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 .
Election/Restrictions
Applicant’s election without traverse of Species 1, pertaining to claims 3-6 and 11-13 in the reply filed on 16 September 2025 is acknowledged.
Claims 7, 8, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply.
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.
Claim(s) 1, 2, 6, 9, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenigk et al. (WO 2018/067412 – disclosed by Applicant) in view of Manion et al. (US Publication no. 2016/0287164 – disclosed by Applicant).
In regard to claim 1, Lenigk et al. discloses an apparatus (e.g., figure 3) comprising: a sweat sensing component 306 for measuring a parameter relating to sweat generated by sweat glands of a subject;
a sweat transport channel 304 (para 31, microchannel); and
a sweat redirecting component 308 (para 31, electrowetting valve) whose form is configured to change in response to a stimulus (para 31, valve 308 opens and closes upon actuation, the actuation caused by electronics module to apply low voltage stimulus to valve 308), so as to redirect sweat and control an amount of sweat able to be transported to the sweat sensing component via the sweat transport channel (para 31, valve 308 allows for on-demand flow control across sensor 306),
wherein the sweat redirecting component 308 is positioned at an outlet 310 (para 31, wicking membrane serves as an outflow of sweat as depicted in fig.3, the direction of sweat through the device 300 is illustrated by arrow 312; as the wicking member is the outflow, the embodiment of figure 3 is considered to show the valve 308 near the outlet) of the sweat transport channel 304, such that, in a first configuration, the form of the responsive material is such that the sweat redirecting component prevents the passage of sweat through the outlet (i.e., when valve 308 closed), and directs the passage of sweat to the sweat sensing component 306; and, in a second configuration (i.e., when valve 308 open), the form of the responsive material is such that the sweat redirecting component permits the passage of sweat through the outlet (para 23, FIG. 3. In this way, the microfluidics module may collect sweat from the surface of the skin of a subject, flow the sweat to the sensor where it may be sensed, and then wick the sensed sweat away from the sensor and into a wicking apparatus in order to maintain a desired fluid flow rate through the device; para 31, valve 308 is for on-demand analyte flow control across the sensor 306 which is considered to accomplish the function claimed here).
Lenigk et al. describe the invention substantially as claimed, and while the valve 308 may be properly construed as a “sweat directing component”, it is not described as a “responsive material.” Manion et al. teaches an apparatus and method for measuring flow rates of a fluid that passes through a channel and measurement point over time (para 1). The fluid may be sweat to measure a rate of perspiration (para 45). Much like Lenigk et al., Manion et al. controls the flow of the fluid through the channel and uses a piezoelectric material that may close a channel upon application of an electrical stimulus signal from an electrode 115 and then opened to allow fluid to be expelled from the channel (para 25-27, an electric charge may cause the piezoelectric material to activate to close the opening 120 and may also close the channel). The piezoelectric material of Manion et al. is considered to comprise a “responsive material” as claimed and suitable alternative equivalent to the electrically activated valves of Lenigk et al. for controlling the directional flow and rate of fluid through the channel. Therefore, modification of the electrowetting valves 308 of Lenigk et al. to be piezoelectric materials is considered to have been obvious to one of ordinary skill in the art since Manion et al. demonstrates that piezoelectric material is suitable for controlling fluid through the channel. The modification is considered to comprise the substitution of a known element for another to yield a predictable result of opening and closing flow through a conduit.
In regard to claim 2, in Lenigk et al., electrowetting valves 308 are activated from a low voltage electrical stimulus signal provided by electronics module 1004 (para 31). It is considered that the valves 308 upon receipt of the low voltage signal may change form, such as from an open to a closed state. Moreover, the piezoelectric material described by Manion et al. is activated in this manner as well (para 25, electrodes 115 may apply a charge to a piezoelectric material of the channel 110. The charge may cause the piezoelectric material to activate). In view that the present invention teaches and claims that the “responsive material” includes a piezoelectric material, it is acknowledge that the piezoelectric material of Manion et al. necessarily then necessarily changes form upon application of the electrical charge.
Additionally, with regard to claim 2, the claimed fluidic stimulus is claimed as alternative language to the electrical stimulus. As this is the case, only one of the alternatives must be taught by the prior art to satisfy the claim which is accomplished by Lenigk et al. and Manion et al.
In regard to claim 6, Lenigk et al. teaches a processor (para 57, electronics module 1004 comprising a microcontroller) configured to: cause the electrical stimulus to be applied to the responsive material (para 31).
In regard to claim 9, in Lenigk et al., the sensor 306, and other sensor embodiments, may be used to sense a parameter related to sweat comprising a concentration of a substance in sweat (para 47, sensors may be used to measure electrolyte composition and ion concentration in physiological situations, such as blood plasma and sweat).
In regard to claim 14, Lenigk et al. teaches the apparatus according to claim 1 (see rejection set forth above), and a processor (para 57, electronics module 1004 comprising a microcontroller) configured to: cause the electrical stimulus to be applied to the responsive material (para 31).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenigk et al. (WO 2018/067412 – disclosed by Applicant) in view of Manion et al. (US Publication no. 2016/0287164 – disclosed by Applicant), further in view of Huijbregts et al. (EP 3895613 – disclosed by Applicant).
In regard to claim 3, Lenigk et al. in view of Manion et al. describe the invention as claimed, however do not teach that the electrical stimulus is applied to the responsive material to at least one of: a parameter value of the sweat measured using the sweat sensing component meeting or exceeding a parameter value threshold; or a sweat rate of sweat from the sweat glands exceeding a sweat rate threshold. Huijbreghts et al. discloses a sweat sensor. The sensor comprises one or more inlets through which the user's sweat can be uptaken into the sensor. Furthermore, the sensor comprises one or more analyzing units that are configured for analyzing the sweat, which was uptaken by the sensor through the one or more inlets. The sensor is configured for controlling a size of an opening of the one or more inlets, which the sensor uses for uptaking the sweat and for analyzing the uptaken sweat (para 20). The sweat sensor of Huijbreghts et al. can react on a determination/measurement of e.g. the sweat rate or the number of sweat glands per inlet by adapting the size of the opening of the inlets that will be used in the next analytical cycle of the sensor. If the sensor has for example determined that the user has a sweat rate that is above a pre-defined threshold value, the sensor can decrease the size of the openings of the inlets, which he will use for next measurements (para 22).
Therefore, it considered to have been obvious to one of ordinary skill in the art to modify Lenigk et al. and Manion et al. to control the electrical stimulus applied to the valves 308 or piezoelectric material based on a sweat rate or sweat rate from sweat glands exceeds a threshold since Huijbreghts et al. explicitly teaches control of inlets based on these parameters. Doing so would maintain proper flow across sensor in Lenigk et al.
In regard to claim 4, Lenigk et al. teaches valves 308 as comprising the sweat redirecting component. However, it is not described as a “responsive material.” Manion et al. controls the flow of the fluid through the channel and uses a piezoelectric material that may close a channel upon application of an electrical stimulus signal from an electrode 115 and then opened to allow fluid to be expelled from the channel (para 25-27, an electric charge may cause the piezoelectric material to activate to close the opening 120 and may also close the channel). The piezoelectric material of Manion et al. is considered to comprise a “responsive material” as claimed and suitable alternative equivalent to the electrically activated valves of Lenigk et al. for controlling the directional flow and rate of fluid through the channel. Therefore, modification of the electrowetting valves 308 of Lenigk et al. to be piezoelectric materials is considered to have been obvious to one of ordinary skill in the art since Manion et al. demonstrates that piezoelectric material is suitable for controlling fluid through the channel. The modification is considered to comprise the substitution of a known element for another to yield a predictable result of opening and closing flow through a conduit.
In regard to claim 5, Lenigk et al. in view of Manion et al. further in view of Huijbreghts et al. describes the invention as claimed. Huijbreghts et al. measures sweat flow rate to control inlet opening (para 22). To this, Huijbreghts et al. includes a flow sensor to measure the flow of sweat (para 24). It would therefore have been obvious to include a sweat rate sensor to measure sweat rate in order to control the opening of valves/inlets since Huijbreghts et al. explicitly teaches control of inlets based on sweat rate and a sensor would be of necessity for obtaining this parameter. Doing so would maintain proper flow across sensor in Lenigk et al.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lenigk et al. (WO 2018/067412 – disclosed by Applicant) in view of Huijbregts et al. (EP 3895613 – disclosed by Applicant), further in view of Manion et al. (US Publication no. 2016/0287164 – disclosed by Applicant).
In regard to claim 11, Lenigk et al. discloses a method of controlling the passage of sweat in an apparatus (para 23, FIG. 3. In this way, the microfluidics module may collect sweat from the surface of the skin of a subject, flow the sweat to the sensor where it may be sensed, and then wick the sensed sweat away from the sensor and into a wicking apparatus in order to maintain a desired fluid flow rate through the device), the apparatus having a sweat sensing component 306 (para 31), a sweat transport channel 304 para 31, microchannel) and a sweat redirecting component 308 (para 31, electrowetting valve) comprising a responsive material (valve opens and closes), the method comprising:
causing an electrical stimulus to be applied to a sweat redirecting component 308 (para 31, electronics module 1004 includes a microcontroller (para 57) to apply a low votlage electrical stimulus to cause valves 308 to open or close);
wherein application of the electrical stimulus to the sweat redirecting component 308 causes a form of the sweat redirecting component 308 to change (e.g. to change from a closed to open state), thereby to redirect sweat and control an amount of sweat able to be transported to the sweat sensing component 306 via the sweat transport channel 304 (para 31, actuation of valves 308 allow for on-demand analyte flow control across the sensor 306, and a wicking membrane 310 for flow rate control),
wherein the sweat redirecting component is positioned at an outlet of the sweat transport channel (para 31, wicking membrane serves as an outflow of sweat as depicted in fig.3, the direction of sweat through the device 300 is illustrated by arrow 312; as the wicking member is the outflow, the embodiment of figure 3 is considered to show the valve 308 near the outlet), such that, in a first configuration, the form of the responsive material is such that the sweat redirecting component prevents the passage of sweat through the outlet (i.e., when valve 308 closed), and directs the passage of sweat to the sweat sensing component 306; and, in a second configuration (i.e., when valve 308 open), the form of the responsive material is such that the sweat redirecting component permits the passage of sweat through the outlet (para 23, FIG. 3. In this way, the microfluidics module may collect sweat from the surface of the skin of a subject, flow the sweat to the sensor where it may be sensed, and then wick the sensed sweat away from the sensor and into a wicking apparatus in order to maintain a desired fluid flow rate through the device; para 31, valve 308 is for on-demand analyte flow control across the sensor 306 which is considered to accomplish the function claimed here).
Lenigk et al. describe the invention as claimed however, do not teach the steps of receiving, at a processor, data indicative of a parameter relating to sweat generated by sweat glands of a subject; and causing an electrical stimulus to be applied to the responsive material based on the received data.
Huijbreghts et al. discloses a sweat sensor. The sensor comprises one or more inlets through which the user's sweat can be uptaken into the sensor. Furthermore, the sensor comprises one or more analyzing units that are configured for analyzing the sweat, which was uptaken by the sensor through the one or more inlets. The sensor is configured for controlling a size of an opening of the one or more inlets, which the sensor uses for uptaking the sweat and for analyzing the uptaken sweat (para 20). The sweat sensor of Huijbreghts et al. can react on a determination/measurement of e.g. the sweat rate or the number of sweat glands per inlet by adapting the size of the opening of the inlets that will be used in the next analytical cycle of the sensor. If the sensor has for example determined that the user has a sweat rate that is above a pre-defined threshold value, the sensor can decrease the size of the openings of the inlets, which he will use for next measurements (para 22).
Therefore, it considered to have been obvious to one of ordinary skill in the art to modify Lenigk et al. to control the electrical stimulus applied to the valves 308 or piezoelectric material based on a sweat rate or sweat rate from sweat glands exceeds a threshold since Huijbreghts et al. explicitly teaches control of inlets based on these parameters. Doing so would maintain proper flow across sensor in Lenigk et al.
Lenigk et al. in view of Huijbreghts et al. describe the invention substantially as claimed, and while the valve 308 may be properly construed as a “sweat directing component”, it is not described as a “responsive material.” Manion et al. teaches an apparatus and method for measuring flow rates of a fluid that passes through a channel and measurement point over time (para 1). The fluid may be sweat to measure a rate of perspiration (para 45). Much like Lenigk et al., Manion et al. controls the flow of the fluid through the channel and uses a piezoelectric material that may close a channel upon application of an electrical stimulus signal from an electrode 115 and then opened to allow fluid to be expelled from the channel (para 25-27, an electric charge may cause the piezoelectric material to activate to close the opening 120 and may also close the channel). The piezoelectric material of Manion et al. is considered to comprise a “responsive material” as claimed and suitable alternative equivalent to the electrically activated valves of Lenigk et al. for controlling the directional flow and rate of fluid through the channel. Therefore, modification of the electrowetting valves 308 of Lenigk et al. to be piezoelectric materials is considered to have been obvious to one of ordinary skill in the art since Manion et al. demonstrates that piezoelectric material is suitable for controlling fluid through the channel. The modification is considered to comprise the substitution of a known element for another to yield a predictable result of opening and closing flow through a conduit.
In regard to claim 12, in Lenigk et al. and Manion et al., an electrical stimulus to be applied to the valves and/or responsive material comprises controlling a power source to supply a current or a voltage to the responsive material. Lenigk et al. teach that low voltage of about 12 V is applied (para 55). Para 64 teaches that the electronics module 1004 includes a power management unit and a battery.
In regard to claim 13, Lenigk et al. includes a microcontroller that is used to operate the sweat sensing device wherein it is considered that the microcontroller necessarily has a computer-readable code embodied therein, the computer-readable code being configured such that, on execution by a suitable computer or processor, the computer or processor is caused to perform the method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 20 November 2025