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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 recite “in induced sweat” in line 7, but instead should recite --in the induced sweat--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7, and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “derive a normalized measurement . . . from the secretion signal” in lines 8-9, but lacks support in the specification. The specification recites “operations of normalizing sweat analyte measurements with respect to a measured secretion rate.” (see para. [0021]) However, there is no explicit detail or support that suggests how the normalization is performed nor that it is reflective of blood levels of the target analyte. A linear model is disclosed as represents a relationship between a target analyte concentration in sweat and blood, but does not provide any details on the normalization and what it reflects (see para. [0021]).
Claim 1 recites “wherein the derived normalized measurement of the target analyte is performed using parameters that are configured to decouple an effect of the secretion rate from measurements of the target analyte in the induced sweat” (emphasis added) in lines 9-12, but appears to lack support in the specification. It is unclear what performs the step and how the step is performed. How can a measurement decouple an effect? Or does the measurement represent the decoupling? Is the step performed by a processor or a measurement. Further clarification required. Same issue is found in claims 7 and 10.
Claim 7 recites “deriving a normalized measurement of the target analyte” in line 5, but lacks support in the specification. While the specification recites the same language found in the claims, the step of deriving the normalized measurement is not explicitly detailed. An example is used, but the example is a linear model that represents a relationship between a target analyte concentration in sweat and blood (see para. [0021]). However, this does not explain or suggest normalizing the target analyte measurement. Clarification required. Same issue applies to claim 10.
Claims 1-17 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 “derive a normalized measurement . . . from the secretion signal” in lines 8-9, but is indefinite. How is the normalized measurement derived from the secretion signal and how does it reflect blood levels of the target analyte? Further clarification required.
Claim 1 recites “wherein the derived normalized measurement of the target analyte is performed using parameters that are configured to decouple an effect of the secretion rate from measurements of the target analyte in the induced sweat” (emphasis added) in lines 9-12, but is indefinite. What component is performing the decoupling step? As written, it is interpreted as a parameter is configured to perform the step of decoupling an effect, but is unclear how that is possible. Is the parameter mathematically performing the decoupling, the processor, or some other element. For the purposes of examination, the recited step is achieved as long as a normalized measurement is derived or taught in the cited prior art, because it is interpreted that the normalized measurement represents the decoupling effect. Further clarification required. Same issue is shared with claims 7 and 10.
Claim 1 recites “to derive a normalized measurement that is reflective of blood levels of the target analyte” in line8-9, but is indefinite. What are blood levels referring to? Blood concentration? The limitation can interpreted as the concentration of blood of the target analyte or the concentration of the target analyte in blood. For examination purposes, the latter will be the interpretation. Clarification is required.
Claim 7 recites “deriving a normalized measurement of the target analyte” in line 5, but is indefinite. How is the normalized measurement derived from the target analyte and how does it reflect blood levels of the target analyte? Further clarification required. Same issue is shared with claim 10.
Claim 16 recites “wherein the calibrating sensor comprises a secretion rate sensor implemented by a capacitive humidity sensor”, but is indefinite. Claim 1 does not comprise a calibrating sensor, but a secretion rate sensor has been disclosed. For examination purposes, the claim is interpreted as the secretion rate sensor is implemented by a capacitive humidity sensor. It appears the rejection can be overcome by amending to recite -- wherein the secretion rate sensor is implemented by a capacitive humidity sensor--.
Claims not listed are rejected by virtue of claim dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 7-8, 10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld et al. (US 20180263538 A1 – previously cited) and further in view of Yamakawa (US 20180000386).
Regarding claim 1, Heikenfeld et al. discloses a sweat sensing device for sweat analysis (see ABSTRACT), comprising:
a sensing module configured to induce sweat and generate a sensing signal responsive to a sweat concentration of a target analyte in induced sweat (see fig.1-5 and para. [0033-34,0040-43,0048,0058], sweat sensing module/device 2 includes electrodes (252-256,220, 260) that indirectly induce sweat and sensor 220 of device 2, generates a sensing signal, such as to determine sweat rate, based on analyte concentration), the sensing module including a secretion rate sensor to generate a secretion signal responsive to a secretion rate of the induced sweat (see fig.1-5 and para. [0042-0048], each sensor generates a sensor signal based on the sweat flow rate (secretion rate) or other metric of the induced sweat) ; and
a processor connected to the sensing module, the processor configured to derive a measurement of the sweat concentration of the target analyte in the sweat from the sensing signal (see fig.1-5 and para. [0039, 0048], the device measures the target analyte concentration from the induced sweat signal gathered from the electrodes).
Heikenfeld fails to teach deriving a normalized measurement of a blood concentration of the target analyte from the secretion rate signal.
Yamakawa teaches a device for measuring concentration of analytes in blood using light signals (see abstract and para. [0021]). The light signals are subject to change over time due to absorption ( see para. [0006]). The light signals therefore represent a rate (change over time) of a secretion of analytes, e.g., glucose, into the blood. The light is normalized to increase the accuracies of the analysis, e.g., concentration of analytes, (see para. [0065]). As such, the normalized measurement of the light signal reflects the target analyte concentration in the blood.
Therefore, 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 Heikenfeld, such that a normalized measurement of the secretion rate signal, reflective of target analyte concentration in blood, is derived, as taught by Yamakawa, to measure analytes with clinical accuracy (see para. [0076] of Yamakawa).
It follows, Heikenfeld in view of Yamakawa teaches wherein the derived normalized measurement of the target analyte is performed using parameters that are configured to decouple the secretion rate from the measurements of the target analyte in the induced sweat (Following the 35 U.S.C. 112(a)-(b) issues with the claim language noted above in view of the teachings by the prior art of disclosing normalization and each element, the derived normalization of Heikenfeld in view of Yamakawa therefore also uses parameters that decouple the secretion rate from the target analyte).
Regarding claim 2 and 12-13, Heikenfeld discloses wherein the one or more sensing modules includes a pair of iontophoresis electrodes (see para. [0034] and fig. 2, electrodes 252,254,256) and a secretory agonist (pilocarpine) adjacent to the pair of iontophoresis electrodes (see para. [0034] and fig. 2); and a sweat analyte sensor (sweat sensor 220) configured to generate a sensing signal to monitor sweat analytes (see para. [0034]).
While the second embodiment of Heikenfeld does not disclose a hydrogel that contains a secretory agonist, the third embodiment discloses a chemical sweat stimulant suspended in gel 380 (see para. [0040]). It would have been obvious before the effective filing date of the present invention to have modified the device of Heikenfeld such that the chemical stimulant is incorporated to the gel as further taught by Heikenfeld in the third embodiment to aid in inducing sweat.
Regarding claim 3, Heikenfeld discloses the sensor, which all are equipped with calibration data as stated above, can be humidity sensors (see para. [0030]).
Regarding claim 7, sections of Heikenfeld et al., cited above, disclose the method as recited performed by the device of claim 1.
Regarding claim 8, Heikenfeld et al., cited above, discloses wherein deriving the concentration of the target analyte in the blood is by using a linear model that relates the concentration of the target analyte in the sweat depending on the size (big or small) of the target analyte and sweat secretion rate (high or low) to the target analyte concentration (high or low) in the blood based on the power (low or high) sent to the electrodes by the power controller (see para. [0058]).
Regarding claim 10, sections of Heikenfeld et al., cited above, disclose the device for sweat analysis of claim 1, inherently comprises a non-transitory computer readable storage medium configured to perform the method as recited in claim 1.
Regarding claim 14, Heikenfeld teaches wherein the secretory agonist comprises a cholinergic sweat gland secretory stimulating compound (see para. [0034], pilocarpine).
Regarding claim 15, Heikenfeld teach wherein the secretory agonist is configured to be released when electrical current is supplied to the iontophoresis electrodes (see para. [0034], iontophoresis electrodes cause the sweat stimulant to be released and cause the skin to generated sweat).
Claims 4-6, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld in view Yamakawa, as applied to claim 1, 7, and 10, in further view of Kim (US 20180000421 A1 – previously cited).
Regarding claim 4, 9 and 11, Heikenfeld et al. discloses the calibrating sensors (252,254,256) include a microfluidic channel (see fig. 2 and para. [0034], channel 230). Heikenfeld in view of Yamakawa fail to teach a set of electrolysis electrodes positioned in an upstream portion of the microfluidic channel and configured to generate microbubbles from the induced sweat; and a set of impedance sensing electrodes positioned in a downstream portion of the microfluidic channel and configured to detect the generated microbubbles.
Kim teaches a device for monitoring flow rate and other characteristics of fluid (see ABSTRACT) wherein the device includes a first set of electrodes that are positioned upstream the microfluidic channel configured to generate the microbubbles and a set of impedance sensing electrodes configured to detect the generated microbubbles downstream to determine the flow rate (See para. [0067,0072,0083-85]). It would have been obvious to someone of ordinary skill in the art before the effective filing date to have modified the device of Heikenfeld in view of Yamakawa, such that it substituted the components to detect sweat secretion rate, as taught by Kim, as it would merely be simple substitution of known elements with the electrochemical impedance transduction teachings to obtain predictable results (flow rate of a liquid) with advantages such as low power operation, simple sensor design/fabrication and compact footprint (see para. [0061] of Kim).
Regarding claim 5, section of Heikenfeld in view of Yamakawa and Kim, cited above, disclose wherein the set of impedance sensing electrodes includes a first set of impedance sensing electrodes positioned in the downstream portion of the microfluidic channel, and a second set of impedance sensing electrodes positioned in the downstream portion of the microfluidic channel and spaced apart from the first set of impedance sensing electrodes (see para. [0072] and fig. 26 of Kim).
Regarding claim 6, sections of Heikenfeld in view of Yamakawa and Kim, cited above, disclose wherein the modified device of Heikenfeld in view of Yamakawa and Kim calculates the flow rate (secretion rate) based on the time of flight/time difference of the detection timepoints of the microbubbles measured by the set of impedance electrodes (see para. [0072] of Kim).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld in view of Yamakawa, as applied to claim 1, and further in view of Peyser et al. (US 20070027383 A1- previously cited), referred to as Peyser hereinafter.
Regarding claim 16, Heikenfeld in view of Yamakawa fail to explicitly teach wherein the calibrating sensor comprises a secretion rate sensor implemented by a capacitive humidity sensor. Heikenfeld does teach a sweat sensor device that measures sweat rate comprising a capacitive sensor and humidity sensor (see para. [0030,0045,0047]). It is further noted the sweat sensor is also a calibration sensor as cited above.
Peyser teaches an analyte measuring device that measures sweat rate using a capacitive humidity sensor (see ABSTRACT and para. [0102]). 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 Heikenfeld in view of Yamakawa, such that the secretion rate is measured by a capacitive humidity sensor, as taught by Peyser, as it would merely be substituting one known element (capacitive humidity sensor) for another (sweat rate sensor) to obtain predictable results (sweat/excretion rate).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Heikenfeld in view of Yamakawa and Peyser, as applied to claim 16, and further in view of Rohmann et al. (US 20200088648 A1- previously cited), referred to as Rohmann.
Regarding claim 17, Heikenfeld in view of Yamakawa and Peyser fail to teach wherein the capacitive humidity sensor includes a hydroscopic dielectric material disposed between a pair of electrodes.
Rohmann teaches a humidity sensor (5) that includes a hydroscopic dielectric material disposed between two electrodes (see para.[0051-52], “As the humidity increases, the dielectric constant of the non-conductive material changes, which in turn changes the capacitance between the electrodes which is measurable”). 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 Heikenfeld in view of Yamakawa and Peyser, to include a hydroscopic dielectric material disposed between a pair of electrodes, as taught by Rohmann, because Heikenfeld in view of Yamakawa and Peyser require a capacitive humidity sensor, but fails to provide details of the structure, and Rohmann teaches that the structure can comprise a hydroscopic dielectric material disposed between a pair of electrodes. Furthermore, the modification would merely be substituting one known element (capacitive humidity sensor that includes a hydroscopic dielectric material disposed between a pair of electrodes) for another (capacitive humidity sensor) to obtain predictable results.
Response to Arguments
Applicant’s arguments filed 02/21/2025 have been fully considered and are not fully persuasive.
Applicant’s arguments with respect to 35 U.S.C. 112(a)-(b) and 103 rejection of independent claims have been considered but are moot because amendments require new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fahmy et al. teach obtaining at least one characteristic of the sensor, applying a first sample having a first known concentration of the analyte to the sensor, measuring the initial current rate conducted by a nanostructure of the sensor in response to the application of the first sample, and normalizing the measured initial current rate by the obtained characteristic, thereby providing a first known normalized device signal. US 20140128278
Chu teaches the output signal from a test sensor that includes a low total salt reagent composition may be correlated accurately to the analyte concentration of whole blood samples. US 20110297540
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791