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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/04/2026 has been entered.
Claims Accounting
Applicant's arguments, filed 05/04/2026, 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 05/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claim 23 has been amended.
Claims 23-35 are the current claims hereby under examination.
Claim Objections
Claim 23 is objected to because of the following informalities:
The claim recites “perform a measurement determine an impairment state of the person” in lines 4-5. This should read “perform a measurement to determine an impairment state of the person”.
Appropriate correction is required.
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 a detached-state when detached from the skin of the person such that the detached-state cannot be changed back to another attached-state” in lines 7-10. The recitation of “the detached-state cannot be changed back to another attached-state” indicates that the patch was previously in “another attached-state”, however there is no previous recitation of “another attached-state”. Therefore it is unclear what is being prevented. 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.
Further regarding claim 23, the claim recites the limitation “another attached-state” in line 10. It is unclear whether the “another attached-state” is another instance of the “attached state” first recited in line 4. Clarification is requested.
For the purposes of examination, “another attached-state” is interpreted as “another attached state”.
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 9,987,427 by Polsky et al. (hereinafter “Polsky”) in view of US Patent Publication 2022/0361776 by Wang et al. (hereinafter “Wang”) in view of WIPO Patent Publication 2020/055791 by Taylor et al. – previously cited (hereinafter “Taylor”).
Regarding claims 23 and 24, Figure 2 of Polsky teaches a system for monitoring a state of a person, the system comprising: a patch configured to be attachable to a skin of the person (Fig. 2, device including microneedles shown to be attached to a person) and, when in an attached state obtain a circulation of blood of the person and perform a measurement (Col. 5, lines 5-18; The device monitors one or more markers in a sample (i.e., blood). Col. 1, lines 55-65; The sampled fluid can be analyzed via electrode arrays. Col. 9, lines 47-54; The device includes a return needle configured to return tested or analyzed fluid back to the target site, the patch further configured to transmit information representative of the measurement when in the attached state (Col 16, lines 20-33; The device is configured to relay the measurements to a health care worker via a module such as a telemetry unit), the patch further configured to be in a detached-state when detached from the skin of the person (the device is capable of being a detached-state (not attached to the skin of the person)); and a monitor external to the patch (Col. 23, line 62 - Col 24, line 8; The circuitry is configured to communicate with an external unit), the monitor including a signal processing circuit configured to receive the information from the patch through a direct wireless communication link (Col 16, lines 20-33; the external unit receives the data transmitted wirelessly, and therefore must include a signal processing unit (e.g., telemetry communications module, etc.) for receiving the data directly.) and generate an output based on the information (For a healthcare worker to access the relayed information, some form of an output must be generated).
Polsky does not teach wherein the system monitors an impairment state of a person by performing a measurement to determine an impairment state of the person.
Wang teaches a wearable patch comprising microneedles configured to sample fluid from a person to which the device is attached. The microneedles sample the fluid such that the fluid comes into contact with electrodes, analytes, such as alcohol can be determined and monitored ([0050]).
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 device of Polsky such that the analytes monitored include alcohol, as taught by Wang ([0050]). This combination merely comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A. It is noted that Polsky teaches that a number of target analytes can be monitored using electrode arrays within the microneedle device, and Wang teaches specific analytes that can be monitored using electrode arrays within microneedles. By monitoring alcohol (one of the analytes taught by Wang), the combination of Polsky and Wang teaches wherein the system monitors an impairment state of a person by performing a measurement to determine an impairment state of the person, as alcohol in the blood is indicative of an impairment state of a person.
Polsky in view of 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 Polsky in view 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, the combination of Polsky, Wang, and Taylor teaches the system of claim 23, wherein the measurement includes a blood alcohol content (BAC) level (Polsky; Col. 24, lines 30-49; the concentration of the analyte/biomarker is detected. In the combination of Polsky, Wang, and Taylor, the analyte is alcohol, and therefore, the concentration would comprise a blood alcohol content).
Claims 25-26 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Polsky in view of Wang in view of Taylor, as applied to claim 23, in view of US Patent Publication 2017/0242428 by Pal et al. – previously cited (hereinafter “Pal”).
Regarding claims 25 and 26, the combination of Polsky, Wang, and Taylor teaches the system of claim 23, as discussed in paragraph 5 above. The combination of Polsky, Wang, and 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 ([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 taught by the combination of Polsky, Wang, and Taylor to include a wireless gateway device, as taught by Pal, in order to 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). This combination of Polsky, Wang, Taylor, and Pal would result in a system wherein the first link and the second link are implemented with wireless signals.
Regarding claims 28 and 29, the combination of Polsky, Wang, and Taylor teaches the system of claim 23, as discussed in paragraph 5 above. The combination of Polsky, Wang, and 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 the combination of Polsky, Wang, and 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 Polsky, Wang, Taylor, and Pal teach the system of claim 28, further teaching wherein the information includes a value directly related to the measurement (Polsky; Col. 24, lines 30-49; the concentration of alcohol in blood is detected and is a value directly related to the measurement).
Regarding claim 31, the combination of Polsky, Wang, Taylor, and Pal teach the system of claim 28, further teaching wherein the information includes an estimation based on the measurement (Polsky teaches that a concentration is detected by the electrochemical array. The concentration is calculated (i.e., estimated) based on the amount of tested fluid and the detected analytes.).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Polsky in view of Wang in view of Taylor, as applied to claim 23, in view of US Patent Publication 2010/0198034 by Thomas et al. – previously cited (hereinafter “Thomas”).
Regarding claim 27, the combination of Polsky, Wang, and Taylor teaches the system of claim 23, wherein the patch includes a radio-frequency circuit (Polsky; Col 16, lines 20-33; The system can relay the information with a radiofrequency module). The combination of Polsky, Wang, and 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 radio-frequency circuit taught by the combination of Polsky, Wang, and Taylor to be 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 Polsky in view of 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 (hereinafter "Hayter”).
The combination of Polsky, 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 and determines whether the sensor is in the proper position to take measurements ([0080, 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 Polsky, 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, in order to ensure proper sensor positioning to take measurements, as taught by Hayter ([0080]).
The combination of Polsky, 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 05/04/2026 have been fully considered.
The amendments to claim 23 does not overcome the rejections of record under 35 U.S.C. 112(b).
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
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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