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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1 May 2026 has been entered.
Response to Arguments
Applicant’s argument on Page 8 regarding the objection to the drawings has been fully considered. The objection to the drawings is withdrawn in view of the amendments.
Applicant’s argument on Page 8 regarding the objections to Claims 3, 12, 15, and 17-18 has been fully considered. The objections to Claims 3, 12, 15, and 17-18 are withdrawn in view of the amendments.
Applicant’s argument on Page 9 regarding the rejection of Claim 8 under 35 U.S.C. 112(b) has been fully considered. The rejection of Claim 8 under 35 U.S.C. 112(b) is withdrawn in view of cancelation of the claim.
Applicant’s argument on Pages 9-16 regarding the rejection of Claims 1, 3-5, 8-13, and 18-19 under 35 U.S.C. 102(a)(1) as being anticipated by Russomanno has been fully considered but is not persuasive under new grounds of rejection as below.
Applicant’s argument on Pages 17-18 regarding the rejection of Claims 6-7 under 35 U.S.C. 103 over Russomanno in view of LeBoeuf has been fully considered but is not persuasive under new grounds of rejection.
Applicant’s argument on Pages 18-19 regarding the rejection of Claims 17 under 35 U.S.C. 103 over Russomanno in view of Lim and Ontiveros has been fully considered but is not persuasive under new grounds of rejection.
Regarding the rejection of all remaining corresponding claims, applicant’s argument submitted on Pages 16 and 18 relies on the supposed deficiencies with respect to the rejection of parent Claim 1. Applicant’s argument is moot for the same reasons detailed above.
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, 3-7, 9-13, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondo et al. (US 20090264774).
Regarding Claim 1, Kondo teaches a wearable sensor device for contacting skin, (Fig. 2 and [0085] “ear-type sphygmomanometer 1”), comprising:
a) a hollow, flexibly deformable protrusion comprising a base and a flat apex, at least part of the flat apex forming a contact area for contacting the skin (Figs. 2 and 6-7, Abstract “The present invention enables making uniform contact with the tragus using inner and outer cuffs, each of said inner and outer cuffs being comprised of a cuff member 40 connected to a duct 4 and a cuff bladder 22 having a body 27 which is fixed onto said cuff member” and [0111] “cuff bladder 22 is integrally molded in a hat-like shape with a body 27 which elastically deforms when pressure is added/withdrawn and a lid 23 having a flat pressing surface 25 extended from the body and protruding and making contact with the tragus.”);
b) an optical sensor module, (Fig. 19), comprising at least a light emitting element, ([0158] “LED 20 as a light-emitting element”), and a light sensor element, ([0158] “phototransistor as a light-receiving element”), that are independently mounted, (Fig. 12), the optical sensor module being mounted on or inside the hollow, flexibly deformable protrusion, (Fig. 12), the optical sensor module being mounted on or against the contact area formed by the at least part of the flat apex of the hollow, flexibly deformable protrusion (Fig. 12); and
c) a wearable sensor device fixating structure configured to press the contact area with a constant pressure against the skin, (Fig. 6), wherein, when the contact area is pressed against the skin, an increase of a force exerted on the wearable sensor device deforms the hollow, flexibly deformable protrusion such that the contact area that is in contact with the skin increases, while the pressure stays the same ([0090] “the pressing surface evenly contacts the tragus 221”).
Regarding Claim 3, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches herein the base is configured as a flexible joint region connecting the protrusion to the wearable device fixating structure, the flexible joint region providing flexible movement of the protrusion in rotational, translational and/or angular directions relative to the base (Fig. 2 and [0140] “The duct 4 is a flexible structure which can be freely bent”).
Regarding Claim 4, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein at least part of the optical sensor module is fixated inside the protrusion against a sheet material forming the contact area of the protrusion (Fig. 12, and [0128] “light permeable layer 30”).
Regarding Claim 5, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the hollow, flexibly deformable protrusion is made of an elastomeric sheet material ([0117] “The cuff bladder 22 is integrally molded from an elastic material including silicon rubber, natural rubber and predetermined synthetic resin materials”).
Regarding Claim 6, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein at least part of the contact area is made of a flexible opaque material, the contact area further comprising one or more transparent windows of a flexible optically transparent material, ([0128] “forming the cuff bladder 22 from a material that does not transmit light and forming a light permeable layer 30 on the pressing surface 25”), the light emitting element and the light sensor element being mounted against a backside side of the contact area in alignment with the one or more transparent windows (Fig. 12).
Regarding Claim 7, Kondo teaches all limitations of Claim 6, as discussed above. Furthermore, Kondo teaches wherein a surface of the contact area comprises one or more recesses at a position of the one or more transparent windows, the one or more recesses being configured to house at least part of the light emitting element and the light sensor element respectively (Fig. 12, where “31” houses LED 20 and light receiving element 21).
Regarding Claim 9, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the protrusion comprises a cavity or a chamber formed by the apex and one or more side walls connecting the apex to the base (Figs. 7-10 and 12).
Regarding Claim 10, Kondo teaches all limitations of Claim 9, as discussed above. Furthermore, Kondo teaches wherein at least part of the one or more side walls have a convex shape so that when the protrusion is deflected and/or compressed, the one or more side walls will deflect outwardly (Fig. 10).
Regarding Claim 11, Kondo teaches all limitations of Claim 9, as discussed above. Furthermore, Kondo teaches wherein cross-sectional dimensions of the protrusion at a joint region are smaller than cross-sectional dimensions of the protrusion at a height of the side walls (Figs. 8-10).
Regarding Claim 12, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the sensor device further comprises a housing comprising electronics for processing sensor signals of the optical sensor module, one or more strips of a flexible and/or stretchable Printed Circuit Board (PCB) electrically connecting the optical sensor module to the electronics (Fig. 19 and [0158] “the interior of the inner cuff assembly 6 of the holding member 3 to be attached to the tragus incorporates the LED 20 as a light-emitting element and the phototransistor 21 as a light-receiving element forming a photoplethysmographic sensor (pulse wave sensor).”).
Regarding Claim 13, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the optical sensor module includes a first sensor element mounted against a first part of an inner side of a material forming the contact area and a second sensor element mounted against a second part of the inner side of the material forming the contact area so that, when an outer surface of the contact area is pressed against the skin, the first sensor element can have an orientation that is different from the orientation of the second sensor element (Fig. 6, inner cuff assembly 6, outer cuff assembly 7).
Regarding Claim 15, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the wearable senor device fixating structure is configured to fixate the contact area against the skin of a backside of an ear ([0180] “one cuff can press the blood vessel (arteriole) on the back side of the external ear and its periphery, and the other cuff can press the superficial temporal artery or its branched blood vessel on the front side of the external ear and its periphery”).
Regarding Claim 16, Kondo teaches all limitations of Claim 9, as discussed above. Furthermore, Kondo teaches wherein the chamber or cavity of the protrusion is airtight, (Figs. 8-10, where one of ordinary skill in the art would understand the design is airtight in order to be pressurized from the condenser tank 107.), and the chamber or cavity is filled with a compressible material ([0132] “the body 27 expands when air pressure is applied from a pressurizing pump 108 via a condenser tank 107”).
Regarding Claim 17, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the wearable sensor device is configured as an ear sensor, the wearable sensor device fixating structure including an ear hook of an elastic material configured to press the contact area against skin of a backside of an ear, (Fig. 6), a first end of the ear hook being sphere shaped contact structure, ([0087] “a tip 54 of the ear mounting member 51 is formed such that it curves toward the viewing position (ie.--toward the observer of the Fig.), and forms a sphere 54a at the tip.”), the sphere shaped contact structure a spherical element and a balloon-structure of a flexible sheet material formed around the spherical element ([0105] “By attaching the cuffs to the holding member 3 via a swivel, it is possible to flexibly accommodate differently shaped tragi of various individuals” and [0180] “one cuff can press the blood vessel (arteriole) on the back side of the external ear and its periphery, and the other cuff can press the superficial temporal artery or its branched blood vessel on the front side of the external ear and its periphery”).
Regarding Claim 18, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the wearable sensor device is configured to be attached to a body part, and further comprising:
a) a protective casing, ([0096] “protector 10”), comprising a top surface, side walls and a bottom surface (Fig. 6); and
b) the bottom surface including a peripheral part, the flexibly deformable protrusion being flexibly connected to the peripheral part, (Fig. 6), the peripheral part including a surface for positioning the wearable sensor device against the skin ([0098] “the tip of the protector 10 is covered with a cushion 15 made from sponge in order to eliminate discomfort when making contact with the temporal region of the examinee's head.”); and
c) wherein the wearable sensor device fixating structure is configured to fixate the peripheral part against the skin, ([0098] “the tip of the protector 10 is covered with a cushion 15 made from sponge in order to eliminate discomfort when making contact with the temporal region of the examinee's head.”), and/or wherein the contact area of the protrusion extends beyond the surface of the peripheral part, so that when the wearable sensor device is fixated against the skin, the contact area will be pressed against the skin with a predetermined pressure (Fig. 6).
Regarding Claim 19, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the protrusion is a cushion or a balloon-shaped protrusion (Abstract “The present invention enables making uniform contact with the tragus using inner and outer cuffs, each of said inner and outer cuffs being comprised of a cuff member 40 connected to a duct 4 and a cuff bladder 22 having a body 27 which is fixed onto said cuff member” and Claim 2 “cuff member is formed in a shape which is congruent to said body,” where cuff bladder 22 is interpreted as a balloon-shaped protrusion.).
Regarding Claim 20, Kondo teaches all limitations of Claim 1, as discussed above. Furthermore, Kondo teaches wherein the wearable sensor device fixating structure includes a flexible clamping structure for clamping the optical sensor module around an ear so that the contact area is pressed against the skin of a backside of the ear ([0085] “ear mounting member 51” and [0180] “one cuff can press the blood vessel (arteriole) on the back side of the external ear and its periphery, and the other cuff can press the superficial temporal artery or its branched blood vessel on the front side of the external ear and its periphery”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kondo et al. (US 20090264774) in view of Taji et al. (“Effect of Pressure on Skin-Electrode Impedance in Wearable […]”).
Regarding Claim 2, Kondo teaches all limitations of Claim 1, as discussed above. However, Kondo does not explicitly teach wherein the pressure is smaller than 8 kPa.
In an analogous wearable biomedical measurement device field of endeavor, Taji teaches a wearable sensor device for contacting skin, (Abstract “This research investigates the effect of applied pressure on the skin-electrode impedance.”), wherein the pressure is smaller than 8 kPa (III. Methodology, B. Measurement set up, 2) Experimental procedures “the cuff was alternating between 0 Pa to 4 kPa.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modifying the teachings of Kondo with the pressure Taji because the modification keeps the discomfort of the patient to a minimum, thereby allowing continuous measurement of the patient by the sensors.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kondo et al. (US 20090264774) in view of Williams et al. (US 20170118838).
Regarding Claim 14, Kondo teaches all limitations of Claim 1, as discussed above. However, Kondo does not explicitly teach wherein the optical sensor module comprises an elongated rigid Printed Circuit Board (PCB) having a longitudinal axis and a transversal axis, the rigid PCB comprising two or more sensors elements mounted thereon and at least two flexible PCB strips, each flexible PCB strip being connected to a long side of the rigid PCB so that the rigid PCB can rotate about its longitudinal axis and its transversal axis.
In an analogous 3D bendable printed circuit board field of endeavor, Williams teaches a wearable sensor device for contacting skin, ([0717] “The combination of rigid-flex PCB fabrication, distributed PCB designs, and electrical redundancy can be applied for a variety of wearable electronics and medical devices.”), wherein the optical sensor module comprises an elongated rigid Printed Circuit Board (PCB) having a longitudinal axis and a transversal axis, ([0044] “rigid PCBs 190A, 190B, and 190C,” where the PCBs have a longitudinal axis and a transversal axis by design.), the rigid PCB comprising two or more sensors elements mounted thereon, ([0528] “sensor elements 498 are distributed over an area in every rigid PCB in a matrix”), and at least two flexible PCB strips, ([0528] “three flex 299 connectors, i.e. PCB 303; four flex connected PCBs 304, and five flex connected PCBs 305.”), each flexible PCB strip being connected to a long side of the rigid PCB so that the rigid PCB can rotate about its longitudinal axis and its transversal axis (Fig. 37B, where because the device may be implemented as a wearable, rotation about the axes (flexing, movement, compression) is understood to occur.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify the teachings of Kondo with the optical sensor module of Williams because the combination allows absorption of mechanical stress, as taught by Williams in [0005], while also offering “versatility for conforming electronic devices to unusual and curved surfaces of the human body,” further taught by Williams in [0717].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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