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 .
Response to Amendment
This office action is responsive to the applicant’s amendments and arguments/remarks filed on 5/14/2026.
The claim status are as follows:
Claim 1 was amended
Claims 12-20 were added.
The received amendments are compliant and entered into the file on record. The content of the amendments is discussed in the response to arguments and claim rejections in the instant office action.
Response to Arguments
Applicant’s amendments and arguments/remarks with regards to the 35 USC 112(b) rejection, see the applicants’ response filed 5/14/2026, have been fully considered and are persuasive. The applicant has amended the claims to recite that “the sweat conduction element 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” cures the indefinite issue to the previous recitation of “a patch outside”. Accordingly, the 35 USC 112(b) rejection of claims 1-11 has been withdrawn.
Applicant's amendments and arguments/remarks filed 5/14/2026 with regard to the 35 USC 102 and 103 rejections, have been fully considered but they are not persuasive. Specifically, the applicant has amended the claims to recite “wherein the sweat conduction element is adjacent to the adhesive layer” and argues that the Lee reference (US 11,559,225) does not disclose or suggest a sweat conduction element that is adjacent to an adhesive layer. The examiner finds this amendment and argument to be non-persuasive for at least the following reasons. First, the examiner contends that Lee’s disclosure still meets the broadest reasonable interpretation of the applicant’s amendment that “the sweat conduction element is adjacent to the adhesive layer”. Specifically, Lee discloses a sweat conduction element (cited in the previous office action as elements 306) and an adhesive layer (cited in the previous office action as elements 312), wherein the sweat conduction element 306 is adjacent to the adhesive layer (see figure 23). The examiner notes that the term “adjacent” is defined by dictionary.com as “lying near, close or continuous; adjoining; neighboring” (see screenshot below) from https://www.dictionary.com/browse/adjacent
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The examiner notes that using the plain definition of adjacent, that the adhesive layer (element 312) of Lee lies “near, close, and neighboring” to the sweat conduction element (element 306) of Lee in figure 23, and thus meets the BRI of the claim as currently recited as the claim does not recite directly adjacent or that the adhesive layer is touching the sweat conduction element. Furthermore, in arguendo that “adjacent” meant directly adjacent or directly neighboring, the examiner contends that Lee contemplates and discloses disposing the adhesive adjacent to the sweat conduction elements (elements 306) in column 21, line 1 – column 22, line 15, specifically column 21, lines 11-22 (bolded for emphasis):
“The flexible fluid capture substrate 300 is similar to the flexible fluid capture substrates 120 and is also configured to be worn on a human body. The flexible fluid capture substrate 30 includes a flexible substrate body 302 having a first, outwardly facing surface 304, a second, skin-facing surface (not shown), and one or more sweat collection or microfluidic channels 306 formed in the flexible substrate body 302. Each microfluidic channel 306 has a first end defining a sweat inlet port 308, and a second end defining a sweat outlet port 310. The skin-facing surface (not shown) includes an adhesive, such as the patterned or striated adhesive 312, that bonds to skin of the wearer, and may be covered by a removable adhesive liner 314 formed from any desired flexible and air/oxygen impermeable material. The striated adhesive 312 also defines fluidic channels that prevent sweat from building up underneath the flexible fluid capture substrate 300, and also includes an opening 316 having a diameter larger than a diameter of the sweat inlet port 308, and configured to allow sweat to pool or accumulate on the skin and to be forced into the sweat inlet port 308.”
Finally, even if one were to further argue that Lee’s flexible substrate (element 322) is interposed between element 302 (substrate in which sweat detection element 306 is formed) and adhesive (element 312), the examiner contends that the claims would still meet the BRI of the claim as elements 308 and 316 of Lee are part of the sweat conduction element (as sweat pools within 316, enters opening 308 and moves through channel 306 until it vents to the external environment through outlet port 310 through vents in element 326, thus forming the entirety of sweat conduction path [wherein examiner notes that as a result of the amendment, the rejection is update to define the sweat conduction element as the combined elements 316, 308, 306, 310 and 327]). In such an interpretation, since element 316 is part of the sweat conduction element, it is adjacent to the adhesive elements 312 as depicted in figure 23 and described in column 21, lines 22-28.
Accordingly, the applicant’s amendments and arguments/remarks have been full considered, but are found to be non-persuasive in view of the examiner’s updated rejection and response to arguments provided herein show that Lee discloses that the adhesive element 312 is adjacent to the sweat conduction element (combined 316, 308, 306, 310 and vent 327 overlaying outlet port 310).
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).
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 (element 312) 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; 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 element 312; also element 306 is lies near adhesive layer element 312 which meets the BRI of adjacent; column 21, line 1 – column 22, line 41; 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 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 312), 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 (element 312) 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; 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 element 312; also element 306 is lies near adhesive layer element 312 which meets the BRI of adjacent; column 21, line 1 – column 22, line 41; 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, element 312, is located between sweat conduction elements when viewed from an angle looking down at the non-skin contacting side of the patch, 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 top down 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 et al (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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2023/0157587 A1 to Javey et al; discloses a wearable patch for continuous analysis of sweat at a naturally secreting rate wherein the patch contains a sweat conducting element (hydrophilic spacer element 102) adjacent to an adhesive layer (element 110) of the patch (see figure 1).
US 12,487,204 B2 to Heikenfeld; discloses a sweat sensing patch that includes sweat conducting elements (element 234) adjacent to an adhesive layer (element 210) (see figure 2).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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