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 .
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 March 6, 2026, no amended claims have been entered. Claims 7 and 18 have been cancelled. New claims 27 and 28 have 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 were not persuasive.
Applicant argues Einck does not teach a film layer that defines a second aperture entirely therethrough. Examiner disagrees and notes that Einck teaches that the wick can be made from a porous medium through which a fluid of a test subject can move via capillary action [par. 91]. Examiner interprets this to indicate an aperture in the wick, which is a part of the film layer that overlaps opening 126 [fig. 14]. Therefore, this equates to a film layer that defines a second aperture entirely therethrough, when taking into consideration broadest reasonable interpretation.
Applicant also argues that modifying Einck with the teachings of Pan would render the testing article in Einck unsatisfactory for its intended purpose. Specifically, Applicant argues the regions 102 of Pan would render Einck unsatisfactory for its intended purpose. However, Examiner explicitly recites the capillary function of elements 702 to be used in Einck, which would allocate the sweat to its intended region and allow Einck to serve its intended purpose, when taking into consideration broadest reasonable interpretation.
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 and 26 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).
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 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]
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 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 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]
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Einck and Pan 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 and Pan teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck and Pan 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 and Pan, 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 and Pan, 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 and Pan 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 and Pan teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck and Pan 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 and Pan, 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 and Pan, 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 and Pan, 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]
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Einck and Pan and in further view of Castiglione (U.S. Patent Application Publication 2003/0211291A1).
Castiglione was applied in the previous office action
Regarding claim 21, Einck and Pan teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck and Pan do not teach the second aperture comprises an elongate aperture that extends along the film layer in a first direction, and wherein the plurality of capillary channels extend from the second aperture in a second direction transverse the first direction
Castiglione teaches the second aperture comprises an elongate aperture that extends along the film layer in a first direction [fig. 5, element 105; par. 72], and wherein the plurality of capillary channels extend from the second aperture in a second direction transverse the first direction [fig. 5, element 82; par. 72]
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 and Pan, to incorporate the second aperture comprises an elongate aperture that extends along the film layer in a first direction, and wherein the plurality of capillary channels extend from the second aperture in a second direction transverse the first direction, for moving the liquid over the structured surface, as evidence by Castiglione [par. 72]
Regarding claim 23, Castiglione teaches the second aperture exhibits a width and the plurality of capillary channels extend from the second aperture a length greater than the width [fig. 5, element 82]
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 and Pan, to incorporate the second aperture exhibits a width and the plurality of capillary channels extend from the second aperture a length greater than the width, for moving the liquid over the structured surface, as evidence by Castiglione [par. 72]
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Einck, Pan and Castiglione and in further view of Rao (U.S. Patent Application Publication 2018/0303388A1).
Rao was applied in Applicant’s IDS submitted on 09/28/22 and the previous office action
Regarding claim 22, Einck, Pan and Castiglione teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above
However, Einck, Pan and Castiglione do not teach the first aperture comprises an elongate aperture that extends along the adhesive layer in the first direction.
Rao teaches the first aperture comprises an elongate aperture that extends along the adhesive layer in the first direction [fig. 2, element “white backing adhesive tape with sweat sample port”; par. 47]
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, Pan and Castiglione, to incorporate the first aperture comprises an elongate aperture that extends along the adhesive layer in the first direction, for sampling sweat, as evidence by Rao [par. 47]
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Einck and Pan and in further view of Belotserkovsky (U.S. Patent Application Publication 2018/0345288A1).
Regarding claim 27, Einck and Pan teach an article comprising an adhesive layer, a film layer and a cover layer, as disclosed above.
However, Einck and Pan do not teach the second aperture is an elongate slot defined within the film layer to facilitate direct fluid communication between the second aperture and the capillary channels
Belotserkovsky teaches the second aperture is an elongate slot defined within the film layer to facilitate direct fluid communication between the second aperture and the capillary channels [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 and Pan, to incorporate the second aperture is an elongate slot defined within the film layer to facilitate direct fluid communication between the second aperture and the capillary channels, for introducing liquid through the layer, as evidence by Belotserkovsky [par. 260]
Regarding claim 28, Belotserkovsky further teaches the plurality of 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 and Pan, 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
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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