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 .
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “sealing member” in Claims 1, 4, 23, 24, and 29.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Based on the specification, the examiner has interpreted “sealing member” to be “any materials that can provide a substantial seal with the subject's skin...can comprise an elastomer seal, a ridge knife-edge seal, an adhesive seal, or any combination thereof” (Paragraph [0060]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 7, 10-11, 16, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited).
Regarding Claim 1, Rogers et. al.’878 discloses a sweat collector, wherein at least a portion of the sweat collector comprises a first portion configured to face and conform to a subject's skin (Paragraph [0010] - In an aspect, the invention provides a device for handling a biofluid comprising: (i) a functional substrate for mounting on a surface of the skin);
a sealing member configured to encompass the sweat collector and form a seal between the sweat collector and the subject's skin (Paragraph [0021] - the functional substrate forms a watertight seal with the skin around the one or more inlets; Paragraph [0114] - Devices are composed of a multilayer stack of three sub-systems: (1 ) a skin- compatible adhesive layer with a micromachined opening that defines the area of sweat collection… A medical-grade acrylic adhesive film ensured stable, strong and seamless adhesion (-5.7 N) of the device to the skin without irritation in a manner that offered compatibility with sweaty or hairy skin (FIG. 8));
an open channel having a width and a height (Paragraph [0045] - microfluidic channel as a function of width (w) and length (L) of the outlet channel with a fixed height of 300; Paragraph [0133] - microfluidics structures described here can hold captured sweat for -125 hours upon removal from the skin and sealing of the open channels), wherein
the open channel has an aspect ratio of the height to the width no greater than about 10 (Paragraph [0045] - aspect ratio (ratio of width 'a' to height 'h' of the serpentine channel… two representative aspect ratios (10:3 and 5:1 )); wherein
the open channel is open to the ambient atmosphere (Paragraph [0133] - In this latter context, it is important to note that we observed that the microfluidics structures described here can hold captured sweat for -125 hours upon removal from the skin and sealing of the open channels (~75 hours without sealing); Paragraph [0170] - Another option involves the introduction of open architectures via removal of regions of the device where the skin adhesive interface is not necessary (FIG. 32b)); wherein
the open channel is configured to continuously receive and transfer an aliquot of collected sweat from the sweat collector (Paragraph [0109] - microfluidic system that can directly and reliably harvest sweat from pores on the surface of the skin. The device routes this sweat to different channels and reservoirs for multi-parametric sensing of markers of interest, with the option to wirelessly interface with external devices for image capture and analysis); and
a sensor that is in fluid communication with the collected sweat and is configured to detect at least one property of the collected sweat, wherein the sensor is positioned at a distance from the first portion such that the sensor has substantially no contact with the subject's skin (Paragraph [0092] - Useful device components for sensing include, but are not limited to electrode elements, chemical or biological sensor elements, pH sensors, temperature sensors, strain sensors, mechanical sensors, position sensors, optical sensors and capacitive sensors; Paragraph [0198] - Biofluid collection structures 60 may form at least a part of microfluidic network 150. Biofluid collection structures 60 and sensor(s) 50 may be positioned on a support surface 35 of functional substrate 30. One or more inlets 130 may be used to convey, transport or exchange biofluid 20 to sensor 50 released from skin surface 45, with inlets aligned in each of the relevant layers; Figure 1 – shows there are layers between the sensors and the skin).
Regarding Claim 4, Rogers et. al.’878 discloses a portion of the sealing member has a slit having a width (Paragraph [0172] - there is 3mm2 opening hole for sweat enters to the microfluidic channel) and wherein the slit defines the open channel (Paragraph [044] - openings that define sweat access and openings that connect to these channels; Paragraph [0111] - Mechanical punches created openings to define the inlets for sweat collection).
Regarding Claim 7, Rogers et. al.’878 discloses an open channel with a cross-sectional area of 0.0001 mm2 to 10 mm2 which includes the range of 0.01 to 0.1 mm2 (Paragraph [0032] - the microfluidic channels are characterized a cross sectional area selected from a range of 100 μm2 to 10 mm2).
Regarding Claim 10, Rogers et. al.’878 discloses the sensor is positioned within the open channel, adjacent to an inlet of the open channel, or adjacent to an outlet of the open channel (Paragraph [0015] - microfluidic channels and/or chambers comprising the sensors – sensors within the channel).
Regarding Claim 11, Rogers et. al.’878 discloses at least one property of the sweat is selected from impedance, conductivity, refraction, temperature, or a combination thereof (Paragraph [0107] - measurement of physical characteristics such as motion, strain, stiffness, temperature, thermal conductivity, biopotential, electrical impedance, and related parameters (1, 3-10), complementary information— often with high clinical value— could be realized through capture and biochemical analysis of biofluids such as sweat).
Regarding Claim 16, Rogers et. al.’878 discloses a distance from the first portion is between 500 µm to 2 mm which contains distances between 0.1 to 1 mm (Paragraph [0019] - the functional substrate has a thickness selected from a range of 500 μm to 2 mm and in some embodiments selected from a range of 500 μm to 1 mm – the sensors are located at some depth within the substrate)
Regarding Claim 24, Rogers et. al.’878 discloses a method of measuring sweat (Paragraph [0004] - measurement mode in such devices may involve the analysis of body fluids (e.g., blood, interstitial fluid, sweat), wherein
the device is positioned on a subject's skin such that the sealing member seals the sweat collector against the subject's skin (Paragraph [0021] - the functional substrate forms a watertight seal with the skin around the one or more inlets);
collecting the sweat within a sweat collection area (Paragraph [0032] - the one or more biofluid collection reservoirs are one or more chambers; Paragraph [0034] - wherein the device is for collecting, storing or analyzing the biofluid); and
measuring at least one property of the sweat by the sensor, wherein the at sensor provides one or more output signals correlated with the at least one property of the sweat (Paragraph [0107] - measurement of physical characteristics such as motion, strain, stiffness, temperature, thermal conductivity, biopotential, electrical impedance, and related parameters (1 , 3-10), complementary information— often with high clinical value— could be realized through capture and biochemical analysis of biofluids such as sweat).
Claim Rejections - 35 USC § 103
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.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), as applied to Claim 1 above, in view of Jason Heikenfeld’450 (WO Patent Publication 2020132450 – previously cited).
Regarding Claim 2, Rogers et. al.’878 discloses the device outlined in Claim 1 above as well as advantages to decreasing the cross-sectional area of a channel, but fails to disclose wherein the sweat collector comprises a decreasing tapered ramp between a portion of the first portion and the open channel. Jason Heikenfeld’450 teaches the sweat collector comprises a decreasing tapered ramp between a portion of the first portion and the open channel (Paragraph [0069] - the channel 380 may be tapered in at least one dimension along the channel length moving right to left). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include a sweat collector with an open channel that includes a decreasing taper in order to prevent backflow into the rest of the device as seen in Jason Heikenfeld’450.
Regarding Claim 6, Rogers et. al.’878 discloses the device outlined in Claim 1 above as well as a device that transfers samples of sweat to and through open channels (Paragraph [0198] - one or more inlets 130 may be used to convey, transport or exchange biofluid 20 to sensor 50 – included within an open channel - released from skin surface 45, with inlets aligned in each of the relevant layers), but fails to disclose transfer through the aliquot of the collected sweat at a flow rate to prevent back-diffusion. Jason Heikenfeld’450 teaches transfer through the aliquot of the collected sweat at a flow rate to prevent back-diffusion (Paragraph [0069] - the channel 380 may be tapered in at least one dimension along the channel length moving right to left. With such a configuration, as the fluid sample 16 flows from right to left, the sample’s deceleration from fluid loss may be reduced, fluid velocity may remain steady, or fluid velocity may actually increase, as the volume of the channel decreases…backflow will contaminate the sample). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include a sweat collector with an open channel that includes a decreasing taper in order to prevent backflow – also known as back-diffusion - into the rest of the device as a way to prevent contamination of the sample as seen in Jason Heikenfeld’450.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited) as applied to Claim 1 above.
Regarding Claim 8, while Rogers et. al.’878 fails to explicitly disclose a sweat collection area is from a range of about 0.1 to about 10 cm2, Rogers et. al.’878 discloses a sweat collection area of about 0.07cm2 (Paragraph [0114] - An opening defined the sweat harvesting area (3 mm diameter, corresponding to -10 sweat glands) (34) through which sweat could pass into the inlet region of the overlying soft microfluidic system (FIG. 1 b)). It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the size of a sweat collection area. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal sweat collection area. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), as applied to Claim 1 above, in view of Tey et. al.’000 (U.S. Pub No. 20110237000 – previously cited), further in view of Rogers et. al.’033 (WO Patent Publication 2018223033 – previously cited), further in view of Davis et. al.’146 (U.S. Patent 11883146 – previously cited).
Regarding Claim 12, Rogers et. al.’878 discloses the device outlined in Claim 1 above as well as sensor elements as electrodes that measure electrical impedance (Paragraph [0091] - Useful device components for sensing include, but are not limited to electrode elements; Paragraph [0107] - measurement of physical characteristics such as…electrical impedance), but fails to disclose measuring the at least one property at a voltage of less than about 1 Volt, and wherein the impedance sensor comprises two electrodes, each having an electrode length from about 0.1 to about 10 mm and positioned opposing each other at an electrode gap from about 50 to about 500 µm.
Tey et. al.’000 teaches measuring at least one property at a voltage of less than about 1 Volt (Paragraph [0004] - Compared with dry state measurements, liquid-gated field effect transistors (LGFET) are preferred for biosensing applications primarily because they are amenable to real-time detection at voltages less than 1 V and because the buffered liquid based environment is suitable for detection of biomolecules). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include liquid-gate effect transistors that measure properties of liquid at less than 1 Volt as seen in Tey et. al.’000 in order to allow a safe voltage level to be applied so close to a person’s skin and still be suitable for detection of biomolecules.
Rogers et. al.’878 in view of Tey et. al.’000 fails to disclose an impedance sensor with two electrodes. Rogers et. al.’033 teaches wherein the impedance sensor comprises two electrodes (Paragraph [0197] - The term "electrical response" or "electrical parameter" may refer to a voltage, current, or impedance response of the electrodes or sensors to the electrical load. For example, applying a current between two electrodes (electrical load) may induce a voltage drop between the two electrodes (electrical response)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 in view of Tey et. al.’000 to include a sensor with two electrodes in order to record an electrical response – such as impedance – as a result of an electrical load as seen in Rogers et. al.’033.
Rogers et. al.’878 in view of Tey et. al.’000 further in view of Rogers et. al.’033 fails to disclose dimensions of electrodes. Davis et. al.’146 teaches an electrode length from about 0.1 to about 10mm (Column 19 Lines 52-53 - The length 400c may range from 2mm to 10mm). Davis et. al.’146 also teaches an electrode gap from about 50 to about 500µm (Column 31 Lines 31-32 - A first row 1106a may have an inter-electrode spacing ranging from 50 microns to 150 microns - microns are the same as micrometers). It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to electrode length and gap between electrodes. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal electrode length and gap between electrodes. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 21, Rogers et. al.’878 in view of Tey et. al.’000, further in view of Rogers et. al.’033, further in view of Davis et. al.’146 discloses the device outlined in Claim 12 above. Rogers et. al.’878 further discloses an additional sensor that is different from an impedance sensor (Paragraph [0092] - Useful device components for sensing include, but are not limited to electrode elements, chemical or biological sensor elements, pH sensors, temperature sensors, strain sensors, mechanical sensors, position sensors, optical sensors and capacitive sensors). Rogers et. al.’878 in view of Tey et. al.’000, further in view of Rogers et. al.’033 fails to disclose an impedance sensor is configured to measure an impedance of the sweat at a rate determined by a rate of measurement of the at least one additional sensor. Davis et. al.’146 teaches an impedance rate determined by a sensor that is different than an impedance sensor such as a heart rate sensor (Column 7 Lines 11-21 - the second sensor 114 may be a miniaturized impedance sensor. In another embodiment, the first sensor 112 and/or the second sensor may be a temperature sensor, a viscosity sensor, an ultrasonic sensor, a humidity sensor, a heart rate sensor, a dietary intake sensor, an electrocardiogram (EKG) sensor, an ECG sensor, a galvanic skin response sensor, a pulse oximeter, an optical sensor, and so forth; Column 45 Lines 50-55 - The change in the volumetric composition may change the impedance in cadence with the heartbeat. Accordingly, changes in impedance may be caused by the heartbeat, and may be correlated directly with a condition, parameter, and/or constituent of the heart and/or circulatory system). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include an additional sensor that measures a parameter such as heart rate to estimate impedance in order to understand underlying conditions, parameters, or constituents of the subject without relying solely on readings from bodily fluid – such as sweat as seen in Davis et. al.’146.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited) in view of Tey et. al.’000 (U.S. Pub No. 20110237000 – previously cited), further in view of Rogers et. al.’033 (WO Patent Publication 2018223033 – previously cited), further in view of Davis et. al.’146 (U.S. Patent 11883146 – previously cited), as applied to Claim 12 above, as evidenced by Sonner et. al.’102 (CN Patent Application 107405102 – previously cited).
Regarding Claim 17, Rogers et. al.’878 in view of Tey et. al.’000, further in view of Rogers et. al.’033, further in view of Davis et. al.’146 discloses the device outlined in Claim 12 above, but fails to disclose the distance from the first portion is greater than the electrode gap. As evidenced by Sonner et. al.’102, the distance between the skin, collection of sweat, and gap between the electrodes can be changed based on what parameters are needed to be measured or captured (Page 6 Last Paragraph to Page 7 First Paragraph - spaced electrodes can be used for changing the impedance measurement depth and facilitates correction when only using a pair of electrodes to measure the impedance caused by the error. For example, the impedance of the electrode for measuring skin surface of closely spaced nearby, and may capture the measure of the resistance of sweat on the skin. far distance of electrodes, such as more than 1 cm, the deeper the measuring impedance, such as body impedance). It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the distance between the sweat collection site and the open channel is greater than the electrode gap. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal distance between the sweat collection site and the open channel as well as an optimal distance for an electrode gap. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited) in view of Tey et. al.’000 (U.S. Pub No. 20110237000 – previously cited), further in view of Rogers et. al.’033 (WO Patent Publication 2018223033 – previously cited), further in view of Davis et. al.’146 (U.S. Patent 11883146 – previously cited), further in view of Sonner et. al.’102 (CN Patent Application 107405102 – previously cited), as applied to Claim 17 above, further in view of Jason Heikenfeld’402 (WO Patent Publication 2017075402 – previously cited).
Regarding Claim 18, Rogers et. al.’878 in view of Tey et. al.’000, further in view of Rogers et. al.’033, further in view of Davis et. al.’146, further in view of Sonner et. al.’102 discloses the device outlined in Claim 17 above, but fails to disclose the impedance sensor operates at one or more frequencies from about 10kHz to about 100kHz. Jason Heikenfeld’402 teaches the impedance sensor operates at one or more frequencies from about 10kHz to about 100kHz (Paragraph [0041] - the sensor 720 could be an impedance based sensor, which is sampled at 100kHz, and EMI shields 790, 792 block external high frequency EMI of greater than 100kHz. The high-pass filter or circuit 753 may block low frequency EMI of less than 10kHz and DC EMI signals). It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to impedance frequencies between 10kHz and 100kHz. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal frequency for impedance sensors. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), as applied to Claim 1 above, in view of Harshman et. al.’298 (U.S. Pub No. 20190365298 – previously cited).
Regarding Claim 22, Rogers et. al.’878 discloses the device outlined in Claim 1 above as well as wireless communication systems (Paragraph [0005] - integrate wireless information transfer in connection with capture, sensing and/or collection, including via near field communication and systems capable of wireless electronic interfaces to external devices, e.g. for image capture and/or analysis). Additionally, Rogers et. al.’878 discloses monitoring hydration state (Paragraph [0107] - monitoring of physiologic health status (e.g., hydration state)), but fails to disclose an information display configured to indicate a hydration status, wherein the hydration status of a subject is correlated to the at least one property of the sweat. Harshman et. al.’298 teaches an information display configured to indicate a hydration status, wherein the hydration status is correlated to feedback from sensors (Paragraph [0045] - The feedback unit 55 may be part of the sensor 15 or it may be a separate component; Paragraph [0048] - the physiological performance data 60 may be output by the feedback unit 55 to provide an alert to the biological subject 25. For example, if the hydration data indicates that the biological subject 25 is becoming (or is) dehydrated, then the alert output by the feedback unit 55 may include the display of an image, video, or both of a cup of water by the feedback unit 55). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include displaying information regarding feedback from the sensors of the device that indicate levels and status of hydration of the subject in order to alert the subject that their hydration level is not where it is supposed to be and therefore be able to act on it as seen in Harshman et. al.’298.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), in view of Rogers et. al.’033 (WO Patent Publication 2018223033 – previously cited), further in view of Davis et. al.’146 (U.S. Patent 11883146 – previously cited).
Regarding Claim 23, Rogers et. al.’878 discloses a sweat collector, wherein at least a portion of the sweat collector comprises a first portion configured to face and to conform to a subject's skin (Paragraph [0010] - In an aspect, the invention provides a device for handling a biofluid comprising: (i) a functional substrate for mounting on a surface of the skin);
a sealing member configured to encompass the sweat collector and form a seal between the sweat collector and the subject's skin (Paragraph [0021] - the functional substrate forms a watertight seal with the skin around the one or more inlets; Paragraph [0114] - Devices are composed of a multilayer stack of three sub-systems: (1 ) a skin- compatible adhesive layer with a micromachined opening that defines the area of sweat collection… A medical-grade acrylic adhesive film ensured stable, strong and seamless adhesion (-5.7 N) of the device to the skin without irritation in a manner that offered compatibility with sweaty or hairy skin (FIG. 8));
an open channel having a width and a height (Paragraph [0045] - microfluidic channel as a function of width (w) and length (L) of the outlet channel with a fixed height of 300; Paragraph [0133] - microfluidics structures described here can hold captured sweat for -125 hours upon removal from the skin and sealing of the open channels); wherein
the open channel has an aspect ratio of the height to the width no greater than about 10 (Paragraph [0045] - aspect ratio (ratio of width 'a' to height 'h' of the serpentine channel… show two representative aspect ratios (10:3 and 5:1)); wherein
the open channel is open to the ambient atmosphere (Paragraph [0133] - In this latter context, it is important to note that we observed that the microfluidics structures described here can hold captured sweat for -125 hours upon removal from the skin and sealing of the open channels (~75 hours without sealing); Paragraph [0170] - Another option involves the introduction of open architectures via removal of regions of the device where the skin adhesive interface is not necessary (FIG. 32b)); and wherein
wherein the open channel is configured to continuously receive and transfer through an aliquot of a collected sweat from the sweat collector (Paragraph [0045] - microfluidic system that can directly and reliably harvest sweat from pores on the surface of the skin. The device routes this sweat to different channels and reservoirs for multi-parametric sensing of markers of interest, with the option to wirelessly interface with external devices for image capture and analysis), and wherein
the sensor is positioned at a distance from the first portion such that the sensor has substantially no contact with the subject's skin (Paragraph [0198] - Biofluid collection structures 60 may form at least a part of microfluidic network 150. Biofluid collection structures 60 and sensor(s) 50 may be positioned on a support surface 35 of functional substrate 30. One or more inlets 130 may be used to convey, transport or exchange biofluid 20 to sensor 50 released from skin surface 45, with inlets aligned in each of the relevant layers; Figure 1 - shows there are layers between the sensors and the skin).
Rogers et. al.’878 fails to disclose a sensor comprising two electrodes are in fluid communication with the collected sweat and wherein the sensor is configured to detect an impedance of the collected sweat and wherein the sensor is positioned at a distance from the first portion such that the sensor has substantially no contact with the subject's skin. Rogers et. al.’033 teaches a sensor comprising two electrodes wherein the sensor is configured to detect an impedance of the collected sweat (Paragraph [0197] - "electrical response" or "electrical parameter" may refer to a voltage, current, or impedance response of the electrodes or sensors to the electrical load. For example, applying a current between two electrodes (electrical load) may induce a voltage drop between the two electrodes (electrical response)). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 in view of Tey et. al.’000 to include a sensor with two electrodes in order to record an electrical response – such as impedance – as a result of an electrical load as seen in Rogers et. al.’033.
Rogers et. al.’878 in view of Rogers et. al.’033 fails to disclose electrodes defined by an electrode length and positioned opposing each other at an electrode gap. Davis et. al.’146 teaches electrodes defined by an electrode length and positioned opposing each other at an electrode gap (Column 19 Lines 52-53 - The length 400c may range from 2 millimeters (mm) to 10mm; Column 31 Lines 31-32 - A first row 1106a may have an inter-electrode spacing ranging from 50 microns to 150 microns). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Rogers et. al.’878 in view of Rogers et. al.’033 to include electrodes of certain lengths and spaced apart from one another in order to obtain readings of the skin at different depths as seen in Davis et. al.’146 (Column 41 Lines 31-33 - a spacing between the positive and negative electrode may be varied until a selected depth is reached).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), as applied to Claim 24 above, in view of Tey et. al.’000 (U.S. Pub No. 20110237000 – previously cited).
Regarding Claim 26, Rogers et. al.’878 discloses the method outlined in Claim 24 above, but fails to disclose the step of measuring comprises measuring an impedance at a voltage of less than about 1 Volt. Tey et. al.’000 teaches the step of measuring comprises measuring parameters of biomolecules at a voltage of less than about 1 Volt (Paragraph [0004] - liquid-gated field effect transistors (LGFET) are preferred for biosensing applications primarily because they are amenable to real-time detection at voltages less than 1 V and because the buffered liquid based environment is suitable for detection of biomolecules). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include liquid-gate effect transistors that measure properties of liquid at less than 1 Volt as seen in Tey et. al.’000 in order to allow a safe voltage level to be applied so close to a person’s skin and still be suitable for detection of biomolecules.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), as applied to Claim 24 above, in view of Begtrup et. al.’170 (U.S. Pub No. 20190117170 – previously cited).
Regarding Claim 27, Rogers et. al.’878 discloses the method outlined in Claim 24 above, but fails to disclose the step of measuring comprises correcting the one or more output signals for an artifact signal due to lack of electrode wetness and/or contamination. Begtrup et. al.’170 teaches the step of measuring comprises correcting the one or more output signals for an artifact signal due to contamination (Paragraph [0066] - When an electrode is skipped, there is uncertainty as to the volume of fluid in the vicinity of the skipped electrode… one or two skipped electrodes indicates the presence of a bubble… the missing volume can be subtracted out from the total volume measured by the device. Sweat rate may then be calculated based on the corrected volume). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Rogers et. al.’878 to include correcting contaminated signals in order to gather a more precise and accurate reading of the sample as seen in Begtrup et. al.’170.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), as applied to Claim 24 above, in view of Harshman et. al.’298 (U.S. Pub No. 20190365298 – previously cited).
Regarding Claim 28, Rogers et. al.’878 discloses the method outlined in Claim 24 above as well as wireless communication systems (Paragraph [0005] - integrate wireless information transfer in connection with capture, sensing and/or collection, including via near field communication and systems capable of wireless electronic interfaces to external devices, e.g. for image capture and/or analysis). Additionally, Rogers et. al.’878 discloses monitoring hydration state (Paragraph [0107] - monitoring of physiologic health status (e.g., hydration state)), but fails to disclose a user interface to produce an information display indicative of the hydration status of the subject. Harshman et. al.’298 teaches an information display configured to indicate a hydration status, wherein the hydration status is correlated to feedback from sensors (Paragraph [0045] - The feedback unit 55 may be part of the sensor 15 or it may be a separate component; Paragraph [0048] - the physiological performance data 60 may be output by the feedback unit 55 to provide an alert to the biological subject 25. For example, if the hydration data indicates that the biological subject 25 is becoming (or is) dehydrated, then the alert output by the feedback unit 55 may include the display of an image, video, or both of a cup of water by the feedback unit 55). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’878 to include displaying information regarding feedback from the sensors of the device that indicate levels and status of hydration of the subject in order to alert the subject that their hydration level is not where it is supposed to be and therefore be able to act on it as seen in Harshman et. al.’298.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.’878 (WO Patent Publication 2017218878 – previously cited), in view of Davis et. al.’146 (U.S. Patent 11883146 – previously cited).
Regarding Claim 29, Rogers et. al.’878 discloses positioning a sealing member such that the sealing member is configured to encompass the sweat collector (Paragraph [0111] - Bonding separate pieces of PDMS formed in this manner defined sealed microfluidic channels and containment reservoirs);
forming an open channel, wherein the open channel has a width and a height (Paragraph [0045] - microfluidic channel as a function of width (w) and length (L) of the outlet channel with a fixed height of 300 μm; Paragraph [0133] - the open channels), wherein
the open channel has an aspect ratio of the height to the width no greater than about 10 (Paragraph [0045] - aspect ratio (ratio of width 'a' to height 'h' of the serpentine channel…two representative aspect ratios (10:3 and 5:1)); wherein
the open channel is open to the ambient atmosphere (Paragraph [0133] - In this latter context, it is important to note that we observed that the microfluidics structures described here can hold captured sweat for -125 hours upon removal from the skin and sealing of the open channels (~75 hours without sealing); Paragraph [0170] - Another option involves the introduction of open architectures via removal of regions of the device where the skin adhesive interface is not necessary (FIG. 32b)); and wherein
the open channel is configured to continuously receive and transfer through an aliquot of a collected sweat from the sweat collector (Paragraph [0109] - microfluidic system that can directly and reliably harvest sweat from pores on the surface of the skin. The device routes this sweat to different channels and reservoirs for multi-parametric sensing of markers of interest, with the option to wirelessly interface with external devices for image capture and analysis); and
positioning a sensor such that the sensor is positioned at a distance from the first portion such that the sensor has substantially no contact with the subject's skin and such that the sensor is in fluid communication with the collected sweat and is configured to detect at least one property of the collected sweat (Paragraph [0038] - wherein the functional substrate provides for microfluidic transport of at least a portion of the biofluid to the one or more sensors; and wherein the one or more sensors provide for characterization of at least one temporal property of the biofluid; Paragraph [0198] - Biofluid collection structures 60 may form at least a part of microfluidic network 150. Biofluid collection structures 60 and sensor(s) 50 may be positioned on a support surface 35 of functional substrate 30. One or more inlets 130 may be used to convey, transport or exchange biofluid 20 to sensor 50 released from skin surface 45, with inlets aligned in each of the relevant layers; Figure 1 - shows there are layers between the sensors and the skin).
Rogers et. al.’878 fails to disclose forming a sweat collector on a rigid material. Davis et. al.’146 teaches forming a sweat collector on a rigid material (Column 10 Lines 51-55 - The substrate may be flexible and/or rigid. Compact arrangement of the sensors may allow for use of a rigid substrate, which may increase the durability of the sensors and/or the wearable device 100 overall). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of manufacturing the device of Rogers et. al.’878 to include a substrate with rigid material in order to increase durability of the sensors and device over a period of time as seen in Davis et. al.’146.
Response to Arguments
Applicant's arguments filed 21 November 2025 have been fully considered but they are not entirely persuasive. Applicant’s amendments to the drawings have overcome the previous objections of the drawings. Applicant’s amendments to the claims have overcome the previous objections. Applicant did not amend “sealing member” and therefore the examiner’s previous interpretation stands. Applicant’s amendment to the claims have overcome the previous 112(b) rejections. Claims 1, 4, 7, 10-11, 16, and 24 are rejected under 35 U.S.C. 102 as addressed in Paragraph 4 above. Claims 2, 6, 8, 12, 17-18, 21-23, and 26-29 are rejected under 35 U.S.C. 103 have been addressed in Paragraphs 5-15 above. It is noted that the applicant has argued that Rogers et. al.’878 fails to disclose “wherein the open channel is open to the ambient atmosphere” because the applicant is looking for “an entire channel that is open at its top surface”, but this was not found to be persuasive. The examiner points out that the applicant does not recite within their claims that “an entire open channel is open to the ambient atmosphere” and therefore this limitation is not read into the claims. Furthermore, the examiner has cited limitations of Rogers et. al.’878 that discloses open architectures of their device as well as “sealing” not being a mandatory element for open channels as seen in Paragraphs 4, 11, and 15 above. The examiner has interpreted “open architectures” to allow microchannels to remain open to the ambient environment as a way to improve flow as seen in Rogers et. al.’878 (Paragraph [0170] - Such layouts improve not only management of flows of sweat in these locations but they also increase the mechanical deformability).
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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