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 .
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
In the specification, the list of reference elements from drawings in paragraph 141 is repeatedly inconsistent with the body of the specification. Few example from the list “158 second sensor; 160 second sensor unit; 165 third sensor; … 190 third sensor unit; 195 third sensor; …, however in the body of the specification has “galvanic skin response (GSR) sensor (158)” [Para 20]; “second sensor 158” [Para 60]; “a second sensor (165) … second sensor unit (165)” [Para 25]; “a third sensor (190) … third sensor unit (195)” [Para 26]. Examiner does not list all the inconsistency; however, the specification should be reviewed to comply with the drawings, descriptive text, and the reference element list.
Claim Objections
Claim 21, 23, 29-30, 38, and 40 is/are objected to because of the following informalities:
In Claim 21, line 5, “a hand of a subject” lacks proper antecedents, should read “the/said hand of the/said subject”.
In Claim 21, “the sensor positioning structure” should read “the sensor-positioning structure”, lack consistency with hyphenates(-).
In Claim 23, line 4, “a hand” should read “the/said hand”.
In Claim 29, line 8-10, “a position on the palm” and “a position on the back” should read “the position on the palm” and “the position on the back”.
In Claim 30, “a portion of the purlicue” should read “a portion of a purlicue” as the claim dependent on doesn’t introduce “purlicue” before.
In Claim 38, line 3, “a hand” should read “the/said hand”.
In claim 40, line 4-5, “a hand” and “a first position on a palm of a subject” should read “the hand” and “the first position on the palm of the subject”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21, 29, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2007190122 A to Terauchi et al. (hereinafter “Terauchi”).
Regarding Claim 21 and 40, Terauchi discloses a biosignal acquisition system (see Abstract: “a biological information measuring apparatus”, Page 3: “a pulse oximeter that is one of the biological information measuring devices”) and a method of acquisition of data (Page 05-06: “the patient brings home, attaches itself to the arm 51 … a third embodiment … showing a state where the probe is attached to the hand”) comprising:
at least a first sensor unit (see Page 3: “probe 21 includes light emitting units 22 a and 22 b and a light receiving unit 23” and Fig 3-4, 6); and
a sensor-positioning structure (see Abstract: “respective holding parts arranged at positions corresponding to the back of a hand and the palm … so as to hold the hand there between when wearing it, and a connection part for integrally connecting the respective holding parts”) configured to extend across a hand of a subject (see page 4: “a holding part 24 attached to the palm of the hand 50 to be measured and a holding part 25 attached to the hand 50” and Fig. 3-4, 6-7), the sensor positioning structure being configured to maintain the first sensor unit at a first position on a palm of a hand of a subject (see Page 4: “the probe 21, the light emitting unit 22 … fixed to the surface of the holding unit 24 with which the hand 50 is in contact, and the light receiving unit 23 is in contact with the hand 50” and Page 5: “the probe 21 has a holding part 24 attached to the palm of the hand 50 and a holding part 25 attached to the hand 50 … the light emitting part 22 is fixed to the holding part 24, and the light receiving part 23 is fixed to the holding part 25”);
arranging the biosignal acquisition system on a hand of the subject such that the first sensor unit is arranged and maintained at a first position on a palm of a subject (see Page 06: “light emitting unit 22 is fixed to the holding unit 24 attached to the palm of the hand 50 of the probe 21, and the light receiving unit 23 is fixed to the holding unit 25 attached to the hand 50”); obtaining biosignals detected by the first sensor unit (see Page 3-4: “ … light emitting units 22a and 22b … light receiving unit 23 … generates a pulse signal … stores oxygen saturation and pulse rate based on the pulse signal” and Page 05: “the patient brings home, attaches itself to the arm 51 before bedtime, attaches to the hand 50 that measures the probe 21, and detects the body from the detection data of the light receiving unit 23 during sleep … calculates biological information, such as oxygen saturation”).
Regarding Claim 29, Terauchi further discloses the biosignal acquisition system, wherein the first sensor unit includes an oximeter (see Page 03: “a pulse oximeter that is one of the biological information measuring devices … the pulse oximeter is provided with … a probe 21”), the oximeter including a light emitter configured to emit light and a light detector configured to detect light emitted by the light emitter that passes through a portion of the hand of the subject (see page 03: “probe 21 includes light emitting units 22 a and 22 b and a light receiving unit 23 …” and Page 04: “the light emitting unit 22 … is fixed to the surface of the holding unit 24 with which the hand 50 is in contact, and the light receiving unit 23 is in contact with the hand 50”),
wherein the sensor-positioning structure is configured to position the light emitter at a position on the back of the hand of the subject and is configured to position the light detector at a position on the palm of the hand of the subject (see Fig. 2-4, 7-8, and Page 06: “light receiving unit 23 may be fixed to the holding unit 25 attached to the palm of the hand 50 …”),
or wherein the sensor-positioning structure is configured to position the light emitter at a position on the palm of the hand of the subject and is configured to position the light detector at a position on the back of the hand of the subject (see Fig. 2-4, 7-8, and Page 06: “light emitting unit 22 is fixed to the holding unit 24 attached to the palm of the hand 50 …”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22-28, 30, 34-37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Terauchi as applied to claims 21 above and in view of US 20210162212 A1 to Kern et al. (hereinafter “Kern”).
Regarding Claim 22-28, Terauchi further disclose the biosignal acquisition system of above, wherein the sensor-positioning structure includes a first end (see Fig.4 (coupling portion 26 constitute a mounting means and attached to the hand 50 has two ends), Fig. 07, and Page 06: “a ring-shaped stretchable string 40 … string 40 may be hung on another finger …”), the connecting means are extendable and bendable and holding portion made of elastic members (see Page 2-3) to contact the palm of the hand, also the probe body is made of soft synthetic resin, rubber; also the connecting portion includes a flexible portion having more flexibility than the first end or the second end, the flexible portion providing flex to the connecting portion ( see Fig. 07 (probe 21 connecting portion has a stretchable string 40 connected)). The discloser has connecting portion as a means to mount and the holding parts that are connected to this are also made of soft material having elasticity such as silicon rubber, thermoplastic elastomer, polypropylene resin to hold onto the hand. Fig.7 and Fig.8 shows alternative uses of the device; therefore, the soft materials of the device may be used to put on the purlicue and the string like structure may be used to strung across the palm, or the elastic property of the material may be used with the structural discloser of Fig.4 to wrap around the palm and purlicue.
However, Terauchi fails to explicitly disclose the first end being configured to conform around and couple to a purlicue of the hand of the subject, the second end being configured to conform around and couple to a lateral portion of the hand, and the bent sections.
Another reference, Kern disclose a device (see Abstract, Para 02, 9-14), wherein the sensor-positioning structure includes a first end (see Fig 1, 3C, 5A-5B, 8D-8E, 10), the first end being configured to conform around and couple to a purlicue of the hand of the subject (see Para 37: “Device 100 is shown in FIG. 1 … integrated into, and attachable to a user's hand by, a band or clip 102 … span the back of a user's hand and/or wrap around the hand between the thumb and forefinger to at least partially cover the user's palm … the user's wrist may be encircled, similar to a bracelet”);
wherein the first end is C-shaped and includes a first bent section that is rigid or at least semi-rigid, the first bent section defining a first concavity and so being shaped and configured to conform to and couple to the purlicue of a hand of the subject (see Fig. 3A-3B, 5A-5B and Para 44-45: “the device 300 has … more like a clip that fits over the back of the user's hand, on or near the first and second knuckles, and extends between thumb and forefinger to cover a portion of the user's palm”);
wherein the sensor-positioning structure further includes a second end, the second end being configured to conform around and couple to a lateral portion of the hand that is opposite to the purlicue of the hand of the subject (see Fig. 3A-3B, 5A-5B and Para 45: “the palm-located portion of the clip may extend across all or most of the width of the palm”);
wherein the second end includes a second bent section that is rigid or at least semi-rigid, the second bent section defines a second concavity and so being shaped and configured to conform the lateral portion of the hand that is opposite to the purlicue of the hand of the subject (see Fig. 1, 3A-3B, 5A-5B and Para 45: “the palm-located portion of the clip may extend across all or most of the width of the palm”, and Fig. 8D-8E (show the bent on both end and to wrap all or most of the palm));
wherein the sensor-positioning structure further includes a connecting portion extending from and coupling to the first end and the second end (see Para 44: “a clip that fits over the back of the user's hand”),
wherein the connecting portion is configured to extend across the back of the hand of the subject (see Para 37: “Device 100 … may span the back of a user's hand and/or wrap around the hand”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed biological information measuring apparatus of Terauchi which already teaches the sensor unit, hand holding structure and positioning of the sensor unit (emitter/detector) on a hand (both back of the hand and palm) with alternative positioning structure (see Fig.7-8) to be combined with the explicitly disclosed teaching of Kern to have band/clip geometric structure to wrap around purlicue and palm to have a more comfortable and better positioned system with specific fixed on sensor positioning structure for higher accuracy and efficient signal detection.
Regarding Claim 30, Terauchi further disclose the modified biosignal acquisition system of above, wherein the sensor-positioning structure is configured to position the oximeter such that light emitted by the light emitter is transmitted through at least a portion of the purlicue of the hand of the subject. The alternative use of the biological information measuring apparatus in Fig.7 and Fig.8 may be used to have to probe 21 placed on the purlicue rather than to the little finger side of the hand and the string 40 maybe placed around the palm for positioning.
Additionally, the geomagnetic structure disclosed by Kern (Para 37: a band or clip 102 .. may span the back of a user's hand and/or wrap around the hand between the thumb and forefinger to at least partially cover the user's palm”) can be combine to achieve the goal of light emitted by the light emitter to transmitted through at least a portion of the purlicue.
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to apply the know alternative placement technique of the device disclosed by Terauchi for improved result or to combine with Kern teaching to position the oximeter to transmit light to at least portion of the purlicue for improved results (see MPEP 2143).
Regarding Claim 34-36, Terauchi further disclose the modified biosignal acquisition system of above, wherein the biosignal acquisition system further comprises a control unit (see Page 03: “a control unit 12 … ”) arranged in a control housing (see page 03: “main body 11 includes a control unit 12” and Fig.1-2), the control unit being configured to receive biosignals received from the first sensor unit (see Page 03-04: “The control unit 12 includes a microprocessor … calculates oxygen saturation, pulse rate, and the like in arterial blood from pulse signals input from the probe 21 … pulse signal is transmitted to the control unit 12”) and transmit data relating to the biosignals received from the first sensor unit (see Page 03-04: “pulse signal is transmitted to the control unit 12 through the cord 32 connected to the conductive line 27c, and as described above, the main body unit 11 calculates, displays, and stores oxygen saturation and pulse rate based on the pulse signal”) to a secondary device that is external to the control unit.
Terauchi teach the control unit, and displays the received data, but fails to teach the data is transmitted to a secondary device (a smart phone, laptop computer, computer, a server, or another external terminal) that is external to the control unit and transmit data by network communication channel, a wireless network, or local area network.
Kern disclose a device (see Abstract, Para 02, 9-14), wherein a control unit arranged in a control housing … receive biosignals received from the first sensor unit and transmit data relating to the biosignals received from the first sensor unit to a secondary device that is external to the control unit (see Para 09: “control unit may also receive sensor inputs and process these inputs”, Para 41: “communications by the control and power unit 110 to separate devices (e.g., a mobile phone) may be by Bluetooth or other known protocol or means”, and Para 37).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Kern teaching of separate/external mobile phone device and Bluetooth communication with the biological information measuring device disclosed by Terauchi to incorporate the external monitoring system with remote access of acquired biological data.
Regarding Claim 37, Terauchi further disclose the biosignal acquisition system of above, wherein the connecting portion includes a hinge that provides a pivoting point such that an axis of the first end is arranged at an offset angle (a) from an axis of the second end (see Fig.7 (probe 21 has several axes that can be defined and they are offset relative to the direction of an axis of string 40 or connecting means 31)).
Regarding Claim 39, Terauchi disclosed the biological information measuring devices with a pulse oximeter, a probe with light emitting units and a light receiving unit, and the probe attached to the palm of the hand. However, fails to disclose a third sensor unit and positioning structure to position such way to position facing away from the back of the hand.
Kern further disclosed a device comprising a third sensor unit including a third sensor, wherein the sensor-positioning structure is configured to maintain the third sensor unit at a position of the sensor-positioning structure facing away from a back of the hand of the subject (see Para 26, 37: “device 100 includes a control and power unit 110 that is integrated into, and attachable to a user's hand by, a band or clip 102 … control and power unit includes … sensors or other components”, and Para 59: “The control and power unit … from one or more sensors …” (control and power unit can have sensors and may span the back of a user's hand and/or wrap around the hand between the thumb and forefinger to at least partially cover the user's palm, therefore can include the third sensor unit placed on control unit which facing outward)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Kern teaching of using one or more sensors to collect various data input from the sensors from wider areas and the position structure with Terauchi disclosure would provide more accurate results and user comfort.
Claims 31-33, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Terauchi as applied to claims 21 above and in view of US 20160292988 A1 to McCleary et al. (hereinafter “McCleary”).
Regarding Claim 31 and 32, Terauchi disclose the biosignal acquisition system of above, where the device includes a sensor unit (pulse oximeter), a light emitting unit, and a light receiving unit to be positioned palm of the hand. However, fails to disclose the sensor unit includes galvanic skin response (GSR) sensor.
Another reference, McCleary disclose a sensing device (see Abstract and Para 03), wherein the first sensor unit includes galvanic skin response (GSR) sensor (see para 18: “sensing device 200 may also include a plurality of biometric sensors”, Para 39: “sensing device may receive biometric data values from a Galvanic Skin Response (GSR) sensor”); wherein the sensor-positioning structure is configured to position the GSR sensor at a position on the palm of the hand (16-17: “wearable sensing device 200 may receive a plurality of biometric data values by a first set of sensors of the sensing device … sensing device 200 is embedded in an armband 100, the sensing device 200 may be embedded in various other articles of clothing or wearable apparel … the apparel may be a glove … apparel may also be … any other suitable apparel for embedding the sensing device 200 and retrieving readings of biometric and environmental data (apparel may also be a hand band around palm)”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the disclosed biological information measuring apparatus of Terauchi which already teaches the sensor unit to include a GSR sensor and to position the sensor on the palm as disclosed/suggested by McCleary to obtain additional biosignal information, thereby help improving and determining mood, sleep stages or state, emotional state, or overall general physiological condition of the wearer.
Regarding Claim 33, Terauchi further discloses the biosignal acquisition system, wherein the first sensor unit includes an oximeter (see Page 03: “a pulse oximeter that is one of the biological information measuring devices … the pulse oximeter is provided with … a probe 21”), the oximeter including a light emitter configured to emit light and a light detector configured to detect light emitted by the light emitter that passes through a portion of the hand of the subject (see page 03: “probe 21 includes light emitting units 22 a and 22 b and a light receiving unit 23 …” and Page 04: “the light emitting unit 22 … is fixed to the surface of the holding unit 24 with which the hand 50 is in contact, and the light receiving unit 23 is in contact with the hand 50”),
wherein the sensor-positioning structure is configured to position the light emitter at a position on the back of the hand of the subject and is configured to position the light detector at a position on the palm of the hand of the subject (see Fig. 2-4, 7-8, and Page 06: “light receiving unit 23 may be fixed to the holding unit 25 attached to the palm of the hand 50 …”).
However, fails to disclose positioning the oximeter such that emit light through portion of the purlicue, GSR sensor and position the sensor at a palm.
McCleary disclose a sensing device (see Abstract and Para 03), wherein the first sensor unit includes galvanic skin response (GSR) sensor (see para 18: “sensing device 200 may also include a plurality of biometric sensors”, Para 39: “sensing device may receive biometric data values from a Galvanic Skin Response (GSR) sensor”); wherein the sensor-positioning structure is configured to position the oximeter such that light emitted by the light emitter is transmitted through at least a portion of the purlicue of the hand of the subject (see Para 16-18 (sensing device may include pulse oximeter sensor and can be embedded in various wearable apparel and positioned suitably for accurate readings of biosignals, therefore the apparel may be hand band/cuff structure and positioned as such to emit light to at least portion of the purlicue)), wherein the sensor-positioning structure is configured to position the GSR sensor at a position on the palm of the hand (16-17: “wearable sensing device 200 may receive a plurality of biometric data values by a first set of sensors of the sensing device … sensing device 200 is embedded in an armband 100, the sensing device 200 may be embedded in various other articles of clothing or wearable apparel … the apparel may be a glove … apparel may also be … any other suitable apparel for embedding the sensing device 200 and retrieving readings of biometric and environmental data (apparel may also be a hand band around palm)”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the disclosed biological information measuring apparatus of Terauchi which already teaches the sensor unit to include a GSR sensor and to position the GSR sensor on the palm and position the oximeter disclosed by McCleary to obtain both optical biosignal and GSR signal from the subject, thereby improving results for determining a mood, emotional state, sleep characteristics or quality, or general physiological condition of the wearer or subject.
Regarding Claim 38, Terauchi in combination with McCleary disclose the biosignal acquisition system of above, where in Terauchi disclose having oximeter components for palm positioning with alternative structures but not explicitly being wrapped around the palm so to be in contact with purlicue of the hand.
However, the alternate positioning combined with McCleary teaching of the wearable sensing device with various suitable embedded wearable apparel is disclosed where the sensor positioning structure with first and second end and the concavity structure around purlicue of hand and to lateral portion opposed to purlicue could be achieved using any suggested apparel like glove, hand bands, or other suitable apparel (see Para 17). Kern further disclose that multiple sensing device can be placed on different positioning with plurality of sensors (see Fig. 1 (armband 100 has multiple sensing device 200), Fig.2 (sensing device 200 have multiple sensors (210, 216), and Para 20: “sensing device 200 may also include a plurality of sensors for sensing particular biometric … the biometric sensors may be an accelerometer 210 … a pulse oximeter, … a temperature sensor 216”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine McCleary teaching of using one or more sensor and sensing device embedded in desired position to collect various data input from the sensors from different areas and the position structure with Terauchi disclosure would provide more accurate results and user comfort.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20120229270 A1 – Art relevant as whole (wearable biofeedback device acquiring biosignal using at least one sensor using a glove like structure and wirelessly transmit to the external device).
US 20080081963 A1 – Art relevant as whole (methods and apparatus for assessing both mental stress and vascular reactivity status using biosignal measurements from body part having maximal autonomic reactivity using cuff/band/strap like structure).
US 20180214080 A1 – Art relevant as whole (wearable gear for holding a physiological sensor such as a pulse oximeter for monitoring a subject and to keep the gear at least partially around a body part of the subject).
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
