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 .
Election/Restrictions
Applicant's election with traverse of Group I, Species 3, and Species A in the reply filed on 3/25/2026 is acknowledged. However, the restriction between Species A-D is hereby withdrawn as these sensor modalities appear to be working together as disclosed in the Specification as filed 5/2/2023. The traversal is on the ground(s) that Groups I, II, III, and IV share a special technical feature: “time-synchronized spatially separated sensors configured for differential measurement that enables cancellation of motion artifacts to extract physiological signals”. This is not found persuasive because this special technical feature is not shared between groups.
The only claimed technical feature that is shared between all groups is a first and second sensor. Claim 79 does not require, for example, that the sensors are time-synchronized. Claim 69 does not require, for example, that the sensors are in any way separated from each other. Claims 1, 39, and 69 share that two sensors are time synchronized. Claims 1, 39, and 79 share that the two sensors are spatially separated. Claims 1 and 39 share that two sensors are spatially and mechanically separated.
In the Requirement for Election due to Lack of Unity mailed 1/20/2026, the special technical feature was considered failing to contribute over the art. Applicant alleges that the combination of Raj and Baxi do not teach “time-synchronized sensors” stating “Baxi’s time synchronization is directed to overcoming ‘synchronization errors from clock skew and/or a non-deterministic delay introduced by the wireless’” and therefore does not teach the time synchronization in the instant claims.
This is not found persuasive because Applicant does not claim any of the features of “differential sensing”. In response to applicant's argument that the references fail to show certain features of the invention, (i.e. “for differential measurement that cancels motion artifacts”) it is noted that the features upon which applicant relies are not recited in the claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that combining Raj with Baxi would render either inoperable for their intended purpose, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Lastly, Applicant alleges that Baxi “teaches away” from any spatial or mechanical separation of sensors, because Baxi recognizes one advantage to co-location of sensors. This is not found persuasive as Baxi nevertheless does not criticize, discredit or otherwise specifically discourage an unspecified amount of spatial or mechanical separation (of which, a magnitude or scale is not claimed).
The requirement is still deemed proper and is therefore made FINAL.
Claims 39-88 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group and/or Specie, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/25/2026.
Specification
The use of the terms “BLE SoC (Bluetooth Low Energy System on a Chip) (Nordic Semiconductor, nRF52840), a PMIC (power management integrated circuit) (Texas Instruments, BQ25120), a 4-gigabit NAND flash memory (Micron, 5 MT29F4G01), and two identical IMUs, each with an embedded temperature sensing unit (STMicroelectronics, LSM6DSL)” comprises multiple trade names or a marks used in commerce. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant’s cooperation is correction of all such usages in the pending application is requested, as the specification is lengthy thorough review for such usages is burdensome.
Claim Objections
Claims 36-38 are objected to because of the following informalities: these claims appear to have a typographical error in the dependency. Claim 36 will be considered from claim 1 rather than from claim ‘I’. Claim 37 will be considered to depend from claim 1. Claim 38 will be considered to depend from claim 1. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: First and second thermal sensing units in claims 11-12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
p. 35 of the Specification as filed 5/2/2023 teaches the thermal sensing unit is the embedded temperature sensor in the STMicroelectronics, LSM6DSL device, see lines 5-6.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claims 13 and 22 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 13, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “from activity of a cardiopulmonary system and movements of a core body”, and the claim also recites “to a diverse collection of processes across thoracic cavity, esophagus, pharynx, and oral cavity related to respiration, speech, swallowing, wheezing, coughing, and sneezing” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It’s not clear what sensing activity is performed, and what the boundaries of the claimed range are. Each claimed process is one of either a cardiopulmonary process or movement of a core body, and the claimed combination of elements renders the claim indefinite.
Regarding claim 22, the claim contains the trademark/trade name Bluetooth, Bluetooth low energy (BLE). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an ad-hoc wireless network and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 101
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 1-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claim 17 is directed to an electronic device comprising two IMUs that are time synchronized and separated from each other, configured to monitor key symptoms of a patient with COVID-19 infection to track progress of recovery and response to therapies in hospital and/or home.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture and a method.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 17 recites the following limitations:
monitor key symptoms of a patient with COVID-19 infection to track progress of recovery and response to therapies in hospital and/or home.
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual receiving IMU data streams, and using human judgment to evaluate a person’s COVID-19 disease progression and/or recovery over time.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified.
In claim 1/17: first and second IMU, microcontroller unit
The IMUs are only nominally tied to the abstract idea and no active data acquisition is performed. If data collection is inferred as data streams from the IMUs, the data is non-specific and functions as pre-solution activity to the abstract idea claimed, as no additional data collection is claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The MCU appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The IMUs are only nominally tied to the abstract idea and no active data acquisition is performed. If data collection is inferred as data streams from the IMUs, the data is non-specific and functions as pre-solution activity to the abstract idea claimed, as no additional data collection is claimed. Therefore the claimed sensors amount to mere data gathering and considered an insignificant extra-solution activity.
The MCU appears to be an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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) 1-2, 4-10, 13-26, and 28-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (U.S. Patent Application Publication No. 2019/0365263) hereinafter referred to as Raj; in view of Shusterman (U.S. Patent Application Publication No. 2018/0020931) hereinafter referred to as Shusterman.
Regarding claim 1, Raj teaches an electronic device for measuring physiological parameters of a living subject (Abstract, sensing acoustic data generated by a user), comprising:
at least a first inertial measurement unit (IMU) (¶[0058], Fig. 4C, mechano-acoustic sensor accelerometer or IMU, ¶¶[0037-0038], and ¶[0040] accelerometer/IMU incorporates a temperature sensor built in) and a second temperature sensor (¶[0042]),
the first IMU and the second temperature sensor are time-synchronized (¶[0065] timestamped and time-aligned and multiple samples associated to one particular timestamp, including in real time in ¶[0027]) and mechanically and spatially separated from each other (¶[0042] positioned in a different location and ¶[0060] mechanically isolated from other sensor islands); and
a microcontroller unit (MCU) (¶[0053]) electronically coupled to the first IMU and the second temperature sensor for processing of data streams from the first IMU and the second temperature sensor (¶[0055] microcontroller performs the functions of the processor, processor performs processing the data streams ¶¶[0031-0032]).
Raj teaches the first IMU comprising a temperature sensor and a locationally different temperature sensor but does not go so far as to teach a second IMU comprising the second temperature sensor.
Raj as modified does not teach a second IMU comprising the second temperature sensor.
Attention is drawn to the Shusterman reference, which teaches a mechano-acoustic conformal patch monitor (Fig. 4A-B), comprising two accelerometers (¶¶0069-0070]), which are spatially and mechanically separated from each other (Fig. 4A-B, two modular sensors element 401 each comprising an accelerometer spaced apart and connected independently to a central unit ¶[0218]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the conformal sensors of Raj to use an IMU with integrated temperature sensor in place of both temperature sensors, because Shusterman teaches that incorporating a second accelerometer-including sensor into a mechano-acoustic monitoring patch improves the function of monitoring, including creating maps or distributions of movement generated by the torso reflecting heart and/or lung activity (see improvements in ¶¶[0121-0138], improvements provided by two locations of BCG from accelerometers in ¶¶[0139-0148]).
Regarding claim 2, Raj as modified teaches the electronic device of claim 1.
Raj further teaches wherein the first IMU is configured to measure data including a first signal related to a physiological signal of the living subject and a second signal, and the second IMU is configured to measure data including at least the second signal (as modified by Shusterman, above, the IMUs of Raj would be configured to measure inertial signals and temperature), wherein the first signal measured by the first IMU has a signal strength greater than that the second signal measured by the first IMU (this is an intended use of the device, and completely dependent on the environment and state of the device, therefore the device of Raj as modified is capable of this use).
Regarding claim 4, Raj as modified teaches the electronic device of claim 2.
Raj further teaches wherein the second signal is related to at least one of ambient motion and vibration (Raj as modified teaching a second mechano-acoustic IMU, teaches the second signal is related to vibration, ¶[0023], ¶[0062], notably the claim broadly interpreted does not require ambient vibration, but instead may be interpreted as ambient motion and/or vibration).
Regarding claim 5, Raj as modified teaches the electronic device of claim 2.
Raj further teaches wherein the data measured by the second IMU includes the first signal and the second signal (as modified by Shusterman, above, the IMUs of Raj would be configured to measure inertial signals and temperature).
Regarding claim 6, Raj as modified teaches the electronic device of claim 2.
Raj further teaches wherein a signal-to-noise ratio (SNR) of a signal measured by the first IMU and the second IMU together is lower than a first SNR of a signal measured by the first IMU individually, or a second SNR of a signal measured by the second IMU individually (this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Regarding claim 7, Raj as modified teaches the electronic device of claim 2.
Raj further teaches wherein both of the first IMU and the second IMU are operably in mechanical communication with the skin of the living subject (¶[0060]).
Shusterman also further teaches wherein both of the first IMU and the second IMU are operably in mechanical communication with the skin of the living subject (Fig. 4A-B).
Regarding claim 8, Raj as modified teaches the electronic device of claim 7.
Raj further teaches wherein one of the first IMU and the second IMU is operably in directly mechanical communication with the skin of the living subject, while the other of the first IMU and the second IMU is operably in indirectly mechanical communication with the skin of the living subject (¶[0068] embodiments with and without flexboard barrier).
Regarding claim 9, Raj as modified teaches the electronic device of claim 8.
Raj further teaches wherein the first IMU and the second IMU are operably in directly mechanical communication with the skin of the living subject (¶[0060], ¶[0068] embodiments with and without flexboard barrier).
Shusterman also further teaches wherein the first IMU and the second IMU are operably in directly mechanical communication with the skin of the living subject (Fig. 4A-B).
Regarding claim 10, Raj as modified teaches the electronic device of claim 2.
Raj further teaches wherein one of the first IMU and the second IMU is separated from the rest of rigid components of the electronic device (¶[0060] the IMU are mechanically separated from other rigid device components to ensure lack of motion artifacts).
Regarding claim 13, Raj as modified teaches the electronic device of claim 1.
Raj further teaches being configured to measure a range of physiological information from activity of a cardiopulmonary system and movements of a core body to a diverse collection of processes across thoracic cavity, esophagus, pharynx, and oral cavity related to respiration, speech, swallowing, wheezing, coughing, and sneezing (¶[0049]).
Regarding claim 14, Raj as modified teaches the electronic device of claim 13.
Raj further teaches being configured to separate signals associated with the cardiopulmonary system and related processes from those due to body movements (this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Shusterman also further teaches being configured to separate signals associated with the cardiopulmonary system and related processes from those due to body movements (¶[0032], ¶¶[0136-0139]).
Regarding claim 15, Raj as modified teaches the electronic device of claim 13.
Raj further teaches being configured to spatiotemporally map movements of the skin at this region of the anatomy onto which the electronic device is attached during cardiac and respiratory activities (this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Shusterman also further teaches being configured to spatiotemporally map movements of the skin at this region of the anatomy onto which the electronic device is attached during cardiac and respiratory activities (see mapping in ¶¶[0121-0138], mapping provided by two locations of BCG from accelerometers in ¶¶[0139-0148]).
Regarding claim 16, Raj as modified teaches the electronic device of claim 13.
Raj further teaches being configured to continuously measure temperature, heart rate (HR), respiratory rate (RR), activity level, and body orientation, across a range of vigorous activities and conditions (¶[0029], and also this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Regarding claim 17, Raj as modified teaches the electronic device of claim 13.
Raj further teaches being configured to monitor key symptoms of a patient with COVID-19 infection to track progress of recovery and response to therapies in hospital and/or home (¶[0029] many parameters are key symptoms for a patient with a COVID-19 infection, further this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Regarding claim 18, Raj as modified teaches the electronic device of claim 13.
Rajfurther teaches being configured to measure any of respiratory or motion related digital biomarkers associated with coughing, swallowing, and/or specific motion related activities (¶[0049], also this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Regarding claim 19, Raj as modified teaches the electronic device of claim 18.
Raj further teaches being configured to assess coughing when the living subject is moving or immobile, and/or to measure muscle motion, when the living subject is moving (notably, the claims do not disavow assessing coughing and muscle motion always simultaneously, motion sensors by definition respond to all motion they are exposed to, and this is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Regarding claim 20, Raj as modified teaches the electronic device of claim 1.
Raj teaches further comprising a bidirectional wireless communication system electronically coupled to the electronic device and configured to send an output signal from the electronic device to an external device (¶[0031], ¶[0033]).
Regarding claim 21, Raj as modified teaches the electronic device of claim 20.
Raj further teaches wherein the bidirectional wireless communication system is further configured to deliver commands from the external device to the electronic device (¶[0026], ¶[0033]).
Regarding claim 22, Raj as modified teaches the electronic device of claim 20.
Raj further teaches wherein the bidirectional wireless communication system comprises a controller that utilizes at least one of near field communication (NFC), Wi-Fi/Internet, Bluetooth, Bluetooth low energy (BLE), and cellular communication protocols for wireless communication (¶[0033]).
Regarding claim 23, Raj as modified teaches the electronic device of claim 20.
Raj teaches further comprising a customized app with a user interface deployed in the external device to allow a user to configure and operate the electronic device for data collection, data transfer, data storage and analysis, wireless charging, and monitoring of user's conditions (¶[0026] control, configure, program wearable sensing devices such as specific signals, location information can be set, ¶[0033] application on user device, ¶¶[0064-0065]).
Regarding claim 24, Raj as modified teaches the electronic device of claim 23.
Raj further teaches wherein the customized app is configured to allow time-synchronized operation of a plurality of the electronic devices simultaneously (¶[0065] timestamped and time-aligned and multiple samples associated to one particular timestamp, including in real time in ¶[0027], further “configured to allow” only disavows specifically preventing synchronous operation therefore Raj meets this limitation).
Regarding claim 25, Raj further teaches the electronic device of claim 20.
Raj further teaches wherein the external device is a mobile device, a computer, or a cloud service (¶[0026]).
Regarding claim 26, Raj as modified teaches the electronic device of claim 1.
Raj teaches further comprising a power module coupled to the first IMU, the second IMU and the MCU for providing power thereto (¶[0036], ¶[0054]).
Regarding claim 28, Raj as modified teaches the electronic device of claim 26.
Raj further teaches wherein the power module comprises at least one battery for providing the power (¶[0036], ¶[0054]).
Regarding claim 29, Raj as modified teaches the electronic device of claim 28.
Raj further teaches wherein the battery is a rechargeable battery (¶[0036], ¶[0054]).
Regarding claim 30, Raj as modified teaches the electronic device of claim 29.
Raj further teaches wherein the power module further comprises a wireless charging module for wirelessly charging the rechargeable battery (¶[0031] charge the battery via induction).
Regarding claim 31, Raj as modified teaches the electronic device of claim 28.
Raj further teaches wherein the second IMU is placed in a manner that it bends and folds over the battery (¶¶[0051-0052] battery is places centrally, and the wings may flex around the battery therefore is placed in a manner that is capable of bending and folding around the battery).
Regarding claim 32, Raj as modified teaches the electronic device of claim 26.
Raj teaches further comprising a flexible printed circuit board (fPCB) (¶[0030] stretchable and conformal electronics, contrasted with embodiments comprising rigid portions, ¶[0047] flex printed circuit board) having flexible and stretchable interconnects electrically connecting to electronic components including the first IMU, the second IMU and the MCU and the power module (¶[0051] flexible interconnects).
Regarding claim 33, Raj as modified teaches the electronic device of claim 32.
Raj teaches further comprising an elastomeric encapsulation layer (¶[0047] encapsulated in an elastomer) at least partially surrounding the electronic components and the flexible and stretchable interconnects to form a tissue-facing surface operably attached to the living subject and an environment-facing surface, wherein the tissue-facing surface is configured to conform to a skin surface of the living subject (¶[0030]).
Regarding claim 34, Raj as modified teaches the electronic device of claim 33.
Raj further teaches wherein the encapsulation layer is formed of a flame retardant material (¶[0047] silicone).
Regarding claim 35, Raj as modified teaches the electronic device of claim 34.
Raj further teaches wherein the elastomeric encapsulation layer is a waterproof and biocompatible silicone enclosure (¶[0047] silicone).
Regarding claim 36, Raj as modified teaches the electronic device of claim 1.
Raj teaches further comprising a biocompatible hydrogel adhesive for attaching the electronic device on the respective region of the living subject, wherein the biocompatible hydrogel adhesive is adapted such that signals from the living subject are operably conductible to the first IMU and the second IMU (¶[0047]).
Regarding claim 37, Raj as modified teaches the electronic device of claim 1.
Raj further teaches being flexible and conformable to the skin (¶[0030], ¶[0047]) with a specific geometrical polarity for mounting in an anatomical location of interest of the living subject (only one surface is skin facing, which comprises a “geometrical polarity” that specifically facilitates mounting in a location on the skin, however, mounting the device on a person is an intended use of the device as it is claimed as a function independent of structural operation, therefore completely dependent on the environment and state of the device, and the device of Raj as modified is capable of this use).
Regarding claim 38, Raj as modified teaches the electronic device of claim 1.
Raj further teaches being a wearable, twistable stretchable, and/or bendable (¶[0030], ¶[0047]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj and Shusterman as applied to claim 1 above, and further in view of Greenberger (U.S. Patent No. 6,028,942) hereinafter referred to as Greenberger.
Regarding claim 3, Raj as modified teaches the electronic device of claim 2.
Raj as modified teaches a wearable patch device with two IMUs for mechano-acoustic monitoring of a subject, but does not teach wherein the data measured by the first IMU and the second IMU are processed such that subtraction of the second signal measured by the second sensor from the second signal measured by the first sensor results in a stronger first signal that is a signal of interest.
Attention is brought to the Greenberger reference, which teaches a first and second mechano-acoustic sensor, in this case accelerometers, where the data from first and second mechano-acoustic sensors are processed such that subtraction of the second signal measured by the second sensor from the second signal measured by the first sensor results in a stronger first signal that is a signal of interest (col. 30, lines 15-34, two sensors are used, and the ambient or noise sensor signal is subtracted from the output of the body sound sensor for the purpose of improving the body sound sensor, col. 30, 62-end improving signal to noise ratio).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj and Shusterman as applied to claim 1 above, and further in view of Li et al. (U.S. Patent Application Publication No. 2015/0035680) hereinafter referred to as Li.
Regarding claim 11, Raj as modified teaches the electronic device of claim 1.
Raj teaches further comprising at least a first thermal sensing unit and a second thermal sensing unit (¶[0058], Fig. 4C, mechano-acoustic sensor accelerometer or IMU, ¶¶[0037-0038], and ¶[0040] accelerometer/IMU incorporates a temperature sensor built in, and ¶[0042]), wherein one of the first and second thermal sensing units is thermally isolated from an ambient environment and configured to measure a body temperature of the living subject (¶[0029] the environment of the wearable device including the skin and/or body temperature).
Raj does not teach the other of the first and second thermal sensing units is configured to measure the ambient temperature.
Attention is brought to the Li reference, which teaches first and second thermal sensing units, where one is configured to measure temperature from a skin surface of a user, and the other is configured to measure ambient temperature (¶¶[0082-0083], ¶[0242]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the temperature sensors of Raj as modified to measure both of skin and ambient temperature, as taught by Li, because the temperature sensor arrangement of Li provides accurate measurement of body temperature (Li, ¶[0200])
Regarding claim 12, Raj as modified teaches the electronic device of claim 11.
Raj further teaches wherein each of the first and second thermal sensing units is embedded in a respective one of the first and second IMUs (¶[0058], Fig. 4C, mechano-acoustic sensor accelerometer or IMU, ¶¶[0037-0038], and ¶[0040] accelerometer/IMU incorporates a temperature sensor built in, and Raj as modified by Shusterman teaches that both temperature sensors comprise an IMU).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raj and Shusterman as applied to claim 1 above, and further in view of Kamen et al. (U.S. Patent Application Publication No. 2012/0238851) hereinafter referred to as Kamen.
Regarding claim 27, Raj as modified teaches the electronic device of claim 26.
Raj does not teach wherein the power module further comprises a failure prevention element including a short-circuit protection component or a circuit to avoid battery malfunction.
Attention is drawn to the Kamen reference, which teaches a wireless charging system and power module for an adhesive patch monitor (¶[0071]), the power module further comprises a failure prevention element including a short-circuit protection component or a circuit to avoid battery malfunction (¶[0397], battery is prevented from unnecessarily drawing current unless it is charging).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the power module of Raj as modified to include a short-circuit prevention, as taught by Kamen, because of the risk associated with an electrical short circuit (Kamen ¶[0397]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2015/0031964 to Bly et al. teaches a decoupling feature for isolation sensors from rigid device components or a rigid environment.
U.S. Patent Application Publication No. 2015/0335288 to Toth et al. teaches subtraction of electrical stretch signals from other electrophysiological signals to improve SNR of a primary signal.
U.S. Patent Application Publication No. 2021/0293616 to Capella et al. teaches subtraction of ambient light signals from a separate light sensor to improve SNR of a primary signal.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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