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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/25 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on July 1, 2026, amended claims 1 and 3-16 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the objections have been fully considered and were persuasive. Therefore, these objections have been withdrawn.
Applicant's remarks and amendments with respect to the rejections under U.S.C. 112 have been fully considered and were persuasive. Therefore, these rejections have been withdrawn.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered and were not persuasive
Applicant argues Raisanen does not teach or suggest the coupling surfaces of the pair of guides and the consumable component are configured to operatively couple in a sealed way so that an electrical connection between the electric connection devices is sealed. Examiner disagrees and notes that Raisanen teaches “Each hook of the pair of hooks 123 comprises a retention portion 123b that comprises one or more holes 123c through which an overmolding material flows to form enclosure” [par. 117]. Additionally, Raisanen teaches “Hooks 123 may also be directly connected to printed circuit board 124 via riveting of holes 123c. Instead of rivets, also small bolts and nuts can be used” [par. 118]. Therefore, this equates to the coupling surfaces of the pair of guides and the consumable component are configured to operatively couple in a sealed way so that an electrical connection between the electric connection devices is sealed, 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 and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Raj (U.S. Patent Application Publication 2020/0397315) and in further view of Matsumoto (U.S. Patent Application Publication 2013/0281802) and Raisanen (U.S. Patent Application Publication 2020/0312453).
Raj and Raisanen were cited in Applicant’s IDS
Raj, Matsumoto and Raisanen were applied in the previous office action
Regarding claim 1, Raj teaches a wearable device for continuous monitoring of health parameters of a user [fig. 1, element 50; par. 63], comprising: a housing having a front surface and a back surface [fig. 1, element 52A; par. 63, claim 18; Examiner interprets the removable persistent portion of the device to be the housing. Additionally, the removable portion would inherently have two sides], the housing configured to attach to apart of a body of the user [par. 11, 65; claim 18]; a processing unit within the housing [fig. 1, element 58; par. 64]; a consumable component configured to be manually removably coupled to the housing [fig. 1, element 52B; par. 63; claim 18], the consumable component comprising: a contact surface configured to be in contact with skin of the user [fig. 9, element 52; par. 68] when the consumable component is removably coupled to the housing and the housing is attached to the part of the body of the user [par. 63, 65; claim 18; Examiner notes the disposable portion 52B and persistent portion 52A are attached to each other and to the skin]; a sweat collection inlet formed in the contact surface [par. 65 “The disposable portion 52B may include… an inlet port (not shown in FIG. 1, but similar to the sweat inlet port 42 of the microfluidic channels 26 shown in FIG. 15, for sweat collection and analysis”]; for collecting sweat when the wearable device is worn by the user [par. 65]; at least one sensor for measuring a sweat biomarker [fig. 1, element 70; par. 65]; and a microfluidic channel [fig. 1, element 26; par. 65] for conveying collected sweat from the inlet to the sweat sensor [par. 65]; and an electric connection device for electrically connecting the sensor with the processing unit [par. 11 “A wireless transmitter is mounted to the sweat sensing device and electrically connected to the at least one sensor”; claim 18]; when the consumable component is operatively coupled with the housing, wherein the processing unit is configured to process data provided by the sensor [par. 64, 67],
However, Raj does not teach a processing unit enclosed within the housing; wherein the housing has a pair of guides opposite each other, wherein the consumable component has a pair of sides wings, wherein the housing and the consumable part are configured; such that the consumable component is couplable with the housing by the side wings of consumable component being respectively inserted in the guides and by moving the consumable component on the back surface of the housing, wherein the electric connection device is on the coupling surfaces of the pair of guides and the consumable component, wherein the coupling surfaces of the pair of guides and the consumable component are configured to operatively couple in a sealed way so that an electrical connection between the electric connection devices is sealed, and wherein the surface of the consumable component configured to contact the surface of the pair of guides comprising the electrical connection device comprises an adhesive surface configured to further seal the electrical connection.
Matsumoto teaches a processing unit enclosed within the housing [fig. 2A, 2B, elements 310, 313; par. 34]; wherein the housing has a pair of guides opposite each other, wherein the consumable component has a pair of sides wings, wherein the housing and the consumable part are configured such that the consumable component is couplable with the housing by the side wings of consumable component being respectively inserted in the guides and by moving the consumable component on the back surface of the housing [fig. 12A, 12B, elements 315a, 315b, 141a, 141b; par. 75, 77]
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 Raj, to incorporate processing unit enclosed within the housing; wherein the housing has a pair of guides opposite each other, wherein the consumable component has a pair of sides wings, wherein the housing and the consumable part are configured such that the consumable component is couplable with the housing by the side wings of consumable component being respectively inserted in the guides and by moving the consumable component on the back surface of the housing, to suitably prevent the sensor member 110 and the signal processing circuit member 310 from being unexpectedly separated in a state in which the sensor system 100 is fixed to the skin s in the living body, as evidence by Matsumoto [par. 75].
Raisanen teaches wherein the electric connection device is on the coupling surfaces of the pair of guides and the consumable component, wherein the coupling surfaces of the pair of guides and the consumable component are configured to operatively couple in a sealed way so that an electrical connection between the electric connection devices is sealed [par. 171 “hook portions 123a fit for providing electrical contact to electrodes arranged on the chest band 150. A segment of each hook portion 123a may be used as electrical contact to an electrode in the chest band. The slot in the chest band 150 to fit to the hooks comprise then two conductive portions”, 179 “Those hooks then are mechanically and galvanically connected to printed circuit board”]
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 Raj, to incorporate the electric connection device is on the coupling surfaces of the pair of guides and the consumable component, wherein the coupling surfaces of the pair of guides and the consumable component are configured to operatively couple in a sealed way so that an electrical connection between the electric connection devices is sealed, to provide electrodes for EDA sensor, as evidence by Raisanen [par. 171].
Although Raisanen does not explicitly teach the surface of the consumable component configured to contact the surface of the pair of guides comprising the electrical connection device comprises an adhesive surface configured to further seal the electrical connection, this would be obvious to one having ordinary skill in the art when the invention was filed since Raisanen also suggests using adhesive for creating an electrical connection between electrical components [par. 147]. Therefore, incorporating the consumable component to have an adhesive between electrical components would only involve routine skill in the art.
Regarding claim 3, Motsumoto further teaches wherein a part of the back surface of the housing is flat, and wherein the consumable component is removably couplable with the housing by moving the consumable component on a plane parallel to said flat part of the back surface, or on a plane coplanar with the flat part of the back surface [fig. 12A, 12B, elements 315a, 315b, 141a, 141b; par. 75, 77]
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 Raj, to incorporate a part of the back surface of the housing is flat, and wherein the consumable component is removably couplable with the housing by moving the consumable component on a plane parallel to said flat part of the back surface, or on a plane coplanar with the flat part of the back surface, to suitably prevent the sensor member 110 and the signal processing circuit member 310 from being unexpectedly separated in a state in which the sensor system 100 is fixed to the skin s in the living body, as evidence by Matsumoto [par. 75].
Regarding claim 4, Raj further teaches the consumable component is a flat body [fig. 10A, element 52]
Regarding claim 5, Raisanen further teaches the housing is configured to couple to a part of a user's body by way of a flexible band having two ends respectively couplable with the housing [fig. 2, 3, elements 122, 150; par.119]
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 Raj, to incorporate the housing is configured to couple to a part of a user's body by way of a flexible band having two ends respectively couplable with the housing, for keeping the wearable sensor in place around the torso, as evidence by Raisanen [par. 119].
Regarding claim 6, Raj further teaches housing is configured to couple to a part of a user's body by way of an adhesive surface configured to be adhered on a user's skin [par. 63, 65; claim 18; Examiner notes the persistent portion is attached to the disposable portion which is attached to the skin]
Regarding claim 8, Raisanen further teaches the housing includes a pair of electric connectors, and each end of the flexible band is fitted with metallic connectors for mechanically and electrically connecting the flexible band and the sensor with the pair of electric connectors of the housing [fig. 3a, 3b; par. 171, 179].
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 Raj, to incorporate the housing includes a pair of electric connectors, and each end of the flexible band is fitted with metallic connectors for mechanically and electrically connecting the flexible band and the sensor with the pair of electric connectors of the housing, for electrically connecting to the circuit board, as evidence by Raisanen [par. 179].
Regarding claim 9, Raisanen further teaches the flexible band includes at least one biosensor arranged for measuring a vital-sign or physiological sign of the user when the device is worn by a user [fig. 2, element 120; par. 111], and wherein the at least one biosensor is selected from any of a heart rate sensor, a respiratory rate sensor, a blood pressure sensor, a body temperature sensor, and an oxygen saturation sensor [par. 108]
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 Raj, to incorporate the flexible band includes at least one biosensor arranged for measuring a vital-sign or physiological sign of the user when the device is worn by a user, and wherein the at least one biosensor is selected from any of a heart rate sensor, a respiratory rate sensor, a blood pressure sensor, a body temperature sensor, and an oxygen saturation sensor, for keeping the sensor close to the skin and heart of the patient, as evidence by Raisanen [par. 119].
Regarding claim 10, Raj further teaches he consumable component further comprises a sweat volume sensor for measuring volume of the collected sweat, and wherein the processing unit is configured to receive and process data provided by the at least one sensor, the at least one biosensor) and the sweat volume sensor [fig. 1, element 66; par. 64, 65, 76]
Regarding claim 11, Raj further teaches comprising a communication module enclosed in the housing [par. 64]; and configured to wirelessly transmit data processed by the processing unit [par. 64, 66, 72]
Regarding claim 12, Raj further teaches the at least one sensor is a sweat lactate sensor [par. 42, 81], and the at least one biosensor is a heart rate sensor [par. 41, 42, 69], and wherein the processing unit is further configured to calculate or estimate a blood lactate concentration based on data provided by: the sweat lactate sensor, the sweat volume sensor and heart rate sensor [par. 41, 42, 80]
Regarding claim 13, Raj further teaches a sensing chamber and at least one of the following additional sensors: a sweat lactate sensor, a sweat conductivity sensor, a metabolites sensor, an ions sensor, and an amino acids sensor [fig. 1, 2A, 2B, elements 74, 76; par. 81], the at least one additional sensor placed in the sensing chamber [fig. 2A, B, par. 81; Examiner notes the area where the interaction occurs is the chamber], wherein the microfluidic channel is configured to communicate the sweat inlet with the sensing chamber [par. 77, 81]
Regarding claim 14, another embodiment of Raj teaches the sweat volume sensor comprises a pair of electrodes and a microfluidic reservoir between the pair of electrodes [fig. 3A, 3B; par. 82], the microfluidic reservoir in fluid communication with a sensing chamber and arranged downstream of the sensing chamber, such that a capacitance value between the pair of electrodes is variable depending on an amount of sweat in the microfluidic reservoir [par. 82-86]
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 Raj, to incorporate the sweat volume sensor comprises a pair of electrodes and a microfluidic reservoir between the pair of electrodes, the microfluidic reservoir in fluid communication with a sensing chamber and arranged downstream of the sensing chamber, such that a capacitance value between the pair of electrodes is variable depending on an amount of sweat in the microfluidic reservoir, for providing an effective means of calculating the volume of sweat, as evidence by Raj [par. 83].
Regarding claim 15, Raj further teaches the adhesive surface is provided on the contact surface of the consumable component [par. 63, 65; claim 18; Examiner notes the disposable portion is attached to the skin]
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Raj, Matsumoto and Raisanen and in further view of Cho (U.S. Patent Application Publication 2016/0278672)
Cho was cited in Applicant’s IDS
Cho was applied in the previous office action
Regarding claim 7, Raj, Matsumoto and Raisanen teach a wearable device for continuous monitoring of health parameters of a user, as disclosed above.
However, Raj, Matsumoto and Raisanen do not teach the housing has a cavity on the surface for receiving a battery for supplying power to the processing unit, and a lid for closing the cavity and enclosing the battery therein, and wherein the wearable device is configured such that the consumable component is overlapped with the lid, when the consumable component is operatively coupled with the housing
Cho teaches the housing has a cavity on the surface for receiving a battery for supplying power to the processing unit, and a lid for closing the cavity and enclosing the battery therein, and wherein the wearable device is configured such that the consumable component is overlapped with the lid, when the consumable component is operatively coupled with the housing [fig. 57, 58; par. 213, 214; Examiner notes that the main body comprises the battery and there is an opening 817 in the main body, which is covered by a sticky pad]
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 Raj, Matsumoto and Raisanen, to incorporate the housing has a cavity on the surface for receiving a battery for supplying power to the processing unit, and a lid for closing the cavity and enclosing the battery therein, and wherein the wearable device is configured such that the consumable component is overlapped with the lid, when the consumable component is operatively coupled with the housing, for providing a power button, as evidence by Cho [par. 212].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Raj, Matsumoto and Raisanen and in further view of Taghipour (U.S. Patent Application Publication 2022/0299459)
Taghipour was applied in the previous office action
Regarding claim 16, Raj, Matsumoto and Raisanen teach a wearable device for continuous monitoring of health parameters of a user, as disclosed above.
However, Raj, Matsumoto and Raisanen do not teach the processing unit is configured to calculate or estimate a blood lactate concentration by way of machine learning algorithms.
Taghipour teaches the processing unit is configured to calculate or estimate a blood lactate concentration by way of machine learning algorithms [par. 42, 54].
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 Raj, Matsumoto and Raisanen, to incorporate the processing unit is configured to calculate or estimate a blood lactate concentration by way of machine learning algorithms, for when a particular target molecule interacts with (e.g., impacts the signal of) more than one sensing node 31, machine learning may be applied to identify and/or quantify the target molecules of interest, based on analyzing the combination of signals from sensing nodes, as evidence by Taghipour [par. 54].
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 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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