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 .
Response to Arguments
Applicant’s arguments with respect to claims 1 and 17-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Inclusion of the newly cited reference Fermigier (US 20220397777 A1) teaches the amended limitations as set forth in the rejection below.
Applicant’s arguments regarding claims 12, 13, and 20 are not persuasive. Applicant argues that the “obvious to try” rationale applied to the aforementioned claims is improper due to impermissible hindsight and alleges that there are an infinite number of functions that PHOSITA would be required to try rather than the two claimed functions (ramp and step function). However, the Examiner respectfully disagrees because Gutierrez ‘736 describes the value of having a discrete and gradual light attenuation (Gutierrez ‘736 ¶[0014][0047]). PHOSITA would recognize that either a step or ramp function would provide the best function for a gradual and discrete light attenuation or modulation and would avoid using any other functions that would create a light attenuation response that is not step wise or linear. Thus the examiner maintains the rejections of claims 12, 13, and 20.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 20190107736 A1, hereinafter Gutierrez ‘736) in view of Fermigier (US 20220397777 A1).
Regarding Claim 1, Gutierrez ‘736 discloses a system comprising: an ophthalmic device, positionable on a surface of an eye (Fig 1A-B ¶[0016] ophthalmic device 100 may be an on-eye wearable device), comprising an electronically-mediated medium configured to modulate an amount of light transmitted through a portion of the ophthalmic device (Fig 2 ¶[0016-0017] optical stack 106 includes electro-optical devices that provide light attenuation and/or filtering) in response to a first electrical signal (¶[0016] The electro-optic devices and the dynamic optic, if included, may be formed from a stack of optical elements and/or electro-optic devices, each receiving a control signal to modulate an associated index of refraction, which alters incident light and/or provides accommodation); and a signal generator encapsulated within the ophthalmic device, the signal generator configured to generate the first electrical signal (Fig 1A [abstract][0017][0022-0023] photo detector 108 outputs a data signal indicative of a property of incident light); and a light sensor configured to detect ambient light (Fig 1A ¶[0015][0022] photodetector 108 senses the spectral content of ambient light) wherein the signal generator is in communication with a controller, comprising a processor, configured to define parameters of the first electrical signal (Fig 1A [abstract][0017][0021][0054][0055] control electronics 112 may receive one or more data signals from the photodetector 108. Comparison of the current and previous photodetector signal(s) may be performed by the control electronics 112).
Gutierrez ‘736 does not explicitly disclose wherein in response to the controller determining that the detected ambient light is above a threshold, the first electrical signal causes the electronically-mediated medium to modulate the amount of light transmitted through the portion of the ophthalmic device.
However, Fermigier teaches a variable transmission contact lens, thus from the same field of endeavor, wherein in response to the controller determining that the detected ambient light is above a threshold, the first electrical signal causes the electronically-mediated medium to modulate the amount of light transmitted through the portion of the ophthalmic device (¶[0010-0014] receiving, from an ambient light sensor, values of a measured parameter related to an illuminance of the environment of the wearer, computing a change of illuminance from the values of the measured parameter during a predetermined time interval, comparing the computed change of illuminance with a first threshold, when the computed change of illuminance is greater than the first threshold, implementing a first command configured for varying the transmission of the variable transmission ophthalmic lens from an initial transmission value corresponding to a current transmission value to a first target transmission value, according to a first variation profile comprising a first phase during which the transmission overshoots the first target transmission value, and a second phase during which the transmission returns to the first target transmission value.) to enhance the comfort of the wearer when the ambient light varies abruptly (¶[0009].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gutierrez ‘736 so that in response to the controller determining that the detected ambient light is above a threshold, the first electrical signal causes the electronically-mediated medium to modulate the amount of light transmitted through the portion of the ophthalmic device, as taught by Fermigier, in order to enhance the comfort of the wearer when the ambient light varies abruptly (as motivated by Fermigier ¶[0009]).
Regarding Claim 14, Gutierrez ‘736/Fermigier discloses that the electronically-mediated medium comprises a material that is one of electrochromic, liquid crystal, pH sensitive, or thermodynamic (¶[0017] electro-optical device may comprise liquid crystal based cells).
Regarding Claim 15, Gutierrez ‘736/Fermigier discloses a battery configured to power the controller and the signal generator (Fig 4 ¶[0041] battery 450 powers controller 436 and photodetector 408); and a wireless transmitter configured to transmit to an external handheld controller (Fig 4 ¶[0048] antenna 444 communicates wirelessly to external reader 405), wherein the external handheld controller can send instructions to the controller of the ophthalmic device (Fig 4 ¶[0050 reader 405 may send instructions to ophthalmic device 400).
Regarding Claim 16, Gutierrez ‘736/Fermigier discloses wherein when the ophthalmic device is positioned on a surface of the eye at least a portion of the electronically-mediated medium is configured to be in front of a lens of the eye (Fig 1A-B optical stack 106, which includes the liquid crystal electro-optical material, is positioned over the center of the eye, thus being configured to be in front of the lens of the eye).
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 20190107736 A1, hereinafter Gutierrez ‘736) in view of Fermigier (US 20220397777 A1), in view of Gutierrez (US 20200214886 A1, hereinafter Gutierrez ‘886).
Regarding Claim 2, Gutierrez ‘736/Fermigier is silent regarding at least one drug reservoir encapsulated within the ophthalmic device, the at least one drug reservoir configured to store a therapeutic agent and to release the therapeutic agent in response to a second electrical signal, wherein the signal generator is further configured to generate the second electrical signal to release the therapeutic agent, and wherein the controller is further configured to define parameters of the second electrical signal.
However, Gutierrez ‘886 teaches programmable therapeutic agent release from an eye mounted device, thus from the same field of endeavor, wherein at least one drug reservoir is encapsulated within the ophthalmic device (Fig 2A ¶[0039] one or more reservoirs 210 are encapsulated in device 200), the at least one drug reservoir configured to store a therapeutic agent and to release the therapeutic agent in response to a second electrical signal (Fig 2A ¶[0017][0045-0046] therapeutic agent 225 is released by an electrical signal that actuates dissolution of a metal film), wherein the signal generator is further configured to generate the second electrical signal to release the therapeutic agent, and wherein the controller is further configured to define parameters of the second electrical signal (Fig 2A [abstract][0014][0017] Upon receipt of the first command signal, the controller determines whether one or more compliance conditions are satisfied. When the one or more conditions are satisfied, the controller initiate a release and delivery protocol that commands a signal generator to generate and send a second command signal causing a capacitor or one or more circuits to deliver an actuation signal causing one or more therapeutic agent delivery mechanisms to open and release the therapeutic agent from one or more reservoirs) to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (¶[0004])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutierrez ‘736/Fermigier to include at least one drug reservoir encapsulated within the ophthalmic device, the at least one drug reservoir configured to store a therapeutic agent and to release the therapeutic agent in response to a second electrical signal, wherein the signal generator is further configured to generate the second electrical signal to release the therapeutic agent, and wherein the controller is further configured to define parameters of the second electrical signal, as taught by Gutierrez ‘886 to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (as motivated by Gutierrez ‘886 ¶[0004]).
Regarding Claim 5, Gutierrez ‘736/Fermigier is silent whether each drug reservoir comprises: a well having an interior configured to hold the therapeutic agent in a non-liquid form; a metal electrode configured to cover an opening of the well and to electrodissolve in response to receiving, from the signal generator, the second electrical signal.
However, Gutierrez ‘886 teaches programmable therapeutic agent release from an eye mounted device, thus from the same field of endeavor, wherein each drug reservoir (Fig 2A reservoir 210) comprises: a well having an interior configured to hold the therapeutic agent in a non-liquid form (Fig 2A ¶[0040] reservoirs 210 may comprise a holding chamber 220 for a therapeutic agent 225, which may be a gel or powder); a metal electrode configured to cover an opening of the well and to electrodissolve in response to receiving, from the signal generator, the second electrical signal (Fig 2A ¶[0017][0045-0046] therapeutic agent 225 is released by an electrical signal that actuates dissolution of a metal film) to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (as motivated by Gutierrez ‘886 ¶[0004]).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 20190107736 A1, hereinafter Gutierrez ‘736), in view of Fermigier (US 20220397777 A1), in view of Gutierrez (US 20200214886 A1, hereinafter Gutierrez ‘886), further in view of Coroneo (US 20200345633 A1).
Regarding Claims 3-4, Gutierrez ‘736/Fermigier/Gutierrez ‘886 is silent whether the therapeutic agent is a muscarinic receptor antagonist, wherein the therapeutic agent is one of atropine, pirenzepine, tropicamide, or scopolamine.
However, Coroneo teaches pharmaceutical compositions for treatment of myopia, thus from the same field of endeavor, wherein the therapeutic agent is a muscarinic receptor antagonist, wherein the therapeutic agent is one of atropine, pirenzepine, tropicamide, or scopolamine (¶[0091] the muscarinic antagonist is atropine, tropicamide, or pirenzepine) to control, slow, reduce, retard, and/or mitigate, the progression of myopia (¶[0094]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutierrez ‘736/Fermigier/Gutierrez ‘886 so that the therapeutic agent is a muscarinic receptor antagonist, wherein the therapeutic agent is one of atropine, pirenzepine, tropicamide, or scopolamine, as taught by Coroneo to control, slow, reduce, retard, and/or mitigate, the progression of myopia (as motivated by Coroneo ¶[0094]).
Claims 6-7, 8-13 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 20190107736 A1, hereinafter Gutierrez ‘736) in view of Fermigier (US 20220397777 A1), in view of Gutierrez (US 20200214886 A1, hereinafter Gutierrez ‘886), further in view of Bodor (TW 201709906 A).
Regarding Claim 6, Gutierrez ‘736/Fermigier discloses wherein the processor of the controller (Fig 1A [abstract][0017][0021][0054][0055] control electronics 112) executes instructions to: apply a first portion of the first electrical signal to the electronically-mediated medium to modulate the amount of the light transmitted through the portion of the ophthalmic device (¶[0016] The electro-optic devices and the dynamic optic, if included, may be formed from a stack of optical elements and/or electro-optic devices, each receiving a control signal to modulate an associated index of refraction, which alters incident light and/or provides accommodation); and apply a second portion of the first electrical signal to the electronically-mediated medium to return the electronically-mediated medium to transmitting a normal amount of the light through the portion of the ophthalmic device (¶[0016] The electro-optic devices and the dynamic optic, if included, may be formed from a stack of optical elements and/or electro-optic devices, each receiving a control signal to modulate an associated index of refraction, which alters incident light and/or provides accommodation).
Gutierrez ‘736/Fermigier is silent regarding applying the second electrical signal, generated by the signal generator, to the at least one drug reservoir to activate electrodissolution of the metal electrode so as to release of the therapeutic agent; determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed.
However, Gutierrez ‘886 teaches programmable therapeutic agent release from an eye mounted device, thus from the same field of endeavor, wherein the processor of the controller (Fig 2A ¶[0054] electronics module 275) executes instructions to: apply the second electrical signal, generated by the signal generator, to the at least one drug reservoir to activate electrodissolution of the metal electrode so as to release of the therapeutic agent (Fig 2A ¶[0017][0054][0045-0046] therapeutic agent 225 is released by an electrical signal that actuates dissolution of a metal film. electronics module 275 may include discrete and/or integrated electronic circuit components (e.g., one or more processors) that implement analog and/or digital circuits capable of producing the functions attributed to the device 200 such as applying a potential to one or more therapeutic agent delivery mechanisms 215, applying a potential to a circuit, or applying a potential to one or more electrodes) to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (¶[0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutierrez ‘736/Fermigier to include applying the second electrical signal, generated by the signal generator, to the at least one drug reservoir to activate electrodissolution of the metal electrode so as to release of the therapeutic agent, as taught by Gutierrez ‘886 to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (as motivated by Gutierrez ‘886 ¶[0004]).
Gutierrez ‘736/Fermigier/Gutierrez ‘886 is silent regarding determine whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed.
However, Bodor teaches treatment of myopia in children using anticholinergic agents, thus from the same field of endeavor, which includes determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil (page 3, paragraph 2 pupil size and duration is tracked after treatment by mydriatic agent); determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed (page 3, paragraph 2 pupil size and duration/recovery is tracked after treatment by mydriatic agent) to slow the progression of myopia in children ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutierrez ‘736/Gutierrez ‘886 to include determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed, as taught by Bodor to slow the progression of myopia in children (as motivated by Bodor [abstract]). In combination, the device of Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor would necessarily be able to determine whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; when the pupil dilation time has elapsed, apply a first portion of the first electrical signal to the electronically-mediated medium to modulate the amount of the light transmitted through the portion of the ophthalmic device; determine whether a pupil dilation recovery time has elapsed; and apply a second portion of the first electrical signal to the electronically-mediated medium to return the electronically-mediated medium to transmitting a normal amount of the light through the portion of the ophthalmic device.
Regarding Claim 7, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor discloses that the first portion of the first electrical signal is applied for a time to the electronically mediated medium to reduce the amount of light transmitted through the portion of the ophthalmic device (¶[0016] The electro-optic devices and the dynamic optic, if included, may be formed from a stack of optical elements and/or electro-optic devices, each receiving a control signal to modulate an associated index of refraction, which alters incident light and/or provides accommodation).
Regarding Claim 9, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor discloses wherein the controller executes the instructions to: after the pupil dilation time has elapsed, detect ambient light via the ambient light sensor at a time; and modulate the amount of light transmitted through the portion of the ophthalmic device in response to the detected light (Fig 2 ¶[0026] control electronics 112 may modulate the light transmitted through the device in response to ambient light conditions).
Regarding Claim 10, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor discloses that the amount of light transmitted through the portion of the ophthalmic device is modulated in response to the detected ambient light further comprises: determine whether the detected ambient light is above a threshold value at the time, if the detected ambient light is above the threshold value, then configure the first portion of the first electrical signal to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium; and if the detected ambient light is below the threshold value, then configure the first portion of the first electrical signal to return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal (Fig 2 ¶[0026] control electronics 112 may modulate the light transmitted through the device in response to ambient light conditions. This modulation may be altered based on desired user settings, i.e. the user may select the threshold values).
Regarding Claim 11, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor discloses that modulating the amount of light transmitted through the portion of the ophthalmic device in response to the detected ambient light further comprises: determine the illuminance of the detected ambient light at the time; and configure the first portion of the first electrical signal to reduce the amount of light in inverse proportion to the illuminance of the ambient light detected at the time (Fig 2 ¶[0026] control electronics 112 may modulate the light transmitted through the device in response to ambient light conditions).
Regarding Claims 12-13, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor does not explicitly disclose that the first portion of the first electrical signal is a step function or a ramp function.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gutierrez ‘736/Gutierrez ‘886/Bodor so that the variable waveform is a step function or a ramp function because having the first portion of the first electrical signal be a step function or a ramp function would have been obvious to try because there are a finite number of solutions to increasing or decreasing the light modulation of the device (2 solutions: either step function or ramp function), and one of ordinary skill would have a reasonable expectation of success to achieve the result of gradually increasing or decreasing the light modulation of the ophthalmic device and would achieve a predictable result of providing tinting or filtering to prevent eye-strain and/or migraine-inducing conditions (Gutierrez ‘736 ¶[0003][0047]).
Regarding Claim 17, Gutierrez ‘736 discloses a method comprising: positioning an ophthalmic device, on a surface of an eye (Fig 1A-B ¶[0016] ophthalmic device 100 may be an on-eye wearable device), wherein the ophthalmic device comprises an electronically-mediated medium (Fig 2 ¶[0016-0017] optical stack 106 includes electro-optical devices that provide light attenuation and/or filtering); detecting ambient light near the eye at a time (Fig 1A ¶[0015][0022] photodetector 108 may include additional diodes and may sense ambient light conditions), activating the electronically-mediated medium to reduce the amount of light transmitted through a portion of the ophthalmic device by filtering the light, wherein the electronically-mediated medium activates in response to receiving a first portion of a second electrical signal (¶[0016] The electro-optic devices and the dynamic optic, if included, may be formed from a stack of optical elements and/or electro-optic devices, each receiving a control signal to modulate an associated index of refraction, which alters incident light and/or provides accommodation); returning the amount of light transmitted through the portion of the ophthalmic device to normal by deactivating the electronically- mediated medium, wherein the electronically-mediated medium deactivates in response to receiving a second portion of the second electrical signal having a zero voltage or a voltage of an opposite polarity (¶[0031-0032] polarities may be selected so that the OFF state corresponds to the default usage mode of the optical stack 206).
Gutierrez ‘736 is silent regarding an ophthalmic device, having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent, wherein the therapeutic agent is configured to cause dilation of a pupil; after a pupil dilation time has elapsed, determining, based on whether the detected ambient light is above a threshold, whether to activate the electronically-mediated medium to reduce the amount of light transmitted through a portion of the ophthalmic device by filtering the light, and after a pupil recovery time has elapsed, returning the amount of light transmitted through the portion of the ophthalmic device to normal by deactivating the electronically-mediated medium.
However, Fermigier teaches a variable transmission contact lens, thus from the same field of endeavor, including determining, based on whether the detected ambient light is above a threshold, whether to activate the electronically-mediated medium to reduce the amount of light transmitted through a portion of the ophthalmic device by filtering the light (¶[0010-0014] receiving, from an ambient light sensor, values of a measured parameter related to an illuminance of the environment of the wearer, computing a change of illuminance from the values of the measured parameter during a predetermined time interval, comparing the computed change of illuminance with a first threshold, when the computed change of illuminance is greater than the first threshold, implementing a first command configured for varying the transmission of the variable transmission ophthalmic lens from an initial transmission value corresponding to a current transmission value to a first target transmission value, according to a first variation profile comprising a first phase during which the transmission overshoots the first target transmission value, and a second phase during which the transmission returns to the first target transmission value.) to enhance the comfort of the wearer when the ambient light varies abruptly (¶[0009].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gutierrez ‘736 to include determining, based on whether the detected ambient light is above a threshold, whether to activate the electronically-mediated medium to reduce the amount of light transmitted through a portion of the ophthalmic device by filtering the light, as taught by Fermigier, in order to enhance the comfort of the wearer when the ambient light varies abruptly (as motivated by Fermigier ¶[0009]).
Gutierrez ‘736/Fermigier is silent regarding an ophthalmic device, having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent, wherein the therapeutic agent is configured to cause dilation of a pupil; after a pupil dilation time has elapsed, whether to activate the electronically-mediated medium to reduce the amount of light transmitted through a portion of the ophthalmic device by filtering the light, and after a pupil recovery time has elapsed, returning the amount of light transmitted through the portion of the ophthalmic device to normal by deactivating the electronically-mediated medium.
However, Gutierrez ‘886 teaches programmable therapeutic agent release from an eye mounted device, thus from the same field of endeavor, including an ophthalmic device (Fig 2A, 200), having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode (Fig 2A ¶[0039][0047] one or more reservoirs 210 are encapsulated in device 200 and may include a metal layer that acts as a valve) ; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent (Fig 2A ¶[0017][0054][0045-0046] therapeutic agent 225 is released from reservoirs 210 by an electrical signal that actuates dissolution of a metal film. electronics module 275 may include discrete and/or integrated electronic circuit components (e.g., one or more processors) that implement analog and/or digital circuits capable of producing the functions attributed to the device 200 such as applying a potential to one or more therapeutic agent delivery mechanisms 215, applying a potential to a circuit, or applying a potential to one or more electrodes) to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (¶[0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gutierrez ‘736/Fermigier to include an ophthalmic device, having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent, as taught by Gutierrez ‘886 to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (as motivated by Gutierrez ‘886 ¶[0004]).
Gutierrez ‘736/Fermigier/Gutierrez ‘886 is silent regarding determine whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed.
However, Bodor teaches treatment of myopia in children using anticholinergic agents, thus from the same field of endeavor, which includes determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil (page 3, paragraph 2 pupil size and duration is tracked after treatment by mydriatic agent); determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed (page 3, paragraph 2 pupil size and duration/recovery is tracked after treatment by mydriatic agent) to slow the progression of myopia in children ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutierrez ‘736/Gutierrez ‘886 to include determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed, as taught by Bodor to slow the progression of myopia in children (as motivated by Bodor [abstract]). In combination, the method of Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor would necessarily be able to: after a pupil dilation time has elapsed, activating the electronically-mediated medium to reduce the amount of light transmitted through a portion of the ophthalmic device by filtering the light, wherein the electronically-mediated medium activates in response to receiving a first portion of a second electrical signal; and after a pupil recovery time has elapsed, returning the amount of light transmitted through the portion of the ophthalmic device to normal by deactivating the electronically- mediated medium, wherein the electronically-mediated medium deactivates in response to receiving a second portion of the second electrical signal having a zero voltage or a voltage of an opposite polarity.
Regarding Claim 18, Gutierrez ‘736 discloses a method comprising: positioning an ophthalmic device, on a surface of an eye (Fig 1A-B ¶[0016] ophthalmic device 100 may be an on-eye wearable device), wherein the ophthalmic device comprises an electronically-mediated medium (Fig 2 ¶[0016-0017] optical stack 106 includes electro-optical devices that provide light attenuation and/or filtering); a detecting ambient light near the eye at a time (Fig 2 ¶[0026] control electronics 112 may modulate the light transmitted through the device in response to ambient light conditions), detecting ambient light near the eye at a time and delivering a first portion of a second electrical signal, comprising a variable waveform, to the electronically-mediated medium in response to the detected ambient light at the time, wherein the electronically-mediated medium undergoes a change to modulate an amount of light transmitted through at least a portion of the ophthalmic device (¶[0016] The electro-optic devices and the dynamic optic, if included, may be formed from a stack of optical elements and/or electro-optic devices, each receiving a control signal to modulate an associated index of refraction, which alters incident light and/or provides accommodation); delivering a second portion of the second electrical signal to return the electronically-mediated medium to transmitting a normal amount of the light through the portion of the ophthalmic device (¶[0031-0032] polarities may be selected so that the OFF state corresponds to the default usage mode of the optical stack 206).
Gutierrez ‘736 is silent regarding an ophthalmic device, having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent, wherein the therapeutic agent is configured to cause dilation of a pupil; when a pupil dilation time has elapsed: detecting ambient light near the eye at a time, and delivering a first portion of a second electrical signal, comprising a variable waveform, to the electronically-mediated medium in response to the detected ambient light at the time being above a threshold, wherein the electronically-mediated medium undergoes a change to modulate an amount of light transmitted through at least a portion of the ophthalmic device; and when a pupil recovery time has elapsed, delivering a second portion of the second electrical signal to return the electronically-mediated medium to transmitting a normal amount of the light through the portion of the ophthalmic device.
However, Fermigier teaches a variable transmission contact lens, thus from the same field of endeavor, including delivering a first portion of a second electrical signal, comprising a variable waveform, to the electronically-mediated medium in response to the detected ambient light at the time being above a threshold, wherein the electronically-mediated medium undergoes a change to modulate an amount of light transmitted through at least a portion of the ophthalmic device (¶[0010-0014] receiving, from an ambient light sensor, values of a measured parameter related to an illuminance of the environment of the wearer, computing a change of illuminance from the values of the measured parameter during a predetermined time interval, comparing the computed change of illuminance with a first threshold, when the computed change of illuminance is greater than the first threshold, implementing a first command configured for varying the transmission of the variable transmission ophthalmic lens from an initial transmission value corresponding to a current transmission value to a first target transmission value, according to a first variation profile comprising a first phase during which the transmission overshoots the first target transmission value, and a second phase during which the transmission returns to the first target transmission value.) to enhance the comfort of the wearer when the ambient light varies abruptly (¶[0009])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Gutierrez ‘736 to include delivering a first portion of a second electrical signal, comprising a variable waveform, to the electronically-mediated medium in response to the detected ambient light at the time being above a threshold, wherein the electronically-mediated medium undergoes a change to modulate an amount of light transmitted through at least a portion of the ophthalmic device, as taught by Fermigier, in order to enhance the comfort of the wearer when the ambient light varies abruptly (as motivated by Fermigier ¶[0009]).
Gutierrez ‘736/Fermigier is silent regarding an ophthalmic device, having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent, wherein the therapeutic agent is configured to cause dilation of a pupil; when a pupil dilation time has elapsed: detecting ambient light near the eye at a time, and delivering a first portion of a second electrical signal, comprising a variable waveform, to the electronically-mediated medium in response to the detected ambient light at the time being above a threshold, wherein the electronically-mediated medium undergoes a change to modulate an amount of light transmitted through at least a portion of the ophthalmic device; and when a pupil recovery time has elapsed, delivering a second portion of the second electrical signal to return the electronically-mediated medium to transmitting a normal amount of the light through the portion of the ophthalmic device.
However, Gutierrez ‘886 teaches programmable therapeutic agent release from an eye mounted device, thus from the same field of endeavor, including an ophthalmic device (Fig 2A, 200), having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode (Fig 2A ¶[0039][0047] one or more reservoirs 210 are encapsulated in device 200 and may include a metal layer that acts as a valve) ; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent (Fig 2A ¶[0017][0054][0045-0046] therapeutic agent 225 is released from reservoirs 210 by an electrical signal that actuates dissolution of a metal film. electronics module 275 may include discrete and/or integrated electronic circuit components (e.g., one or more processors) that implement analog and/or digital circuits capable of producing the functions attributed to the device 200 such as applying a potential to one or more therapeutic agent delivery mechanisms 215, applying a potential to a circuit, or applying a potential to one or more electrodes) to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (¶[0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gutierrez ‘736 to include an ophthalmic device, having at least one encapsulated drug reservoir configured to store a therapeutic agent covered by a metal electrode; delivering a first electrical signal to the metal electrode covering a certain drug reservoir of the at least one encapsulated drug reservoir so the metal electrode undergoes electrodissolution to release the therapeutic agent, as taught by Gutierrez ‘886 to provide a targeted, concentrated delivery of a therapeutic agent to an area of interest while reducing the relative concentration of the agent in the remaining tissues (as motivated by Gutierrez ‘886 ¶[0004]).
Gutierrez ‘736/Gutierrez ‘886 is silent regarding determine whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed.
However, Bodor teaches treatment of myopia in children using anticholinergic agents, thus from the same field of endeavor, which includes determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil (page 3, paragraph 2 pupil size and duration is tracked after treatment by mydriatic agent); determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed (page 3, paragraph 2 pupil size and duration/recovery is tracked after treatment by mydriatic agent) to slow the progression of myopia in children ([abstract]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gutierrez ‘736/Gutierrez ‘886 to include determining whether a pupil dilation time for the therapeutic agent has elapsed since release of the therapeutic agent started, wherein the therapeutic agent causes dilation of a pupil; determining when the pupil dilation time has elapsed; and determining whether a pupil dilation recovery time has elapsed, as taught by Bodor to slow the progression of myopia in children (as motivated by Bodor [abstract]). In combination, the method of Gutierrez ‘736/Gutierrez ‘886/Bodor would necessarily be able to: when a pupil dilation time has elapsed: detecting ambient light near the eye at a time, and delivering a first portion of a second electrical signal, comprising a variable waveform, to the electronically-mediated medium in response to the detected ambient light at the time, wherein the electronically-mediated medium undergoes a change to modulate an amount of light transmitted through at least a portion of the ophthalmic device; and when a pupil recovery time has elapsed, delivering a second portion of the second electrical signal to return the electronically-mediated medium to transmitting a normal amount of the light through the portion of the ophthalmic device.
Regarding Claim 19, Gutierrez ‘736/Gutierrez ‘886/Bodor does not explicitly disclose further comprising: determining whether to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium or return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal based on whether the detected ambient light at the time is above or below a threshold, respectively; wherein when the detected ambient light is above the threshold, then configuring the variable waveform of the first portion of the second electrical signal to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium; and wherein when the detected ambient light is below the threshold, then configuring the variable waveform of the first portion of the second electrical signal to return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal.
However, Fermigier teaches a variable transmission contact lens, thus from the same field of endeavor, including determining whether to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium or return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal based on whether the detected ambient light at the time is above or below a threshold (¶[0010-0014] receiving, from an ambient light sensor, values of a measured parameter related to an illuminance of the environment of the wearer, computing a change of illuminance from the values of the measured parameter during a predetermined time interval, comparing the computed change of illuminance with a first threshold, when the computed change of illuminance is greater than the first threshold, implementing a first command configured for varying the transmission of the variable transmission ophthalmic lens from an initial transmission value corresponding to a current transmission value to a first target transmission value, according to a first variation profile comprising a first phase during which the transmission overshoots the first target transmission value, and a second phase during which the transmission returns to the first target transmission value.), respectively; wherein when the detected ambient light is above the threshold, then configuring the variable waveform of the first portion of the second electrical signal to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium (¶[0014] when the computed change of illuminance is greater than the first threshold, implementing a first command configured for varying the transmission of the variable transmission ophthalmic lens from an initial transmission value corresponding to a current transmission value to a first target transmission value, according to a first variation profile comprising a first phase during which the transmission overshoots the first target transmission value); and wherein when the detected ambient light is below the threshold, then configuring the variable waveform of the first portion of the second electrical signal to return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal (¶[0062-0066] 0062] when the absolute value of the computed further change of illuminance is greater than the absolute value of the first threshold, interrupting the transmission variation resulting of the first command and implementing a third command for varying the transmission of the variable transmission ophthalmic lens from the temporary transmission value to a third target transmission value, and when the absolute value of the computed further change of illuminance is smaller than, or equal to, the absolute value of the first threshold, proceeding with the transmission variation resulting of the first command. This allows interrupting the transmission variation when the current illumination is detected to have returned closer to the initial value, thus removing the need for a quick response time to prevent glare. In some examples, the second target transmission value corresponds to the initial transmission value. This allows cancelling the first command and the associated transmission variation while underway.) in order to enhance the comfort of the wearer when the ambient light varies abruptly (¶[0009]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gutierrez ‘736/Gutierrez ‘886/Bodor to further comprise: determining whether to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium or return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal based on whether the detected ambient light at the time is above or below a threshold, respectively; wherein when the detected ambient light is above the threshold, then configuring the variable waveform of the first portion of the second electrical signal to reduce the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium; and wherein when the detected ambient light is below the threshold, then configuring the variable waveform of the first portion of the second electrical signal to return the amount of light transmitted through the portion of the ophthalmic device by the electronically-mediated medium to normal, as taught by Fermigier in order to enhance the comfort of the wearer when the ambient light varies abruptly (as motivated by Fermigier ¶[0009]).
Regarding Claim 20, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor discloses determining the illuminance of the detected ambient light at the time ( Fig 2 ¶[0026] control electronics 112 may modulate the light transmitted through the device in response to ambient light conditions); and configuring the variable waveform of the first portion of the second electrical signal to modulate the amount of light in inverse proportion to the illuminance of the ambient light detected at the time (¶[0055]).
Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor does not explicitly disclose wherein the variable waveform is a step function or a ramp function.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor so that the variable waveform is a step function or a ramp function because having the variable waveform be a step function or a ramp function would have been obvious to try because there are a finite number of solutions to gradually increasing or decreasing the light modulation of the device (2 solutions: either step function or ramp function), and one of ordinary skill would have a reasonable expectation of success to achieve the result of gradually increasing or decreasing the light modulation of the ophthalmic device and would achieve a predictable result of providing tinting or filtering to prevent eye-strain and/or migraine-inducing conditions (Gutierrez ‘736 ¶[0003]).
Regarding Claim 21, Gutierrez ‘736/Fermigier/Gutierrez ‘886/Bodor discloses that the portion of the ophthalmic device is configured to substantially discretely transition from a first configuration to a second configuration, the second configuration filtering more light than the first configuration (¶[0056] adjustment of the first LC cell may result in more light attenuation, filtering more light than a first configuration).
Conclusion
THIS ACTION IS MADE FINAL. 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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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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