated sympathetic tone [18,23,34]. Our findings are particularly relevant in light of a recent review that challenged the fundamental concept of an impaired heart rate variability and a physiological hyperarousal in insomnia due to lack of reproducibility [35]. The validated overnight pulse wave analysis detected signs of autonomic activity changes during nighttime and, as a surrogate marker of pulse wave velocity and arterial stiffness, the lower PPT in insomniacs with low SE suggested more rigid vessels during sleep. A composite variable, the Cardiac Risk Index, associated with conventional CV risk markers, was higher in insomniacs with low SE compared to insomniacs with objective good sleep and controls. These findings support a link between high autonomic tone, vascular stiffness and the appearance of insomnia at least in the low-SE group. Surrogate measures of autonomic activity may have yet unexplored applications in sleep medicine including insomnia classification and assessment of therapeutic interventions). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He’677 in view of Ferber et. al.'040 to include analyzing pulse waves and quality of sleep that relate to sleeping disorders in order to assess potential therapeutic interventions as seen in Laharnar et. al.’2020. Regarding Claim 7, He’677 in view of Ferber et. al.’040 and further in view of Laharnar et. al.’2020 discloses the method outlined in Claim 6 above. He’677 further discloses determining, by the at least one processor, a sleeping state of the user (Paragraph [0139] - The processor can also be programmed to use the PPG data and accelerometer data to detect sleep disorders, such as sleep apnea, and to deduce sleep quality and sleep stages) . 07-22-aia AIA Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over He'677 (U.S. Publication Number 20160302677) in view of Ferber et. al.'040 (U.S. Publication Number 20180085040) as applied to Claim 8 above, and further in view of Miwa'680 (U.S. Patent 6241680) . Regarding Claim 9, He’677 in view of Ferber et. al.’040 discloses the method outlined in Claim 8 above. He’677 further discloses estimating, by the at least one processor, the peripheral hemodynamic state of the user based on a change in the pulse wave transmission time measured over the period of one day or longer (Paragraph [0107] - blood pressure measurements based on continuously acquired data can be made available for each individual by converting the MPTT and SV into systolic and diastolic pressures as described above; Paragraph [0111] - the blood pressure can be determined with increased reliability may be expanded by determining a relationship between a change in MPTT (ΔMPTT) and the corresponding change in blood pressure (ΔBP); Paragraph [0251] - The application can include one or more user interfaces that allow the user to review the variations over the course of a particular time period (e.g., a day, overnight, a week, or a month)). He’677 fails to disclose a peripheral blood circulation disorder state of the user based on a change in the pulse wave transmission time measured over the period of one day or longer. Miwa'680 teaches identifying a blood circulation condition using pulse wave analysis (Paragraph [0008] - The index value may be one which is indicative of a condition of circulation of blood in the patient and which can be non-invasively obtained without pressing any body portions of the patient. For example, the index value may be a piece of pulse-wave-propagation ("PWP") relating information, such as a PWP velocity or a PWP time, that relates to propagation of a pulse wave through an arterial vessel of the patient; a piece of pulse-relating information, such as a pulse rate (i.e., heart rate) or a pulse period; or a piece of blood-flow-amount-relating information, such as a peripheral-pulse-wave area, that relates to an amount of flow of blood through a peripheral body portion of the patient). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of He’677 in view of Ferber et. al.'040 to include indicating a blood circulation condition based on pulse wave analysis in order to understand and monitor better the condition of the circulatory system in a user as seen in Miwa’680 (Column 13 Lines 58-59 - indicative of the condition of the circulatory system of the living subject) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pantelopoulos et. al.'055 (U.S. Publication Number 20170209055) teaches a wearable device comprising pulse wave analysis as a way to understand PPG and other blood related measurements . Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SARAH ANN WESTFALL/Examiner, Art Unit 3791 /ETSUB D BERHANU/Primary Examiner, Art Unit 3791 Application/Control Number: 18/773,900 Page 2 Art Unit: 3791 Application/Control Number: 18/773,900 Page 3 Art Unit: 3791 Application/Control Number: 18/773,900 Page 4 Art Unit: 3791 Application/Control Number: 18/773,900 Page 5 Art Unit: 3791 Application/Control Number: 18/773,900 Page 6 Art Unit: 3791 Application/Control Number: 18/773,900 Page 7 Art Unit: 3791 Application/Control Number: 18/773,900 Page 8 Art Unit: 3791 Application/Control Number: 18/773,900 Page 9 Art Unit: 3791 Application/Control Number: 18/773,900 Page 10 Art Unit: 3791 Application/Control Number: 18/773,900 Page 11 Art Unit: 3791 Application/Control Number: 18/773,900 Page 12 Art Unit: 3791 Application/Control Number: 18/773,900 Page 13 Art Unit: 3791 Application/Control Number: 18/773,900 Page 14 Art Unit: 3791 Application/Control Number: 18/773,900 Page 15 Art Unit: 3791 Application/Control Number: 18/773,900 Page 16 Art Unit: 3791 Application/Control Number: 18/773,900 Page 17 Art Unit: 3791 Application/Control Number: 18/773,900 Page 18 Art Unit: 3791 Application/Control Number: 18/773,900 Page 19 Art Unit: 3791 Application/Control Number: 18/773,900 Page 20 Art Unit: 3791 Application/Control Number: 18/773,900 Page 21 Art Unit: 3791 Application/Control Number: 18/773,900 Page 22 Art Unit: 3791 Application/Control Number: 18/773,900 Page 23 Art Unit: 3791 Application/Control Number: 18/773,900 Page 24 Art Unit: 3791 Application/Control Number: 18/773,900 Page 25 Art Unit: 3791
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