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, 3, 11, and 34-38 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. Regarding claim 2, as claim 1 has been amended to recite that the first chemical indicator is associated with sodium and the second chemical indicator is associated with potassium, it is unclear in claim 2 if the “first chemical” and “second chemical” are sodium and potassium, respectively, or if they are different chemicals. The same indefiniteness issue applies to claim 11 because of its recitation of “a first analyte” and “a second analyte”. Is the first analyte sodium and the second analyte potassium? For examination purposes, the first chemical and first analyte of claims 2 and 11, respectively, are being interpreted as sodium, and the second chemical and second analyte of claims 2 and 11, respectively, are being interpreted as potassium. Claims 2 and 34-38 are rejected due to their dependence on claims 2 and 11, respectively.
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 1-3, 10, 11, 32-35, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al.’190 (US Pub No. 2022/0047190 – previously cited) in view of Blais et al.’657 (US Pub No. 2009/0098657 – previously cited) further in view of Dong et al.’524 (US Pub No. 2019/0133524 – previously cited) further in view of Haber et al.’993 (USPN 5,231,993 – previously cited) further in view of Levinson et al.’990 (US Pub No. 2017/0127990 – previously cited) further in view of Khosravi et al.’384 (USPN 11,054,384 – previously cited).
Regarding claim 1, Figures 1-3 of Taylor et al.’190 disclose a system comprising: a wearable device 10 (see ABSTRACT) that includes: a first set of needles 12 sized for access to interstitial fluid (section [0027-0028]); and a first type of chemical indicator associated with and positioned within each needle of the first set of needles (section [0020]). Figure 5 discloses an embodiment wherein the wearable device includes a first set of needles and a second set of needles (section [0030]), each needle of the sets of needles including a chemical indicator associated with and positioned within the needle (section [0020]). Taylor et al.’190 further discloses that the system comprises a bar code (section [0022]).
Taylor et al.’190 discloses all of the elements of the current invention, as discussed above, except for the wearable device comprising a first type of chemical indicator associated with and positioned within each needle of the first set of needles and a second type of chemical indicator associated with and positioned within each needle of the second set of needles. Section [0033], however, indicates that more than one target substance may be detected. Sections [0016] and [0021] teach detecting the presence of alcohol and abusive substances in interstitial fluid, and section [0046] teaches the benefits of detecting glucose, lactate, pH and ketone bodies in interstitial fluid. One of ordinary skill in the art would have realized that different chemical indicators would be used for different target substances. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have configured the system of Taylor et al.’190 such that it includes a first type of chemical indicator associated with and positioned within each needle in the first set of needles and a second type of chemical indicator associated with and positioned within each needle of the second set of needles, as this would allow the wearable device to detect different target substances in the interstitial fluid (e.g., alcohol, drugs, glucose, lactate, pH, and/or ketone bodies).
Taylor et al.’190 discloses all of the elements of the current invention, as discussed above, except for the system comprising a temperature sensor. Blais et al.’657 teaches measuring the temperature of a glucose sensor with a temperature sensor and using the measured temperature to correct an interstitial blood glucose measurement taken by the glucose sensor in order to provide a more accurate glucose reading (ABSTRACT, sections [0002], [0005], [0036], [0050]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 to include a temperature sensor that measures the temperature of the glucose sensor, as this would provide a means by which to measure the temperature of the glucose sensor, correct a glucose measurement based on the measured temperature, and thus provide a more accurate glucose reading.
Taylor et al.’190 in view of Blais et al.’657 discloses all of the elements of the current invention, as discussed above, except for the first type of chemical indicator, the second type of chemical indicator, and the temperature sensor being viewable through a top surface of the wearable device via a window, and the wearable device further including a moisture barrier comprising the window and arranged on the wearable device to seal the first type of chemical indicator in the first set of needles and to seal the second type of chemical indicator in the second set of needles. Dong et al.’524 teaches providing a moisture barrier (the moisture barrier consists of protection sheet 140 and transparent readout sheet 150 of Figure 1) comprising a window (transparent readout sheet 150 is a window – see ABSTRACT and sections [0026] and [0081]) and arranged on a wearable device, wherein the moisture barrier is used to seal any fluid in the wearable device within the wearable device (section [0081]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 to include the moisture barrier with window of Dong et al.’524, as it would ensure that the components of the wearable device remain within the wearable device, while also allowing any color changes resulting from the interaction of the interstitial fluid with the chemical indicators to be seen and processed.
It is noted that sections [0056], [0059], and [0063-0064] of Blais et al.’657 teach that the temperature sensor can be a color-changing temperature sensor that is read by an optical-sensing system, and that section [0071] teaches that the temperature sensor should be stored in a sealed container. With these teachings by Blais et al.’657, one of ordinary skill in the art would have found it obvious to also seal the temperature sensor underneath the moisture barrier and window, with the temperature sensor viewable through a top surface of the window. This would prevent the temperature sensor from degrading (section [0071] of Blais et al.’657), and would also allow an optical-sensing system to read the color changes of the temperature sensor.
Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 discloses all of the elements of the current invention, as discussed above, except for the wearable device further including color references positioned throughout the wearable device adjacent to the first type of chemical indicators and the second type of chemical indicators. Haber et al.’993 teaches a device wherein a biological fluid sample interacts with a chemical indicator and changes color based on the interaction. Haber et al.’993 further discloses that a color code (color references) is provided adjacent to the chemical indicator in order to allow for the visual interpretation of the color change (col. 4, lines 22-49). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 to include color references positioned throughout the wearable device adjacent to the chemical indicators, as Haber et al.’993 teaches that providing color references would allow for the visual interpretation of any color changes generated by a biological fluid interacting with the chemical indicator. The modification to Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 would allow a user to manually determine whether the target substance is at a low, normal, or high concentration level (see col. 4, lines 22-28 of Haber et al.’993). Furthermore, section [0033] of Taylor et al.’190 teaches producing different colors according to a concentration; in combination with Haber et al.’993, the color reference would include a reference to each different color.
Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 discloses all of the elements of the current invention, as discussed above, except for the first type of chemical indicator being associated with sodium and the second type of chemical indicator being associated with potassium. It is noted that section [0016] of Taylor et al.’190 teaches that the wearable device can be used to indicate the presence of a target substance that is associated with “one or more medical conditions or diseases”. Sections [0072-0073] of Levinson et al.’990 teach that interstitial fluid contains various analytes, including sodium and potassium, that are important for diagnostic purposes, and section [0048] teaches various chemical indicators that can be used to detect the presence of such analytes. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 such that it includes a first chemical indicator associated with sodium and a second chemical indicator associated with potassium, as Levinson et al.’990 teaches that sodium and potassium are important analytes to detect for diagnostic purposes. The modification to Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 would allow the wearable device of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 to be used to monitor one or more medical conditions or diseases associated with sodium and/or potassium.
Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 discloses all of the elements of the current invention, as discussed above, except for the wearable device including a protective film removably coupled to the moisture barrier. Khosravi et al.’384 teaches providing a removable protective film around a sensing device, wherein the protective film protects the sensing device prior to use and is then removed when the sensing device is to be used (col. 20, lines 4-16). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 to include a protective film removably coupled to the moisture barrier, as the protective film would protect the wearable device prior to its use.
Regarding claim 2, as modified above, sections [0022], [0027], and [0033] of Taylor et al.’190 teach that the first type of chemical indicator includes a first material that changes color to indicate a first concentration of a first chemical in the interstitial fluid, that the second type of chemical indicator includes a second material that changes color to indicate a second concentration of a second chemical in the interstitial fluid, and that the first chemical and the second chemical are different.
Regarding claim 3, Figure 5 of Taylor et al.’190 discloses a third set of needles sized for access to interstitial fluid. As discussed above with regard to claims 1 and 2, it would have been obvious to one of ordinary skill in the art for the wearable device to include a third type of chemical indicator associated with and positioned within each needle within the third set of needles, wherein the third type of chemical indicator includes a third material that changes color to indicate a third concentration of a third chemical in the interstitial fluid, wherein the third chemical is different than the first chemical and the second chemical.
Regarding claim 10, the wearable device is a patch attachable to a patient’s skin (section [0016] of Taylor et al.’190).
Regarding claim 11, Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384 discloses all of the elements of the current invention, as discussed above, except for the system comprising a smart phone comprising an image sensor. Dong et al.’524 teaches a system comprising a wearable device with chemical indicators and a smart phone (sections [0040-0044]). The wearable device is configured to acquire a biological fluid sample, wherein the fluid sample interacts with the chemical indicator and causes a color change in the chemical indicator (sections [0019], [0040-0044], [0083], and [0088]). The smart phone comprises an image sensor, wherein the image sensor is used to capture digital images of the color change of the chemical indicator and calculate the concentration of an analyte based on the digital images (sections [0019], [0040-0044], [0083], and [0088]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384 to include a smart phone comprising an image sensor, wherein the smart phone is programmed to determine the concentration of a first analyte based, at least in part, on a first color of the first type of chemical indicator, and to determine the concentration of a second analyte based, at least in part, on a second color of the second type of chemical indicator, as Dong et al.’524 teaches that smart phones can be used to automatically determine the concentration of a target substance based on a captured digital image of a color of a chemical indicator. The modification to Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384 would provide more precise concentration determinations of the target substances than the visual color inspection taught by Taylor et al.’190.
Regarding claim 32, Blais et al.’657 teaches the temperature sensor comprising a liquid crystal material configured to change color with changes in temperature (sections [0056], [0059], [0061-0064], [0076-0077]).
Regarding claim 33, section [0005] of Blais et al.’657 teaches that the conventional way to measure the temperature of a test sensor is to use a thermistor. Furthermore, Blais et al.’657 teaches the temperature sensor being any of a thermistor, a thermocouple, and/or a semiconductor junction (sections [0051-0052]).
Regarding claims 34, 35, and 37, Official notice is being taken that it is well known in the art that smart phones include light sources configured to emit visible light and monochromatic light (see, for example, section [0031] of Kwon et al.’851 – US Pub No. 2009/0179851; section [0125] of Chornenky’949 – US Pub No. 2013/0234949; section [0019] of McKee et al.’247 – US Pub No. 2014/0312247; and section [0211] of Davis et al.’303 – US Pub No. 2014/0313303).
Regarding claims 38 and 39, wearable device 10 of Taylor et al.’190 does not include any active electronics.
Claims 12 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 (US Pub No. 2020/0082139 – previously cited) further in view of Estes et al.’508 (US Pub No. 2014/0005508 – previously cited).
Regarding claim 12, the rejections of claims 11 and 34 in paragraph 5 above explain how Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 discloses elements of the current invention. Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 discloses all of the elements of the current invention, except for the digital image including color reference sections on the wearable device, wherein the first concentration and the second concentration are both further based on the color reference sections. Peeters’139 teaches providing color reference sections on a wearable device in order to allow an image sensor of a smart phone to properly calibrate and to properly read the colors of optical sensors on the wearable device (sections [0047-0050). Peeters’139 further teaches that the color reference sections can be placed on a wearable device comprising a layer of microneedles (section [0081]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 such that the digital image includes color reference sections, as taught by Peeters’139, as this would allow the image sensor to properly calibrate and properly read the first and second colors.
Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 discloses all of the elements of the current invention, as discussed above, except for the smart phone being programmed to read the barcode and access information about the wearable device. Peeters’139 teaches that using bar codes for product authentication has been used for a long time (section [0007]). Peeters’139 further teaches encoding device-specific information with a bar code for authentication and informational purposes (sections [0054-0056], [0060-0061]). 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 bar code of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 to be configured to be read by the smart phone such that information about the wearable device is accessed by the smart phone, as this would provide authentication means for the system, thus increasing the security/privacy of the data obtained and processed by the system. Furthermore, it would provide device-specific information about the wearable device (e.g., date and time of manufacture, unique serial number, information to decode the sensor, web links, access codes, etc., as seen in section [0060] of Peeters’139).
It is noted that because multiple test sensors are used in Taylor et al.’190 (due to multiple needles), the wearable device includes multiple temperature sensors (one for each needle). Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 discloses all of the elements of the current invention, as discussed above, except for the smart phone being programmed to determine the temperature based on an average. Estes et al.’508 teaches that calculating an average temperature can provide for a more accurate determination of a temperature compensation factor (section [0203]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 such that the smart phone is programmed to determine the temperature based on an average, as this would provide for a more accurate determination of a temperature correction factor.
Regarding claim 27, section [0005] of Blais et al.’657 teaches that the conventional way to measure the temperature of a test sensor is to use a thermistor. Furthermore, Blais et al.’657 teaches the temperature sensor being any of a thermistor, a thermocouple, and/or a semiconductor junction (sections [0051-0052]).
Regarding claim 28, Blais et al.’657 teaches the temperature sensor comprises a liquid crystal material configured to change color with changes in temperature (sections [0056], [0059], [0061-0064], [0076-0077]).
Regarding claim 29, the combination of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 further in view of Estes et al.’508 results in a system wherein the smart phone is programmed to determine (1) the first concentration and the second concentration based, at least in part, on a temperature (Blais et al.’657 teaches correcting a concentration determination based on a temperature measurement, Dong et al.’524 teaches using a smart phone to determine a concentration), and (2) the temperature based on color of the temperature sensor (Blais et al.’657 teaches that the temperature of a test sensor can be determined using an optical-sensing system that senses a color change of a temperature sensor, the smart phone of Dong et al.’524 is an optical-sensing system).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 further in view of Estes et al.’508, as applied to claim 12, further in view of Levinson et al.’990.
Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 further in view of Estes et al.’508 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the first analyte concentration being a sodium concentration and the second analyte concentration being a potassium concentration. It is noted that section [0016] of Taylor et al.’190 teaches that the wearable device can be used to indicate the presence of a target substance that is associated with “one or more medical conditions or diseases”. Sections [0072-0073] of Levinson et al.’990 teach that interstitial fluid contains various analytes, including sodium and potassium, that are important for diagnostic purposes, and section [0048] teaches various chemical indicators that can be used to detect the presence of such analytes. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 further in view of Estes et al.’508 such that it determines a sodium concentration and a potassium concentration, as Levinson et al.’990 teaches that sodium and potassium are important analytes to detect for diagnostic purposes. The modification to Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 further in view of Estes et al.’508 would allow the wearable device of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Peeters’139 further in view of Estes et al.’508 to be used to monitor one or more medical conditions or diseases associated with sodium and/or potassium.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384, as applied to claim 34, further in view of Djakovic et al.’305 (US Pub No. 2018/0054305).
Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384 discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for explicitly teaching that the light source of the smart phone is configured to emit ultraviolet light. Djakovic et al.’305 teaches that it is known in the art that smart phones include light sources configured to emit ultraviolet light (section [0054]). 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 smart phone of Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384 to include a light source configured to emit ultraviolet light, as Djakovic et al.’305 teaches that light sources included within smart phones can emit ultraviolet light. The modification to Taylor et al.’190 in view of Blais et al.’657 further in view of Dong et al.’524 further in view of Haber et al.’993 further in view of Levinson et al.’990 further in view of Khosravi et al.’384 would merely be combining prior art elements according to known methods to yield predictable results.
Response to Arguments
Applicant’s Remarks, filed 10 November 2025, do not contain arguments with respect to the prior art rejections of the claims. Instead, Applicant states that amendments have been made to claims 1 and 11, and merely asserts that the proposed combination of references fails to teach or suggest the amended features. Applicant’s assertion is not persuasive as it fails to point out any deficiencies in the previously cited prior art combinations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peyser et al.’483 (US Pub No. 2010/0312483 – previously cited) teaches calibrating a glucose sensor measurement based on a temperature of the glucose sensor. Nakanishi et al.’706 (US Pub No. 2012/0116706 – previously cited) teaches calibrating a glucose sensor measurement based on a temperature of the glucose sensor. Koyama et al.’407 (US Pub No. 2013/0261407 – previously cited) teaches that a more accurate temperature measurement can be determined by averaging temperature measurements from multiple temperature sensors. Kim et al.’000 (US Pub No. 2020/0261000 – previously cited) teaches that a more accurate temperature measurement can be determined by averaging temperature measurements. Lamego et al.’676 (US Pub No. 2021/0022676 – previously cited) teaches that a more accurate temperature measurement can be determined by averaging temperature measurements from multiple temperature sensors. Li et al.’177 (US Pub No. 2022/0133177 – previously cited) teaches chemical indicators comprised of lipophilic indicator dye, the lipophilic indicator dye comprising ionophores or fluorophores (sections [0132-0133]). Ledden’709 (US Pub No. 2021/0282709 – previously cited), as modified by Blais et al.’657 and Dong et al.’524, teaches a system comprising the elements of claims 1 and 12. Yang et al.’351 (US Pub No. 2022/0125351 – previously cited) teaches providing a moisture barrier comprising a window on a wearable analyte sensing device. Horikawa’723 (US Pub No. 2017/0358723 – previously cited) teaches a protective layer of a sensing device, the protective layer being a protective film. Le’524 (US Pub No. 2017/0248524 – previously cited) teaches that using a smart phone to assess color changes allows for accurate analyte determinations. Zhu et al. (Colorimetric microneedle patches… – previously cited) teaches a system comprising the elements of claims 1 and 12.
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.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791