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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 04/15/2026. As directed by the amendment: claims 1, 3-5, and 10-17 have been amended, claims 2, 6-9, and 18 have been cancelled, and no claims have been added. Claims 68-70 were previously withdrawn due to a Restriction Requirement. Thus, claims 1, 3-5, and 10-17 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 7, filed 04/15/2026, with respect to claim objections have been fully considered and are persuasive. The objection of the claims has been withdrawn.
Applicant's arguments, see page 7, filed 04/15/2026, with respect to 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues that the claim recites an improved display. Examiner notes that the improved display is an additional element for displaying data, which does not integrate the judicial exception into practical application. Therefore, the rejection of record is maintained.
Applicant’s arguments, see page 7, filed 04/15/2026, with respect to 35 U.S.C. 112(a)/(b) have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant’s arguments, see page 7, filed 04/15/2026, with respect to 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Amendments to the claim obviate the rejection of record. The rejection of the claims has been withdrawn. See updated rejection below.
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, 3-5, and 10-17 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to include the limitation, " change an appearance of the at least one display element corresponding to the orientation of a plurality of display elements corresponding to the plurality of orientations responsive to an amount of time the user is in the orientation ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for the changing of an appearance of the display corresponding to the display elements being based on the value of the timer at an orientation of the user ([0091] of PG Pub US 20240049986). However, the specification does not provide support for changing the appearance of the display corresponding to the orientation of the display elements corresponding to the plurality of orientations. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " change an appearance of the at least one display element corresponding to the orientation of a plurality of display elements corresponding to the plurality of orientations responsive to an amount of time the user is in the orientation”. Therefore, the new claim limitations introduce new matter.
Claim 4 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 4 fails to sufficiently describe any “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 “risk” cannot be found in the instant specification in which motion data is used to determine this “risk”. One potential “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 risk. The instant specification fails to disclose any embodiment/species of “risk”, and therefore does not have a representative number of species to claim the genus, as instantly claimed. Therefore, the specification does not provide support for broader limitation of “a risk”, which can encompass any type of risk and not simply a ‘health risk’, as 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, 3-5, and 10-17 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 1, it is unclear how the housing can be “removable secure” to the dock as the terms are opposite traits. It is not possible for the housing to be secure to the dock if it removable. If Applicant is trying to claim that the housing is configured to be removable from the dock, that is different than the condition of the housing being secure to the dock, Examiner suggests making the clarification.
Claim 1 recites the limitation " the orientation of a plurality of display elements" in line 23. There is insufficient antecedent basis for this limitation in the claim. The claim recites the orientation of a user, and not of the display elements.
Regarding claim 1, it is unclear if the “plurality of display elements” of line 23, is the same or different than the “at least one display element” of line 9 and 22.
Claims 3-5 and 10-17 are dependent on rejected claim 1.
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, 3-5, and 10-17 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 at the first time relative to a surface responsive to said one or more motion signals, 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 at the first time relative to a surface responsive to said one or more motion signals”, 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.
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 “(plurality of) display/display element confined a first/second arch and edge” 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”, “(plurality of) orientation(s)”, “motion signals”, “appearance”, “first/amount of time”, 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 “(plurality of) display/display element confined a first/second arch and edge” 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/ user inputs” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “user inputs”, “(plurality of) orientation(s)”, “motion signals”, “appearance”, “first/amount of time”, 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. The housing and dock are generic structure that are well-understood, routine, and conventional, as seen in Chang [0013] (US 20140275836).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 accelerometer is 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 Roovers et al (US 20170007166) teaches an accelerometer for detecting motion signals ([0008]).
Dependent claims 3-5, and 10-17 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 3-5, 12, 16), 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, 3-5, and 10-17 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
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, 3, 5, 10, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 20140275836)(Hereinafter Chang) in view of Banet et al. (US 20200054246)(IDS)(Hereinafter Banet).
Regarding claim 1, Chang teaches A self-contained adhesively and removably attached wearable electronic monitoring device ([0013] “Diaphragm [dock] 120 includes, for example, a diaphragm member of, for example, a hard epoxy with an over-molded silicon flexible surround that may be formed fitted or adhesively connected to sidewalls of enclosure 110. In one embodiment, diaphragm 120 is similar to acoustic diaphragms used in conventional stethoscopes, and is intended to augment the acoustic signals from respiration. The skin contact surface can be adhered to the skin using a vacuum suction mechanism, or by a disposable cover with adhesive hydrogel.” Fig. 4A-B show device 100 on the chest.) comprising:
a dock comprising an adhesive configured to secure the dock to a chest of a user ([0013] “Diaphragm [dock] 120 includes, for example, a diaphragm member of, for example, a hard epoxy with an over-molded silicon flexible surround that may be formed fitted or adhesively connected to sidewalls of enclosure 110. In one embodiment, diaphragm 120 is similar to acoustic diaphragms used in conventional stethoscopes, and is intended to augment the acoustic signals from respiration. The skin contact surface can be adhered to the skin using a vacuum suction mechanism, or by a disposable cover with adhesive hydrogel.” Fig. 4A-B show device 100 on the chest.);
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. 3 shows a top portion with a display, a bottom portion facing downwards, and to the body of a user in Fig. 4A-B, and a controller is inside the housing/enclosure 110, as disclosed in [0014].);
a motion sensor positioned within the interior of the housing, said motion sensor configured to generate one or more signals based on an orientation of the user ([0014] “Disposed within enclosure 110 of device 100 in this embodiment are accelerometer 130, microphone sensor 140, microphone sensor 150, microcontroller unit 140 and button 170. In one embodiment, accelerometer 130 is a tri-axial accelerometer based on the HDK HAAM-372. These accelerometers have the range of .+-.2 g and .+-.8 g, and a digital output that minimizes noise. The accelerometers feature programmable threshold detection, such that a microcontroller unit (MCU) can be put to sleep and awakened by motion triggering…Accelerometer 130 is configured to detect motion, specifically, chest motion during at least one of inspiration and expiration. An algorithm for motion detection based on accelerometer data has been developed and tested.”), wherein the housing is configured to removably secure to the dock ([0013] “Connected to a surface of enclosure 110, surface of intended skin contact, is diaphragm 120. Diaphragm 120 includes, for example, a diaphragm member of, for example, a hard epoxy with an over-molded silicon flexible surround that may be formed fitted or adhesively connected to sidewalls of enclosure 110.” Examiner notes that the adhesive connection provides a secure connection between the housing and dock, that can be ripped apart at a strong enough force, thereby being capable of being removable.);
a display proximate the top portion of the housing, the display including at least one display element configured to display a plurality of orientations of the user over a period of time, wherein the display is confined between a first edge that follows a first arch and a second edge that follows a second arch to create a display region that has an arch shape ([0025] “a display screen such as a liquid crystal display (LCD) or light emitting diode (LED) screen is placed on the top surface of device 100. In addition to the indicator light, display screen 190 can visually display the results of accelerometer and microphone airway sounds, and the interpretation of the sensor inputs listed in Table 1. In one embodiment, MCU 160 can direct screen to display the condition detected by analysis of the sensor data in text form in display screen 190.” See Fig. 3 with the first and second arches with edges connecting the arches for display 190.);
one or more other sensors or user inputs ([0014] “Disposed within enclosure 110 of device 100 in this embodiment are accelerometer 130, microphone sensor 140, microphone sensor 150, microcontroller unit 140 and button 170 [user input].); and
one or more hardware processors positioned within the interior of the housing ([0014] “Disposed within enclosure 110 of device 100 in this embodiment are accelerometer 130, microphone sensor 140, microphone sensor 150, microcontroller unit 140 and button 170.);
wherein the one or more hardware processors are configured to ([0016] “In addition to the sensors (accelerometer and one or more microphones), device 100 also includes microcontroller unit (MCU) 160 for signal processing based on a predetermined algorithm.”).
However, Chang does not teach the motion signal at the first time used to determine the orientation and change an appearance of the at least one display element corresponding to the orientation of a plurality of display elements corresponding to the plurality of orientations responsive to an amount of time the user is in the orientation. Banet, in the same field of endeavor, teaches a wearable device including a motion sensor that collects acceleration data (Abstract), and further teaches
receive said one or more motion signals at a first time ([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 [first time]. 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.”);
determine the orientation of the user at the first time 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 [relative to the surfaces of the attachment].” [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 [first time]. 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.”); and
change an appearance of the at least one display element corresponding to the orientation of a plurality of display elements corresponding to the plurality of orientations responsive to an amount of time the user is in the orientation ([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.” [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 time is the 160 seconds where the plurality of orientation is changed, which changes the appearance of the display based on the alert that is determined. Examiner further notes that the display that includes a plurality of leds (display elements) is oriented on the device.) to alert for a condition to a medical provider ([0139]). 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 Chang, with the motion signal at the first time used to determine the orientation and change an appearance of the at least one display element corresponding to the orientation of a plurality of display elements corresponding to the plurality of orientations responsive to an amount of time the user is in the orientation of Banet, because such a modification would allow to alert for a condition to a medical provider.
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 10, Chang teaches wherein:
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 ([0025] “a display screen such as a liquid crystal display (LCD) or light emitting diode (LED) screen is placed on the top surface of device 100. In addition to the indicator light, display screen 190 can visually display the results of accelerometer and microphone airway sounds, and the interpretation of the sensor inputs listed in Table 1. In one embodiment, MCU 160 can direct screen to display the condition detected by analysis of the sensor data in text form in display screen 190.” See Fig. 3 with the first and second arches with edges connecting the arches for display 190.).
Regarding claim 12, Chang 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”).
Claim(s) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 20140275836)(Hereinafter Chang) in view of Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) and Al-Ali et al. (US 20170055896)(Hereinafter Al-Ali).
Regarding claim 4, claim 1 is obvious over Chang and Banet. Chang in view of Banet do 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 all orientation of a plurality of orientations of the user with respect to the surface (Fig. 11B):
increase a value of a timer associated with a 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 a risk to the user 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 the value of the timer ([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.” Plot 1102B is based on the time value of a timer for each position.) 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 Chang in view 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 (Abstract), the displaying of the change of appearance can be done on the device of Chang. 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.
Regarding claim 11, claim 1 is obvious over Chang and Banet. Chang in view of Banet do not teach said display only illustrates the plurality of orientations of the user over a period of time and does not include any other information. 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 said display only illustrates the plurality of orientations of the user over a period of time and does not include any other information ([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.” Plot 1102B is based on the time value of a timer for each position.) 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 Chang in view of Banet, with said display only illustrates the plurality of orientations of the user over a period of time and does not include any other information of Al-Ali, 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 Chang et al. (US 20140275836)(Hereinafter Chang) in view of Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) and Christensen et al. (US 20110034831)(Hereinafter Christensen).
Regarding claim 15, claim 1 is obvious over Chang and Banet. Chang in view of Banet do 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, Chang in view of Banet do 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 Chang et al. (US 20140275836)(Hereinafter Chang) in view of Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) and Arne et al. (US 20150248833)(IDS)(Hereinafter Arne).
Regarding claim 13, claim 1 is obvious over Chang and Banet. Chang in view of Banet do 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 Chang in view 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, claim 1 is obvious over Chang and Banet. Chang in view of Banet do 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 Chang in view 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 Chang et al. (US 20140275836)(Hereinafter Chang) in view of Banet et al. (US 20200054246)(IDS)(Hereinafter Banet) and Thompson et al. (US 20140206976)(IDS)(Hereinafter Thompson).
Regarding claim 17, claim 1 is obvious over Chang and Banet. Chang in view of Banet do 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 Chang in view 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 Chang et al. (US 20140275836)(Hereinafter Chang) in view of Banet et al. (US 20200054246)(IDS)(Hereinafter Banet), Shi et al. (US 20180028072)(IDS)(Hereinafter Shi), and Christensen et al. (US 20110034831)(Hereinafter Christensen).
Regarding claim 16, claim 1 is obvious over Chang and Banet. Chang in view of Banet do 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 Chang in view 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, Chang in view of Banet and 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 Chang in view of Banet and Shi, 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 Chang in view of Banet, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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