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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 12, 31 and claims dependent therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is not clear what is meant by “upstanding members forming a capillary pattern”. It seems from the specification that these members are vertically oriented transverse to the flow of the channel but it is not clear if upstanding means something else or what a capillary pattern is.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear how the first working electrode determines potassium if it’s a sodium detecting electrode.
Claim 27 and claims dependent therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear what is considered “a capillary pattern” it is presumed this is the upstanding members in the reservoir.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation solid state electrode, and the claim also recites the electrode is a composite coated wire which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear if the wire type electrode is just a more specific solid state electrode or a different type of electrode. The specification does not provide particular details of what a solid-state electrode is.
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.
Claim(s) 1, 2, 4, 5, 7, 12-14, 16, 17, 19, 26-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. US 2021/0338157 (herein after Wang) in view of Shetty et al. US 2022/0031250 and Wang et al. US 2020/0337641 (herein after 641)
Regarding claim 1, Wang discloses a device comprising:
a sensor ([¶22] electrode sensor); and
a biocompatible body ([¶30] silicone) configured to:
be inserted into a mouth of a user ([¶30] device is shaped as a pacifier); and
receive saliva from the user and, via a channel, direct saliva into sensory communication with the sensor ([32,43] a channel is formed in the pacifier);
Wang discloses determining analyte levels ([¶41] electrodes for sensing glucose) but does not specifically disclose measuring an electrolyte in the saliva. Shetty teaches a similar oral sensing device that has electrodes for sensing electrolytes ([FIG.1][¶24]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang with the sensors of Shetty in order to track health and disease linked to electrolytes ([¶69]) and providing more parameters than just glucose.
Wang does not specifically disclose the hydrophilic material. ‘641 teaches a similar flow biosensor that can be used with saliva ([¶34]) that is configured to measure an electrolyte level present in the saliva ([¶54,56]); and at least a portion of the channel comprises a hydrophilic material configured to draw saliva into the channel ([¶92] PDMS is used for the layers). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang with the teachings of ‘641 in order to eliminate the need for a separate housing for an electrochemical cell in Wang.
Regarding claim 2, ‘641 teaches the channel comprises a reservoir in which the sensor is disposed ([¶44,49] the channel has a reservoir with the electrodes); and the sensor comprises a first working electrode, a second working electrode, and a reference electrode, wherein the reservoir comprises upstanding members forming a capillary pattern configured to draw the biofluid past the first working electrode, the reference electrode, and the second working electrode ([¶52,125] the device has multiple working electrodes and a reference electrode).
Regarding claim 4, Wang discloses the channel comprises:
an inlet comprising a microfluidic channel ([¶44] the inlet is microfluidic);
a reservoir in fluid communication with the microfluidic channel ([¶22] the detection chamber is a reservoir) and
configured to contain:
at least a portion of the saliva ([¶22] the saliva is conducted by the channel to the detection chamber); and
the sensor ([¶22] the chamber contains the electrodes); and
an outlet in fluid communication with the reservoir and configured to exit
saliva from the reservoir ([¶45] a hydrophilic thread conducts saliva through an outlet out of the detection chamber); and
the microfluidic channel is configured to unidirectionally pass saliva from the user's mouth to the reservoir ([¶22]).
Regarding claim 5, ‘641 teaches the channel comprises:
a base layer in which the microfluidic channel is formed; and
a top layer, bonded to the base layer ([¶70] the layers are bonded).
Regarding claim 7, ‘641 teaches the base layer and top layer comprise the hydrophilic material ([¶92] PDMS is used).
Regarding claim 12, ‘641 teaches the sensor comprises:
a first working electrode,
a reference electrode; and
a second working electrode ([¶52,125] the device has multiple working electrodes and a reference electrode) and wherein
the reservoir comprises upstanding members forming a capillary pattern configured to draw saliva past the first working electrode, the reference electrode, and the second working electrode ([¶92-94] the reservoir has micropillars which increases flow).
Regarding claim 13, ‘641 teaches that the sensor comprises:
a first working electrode configured to detect sodium ions; and
a second working electrode configured to detect potassium ions ([¶52,125] the device has ion-selective electrodes for sodium and potassium).
Regarding claim 14, Wang discloses the sensor comprises:
a first working electrode comprises comprising a solid-state electrode; and
a second working electrode comprises comprising a solid-state electrode ([¶41] the electrodes are silver).
Regarding claim 16, ‘641 teaches the device further comprises a control circuit;
the sensor further comprises a reference electrode ([¶125] reference electrode 803); and
the control circuit is configured to ([¶40] electronic board):
obtain, from the sensor, data related to the sodium ions based on potential
differences between the first working electrode and the reference electrode;
obtain, from the sensor data, related to the potassium ions based on potential
differences between the first working electrode and the reference electrode ([¶125] the sensor is potentiometric using the sodium selective electrode, the potassium selective electrode and the reference electrode to determine voltage differences between the working electrode and the reference electrode); and
transmit the data related to the sodium ions and the data related to the potassium
ions to an end-user device ([¶40] the data can be sent to a mobile device).
Regarding claim 17, ‘641 teaches a method of manufacturing a pacifier for monitoring salivary electrolytes, the method the device of claim 1 comprising:
forming the channel ([¶41,44] the inlet channel is made in the layer);
fixing the sensor comprising a first working electrode and a reference electrode
in the channel ([¶49] sensors are affixed in the reservoir);
operatively coupling a control circuit to the sensor ([¶57] the circuitry is attached);
fixing the channel and the control circuit to the device ([¶57).
Regarding claim 19 and 28,‘641 teaches fixing a second working electrode in the channel; and operatively coupling the control circuit to the second working electrode ([¶125] the sensor has at least two sensing electrodes in the channel).
Regarding claim 26, Wang discloses detecting a concentration level of an electrolyte in saliva and transmitting the concentration to a user level ([¶41] the sensing information is sent to a computer).
Regarding claim 27, Wang discloses detecting the concentration level of the electrolyte
with the device of claim 1 comprises:
continuously drawing saliva from the mouth of the user from an inlet of the
channel comprising a microfluidic channel to a reservoir of the channel ([¶25] saliva is drawn into the inlet);
obtaining a first signal from a first working electrode of the sensor; and
comparing the first signal to a reference signal from a reference electrode of the
sensor ([¶25] the sensor is amperometric with a oxidase working electrode and a reference electrode. The potential difference is determined between the working electrode and the reference electrode):
Wang does not specifically disclose the first working electrode and the reference electrode are disposed in a capillary pattern contained within the reservoir. ‘641 teaches a similar electrode body fluid device that teaches the first working electrode and the reference electrode are disposed in a capillary pattern contained within the reservoir ([¶45,92-94] the electrodes are in the reservoir and the reservoir has pillar structures that provide capillary action). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang with the teachings of ‘641 in order to eliminate the need for a separate housing for an electrochemical cell in Wang.
Regarding claim 29, ‘641 teaches comparing the first signal to the reference signal yields a first electrical potential difference ([¶125] the sensor is potentiometric using the sodium selective electrode, the potassium selective electrode and the reference electrode to determine voltage differences between the working electrode and the reference electrode);;
the method further comprises converting the first electrical potential difference to a
concentration of a first electrolyte based on a calibration factor;
comparing the second signal to the reference signal yields a second electrical potential
difference; and
the method further comprises converting the second electrical potential difference to
a concentration of a second electrolyte based on the calibration factor ([¶161,162] concentrations are determined based on the electrode reading and a calibration curve to determine electrolyte levels).
Claim(s) 15 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Shetty and Wang ‘641 further in view of Li et al. US 2018/0325437.
Regarding claim 15, ‘641 teaches that the sensor comprises:
a first working electrode comprising a composite-coated electrode
and a sodium selective membrane; and
a second working electrode further comprises comprising a composite-coated
electrode and a potassium selective membrane ([¶125,133] the electrodes are coated in a composite membrane that is sodium selective or potassium selective).
‘641 does not teach that the electrodes are specifically wire electrodes. Li teaches a
similar analyte sensor that uses wire type electrodes ([¶461,462] the electrodes are formed of coated platinum wire). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang and ‘641 with the wire electrodes of Li to provide superior performance to deposited electrodes ([¶463]).
Regarding claim 31, ‘641 teaches the reservoir comprises a plurality of upstanding members forming a capillary pattern configured to draw saliva past the first working electrode, the reference electrode, and the second working electrode ([¶45,92-94] the electrodes are in the reservoir and the reservoir has pillar structures that provide capillary action);
the first electrolyte is sodium and the second electrolyte is potassium ([¶52,125] the device has ion-selective electrodes for sodium and potassium);
the first working electrode comprises a solid-state electrode;
the second working electrode comprises a solid-state electrode ([¶52,125] the device has ion-selective electrodes for sodium and potassium);
‘641 teaches the electrodes have a composite ion-selective composite coating ([¶52,125]) but does not specifically teach the electrodes are a wire. Li teaches a similar analyte sensor that uses wire type electrodes ([¶461,462] the electrodes are formed of coated platinum wire). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang and ‘641 with the wire electrodes of Li to provide superior performance to deposited electrodes ([¶463]).
Claim(s) 6 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Shetty and Wang 641 in view of Cohen US 2009/0156967.
Regarding claim 6, Wang discloses the top layer is bonded to the base layer but does not specifically disclose using a medical grade epoxy. Cohen teaches a similar pacifier sensing device that uses epoxy to bond its components ([¶46]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang with the epoxy bonding of Cohen as it is no more than the substitution of one known bonding method for another that arrives at the predictable result of a bonded sensor and device.
Regarding claim 20, Wang discloses forming the channel comprises:
aligning an inlet of the channel with an aperture of the pacifier device ([¶43] the outlet of the channel flows saliva to the detection chamber);
forming a reservoir, a microfluidic channel leading from the inlet to the reservoir, and an
outlet in a base layer of a material ([¶41,43] the channel flows to the reaction chamber or reservoir and has an outlet from there to remove saliva from the sensing electrodes); and
Wang does not disclose the sensors are in the reservoir of the channel. ‘641 teaches fixing the first working electrode comprises placing the first working electrode in the reservoir prior to bonding the top layer to the base layer; and fixing the second working electrode comprises placing the second working electrode in the reservoir prior to bonding the top layer to the base layer ([¶70] the top layer is bonded over the electrode layer with the electrodes in the reservoir area).
Wang as modified by ‘641 does not disclose bonding with epoxy. Cohen teaches a similar pacifier sensing device that uses epoxy to bond its components ([¶46]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Wang with the epoxy bonding of Cohen as it is no more than the substitution of one known bonding method for another that arrives at the predictable result of a bonded sensor and device.
Claim(s) 8 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Shetty and Wang 641 further in view of Goh et al. “Peg Surface Modification to Control Biofouling in Microfluidic High Content Screening Devices.”
Regarding claims 8 and 22, ‘641 teaches using PDMS as the channel material but does not disclose specifically using PDMS-PEG. Goh teaches a microfluidic device that uses PDMS-PEG ([abstract ¶3-4]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of ‘641 with the teaches of Goh as the PEG modification reducing biofouling ([abstract ¶2]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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