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 .
Claim Objections
Claims 1,7,10, and 18 are objected to because of the following informalities:
Regarding claims 1,10, and 18, “communication circuitry, coupled to the processor” refers to “the processor” which is not positively set forth until later in the claim. Since there is only a single processor claimed, “the processor” is interpreted to refer to “a processor” later set forth. The examiner suggests changing “the processor” to –a processor—and the later reference to “a processor” changed to –the processor--.
Regarding claim 7, “an abdomen locations” should be changed to –an abdomen--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 10-17 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7 and 19, line 2, “the multiple locations” lacks antecedent basis.
Regarding claim 10, The claim sets forth “a first plurality of bioimpedance sensors” and a “second plurality of bioimpedance sensors” and in the penultimate line refers to “the plurality of sensors”. It is unclear if “the plurality of sensors” refers to “the first plurality of bioimpedance sensors”, “the second plurality of bioimpedance sensors” or both.
Regarding claim 11, the claim sets forth “the circuitry module further includes power circuitry, first and second plurality of bioimpedance sensors, to provide power to the first and second plurality of bioimpedance sensors.” And it is unclear if applicant is intending to add additional sensors to the circuitry module or similarly to claim 4 , the power circuitry should be –coupled to the first and second plurality of bioimpedance sensors --.
Regarding claim 16, last line, “the fluid state of the body” lacks antecedent basis. Claim 10 does not include a determination of the fluid state of the body as set forth in the preambles of claims 1 and 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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 - 17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Both claims 1 and 10 set forth “a circuitry module physically coupled to the body of the user” which should be change to -- a circuitry module configured to be coupled to the body of the user – to overcome the rejection.
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).
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).
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.
Hassan-Ali(US 20200037954) teaches systems and methods for a garment comprising a fabric layer, a plurality of biometric sensors integrated into the fabric layer, and a connectivity layer integrated into the fabric layer. The connectivity layer can comprise signal conductors and power conductors coupled with each of the plurality of biometric sensors. The garment can further comprise a power source coupled with each of the power conductors and providing, via the power conductors of the connectivity layer, electrical power to each of the plurality of biometric sensors, a signal monitor coupled with the connectivity layer and receiving, via the signal conductors of the connectivity layer, a signal comprising biometric information from each of the plurality of biometric sensors, and a gateway coupled with the signal monitor, the gateway receiving the biometric information from the signal monitor and providing the biometric information to an external computer system.
LONGINOTTI-BUITONI( 20180184735) teaches Described herein are apparatuses (e.g., garments, including but not limited to shirts, pants, and the like) for detecting and monitoring physiological parameters, such as respiration, cardiac parameters, and the like that include individual skin contact-enhancing expandable elements. [0294] Any of the garments described herein may include sensors that detect other physiological parameters in addition to respiration and heart beat and rhythms. For example, extended-wear monitoring garments described herein may include sensors for detecting a wearer's body temperature. In the physical activity monitoring scenario, the extended-wear monitoring garment may warn the wearer if a set critical temperature is reached via a signal or alarm. The signal or alarm will help the wearer from overheating and suffering from heat exhaustion during physical activity and indicate to the wearer that it may be time to pause for hydration or to seek cover if it is an inordinately hot day.
Miller et al.( 11363997) teaches a method, system, apparatus, and/or device that may include: a housing, a sensor interface, and a processing device. The housing may be shaped to be affixed to a body of a user and may include an inner cavity that houses electronic components and an impedance sensor. The impedance sensor may include a first contact terminal and a second contact terminal. The sensor interface may be configured to: generate an electric signal; receive the electric signal through a skin layer below a surface of the body of the user; and determine an impedance measurement between the first contact terminal and the second contact terminal based on the electric signal. The processing device may be configured to determine, based on the impedance measurement: a condition of a vascular system of the user; an amount of a constituent of the vascular system of the user; or a hydration condition of the user.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791