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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/18/2026 has been entered by RCE filed on 9/2/2026.
Response to Amendments and Arguments
Applicants’ amendments and arguments filed on 8/18/2026 have been fully considered but are moot because the new ground of rejections. The examiner notes that the new grounds of rejection relies on a different interpretation of the previous reference Lee et al (US 11,559,225). Specifically, the examiner previously relied on element 312 of figures 23, 23a and 26a-c to teach an adhesive layer arranged on an underside of the patch, the adhesive layer being adapted to adhere to human skin (see section 6 of final rejection mailed on 6/4/2026). However, upon further consideration and review of the Lee reference and applicant’s amendments and arguments, newly presented 35 USC 102(a)(1) rejection as anticipated over Lee below relies on column 21, line 42 – column 22, line 2 and figures 23, 23a and 26a-c to which discloses an adhesive layer on the underside of skirt element 326 which extends past the outer periphery of elements 323, 302, 322 and 312 and acts to adhere the patch to the skin. In such an interpretation, the sweat conduction element (combined element 316, 308, 306, 310 and 327) is configured to be arranged between at least a portion of the adhesive layer (portion of the adhesive on the underside of skirt element 326) and the human skin. Therefore, the new interpretation of the Lee reference meets the BRI of the instant claims, at least as broadly as currently recited. The examiner encourages the applicant to recite additional structural difference between Lee and the instant invention to overcome such an interpretation.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5, 7-13, 15, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al (US 11,559,225), at least as broadly as currently recited.
Regarding claims 1, 3-5 and 7-12; Lee discloses a patch for attaching a sensor to human skin (figures 23, 23a and 26a-c), the patch comprising:
an adhesive layer (adhesive layer on underside of skirt element 326) arranged on an underside of the patch, the adhesive layer being adapted to adhere to human skin (column 21, line 1 – column 22, line 41, specifically column 21, line 42 – column 22, line 2; figures 23, 23a and 26a-c);
a protective layer (top surface of electronics module, element 254) arranged on an upper side of the patch, facing away from the underside (column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c); and
a sweat conduction element (wherein the microfluidic channel path, defined by combined elements 316, 308, 306, 310 and vent 327 overlaying outlet port 310, through which sweat is conducted through is made up of substrate body element 302 and defined by adhesive element 316; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c));
wherein the patch has an area (element 350) for receiving the sensor (wherein electronics module element 254 is equivalent of reusable electronic module element 12 and can have a temperature sensor; column 7, line 43 – column 8, line 10; column 21, line 1 – column 22, line 41; figures 3, 23, 23a and 26a-c); ,
wherein the sweat conduction element (microfluidic channel, elements 306) extends in a base surface of the patch (wherein lower disposable part, element 300, acts as the base of the completed patch; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c), and
wherein the sweat conduction element is adjacent to the adhesive layer (wherein the sweat conduction element, defined as combined elements 316, 308, 306, 310 and vent 327 overlaying outlet port 310, is adjacent to the adhesive layer on underside of skirt element 326; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c)
wherein the sweat conduction element (combined elements 316, 308, 306, 310 and vent 327 overlaying outlet port 310) is configured to be arranged between at least a portion of the adhesive layer (portion of adhesive layer on underside and outer periphery of skirt element 326) and the human skin (wherein adhesive on the underside of skirt element 326 overlays entirety of sweat conduction element to press and adhere to the skin to provide a mechanical transition between the mechanical modulus of skin and the modulus of a flexible fluid capture substrate sub-assembly 300a; column 21, line 1 – column 22, line 41, specifically column 21, line 42 – column 22, line 2; figures 23, 23a and 26a-c)
wherein the sweat conduction element (part element 306) is connected to a side surface of the patch or to a peripheral surface of the patch to dissipate sweat to an environment outside of the patch (wherein microfluidic channel has an outlet, element 310, to the outside peripheral surface of the patch to the atmosphere via vent holes element 327; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c)).
Further regarding claim 3; Lee discloses the sweat conduction element is configured as a sweat conduction slit (wherein microfluidic channels, elements 306 meet the BRI of a sweat conduction slit as they are cutout of substrate material, element 304; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 4; Lee discloses the patch comprises a plurality of sweat conduction elements (microfluidic channel, elements 306) including the sweat conduction element and at least another sweat conduction element (wherein Lee discloses there can be more than one microfluidic channel, element 306; column 21, line 1 – column 22, line 41, specifically column 21, lines 14-18; figures 23, 23a and 26a-c).
Further regarding claim 5; Lee discloses the protective layer comprises a material for thermal insulation of the sensor (cover of electronics module, element 254a, is disclosed as being made of a glass-reinforced epoxy laminate material, such as FR4 which has a thermal conductivity of about .25 W/mK, thus making it a good thermal insulator (column 19, lines 32-38), and/or wherein the adhesive layer comprises an adhesive selected from silicone adhesive, acrylic adhesive and/or hydrogel
Examiner’s Note: the broadest reasonable interpretation (BRI) of “and/or” is “or”, and thus Lee discloses the BRI of the claim 5 as it discloses the first limitation of the protective layer comprises a material for thermal insulation of the sensor. For the sake of advancing prosecution, the examiner further noted that Lee discloses the use of an adhesive (element 312), but is silent to what the adhesive is made of, but would be obvious in a 35 USC 103 rejection in view of MPEP 2144.05.
Further regarding claim 7; Lee discloses an electrically conductive element (element 318 and 320) in or on the adhesive layer (wherein electrical traces can be on bottom of element 322, which would be adjacent/on adhesive element on the bottom of element 326), wherein the electrically conductive element is arranged to form an electrical connection between the human skin and the sensor (wherein the electrodes and electrical traces would provide an electrical connection to the skin when sweat is present; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 8; Lee discloses the protective layer (electronics module, element 254) is configured to form a first structural unit (interchangeable electronics module), wherein the adhesive layer is arranged to form a second structural unit (element 300) and, and wherein the second structural unit (element 300) is detachably connected to the first structural unit, so that the first structural unit is reusable (wherein electronics module, element 254, is connectable and removeable from adhesive patch, element 300, via connection means elements 350, 352 and 354; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 9; Lee discloses the sensor is configured as a temperature sensor and/or as a heat flow sensor (wherein it is disclosed that the electronics module, element 254, can include a temperature sensor; column 7, line 43 – column 8, line 10, column 21, line 1 – column 22, line 41; figures 3, 23, 23a and 26a-c).
Further regarding claim 10; Lee discloses the patch comprising the sensor (wherein combined patch of element 254 and element 300 includes the temperature sensor in the electronics module; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 11; Lee discloses the protective layer is not interrupted by perforations or other ventilation openings (wherein the examiner notes that element 254a of electronics module is the protective layer on the top of the patch and is uninterrupted by perforations or other ventilation openings; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 12; Lee discloses the base surface of the patch defines a skin contacting surface configured to contact the skin, the sweat conduction element being configured to be adjacent the skin (wherein the examiner notes that element 316 acts as part of the sweat conduction element and is adjacent to the skin when placed on the body; see figure 23)
Regarding claims 13, 15, 17, 19 and 20; Lee discloses a patch for attaching a sensor to human skin (figures 23, 23a and 26a-c), the patch comprising:
a patch structure (figures 23, 23a and 26a-c) comprising:
an adhesive layer (adhesive layer on underside of skirt element 326) arranged on an underside of the patch, the adhesive layer being adapted to adhere to human skin (column 21, line 1 – column 22, line 41, specifically column 21, line 42 – column 22, line 2; figures 23, 23a and 26a-c);
a protective layer (top surface of electronics module, element 254) arranged on an upper side of the patch, facing away from the underside (column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c); and
a sweat conduction element (wherein the microfluidic channel path, defined by combined elements 316, 308, 306, 310 and vent 327 overlaying outlet port 310, through which sweat is conducted through is made up of substrate body element 302 and defined by adhesive element 316; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c));
wherein the patch has an area (element 350) for receiving the sensor (wherein electronics module element 254 is equivalent of reusable electronic module element 12 and can have a temperature sensor; column 7, line 43 – column 8, line 10; column 21, line 1 – column 22, line 41; figures 3, 23, 23a and 26a-c); ,
wherein the sweat conduction element (microfluidic channel, elements 306) extends in a base surface of the patch (wherein lower disposable part, element 300, acts as the base of the completed patch; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c), and
wherein the sweat conduction element is adjacent to the adhesive layer (wherein the sweat conduction element, defined as combined elements 316, 308, 306, 310 and vent 327 overlaying outlet port 310, is adjacent to the adhesive on the underside of skirt element 326 which adheres to the skin; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c)
wherein the sweat conduction element (combined elements 316, 308, 306, 310 and vent 327 overlaying outlet port 310) is configured to be arranged between at least a portion of the adhesive layer (portion of adhesive layer on underside and outer periphery of skirt element 326) and the human skin (wherein adhesive on the underside of skirt element 326 overlays entirety of sweat conduction element to press and adhere to the skin to provide a mechanical transition between the mechanical modulus of skin and the modulus of a flexible fluid capture substrate sub-assembly 300a; column 21, line 1 – column 22, line 41, specifically column 21, line 42 – column 22, line 2; figures 23, 23a and 26a-c)
wherein the sweat conduction element (elements 306) is connected to a side surface of the patch or to a peripheral surface of the patch to dissipate sweat to an environment outside of the patch (wherein microfluidic channel has an outlet, element 310, to the outside peripheral surface of the patch to the atmosphere via vent holes element 327; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c)).
Further regarding claim 15; Lee discloses the sweat conduction element is configured as a sweat conduction slit (wherein microfluidic channels, elements 306 meet the BRI of a sweat conduction slit as they are cutout of substrate material, element 304; column 21, line 1 – column 22, line 41; figures 23, 23a and 26a-c).
Further regarding claim 16; Lee discloses the patch comprises a plurality of sweat conduction elements (microfluidic channel, elements 306) including the sweat conduction element and at least another sweat conduction element, wherein a portion of the adhesive layer is located between the sweat conduction element and the at least another sweat conduction element (wherein Lee discloses there can be more than one microfluidic channel, element 306, and the adhesive layer, adhesive on the underside of skirt element 326, is located between sweat conduction elements when viewed from an angle looking through a side cross section of figure 23, i.e. the parts of the adhesive that extend across the width of the body would extend between adjacent microfluidic channel elements 306 from the side cross-sectional view; column 21, line 1 – column 22, line 41, specifically column 21, lines 14-18; figures 23, 23a and 26a-c).
Further regarding claim 17; Lee discloses the protective layer comprises a material for thermal insulation of the sensor (cover of electronics module, element 254a, is disclosed as being made of a glass-reinforced epoxy laminate material, such as FR4 which has a thermal conductivity of about .25 W/mK, thus making it a good thermal insulator (column 19, lines 32-38), and/or wherein the adhesive layer comprises an adhesive selected from silicone adhesive, acrylic adhesive and/or hydrogel
Examiner’s Note: the broadest reasonable interpretation (BRI) of “and/or” is “or”, and thus Lee discloses the BRI of the claim 5 as it discloses the first limitation of the protective layer comprises a material for thermal insulation of the sensor. For the sake of advancing prosecution, the examiner further noted that Lee discloses the use of an adhesive (element 312), but is silent to what the adhesive is made of, but would be obvious in a 35 USC 103 rejection in view of MPEP 2144.05.
Further regarding claim 19; Lee discloses the base surface of the patch defines a skin contacting surface configured to contact the skin, the sweat conduction element being configured to be adjacent the skin (wherein the examiner notes that element 316 acts as part of the sweat conduction element and is adjacent to the skin when placed on the body; alternatively the inlet element 308 of microfluidic channel element 306 is placed adjacent to the skin as there is nothing in between the inlet element 308 and the skin; see figure 23).
Further regarding claim 20; Lee discloses the base surface of the patch structure defines an outer surface of the patch structure, the outer surface being configured to contact the skin, the sweat conduction element defining a portion of the outer surface of the patch structure (wherein the examiner notes that element 316 acts as part of the sweat conduction element and defines the outer surface of the base, the outer surface defines by the base of the patch and the adhesive is adjacent to the skin when placed on the body; alternatively the inlet element 308 of microfluidic channel element 306 is part of the outer surface and is placed adjacent to the skin as there is nothing in between the inlet element 308 and the skin; see figure 23).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 6, 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 11,559,225 B1).
Regarding claims 2, 6, 14 and 18; Lee is described in the rejection of claims 1 and 13 above; however, the third embodiment of Lee depicted in figures 23, 23a and 26a-c and relied for the rejection of claims 1 and 13 does not explicitly disclose the sweat conduction element comprises a sweat conduction material, wherein the sweat conduction material comprises a material selected from a porous plastic fiber composite, a sintered porous plastic, and/or a textile.
Lee does teach an alternative embodiment in figure 13 wherein the sweat conducting element (element 206) is a sweat conducting material, wherein the sweat conducting material comprises a material selected from a porous plastic fiber composite, a sintered porous plastic, and/or a textile (column 17, lines 22-60; figure 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to substitute the sweat conducting element of Lee’s third embodiment (element 302) with an alternative sweat conducting element made of a sweat conducting material comprises a material selected from a porous plastic fiber composite, a sintered porous plastic, and/or a textile of Lee’s embodiment of figure 13, as simple substitution of one known element for another to yield a predictable result (Lee’s third embodiment wherein flexible substrate layer 302 with the microfluidic channels is replaced by a sweat conducting of sweat conducting material, element 206, from Lee’s embodiment depicted in figure 13).
Further regarding claim 6 and 18; Lee discloses the sweat conducting material comprises a textile (wherein the examiner notes that cotton, polyester, and nylon are examples of textiles; column 17, lines 43-49).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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