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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 06/15/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 is being considered by the examiner.
Response to Amendment
The examiner acknowledges the amendments made to the claims 1 and 36. Claims 1, 24-45 are currently pending in prosecution.
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.
Claim(s) 1, 24-26, 28-29, 31, 33-40, 42-43, 45 is/are rejected under 35 U.S.C. 103 as being anticipated by Linder (US Patent No 8721572) in view of Badawi (US Patent No 10973680).
Regarding claim 1, Linder teaches a tear stimulation device (eye therapy device 300, fig 3) comprising a housing (housing 342, fig 3); a controller (temperature delivery module 320, which also controls temperature, [Detailed Description (36)]); a power supply (may have USB or battery power source, [Detailed Description (24)]); and one or more energy terminals arranged about the housing (see in fig 3 in which the temperature delivery module 320 equated to an energy terminal to transfer heat to the patient eye, [Detailed Description (36)]) for the transfer of thermal energy to and from a thermo-responsive region of the face such as to trigger or increase the involuntary activation of tear production (in which the purpose of the heat compress is to heat gland oil above melting point as to allow for viscosity and flow resulting in tears, [Background (5)]); wherein the controller is arranged to cycle the temperature of the one or more energy terminals to deliver sequential heating and cooling phases (wherein the temperature delivery module is configured to apply sequential heating and cooling to the target area, [Detailed Description (36)]), and wherein the controller is arranged in at least one of the cooling phases to reduce the temperature of the one or more energy terminals at a rate of between 0.010C/s and 430C/s (see from [Detailed Description (24)] in which the cooling rate occurs to be 2-5 degrees centigrade every 10 to 30 seconds which results in a cooling rate of about 0.5 degrees centigrade a second, falling within the claimed range).
Linder does not explicitly teach that the cooling phase is done by active temperature control via the controller.
However, the analogous dry eye treatment control device taught by Badawi does disclose that the cooling phase is done by active temperature control via the controller (see in which the controller 37 is programmable such that it can control the temperature ranges and treatment times as well as having a feedback system that allows the controller to actively regulate the output treatment temperature, [0064], furthermore, the control device is able to deliver active cooling thermoelectrically on the temperature layer 36 via Peltier element, [0070]).
Therefore, it would have been obvious to combine the tear simulation housing device and control system taught by Linder, to contain the active cooling temperature control system taught by Badawi, as the prior art of Linder already teaches passive cooling phases delivered to the eye and having active cooling phases is obvious and well known in the art to allow for a more regulated temperature and cooling control during treatment, as taught by Badawi, [0070].
Regarding claim 24, Linder teaches the tear stimulation device of claim 1 in which the controller is arranged to maintain a fixed temperature at the one or more energy terminals during one or more of the heating and/or cooling phases for a period of between 1 and 6000 seconds, (see from [Detailed Description (20)] in which the heat delivery device is configured to deliver a first heat therapy between 35 to 45 degrees centigrade for a period of up to two minutes, in which the time period falls within the claimed range).
Regarding claim 25, Linder teaches the tear stimulation device of claim 1 in which the controller is arranged to set a temperature at the one or more energy terminals of between 00C and 480C (see from [Detailed Description (20)] in which the heat delivery device is configured to deliver a first heat therapy between 35 to 45 degrees centigrade for a period of up to two minutes, in which the temperature setting falls within the claimed range).
Regarding claim 26, Linder teaches the tear stimulation device of claim 1 in which the controller is arranged to modulate the cycle frequency or intensity of the thermal energy (see from [Detailed Description (24)], in which the therapeutic temperature delivered to the eye may be changed by plus or minus 5 degrees, thereby definition changing the intensity of the thermal energy).
Regarding claim 28, Linder teaches the tear stimulation device of claim 1 in which the controller is arranged to vary the rate of temperature change during the at least one cooling phase or between different cooling phases (see from [Detailed Description (24)], in which the therapeutic temperature delivered to the eye may be changed by the control circuitry to plus or minus 5 degrees, thereby definition changing the rate of temperature change).
Regarding claim 29, Linder teaches the tear stimulation device of claim 1 in which the controller is arranged to cycle the thermal energy between sequential heating and cooling phases at a frequency of two or more phases per hour (see in which Linder teaches in the [Summary of Invention (20)] that a first heat therapy is applied for a period of up to two minutes and then a second heat or cooling therapy is applied sequentially for another period of time of up to two minutes, thereby teaching sequential phases that have phase change within the claimed time range).
Regarding claim 31, Linder teaches the tear stimulation device of claim 1 in which the one or more energy terminals are positioned to apply the thermal energy to an area on or adjacent one or more lacrimal glands or the supraorbital foramen (in which Linder teaches in the [Summary of Invention (23)] that the system is applied to the meibomian gland which is found adjacent to the lacrimal gland).
Regarding claim 33, Linder teaches the tear stimulation device of claim 1 in which the housing comprises a support operable to releasably secure the device to a user or user worn apparel (see in [Detailed Description (35)] in which the housing module may be placed within the mask device 200 and may be held in place via elastic components during use, making it releasably securable).
Regarding claim 34, Liner teaches the tear stimulation device of claim 1 in which the support comprises a headband (see headband component 210 from fig 2).
Regarding claim 35, Linder teaches the tear stimulation device of claim 1 in which the one or more energy terminals comprise one or more energy transfer interfaces operable to deliver thermal energy to the thermo-responsive region (see in [Detailed Description (36)] in which the temperature delivery module 320 may be found within a temperature delivery housing to effectively deliver the temperature therapy to the target area).
Regarding claim 36, Linder teaches a method of triggering or increasing tear stimulation (in which the purpose of the heat compress is to heat gland oil above melting point as to allow for viscosity and flow resulting in tears, [Background (5)]) comprising the steps of applying one or more energy terminals to a thermo-responsive region of the face (see in fig 3 in which the temperature delivery module 320 equated to an energy terminal to transfer heat to the patient eye, [Detailed Description (36)]); transferring thermal energy through the one or more energy terminals to and from the thermo-responsive region to sequentially heat and cool the thermo-responsive region (wherein the temperature delivery module is configured to apply sequential heating and cooling to the target area, [Detailed Description (36)]); wherein in at least one cooling phase reducing the temperature of the one or more energy terminals at a rate of between 0.01°C/s and 43 °C/s (see from [Detailed Description (24)] in which the cooling rate occurs to be 2-5 degrees centigrade every 10 to 30 seconds which results in a cooling rate of about 0.5 degrees centigrade a second, falling within the claimed range).
Linder does not explicitly teach that the cooling phase is done by active temperature control via the controller.
However, the analogous dry eye treatment control device taught by Badawi does disclose that the cooling phase is done by active temperature control via the controller (see in which the controller 37 is programmable such that it can control the temperature ranges and treatment times as well as having a feedback system that allows the controller to actively regulate the output treatment temperature, [0064], furthermore, the control device is able to deliver active cooling thermoelectrically on the temperature layer 36 via Peltier element, [0070]).
Therefore, it would have been obvious to combine the tear simulation housing device and control system taught by Linder, to contain the active cooling temperature control system taught by Badawi, as the prior art of Linder already teaches passive cooling phases delivered to the eye and having active cooling phases is obvious and well known in the art to allow for a more regulated temperature and cooling control during treatment, as taught by Badawi, [0070].
Regarding claim 37, Linder teaches the method of claim 36 comprising maintaining the one or more energy terminals at a fixed temperature during one or more of the heating or cooling phases for a period of between 1 and 6000 seconds (see from [Detailed Description (20)] in which the heat delivery device is configured to deliver a first heat therapy between 35 to 45 degrees centigrade for a period of up to two minutes, in which the time period falls within the claimed range).
Regarding claim 38, Linder teaches the method of claim 36 comprising setting a temperature at the one or more energy terminals of between 0°C and 48°C (see from [Detailed Description (20)] in which the heat delivery device is configured to deliver a first heat therapy between 35 to 45 degrees centigrade for a period of up to two minutes, in which the temperature setting falls within the claimed range).
Regarding claim 39, Linder teaches the method of claim 36 comprising modulating the cycle frequency or intensity of the thermal energy (see from [Detailed Description (24)], in which the therapeutic temperature delivered to the eye may be changed by plus or minus 5 degrees, thereby definition changing the intensity of the thermal energy).
Regarding claim 40, Linder teaches the method of claim 36 comprising varying the rate of temperature change during the at least one cooling phase or between different cooling phases (see from [Detailed Description (24)], in which the therapeutic temperature delivered to the eye may be changed by the control circuitry to plus or minus 5 degrees, thereby definition changing the rate of temperature change).
Regarding claim 42, Linder teaches the method of claim 36 comprising the step of cycling the thermal energy between sequential heating and cooling phases at a frequency of two or more phases per hour (see in which Linder teaches in the [Summary of Invention (20)] that a first heat therapy is applied for a period of up to two minutes and then a second heat or cooling therapy is applied sequentially for another period of time of up to two minutes, thereby teaching sequential phases that have phase change within the claimed time range).
Regarding claim 43, Linder teaches the method of claim 36 comprising applying the thermal energy to an area on or adjacent one or more lacrimal glands or the supraorbital foramen (in which Linder teaches in the [Summary of Invention (23)] that the system is applied to the meibomian gland which is found adjacent to the lacrimal gland).
Regarding claim 45, Linder teaches the method of claim 36 comprising electrically or physically manipulating the eyelids (see from Linder [Detailed Description (36)] wherein the device 300 may also contain pressure rollers 344 which massage and physically manipulate the eyelids for therapy treatment).
Claim(s) 27, 30, 32, 41, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linder (US Patent No 8721572) in view of Badawi (US Patent No 10973680) further in view of Alvarez (US Patent No 20210169682). The examiner acknowledges that the US publication of Alvarez was published after the foreign priority date given to the present application, however the Alvarez disclosure claims priority dating back to 4/04/2018 therefore qualifying it as relevant prior art of record.
Regarding claim 27 and 41, Linder and Badawi teach the tear stimulation device of claims 1 and 36.
The combination does not teach in which the controller is arranged to affect a pulsed temperature change of the one or more energy terminals during at least a part of at least one cooling phase.
However, the analogous eye heating and cooling device taught by Alvarez does teach in which the controller is arranged to affect a pulsed temperature change of the one or more energy terminals during at least a part of at least one cooling phase (wherein the eye patch may deliver a pulsed energy delivery to the glands during the heating and cooling cycles as programmed by the controller, [0190]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the tear simulation device taught by Linder and Badawi with that of the specific control and pulsed energy delivery technique taught by Alvarez in order to maintain better control of the therapeutic energy delivery as well performing more efficient delivery methods for the device as taught by Alvarez, [0190].
Regarding claim 30, the combination teaches the tear stimulation device of claim 1 in which the one or more energy terminals comprise a thermoelectric cooler (from Alvarez, wherein the application of cooling energy is applied via a Peltier effect caused from thermoelectric cooling, [0124]).
Regarding claim 32 and 44, the combination teaches the tear stimulation device of claims 1 and 36 comprising one or more temperature sensors positioned at or adjacent the one or more energy terminals (from Alvarez, wherein there are temperature sensors present adjacent to the PCB 320 in which the heating energy is derived, [0151]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 36 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.
In regards to the newly amended claim limitation in the independent claims 1 and 36 and the argument that the prior art of Linder discloses passive cooling phases as opposed to active control cooling phases has been considered but ultimately falls moot. The examiner agrees with the applicant that the prior art of Linder alone does not teach active control cooling phases within the device, however, upon further search and consideration necessitated by the amended claim language it has been found that the analogous dry eye treatment system taught by Badawi does disclose the limitations of the newly amended claims. Specifically Badawi does disclose that the cooling phase is done by active temperature control via the controller (see in which the controller 37 is programmable such that it can control the temperature ranges and treatment times as well as having a feedback system that allows the controller to actively regulate the output treatment temperature, [0064], furthermore, the control device is able to deliver active cooling thermoelectrically on the temperature layer 36 via Peltier element, [0070]). Therefore, as the prior art of record discloses active cooling control, the amended claims 1 and 36 remain rejected under the new prior art of record of Linder in view of Badawi set forth in the present office action.
Furthermore, in regards to the argument presented that the prior art of Linder fails to teach “one or more energy terminals that trigger or increase the involuntary activation of tear production” because Linder’s heat compress system arranged is to heat gland oil in the meibomian gland above melting point as to allow for viscosity and flow and doesn’t directly teach tear production has been considered but ultimately falls unpersuasive. The examiner agrees with the applicant that Linder’s heat compress system is arranged to heat gland oil in the meibomian gland, however after further search and consideration the examiner has found that the meibomian gland does impact both tear production and tear retention. In a WebMD article written by Julie Canter about the meibomian gland, it is explained that the meibomian gland is an essential gland for creating the tear film, the fluid or tears that keep the eyes moist, in which case tear production may cease or dry eyes may occur when the meibomian gland is not functioning properly. Therefore, as the meibomian gland is known as being an essential factor for creating the tear film for the eyes, the heat compress system of Linder which is arranged to heat gland oil in the meibomian gland above melting point as to allow for viscosity and flow would result in the involuntary activation and retention of tear production as presently claimed in the application. Therefore, as Linder continues to teach “one or more energy terminals that trigger or increase the involuntary activation of tear production,” as broadly as claimed, the claims remain rejected under the previous prior art of record rejection of Linder set forth in the previous office action. Furthermore, as the control system in the analogous prior art of Linder is disclosed as being structurally equivalent and having sequential cycles of heating and cooling of the eye region, as similarly claimed by the present application, the prior art of Linder is capable of triggering tear production in a thermo-responsive region. As Linder is capable of triggering tear production in the thermo-responsive region, the claims remain rejected under the prior art of Linder in view of Badawi set forth in the present office action.
As no further remarks were presented, all other claims remain rejected under their dependency of the rejected claims 1 and 36.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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