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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 31, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/28/22 and 06/02/23 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on July 31, 2026, amended claims 1, 3-6, 15, 19-23, 25, 26 and 28 have been entered. Claim 27 has been cancelled. New claim 29 has been added.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office
action were fully considered, but are moot in view of the current combination of references that were
necessitated by amendment. Please see prior art section below for more detail, updated citations
(Ocampo and Letourneau references), and updated obviousness rationale.
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 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.
Claims 1, 3-6, 9, 10, 15, 21-23, 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Einck (U.S. Patent Application Publication 2020/0178893A1) and in further view of Pan (U.S. Patent Application Publication 2017/0071268A1), Ocampo (U.S. Patent Application Publication 2019/0307372A1) and Letourneau (U.S. Patent Application Publication 2017/0209313A1)
Einck and Pan were applied in the previous office action
Regarding claim 1, Einck teaches article comprising: a) an adhesive layer having a first major surface and an opposing second major surface [fig. 14, element 120; par. 116, 120], wherein the second major surface includes an adhesive to adhere the adhesive layer to a skin surface [par. 120, Examiner notes any element, including 120, may comprise an adhesive layer to attach to the skin], wherein the adhesive layer defines a first aperture having at least one edge and that is to receive an aqueous fluid from the skin surface [fig. 14, element 126; par. 117], wherein the first major surface of the adhesive layer lacks spontaneous wicking when contacted with the aqueous fluid [par. 116 “the second moisture vapor barrier layer 120 can be water resistant”]; b) a film layer having a first major surface and a second major surface [fig. 14, element 102], wherein the first major surface of the film layer is bonded to the first major surface of the adhesive layer [par. 120, “The testing articles described herein can further include an adhesive layer disposed over any combination of the components”], wherein the film layer defines a second aperture entirely therethrough and that is disposed partially overlapping the first aperture to receive the aqueous fluid from the first aperture [fig. 14, element 108; par. 119], and c) a cover layer disposed on the plurality of capillary channels of the film layer [fig. 14, element 118; par. 116].
However, Einck does not teach and wherein the first aperture is a first elongate slot defined within the adhesive layer; and wherein the second aperture is a second elongate slot defined within the film layer to facilitate direct fluid communication between the first elongate slot and the capillary channels
Ocampo teaches wherein the first aperture is a first elongate slot defined within the adhesive layer [fig. 1, element 200; fig. 2B, element 203]; wherein the second aperture is a second elongate slot [fig. 3A, element 303] defined within the film layer to facilitate direct fluid communication between the first elongate slot and the capillary channels [par. 27, 34]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the first aperture is a first elongate slot defined within the adhesive layer; and wherein the second aperture is a second elongate slot defined within the film layer to facilitate direct fluid communication between the first elongate slot and the capillary channels, for allowing the subject's sweat to enter the wearable patch 100 without the chemical composition of the sweat being affected, as evidence by Ocampo [par. 27]
However, Einck does not teach wherein the second major surface of the film layer is a microstructured surface comprising a plurality of capillary channels each in fluid communication with the second aperture and extending from opposing edges of the second aperture toward a perimeter of the film layer, and wherein a surface of each of the capillary channels exhibits spontaneous wicking when contacted with the aqueous fluid.
Pan teaches wherein the second major surface of the film layer [fig. 7C, element 104] is a microstructured surface comprising a plurality of capillary channels each in fluid communication with the second aperture and extending from opposing edges of the second aperture toward a perimeter of the film layer [fig. 7C, element 702; par. 123], and wherein a surface of each of the capillary channels exhibits spontaneous wicking when contacted with the aqueous fluid [par. 123].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the second major surface of the film layer is a microstructured surface comprising a plurality of capillary channels each in fluid communication with the second aperture and extending from opposing edges of the second aperture toward a perimeter of the film layer, and wherein a surface of each of the capillary channels exhibits spontaneous wicking when contacted with the aqueous fluid, for allowing moisture collection, as evidence by Pan [par. 123]
However, Einck does not teach the second elongate slot overlaps an end of first elongate slot such that the first and second elongate slots co-operatively exhibit a T-shape
Letourneau teaches the second elongate slot overlaps an end of first elongate slot such that the first and second elongate slots co-operatively exhibit a T-shape [fig. 5, element 23, 18, par. 195]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the second elongate slot overlaps an end of first elongate slot such that the first and second elongate slots co-operatively exhibit a T-shape, for dividing the detection layer into two halves, for example, to be used to detect two target substances, as evidence by Letourneau [par. 123]
Regarding claim 3, Pan further teaches a first portion of the plurality of the capillary channels extend from the second aperture to a first edge at the perimeter of the film layer and a second portion of the plurality of the capillary channels extend from the second aperture to an opposing second edge at the perimeter of the film layer [fig. 7C, element 702].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate a first portion of the plurality of the capillary channels extend from the second aperture to a first edge at the perimeter of the film layer and a second portion of the plurality of the capillary channels extend from the second aperture to an opposing second edge at the perimeter of the film layer, for allowing moisture collection, as evidence by Pan [par. 123]
Regarding claim 4, Einck further teaches a first reagent disposed in a first portion of the film layer [par. 117].
However, Einck does not teach capillary channels
Pan teaches capillary channels [fig. 7C, element 702]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate capillary channels, for allowing moisture collection, as evidence by Pan [par. 123]
Regarding claim 5, Einck further teaches a second reagent disposed in a second portion of the film layer [par. 117].
However, Einck does not teach capillary channels
Pan teaches capillary channels [fig. 7C, element 702]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate capillary channels, for allowing moisture collection, as evidence by Pan [par. 123]
Regarding claim 6, Einck further teaches the first reagent, the second reagent, or both is configured to react with a sample and provide a response selected from electrochemical, optical, fluorescent, chemiluminescent, pH adjustment, or a combination thereof [par. 117].
Regarding claim 9, Einck further teaches the cover layer comprises an opaque region and a viewing window region [fig. 14, element 118, 122; par. 116, 117]
Regarding claim 10, Einck further teaches the opaque region comprises indicia related to volume of a sample, chemistry of a sample, or both [par. 95].
Regarding claim 21, Ocampo further teaches the second elongate slot aperture extends along the film layer in a first direction, and wherein the capillary channels extend from the second elongate slot in a second direction transverse the first direction [fig. 3A, elements 302, 303; par. 29-33]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the second elongate slot aperture extends along the film layer in a first direction, and wherein the capillary channels extend from the second elongate slot in a second direction transverse the first direction, for directing the flow of the sweat, as evidence by Ocampo [par. 34]
Regarding claim 22, Ocampo further teaches the first elongate slot extends along the adhesive layer in the first direction [fig. 3A element 303]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the first elongate slot extends along the adhesive layer in the first direction, for allowing the subject's sweat to enter the wearable patch 100 without the chemical composition of the sweat being affected, as evidence by Ocampo [par. 27]
Regarding claim 23, Ocampo further teaches wherein the second aperture exhibits a width and the capillary channels extend from the second aperture a length greater than the width [fig. 3A, elements 302, 303; par. 29-33]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the second aperture exhibits a width and the capillary channels extend from the second aperture a length greater than the width, for directing the flow of the sweat, as evidence by Ocampo [par. 34]
Regarding claim 26, Einck teaches an article, comprising: an adhesive layer including an adhesive to adhere the adhesive layer to a skin surface [fig. 14, element 120; par. 116, 120, Examiner notes any element, including 120, may comprise an adhesive layer to attach to the skin], wherein the adhesive layer defines a first aperture [fig. 14, element 126; par. 117] and comprises a hydrophobic surface [par. 116 “the second moisture vapor barrier layer 120 can be water resistant”]; a film layer [fig. 14, element 102] coupled to the adhesive layer [par. 120, “The testing articles described herein can further include an adhesive layer disposed over any combination of the components”], wherein the film layer defines a second aperture entirely therethrough and at least partially overlapping with the first aperture [fig. 14, element 108; par. 119], and a cover layer disposed over the film layer [fig. 14, element 118; par. 116].
However, Einck does not teach wherein the adhesive layer defines a first elongate slot and the film layer defines a second elongate slot entirely therethrough and at least partially overlapping an end of the first elongate slot
Ocampo teaches wherein the adhesive layer defines a first elongate slot [fig. 1, element 200; fig. 2B, element 203]; and the film layer defines a second elongate slot entirely therethrough and at least partially overlapping an end of the first elongate slot [fig. 3A, element 303; par. 27, 34]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate wherein the adhesive layer defines a first elongate slot and the film layer defines a second elongate slot entirely therethrough and at least partially overlapping an end of the first elongate slot, for allowing the subject's sweat to enter the wearable patch 100 without the chemical composition of the sweat being affected, as evidence by Ocampo [par. 27]
However, Einck does not teach the first and second elongate slots co-operatively exhibit a T-shape
Letourneau teaches the first and second elongate slots co-operatively exhibit a T-shape [fig. 5, element 23, 18, par. 195]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate the first and second elongate slots co-operatively exhibit a T-shape, for dividing the detection layer into two halves, for example, to be used to detect two target substances, as evidence by Letourneau [par. 123]
However, Einck does not teach wherein the film layer defines capillary channels in fluid communication with the second aperture and extending from opposing edges of the second aperture toward a perimeter of the film layer, and wherein a surface of the capillary channel comprises a hydrophilic surface
Pan teaches wherein the film layer defines capillary channels in fluid communication with the second aperture and extending from opposing edges of the second aperture toward a perimeter of the film layer [fig. 7C, element 702; par. 123], and wherein a surface of the capillary channel comprises a hydrophilic surface [par. 123]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, to incorporate he film layer defines capillary channels in fluid communication with the second aperture and extending from opposing edges of the second aperture toward a perimeter of the film layer, and wherein a surface of the capillary channel comprises a hydrophilic surface, for allowing moisture collection, as evidence by Pan [par. 123]
Regarding claim 29, Einck further teaches a cover layer disposed on the plurality of capillary channels of the film layer [fig. 14, element 118; par. 116].
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Einck, Ocampo Pan and Letourneau and in further view of Heikenfeld (U.S. Patent Application Publication 2019/0082999A1).
Heikenfeld was applied in Applicant’s IDS submitted on 09/28/22 and previous office action
Regarding claim 2, Einck, Ocampo, Pan and Letourneau teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck, Ocampo, Pan and Letourneau do not teach wherein the cover layer is attached to the first major surface of the adhesive layer adjacent to the perimeter of the film layer, wherein a height difference between the film layer and the adhesive layer defines a gap between the perimeter of the film layer and the cover layer, and wherein the cover layer defines at least one vent in fluid communication with the gap.
Heikenfeld teaches wherein the cover layer is attached to the first major surface of the adhesive layer adjacent to the perimeter of the film layer, wherein a height difference between the film layer and the adhesive layer defines a gap between the perimeter of the film layer and the cover layer, and wherein the cover layer defines at least one vent in fluid communication with the gap [fig. 7, elements 715, 710; par. 69].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, Ocampo, Pan and Letourneau, to incorporate the cover layer is attached to the first major surface of the adhesive layer adjacent to the perimeter of the film layer, wherein a height difference between the film layer and the adhesive layer defines a gap between the perimeter of the film layer and the cover layer, and wherein the cover layer defines at least one vent in fluid communication with the gap, for securing the microfluidic component to the skin, as evidence by Heikenfeld [par. 69]
Regarding claim 11, Heikenfeld further teaches the cover layer further comprises a sensor [fig. 7, element 721; par, 69].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, Ocampo, Pan and Letourneau, to incorporate the cover layer further comprises a sensor, to measure how full or hydrated the gel or absorbing material is, as evidence by Heikenfeld [par. 69]
Claims 15, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Einck, Ocampo, Pan and Letourneau and in further view of Johnston (U.S. Patent Number 7223364B1).
Johnston was applied in Applicant’s IDS submitted on 09/28/22 and previous office action
Regarding claim 15, Einck, Ocampo, Pan and Letourneau teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck, Ocampo, Pan and Letourneau do not teach the plurality of capillary channels has a surface comprising a surfactant, a surface treatment, a hydrophilic polymer, or a combination thereof
Johnston teaches the plurality of capillary channels has a surface comprising a surfactant, a surface treatment, a hydrophilic polymer, or a combination thereof [col. 7: lines 12-46, col. 12: lines 40-57].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, Ocampo, Pan and Letourneau, to incorporate the plurality of capillary channels has a surface comprising a surfactant, a surface treatment, a hydrophilic polymer, or a combination thereof, to ensure sufficient capillary forces of the film, as evidence by Johnston [col. 12: lines 40-41]
Regarding claim 24, Johnston further teaches each capillary channel is defined by a pair of opposing sidewalls [fig. 1c, element 118]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, Ocampo, Pan and Letourneau, to incorporate each capillary channel is defined by a pair of opposing sidewalls, for forming a secondary channel, as evidence by Johnston [col. 10: lines 25-26]
Regarding claim 25, Johnston further teaches at least one of the plurality of capillary channels is defined by a bottom surface that defines a plurality of secondary channels [fig. 1c, element 134]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, Ocampo, Pan and Letourneau, to incorporate at least one of the plurality of capillary channels is defined by a bottom surface that defines a plurality of secondary channels, for providing smaller channels distributed therein, as evidence by Heikenfeld [col. 8: lines 49-59]
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Einck, Ocampo, Pan and Letourneau, and in further view of Belotserkovsky (U.S. Patent Application Publication 2018/0345288A1).
Belotserkovsky was applied in the previous office action
Regarding claim 28, Einck, Ocampo, Pan and Letourneau, teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck, Ocampo, Pan and Letourneau, do not teach the capillary channels extend orthogonally from the opposing edges toward the perimeter of the film layer
Belotserkovsky teaches the capillary channels extend orthogonally from the opposing edges toward the perimeter of the film layer [fig. 3A, element 303; Examiner notes the aperture is the middle opening and the capillary channels are the openings on either side of the middle portion; par. 260]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Einck, Ocampo, Pan and Letourneau, to incorporate the plurality of capillary channels extend orthogonally from the opposing edges toward the perimeter of the film layer, for introducing liquid through the layer, as evidence by Belotserkovsky [par. 260]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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