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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Paragraph 73 seems to be an unfinished sentence.
Paragraph 89, lines 5-6, the meaning of the sentence “the limits within which the area and distance between the electrodes” is unclear.
Paragraph 91, it seems “an Electromechanical switch or relay. Transistor or…” should instead read “an electromechanical switch or relay, transistor or…”
Paragraph 145, line 3, is missing a period at the end of the sentence.
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: “attachment structure” in claim 1. The term “structure” can be interpreted as a generic placeholder because it does not actually define or limit any particular structure that performs the attachment.
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. In the instant case, “attachment structure” is interpreted as an adhesive (paragraph 168 of the Specification), and equivalents thereof.
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 § 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 1-11 and 17 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.
Claim 1 recites “configured to be attachable to a band”. The band is recited as part of a functional limitation and is not positively claimed. It is unclear whether the band is considered part of the device or not. Claims 3-5 include language which further suggests the band is a separate component that is not part of the device (i.e., “configured for detachment from the band of a wearable” in claim 5 also recites “a wearable” which is not positively claimed), so to expedite prosecution, the band is interpreted as not a component of the device and merely part of a functional limitation. Applicant may amend the claim, confirm the Examiner’s interpretation, or provide other remarks as to whether the band is part of the device.
Claim 4 recites “wherein the device is on a flexible substrate comprising an adhesive”. However, the flexible substrate comprising an adhesive is not positively recited as a component of the device. It is unclear whether the flexible substrate should be interpreted as a component of the device or attachment structure or if the flexible substrate is not considered part of the device. To expedite prosecution, the flexible substrate will be interpreted as the attachment structure. Following this interpretation, the claim should be amended as follows: “wherein [[the device is on]] the attachment structure comprises a flexible substrate comprising an adhesive for attaching the device to the band.”
Claim 6 recites that the electrodes are “easy to clean”. The term “easy” in claim 6 is a relative term which renders the claim indefinite. The term “easy” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. To expedite prosecution, any electrodes that are reusable will be considered easy to clean.
Claim 7 recites “wherein the sensor is electrically connected to an ion sensing circuit comprising a microcontroller”. The ion sensing circuit and microcontroller are not positively claimed, and it is unclear as to whether they should be considered components of the device. Since they perform the function of providing the direct current pulse signal stimuli necessary for the device to measure hydration, it seems they should be positive limitations in the claim and will be interpreted this way for examination. The claim should be amended as follows: “The device of claim 1, further comprising an ion sensing circuit comprising a microcontroller that generates the direct current pulse signal stimuli, wherein the sensor is electrically connected to [[an]] the ion sensing circuit
Claims 2-3, 5, 8-11 are rejected by virtue of dependency.
Claim 17 recites “wherein the reading node is electrically connected to a transmitter”. The transmitter is not positively claimed, and it is unclear as to whether it is considered part of the device. To expedite prosecution, the transmitter is interpreted as not being part of the device. The claim should be amended as follows: “wherein the reading node is configured to be electrically connected to a transmitter.”
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites the electrodes are reusable and, following the interpretation of claim 6 under the 112(b) rejection above, does not recite additional limitations. Since claim 1 already recites that the electrodes are configured for reusability, claim 6 does not further limit the claim scope. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mirov (US 2017/0049352).
Regarding claim 20, Mirov teaches a band (520, Fig. 5) comprising:
a device comprising a sensor comprising a pair of electrodes (first electrical contact 410 and second electrical contact 415, Fig. 4; or a pair of electrical contacts 630a, 630b, 630c, 630d, Fig. 6B), wherein the pair of electrodes are in direct contact with a user (“passing a current through and/or applying a voltage to skin proximate to the wearable device and detecting a corresponding voltage across and/or current through the pairs of the electrical contacts 630a, 630b, 630c, 630d,” par. 111);
wherein the pair of electrodes are configured for reusability (“removably couple to external systems…an external charger could provide power (e.g., power to recharge a battery of a wearable device,” par. 31; “the user could then re-mount the device (e.g., remove and reposition the device, reapply an adhesive,” par. 41; being able to reposition the device and recharge the device suggests the electrodes are reusable);
wherein the device is configured to measure hydration level using an electrical resistance of a fluid of the user in contact with the pair of electrodes (“pairs of the electrical contacts…could be operated to detect impedances, a skin resistance…a body water content,” par. 111; “detecting the impedance (e.g., the resistance…) between two or more such electrical contacts…could be used to determine a physiological parameter, e.g., to determine a galvanic skin response…a skin hydration level,” par. 25) by providing direct current pulse signal stimuli (“the applied specified voltage and/or current could have a specified waveform…pulse width, pulse repetition frequency,” par. 28; “the applied voltage and/or current could be substantially constant (e.g., a DC voltage or current) during a specified period of time to provide for the detection of a DC impedance,” par. 28); and
wherein the device is removably attached to the band (Fig. 6C).
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 1-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov (US 2017/0049352) in view of Wang (US 2017/0325724, cited by Applicant).
Regarding claim 1, Mirov teaches a device comprising: a sensor comprising a pair of electrodes (first electrical contact 410 and second electrical contact 415, Fig. 4; or a pair of electrical contacts 630a, 630b, 630c, 630d, Fig. 6B), wherein the pair of electrodes are configured for reusability (“removably couple to external systems…an external charger could provide power (e.g., power to recharge a battery of a wearable device,” par. 31; “the user could then re-mount the device (e.g., remove and reposition the device, reapply an adhesive,” par. 41; being able to reposition the device and recharge the device suggests the electrodes are reusable); wherein the device is configured to be attachable to a band (Fig. 5); and wherein the device is configured to measure hydration of a user using an electrical resistance of a fluid of the user (“pairs of the electrical contacts…could be operated to detect impedances, a skin resistance…a body water content,” par. 111; “detecting the impedance (e.g., the resistance…) between two or more such electrical contacts…could be used to determine a physiological parameter, e.g., to determine a galvanic skin response…a skin hydration level,” par. 25) in contact with the pair of electrodes by providing direct current pulse signal stimuli (“the applied specified voltage and/or current could have a specified waveform…pulse width, pulse repetition frequency,” par. 28; “the applied voltage and/or current could be substantially constant (e.g., a DC voltage or current) during a specified period of time to provide for the detection of a DC impedance,” par. 28).
Under 35 USC 112(f), the limitation “an attachment structure” is interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. “Attachment structure” is interpreted as an adhesive (paragraph 168 of the Specification). While Mirov does not teach an adhesive for attaching the device to a band, Mirov still teaches the device is attachable to a band (Figs. 5-6), and that adhesive may be combined with a band for attaching the device (“a mount 520a, such as a belt, wristband, ankle band, etc. can be provided to mount the device at, on or in proximity to the external body surface. In some embodiments, a mount could additionally or alternatively include an adhesive,” par. 93). Wang teaches an analogous reusable and wearable non-invasive sensor comprising first and second electrodes (“the disclosed biosensor is reusable for multiple testing that allows for the continuous or quasi-continuous monitoring,” par. 4; Fig. 31E). The electrodes are printed on a flexible substrate, which can then be attached to a wearable device such as a band using an adhesive (“adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item,” par. 219; “a substrate formed of a flexible electrically insulative material structure to adhere to skin or a wearable item,” par. 222; “biosensors can be…included on the surface of a wearable item, e.g., including, but not limited to, a wristwatch, armband, chest-strap, belt, or headband for direct epidermal contact and sensing,” par. 231)
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov to provide the electrodes on a substrate that can then be adhesively attached to a band. One would be motivated to do so because Wang teaches this arrangement is cost-effective for mass production (“electrodes are fabricated by screen-printing on a wearable tattoo platform, which is easy to fabricate, wear, and remove as well as cost-effective for mass-production,” par. 159). While Wang teaches the electrodes are used for analyte sensing instead of skin resistance measurements, Wang is still relevant for its teachings of wearable, non-invasive sensors for measuring a property of a body fluid.
Regarding claim 2, Mirov teaches the pair of electrodes are in direct contact with the user (“passing a current through and/or applying a voltage to skin proximate to the wearable device and detecting a corresponding voltage across and/or current through the pairs of the electrical contacts 630a, 630b, 630c, 630d,” par. 111).
Regarding claims 3 and 5, Mirov teaches that ideally the sensor mounts (adhesive and/or bands) allow for repositioning (“A mount 520a, such as a belt, wristband, ankle band, etc. can be provided to mount the device at, on or in proximity to the external body surface. In some embodiments, a mount could additionally or alternatively include an adhesive,” par. 93; “remove and reposition the wearable device, reapply an adhesive, tighten a strap or other means for mounting,” par. 144). Wang teaches that the sensors can be configured for reusability (“a variety of reusable protocols can be implemented to performing…monitoring over a period of time continuously or periodically,” par. 4). Wang further teaches that the device is removable (“the user can remove or replace the device,” par. 115).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify in view of Wang teaches the attachment structure is configured such that the device is attached temporarily to the band of a wearable and can be detached and reattached. One would be motivated to do so in order to allow for repositioning of the electrodes, as suggested by Mirov (par. 144).
Regarding claim 4, Mirov in view of Wang teaches the device is on a flexible substrate comprising an adhesive for attaching the device to the band (“adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item,” Wang par. 219; “a substrate formed of a flexible electrically insulative material structure to adhere to skin or a wearable item,” Wang par. 222; “biosensors can be…included on the surface of a wearable item, e.g., including,…wristwatch, armband, chest-strap, belt, or headband for direct epidermal contact and sensing,” Wang par. 231).
Regarding claim 6 (see interpretation under the 112(b) rejection above), Mirov teaches the electrodes comprise a first electrode and a second electrode and the pair of electrodes are reusable and are easy to clean (“removably couple to external systems…an external charger could provide power (e.g., power to recharge a battery of a wearable device,” par. 31; “the user could then re-mount the device (e.g., remove and reposition the device, reapply an adhesive,” par. 41; being able to reposition the device and recharge the device suggests the electrodes are reusable).
Regarding claim 7, Mirov teaches the sensor is electrically connected to an ion sensing circuit comprising a microcontroller (controller 850) that generates the direct current pulse signal stimuli (“the biopotential sensor 820 could further include analog and/or digital electronic components to enable application of currents and/or voltages through/across the electrical contacts,” par. 125; “the controller 850 and elements thereof (e.g., an ADC of the processor(s) 860) could be considered part of an overall biopotential sensor configured to detect…biosignal waveform,” par. 127).
Regarding claim 8, Mirov teaches the ion sensing circuit is operable to detect an ion concentration of the fluid in real time (Fig. 3).
Regarding claim 11, Mirov teaches the device further comprises a wireless communication circuit that is operable to perform wireless transmission and reception (communication interface 840; “sending and/or receiving information via a wireless antenna,” par. 136).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mirov (US 2017/0049352) in view of Wang (US 2017/0325724), as applied to claim 7 above, and further in view of Hagino (US 2008/0208024). Kendall (US 2021/0402182) is relied on as an evidentiary reference.
Regarding claim 9, neither Mirov nor Wang teach or suggest determining and monitoring glucose by establishing a relationship between glucose and electrolyte concentration. Hagino teaches an analogous skin hydration sensor (Abstract). Hagino teaches that glucose levels can be corrected through conductance measurements (“a specific relational equation has been established experimentally for the glucose permeability P and the conductance k of the extraction region,” par. 77; “the glucose concentration can therefore be determined more accurately by correcting the glucose extraction amount by the conductance value,” par. 51). Conductance is related to the concentration of conductive ions, as evidenced by Kendall (“as the subject’s level of hydration increases or decreases, there will be a corresponding fall or rise in ion concentrations, thereby resulting in a change in conductivity of the fluid,” par. 238; “ Conductivity of interstitial fluid (ISF) is intimately related to the concentration of conductive ions,” par. 624).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov in view of Wang to derive glucose levels based on a relationship between glucose and electrolyte concentration, as suggested by Hagino. One would be motivated to do so in order to more accurately measure the blood glucose level without drawing blood, as taught by Hagino (“glucose concentration can therefore be determined more accurately by correcting the glucose extraction amount by the conductance value…the blood sugar level of the subject can be measured without collecting blood from the subject,” par. 51).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mirov (US 2017/0049352) in view of Wang (US 2017/0325724), as applied to claim 1 above, and further in view of Myers (US 2016/0338639).
Regarding claim 10, Mirov teaches the electrodes may be configurable to different shapes (“the shape and/or surface texture of the electrical contacts could be specified to control one or more properties of the electrical interface of the electrical contacts with skin,” par. 62; see 530a, 530b, 530c, and 530d in Figs. 5A-5D). Wang teaches the electrodes may be carbon printed and are configurable to different shapes (“printing the electrode pattern…the electrode pattern can further include an electrically semi-conductive material…including, but not limited to, amorphous carbon, carbon black, graphite, carbon nanotubes, and/or graphene,” par. 219; “the disclosed fabrication methods allow development of the exemplary ISE tattoo sensors in a variety of designs,” par. 281). Myers teaches an analogous hydration monitor electrodes for a hydration sensor can comprise carbon printed 2D flexible flat electrodes (“patterning followed by transfer printing,” par. 29; “the flexible electrode includes a plurality of conductive nanowires or carbon nanotubes,” par. 30).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov in view of Wang to comprise carbon printed flexible electrodes. One would be motivated to do so because such electrodes were already known in the art for measuring hydration, as taught by Myers paragraphs 29-30, and could be substituted for the electrodes taught in Mirov.
Claims 12, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of view of Wang (US 2017/0325724) and Kendall (US 2021/0402182).
Regarding claim 12, Mirov teaches a device (Figs. 5-6) comprising:
a sensor comprising a pair of electrodes, the pair of electrodes comprising a first electrode and a second electrode (first electrical contact 410 and second electrical contact 415, Fig. 4; or a pair of electrical contacts 630a, 630b, 630c, 630d, Fig. 6B); and an ion sensing circuit (Figs. 4, 8); wherein the pair of electrodes are arranged such that the first electrode is in proximity of the second electrode (Fig. 6B); wherein the sensor is electrically connected to the ion sensing circuit comprising a microcontroller (controller 850) that generates a direct current pulse signal stimuli (“analog and/or digital electronic components to enable application of currents and/or voltages through/across the electrical contacts,” par. 125; “the controller 850 and elements thereof (e.g., an ADC of the processor(s) 860) could be considered part of an overall biopotential sensor configured to detect…biosignal waveform,” par. 127); wherein the microcontroller reads resistance (“pairs of the electrical contacts…could be operated to detect impedances, a skin resistance…a body water content,” par. 111; “detecting the impedance (e.g., the resistance…) between two or more such electrical contacts,” par. 25) using the direct current pulse signal stimuli (“the applied specified voltage and/or current could have a specified waveform…pulse width, pulse repetition frequency,” par. 28; “the applied voltage and/or current could be substantially constant (e.g., a DC voltage or current) during a specified period of time to provide for the detection of a DC impedance,” par. 28).
Mirov explicitly teaches all limitations of claim 12 except for the electrodes being on a flexible substrate determining an ion concentration in a fluid of a subject based on the resistance.
Regarding determining an ion concentration, Kendall teaches an analogous wearable biosensor that measures hydration (Fig. 2; “as the subject's level of hydration increases or decreases, there will be a corresponding fall or rise in ion concentrations, thereby resulting in a change in conductivity of the fluid,” par. 238). Kendall teaches skin hydration, impedance, conductivity and ion concentration are all related (“impedance of the fluid can in turn be used to derive information regarding fluid conductivity, which is in turn indicative of ion concentrations and hence fluid levels,” par. 238; “Conductivity of interstitial fluid (ISF) is intimately related to the concentration of conductive ions, and therefore these different modes of hydration change can be discerned based on changes in impedance,” par. 624; “as the skin contains more ions than what is in PBS, resulting in greater conductivity (lower resistance),” par. 693).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov to derive an ion concentration based on the resistance. One would be motivated to do so because an ion concentration can provide more information about a subject’s hydration state, as suggested by Kendall (“changes in impedance to be used to track changes in fluid levels and hence a hydration state of the subject. Such fluid levels could include any one or more of …ion concentration in interstitial fluid, a change in an ion concentration in interstitial fluid,” par. 238; “if a hydration level is maintained or approximately constant then a change in impedance is indicative of a change in ion concentrations,” par. 626). While Kendall teaches measuring an impedance, a relationship between impedance and resistance is known in the art (“detecting the impedance (e.g., the resistance…) between two or more such electrical contacts,” Mirov par. 25; “the applied voltage and/or current could be substantially constant…to provide for the detection of a DC impedance,” Mirov par. 28; “greater conductivity (lower resistance),” par. 693), so ion concentration and resistance are also related.
Regarding the flexible substrate, Wang teaches an analogous reusable and wearable non-invasive sensor comprising first and second electrodes (“the disclosed biosensor is reusable for multiple testing that allows for the continuous or quasi-continuous monitoring,” par. 4; Fig. 31E). The electrodes are printed on a flexible substrate, which can then be attached to a wearable device such as a band using an adhesive (“adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item,” par. 219; “a substrate formed of a flexible electrically insulative material structure to adhere to skin or a wearable item,” par. 222; “biosensors can be…included on the surface of a wearable item, e.g., including, but not limited to, a wristwatch, armband, chest-strap, belt, or headband for direct epidermal contact and sensing,” par. 231).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov to provide the electrodes on a flexible substrate. One would be motivated to do so because Wang teaches this arrangement is cost-effective for mass production (“electrodes are fabricated by screen-printing on a wearable tattoo platform, which is easy to fabricate, wear, and remove as well as cost-effective for mass-production,” par. 159) and the flexible substrate helps the electrodes conform to the skin surface (“The flexible and conformal nature of the tattoo sensors enable them to be mounted on nearly any exposed skin surface for real-time pH monitoring of the human perspiration,” par. 276). While Wang teaches the electrodes are used for analyte sensing instead of skin resistance measurements, Wang is still relevant for its teachings of wearable, non-invasive sensors for measuring a property of a body fluid.
Regarding claim 14, Mirov in view of Wang and Kendall teaches the device is operable to determine hydration level from detecting the ion concentration of the fluid of the subject, by measuring conductance of the fluid of the subject (“measuring the impedance of the fluid can in turn be used to derive information regarding fluid conductivity, which is in turn indicative of ion concentrations and hence fluid levels,” Kendall par. 238).
Regarding claim 16, Mirov in view of Wang and Kendall teaches the pair of electrodes are operable to an area and a distance between the pair of electrodes wherein the area and the distance between the pair of electrodes is varied (“the shape and/or surface texture of the electrical contacts could be specified to control one or more properties of the electrical interface of the electrical contacts with skin. For example, the electrical contacts could have a specified large area in contact with skin,” Mirov par. 62; see 530a, 530b, 530c, and 530d in Mirov Figs. 5A-5D; “the disclosed fabrication methods allow development of the exemplary ISE tattoo sensors in a variety of designs,” Wang par. 281).
Regarding claim 19, Mirov teaches the device further comprises a wireless communication circuit that is operable to perform wireless transmission and reception (communication interface 840; “sending and/or receiving information via a wireless antenna,” par. 136).
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov (US 2017/0049352) in view of Wang (US 2017/0325724) and Kendall (US 2021/0402182), as applied to claim 12 above, and further in view of Myers (US 2016/0338639).
Regarding claim 15, Wang teaches the pair of electrodes are carbon printed on one side of the flexible substrate with adhesive on another side of the flexible substrate (Fig. 31D; “the adhesive sheet can include polydimethylsiloxane (PDMS)…printing the electrode pattern…the electrode pattern can further include an electrically semi-conductive material…including, but not limited to, amorphous carbon, carbon black, graphite, carbon nanotubes, and/or graphene,” par. 219). Myers teaches an analogous hydration monitor electrodes for a hydration sensor can comprise carbon printed 2D flexible flat electrodes (“patterning followed by transfer printing,” par. 29; “the flexible electrode includes a plurality of conductive nanowires or carbon nanotubes,” par. 30).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov in view of Wang and Kendall to comprise carbon printed flexible electrodes. One would be motivated to do so because such electrodes were already known in the art for measuring hydration, as taught by Myers paragraphs 29-30, and could be substituted for the electrodes taught in Mirov.
Regarding claim 18, Mirov teaches the microcontroller is operable to control an energy source (“a housing containing a battery,” par. 109; voltage source 441, Fig. 4) and provide the direct current pulse signal stimuli (“the voltage source 441, voltage sensor 447, voltage source switch 443, and/or other elements of the impedance detector 440 could be elements of a microprocessor,” par. 84; “the controller 850 and elements thereof (e.g., an ADC of the processor(s) 860) could be considered part of an overall biopotential sensor configured to detect…biosignal waveform,” par. 127), wherein the direct current pulse signal stimuli are at 0 Hz (“the impedance at a particular frequency (e.g.,…at approximately 0 Hertz or ‘DC’),” par. 35). Myers teaches a frequency range of measurement can be from 0.1-1000 Hz to measure hydration in the topmost layer of skin (“The sensing frequency between the two electrodes determine the sensitivity and the depth of the skin being interrogated…At lower frequencies, such as between about 0.1-1000 Hz, for example, the α relaxation response is mainly due to the topmost layer of skin,” par. 60).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mirov to measure at frequencies from 0-200 Hz. One would be motivated to do so in order to optimize the sensitivity and depth of measurement desired, as suggested by Myers (“The sensing frequency between the two electrodes determine the sensitivity and the depth of the skin being interrogated,” par. 60). Since Mirov teaches sensing on the skin surface (“a degree of moisture and/or hydration on/within the skin,” par. 24), a shallow depth of measurement using a lower frequency should be suitable.
Claim 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov (US 2017/0049352) in view of Wang (US 2017/0325724) and Kendall (US 2021/0402182), as applied to claim 12 above, and further in view of Hassibi (US 2005/0006234).
Mirov, Wang, and Kendall do not explicitly teach or suggest resistors and capacitors in the claimed arrangement. Hassibi teaches an analogous biosensor array with sensor circuitry configured for impedance measurement (“the impedance measured is a function of three factors: mobility of ions in the solution and their diffusion rate…the observed impedance is a function of the system, any structural or quantitative change which electrically affects the system in steady state can be observed and measured,” paragraph 53). Hassibi teaches an electrode design where two electrodes A (active electrode) and R (reference electrode) are connected in parallel to a resistor (impedance Rp, Fig. 8; paragraphs 57-58), and a capacitor C1 in series with a resistor R1 is connected to the parallel connection between the impedance and the electrodes via a first reading node. A second node at electrode R connects back to the circuit. A voltage source is connected to the R1 and C1 (Fig. 8). The load impedance Rp provides higher sensitivity in the circuit (paragraph 58).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the electrodes of Mirov, Wang, and Kendall to combine the electrodes with the resistor and capacitor arrangement taught by Hassibi. One would be motivated to do so because Hassibi teaches that this arrangement is known for creating an electrode circuit to provide higher sensitivity before the signal is sent to amplifiers for further processing (par. 58).
Regarding claim 17, Mirov teaches a transmitter (communication interface 840; “sending and/or receiving information via a wireless antenna,” par. 136) but does not explicitly teach or suggest connecting the transmitter to the reading node. Hassibi teaches that processing via an A/D converter 360 can be external to the biosensor array (pars. 33-34, 38).
It would be obvious to one of ordinary skill before the effective filing date of the invention to modify Mirov, Wang, Kendall, and Hassibi to transmit the output of the reading node using a transmitter. One would be motivated to do so in order to send the sensor signal for further processing at a remote location, as suggested by Mirov and Hassibi (“wearable devices 710 may be configured to transmit data via a communication interface 715 over one or more communication networks 720 to a remote server 730,” Mirov par. 117; Hassibi pars. 33-34, 38).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12-17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 12 of U.S. Patent No. 11,523,775.
Although the claims at issue are not identical, they are not patentably distinct from each other because the only difference between the claims is that the patent claim 1 recites “the microcontroller only reads resistance” while instant claim 12 recites more broadly “the microcontroller reads resistance”. The more specific patent claims still anticipate the instant claims. Following the rationale in In re Goodman, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. The claims are reproduced below for easy comparison.
Patent 11,523,775 Claims
Instant claims
1. A device comprising:
a sensor comprising a pair of electrodes on a flexible substrate, the pair of electrodes comprising a first electrode and a second electrode; and
an ion sensing circuit;
wherein the pair of electrodes are arranged such that the first electrode is in proximity of the second electrode;
wherein the sensor is electrically connected to the ion sensing circuit comprising a microcontroller that generates a direct current pulse signal stimuli;
wherein the microcontroller only reads resistance using the direct current pulse signal stimuli; and
wherein the microcontroller is operable to determine ion concentration in a fluid of a subject based on the resistance.
2. The device of claim 1, wherein the ion sensing circuit further comprises:
at least a first resistor;
a capacitor electrically connected in series with the at least the first resistor; at least a second resistor electrically connected in parallel with the pair of electrodes; and a first node which is a reading node, electrically connected to the second resistor connected to a second node which is in parallel to the capacitor and the first resistor, wherein the reading node is configured to read an output signal from the sensor.
4. The device of claim 1, wherein the device is operable to determine hydration level from detecting the ion concentration of the fluid of the subject, by measuring conductance of the fluid of the subject.
6. The device of claim 1, wherein the pair of electrodes are carbon printed on one side of the flexible substrate with adhesive on another side of the flexible substrate.
7. The device of claim 1, wherein the pair of electrodes are operable to an area and a distance between the pair of electrodes wherein the area and the distance between the pair of electrodes can be varied.
3. The device of claim 2, wherein the reading node is electrically connected to a transmitter.
11. The device of claim 1, wherein the direct current pulse signal stimuli are in a frequency range from 0 to 200 Hertz.
12. The device of claim 1, wherein the device further comprises a wireless communication circuit that is operable to perform wireless transmission and reception.
12. A device comprising:
a sensor comprising a pair of electrodes on a flexible substrate, the pair of electrodes comprising a first electrode and a second electrode; and
an ion sensing circuit;
wherein the pair of electrodes are arranged such that the first electrode is in proximity of the second electrode;
wherein the sensor is electrically connected to the ion sensing circuit comprising a microcontroller that generates a direct current pulse signal stimuli;
wherein the microcontroller reads resistance using the direct current pulse signal stimuli; and
wherein the microcontroller is operable to determine ion concentration in a fluid of a subject based on the resistance.
13. The device of claim 12, wherein the ion sensing circuit further comprises:
at least a first resistor;
a capacitor electrically connected in series with the at least the first resistor; at least a second resistor electrically connected in parallel with the pair of electrodes; and a first node which is a reading node, electrically connected to the second resistor connected to a second node which is in parallel to the capacitor and the first resistor, wherein the reading node is configured to read an output signal from the sensor.
14. The device of claim 12, wherein the device is operable to determine hydration level from detecting the ion concentration of the fluid of the subject, by measuring conductance of the fluid of the subject.
15. The device of claim 12, wherein the pair of electrodes are carbon printed on one side of the flexible substrate with adhesive on another side of the flexible substrate.
16. The device of claim 12, wherein the pair of electrodes are operable to an area and a distance between the pair of electrodes wherein the area and the distance between the pair of electrodes is varied.
17. The device of claim 13, wherein the reading node is electrically connected to a transmitter.
18. The device of claim 12, wherein the microcontroller is operable to control an energy source and provide the direct current pulse signal stimuli, wherein the direct current pulse signal stimuli are in a frequency range from 0 to 200 Hertz.
19. The device of claim 12, wherein the device further comprises a wireless communication circuit that is operable to perform wireless transmission and reception.
Claim 18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,523,775 (see the above table for comparison between the claims) in view of Mirov (US 2017/0049352).
Patent claim 11 includes all the same limitations as instant claim 18 except for that the microcontroller is operable to control an energy source and provide the direct current pulse signal stimuli. Mirov teaches an analogous resistance and hydration sensor (“pairs of the electrical contacts…could be operated to detect impedances, a skin resistance…a body water content,” par. 111). Mirov teaches the microcontroller (controller 850 and/or processor 860) can control an energy source (“the voltage source 441, voltage sensor 447, voltage source switch 443, and/or other elements of the impedance detector 440 could be elements of a microprocessor,” par. 84; “the controller 850 and elements thereof (e.g., an ADC of the processor(s) 860) could be considered part of an overall biopotential sensor configured to detect…biosignal waveform,” par. 127) and provide the direct current pulse signal stimuli (“the applied specified voltage and/or current could have a specified waveform…pulse width, pulse repetition frequency,” par. 28; “the applied voltage and/or current could be substantially constant (e.g., a DC voltage or current) during a specified period of time to provide for the detection of a DC impedance,” par. 28) to measure a resistance.
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Patent claim 11 to configure the microcontroller to control an energy source and provide the DC pulse signal stimuli. One would be motivated to do so because this arrangement was already known in the art to control resistance measurements, as taught by Mirov (“the biopotential sensor 820 could further include analog and/or digital electronic components to enable application of currents and/or voltages through/across the electrical contacts,” par. 125; “the controller 850 and elements thereof (e.g., an ADC of the processor(s) 860) could be considered part of an overall biopotential sensor configured to detect…biosignal waveform,” par. 127).
Claims 1-8, 10-11, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 12 of U.S. Patent No. 11,523,775 in view of Mirov (US 2017/0049352) and Wang (US 2017/0325724, cited by Applicant). The claims are reproduced below for comparison, with differences underlined.
1. A device comprising:
a sensor comprising a pair of electrodes on a flexible substrate, the pair of electrodes comprising a first electrode and a second electrode; and
an ion sensing circuit;
wherein the pair of electrodes are arranged such that the first electrode is in proximity of the second electrode;
wherein the sensor is electrically connected to the ion sensing circuit comprising a microcontroller that generates a direct current pulse signal stimuli;
wherein the microcontroller only reads resistance using the direct current pulse signal stimuli; and
wherein the microcontroller is operable to determine ion concentration in a fluid of a subject based on the resistance.
5. The device of claim 1, wherein the pair of electrodes are carbon printed 2D flexible flat electrodes and are configurable to different shapes.
12. The device of claim 1, wherein the device further comprises a wireless communication circuit that is operable to perform wireless transmission and reception.
1. A device comprising:
a sensor comprising a pair of electrodes on a flexible substrate, the pair of electrodes comprising a first electrode and a second electrode; and
an ion sensing circuit; wherein the pair of electrodes are arranged such that the first electrode is in proximity of the second electrode;
wherein the sensor is electrically connected to the ion sensing circuit comprising a microcontroller that generates a direct current pulse signal stimuli;
wherein the microcontroller only reads resistance using the direct current pulse signal stimuli; and
wherein the microcontroller is operable to determine ion concentration in a fluid of a subject based on the resistance.
1. A device comprising:
a sensor comprising a pair of electrodes, wherein the pair of electrodes are configured for reusability; an attachment structure configured to be attachable to a band; and
wherein the device is configured to measure hydration of a user using an electrical resistance of a fluid of the user in contact with the pair of electrodes by providing direct current pulse signal stimuli.
2. The device of claim 1, wherein the pair of electrodes are in direct contact with the user.
3. The device of claim 1, wherein the attachment structure is configured such that the device is attached temporarily to the band of a wearable.
4. The device of claim 1, wherein the device is on a flexible substrate comprising an adhesive for attaching the device to the band.
5. The device of claim 1, wherein the attachment structure is further configured for detachment from the band of a wearable and reattachment to the band of the wearable.
6. The device of claim 1, wherein the pair of electrodes comprise a first electrode and a second electrode and the pair of electrodes are reusable and are easy to clean.
7. The device of claim 1, wherein the sensor is electrically connected to an ion sensing circuit comprising a microcontroller that generates the direct current pulse signal stimuli.
8. The device of claim 7, wherein the ion sensing circuit is operable to detect an ion concentration of the fluid in real time.
10. The device of claim 1, wherein the pair of electrodes are carbon printed 2D flexible flat electrodes and are configurable to different shapes.
11. The device of claim 1, wherein the device further comprises a wireless communication circuit that is operable to perform wireless transmission and reception.
20. A band comprising: a device comprising
a sensor comprising a pair of electrodes, wherein the pair of electrodes are in direct contact with a user; wherein the pair of electrodes are configured for reusability;
wherein the device is configured to measure hydration level using an electrical resistance of a fluid of the user in contact with the pair of electrodes by providing direct current pulse signal stimuli; and wherein the device is removably attached to the band.
Regarding instant claim 1, Patent claim 1 teaches all limitations except for the pair of electrodes are configured for reusability, an attachment structure configured to be attachable to a band, and wherein the device is configured to measure hydration of a user using the resistance. Mirov teaches an analogous resistance and hydration sensor (“pairs of the electrical contacts…could be operated to detect impedances, a skin resistance…a body water content,” par. 111). Mirov teaches the pair of electrodes are configured for reusability (being able to reposition the device and recharge the device suggests the electrodes are reusable – see pars. 31, 41), the device is configured to be attachable to a band (Fig. 5), and measuring a hydration of the user from the resistance (“pairs of the electrical contacts…could be operated to detect impedances, a skin resistance…a body water content,” par. 111; “detecting the impedance (e.g., the resistance…) between two or more such electrical contacts…could be used to determine a physiological parameter, e.g., to determine a galvanic skin response…a skin hydration level,” par. 25).
Under 35 USC 112(f), “attachment structure” is interpreted as an adhesive (paragraph 168 of the Specification). Wang teaches an analogous reusable and wearable non-invasive sensor comprising first and second electrodes (“the disclosed biosensor is reusable for multiple testing that allows for the continuous or quasi-continuous monitoring,” par. 4; Fig. 31E). The electrodes are printed on a flexible substrate, which can then be attached to a wearable device such as a band using an adhesive (“adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item,” par. 219; “a substrate formed of a flexible electrically insulative material structure to adhere to skin or a wearable item,” par. 222; “biosensors can be…included on the surface of a wearable item, e.g., including, but not limited to, a wristwatch, armband, chest-strap, belt, or headband for direct epidermal contact and sensing,” par. 231)
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Patent claim 1 to configure the electrodes for reusability, an adhesive for attaching the electrodes to a band, and measuring hydration using the resistance. One would be motivated to do so in order to derive hydration information about the user (“detecting the impedance (e.g., the resistance…) between two or more such electrical contacts…could be used to determine a physiological parameter, e.g., to determine a galvanic skin response…a skin hydration level,” Mirov par. 25) and because this arrangement is cost-effective for mass production (“electrodes are fabricated by screen-printing on a wearable tattoo platform, which is easy to fabricate, wear, and remove as well as cost-effective for mass-production,” Wang par. 159). While Wang teaches the electrodes are used for analyte sensing instead of skin resistance measurements, Wang is still relevant for its teachings of wearable, non-invasive sensors for measuring a property of a body fluid.
Regarding instant claim 2, Mirov teaches the pair of electrodes are in direct contact with the user (“passing a current through and/or applying a voltage to skin proximate to the wearable device and detecting a corresponding voltage across and/or current through the pairs of the electrical contacts 630a, 630b, 630c, 630d,” par. 111).
Regarding instant claims 3 and 5, Mirov teaches that ideally the sensor mounts (adhesive and/or bands) allow for repositioning (“A mount 520a, such as a belt, wristband, ankle band, etc. can be provided to mount the device at, on or in proximity to the external body surface. In some embodiments, a mount could additionally or alternatively include an adhesive,” par. 93; “remove and reposition the wearable device, reapply an adhesive, tighten a strap or other means for mounting,” par. 144). Wang teaches that the sensors can be configured for reusability (“a variety of reusable protocols can be implemented to performing…monitoring over a period of time continuously or periodically,” par. 4). Wang further teaches that the device is removable (“the user can remove or replace the device,” par. 115).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify in view of Wang teaches the attachment structure is configured such that the device is attached temporarily to the band of a wearable and can be detached and reattached. One would be motivated to do so in order to allow for repositioning of the electrodes, as suggested by Mirov (par. 144).
Regarding instant claim 4, Mirov in view of Wang teaches the device is on a flexible substrate comprising an adhesive for attaching the device to the band (“adhesive sheet to enable adhesion of the electrochemical sensor to the skin or the wearable item,” Wang par. 219; “a substrate formed of a flexible electrically insulative material structure to adhere to skin or a wearable item,” Wang par. 222; “biosensors can be…included on the surface of a wearable item, e.g., including,…wristwatch, armband, chest-strap, belt, or headband for direct epidermal contact and sensing,” Wang par. 231).
Regarding instant claim 6 (see interpretation under the 112(b) rejection above), patent claim 1 recites first and second electrodes, and Mirov further teaches the pair of electrodes are reusable and are easy to clean (“removably couple to external systems…an external charger could provide power (e.g., power to recharge a battery of a wearable device,” par. 31; “the user could then re-mount the device (e.g., remove and reposition the device, reapply an adhesive,” par. 41; being able to reposition the device and recharge the device suggests the electrodes are reusable).
Regarding instant claims 7 and 8, patent claim 1 teaches the same limitations. Instant claim 10 and 11 are taught by patent claims 5 and 12, respectively. Instant claim 20 is also taught by Patent claim 1 in combination with Mirov and Wang (see rejections of instant claims 1-3 and 5 above).
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,523,775 in view of Mirov (US 2017/0049352) and Wang (US 2017/0325724, cited by Applicant), as applied to instant claim 1 above, and further in view of Hagino (US 2008/0208024). Kendall (US 2021/0402182) is relied on as an evidentiary reference.
Regarding instant claim 9, patent claim 1, Mirov, and Wang do not teach or suggest determining and monitoring glucose by establishing a relationship between glucose and electrolyte concentration. Hagino teaches an analogous skin hydration sensor (Abstract). Hagino teaches that glucose levels can be corrected through conductance measurements (“a specific relational equation has been established experimentally for the glucose permeability P and the conductance k of the extraction region,” par. 77; “the glucose concentration can therefore be determined more accurately by correcting the glucose extraction amount by the conductance value,” par. 51). Conductance is related to the concentration of conductive ions, as evidenced by Kendall (“as the subject’s level of hydration increases or decreases, there will be a corresponding fall or rise in ion concentrations, thereby resulting in a change in conductivity of the fluid,” par. 238; “ Conductivity of interstitial fluid (ISF) is intimately related to the concentration of conductive ions,” par. 624).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Patent claim 1 in view of Mirov and Wang to derive glucose levels based on a relationship between glucose and electrolyte concentration, as suggested by Hagino. One would be motivated to do so in order to more accurately measure the blood glucose level without drawing blood, as taught by Hagino (“glucose concentration can therefore be determined more accurately by correcting the glucose extraction amount by the conductance value…the blood sugar level of the subject can be measured without collecting blood from the subject,” par. 51).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALICE L ZOU whose telephone number is (571)272-2202. The examiner can normally be reached Monday-Friday 9-6 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALICE LING ZOU/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791