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 .
Claims Accounting
Applicant' s arguments, filed 08/14/2025, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 08/14/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 23, 30-31, and 34 have been amended.
Claims 23-35 are the current claims hereby under examination.
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 23-35 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 23, the claim recites “the patch further configured to be in an attached-state when attached to the skin of the person and in a detached-state when detached from the skin of the person such that the detached-state cannot be changed back to the attached-state” in lines 5-8. The claim also recites “a patch configured to be attached to a skin of a person” in line 3, indicating that the patch must initially be detached (i.e., in a detached-state). It is unclear how the patch enters an attached-state if the initial state is detached and the state cannot be changed from detached to attached. Further, the recitation of “the detached-state cannot be changed back to the attached-state” indicates that the patch is configured to be in an attached-state before it is in a detached-state, however this conflicts with the recitation of line 3. It is further unclear what the intended structure of the patch is that prevents it from being from changed from a detached-state to an attached-state. Clarification is requested.
For the purposes of examination, the detached-state is considered as the patch being detached after previously being attached.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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 23-24 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2017/0325724 by Wang et al. – previously cited (hereby referred to as “Wang”) in view of WIPO Patent Publication 2020/055791 by Taylor et al. (hereby referred to as “Taylor”).
Regarding claims 23 and 24, Figure 11 of Wang teaches a system for monitoring impairment state of a person, the system comprising:
a patch 1102 configured to be attached to a skin of the person (Abstract, via an adhesive membrane) adhesive and obtain a measurement indicative of an impairment state of the person (sections [0160-0162], amperometric detection by integrated flexible electronics), the patch further configured to transmit information representative of the measurement, (sections [0160-0162]) the patch further configured to be in an attached-state when attached to the skin of the person and in a detached-state when detached from the skin of the person (the patch 1102 is capable of being a detached-state (not attached to the skin of the person) and an attached-state (attached to the skin of the person)); and a monitor external to the patch (laptop/mobile device seen in Figure 11C), the monitor including a signal processing circuit ([0162] the laptop/mobile device receives the data transmitted wirelessly, and therefore must include a signal processing unit (e.g., Bluetooth communications module, etc.) for receiving the data) configured to receive the information from the patch through a direct wireless communication link and generate an output based on the information (sections [0160-0162]).
Wang does not teach that the patch is configured such that the detached-state cannot be changed back to the attached-state.
Taylor teaches a patch for physiological monitoring of alcohol that may be configured as a single application adhesive such that the patch can only be attached once. Detaching the patch would prohibit the patch from being reapplied as the adhesive is formulated in such a way that upon first application it initially attaches to the skin but wherein, when removed, the patch takes some epithelial cells along with it, thereby preventing the patch from attaching a second time ([036]). This component enforces or ensures compliance and/or tamper resistance while the patch is worn ([033]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the patch of Wang such that the adhesive membrane comprises a single use adhesive, such that the detached-state of the patch cannot be changed back to the attached-state, as this enforces or ensures compliance and/or tamper resistance while the patch is worn, as taught by Taylor ([033]).
Regarding claim 35, Wang in view of Taylor teaches the system of claim 23, wherein the measurement includes a blood alcohol content (BAC) level (Wang; sections [0155] and [0159] disclose that the patch is used to determine blood alcohol content).
Claims 25-26 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Taylor, as applied to claim 23, in view of US Patent Publication 2017/0242428 by Pal et al. – previously cited (hereby referred to as "Pal").
Regarding claims 25 and 26, Wang in view of Taylor teaches the system of claim 23, as discussed in paragraph 5 above. Wang in view of Taylor fails to teach that the communication link between the patch and the monitor includes an intermediate component such that a first link provides a wireless communication between the patch and the intermediate component and a second link provides a wireless communication between the intermediate component and the monitor.
Pal teaches use of a gateway device (Figure 1, element 102) to communicatively couple a wearable diagnostic patch (Figure 1, element 104) to multiple external devices (Figure 1, external devices 106,108,110,114,116,118,120), the communication being wireless communication (sections [0026-0028]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Wang in view of Taylor to include a wireless gateway device, as taught by Pal, as it would allow the patch to communicate with multiple external devices in addition to the monitor (e.g., emergency support as described in [0034-0035] of Pal).
Regarding claims 28 and 29, Wang in view of Taylor teaches the system of claim 23, as discussed in paragraph 5 above. Wang in view of Taylor fails to teach that the system further comprises a vehicle electronic control unit configured to receive the output of the monitor and either enable or disable an operation of a corresponding vehicle, and wherein the operation of the vehicle includes starting of an internal combustion engine or energizing of an electric drive motor.
Pal teaches an electronic control unit of a vehicle, such that if the alcohol level associated with a user is greater than a preset safety limit, the ignition key or button is disabled so that the user is unable to start the vehicle ([0070-0071]). When the alcohol level associated with the user is below the preset safety limit, the electronic control unit may be enabled so that the user can start the vehicle. The electronic control unit can reduce the number of drivers under the influence by restricting those drivers from starting the vehicle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system taught by Wang in view of Taylor to include the vehicle electronic control unit to receive the output of the monitor and either enable or disable the operation of a corresponding vehicle, as Pal teaches that this would prevent drivers who are under the influence from operating a vehicle.
In the case of the vehicle being an internal combustion engine, the vehicle control module will prevent starting the engine; in the case of the vehicle being an electric vehicle the vehicle control module will prevent the energizing of an electric drive motor.
Regarding claim 30, the combination of Wang, Taylor, and Pal teach the system of claim 28, further teaching wherein the information includes a value directly related to the measurement ([0162], the level of alcohol in sweat is detected and is a value directly related to the measurement).
Regarding claim 31, the combination of Wang, Taylor, and Pal teach the system of claim 28, further teaching wherein the information includes an estimation based on the measurement (Wang, [0155]; “Based on a correlation between alcohol concentration in sweat and blood, the disclosed skin-worn electrochemical biosensor measures transdermal alcohol content (TAC) in induced sweat via iontophoresis to estimate BAC, with the measured data wirelessly transmitted to laptop or mobile device for real-time analysis.”. The measurement is performed based on iontophoresis and is used to estimate BAC).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Taylor, as applied to claim 23, in view of US Patent Publication 2010/0198034 by Thomas et al. – previously cited (hereby referred to as "Thomas").
Regarding claim 27, Wang in view of Taylor teaches the system of claim 23, as discussed in paragraph 5 above. Wang in view of Taylor fails to teach the patch including a radio-frequency identification (RFID) circuit configured to receive an interrogation signal and transmit the information in response to receipt of the interrogation signal.
Thomas discloses an RFID system, where an RFID reader/receiver unit sends an interrogation signal to a patch comprising a sensor and RFID circuit. Data associated with a measurement obtained from a sensor is sent in response to the interrogation signal (Thomas, [0108]). This RFID communication allows the user to conveniently determine the measurement of the sensor at any time (Thomas, [0157]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system taught by Wang in view of Taylor to include an RFID circuit configured to transmit information upon receipt of an interrogation signal, as Thomas teaches that this would allow the user to conveniently determine the measurement of the sensor at any time ([0157]).
Claims 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Taylor in view of Pal, as applied to claim 28, further in view of US Patent Publication 2008/00256048 by Hayter – previously cited (hereby referred to as "Hayter").
The combination of Wang, Taylor, and Pal teaches the system of claim 28, but is silent regarding: wherein the output of the monitor is based on determination of whether or not the patch remains attached to the skin of the person, wherein the patch is configured to sense detachment of the patch from the skin of the person, and wherein the determination of whether or not the patch remains attached to the skin of the person is based on a comparison of the measurement with an expected value.
Hayter teaches an algorithm (the sensor removal detection routine), shown in Fig 7, for sensing whether the current analyte level indicates the sensor being removed, and generating output data based on the operational state (the sensor being in place or removed). The algorithm detects whether the sensor is attached or removed based on comparing current analyte related signal to a predetermined characteristic signal (lack of signal relative to skin contact to determine sensor removal ([0076]). This algorithm presents the operational state to the user and remote monitoring without relying upon the user input ([0084]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system taught by the combination of Wang, Taylor, and Pal such that the output of the monitor is based on the determination of whether or not the patch remains attached to the skin based on a comparison of the measurement with an expected value, as Hayter teaches that this would ensure proper sensor placement during measurements.
The combination of Wang, Taylor, Pal, and Hayter teaches that the patch, in conjunction with the removal detection routine, is able to sense detachment of the patch from the skin of the person.
Response to Arguments
Applicant’s arguments filed 08/14/2025 have been fully considered.
The amendments to claims 30-31 and 34 overcome the rejections of record under 35 U.S.C. 112(b), however the amendments to the claims necessitate new rejections of claim 23.
Upon further consideration, the rejections under 35 U.S.C. 101 of claims 23-27 and 35 are withdrawn.
Applicants remarks regarding the prior art rejection of claim 23 is acknowledged but are moot as they are based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2020/0237277 by Ouyang et al. teaches a patch configured to obtain a measurement indicative of an impairment state of a person and disable a vehicle based on the measurement.
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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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791