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
The amendment filed 07/06/2026 has been entered. New claims 17-21 are acknowledged. Claims 1-21 remain pending in the application.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 3-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samarasekera et al. (US 20240382963 A1) in view of Pollack (US 20150212043 A1).
Regarding claim 1, Samarasekera discloses an apparatus for transporting sweat droplets (title, [0048]: “sweat”), the apparatus comprising: a plurality of chambers ([0023]: “a plurality of multi-outlet dispensers”) defined in a substrate ([0023]: "(b) a bottom substrate, the bottom substrate having a plurality of droplet operations electrodes, wherein the top substrate and bottom substrate are space apart from the bottom substrate forming a droplet operations gap therebetween"), each of the chambers having an inlet for receiving sweat from the skin ([0173]: “can be left near the outlet 132-2 of dual-sided dispenser 130, which is the gap height h3-portion of dual-sided dispenser 130”, Fig 39A inlet at element 132-1 leading into the chamber defined by h1), and an outlet arranged such that a sweat droplet forms and protrudes therefrom following filling of the chamber with sweat ([173]: ““prime” droplet 554 at outlet 132-2..”, Fig 39A outlet at 132-2); and an electrowetting arrangement ([0049]: “the manipulation of droplets by a droplet actuator may be electrode mediated, e.g., electrowetting mediated”) comprising: a plurality of electrodes (Fig 39 elements 113 and 114) , each electrode being electrically chargeable and dischargeable ([0047]: “affecting a change in the electrical state of the one or more electrodes which, in the presence of a droplet, results in a droplet operation. Activation of an electrode can be accomplished using alternating current (AC) or direct current (DC)”), wherein the electrowetting arrangement comprises first, second, and third limbs of electrodes (Fig 32 elements 118-1, 118-2, 118-3, [0166]: “dual-sided dispenser 130… dual-sided dispenser 130 is shown and described hereinbelow with reference to FIG. 39A through FIG. 39F.”, wherein the element 130 in fig 32 corresponds to the element 130 disclosed in fig 38) configured to permit transport of the sweat droplets to or towards a central region from the first group in the case of the first limb, to or towards the central region from the second group in the case of the second limb, and to or towards the central region from the third group in the case of the third limb by charging and discharging of the electrodes ([0076]: " can include an electrode arrangement 112 that can include, but is not limited to, any arrangements (e.g., lines, paths, arrays) of droplet operations electrodes 114 (i.e., electrowetting electrodes) that can be used to fluidly connect any arrangements of one or more reservoirs 116, one or more localized surface plasmon resonance (LSPR) sensors 120, and one or more multi-sided or multi-outlet dispensers 130.", Fig 32 element 112); and a conductive trace arrangement arranged to electrically connect electrodes of the first, second, and third limbs to each other (Fig 32, [0049]: “a conductive material (e.g., an epoxy, such as MASTER BOND™ Polymer System EP79, available from Master Bond, Inc., Hackensack, NJ) provides the electrical connection between electrodes on one substrate and electrical paths on the other substrates, e.g., a ground electrode on a top substrate may be coupled to an electrical path on a bottom substrate by such a conductive material” wherein the limbs are connected via conductive paths along electrodes), wherein the plurality of electrodes comprises a plurality of sets of electrodes (Fig 32 element 112 consisting of the electrode squares along 118-1, 118-2, and 118-3), each set comprising electrodes from the first, second and third limbs which are connected to each other (Fig 32 elements 118-1, 118-2, and 118-3), and wherein a first conductive trace included in the conductive trace arrangement is configured to connect one of the electrodes of the first limb to one of the electrodes of the second limb (Fig 32 electrodes along line 304, see arrows in Fig 24, [0049]: “a conductive material… provides the electrical connection between electrodes on one substrate and electrical paths on the other substrates”), and a second conductive trace included in the conductive trace arrangement is configured to connect said one of the electrodes of the second limb to one of the electrodes of the third limb (Fig 32 connections along line 302, see arrows in Fig 20, [0049]), wherein at least one further conductive trace is included in the conductive trace arrangement and configured to connect electrodes within one of first, second, and third limbs to each other (Fig 32 connections along line 300, see arrows in Fig 10, [0049]).
While Samarasekera discloses wherein the outlets are grouped around a central portion of the surface of the substrate to define at least first, second and third groups of chambers ([0078]: “On-cartridge reservoirs 116, for example, can be formed of particular arrangements of droplet operations electrodes 114, such as shown in FIG. 6 through FIG. 32 .” Fig 32 wherein the limbs are grouped around central portion 116-2), they fail to disclose wherein the outlets are radially grouped around a central portion.
Pollack discloses an apparatus (100) for transporting sweat droplets (title, [0024]: “sweat”) wherein the outlets are radially grouped around a central portion of the surface of the substrate to define at least first, second and third groups of chambers (Fig 4, [0046]: “electrode arrangement 400 provides a radial architecture in which four reservoir electrodes 410 (e.g., reservoir electrodes 410A, 410B, 410C, and 410D) are arranged substantially equal distance from a 4.times.4 array of outlet electrodes 118.”),
As Samarasekera discloses multiple arrangements ([0076]: “an electrode arrangement 112 that can include, but is not limited to, any arrangements (e.g., lines, paths, arrays) of droplet operations electrodes 114 (i.e., electrowetting electrodes) that can be used to fluidly connect any arrangements of one or more reservoirs 116”), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known grouping disclosed by Samarasekera with the known radial grouping disclosed by Pollack for the predictable result of guiding a sample towards a central region.
Regarding claim 3, Samarasekera further discloses wherein the first limb comprises at least one series of first electrodes ([0076]: “arrangements (e.g., lines, paths, arrays) of droplet operations electrodes 114 (i.e., electrowetting electrodes) that can be used to fluidly connect any arrangements of one or more reservoirs 116”), each first electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet (114) in the first group ([0060]: “, for example, a line of multiple (e.g., three) dispenser electrodes, an arrangement of droplets operations electrodes leading away from one end of the line of dispenser electrodes to provide an first outlet, and an arrangement of droplets operations electrodes leading away from the other end of the line of dispenser electrodes to provide a second outlet”).
Regarding claim 4, Samarasekera discloses wherein the first limb comprises at least one further series of first electrodes (Fig 2B left versus right electrodes) configured to receive sweat droplets from each series of the at least one series of first electrodes (Figs 3A to 3B), and transport said sweat droplets away from the at least one series of first electrodes (Fig 3A to 3B).
Regarding claim 5, Samarasekera discloses wherein the first limb comprises an additional series of first electrodes (Fig 6), and wherein the first limb comprises a plurality of said further series of first electrodes (Fig 6), the additional series of first electrodes being configured to receive sweat droplets from each further series of the plurality of further series of first electrodes (Figs 7-8), and transport said sweat droplets away from the plurality of further series of first electrodes (Figs 7-8).
Regarding claim 6, Samarasekera discloses wherein the second limb comprises at least one series of second electrodes (Fig 2A left and right side, wherein the structure is repeated), each second electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet in the second group (Figs 3A to 3B).
Regarding claim 7, Samarasekera discloses wherein the second limb comprises at least one further series of second electrodes configured to receive sweat droplets from each series of the at least one series of second electrodes (Fig 6), and transport said sweat droplets away from the at least one series of second electrodes (Figs 7-9).
Regarding claim 8, Samarasekera discloses wherein the second limb comprises an additional series of second electrodes (Fig 6), and wherein the second limb comprises a plurality of said further series of second electrodes (Fig 6), the additional series of second electrodes being configured to receive sweat droplets from each further series of the plurality of further series of second electrodes, and transport said sweat droplets away from the plurality of further series of second electrodes (Figs 7-9, second branch).
Regarding claim 9, Samarasekera discloses wherein the third limb comprises at least one series of third electrodes (Fig 6), each third electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet in the third group (Figs 7-9)
Regarding claim 10, Samarasekera discloses wherein the third limb comprises at least one further series of third electrodes (Fig 6) configured to receive sweat droplets from each series of the at least one series of third electrodes (Fig 6 third branch)), and transport said sweat droplets away from the at least one series of third electrodes (Figs 7-9); optionally wherein the third limb (138) comprises an additional series of third electrodes, and wherein the third limb comprises a plurality of said further series of third electrodes, the additional series of third electrodes being configured to receive sweat droplets from each further series of the plurality of further series of third electrodes, and transport said sweat droplets away from the plurality of further series of third electrodes
Regarding claim11, Samarasekera discloses wherein the at least one series of first electrodes comprises a plurality of series of first electrodes (Fig 7), each of the plurality of series of first electrodes intersecting with one further series of said at least one further series of first electrodes at different positions relative to each other along said one further series of first electrodes (fig 7 connections among the lines of electrodes); and/or wherein the at least one series of second electrodes comprises a plurality of series of second electrodes, each of the plurality of series of second electrodes intersecting with one further series of said at least one further series of second electrodes at different positions relative to each other along said one further series of second electrodes (Fig 7 connections along second row of electrodes); and/or wherein the at least one series of third electrodes comprises a plurality of series of third electrodes, each of the plurality of series of third electrodes intersecting with one further series of said at least one further series of third electrodes at different positions relative to each other along said one further series of third electrodes (Fig 7 connections along third lines of electrodes).
Regarding claim 12, Samarasekera discloses at least one of a first sweat rate sensor, a second sweat rate sensor, and a third sweat rate sensor ([0080]: "LSPR sensors 120 can be used to determine the KD value, the kON value, and/or the kOFF value of the analyte sample with an immobilized ligand, wherein the KD value is a quantitative measurement of analyte affinity, the kON value indicates the kinetic ON-rate of the analyte sample, and the kOFF value indicates the kinetic OFF-rate of the analyte sample."), the first sweat rate sensor being arranged downstream of the outlets (114) of the first group and configured to determine a sweat rate from sweat droplets transported by the first limb (134), the second sweat rate sensor being arranged downstream of the outlets of the second group and configured to determine a sweat rate from sweat droplets transported by the second limb (136), and the third sweat rate sensor being arranged downstream of the outlets of the third group and configured to determine a sweat rate from sweat droplets transported by the third limb ([0140]: “moved via droplet operations to LSPR sensors 120 at the ends of flow paths 118-1, 118-2, 118-3.”)
Regarding claim 13, Samarasekera discloses comprising a biosensor configured to determine a sweat analyte concentration ([0140]: “Any color change generated in the HRP-TMB reaction is amplified due to etching of the gold nano-urchins (AuNU) in the AuNU droplets 320, which is proportional to the concentration of the oxidized TMB colored product in the TMP droplets 322”), wherein the biosensor is arranged to receive sweat droplets transported thereto by the first, second and third limbs ([0140]: “moved via droplet operations to LSPR sensors 120 at the ends of flow paths 118-1, 118-2, 118-3.”); optionally wherein the apparatus further comprises a sweat collector downstream of the biosensor (Fig 32 element 116).
Regarding claim 14, Pollack discloses an electric field generator for charging and discharging each of the electrodes of the electrowetting arrangement such as to transport each said sweat droplet ([0075]: “an electric field generating mechanism”).
Regarding claim 16, Samarasekera discloses the first limb comprises at least one series of first electrodes (Fig 3A left electrode), each first electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet in the first group (Figs 3A to 3B), the first limb comprising three of said series of first electrodes (Fig 6, first branch), the second limb comprises at least one series of second electrodes (Fig 3A left and right electrodes), each second electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet in the second group (Figs 3A to 3B), the second limb comprising three of said series of second electrodes (Fig 6 second branch of electrodes), the third limb comprises at least one series of third electrodes (Fig 3A left and right electrodes), each third electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet in the third group (Fig 3A to 3B), the third limb comprising three of said series of third electrodes (Fig 6 third branch), and two further conductive traces per limb connect the three series of electrodes within each limb to each other (Fig 6 connections between branches).
Claim(s) 15 and 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Samarasekera in view of Pollack in further view of Wildhaber et al. (US 20220401012 A1).
Regarding claim 15, Samarasekera in view of Pollack discloses the apparatus according to claim 1, but fails to discloses a wearable device comprising the apparatus according to any of claim 1;optionally wherein the wearable device comprises an attachment arrangement configured to enable attachment of the apparatus to a body part such that said inlets receive sweat from the skin of said body part.
Wildhaber discloses an apparatus for transporting sweat droplets (title) including a wearable device comprising the apparatus ([0028]: “within an electronic device (e.g., in an adhesive patch or in a wearable device (e.g., a wrist-band, a head-band, a bandage, a sock, a glove, an arm-band, a waist-band, an ankle-band, and a knee-band).”); optionally wherein the wearable device comprises an attachment arrangement configured to enable attachment of the apparatus to a body part ([0041]: “the system includes a wearable housing (e.g., said housing non-invasively attachable and detachable from skin of the subject, e.g., via an adhesive surface)”) such that said inlets receive sweat from the skin of said body part ([0030]: “the collection and delivery module includes a collection surface, one or more collection structures, and/or one or more inlets”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the apparatus disclosed by Samarasekera in view of Pollack to include the wearable device disclosed by Wildhaber in order to improve ease of sweat collection (Wildhaber [0004]).
Regarding claim 17, Samarasekera further discloses wherein the first limb comprises at least one series of first electrodes ([0076]: “arrangements (e.g., lines, paths, arrays) of droplet operations electrodes 114 (i.e., electrowetting electrodes) that can be used to fluidly connect any arrangements of one or more reservoirs 116”), each first electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet (114) in the first group ([0060]: “, for example, a line of multiple (e.g., three) dispenser electrodes, an arrangement of droplets operations electrodes leading away from one end of the line of dispenser electrodes to provide an first outlet, and an arrangement of droplets operations electrodes leading away from the other end of the line of dispenser electrodes to provide a second outlet”).
Regarding claim 18, Samarasekera discloses wherein the first limb comprises at least one further series of first electrodes (Fig 2B left versus right electrodes) configured to receive sweat droplets from each series of the at least one series of first electrodes (Figs 3A to 3B), and transport said sweat droplets away from the at least one series of first electrodes (Fig 3A to 3B).
Regarding claim 19, Samarasekera discloses wherein the first limb comprises an additional series of first electrodes (Fig 6), and wherein the first limb comprises a plurality of said further series of first electrodes (Fig 6), the additional series of first electrodes being configured to receive sweat droplets from each further series of the plurality of further series of first electrodes (Figs 7-8), and transport said sweat droplets away from the plurality of further series of first electrodes (Figs 7-8).
Regarding claim 20, Samarasekera discloses wherein the second limb comprises at least one series of second electrodes (Fig 2A left and right side, wherein the structure is repeated), each second electrode of the at least one series being configured to release and/or transport one of said sweat droplets protruding from a respective outlet in the second group (Figs 3A to 3B).
Regarding claim 21, Samarasekera discloses wherein the second limb comprises at least one further series of second electrodes configured to receive sweat droplets from each series of the at least one series of second electrodes (Fig 6), and transport said sweat droplets away from the at least one series of second electrodes (Figs 7-9).
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive.
Applicant argues on page 9 of Remarks that Samarasekera is not directed to the collection of sweat as the device discloses chambers and inlets directed to a droplet as opposed to directly sweat. However, Samarasekera explicitly discloses that the droplet may be sweat ([0048]). MPEP 2183 states that a prior art element is equivalent when (A) The prior art element performs the identical function specified in the claim in substantially the same way and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000). As the disclosed droplet may be sweat, the device disclosed by Samarasekera is capable of the function disclosed by claim 1. Furthermore, whether or not the chamber as disclosed by Samarasekera is preloaded, the droplet protrudes after the chamber fills with sweat. The language of claim 1 recites “receiving sweat from the skin” as opposed to directly contacting the skin. As the sweat in question is obtained from the skin, the recitation meets the limitation. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Though Samarasekera fails to disclose a radial structure, this structure is disclosed by Pollack (see rejection above). Though Pollack fails to disclose the reservoirs in the exact manner characterized by claim 1, this structure is disclosed by Samarasekera. Applicant further argues on pages 11-12 of Remarks that the conductive traces are not disclosed by Samarasekera nor does it disclose the limbs as defined by claim 1. It is, however, unclear in what way the limbs as disclosed by Samarasekera differ from the limbs as disclosed by claim 1. The limitation as stated puts forth that the conductive trace arrangement electrically connects the first second and third limbs together. Samarasekera discloses electrical connections between said limbs of electrodes. If applicant is alleging the conductive traces are of a different material or some specific configuration, this is not stipulated by the claim language. Finally, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, per MPEP 2141, “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability”. Samarasekera discloses several variations of structure directed towards guiding a droplet towards a central region, and thus the substitution of a structure disclosed by Pollack for obtaining the same predictable result would have been obvious to a person of ordinary skill in the art. As such, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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