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 Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection adding the reference to Connor(US 20150366504) sited by applicant which teaches using subsets of sensor arrays to measure specific and localized areas of the user’s body during activity to obtain more efficient physiologic measurements of localized areas and to better handle if a subset of sensors malfunctions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romem(WO 2012176193) hereinafter Romem(6193) in view of Romem(WO 2015056262) hereinafter Romem(6262) and further in view of Connor( US 20150366504) hereinafter Connor.
Romem(6193) teaches a seamless, substantially continuous, independent and wearable health monitoring and self-alert system, configured for use by a living being on a daily basis, including by a healthy living being. The wearable health monitoring and self-alert system includes a garment worn by the living being adjacently to preconfigured portions of the body of the living being. The system further includes a garment-control device that includes a garment-processor and a battery. The system further includes multiple sensing devices selected from the group consisting of sensors and electrodes. At least one of the sensing devices is embedded into the garment, wherein each of the sensing devices is configured to detect a predetermined physiological or chemical parameter of the living being. The terms "underwear" or "garment", as used herein with conjunction with wearable clothing items, refers to seamless wearable clothing items that preferably, can be tightly worn adjacently to the body of a monitored living being, typically adjacently to the skin, including undershirts, brassiere, underpants, socks and the like. Typically, the terms "underwear" or "garment" refer to a clothing item that is worn adjacently to the external surface of the user's body, under external clothing or as the only clothing, in such way that the fact that there are sensors embedded therein and/or integrated therein, is not seen by any other person in regular daily behavior. An underwear item may also include a clothing item that is not underwear per se, but still is in direct and preferably tight contact with the skin, such as a T-shirt, sleeveless or sleeved shirts, sport-bra, tights, dancing-wear, and pants. The sensors, in such a case, can be embedded in such a way that are still unseen by external people to comply with the "seamless" requirement. The term "tightly" means that specific portions of the garment where there are electrodes or other sensors that require certain pressure on the body to obtain a satisfactory signal, are designed to be as tight as needed. However, all the other parts of the garment may be not as tight. Optionally, there is a provision to facilitate tightening or releasing certain portions of the garment, by built-in straps or other tightening means, so that the need for more or less tightness does not require the replacement of the whole garment. Notes pages 3-4.
Regarding claims 1, 10 and 18, Romem(6193) teaches wearable sensing garment to be worn on the body by the user in situ, the wearable sensing garment including: a plurality of bioimpedance sensors disposed on the wearable sensing garment wherein each bioimpedance sensor: is located at a unique spatial location on the garment and is configured to contact a body of the user that corresponds to the unique spatial location of the associated bioimpedance sensor, and in operation, measures bioimpedance data at the unique spatial location of the associated bioimpedance sensor; and
a circuitry module physically coupled to the body of the user and
configured to be communicatively coupled to the plurality of bioimpedance sensors, wherein the circuitry module includes: communication circuitry, coupled to the processor, to receive the
measured bioimpedance data from the plurality of bioimpedance sensors, a processor configured, in operation, to process the measured bioimpedance data to determine the fluid state of the body of the user, or a change therein, and a battery to power the circuitry module; and
wherein, in operation, the plurality of bioimpedance sensors are configured to transmit the measured bioimpedance data to the circuitry module. Note Figure 1, page 7, lines 3-12, “The wearable health monitoring and self-alert system includes a garment worn by the living being adjacently to preconfigured portions of the body(unique spatial locations) of the living being. The system further includes a garment-control device that includes a garment- processor and a battery. Optionally, the garment-processor and the battery are operatively disposed in a designated pocket in the monitoring-garment, wherein the garment-processor and the battery are removably connected to a respective designated button.” , page 18, lines 9-25, “Preferably, also embedded into garment-body 102 of monitoring-garment 100 are wires interconnecting some of the sensors (e.g. between couples of impedance sensors 150). Also embedded into garment-body 102 of undershirt 100 are wires connecting all of the sensors (120, 130, 140, 150 and 160). Optionally, also embedded in the monitoring-garment, are wires interconnecting some of the sensors (e.g. between couples of impedance sensors 150). Reference is also made to Fig. 2b, a detailed view illustration of a window A, as shown in Fig. 2a; and to Fig.3, a schematic block diagram of one embodiment of garment-control device 110. Also embedded into garment-body 102 of undershirt 100 is garment-control device 110, wherein wires 115 interconnect all of the sensors (120, 130, 140, 150 and 160) (Circuitry coupling the sensors) to garment-control device 110, preferably by wires 115 knitted into monitoring-garment 100. Garment-control device 110 includes a garment-processor 112 and a preferably rechargeable battery 180, wherein garment-processor 112 and battery 180 are preferably removable. Preferably, garment-control device 110 further includes a transmitter 114, typically short range transmitter(communication circuitry) such as Bluetooth, facilitating wireless communication between garment-processor 112 and remote-processor 510 of mobile device 500. Optionally, garment-control device 110 further includes an alerting unit 116. Page 20, lines 4-7, “…impedance sensors 150 are for detecting congestive heart failure (CHF)…The sensors may further include sweat analysis sensors( indicative of a fluid state of the body), temperature and other sensors.” . It is noted that using impedance sensors to measure congestive heart failure would include measuring the impedance of the thoracic tissue and fluid accumulation within the lungs which may be interpreted as using impedance sensors to measure a fluid or hydration state of the body. It is also noted that Romem(6193) does teaches that The terms "underwear" or "garment", as used herein with conjunction with wearable clothing items, refers to seamless wearable clothing items that preferably, can be tightly worn adjacently to the body of a monitored living being, typically adjacently to the skin and an underwear item may also include a clothing item that is not underwear per se, but still is in direct and preferably tight contact with the skin, such as a T-shirt, sleeveless or sleeved shirts, sport-bra, tights, dancing-wear, and pants. The sensors, in such a case, can be embedded in such a way that are still unseen by external people to comply with the "seamless" requirement. The examiner interprets this to meet claim limitations wherein the sensors are part of shirts or vests and pants including and all aspects of the sensors, circuitry, control modules, processors and communications could be incorporated into a shirt with pants combination.
Romem(6193) does teach impedance sensors for monitoring congestive heart failure and sweat analysis however Romem(6193) does not specifically teach monitoring a “hydration” state of the user.
Romem(6262) teaches in the same field of endeavor an independent wearable health monitoring system, configured for use by a living being on a daily basis. The system includes a knitted garment worn by the living being adjacently to preconfigured body locations, a garment-processing device having processor, and a multiplicity of sensors adapted to measure health parameters, wherein at least some sensors are integrally knitted with the knitted garment, the system is adapted to plug-in external medical and other devices, such as a defibrillator, a team-tracker (sport, games, first-responders etc.) or an ergometer, that utilize ECG data or any other relevant system data such as blood pressure, oxygen saturation, breathing, temperature, dehydration, impedance and data obtained from any other sensors (and may be processed) that are in operative communicating with the controlling unit of the system.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Romem(6193) not only impedance sensors for detecting congestive heart failure and sweat analysis but the analysis of the hydration state including dehydration of the user as taught by Romem(6262).
Romem(6193) as modified by Romem(6262) does teach in Romem(6193) interconnecting “couples of impedance sensors” and where the “garment-control device 110 is subdivided into multiple, individual processing units, wherein each of the individual processing unit is operatively coupled with one or more sensors.” .
However, Romem(6193) as modified by Romem(6262) does not specifically teach “wherein the plurality of bioimpedance sensors are arranged in a bioimpedance sensor network comprising one or more bioimpedance sensor subnetworks” or “ processing the measured bioimpedance data on a subnetwork basis to determine a fluid state of a portion of the body of the user contacted by the bioimpedance sensors of a given bioimpedance sensor subnetwork, or body of the user, or a change therein, using only measured bioimpedance data from the bioimpedance sensors of the given bioimpedance sensor subnetwork”.
Connor teaches in the same field of endeavor an article of clothing with electromyographic (EMG) sensors which measures body motion and/or muscle activity. This clothing can be a short-sleeve shirt or a pair of shorts, wherein the electromyographic (EMG) sensors are on the cuffs. The electromyographic (EMG) sensors can be modular; they can be removably attached to different locations in order to create a customized article of electromyographic clothing which optimally measures the muscle activity of a particular person or muscle activity during a particular sport. Paragraphs [0114] – [0118] teach multiple types of additional sensors including impedance and hydration sensors. And, in paragraph [0110], an article of electromyographic clothing can have an available array of electromyographic (EMG) sensors, but only a subset of that array is activated in order to measure the muscle of a specific person or muscle activity during a specific sport (or other type of physical activity). In an example, the entire available array of sensors can be activated to collect data during a calibration or test period and this data can then be used to select the subset of sensors which are activated on an ongoing basis. In an example, a master model of an article of electromyographic clothing can have a large and/or dense array of sensors, but a customized article of electromagnetic clothing can be created for a specific person or sport with only a subset of the sensors in the master model. In an example, data collected when a person is wearing the master model is used to identify the subset of sensors which is to be included in a customized article of clothing for that person. In an example, data from a large array of sensors can be used to identify the smaller subset of sensors which can most efficiently collect muscle activity for a specific person or during a specific sport. Note also paragraphs [0118] and [0203] – [0206]. This is interpreted by the examiner as a teaching of utilizing a subset of sensors for measuring some physiologic aspect of a user which could include impedance and hydration states based on specific subsets of an array of sensors.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Romem(6193) as modified by Romem(6262) utilization of an array of sensors and measuring a physiologic parameter of the user from a subset of the array of sensors as taught by Connor to more efficiently collect user physiologic data from localized areas of the body and improve measurement if a subset of sensors malfunctions.
Regarding claim 2, Romem(6193) teaches the circuitry module further includes power circuitry, coupled to the plurality of bioimpedance sensors, to provide power to the plurality of bioimpedance sensors. Note Figure 1, page 7, lines 3-12 and page 18, lines 9-25.
Regarding claim 3, Romem(6193) teaches the wearable sensing garment is configured to fit tightly to the body of the user. Note Figure 1, page 10, lines 21-28: “ Optionally, the monitoring-garment includes a controlled adjustable tightening- mechanism, facilitating manual tightening of special wires/threads in specific regions of the monitoring-garment, when a specific sensor requires better contact with the body of the living being. Optionally, the adjustable tightening-mechanism includes contractible threads operatively controlled by the garment-processor. In response to sensed data received from the specific sensor, the garment-processor activates, for example, an external knitting system, to thereby adjust the length of the special tightening wires/threads.” Note also, Pages 17 lines 25-34, page 18 lines 5-8.
Regarding claims 4 , 11 and 14, 15, Romem(6193) teaches the circuitry module further includes power circuitry, wirelessly coupled to the plurality of bioimpedance sensors, to provide power to the plurality of bioimpedance sensors. Note fig. 1 and page 7 lines 17-23: Optionally, a removal of the battery facilitates recharging the battery without having to attach the charging device to the monitoring-garment. In some variations of the current invention, the recharging may be done without removing the battery from the monitoring-garment, for example, by using a cable between the recharger and the battery (using a USB connector or any other connector) or by wireless techniques (charging plate, charging hanger etc.).
Regarding claim 5, Romem(6193) teaches the wearable sensing garment consists essentially of a shirt or vest that is configured to fit tightly to a chest and an abdomen of the user, the plurality of bioimpedance sensors, the circuitry module, and wiring to connect the plurality of bioimpedance sensors to the circuitry module. Note Figure 1, page 7, lines 3-12 and page 18, lines 9-25.
Regarding claim 6, Romem(6193) teaches the wearable sensing garment further includes a pouch or pocket to receive the circuitry module. Note Figure 1, page 7, lines 3-12 and page 18, lines 9-25.
Regarding claim 7, 19 and 20, Romem(6193) teaches the plurality of sensors are respectively placed at the multiple locations on the wearable sensing garment so as to correspond to different locations on a chest, an abdomen locations, and limbs of the body of the user. Note Figure 1, page 7, lines 3-12 and page 18, lines 9-25.
Regarding claim 8, Romem(6193) teaches the wearable sensing garment is configured to fit tightly to the body of the user such that the plurality of sensors substantially continuously contact the body of the user in situ. Note Figure 1, page 7, lines 3-12 and page 18, lines 9-25.
Regarding claims 9, 16, and 17, Romem(6193) teaches the processor of the circuitry module is configured to determine a change in state of hydration of the body of the user using the measured bioimpedance data. Page 20, lines 4-7, “…impedance sensors 150 are for detecting congestive heart failure (CHF)…The sensors may further include sweat analysis sensors( indicative of a fluid state of the body), temperature and other sensors.” . It is noted that using impedance sensors to measure congestive heart failure would include measuring the impedance of the thoracic tissue and fluid accumulation within the lungs which may be interpreted as using impedance sensors to measure a fluid or hydration state of the body.
Regarding claim 12, Romem(6193) teaches the first garment of the wearable sensing garment is configured to fit tightly to the chest and abdomen of the user, and the second garment of the wearable sensing garment is configured to fit tightly to the legs of the user. Note pages 3 lines 28 to page 4 lines 1-7. It is also noted that Romem(6193) does teaches that The terms "underwear" or "garment", as used herein with conjunction with wearable clothing items, refers to seamless wearable clothing items that preferably, can be tightly worn adjacently to the body of a monitored living being, typically adjacently to the skin and an underwear item may also include a clothing item that is not underwear per se, but still is in direct and preferably tight contact with the skin, such as a T-shirt, sleeveless or sleeved shirts, sport-bra, tights, dancing-wear, and pants. The sensors, in such a case, can be embedded in such a way that are still unseen by external people to comply with the "seamless" requirement. The examiner interprets this to meet claim limitations wherein the sensors are part of shirts or vests and pants including and all aspects of the sensors, circuitry, control modules, processors and communications could be incorporated into a shirt with pants combination.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CHAHINE et al(WO 2019134033) teaches a garment comprising a plurality of interlaced non-conductive fibers making up a body of the garment including: a top portion and a bottom portion of the body separated by an intermediate portion, the intermediate portion for positioning over a joint of limb of a wearer of the garment; a network of conductive pathways in the body for connecting to a controller device; a plurality of strain sensors of the body positioned to either side of the intermediate portion and coupled to the network of conductive pathways; an IMU sensor mounted on the body and configured for communication with the controller device; and a plurality of bio impedance sensors of the body for providing bio impedance measurements of tissues of the wearer positioned adjacent to the body when the garment is worn by the wearer, the plurality of bio impedance sensors connected to the network of conductive pathways. Bio impedance sensors 43 are used to measure fluid content in the limb tissues, as a current is passed between pairs of bio impedance sensors 43 through the limb tissue, as controlled by the processor 116. The processor 116 interprets the current measurements as calibrated against a set of fluid content values stored in the storage 118 (e.g. bio impedance is about the electrical properties of the body, e.g. to what extent the body is a good conductor, such that bio impedance is a measure of how well the body impedes electric current flow - recognizing fat has high resistivity while blood/fluid has lower relative resistivity). Accordingly, as the resistivity in the limb goes down, the processor 116 would determine that the fluid content (i.e. swelling) of the limb is rising. Further, increases in strain/stretch by the stretch sensors 34 signal data can also, or in addition to the bio impedance signal data, be interpreted by the processor 116 as indicative of swelling increase or decrease over time.
[0070] A method 300 of Figure 4 is presented for estimation of fluid content in the limb tissues for detection of peripheral swelling and edema of the limb using the combination of sensors 34,43 shown in the garment 10 embodiment of Figure 3.
BAO (CN 106344014) teaches a body fat ratio detecting technology, especially relates to a method for measuring human body impedance of clothing and its manufacturing method, and system of this kind of clothes for monitoring body fat ratio.
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 BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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