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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/5/2025 has been entered.
Response to Arguments
Applicant’s amendments filed 12/5/2025 merit new grounds for rejection in view of Wilkinson as modified (U.S. Patent Application Publication No. 2006/0037615) hereinafter referred to as Wilkinson. Applicant’s remarks filed 12/5/2025 have been fully considered but are not persuasive.
Applicant’s remarks on pp. 13-16 are solely directed at whether the previous combination of references teaches the newly added claim amendments, specifically a location for measuring at a region of the supra-sternal notch of a user, and are therefore not persuasive in light of the new grounds for rejection below.
Raj as (previously) modified teaches all of the claimed device, including mounting to skin, an accelerometer sensing mechano-acoustic signals originating from physiological activities of the user at a skin-mounted location, and impedance matching to the user’s epidermal properties at the skin-mounted location. However, Raj as modified does not specify that the device is mounted at a suprasternal notch region of the user.
The Wilkinson reference teaches a skin-mounted detector including an accelerometer sensing mechano-acoustic physiological activity from a user (¶[0258]) and the detector is mounted at the region of the supra-sternal notch, sized to fit within this notch (¶[0257]). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensor of Raj as modified to be sized and shaped to fit on the user’s throat, as taught by Wilkinson, because Wilkinson teaches that the supra-sternal notch region is “advantageous for monitoring the sound level in the trachea, as the amount of tissue at the notch is suitably low so as to provide a good detection signal with little attenuation,” (Wilkinson ¶[0053], ¶[0257]).
On p. 17, Applicant argues that the embodiments of Raj teach an encapsulation that specifically implies a “conformal, void-free enclosure around the components without any deliberate air pockets at either the bottom or top.” The Examiner agrees with this assertion, therefore Raj teaches a lack of air pocket at the bottom of the encapsulation.
However, Applicant goes on to say that Raj therefore does not teach an air pocket at the top either. The Examiner also agrees with this statement but notes that no air pocket is claimed in any of the independent claims, and the air pocket is instead taught in combination with the Lucrecio reference for dependent claim 133.
On pp. 17-18, Applicant argues that a combination of Raj and Harry would not be obvious because Raj teaches passive sensing (lacking stimulation), and Harry teaches stimulation, therefore a modification in view of Harry changes the principle of operation of Raj. Applicant identifies the principle of operation of Raj to “pure sensing” and correspondingly characterizes Harry as “active intervention” with “potential” interference to the signal capture.
Contrary to Applicant’s characterization, the combination of a sensing system with a stimulation system not neither alter the principle of operation of a sensing system. Raj, configured to sense mechano-acoustic signals would still sense mechano-acoustic signals in the same fashion when modified with the proposed combination. Further, in contrast to Applicant’s summary of the Harry reference, Harry does teach that stimulation is provided in response to a threshold, and the input signals that are considered and compared to the threshold are in response to user-specific mechano-acoustic data. From Harry, ¶[0064]: “An input signal might be initiated by, for example, a touch, a movement of a body segment, a sound wave or light.”
Applicant correctly identifies that Harry does not teach an integrated accelerometer, but this is not found persuasive as Raj already teaches that an integrated accelerometer provides the input signals in the form of mechano-acoustic data.
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).
In the instant rejection, the Harry reference provides a tangible benefit to the invention of Raj alone, in that it enhances neuromuscular performance for a user, and therefore the combination properly establishes a motivation to combine the teachings of Raj and Harry.
On pp. 18-19, Applicant argues that the cited Chung reference “at best teaches general user-to-user variability recognition, but not in the context of mechano-acoustic biofeedback with personalized thesholds,” apparently considering Chung to be non-analogous.
However, this is not persuasive as Chung teaches a microphone sensor for mechano-acoustic sensing in ¶¶[0102-0103] and claim 8. Furthermore, Chung is cited in the rejections of claims 12-15 and 72-74 to teach additional limitations such as a machine learning model for analysis of output signals that ultimately serves the purpose of “improv(ing) a sensor performance parameter used for diagnostic sensing or a therapeutic application and/or a personalized user performance parameter.” The biofeedback with personalized thresholds is already taught by Harry in the rejection of claim 1, for example.
The remaining remarks are unpersuasive as they amount to a general allegation of patentability and no specific arguments.
Claim Interpretation
The claims are directed to a medical sensor/apparatus that includes a sensor and generally include functionally directed limitations without a processor. While the functions are given some limited patentable weight, in order for them to be considered structural limitations of the apparatus, they should be tied to a processor configured to perform the claimed function. Claims that do not require a processor, also do not require the claimed functional limitations.
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.
Claim(s) 1-7, 11, 18-21, 23, 58-64, 67-68, 71, 76, 79-83, 87-92, and 95-100 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Raj et al. (U.S. Patent Application Publication No. 2019/0365263) hereinafter referred to as Raj; in view of Harry et al. (U.S. Patent Application Publication No. 2008/0077192) hereinafter referred to as Harry; in view of Rogers et al. (U.S. Patent Application Publication No. 2013/0041235) hereinafter referred to as Rogers; in view of Wilkinson as modified (U.S. Patent Application Publication No. 2006/0037615) hereinafter referred to as Wilkinson.
Regarding claims 1 and 58-61, Raj teaches a medical sensing device (Abstract) comprising:
an electronic device (Fig. 4C, element 110 sensor device) comprising an accelerometer to sense one or more mechano-acoustic signals of a user (¶[0023], Fig. 4C, mechano-acoustic pressure waves from physiological processes); and
a bidirectional wireless communication system (¶[0031] wireless transceivers) electronically connected to the electronic device for sending an output signal from the electronic device to an external device (¶¶[0064-0065] sending information for the sensor devices to the user device) and receiving commands from an external controller to the electronic device (¶[0064] user device sets configuration of sensors); and
a flexible (¶[0030]) epidermal mounted encapsulation (Fig. 4C, element 470 encapsulation material against element SKIN) including an elastic modulus to provide strain isolation (¶[0053], ¶[0058], ¶[0060]) and epidermal matching mechano-acoustic impedance (¶0047], noted: applicant’s specification states that matching skin properties for elastic modulus and mass density solves the problem of matching impedance), wherein that surrounds the electronic device (Fig. 4C), wherein the flexible encapsulation layer comprises:
a bottom encapsulating layer (Fig. 4C, bottom);
a top encapsulating layer (Fig. 4C, top); and
a strain isolation layer (¶[0060] element 412), wherein the strain isolation layer is supported by the bottom encapsulating layer (Fig. 4C, bottom layer of element 470 overlaps the island element 412, and ¶[0058] encapsulant surrounds the island 412), such that no air pocket exists between the electronic device and the bottom encapsulating layer (Fig. 4C, no air pocket between island and bottom encapsulation),
wherein the bottom encapsulating layer and the top encapsulating layer are bonded to package the electronic device therein (Fig. 4C, ¶[0047]).
Raj does not teach a stimulator to provide stimulus to the user based on a threshold and responsive to one or more mechano-acoustic signals; wherein a threshold is used to provide a trigger for a corrective, stimulatory, biofeedback, or reinforcing signal back to the user, and wherein said threshold is personalized for the user.
Attention is brought to the Harry reference, which teaches an electronic device further comprises a stimulator in electronic communication (¶[0050]) to provide a stimulus to a user of the medical sensing device with the stimulator (¶[0067], ¶[0189]), wherein a threshold (¶[0060] detect input signal, the threshold is a detected input signal) is used to provide a trigger for a corrective, stimulatory, biofeedback, or reinforcing signal back to the user (¶[0064], ¶[0067]) and is personalized for the user (¶[0064] depends on the sensory system targeted, therefore personalized by the target sensory system for the user, and Harry further teaches calibrating the input signal with a bias particular to each user in ¶[0057]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensing patch of Raj to include vibrational stimulation to assist a user, as taught by Harry, because Harry teaches that it results in improved neuromuscular performance for a user (Harry ¶[0211]).
Raj as modified does not teach any mass density of the materials.
Attention is brought to the Rogers reference, which teaches epidermal matched encapsulating materials, including mass density and elastic modulus (¶[0521], see claim 1, ¶¶[0013-0014]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the epidermal sensor of Raj as modified to choose a mass density and elastic modulus sufficient for achieving epidermal property matching, as taught by Rogers, because Rogers teaches that “(t)hese mechanical characteristics lead to robust adhesion to the skin…without any mechanical fixturing hardware or adhesive tapes,” and “impose negligible mechanical or mass loading…without any apparent constraints in motion due to the devices,” (Rogers ¶[0524]).
Raj as modified teaches all of the claimed device, including mounting to skin, an accelerometer sensing mechano-acoustic signals originating from physiological activities of the user at a skin-mounted location, and impedance matching to the user’s epidermal properties at the skin-mounted location. However, Raj as modified does not specify that the device is mounted at a suprasternal notch region of the user.
Attention is brought to the Wilkinson reference, which teaches a skin-mounted detector including an accelerometer sensing mechano-acoustic physiological activity from a user (¶[0258]) and the detector is mounted at the region of the supra-sternal notch, sized to fit within this notch (¶[0257]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensor of Raj as modified to be sized and shaped to fit on the user’s throat, as taught by Wilkinson, because Wilkinson teaches that the supra-sternal notch region is “advantageous for monitoring the sound level in the trachea, as the amount of tissue at the notch is suitably low so as to provide a good detection signal with little attenuation,” (Wilkinson ¶[0053], ¶[0257]).
Regarding claims 2 and 62, Raj as modified teaches the medical sensing device of claims 1/58.
Raj further teaches wherein the medical sensing device is configured to be wearable, tissue mounted or implantable or in mechanical communication or direct mechanical communication with tissue of a subject (Fig. 4C, see SKIN contact).
Regarding claims 3, 63, and 95 Raj as modified teaches the medical sensing device of claims 1/58.
Raj teaches further comprising a wireless re-chargeable power system for powering the electronic device (¶[0031]).
Regarding claims 4 and 64, Raj as modified teaches the medical sensing device of claims 1/58.
Raj further teaches a processor (¶[0032]) to provide a real-time metric (¶[0032]) eliminating the need for post-processing, (¶[0027] can be processed in real time).
Regarding claim 5, Raj as modified teaches the medical sensing device of claim 4.
Raj further teaches wherein the processor (¶[0035]) is on-board with the electronic device (¶[0035]) or is positioned in the external device that is located at a distance from the medical sensing device and in wireless communication with the wireless communication system (¶¶[0031-0032]).
Regarding claim 6, Raj as modified teaches the medical sensing device of claim 5.
Raj further teaches wherein the processor is part of the external device (¶[0033], ¶[0041] user device).
Regarding claim 7, Raj as modified teaches the medical sensing device of claim 1.
Raj further teaches wherein the medical sensing device is configured to continuously monitor and generate a real-time metric (¶[0027] can be processed in real time).
Regarding claims 11 and 71, Raj as modified teaches the medical sensing device of claims 1/58.
Raj further teaches a processor configured to analyze the output signal (¶[0032]).
Regarding claim 18, Raj as modified teaches the medical sensing device of claim 1.
Raj further teaches wherein the electronic device further comprises a stretchable electrical interconnect (Fig. 4B, element 422, ¶[0051] and ¶[0053]), and a microprocessor (¶[0003]).
Regarding claim 19, Raj as modified teaches the medical sensing device of claim 18.
Raj further teaches wherein the medical sensing device is configured to sense single or multiple physiological signals from the user (¶[0034]).
Regarding claims 20-21, Raj as modified teaches the medical sensing device of claim 19.
Raj further teaches wherein the electronic device further comprises a network (¶[0031]) comprising a plurality of sensors (Fig. 1, elements 110, 112, 114, 116), wherein at least one of said plurality of sensors is for sensing said single or multiple physiological signals from the user and at least one of said sensors is for providing a feedback signal to the user (¶[0066-0067]).
Regarding claim 23, Raj as modified teaches the medical sensing device of claim 19.
Raj does not teach a stimulator.
Harry further teaches wherein the stimulator comprises one or more of a vibratory motor, an electrode, a light emitter, a thermal actuator and an audio notification (¶[0014]).
Regarding claim 67, Raj as modified teaches the medical sensing device of claim 58.
Raj further teaches wherein the medical sensing device is configured to continuously monitor and generate a real-time metric (¶[0027] can be processed in real time).
Regarding claim 68, Raj as modified teaches the medical sensing device of claim 67.
Raj further teaches wherein the real-time metric is a social metric or a clinical metric (¶[0027] can be processed in real time, ¶[0032] clinical metrics).
Regarding claims 76, 79-83, and 100, Raj as modified teaches the medical sensor claim 58.
The location of the claimed medical device is an intended use of the device, as it is not tied to any structure for achieving application in a particular location. The device of Raj as modified is capable of placement on any part of a human body, and therefore meets these claims.
Regarding claim 87, Raj as modified teaches the medical sensing device claim 58.
Raj further teaches wherein the electronic device is a flexible device (¶[0047]).
Regarding claims 88 and 90, Raj as modified teaches the medical sensing device of claim 58.
Raj further teaches a stretchable device (¶[0047]), at least partially supported by an elastomer substrate, superstrate or both (¶[0047).
Regarding claim 89, Raj as modified teaches the medical sensing device of claim 58.
Raj further teaches wherein the electronic device has a multilayer floating device architecture (Fig. 4C).
Regarding claim 91, Raj as modified teaches the medical sensing device of claim 58.
Raj further teaches wherein the electronic device is at least partially supported by a silicone elastomer providing for strain isolation (¶[0047], ¶[0058]).
Regarding claim 92, Raj as modified teaches the medical sensing device of claim 58.
Raj further teaches wherein the electronic device is at least partially encapsulated by a moisture resistant enclosure (¶[0046], ¶[0047] encapsulation is waterproof)
Regarding claim 96, Raj as modified teaches the medical sensing device of claim 95.
Raj further teaches wherein the wireless re-chargeable system comprises one or more of a rechargeable battery, and an inductive coil (¶[0031]).
Regarding claims 97-99, Raj as modified teaches the medical sensing device claim 58.
Raj further teaches comprising a high frequency 3-axis gyroscope and a magnetometer (¶[0038], IMU comprising accelerometers, gyroscopes, and magnetometers, in 3 axes).
Claim(s) 12-15 and 72-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj, Harry, Rogers, and Wilkinson as applied to claim 11 and 71 above, and further in view of Chung et al. (U.S. Patent Application Publication No. 2015/0106020) hereinafter referred to as Chung.
Regarding claims 12-14 and 72-74, Raj as modified teaches the medical sensing device of claims 11/71.
Raj as modified does not teach wherein the processor utilizes machine learning to recognize one or more user-to-user variables between a plurality of users and customize the analysis to an individual user of the medical sensing device;
wherein the machine learning comprises one or more supervised learning algorithms and/or unsupervised learning algorithms customizable to the user; and
wherein the machine learning improves a sensor performance parameter used for diagnostic sensing or a therapeutic application and/or a personalized user performance parameter.
Attention is brought to the Chung reference, which teaches wherein a processor utilizes machine learning to recognize one or more user-to-user variables between a plurality of users (¶[0105] data mining techniques and k means clustering for identifying sensing parameters) and customize the analysis to an individual user of the medical sensing device (¶[0047]);
wherein the machine learning comprises one or more supervised learning algorithms and/or unsupervised learning algorithms customizable to the user (¶[0047]); and
wherein the machine learning improves a sensor performance parameter used for diagnostic sensing or a therapeutic application and/or a personalized user performance parameter (¶¶[0047-0048]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Raj as modified to include machine learning algorithms, as taught by Chung, because it personalizes modeling, classification and prediction to the individual (Chung ¶[0170]).
Regarding claim 15, Raj as modified teaches the medical sensing device of claim 11.
Raj further wherein the processor is configured to filter and analyze a measured output from the electronic device to improve a sensor performance parameter (¶[0062]).
Claim(s) 29-32 and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj, Harry, Rogers, and Wilkinson as applied to claims 1 and 58 above, and further in view of Ludlow et al. (U. S. Patent Application Publication No. 2017/0273862) hereinafter referred to as Ludlow.
Regarding claim 29, Raj as modified teaches the medical sensing device of claim 1.
Raj further teaches wherein the medical sensing device is configured to be worn by a user for a therapeutic swallow application (this is an intended use, the device of Raj is capable of this use).
However, in case Applicant disagrees, attention is brought to the Ludlow reference, which teaches a medical sensing device is configured to be worn by a user for a therapeutic swallow application (¶[0019]).
It would have been obvious to one of ordinary skill in the art to modify the sensor system of Raj as modified to include parameters for dysphagia monitoring, as taught by Ludlow, because patients with swallowing disorders require 24-hour monitoring, and an external wearable device is more comfortable than other sensors and can provide stimulation for a user to regain safe swallowing (Ludlow, ¶[0004] and ¶[0129]).
Regarding claim 30, Raj as modified teaches the medical sensing device of claims 29.
Ludlow further teaches wherein the medical sensing device is configured for use in the therapeutic swallow application, wherein the output signal is for one or more swallow parameters (¶[0019]) selected from the group consisting of swallow frequency, swallow count (¶[0017] piezoelectric swallowing receptor), and swallow energy.
Regarding claims 31 and 40, Raj as modified teaches the medical sensing device of claim 30/38.
Raj does not teach a stimulator.
The stimulator of Harry is contemplated to be applicable to enhancing swallowing function (¶[0189]).
Attention is brought to the Ludlow reference, which teaches a stimulator that provides a haptic signal to a user to engage in a safe swallow (¶[0128]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the swallow analysis of Raj as modified to include haptic stimulation for triggering safe swallows, as taught by Ludlow, because Ludlow teaches that it allows a user to regain volitional swallowing control (Ludlow ¶[0129]).
Regarding claim 32, Raj as modified teaches the medical sensing device of claim 31.
Ludlow further teaches wherein the safe swallow is determined by sensing onset of inspiration and expiration of a respiratory cycle of the user (¶[0084]).
Regarding claim 38, Raj as modified teaches the medical sensing device of claim 29.
Ludlow further teaches wherein the medical sensing device is configured for use in the stroke rehabilitation device (¶[0113] it is noted that this is an intended use of the device), wherein the output signal is for a swallow parameter (¶[0017] piezoelectric swallowing receptor).
Regarding claim 39, Raj as modified teaches the medical sensing device of claim 38.
Raj further teaches wherein the output signal is for use with one or more additional stroke rehabilitation parameters consisting of falls (“for use with” is a statement of intended use and is not tied to any structure, therefore not given patentable weight).
Claim(s) 33-34, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj, Harry, Rogers, Wilkinson, and Ludlow as applied to claims 29-32 and 38-40 above, and further in view of Wingeier (U.S. Patent Application Publication No. 2017/0361096) hereinafter referred to as Wingeier.
Regarding claim 33, Raj as modified teaches the medical sensing device of claim 31.
Raj as modified does not teach further teaches wherein one or more machine learning algorithms are used in a feedback loop for optimization of timing of the haptic signal.
Attention is brought to the Wingeier reference, which teaches one or more machine learning algorithms are used in a feedback loop for optimization of timing of a haptic signal (¶[0041] machine learning used to optimize feedback, ¶[0026] haptic feedback).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensor system of Raj as modified to include machine learning in adjustment of feedback, as taught by Wingeier, because Wingeier teaches that it improves provision and modulation of stimulation treatment (Wingeier ¶[0041]).
Regarding claims 34 and 37, Raj as modified teaches the medical sensing device of claim 29.
Raj as modified does not teach social interaction metrics/parameters, or a haptic feedback to a user for engaging in social interaction.
Attention is brought to the Wingeier reference, which teaches a device configured to be worn by a user (Fig. 8) and for use as a social interaction meter, wherein the output signal is for one or more social parameters selected from the group consisting of a talking time, a number of words (fluency rate), a phonatory parameter, a linguistic discourse parameter and a conversation parameter (¶[0026] sensing speech including talking on a phone ¶[0024] which encompasses conversation parameters) and further comprising a stimulator that provides a haptic signal to a user (¶[0074]) to engage in a social interaction event (¶[0019] speech and learning related tasks).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the biofeedback for stroke rehabilitation of Raj as modified to include speech ability coaching, as taught by Wingeier, because the stimulation increases neuroplasticity in a user (Wingeier ¶[0028]) and improves a subject’s abilities in multiple areas of rehabilitation (Wingeier ¶[0019]).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj, Harry, Rogers, and Wilkinson as applied to claim 1 above, and further in view of Wingeier (U.S. Patent Application Publication No. 2017/0361096) hereinafter referred to as Wingeier.
Regarding claim 43, Raj as modified teaches the medical sensing device of claim 1.
Raj does not teach an external sensor operably connected to the electronic device.
Attention is brought to the Wingeier reference, which teaches an external sensor operably connected to the electronic device (¶[0136] microphone).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the system of Raj as modified to include a microphone, as taught by Wingeier, because it promotes and enables user interaction (Wingeier ¶[0136] and includes a voice command module, etc.).
Claim(s) 133 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj, Harry, Rogers, and Wilkinson as applied to claim 1 above, and further in view of Lucrecio et al. (U.S. Patent Application Publication No. 2017/0135417) hereinafter referred to as Lucrecio.
Regarding claim 133, Raj as modified teaches the medical sensing device of claim 1.
Raj as modified does not teach an air pocket between the electronic device and the top encapsulating layer.
Attention is brought to the Lucrecio reference, which teaches a bottom encapsulating layer and a top encapsulating layer, bonding to package an electronic device with an air pocket between the electronic device and the top encapsulating layer (Fig. 2, air pocket element 110, top and bottom encapsulation layers visible, electronic device element 115, ¶[120]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the encapsulation of Raj as modified to include an air pocket, as taught by Lucrecio, because it provides for more precise measurements for MEMS sensors that are sensitive to temperature and humidity changes (Lucrecio ¶[0034]).
Conclusion
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792