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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 8-9, 14-16, 19-20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Vallius [US 20230113714 A1].
Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1). Alternatively, applicant may rely on the exception under 35 U.S.C. 102(b)(1)(B) by providing evidence of a prior public disclosure via an affidavit or declaration under 37 CFR 1.130(b).
As per claim 1, Vallius teaches a wearable device (Vallius Figs 2,6), comprising:
a housing comprising an external surface and an internal surface, the internal surface configured to at least partially contact a tissue of a user (Vallius Fig 2, items 205-a, 205b, ¶0036 wearable device ring 104);
a first protrusion extending from the internal surface of the housing a first distance resulting in a first contact pressure between the tissue and the first protrusion (Vallius Fig 6, protrusion for 608-a. The protrusion inherently has height / distance, and when it contacts skin for measurement there is a contact pressure);
a second protrusion extending from the internal surface of the housing a second distance resulting in a second contact pressure between the tissue and the second protrusion (Vallius Fig 6 protrusion for 608-b. The protrusion inherently has height / distance, and when it contacts skin for measurement there is a contact pressure);
a plurality of optical components comprising one or more light- transmitting components and one or more light-receiving components (Vallius Fig 6 items PD and LEDs),
the plurality of optical components comprising at least a first optical component disposed within the first protrusion, and at least a second optical component disposed within the second protrusion (Vallius Fig 6 green LEDs inside the protrusions); and
one or more processors communicatively coupled with the plurality of optical components (Vallius Fig 2 modules inside ring 104), the one or more processors configured to:
acquire physiological data from the user via at least a first optical channel including the first optical component, and a second optical channel including the second optical component (Vallius Fig 10 steps 1000-1015 evaluating different channels / wavelengths);
determine respective measurement quality metrics associated with the first optical channel and the second optical channel based at least in part on the physiological data (Vallius Fig 14 step 1415 “he signal quality component 1135 may be configured as or otherwise support a means for determining a signal quality metric associated with the one or more signals.”);
select the first optical channel or the second optical channel based at least in part on a comparison of the respective measurement quality metrics (Vallius Fig 10 step 1020, Fig 14 step 1420);
and acquire additional physiological data using the first optical channel or the second optical channel based at least in part on the selecting (Vallius Fig 10 step 1025 to step 1005).
As per claim 2, Vallius further teaches wherein the first optical component comprises a first light-emitting component disposed within the first protrusion (Vallius Fig 6 protrusion or green led 608-a), wherein the first light-emitting component is configured to emit first light associated with a first wavelength that penetrates the tissue of the user to a first penetration depth based at least in part on the first contact pressure (Vallius Fig 6 protrusion for reflective ppg using green implies a penetration depth and contact pressure when device contacts finger for measurement ), and wherein the second optical component comprises a second light-emitting component disposed within the second protrusion (Vallius Fig 6 protrusion or green led 608-b), wherein the second light-emitting component is configured to emit second light associated with the first wavelength that penetrates the tissue of the user to a second penetration depth based at least in part on the second contact pressure (Vallius Fig 6 protrusion for reflective ppg using green implies a penetration depth and contact pressure when device contacts finger for measurement).
As per claim 4, Vallius further teaches wherein the wearable device comprises a wearable ring device, wherein the first protrusion is positioned at a first radial position along an inner curved surface of the wearable ring device, and wherein the second protrusion is positioned at a second radial position along the inner curved surface of the wearable ring device, and wherein the light-receiving component is positioned at a third radial position along the inner curved surface of the wearable ring device that is between the first and second radial positions (Vallius Fig 6, protrusions / emitters and PD are arranged on radial positions of the ring on the inner curved surface).
As per claim 8, Vallius further teaches a third protrusion extending from the internal surface of the housing a third distance resulting in a third contact pressure between the tissue and the third protrusion, wherein the plurality of optical components further comprise at least a third optical component disposed within the third protrusion (Vallius Fig 6 protrusion for IR/Red).
As per claim 9, Vallius further teaches wherein the one or more processors are further configured to: determine respective power consumption metrics associated with the first optical channel and the second optical channel based at least in part on acquiring the physiological data, wherein the selecting is based at least in part on the respective power consumption metrics (Vallius ¶0133 “to support determining the signal quality metric, the PPG signal component 1245 may be configured as or otherwise support a means for determining an amplitude of the PPG signal, an amount of noise in the PPG signal, a form of the PPG signal, a power consumption associated with determining the PPG signal, or a combination thereof.”).
As per claim 14, Vallius further teaches wherein the wearable device comprises a wrist-worn wearable device (Vallius ¶0017).
As per claims 15-16, 19-20 have limitations similar to claims 1-2 and are rejected for same reasons as above.
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.
Claims 1-3, 4-5, 8-10, 13-16, 19-20 rejected under 35 U.S.C. 103 as being unpatentable over Allec [US 20170325744 A1] in view of Robinson [US 20220096007 A1].
As per claim 19, Allec teaches a wearable device (Allec Fig 2A, ¶0029), comprising:
a housing comprising an external surface and an internal surface (Allec Fig 6A, back surface of a device including cover structures 607, this side is the internal surface which contacts skin and other (underside in Fig 6A) is an external surface),
the internal surface configured to at least partially contact a tissue of a user (Allec Fig 6A -Fig 6B);
a first protrusion extending from the internal surface of the housing a first distance resulting in a first contact pressure between the tissue and the first protrusion (Allec Fig 6A-6B protrusion 604 and contact pressure 622. ¶0046 “the back surface of the device can include three protrusions, each having different heights and configured to create different amounts of pressure.” Height of protrusion is a distance);
second protrusion extending from the internal surface of the housing a second distance resulting in a second contact pressure between the tissue and the second protrusion (Allec Fig 6A-6B protrusion 602 and contact pressure 620. ¶0046 “the back surface of the device can include three protrusions, each having different heights and configured to create different amounts of pressure.” Height of protrusion is a distance. It is noted that, the claim does not require the first/ second distances and contact pressures to be different, and claim language broadly includes interpretation where they are same/equal. However, for these rejections using Allec, examiner is interpreting as “different” in view of the applicant disclosure, so as to enhance compact prosecution. Instant reference Allec has been selected and applied so as to identify and address this particular feature. Examiner suggests clarifying or amending this in the response);
a first light-emitting component disposed within the first protrusion (Allec Light elements for protrusion 604. ¶0049 “One or more light emitters (e.g., light emitter 206 and light emitter 216 illustrated in FIG. 2A) can emit light towards the individual's skin”. See Fig 7B, item 704 for e.g.),
wherein the first light-emitting component is configured to emit first light associated with a first wavelength that penetrates the tissue of the user (Allec ¶0049 “the emitted light to pass through to the individual's skin (step 656 of process 650). Light can interact with some or all of the one or more skin regions (step 658 of process 650) and can reflect and/or scatter back to the device.”. A first wavelength is implied since light is being emitted)
to a first penetration depth based at least in part on the first contact pressure (Allec ¶0046 “back surface of the device can include three protrusions, each having different heights and configured to create different amounts of pressure”. Any depth the light travels to will depend on the different pressures);
a second light-emitting component disposed within the second protrusion, wherein the second light-emitting component is configured to emit second light associated with a wavelength that penetrates the tissue of the user to a second penetration depth based at least in part on the second contact pressure (Allec Fig 6A, 6B, 7B, ¶0046, ¶0049. Light elements for protrusion 602); and
one or more light-receiving components configured to receive light emitted by the first light-emitting component, the second light-emitting component, or both (Allec ¶0049).
The only difference from claim is that Allec does not expressly recite the second light emitting component also emits the “first” wavelength, i.e. same wavelength as the first slight emitting component. Allec is silent about any wavelength / color / frequency in the disclosure.
Robinson, in a related field of wearable non-invasive systems teaches emitters with same wavelengths (Robinson Fig 19, ¶0159 “an optical sensor system comprising one or more emitters (1905 and 1906) …The emitters can have the same emitting wavelength”).
As per MPEP 2143.I.E, Example of rationales that may support a conclusion of obviousness include: (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Robinson discloses using either same or different wavelengths to gather biological parameters via optical sensing. Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to obvious to try the known methods for biological sensing, including using same wavelengths with a reasonable expectation of success, that optical information may be gathered.
As per claim 20, Allec in view of Robinson in view of further teaches wherein the first light-emitting component, the second light-emitting component, or both, are further configured to transmit light associated with a second wavelength (Robinson ¶0159 “emitters can have the same emitting wavelength or different wavelengths. A given emitter can also represent a package of LEDs, with the capability to emit a plurality of wavelengths”. This means the emitters can be configured to transmit second wavelengths).
As per claims 1-2, 5, have limitations similar to claim 19-20 and is rejected for same reasons a above. Allec in view of Robinson further teaches one or more processors communicatively coupled with the plurality of optical components (Robinson ¶0162 “An optical sampling control system (1911)”, ¶0163 “An analysis system (1912)”, ¶0164 “signal suitability system (1913),”. See Fig 19),
the one or more processors configured to:
acquire physiological data from the user via at least a first optical channel including the first optical component, and a second optical channel including the second optical component (Robinson ¶0162-¶0163 “use of both emitters (1905 and 1906) with a near infrared wavelength (e.g., peak wavelength of 940 nm) at near maximal intensity (e.g., drive current of 60 mA); use of detector 1908 to… An analysis system (1912) receives signals from one or more detectors in the optical sensor system”);
determine respective measurement quality metrics associated with the first optical channel and the second optical channel based at least in part on the physiological data (Robinson ¶0164 “a signal suitability system (1913), which determines a metric indicative of the suitability of the acquired signals … based on a variety of factors, to include the stability and consistency of the raw or processed detector signals”);
select the first optical channel or the second optical channel based at least in part on a comparison of the respective measurement quality metrics (Robinson ¶0164 “the signal suitability system can be configured to provide information to the optical sampling control system such that changes in operational parameters can be implemented”, Operational parameters include parameters of the optical sensor system that can be configured at the initiation of sampling, to include emitter and detector selection, wavelength selection, ¶0162 “ Operational parameters include parameters of the optical sensor system that can be configured at the initiation of sampling, to include emitter and detector selection, wavelength selection”,¶0186, selecting emitters and wavelengths based on suitability of metrics); and
acquire additional physiological data using the first optical channel or the second optical channel based at least in part on the selecting (Robinson Figs 31-32 proceeds for hydration determination with determined set of parameters).
As per claim 3, Allec in view of Robinson further teaches wherein the first optical channel comprises the first light-emitting component and a light-receiving component, and wherein the second optical channel comprises the second light-emitting component and the light-receiving component, a first distance between the first light-emitting component and the light-receiving component, a second distance between the second light-emitting component and the light-receiving component (Allec Fig 9B, distances between optical centers and light sensor).
Although, the arrangement in Allec Fig 9B is shown to be substantially symmetric, Allec in view of Robinson does not expressly recite wherein a first distance and second distance are equal. However, as per MPEP2144.05 “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. In the instant case general arrangement of emitters and sensors are shown in Allec in view of Robinson. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Allec in view of Robinson, by providing distances, either equal or unequal, so as to find optimum arrangement and monitoring parameters by device.
As per claim 4, Allec in view of Robinson further teaches the wearable device comprises a wearable ring device, wherein the first protrusion is positioned at a first radial position along an inner curved surface of the wearable ring device, and wherein the second protrusion is positioned at a second radial position along the inner curved surface of the wearable ring device, and wherein the light-receiving component is positioned at a third radial position along the inner curved surface of the wearable ring device that is between the first and second radial positions (Robinson Fig 19, protrusions and detectors on radial positions).
As per claim 8, Allec in view of Robinson further teaches a third protrusion extending from the internal surface of the housing a third distance resulting in a third contact pressure between the tissue and the third protrusion, wherein the plurality of optical components further comprise at least a third optical component disposed within the third protrusion (Allec Fig 6A).
As per claim 9, Allec in view of Robinson further teaches wherein the one or more processors are further configured to: determine respective power consumption metrics associated with the first optical channel and the second optical channel based at least in part on acquiring the physiological data, wherein the selecting is based at least in part on the respective power consumption metrics (Robinson ¶0612 “operational parameters can be altered to reduce power requirements and conserve battery life.” ¶0187 “the system can modify operational parameters concurrently, in parallel, or in sequence with changes in transmural pressure to achieve suitable signal with the minimal power expenditure”).
As per claim 10, Allec in view of Robinson further teaches wherein the respective measurement quality metrics associated with the first optical channel and the second optical channel are based at least in part on the first contact pressure and the second contact pressure (Robinson ¶0170 “The apparatus can be configured with mechanisms that change the transmural pressure at the sampling site..” Signal suitability will inherently be determined by the contact pressures. See ¶0174).
As per claim 13, Allec in view of Robinson further teaches the first protrusion comprises a first light-blocking element extending a first height from the internal surface of the housing, and wherein the second protrusion comprises a second light- blocking element extending a second height from the internal surface of the housing (Allec ¶0057 “one or more protrusions can include an isolation that can extend through the protrusion, where the isolation can be configured to separate light rays of the optical components”).
As per claim 14, Allec in view of Robinson further teaches wherein the wearable device comprises a wrist-worn wearable device (Allec ¶0029 “device 200 can be held in an individual's hand or strapped to an individual's wrist, among other possibilities”).
As per claims 15-16, it has limitations similar to claims 1-2 and are rejected for same reasons as above.
Allowable Subject Matter
Claims 6-7, 11-12, 17-18 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. None of references or record anticipate the claims. As per claim 6, it recites features of pressure gradient determination, in combination with features of the device. As per claim 11, 17 they recites features of time intervals in combination with features of the device. Examiner does not further find it obvious to modify references of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797
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