DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
Claim(s) 3-7 is/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 Claim 4-7
In Claim(s) 4-7, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Regarding Claim 5
Claim 5 recites, "physiological monitor devices integers". This claim terminology appears to be intended as physiological monitor integers instead. For the purpose of examination, the Examiner is interpreting the claimed elements of physiological monitor device integers and physiological monitor integers to be the same claimed element.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8, 10-14, 21 & 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vule et al. (U.S. Patent Application 2020/0323440 A1).
Claim 1: Vule teaches –
A medical device [apparatus] (Figure 1, Element 100), comprising:
a first monitoring interface [optical detectors] (Figure 1, Element 160) having a main housing [lower module] (Figure 1, Element 150), the main housing [lower module] (Figure 1, Element 150) terminating in opposing securing elements (See Exhibit 1 labeled with securing element);
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[AltContent: textbox (Exhibit 1 – Annotated Figure 3 of Vule)]
a subsidiary module [upper module] (Figure 1, Element 110) operatively associated with the first monitoring interface [optical detectors] (Figure 1, Element 160) and a second monitoring interface [contact pressure/tonometry sensors] (Figure 1, Element 170);
a distal end of the securing elements (See Exhibit 1 labeled with securing element) incorporating a biasing component (See Exhibit 2 labeled with biasing element);
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[AltContent: textbox (Exhibit 2 – Annotated Figure 1 of Vule)]
wherein the biasing component is configured to urge the first monitoring interface against the skin of a wearer and urge a nominal contact force between the first monitoring interface and the dorsal wrist portion of the wearer [the wearable device is a watch, band, or strap that can be worn on the wrist of a user such that the upper and lower modules are each in contact with a side of the wrist] (Para 0024); and
wherein the biasing component is further configured to urge the subsidiary module against the skin of a wearer and urge a nominal contact force between the second monitoring interface and the volar wrist portion of the wearer [the wearable device is a watch, band, or strap that can be worn on the wrist of a user such that the upper and lower modules are each in contact with a side of the wrist] (Para 0024).
Claim 2/1: Vule teaches wherein operatively associated with the first monitoring interface [optical detectors] (Figure 1, Element 160) and the second monitoring interface [contact pressure/tonometry sensors] (Figure 1, Element 170), and contained in the main housing [lower module] (Figure 1, Element 150) and the subsidiary module [upper module] (Figure 1, Element 110) are two or more physiological monitor integers [optical detectors] (Figure 1, Element 160) [contact pressure/tonometry sensors] (Figure 1, Element 170).
Examiner’s Note: The claim interpretation of the Examiner is that the physiological monitor integers (as in sensors) are contained in both the main housing and the subsidiary housing and are operatively associated with the first and second monitoring interfaces.
Claim 3/2/1: Vule teaches wherein the two or more operatively associated physiological monitor integers include sensors (Figure 1, Element 160 and/or 170), biomarkers, or the like, that when the first monitoring interface and the second monitoring interface have effective skin contact [upper and lower modules are each in contact with a side of the wrist] (Para 0024; as the upper and lower modules are understood to house the first and second monitoring interfaces), the two or more physiological monitor devices sense or monitor physiological parameters [Each of the upper and lower modules may comprise one or more sensors, including but not limited to optical/PPG sensors, ECG sensors/electrodes, bio impedance sensors, galvanic skin response sensors, tonometry/contact sensors, accelerometers, pressure sensors, acoustic sensors, electro-mechanical movement sensors, and/or electromagnetic sensors] (Para 0026).
Claim 4/2/1: Vule teaches wherein the two or more operatively associated physiological monitor integers include sensors (Figure 1, Element 160 and/or 170), biomarkers, or the like, that when the first monitoring interface and the second monitoring interfaces have effective skin contact [upper and lower modules are each in contact with a side of the wrist] (Para 0024; as the upper and lower modules are understood to house the first and second monitoring interfaces), the two or more physiological monitor devices sense, monitor or determine a disease or disorder [health and wellness monitoring] (Para 0030).
Claim 5/4/2/1: Vule teaches wherein the two or more operatively associated physiological monitor devices integers include sensors (Figure 1, Element 160 and/or 170), biomarkers, or the like, that when the first monitoring interface and the second monitoring interfaces have effective skin contact [upper and lower modules are each in contact with a side of the wrist] (Para 0024; as the upper and lower modules are understood to house the first and second monitoring interfaces), the two or more physiological monitor devices sense, monitor or determine treatment of disease or disorder [health and wellness monitoring] (Para 0030).
Examiner’s Note: The Specification of the Applicant as originally filed discloses measuring biomarkers to measure the onset or the progress of a disease, the effects of treatment or regimen, etc. (Page 17, Line 24-26). The sensor of Vule is capable of “sense, monitor or determine treatment of disease or disorder” since it can similarly to the disclosure of the Applicant measure biomarkers (Para 0030 of Vule).
Claim 6/2/1: Vule teaches wherein the two or more operatively associated physiological monitor integers include sensors (Figure 1, Element 160 and/or 170), biomarkers, or the like, that when the first monitoring interface and the second monitoring interfaces have effective skin contact [upper and lower modules are each in contact with a side of the wrist] (Para 0024; as the upper and lower modules are understood to house the first and second monitoring interfaces), the two or more physiological monitor devices sense, monitor or determine treatment of disease or disorder continuously [the upper and/or lower modules 110, 150 can be configured to continuously collect data] (Para 0078) and/or in real-time.
Claim 7/2/1: Vule teaches wherein the two or more operatively associated physiological monitor integers include sensors (Figure 1, Element 160 and/or 170), biomarkers, or the like, that when the first monitoring interface and the second monitoring interface have effective skin contact [upper and lower modules are each in contact with a side of the wrist] (Para 0024; as the upper and lower modules are understood to house the first and second monitoring interfaces), the two or more physiological monitor devices sense, monitor or determine user activity, fitness, sleep and general wellness [health and wellness monitoring] (Para 0030).
Claim 8/3/2/1: Vule teaches wherein the biomarker is respiration rate (RR) [respiration rate] (Para 0079).
Claim 10/3/2/1: Vule teaches wherein the biomarker is oxygen saturation SpO2 [user's oxygen levels (SvO2)] (Para 0079).
Claim 11/3/2/1: Vule teaches wherein the biomarker is cardiac rhythm [The features extracted from single pulses and series of pulses can include statistical averages of various features across a series, information regarding the morphological shape of each pulse, the average and standard deviation of morphology of a series of pulses, temporal features such as the timing of various features within single pulses, the duration of a single pulse, as well as the average and standard deviation of the timing of a feature or duration of pulses within a series of pulses, and the timing of morphological features across a series of pulses (i.e., the frequency with which a particular pulse shape occurs in a series)] (Para 0067).
Examiner’s Note: The Examiner contends that Para 0067 discloses the pulse analyze that encompasses cardiac rhythm in analyzing the series of pulses.
Claim 12/3/2/1: Vule teaches wherein the biomarker is pulse transit time (PTT) [Disclosed herein are also implementations of an apparatus for measuring blood pressure…derived or calculated from a pulse transmission time (PTT)] (Para 0090).
Claim 13/3/2/1: Vule teaches wherein the biomarker is pulse [can be analyzed to estimate physiological parameters such as blood flow and pulse rate] (Para 0057).
Claim 14/3/2/1: Vules teaches wherein the biomarker is blood pressure [the physiological information sensed, measured, analyzed, or displayed can include…blood pressure] (Para 0030).
Claim 21/1: Vule teaches wherein a subject is monitored continuously [the upper and/or lower modules 110, 150 can be configured to continuously collect data] (Para 0078).
Claim 23/1: Vule teaches wherein the sensor is light-emitting diode (LED) [one light source may be an IR light source] (Para 0062).
Claim 24/1: Vule teaches wherein the sensor is an optical sensor [Each of the upper and lower modules may comprise one or more sensors, including but not limited to optical/PPG sensors] (Para 0026).
Claim 25/1: Vule teaches wherein the biasing component can be one or more selected from the group consisting of pins and loops buckle, butterfly clasp, fold-over push-button deployment clasp, push-button deployment clasp, hidden deployment clasp, deployment clasp, hook-and-loop fastener strap, sliding buckle, friction-fit clickable clasp, resealable component, resealable magnetic component and resealable adhesive component (See attached Exhibit 2 above).
Claim 26/1: Vule teaches wherein the blood pressure is calculated using a formula based on a machine learning model [deriving the blood pressure from the pressure measurements. Some of the techniques may be data-driven (e.g., based on machine learning)] (Para 01260127) that incorporates the correlation [The blood velocity and the blood pressure are correlative] (Para 0118) of the distance [the distance from the heart to the wrist] (Para 0122) between inflection points [calculated by measuring how the peak (i.e., the epicenter 1118) of a pulse travels] (Para 121) in two blood pulse waves [The swing effect can be used to estimate the different times (e.g., the delta times) that a pressure wave hits (e.g., arrives at) each pressure sensor] (Para 0118) (See Para 0118-0126).
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.
Claim(s) 9 & 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vule et al. (U.S. Patent Application 20200323440 A1) and further in view of Toth et al. (U.S. Patent Application 2015/0335288 A1).
Claim 9/3/2/1: Vule fails to teach wherein the biomarker is partial pressure of oxygen PaO2. However, Toth teaches wherein the biomarker is partial pressure of oxygen PaO2 [blood oxygen partial pressure] (Para 0308) in order to obtain more diagnostic information which can lead to a more accurate health monitoring and improved patient outcomes (Para 0308).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the biomarker being partial pressure of oxygen as taught by Toth in order to obtain more diagnostic information which can lead to a more accurate health monitoring and improved patient outcomes (Para 0308).
Claim 22/1: Vule fails to teach wherein a subject is monitored continuously in real-time. However, Toth teaches wherein a subject is monitored continuously in real-time (Para 0312) in order to allow for real time health monitoring for improved patient outcomes as changes in patient conditions can be handle more quickly as time is of the essence in treating patients (Para 0312).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include real time monitoring as taught by Toth in order to allow for real time health monitoring for improved patient outcomes as changes in patient conditions can be handle more quickly as time is of the essence in treating patients (Para 0312).
Claim(s) 15-20 & 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vule et al. (U.S. Patent Application 20200323440 A1) and further in view of Phillips et al. (U.S. Patent Application 2020/0214579 A1).
Claim 15/8/3/2/1: Vule teaches wherein the first monitoring interface and the second monitoring interface sense, monitor or determine the pulse wave [The swing effect can be used to estimate the different times (e.g., the delta times) that a pressure wave hits (e.g., arrives at) each pressure sensor] (Para 0118) (See Para 0118-0126).
Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches monitoring interface sense, monitor or determine the capillary pulse wave and the arterial pulse wave [measurement of the relative resistance of smaller capillaries at shallower depth as registered in the blue or green spectrum versus larger arterioles and arteries as registered in the red and infrared spectrum which is related to the change of capillary tone over time and is a factor that affects blood pressure] (Para 0065) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the monitoring of capillary and arterial pulse waves as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Claim 16/15/8/3/2/1: Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches wherein the capillary pulse wave and the arterial pulse wave are determined simultaneously, sequentially or concomitantly [processor allow the simultaneous measurement of blood volume changes] (Para 0063) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the capillary and arterial pulse waves determined simultaneously as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Claim 17/15/8/3/2/1: Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches wherein the capillary pulse wave and the arterial pulse wave are determined simultaneously [processor allow the simultaneous measurement of blood volume changes] (Para 0063) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the capillary and arterial pulse waves determined simultaneously as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Claim 18/16/15/8/3/2/1: Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches wherein the capillary pulse wave and the arterial pulse wave are corelated [pulse waveform cycle to propagate from deeper arteries and arterioles to shallower capillaries is directly correlated] (Para 0065) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the capillary pulse wave and the arterial pulse wave are corelated as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Claim 19/16/15/8/3/2/1: Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches wherein the capillary pulse wave and the arterial pulse wave are calculated using a formula based on a machine learning model [as input to a machine learning (“ML”) algorithm that predicts changes in blood pressure from the combined analysis of morphological features and time-frequency domain analysis of the multispectral pulse waveforms] (Para 0063) that incorporates the correlation of the distance between inflection points of the capillary pulse wave and the arterial pulse wave [The time that the pulse wave cycle takes to propagate from deeper arterioles to the shallower capillaries can be measured by measuring the time differences between pulse waveform cycles recorded at the red spectrum to those recorded at the blue spectrum, respectively] (Para 0065) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
Examiner’s Note: The Examiner is interpreting “the time differences between pulse waveform cycles” and the distance between inflection points to refer to the same measurement of features on the waveform.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the capillary pulse wave and the arterial pulse wave are calculated using a formula based on a machine learning model as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Claim 20/19/16/15/8/3/2/1: Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches wherein the capillary pulse wave and the arterial pulse wave are corelated using computational software analysis [analysis was performed using a custom developed device and software] (Para 0079) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
Examiner’s Note: The Examiner is interpreting “the time differences between pulse waveform cycles” and the distance between inflection points to refer to the same measurement of features on the waveform.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include wherein the capillary pulse wave and the arterial pulse wave are corelated using computational software analysis as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Claim 27/26/1: Vule fails to teach the capillary pulse wave and the arterial pulse wave. However, Phillips teaches wherein the blood pressure is calculated using a formula based on a machine learning model [as input to a machine learning (“ML”) algorithm that predicts changes in blood pressure from the combined analysis of morphological features and time-frequency domain analysis of the multispectral pulse waveforms] (Para 0063) that incorporates the correlation of the distance between inflection points of the capillary pulse wave and the arterial pulse wave [The time that the pulse wave cycle takes to propagate from deeper arterioles to the shallower capillaries can be measured by measuring the time differences between pulse waveform cycles recorded at the red spectrum to those recorded at the blue spectrum, respectively] (Para 0065) in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032)
Examiner’s Note: The Examiner is interpreting “the time differences between pulse waveform cycles” and the distance between inflection points to refer to the same measurement of features on the waveform.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vule to include the capillary pulse wave and the arterial pulse wave are calculated using a formula based on a machine learning model as taught by Phillips in order to have systems and methods advantageously increase the accuracy of blood pressure measures, are convenient ambulatory use, and enhance the validity of blood pressure and heart function measures during physical activity (Para 0032).
Response to Arguments
Applicant’s arguments, see Page 7, filed 12/09/2025, with respect to the Claim Objections have been fully considered and are persuasive. The Objection of the Claims has been withdrawn.
Rejections Under 35 USC § 112
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive.
35 USC § 112 Part A (Pages 7-9)
The Applicant submitted arguments that “or the like” does not render the claim indefinite because the Specification provides extensive guidance as to what falls within the scope of “sensors, biomarkers, or the like”. The Examiner respectfully disagrees. The Specification that the Applicant listed on Page 8 of the Remarks, filed 12/09/2025, lists body mass index. The Applicant further states that there are four functional limitations of 1) skin contact 2) sensing or monitoring parameters 3) wrist worn and 4) perform specific functions. The Examiner contends that, as an example, the biomarker of BMI does not meet the functional limitations. A wrist worn, skin contact sensor is not capable of sensing or monitoring a person’s weight and height to determine BMI. At most data entry input from the patient into the device would be required to monitor the BMI biomarker. However, data entry of biomarkers is not within the four functional limitations. The Examiner contends that the Specification is not so definitive or clear in the disclosure. While the Examiner points to BMI, there are other disclosed biomarkers and undisclosed biomarkers that under similar analysis cannot meet the functional limitations as listed by the Applicant. Thus, one of ordinary skill in the art will be confused as to the metes and bounds of “or the like”. The argument is unconvincing.
Applicant’s arguments, see Page 10, filed 12/09/2025, with respect to the Rejection under 35 USC § 112(b) regarding Physiological Monitor Integers have been fully considered and are persuasive. The Rejection under 35 USC § 112(b) of the Claims has been withdrawn.
35 USC § 112 Part B (Page 10)
The Applicant submitted arguments that “physiological monitor integers” are physical sensors that are incorporated into the device. The Applicant then further asserts that “physiological monitor integers” are specific biomarker measurements. The Examiner contends that the Applicant is contending that the “physiological monitor integers” are both software and hardware. As the specific biomarker measurements are disclose as being calculated by software (See Line 2-3 of Page 16 of the Specification as originally filed). As a result of the clarifying remarks of the Applicant, the claim limitation is being interpreted as hardware or software. Thus, it can be that one sensor and two software modules calculating different biomarkers reads on the claim limitation.
Applicant’s arguments, see Page 10, filed 12/09/2025, with respect to the Rejection under 35 USC § 112(b) regarding physiological monitor devices have been fully considered and are persuasive. The Rejection under 35 USC § 112(b) of the Claims has been withdrawn.
35 USC § 112 Part C (Pages 10)
The Applicant amended the claims to replace devices with integers and thus overcoming the lack of antecedent basis rejection.
Applicant’s arguments, see Page 11, filed 12/09/2025, with respect to the Rejection under 35 USC § 112(b) regarding biomarkers have been fully considered and are persuasive. The Rejection under 35 USC § 112(b) of the Claims has been withdrawn.
35 USC § 112 Part D (Pages 11)
As a result of the clarifying remarks of the Applicant, the claim limitation of biomarker is being interpreted as software, where the biomarker is calculated or processed. Thus, it can be that one sensor and a software module for calculating that reads on the claim limitation.
Applicant’s arguments, see Page 12, filed 12/09/2025, with respect to the Rejection under 35 USC § 112(b) regarding physiological monitor devices have been fully considered and are persuasive. The Rejection under 35 USC § 112(b) of the Claims has been withdrawn.
35 USC § 112 Part E (Pages 12)
The Applicant amended the claims to replace Velcro with hook-and-loop fastener and thus overcoming the lack of antecedent basis rejection.
Rejections Under 35 USC § 102
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive.
35 USC § 102 Part A (Pages 12-14)
Part 1) The Applicant submitted arguments that the present invention uses two optical PPG sensors only, with no mechanical pressure sensors or tonometry components. The Applicant contends that the system of Vule requires mechanical and optical measurements combined, while the present invention uses “purely optical sensing”. The Examiner contends that while the above maybe true, none of the differences of “PPG sensors only” or “purely optical sensing” are stated in the claim limitations. The argument is unconvincing as the Applicant is comparing the Disclosures of the prior art and the present invention rather than comparing the claim limitations to the prior art disclosure.
Part 2) The Applicant submitted arguments that the present invention specifically places sensors on the dorsal wrist portion, measuring arterial pulse wave and on the volar wrist portion measuring capillary pulse wave. The Examiner contends that as in Part 1, the Applicant is not submitting arguments with respect to the claim limitations. There is nothing withing Claim 1 with respect to measuring arterial pulse wave on the dorsal wrist and measuring capillary pulse wave on the volar wrist. At most the claim recites, “contact force between the first monitoring interface and the dorsal wrist portion” and “contact force between the second monitoring interface and the volar wrist”. The volar and dorsal portions of the wrist are the top and bottom of the wrist. The Examiner contends that Vule discloses that “the upper and lower modules are each in contact with a side of the wrist” (Para 0024). Vule teaches that the upper and lower modules each comprise one or more sensors (Para 0026) and are in contact with a side of the wrist; upper and lower sides, top and bottom sides and volar and dorsal (See Figure 4B, Element 410 & 450 for additional support of the interpretation of the prior art of Vule). The argument is unconvincing.
Part 3) The Applicant submitted arguments that the present invention’s biasing component servers only to maintain “nominal contact force” for optical coupling. The Applicant contends that Vule requires active mechanical pressure. The Examiner respectfully disagrees. Vule teaches biasing components that server only to maintain nominal contact force [the strap or band of the wearable device may be configured so as to facilitate proper placement of one or more sensors of the upper and/or lower modules while still affording the user a degree of comfort in wearing the device] (Para 0027). The argument is unconvincing.
35 USC § 102 Part B (Pages 14)
The Applicant submitted arguments that Vule cannot achieve the purely optical measurements because the system of Vule fundamentally relies on the combination of mechanical and optical sensors working together. The Examiner contends that the claims are not directed to “purely optical measurements” and the combined mechanical pressure sensors and optical sensors working together read on the claim limitations as demonstrated in the rejection above. The Examiner contends that comparing the claims to the prior art of Vule will be more convincing than comparing the present invention to the prior art of Vule. The argument is unconvincing.
35 USC § 102 Part C (Pages 15)
The Applicant submitted arguments that Vule cannot measure the biomarkers using a purely optical, non-mechanical method. The Examiner contends that the claims do not recite “using a purely optical, non-mechanical method”. The argument is unconvincing.
35 USC § 102 Part D (Pages 15-16)
The Applicant submitted arguments that Vule teaches continuous data collections but this is achieved through a mechanical/optical hybrid system, not the purely optical system of the present invention. The Examiner contends that the claims do not recite “purely optical system”. The argument is unconvincing.
Rejections Under 35 USC § 103
35 USC § 103 Part A (Pages 16-17)
The Applicant submitted arguments that Toth uses an entirely different technology. The Applicant contends that Toth teaches invasive gas sensors, using electrochemical detection, operates in a controlled hospital/lab environment, not wearable, no optical PPG sensors. The Examiner respectfully disagrees. Toth discloses a non-invasive optical sensor that measures PaO2 (Para 0308 as cited above within the rejection of record), at the bedside (Para 0354), worn by the subject (Para 0355) and an optical sensor (Para 0278). The Examiner contends that a search of Toth failed to disclose “electrochemical detection”. The Examiner contends that Toth is relevant technology of wearable sensors. The argument is unconvincing.
35 USC § 103 Part B (Pages 17-20)
The Applicant submitted arguments with respect to the Specification of Phillips to the Specification of the Applicant. The argument is unconvincing because the Applicant has failed to point out the differences between the claim language and the teachings of the prior art.
The Applicant further argued that one skilled in the art would not be motivated to modify Vule by incorporating Phillips’s teaching of depth-based wavelength analysis at a single site. The Applicant continues to argue elements that are not claimed. The argument is not convincing because the claims are very high level in terms of generality. The combination would be obvious because determining the capillary pulse wave and arterial pulse wave are known biomarkers within the art. The teaching away and other arguments may be convincing if the claim were limited more to specific details. However, at such a high level of generality the teachings of Phillips are obvious in combination with Vule.
Thus the arguments are all unconvincing. The rejection is deemed proper and is hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797