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 without traverse of species a (claim 18) in the reply filed on 10/15/2025 is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/15/2025.
Claims 1-18 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/12/2024, 03/12/2024, 03/12/2024, 07/11/2024, 07/11/2024, 10/09/2024, 04/18/2025, and 04/18/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2-18 are objected to because of the following informalities: the phrase “The device of Claim X” should remain in lowercase letters and should recite “The device of claim X”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. For some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP 2163 (II)(2).
A "representative number of species" means that the species which are adequately described are representative of the entire genus. See MPEP 2163(III)(a)(ii).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand inventor to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species). See MPEP 2163(III)(a)(ii).
Claim 1 fails to sufficiently describe any “health risk” of a subject in enough detail for one skilled in the art to have possession of the broadly claimed genus. Although the term “health risk” is used in the instant specification, the instant specification fails to define the health risk and what risk may be encompassed. The instant specification also fails to encompass any health risk to ever exist. For example, health risks like atrial fibrillation (or any arrhythmia), high blood pressure/hypertension, pneumonia, heart failure, glaucoma, and many others are not contemplated in the instant specification. Such a generic recitation of “health risk” cannot be found in the instant specification in which motion data is used to determine this “health risk”. One potential “health risk” that the instant specification nominally describes is the risk of fall, which would be incorporated by reference to U.S. Pat Pub. No. US2021/0330200 (see [0008] of the instant specification). Similar to Lizardtech, there is no evidence that the specification contemplated a more generic processing step of determining an amount of health risk. The instant specification fails to disclose any embodiment/species of “health risk”, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, claims 1-18 do not provide sufficient detail for a person skilled in the art to have been in possession of the invention as broadly claimed.
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 1-18 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.
Claim 1 recites the limitation "said one or more motion signals" in lines 13-15. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “said one or more signals” in line 13 or “one or more motion signals” in line 7 to fall in line with the scope and the specification.
Regarding claim 1, it is unclear if the “interior of the housing” of line 6, is the same “interior” of the “housing” of line 3. Both phrases are modified by the article “an” thus implying two separate and distinct interiors.
Regarding claim 1, the phrase “determine the amount of health risk responsive to the orientation of the user” is unclear if the limitation is referring to the determining of an amount of health risk or the amount contribution of orientation that is contributes to the health risk. Examiner will interpret the phrase to mean that the amount is referring to the orientation, and how much influence/amount of influence that orientation has on health risk.
Regarding claims 4 and 5, it is unclear how there are multiple orientations (see the phrase “each respective orientation” in line 3 of claim 4) when claim 1 recites only 1 orientation.
Claim 4 recites the limitation "the respective orientation" in lines 5-9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 4, 6, and 12, it is unclear how there are multiple display elements (see the phrase “a plurality of display elements” in line 11 of claim 4) when claim 1 recites at least 1 display element.
Regarding claim 6, it is unclear “the appearance” is the appearance of claims 1 or 4.
Regarding claim 7, it is unclear how a plurality of orientations can be “between” the first and second orientation including the third. Specifically, it is unclear how multiple orientations can be between the first and second, and how the third orientation is tied into what is included in the “between”. Further, the phrase “said plurality of orientations further comprises a plurality of orientations” is redundant and does not make sense as to why the phrase is repeated. Is the “plurality of orientations” the same or different than “said plurality of orientations” or the “orientation” of claim 1?
Claim 9 recites the limitation "said factors" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests to amend to recite “said plurality of factors” in line 13 or “one or more motion signals” in line 7 to fall in line with the scope and the specification.
Claim 18 recites the limitation "said one or more signals" in lines 4-5 which is unclear whether the signals are referring to the motion signals of claim 1 or the ECG signals of claim 18.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claim 1recites a step determine the orientation of the user relative to a surface responsive to said one or more motion signals and determine the amount of health risk responsive to the orientation of the user, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. A hardware processor), determine orientation, and determining health risk do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and determine a health risk, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claim 1, the following step is an abstract idea:
“determine the orientation of the user relative to a surface responsive to said one or more motion signals and determine the amount of health risk responsive to the orientation of the user”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze the orientation of a user from the signals and determine a health risk based on the orientation.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 1, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a hardware processor” and “display/display element” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “motion sensor” and “other sensors” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “user inputs”, “orientation”, “motion signals”, “appearance”, and “health risk” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a hardware processor” and “display/display element” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “motion sensor” and “other sensors” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “user inputs”, “orientation”, “motion signals”, “appearance”, and “health risk” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claim 1, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, hardware processor, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor, EKG sensor, pulse oximeter sensor, temperature sensor, blood pressure sensor, accelerometer, or heart sound sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]), Boppart (US 20090306489) teaches the use of a pulse oximetry sensor to measure oxygen saturation ([0011]), Shin et al (US 20060253041) teaches a blood pressure sensor for measuring blood pressure ([0011]-[0012]), Roovers et al (US 20170007166) teaches an accelerometer for detecting motion signals ([0008]), and Gopinathan et al (US 20210338190) teaches a heart sound sensor for detecting heart sounds ([0196]-[0198]).
Dependent claims 2-18 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1. The dependent claim limitations are directed to extra-solution activity (claims 2-9, 12, 15), generic computing structure (claim 10-11, 13-15, and 17), and to generic gathering structure (claims 16 and 18), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-18 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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) 1-3, 5, 7-11, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Banet et al. (US 20200054246)(IDS)(Hereinafter Banet).
Regarding claim 1, Banet teaches A self-contained adhesively and removably attached wearable electronic monitoring device ([0142] “a wrist-worn transceiver 72, described in more detail in FIG. 5, featuring a touch panel interface 73 that displays RR and other vital signs.” Examiner notes that Fig. 5 is a worn device and must be adhesively contained to be kept together.) comprising:
a housing comprising an interior, a top portion, and a bottom portion, said bottom portion configured to face toward a user during monitoring of one or more physiological parameters of the user (Fig. 5 shows a top portion with a display, a back portion, and a PCB is inside the housing, as disclosed in [0142].);
a motion sensor positioned within an interior of the housing, said motion sensor configured to generate one or more signals based on an orientation of the user ([0142] “The first accelerometer is surface-mounted on a circuit board [interior housing] in the wrist-worn transceiver 72 and measures signals associated with movement of the patient's wrist.”);
a display proximate the top portion of the housing, the display including at least one display element responsive to an amount of health risk associated with the orientation of the user ([0142] “a touch panel interface 73 that displays RR and other vital signs” [0146] “the GUI 73 displays vital sign data and other medical diagnostic information appropriate for medical professionals.”);
one or more other sensors or user inputs ([0142] “The third accelerometer is mounted in the sensor module 74 that connects through cables 80a-c to ECG electrodes 78a-c.”); and
one or more hardware processors positioned within the interior of the housing ([0019] “The processing system is typically worn on the patient's wrist.”);
wherein the one or more hardware processors are configured to (Abstract “The processing system receives the IP and motion signals, and processes them to determine, respectfully, frequency-domain IP and motion spectra. Both spectra are then collectively processed to remove motion components from the IP spectrum and determine RR.”):
receive said one or more motion signals ([0130] “a patient's posture can influence how the above-described system generates alarms/alerts from RR, cNIBP, and other vital signs. For example, the alarms/alerts related to both RR and cNIBP may vary depending on whether the patient is lying down or standing up. FIG. 29 indicates how the body-worn monitor can determine motion-related parameters (e.g. degree of motion, posture, and activity level) from a patient 410 using time-dependent ACC waveforms continuously generated from the three accelerometers 412, 413, 414 worn, respectively, on the patient's chest, bicep, and wrist.”);
determine the orientation of the user relative to a surface responsive to said one or more motion signals ([0130] “a patient's posture can influence how the above-described system generates alarms/alerts from RR, cNIBP, and other vital signs. For example, the alarms/alerts related to both RR and cNIBP may vary depending on whether the patient is lying down or standing up. FIG. 29 indicates how the body-worn monitor can determine motion-related parameters (e.g. degree of motion, posture, and activity level) from a patient 410 using time-dependent ACC waveforms continuously generated from the three accelerometers 412, 413, 414 worn, respectively, on the patient's chest, bicep, and wrist.”);
determine the amount of health risk responsive to the orientation of the user ([0130] “a patient's posture can influence how the above-described system generates alarms/alerts from RR, cNIBP, and other vital signs. For example, the alarms/alerts related to both RR and cNIBP may vary depending on whether the patient is lying down or standing up. FIG. 29 indicates how the body-worn monitor can determine motion-related parameters (e.g. degree of motion, posture, and activity level) from a patient 410 using time-dependent ACC waveforms continuously generated from the three accelerometers 412, 413, 414 worn, respectively, on the patient's chest, bicep, and wrist.” [0139] “For this study the patient rapidly alternated between standing, lying on their back, chest, right side, and left side within a time period of about 160 seconds. As described above, different alarm/alert conditions (e.g. threshold values) for vital signs can be assigned to each of these postures, or the specific posture itself may result in an alarm/alert.” Examiner notes that the amount is referring to the orientation, and how much influence/amount of influence that orientation has on health risk. In the instant case, the time frame of 160 seconds is the amount of time is used for alarms for conditions.); and
change an appearance of the at least one display element responsive to the health risk ([0094] “the waveforms are fully processed on the remote server with adaptive filtering, and values of RR are transmitted back to the wrist-worn transceiver. In both cases, once received, the values of RR are displayed and availed for any follow-on alarming/alerting applications.” An alarm and alert changes the display while also alerting a health risk; specifically, the change of appearance that Examiner is noting is the changes in numbers/values of the RR values which shows a health risk due to the alarm going off.).
Regarding claim 2, Banet teaches wherein said health risk is at least partially dependent upon an amount of time the user is in the orientation (Fig. 30B).
Regarding claim 3, Banet teaches wherein said amount of time is not consecutive (Fig, 30B).
Regarding claim 5, Banet teaches wherein:
a first one of said plurality of orientations is associated with a left side orientation of the user with respect to the surface (Fig. 30B(4));
a second one of said plurality of orientations is associated with a right side orientation of the user with respect to the surface (Fig. 30B(3)); and
a third one of said plurality of orientations is associated with a supine orientation of the user with respect to the surface (Fig. 30B(1)).
Regarding claim 7, Banet teaches wherein said plurality of orientations further comprises a plurality of orientations between said first one and said second one of said plurality of orientations including said third one (Examiner notes that the “standing upright” and “lying on chest” is a plurality of other orientations, found in Fig. 30B.).
Regarding claim 8, Banet teaches wherein said health risk is associated with a combination of a plurality of factors ([0145] “Heart rate and RR are determined directly from the ECG waveform using known algorithms, such as those described above. More sophisticated ECG circuits (e.g. five and twelve-lead systems) can plug into the wrist-worn transceiver to replace the three-lead system shown in FIGS. 4A and 4B.” The algorithm and ECG waveform [plurality of factors], are used alongside the ACC to determine RR during abnormality.).
Regarding claim 9, Banet teaches wherein at least one of said factors is a physiological parameter of the user ([0145] “Heart rate and RR are determined directly from the ECG waveform [physiological parameter] using known algorithms, such as those described above. More sophisticated ECG circuits (e.g. five and twelve-lead systems) can plug into the wrist-worn transceiver to replace the three-lead system shown in FIGS. 4A and 4B.”).
Regarding claim 10, Banet teaches wherein said display comprises an arch shape (
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).
Regarding claim 11, Banet teaches wherein:
said display comprises a border having at least a first edge and a second edge (
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); and
each of said plurality of display elements of the display comprises a line or a region extending between the first and second edges of the border (
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).
Regarding claim 18, Banet teaches further comprising a plurality of cables and corresponding external ECG electrodes, said external ECG electrodes configured to attach to the user and output one or more signals responsive to the user's cardiac electrical activity ([0018] “an ECG circuit (corresponding to a three, five, or twelve-lead ECG) for measuring an ECG waveform. In embodiments, the sensor module simply rests on the patient's chest during a measurement, or can be connected with a small piece of medical tape. Alternatively, the housing features a connector that connects directly to an ECG electrode worn on the patient's torso.”);
wherein the one or more hardware processors are further configured to:
receive said one or more signals from said external ECG electrodes responsive to the user's cardiac electrical activity ([0067] “This component typically includes a differential amplifier and a series of analog filters with passbands that pass the high and low-frequency components that contribute to the ECG waveform, but filter out components associated with electrical and mechanical noise.”); and
determine an ECG of the user responsive to said one or more signals ([0067] “Typically the analog filters in the IP circuit 27 are chosen to filter out high-frequency components that contribute to the ECG QRS complex.”).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) in view of Chang et al. (US 20140275836)(Hereinafter Chang) and Al-Ali et al. (US 20170055896)(Hereinafter Al-Ali).
Regarding claim 4, Banet teaches the invention of claim 1 Banet does not teach one or more hardware processors are further configured to: for each respective orientation of a plurality of orientations of the user with respect to the surface: increase a value of a timer associated with the respective orientation when the user is in the respective orientation; decrease the value of the timer when the user is not in the respective orientation; determine the amount of health risk for the respective orientation based at least in part on the value of the timer; and for each respective one of a plurality of display elements of the display: change an appearance of the respective one of the plurality of display elements based at least in part on the health risk associated with one of said plurality of orientations. Al-Ali, in the same field of endeavor, teaches wireless adhesive wearable sensor for the measures orientation of a user and displaying data (Abstract), and further teaches wherein the one or more hardware processors are further configured to:
for each respective orientation of a plurality of orientations of the user with respect to the surface (Fig. 11B):
increase a value of a timer associated with the respective orientation when the user is in the respective orientation (See Fig. 11B where the value of the timer for each position increases during each respective orientation.);
decrease the value of the timer when the user is not in the respective orientation (Fig. 11B where position 2 decreases when the position 2 is changed to position 3 for a brief time period.);
determine the amount of health risk for the respective orientation based at least in part on the value of the timer (Fig. 11B where the position 2 orientation crosses the 3 hour mark for an alarm to be produced. [0136] “Once the total time spent in a position, taking into account the patient's growth and decay rates, reaches the threshold time (e.g. 3 hours in this example), an alarm can alert the caregiver.”); and
for each respective one of a plurality of display elements of the display ([0158] “the plot 1102B may be part of a display to a caregiver on a bedside monitor, a multi-room monitor, both, or the like. The plot can be updated in real time, at predefined intervals, and/or manually.”):
change an appearance of the respective one of the plurality of display elements based at least in part on the health risk associated with one of said plurality of orientations ([0158] “the plot 1102B may be part of a display to a caregiver on a bedside monitor, a multi-room monitor, both, or the like. The plot can be updated in real time, at predefined intervals, and/or manually. In other embodiments, the paradigm may be illustrative of the signal processing performed by a signal processor to determine when to activate an alarm informing a caregiver of the potential of a pressure ulcer if a patient is not repositioned.”) to monitor the condition of a user ([0158]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the one or more hardware processors are further configured to: for each respective orientation of a plurality of orientations of the user with respect to the surface: increase a value of a timer associated with the respective orientation when the user is in the respective orientation; decrease the value of the timer when the user is not in the respective orientation; determine the amount of health risk for the respective orientation based at least in part on the value of the timer; and for each respective one of a plurality of display elements of the display: change an appearance of the respective one of the plurality of display elements based at least in part on the health risk associated with one of said plurality of orientations of Al-Ali, because such a modification would allow to monitor the condition of a user.
However, Al-Ali does not teach the display on the wearable device. Although Al-Ali discloses the display as a paired device (), the displaying of the change of appearance can be done on the device of Banet. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to display the change of appearance on the wearable device of Banet, for the purpose of monitoring a user, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 6 and 12, is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) in view of Chang et al. (US 20140275836)(Hereinafter Chang).
Regarding claim 6, Banet teaches the invention of claim 1. Banet does not teach cause the appearance of the respective one of the plurality of display elements to have a first color when the health risk is greater than or equal to a threshold and cause the appearance of the respective one of the plurality of portions to have a second color when the health risk is below the threshold, said second color being different than said first color. Chang, in the same field of endeavor, teaches wireless adhesive wearable sensor for data transfer (Abstract), and further teaches wherein, for each respective one of the plurality of display elements of the display, the one or more hardware processors are further configured to:
cause the appearance of the respective one of the plurality of display elements to have a first color when the health risk is greater than or equal to a threshold ([0023] “If the sensors indicate three respiratory cycles of chest movements and corresponding inspiratory/expiratory breath sounds, MCU 160 directs indicator 180 on device 100 to illuminate a solid green color indicating successful intubation (block 265).” The threshold is 3 respiratory cycles.); and
cause the appearance of the respective one of the plurality of portions to have a second color when the health risk is below the threshold, said second color being different than said first color ([0023] “MCU 160 simultaneously assesses the chest movement and air movement sounds (bronchial breath sounds) provided by the sensor data. If both are absent, MCU 160 directs indicator 180 on device 100 to flash red at a rate of one flash per second (block 240).” Anything other than 3 respiratory cycles [threshold] yield a red indicator.) to monitor the condition of a user ([0024]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the cause the appearance of the respective one of the plurality of display elements to have a first color when the health risk is greater than or equal to a threshold and cause the appearance of the respective one of the plurality of portions to have a second color when the health risk is below the threshold, said second color being different than said first color of Chang, because such a modification would allow to monitor the condition of a user.
Regarding claim 12, Banet teaches the invention of claim 1. Banet does not teach said display only illustrates said health risk and does not include any other information. Chang, in the same field of endeavor, teaches wireless adhesive wearable sensor for data transfer (Abstract), and further teaches wherein said display only illustrates said health risk and does not include any other information ([0024] “MCU 160 analyzes for conditions of right main stem intubation, esophageal intubation, blocked endotracheal tube, pneumothorax, or chest movement artifacts (e.g., chest movement associated with an extraneous action such as chest compressions) (block 275). If any of the conditions are detected, MCU 160 directs indicator 180 to illuminate an indicator light of red”) to monitor the condition of a user ([0024]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the said display only illustrates said health risk and does not include any other information of Chang, because such a modification would allow to monitor the condition of a user.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) in view of Chang et al. (US 20140275836)(Hereinafter Chang) and Christensen et al. (US 20110034831)(Hereinafter Christensen).
Regarding claim 15, Banet teaches the invention of claim 1. However, Banet does not teach the bottom portion of the housing comprises a first opening; the device further comprises: a diaphragm operably positioned proximate said first opening in said bottom portion, wherein, during monitoring, at least a portion of said diaphragm is configured to vibrate responsive to at least one of cardiac activity and lung activity of the user; a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device; and the one or more other sensors or user inputs comprise an audio transducer positioned within the interior of the housing and responsive to vibration of said diaphragm to output one or more transducer signals; wherein the one or more hardware processors are further configured to: receive said one or more transducer signals; determine at least one of a cardiac measurement and a lung measurement responsive to said one or more transducer signals; and wirelessly output to the separate device through the communication module data indicative of determined parameters of the user. Chang, in the same field of endeavor, teaches wireless adhesive wearable sensor for data transfer (Abstract), and further teaches wherein:
the device further comprises:
a diaphragm operably positioned proximate said first opening in said bottom portion, wherein, during monitoring, at least a portion of said diaphragm is configured to vibrate responsive to at least one of cardiac activity and lung activity of the user ([0015] “microphone sensor 140 is placed in the center of enclosure 110 corresponding to (e.g., sensor facing) the skin contact surface of the device with acoustic diaphragm 120 to augment the respiratory sound.”);
a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device ([0017] “wireless transmitter, based on radiofrequency such as Bluetooth 4.0 protocol, is installed for transmission of chest rise and sound signals to a remote receiver.”); and
the one or more other sensors or user inputs comprise an audio transducer positioned within the interior of the housing and responsive to vibration of said diaphragm to output one or more transducer signals ([0015] “microphone sensor 140 is placed in the center of enclosure 110 corresponding to (e.g., sensor facing) the skin contact surface of the device with acoustic diaphragm 120 to augment the respiratory sound.”);
wherein the one or more hardware processors are further configured to:
receive said one or more transducer signals ([0023] “MCU 160 simultaneously assesses the chest movement and air movement sounds (bronchial breath sounds) provided by the sensor data.”);
determine at least one of a cardiac measurement and a lung measurement responsive to said one or more transducer signals ([0023] “MCU 160 simultaneously assesses the chest movement and air movement sounds (bronchial breath sounds) provided by the sensor data.”); and
wirelessly output to the separate device through the communication module data indicative of determined parameters of the user ([0017] “wireless transmitter, based on radiofrequency such as Bluetooth 4.0 protocol, is installed for transmission of chest rise and sound signals to a remote receiver.”) to analyze inhalation and exhalation ([0023]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the bottom portion of the housing comprises a first opening; the device further comprises: a diaphragm operably positioned proximate said first opening in said bottom portion, wherein, during monitoring, at least a portion of said diaphragm is configured to vibrate responsive to at least one of cardiac activity and lung activity of the user; a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device; and the one or more other sensors or user inputs comprise an audio transducer positioned within the interior of the housing and responsive to vibration of said diaphragm to output one or more transducer signals; wherein the one or more hardware processors are further configured to: receive said one or more transducer signals; determine at least one of a cardiac measurement and a lung measurement responsive to said one or more transducer signals; and wirelessly output to the separate device through the communication module data indicative of determined parameters of the user of Chang, because such a modification would allow to analyze inhalation and exhalation.
However, Banet in view of Chang does not teach the bottom portion of the housing comprises a first opening. Christensen, in the same field of endeavor, teaches wireless adhesive wearable sensor for data transfer (Abstract), and further teaches the bottom portion of the housing comprises a first opening ([0035] “The opening 8 is large enough for the lead to pass through, but small enough to ensure a snug fit, such that excessive noise does not pass through the hole to interfere with the recordings made by the microphone 5.”) to avoid excessing noise ([0035]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet in view of Chang, with the bottom portion of the housing comprises a first opening of Christensen, because such a modification would allow to avoid excessing noise.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) in view of Arne et al. (US 20150248833)(IDS)(Hereinafter Arne).
Regarding claim 13, Banet teaches the invention of claim 1. However, Banet does not teach the device comprises a first portion configured to be attached to the user and a second portion configured to removably secure to the first portion, the second portion comprising said housing. Arne, in the same field of endeavor, teaches wireless wearable sensor for data transfer (Abstract), and further teaches wherein the device comprises a first portion configured to be attached to the user and a second portion configured to removably secure to the first portion, the second portion comprising said housing (Fig. 6 where the first portion includes flex circuit 103 that is attached to the user via adhesive 107 and PCB, and the second portion being housing 102.) to maintain a compact and small design ([0032]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the device comprises a first portion configured to be attached to the user and a second portion configured to removably secure to the first portion, the second portion comprising said housing of Arne, because such a modification would allow to maintain a compact and small design.
Regarding claim 14, Banet teaches the invention of claim 1. However, Banet does not teach the first portion comprises a frame and a substrate coupled to the frame, the substrate configured to be attached to the user. Arne, in the same field of endeavor, teaches wireless wearable sensor for data transfer (Abstract), and further teaches wherein the first portion comprises a frame and a substrate coupled to the frame, the substrate configured to be attached to the user (Fig. 6 where the first portion includes flex circuit 103 that is attached to the user via adhesive 107 and PCB [The PCB 118 acts as a frame in Figs. 8 and 9 that is touching the housing], and the second portion being housing 102.) to maintain a compact and small design ([0032]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the first portion comprises a frame and a substrate coupled to the frame, the substrate configured to be attached to the user of Arne, because such a modification would allow to maintain a compact and small design.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) in view of Thompson et al. (US 20140206976)(IDS)(Hereinafter Thompson).
Regarding claim 17, Banet teaches the invention of claim 1. However, Banet does not teach the one or more other sensors or user inputs comprise: a user input proximate the top portion of the housing; and wherein the device further comprises: a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device; wherein the one or more hardware processors are further configured to: receive one or more user input signals responsive to said user input; and wirelessly output to the separate device through the communication module one or more communication signals based on said received one or more user input signals. Thompson, in the same field of endeavor, teaches a skin wearable device that transmits communication between devices (Abstract), and further teaches wherein the one or more other sensors or user inputs comprise:
a user input proximate the top portion of the housing (Fig. 4(108)); and
wherein the device further comprises:
a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device ([0085] “The default settings also may be modified such that the subject 602 can transmit and record meaningful inputs and messages to the body associated device 604 by communicating a simple language of finger taps, jiggles, scratches or other physical inputs initiated by the subject 602. In one aspect, the living subject 602 can communicate with the body associated device 604 through the pushbutton switch 108 (FIG. 1), which activates the switch 140 (FIG. 17). Through the body associated device 604 communications architecture, e.g., a Bluetooth or other communication links, to other devices beyond the body, the composite set of sensed physiology, tactile inputs, and outputs can be transmitted to other individuals, groups, caregivers, and related products, e.g., online games, of the subject's 602 choosing via the external local node 606, network 608, and/or the remote node 610.”);
wherein the one or more hardware processors are further configured to:
receive one or more user input signals responsive to said user input ([0085] “The default settings also may be modified such that the subject 602 can transmit and record meaningful inputs and messages to the body associated device 604 by communicating a simple language of finger taps, jiggles, scratches or other physical inputs initiated by the subject 602. In one aspect, the living subject 602 can communicate with the body associated device 604 through the pushbutton switch 108 (FIG. 1), which activates the switch 140 (FIG. 17). Through the body associated device 604 communications architecture, e.g., a Bluetooth or other communication links, to other devices beyond the body, the composite set of sensed physiology, tactile inputs, and outputs can be transmitted to other individuals, groups, caregivers, and related products, e.g., online games, of the subject's 602 choosing via the external local node 606, network 608, and/or the remote node 610.”); and
wirelessly output to the separate device through the communication module one or more communication signals based on said received one or more user input signals ([0085] “The default settings also may be modified such that the subject 602 can transmit and record meaningful inputs and messages to the body associated device 604 by communicating a simple language of finger taps, jiggles, scratches or other physical inputs initiated by the subject 602. In one aspect, the living subject 602 can communicate with the body associated device 604 through the pushbutton switch 108 (FIG. 1), which activates the switch 140 (FIG. 17). Through the body associated device 604 communications architecture, e.g., a Bluetooth or other communication links, to other devices beyond the body, the composite set of sensed physiology, tactile inputs, and outputs can be transmitted to other individuals, groups, caregivers, and related products, e.g., online games, of the subject's 602 choosing via the external local node 606, network 608, and/or the remote node 610.”) to communicate information to healthcare provides for a proper action to be taken ([0076]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the one or more other sensors or user inputs comprise: a user input proximate the top portion of the housing; and wherein the device further comprises: a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device; wherein the one or more hardware processors are further configured to: receive one or more user input signals responsive to said user input; and wirelessly output to the separate device through the communication module one or more communication signals based on said received one or more user input signals of Thompson, because such a modification would allow to communicate information to healthcare provides for a proper action to be taken.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) in view of Shi et al. (US 20180028072)(IDS)(Hereinafter Shi) and Christensen et al. (US 20110034831)(Hereinafter Christensen).
Regarding claim 16, Banet teaches the invention of claim 1. However, Banet does not teach one or more other sensors or user inputs comprise: a first temperature sensor and a second temperature sensor positioned within the interior of the housing, each of said first and second temperature sensors configured to generate one or more first temperature signals responsive to detected thermal energy, said first temperature sensor operably positioned to be closer to the user during monitoring than the second temperature sensor; and a third temperature sensor and a fourth temperature sensor positioned within the interior of the housing, each of said third and fourth temperature sensors configured to generate one or more second temperature signals responsive to detected thermal energy, said third temperature sensor operably positioned to be closer to the user during monitoring than the fourth temperature sensor; wherein the device further comprises: a thermally conductive element comprising a portion positioned between the third and fourth temperature sensors; a first thermally conductive probe proximate the second opening of the housing and substantially aligned with the first temperature sensor; a second thermally conductive probe proximate the third opening of the housing and substantially aligned with the third temperature sensor; a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device; wherein the one or more hardware processors are further configured to: receive said first and second temperature signals; determine an indication of body temperature responsive to said first and second temperature signals; and wirelessly output to the separate device through the communication module the determined indication of body temperature. Shi, in the same field of endeavor, teaches a skin wearable device (Abstract) that can collect physiological parameters ([0005]), and further teaches wherein the one or more other sensors or user inputs comprise:
a first temperature sensor and a second temperature sensor positioned within the interior of the housing, each of said first and second temperature sensors configured to generate one or more first temperature signals responsive to detected thermal energy, said first temperature sensor operably positioned to be closer to the user during monitoring than the second temperature sensor (Fig. 11B(1055A-B) Where 1055B is closer to the user.);
and a third temperature sensor and a fourth temperature sensor positioned within the interior of the housing, each of said third and fourth temperature sensors configured to generate one or more second temperature signals responsive to detected thermal energy, said third temperature sensor operably positioned to be closer to the user during monitoring than the fourth temperature sensor (Fig. 11B(1055C-D) Where 1055D is closer to the user.);
wherein the device further comprises:
a thermally conductive element comprising a portion positioned between the third and fourth temperature sensors (Fig. 11B(1052B));
a first thermally conductive probe proximate the second opening of the housing and substantially aligned with the first temperature sensor (Fig. 11B(1070));
a second thermally conductive probe proximate the third opening of the housing and substantially aligned with the third temperature sensor (Fig. 11B(1070));
a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device ([0081] “the semiconductor chip 1025 processes the electric signal and outputs an electrical signal which enables the antenna 1026 to transmit a wireless signal carrying the measurement data to another external device such as a mobile phone or a computer.”);
wherein the one or more hardware processors are further configured to:
receive said first and second temperature signals ([0019] “wherein the antenna can wirelessly send temperatures measured by the one or more temperature sensors or calculated temperature values to an external device.”);
determine an indication of body temperature responsive to said first and second temperature signals ([0019] “wherein the antenna can wirelessly send temperatures measured by the one or more temperature sensors or calculated temperature values to an external device.”); and
wirelessly output to the separate device through the communication module the determined indication of body temperature ([0081] “the semiconductor chip 1025 processes the electric signal and outputs an electrical signal which enables the antenna 1026 to transmit a wireless signal carrying the measurement data to another external device such as a mobile phone or a computer.”) to effectively exchange heat with the human tissue ([0076]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet, with the one or more other sensors or user inputs comprise: a first temperature sensor and a second temperature sensor positioned within the interior of the housing, each of said first and second temperature sensors configured to generate one or more first temperature signals responsive to detected thermal energy, said first temperature sensor operably positioned to be closer to the user during monitoring than the second temperature sensor; and a third temperature sensor and a fourth temperature sensor positioned within the interior of the housing, each of said third and fourth temperature sensors configured to generate one or more second temperature signals responsive to detected thermal energy, said third temperature sensor operably positioned to be closer to the user during monitoring than the fourth temperature sensor; wherein the device further comprises a thermally conductive element comprising a portion positioned between the third and fourth temperature sensors; a first thermally conductive probe proximate the second opening of the housing and substantially aligned with the first temperature sensor; a second thermally conductive probe proximate the third opening of the housing and substantially aligned with the third temperature sensor; a communication module positioned within the interior of the housing and configured to allow the device to wirelessly communicate with a separate device; wherein the one or more hardware processors are further configured to: receive said first and second temperature signals; determine an indication of body temperature responsive to said first and second temperature signals; and wirelessly output to the separate device through the communication module the determined indication of body temperature of Shi, because such a modification would allow to effectively exchange heat with the human tissue.
However, Banet in view of Shi does not teach the second and a third opening in said bottom portion of the housing. Christensen, in the same field of endeavor, teaches wireless adhesive wearable sensor for data transfer (Abstract), and further teaches a second and a third opening in said bottom portion of the housing ([0035] “The opening 8 is large enough for the lead to pass through, but small enough to ensure a snug fit, such that excessive noise does not pass through the hole to interfere with the recordings made by the microphone 5.”) to avoid excessing noise ([0035]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Banet in view of Chang, with the second and a third opening in said bottom portion of the housing of Christensen, because such a modification would allow to avoid excessing noise.
Although Banet in view of Shi and Christensen teaches a hole, Christensen does not teach a plurality of holes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a plurality of holes, for the purpose of allowing for a wires to go through the device, since It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796