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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/21/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, 5-6, 9-10, 12-15 and 18-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Otis et al. (US 8,870,370 B1) in view of Okvist et al. (US 2026/0198771 A1).
Regarding claim 1, Otis discloses a device (Figures 1 and 2A) for facilitating monitoring of tear film thickness of an eye, the device comprising:
a lens (Figure 1 depicts: 102, contact lens; Figures 2A depict: 200, contact lens; Examiner notes that these are considered the same contact lens but annotated according to different figures); and
one or more electronic components coupled to the lens (Col. 4 lines 8-12 disclose: 204, sensing component and 206 antenna included in contact lens; thus considered coupled to the lens), the one or more electronic components operable to:
receive a first wireless signal from an external device (Col. 3 lines 36-45 disclose: 112, RF reader can transmit 108, RF signal to 102, contact lens to interrogate the contact lens; the antenna is considered to receive the RF signal); and
responsive to the first wireless signal, transmit a second wireless signal (Col. 3 lines 36-45 disclose: upon receiving the RF signal, the antenna can transmit 110, reflected RF signal, back to 112, RF reader) associated with an electrical characteristic of the one or more electrical components or indicative of a parameter of the eye (Col. 3 lines 36-45 disclose: reflected signal includes magnitude, phase and/or frequency of 108, RF signal can be modified based on impedance of the antenna; Col 1 lines 40-44 disclose: impedance is related to change in capacitance; Col 3 lines 5-24 discloses: detecting fluid levels and temperature changes related to contact lens and thus indicative parameter of the eye), wherein the external device is operable to receive the second wireless signal (Col. 3 lines 36-45 disclose: the antenna can transmit 110, reflected RF signal, back to 112, RF reader).
Otis fails to disclose a device to determine the tear film thickness based on the electrical characteristic or the parameter. Otis and Okvist are related because both disclose optical devices.
Okvist teaches a device to determine the tear film thickness based on the electrical characteristic or the parameter ([0028] teaches: 12, interface for external communication with 7, external managing device; Claim 30 teaches: method for determining thickness of a post lens tear film; [0087] teaches: transmitting measurement results; Examiner notes that this is considered transmitting a tear film thickness based on an electrical characteristic from 12, interface to 7, external managing device).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Okvist and provide a device to determine the tear film thickness based on the electrical characteristic or the parameter. Doing so would allow for the tear film thickness information to be remotely obtained from the smart contact lens using a low complexity wireless interrogation arrangement, thereby improving the practicality of continuous tear film monitoring.
Regarding claim 3, the modified Otis discloses the device of claim 1, wherein the one or more electronic components comprise an antenna (Col. 4 lines 8-12 disclose: 204, sensing component and 206 antenna; considered the one or more electronic components).
Regarding claim 5, the modified Otis discloses the device of claim 3, wherein the electrical characteristic comprises a resonance frequency of the antenna (Col. 5 lines 26-34 teach: RF signal modified at a selected resonance frequency; therefore consider and electrical characteristic of the antenna).
Regarding claim 6, the modified Otis discloses the device of claim 3, wherein:
the one or more electronic components comprise a capacitive element; and
the electrical characteristic comprises capacitance (Col. 3 lines 36-45 disclose: reflected signal includes magnitude, phase and/or frequency of 108, RF signal can be modified based on impedance of the antenna; Col 1 lines 40-44 disclose: impedance is related to change in capacitance; Col. 3 lines 5-10 disclose: sensing component can be a capacity proximity sensor, and sensing of 102, contact lens over 104 eye).
Regarding claim 9, Otis discloses a system (Figures 1 and 2A) for monitoring tear film thickness of an eye, the system comprising:
an external device operable to transmit a first wireless signal (Col. 3 lines 36-45 disclose: 112, RF reader and 108, RF signal);
a lens (Figure 1 depicts: 102, contact lens; Figures 2A depict: 200, contact lens; Examiner notes that these are considered the same contact lens but annotated according to different figures); and
one or more electronic components coupled to the lens (Col. 4 lines 8-12 disclose: 204, sensing component and 206 antenna included in contact lens; thus considered coupled to the lens), the one or more electronic components operable to:
receive the first wireless signal from the external device (Col. 3 lines 36-45 disclose: 112, RF reader can transmit 108, RF signal to 102, contact lens to interrogate the contact lens; the antenna is considered to receive the RF signal); and
responsive to the first wireless signal, transmit a second wireless signal (Col. 3 lines 36-45 disclose: upon receiving the RF signal, the antenna can transmit 110, reflected RF signal, back to 112, RF reader) associated with an electrical characteristic of the one or more electrical components or indicative of a parameter of the eye to the external device (Col. 3 lines 36-45 disclose: reflected signal includes magnitude, phase and/or frequency of 108, RF signal can be modified based on impedance of the antenna; Col 1 lines 40-44 disclose: impedance is related to change in capacitance; Col 3 lines 5-24 discloses: detecting fluid levels and temperature changes related to contact lens and thus indicative parameter of the eye), wherein the external device is operable to receive the second wireless signal (Col. 3 lines 36-45 disclose: the antenna can transmit 110, reflected RF signal, back to 112, RF reader, considered the second wireless signal).
Otis fails to disclose a device to determine the tear film thickness based on the electrical characteristic or the parameter. Otis and Okvist are related because both disclose optical devices.
Okvist teaches a device to determine the tear film thickness based on the electrical characteristic or the parameter ([0028] teaches: 12, interface for external communication with 7, external managing device; Claim 30 teaches: method for determining thickness of a post lens tear film; [0087] teaches: transmitting measurement results; Examiner notes that this is considered transmitting a tear film thickness based on an electrical characteristic from 12, interface to 7, external managing device).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Okvist and provide a device to determine the tear film thickness based on the electrical characteristic or the parameter. Doing so would allow for the tear film thickness information to be remotely obtained from the smart contact lens using a low complexity wireless interrogation arrangement, thereby improving the practicality of continuous tear film monitoring.
Regarding claim 10, the modified Otis discloses the system of claim 9, wherein the one or more electronic components comprise an antenna (Col. 4 lines 8-12 disclose: 204, sensing component and 206 antenna; considered the one or more electronic components).
Regarding claim 12, the modified Otis discloses the system of claim 10, wherein the electrical characteristic comprises a resonance frequency of the antenna (Col. 5 lines 26-34 teach: RF signal modified at a selected resonance frequency; therefore consider and electrical characteristic of the antenna).
Regarding claim 13, the modified Otis discloses the system of claim 12, wherein the external device is further operable to:
receive the second wireless signal (Otis: Col. 3 lines 36-45 disclose: 112, RF reader receives information for 110, RF reflected signal; Col. 5 lines 30-35 teach: signal in response to interrogation); and
determine the tear film thickness of the eye based on the second wireless signal (Okvist: [0029] teaches: 7, external managing device having 8, interface and 9, processing unit for receiving/processing measurement data from the smart contact lens and calculating gap-step values; the associated managing application determines cumulative gap values over time, i.e. tear-film thickness).
Regarding claim 14, the modified Otis discloses the system of claim 10, wherein:
the one or more electronic components comprise a capacitive element; and
the electrical characteristic comprises capacitance (Col. 3 lines 36-45 disclose: reflected signal includes magnitude, phase and/or frequency of 108, RF signal can be modified based on impedance of the antenna; Col 1 lines 40-44 disclose: impedance is related to change in capacitance; Col. 3 lines 5-10 disclose: sensing component can be a capacity proximity sensor, and sensing of 102, contact lens over 104 eye).
Regarding claim 15, the modified Otis discloses the system of claim 14, wherein the external device is further operable to:
receive the second wireless signal (Col. 3 lines 36-45 disclose: reflected signal includes magnitude, phase and/or frequency of 108, RF signal can be modified based on impedance of the antenna; Col 1 lines 40-44 disclose: impedance is related to change in capacitance; Col. 3 lines 5-10 disclose: sensing component can be a capacity proximity sensor, and sensing of 102, contact lens over 104 eye); and
determine the tear film thickness of the eye based on the second wireless signal (Okvist: [0029] teaches: 7, external managing device having 8, interface and 9, processing unit for receiving/processing measurement data from the smart contact lens and calculating gap-step values; the associated managing application determines cumulative gap values over time, i.e. tear-film thickness).
Regarding claim 18, Otis discloses a method (Figures 1 and 2A) of monitoring tear film thickness of an eye, the method comprising:
sending a first wireless signal to a device operable to facilitate monitoring (Col. 3 lines 36-45 disclose: 112, RF reader, can transmit 108, RF signal to 102, contact lens to interrogate the contact lens for information associated with sensed features), the device comprising:
a lens (Figure 1 depicts: 102, contact lens; Figures 2A depict: 200, contact lens; Examiner notes that these are considered the same contact lens but annotated according to different figures); and
one or more electronic components coupled to the lens (Col. 4 lines 8-12 disclose: 204, sensing component and 206 antenna included in contact lens; thus considered coupled to the lens);
responsive to the first wireless signal, receiving a second wireless signal transmitted by the device (Col. 3 lines 36-45 disclose: upon receiving the RF signal, the antenna can transmit 110, reflected RF signal, back to 112, RF reader), wherein the second wireless signal is associated with an electrical characteristic associated with the one or more electrical components or indicative of a parameter of the eye (Col. 3 lines 36-45 disclose: reflected signal includes magnitude, phase and/or frequency of 108, RF signal can be modified based on impedance of the antenna; Col 1 lines 40-44 disclose: impedance is related to change in capacitance; Col 3 lines 5-24 discloses: detecting fluid levels and temperature changes related to contact lens and thus indicative parameter of the eye), wherein the external device is operable to receive the second wireless signal (Col. 3 lines 36-45 disclose: the antenna can transmit 110, reflected RF signal, back to 112, RF reader)
Otis fails to disclose a device to facilitate monitoring of tear film thickness and determine the tear film thickness based on the electrical characteristic or the parameter. Otis and Okvist are related because both disclose optical devices.
Okvist teaches a device to facilitate monitoring of tear film thickness and to determine the tear film thickness based on the electrical characteristic or the parameter ([0028] teaches: 12, interface for external communication with 7, external managing device; Claim 30 teaches: method for determining thickness of a post lens tear film; [0087] teaches: transmitting measurement results; Examiner notes that this is considered transmitting a tear film thickness based on an electrical characteristic from 12, interface to 7, external managing device).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Okvist and provide a device to determine the tear film thickness based on the electrical characteristic or the parameter. Doing so would allow for the tear film thickness information to be remotely obtained from the smart contact lens using a low complexity wireless interrogation arrangement, thereby improving the practicality of continuous tear film monitoring.
Regarding claim 19, the modified Otis discloses the method of claim 18, wherein the electrical characteristic comprises at least one of a resonance frequency, capacitance, or temperature (Col. 5 lines 26-34 teach: RF signal modified at a selected resonance frequency; therefore consider and electrical characteristic of the antenna).
Regarding claim 20, the modified Otis discloses the method of claim 18, further comprising alerting a user responsive to the tear film thickness being below a defined range (Okvist: [0084] teaches: detecting the determined thickness of the post lens tear is below a set threshold thickness and reporting this to 7, external device; Examiner notes that the same motivation to combine applied to an earlier claim, 18, also applies here, and no further analysis is required, consistent with MPEP § 2143, which permits reliance on previously articulated rationale where the combination and reasonings remain unchanged).
Claim 2 is rejected under 35 U.S.C. § 103 as being unpatentable over Otis et al. (US 8,870,370 B1) in view of Okvist et al. (US 2026/0198771 A1), as applied to claim 1 above, in view of Iwaskai et al. (US 2024/0295758 A1).
Regarding claim 2, the modified Otis discloses the device of claim 1.
Otis fails to disclose a device wherein the one or more electronic components are coupled to an outside surface of the lens. Otis and Iwaskai are related because both disclose optical devices.
Iwaskai teaches a device wherein the one or more electronic components are coupled to an outside surface of the lens ([0059] teaches: antenna elements provided on a surface of the lens substrate, see Figure 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Iwaskai and provide a device wherein the one or more electronic components are coupled to an outside surface of the lens. Doing so would allow for maintaining communication with an external device, thereby facilitating placement and operation of the electronic components.
Claims 4, 8 and 11 are rejected under 35 U.S.C. § 103 as being unpatentable over Otis et al. (US 8,870,370 B1) in view of Okvist et al. (US 2026/0198771 A1), as applied to claims 3 and 1 above, in view of Leobandung et al. (US 2016/0073872 A1).
Regarding claim 4, the modified Otis discloses the device of claim 3.
Otis fails to disclose a device wherein the antenna comprises a radio frequency identification (RFID) antenna. Otis and Leobandung are related because both disclose optical devices.
Leobandung teaches a device wherein the antenna comprises a radio frequency identification (RFID) antenna ([0003] teaches: a RFID antenna).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Leobandung and provide a device wherein the antenna comprises a radio frequency identification (RFID) antenna. Doing so would allow for passive or remotely powered wireless communication with the lens-mounted electronics, thereby reducing the need for an onboard power source.
Regarding claim 8, the modified Otis discloses the device of claim 1.
Otis fails to disclose a device wherein the first wireless signal is operable to activate the one or more electronic components. Otis and Leobandung are related because both disclose optical devices.
Leobandung teaches a device wherein the first wireless signal is operable to activate the one or more electronic components ([0004] teaches: RFID is powered by the presence of a radio frequency field received by the antenna).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Leobandung and provide a device wherein the first wireless signal is operable to activate the one or more electronic components. Doing so would allow the lens mounted electronics to be activated by the external wireless interrogation signal, thereby reducing or eliminating the need for a separate onboard power source.
Regarding claim 11, the modified Otis discloses the system of claim 10.
Otis fails to disclose a device wherein the antenna comprises a radio frequency identification (RFID) antenna. Otis and Leobandung are related because both disclose optical devices.
Leobandung teaches a device wherein the antenna comprises a radio frequency identification (RFID) antenna ([0003] teaches: a RFID antenna).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Leobandung and provide a device wherein the antenna comprises a radio frequency identification (RFID) antenna. Doing so would allow for passive or remotely powered wireless communication with the lens-mounted electronics, thereby reducing the need for an onboard power source.
Claims 7 and 16-17 are rejected under 35 U.S.C. § 103 as being unpatentable over Otis et al. (US 8,870,370 B1) in view of Okvist et al. (US 2026/0198771 A1), as applied to claims 3 above, in view of Lai (US 2015/0119750 A1).
Regarding claim 7, the modified Otis discloses the device of claim 3.
Otis fails to disclose a device wherein: the one or more electronic components comprise a temperature sensor; and the parameter comprises temperature at a surface of the eye. Otis and Lai are related because both disclose optical devices.
Lai teaches a device wherein: the one or more electronic components comprise a temperature sensor ([0043] teaches: 22, temperature sensing device); and the parameter comprises temperature at a surface of the eye ([0043] teaches: ocular temperature measurement apparatus for measuring an ocular temperature).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Lai and provide a device wherein: the one or more electronic components comprise a temperature sensor; and the parameter comprises temperature at a surface of the eye. Doing so would allow for monitoring temperature changes at the ocular surface, thereby providing an additional parameter indicative of ocular and tear-film condition.
Regarding claim 16, the modified Otis discloses the system of claim 10.
Otis fails to disclose a device wherein: the one or more electronic components comprise a temperature sensor; and the parameter comprises temperature at a surface of the eye. Otis and Lai are related because both disclose optical devices.
Lai teaches a device wherein: the one or more electronic components comprise a temperature sensor ([0043] teaches: 22, temperature sensing device); and the parameter comprises temperature at a surface of the eye ([0043] teaches: ocular temperature measurement apparatus for measuring an ocular temperature).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Otis in view of Lai and provide a device wherein: the one or more electronic components comprise a temperature sensor; and the parameter comprises temperature at a surface of the eye. Doing so would allow for monitoring temperature changes at the ocular surface, thereby providing an additional parameter indicative of ocular and tear-film condition.
Regarding claim 17, the modified Otis discloses the system of claim 16, wherein the external device is further operable to:
receive the second wireless signal (Col. 3 lines 36-45 disclose: the antenna can transmit 110, reflected RF signal, back to 112, RF reader, considered the second wireless signal); and
determine the tear film thickness of the eye based on the second wireless signal (Okvist: [0028] teaches: 12, interface for external communication with 7, external managing device; Claim 30 teaches: method for determining thickness of a post lens tear film; [0087] teaches: transmitting measurement results; Examiner notes that this is considered transmitting a tear film thickness based on an electrical characteristic from 12, interface to 7, external managing device).
Compact Prosecution
Applicant may potentially overcome the rejection by amending an independent claim to require that the external device predict a future tear film thickness based on historical tear film data and provide an alert before the tear film thickness is predicted to fall outside a desired range, if supported by the specification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Guez et al (US 2007/0075140 A1) and Pugh et al. (US 8,857,983 B2) both disclose relevant optical systems but fail to disclose the correct functional integration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Sipes whose telephone number is (703)756-1372. The examiner can normally be reached Monday - Friday 4:30-9:30/12:30-7:30 (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bumsuk Won can be reached at (571) 272-2713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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John Sipes
Examiner
Art Unit 2872
/J.C.S./ Examiner, Art Unit 2872
/BUMSUK WON/ Supervisory Patent Examiner, Art Unit 2872
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