DETAILED ACTION
Applicant’s arguments, filed on 07/06/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 07/06/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-3, 5-6, and 29-49 are the current claims hereby under examination.
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 .
Claim Objections
Claim 49 is objected to because of the following informalities:
In claim 49, line 2, “the tear secretion disturbances comprise Sjögren syndrome” should read “the tear secretion disturbances further comprise Sjögren syndrome”
Appropriate correction is required.
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.
Claims 1, 3, 5-6, 29, 31, and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Belmonte (WO 9412104) in view of Situ (US 20190000312). Citations to WO 9412104 will refer to the English Machine Translation that accompanies this Office Action.
Regarding independent claim 1, Belmonte teaches a method for generating a maximal reflex tear secretion (Abstract: “The method comprises: (a) applying to the cornea or conjunctiva of the eye, whose sensitivity is to be determined, a flow of gas which contains CO2 and air in variable concentrations”), comprising chemically stimulating a cornea of an eye of a human subject by applying towards the said cornea a controlled jet or puff of a gas mixture with a C02 content of at least 99% C02 (Abstract: “The method comprises: (a) applying to the cornea or conjunctiva of the eye, whose sensitivity is to be determined, a flow of gas which contains CO2 and air in variable concentrations”; Page 3: “Mixtures of C0 .sub.2 contained in separate containers in 8 individuals were used. Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”. This limitation describes the gas mixture having a CO2 concentration of 98.5%, which can be interpreted as teaching on the gas mixture being 99% CO2, the prior art limitation is close enough such that one skilled in the art would have expected them to have the same properties (MPEP 2144.05(i). Alternatively, Belmonte teaches that the concentrations are subject to change. The CO2 concentration would depend upon the desired effect. As such, the CO2 concentration is a results-effective variable that would have been optimized through routine experimentation based on the desired effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the CO2 concentration so as to obtain the desired effect. Alternatively, the 98.5% concentration of CO2 is considered to be interpretated to be 99% concentration by interpreting the term by conventional rounding up for more convenient reference; Page 3: “In one part of the studies on human sensations, the same calibrated mixtures of gases used in animal experiments were used (0, 35, 50, 65, 80 and 98.5%)”. This limitation states that this device is also used on humans with this concentration of CO2.) from a gas outlet nozzle (Fig. 1; valve 8 is the gas outlet nozzle; Page 2: “An electronic valve system allowed air or a given mixture of C0 .sub.2 to be alternately expelled through the lower outlet of the Y-tube”).
However, Belmonte is silent on the flow rate of the gas.
Situ discloses a method of using an esthesiometer. Specifically, Situ teaches wherein the jet or puff of gas is applied towards a corneal surface with a flow rate of 200 ml / minute ([0019]: “the system 10 may be capable under the control of a controller 20 of providing controlled air flow rates ranging from 0 ml/min to 200 ml/min. Suitable pneumatic esthesiometers, also known as Belmonte esthesiometers or gas esthesiometers, are well-known to those skilled in the art”). Belmonte and Situ are analogous art as they are both related to methods of using esthesiometers.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the flow rate of the gas from Situ into the device from Belmonte as Belmonte is silent on the flow rate, and Situ discloses a suitable flow rate in an analogous device.
The Belmonte/Situ combination teaches while maintaining a separation distance between the gas outlet nozzle and the corneal surface equal to or greater than 1 mm (Belmonte, Page 3: “One of the valve outlets was connected to a 0.5 mm diameter silicone tube and taken to a universal lens holder for graduation tests. The end of this tube was placed in the center of the lens holder by means of a stereoscopic vision lens, placing it perpendicularly to the center of the cornea and at a distance of 8-10 mm from the corneal surface”), in order to produce a transient decrease in pH of a tear film that covers the cornea, due to immediate formation of carbonic acid resulting from an interaction in the tear of the C02 with the H2O of the tear, which leads to a release of protons that stimulate nerve endings of polymodal nociceptors of the corneal surface, this chemical stimulation, combined with mechanical and cold stimulation evoked by the gas jet or puff, leading to a maximal reflex tear secretion, whose magnitude can be measured by conventional techniques for tear flow measurement used in Ophthalmology and Optometry for diagnosis of tear secretion disturbances (This limitation is an intended effect, therefore since the method from Belmonte describes a method with the same steps as the claimed invention, it is deemed capable of providing this intended effect.).
Regarding claim 3, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 1, wherein the content of the gas used comprises a percentage of 99% of CO2 (Belmonte, Abstract: “The method comprises: (a) applying to the cornea or conjunctiva of the eye, whose sensitivity is to be determined, a flow of gas which contains CO2 and air in variable concentrations”; Page 3: “Mixtures of C0 .sub.2 contained in separate containers in 8 individuals were used. Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”. This limitation describes the gas mixture having a CO2 concentration of 98.5%, which can be interpreted as teaching on the gas mixture being 99% CO2, the prior art limitation is close enough such that one skilled in the art would have expected them to have the same properties (MPEP 2144.05(i).; Alternatively, Belmonte teaches that the concentrations are subject to change. The CO2 concentration would depend upon the desired effect. As such, the CO2 concentration is a results-effective variable that would have been optimized through routine experimentation based on the desired effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the CO2 concentration so as to obtain the desired effect. Alternatively, the 98.5% concentration of CO2 is considered to be interpretated to be 99% concentration by interpreting the term by conventional rounding up for more convenient reference).
Regarding claim 5, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 1, wherein the jet or puff of gas is a puff of a short duration applied in the direction of the corneal surface for a preset time comprised between 2 and 6 seconds (Belmonte, Page 3: “Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”).
Regarding claim 6, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 1, wherein the separation distance is equal to or greater than 10 mm (Belmonte, Page 3: “One of the valve outlets was connected to a 0.5 mm diameter silicone tube and taken to a universal lens holder for graduation tests. The end of this tube was placed in the center of the lens holder by means of a stereoscopic vision lens, placing it perpendicularly to the center of the cornea and at a distance of 8-10 mm from the corneal surface”).
Regarding claim 29, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 5, wherein the preset time is 4 seconds (Belmonte, Page 3: “Gas flows continuously through this outlet except when the electronic valve momentarily changes the direction of flow to the surface of the cornea, for a pre-established period of time (0.1-10 s)”).
Regarding claim 31, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 1.
However, the Belmonte/Situ combination does not teach wherein the tear secretion disturbances comprise dry eye disease.
Situ teaches wherein the tear secretion disturbances comprise dry eye disease ([0004]: “Accumulating evidence suggests that adaptation and sensitization of the sensory system play an important role in contact lens-induced discomfort and dryness”: [0016]: “a hypothesis is depicted that the main sensory cause of contact lens-induced symptoms of dryness and discomfort is an imbalance of the sensory response. A test of the hypothesis is to determine whether a difference in the balance between sensitization and adaptation occurs in symptomatic and asymptomatic contact lens wearers. The present disclosure studied a symptomatic group and an asymptomatic group and determined that they generally exhibited different sensory responses to a cooling mechanical stimulus as well as the ability to adapt to repetitive cooling mechanical stimuli”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include evaluating dry eye disease from Situ into the Belmonte/Situ combination as the combination is silent on the specific diseases being evaluated, and Situ discloses a suitable disease in an analogous device.
Regarding claim 39, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 31, wherein the content of the gas used comprises a percentage of 99% of CO2 (Belmonte, Abstract: “The method comprises: (a) applying to the cornea or conjunctiva of the eye, whose sensitivity is to be determined, a flow of gas which contains CO2 and air in variable concentrations”; Page 3: “Mixtures of C0 .sub.2 contained in separate containers in 8 individuals were used. Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”. This limitation describes the gas mixture having a CO2 concentration of 98.5%, which can be interpreted as teaching on the gas mixture being 99% CO2, the prior art limitation is close enough such that one skilled in the art would have expected them to have the same properties (MPEP 2144.05(i).; Alternatively, Belmonte teaches that the concentrations are subject to change. The CO2 concentration would depend upon the desired effect. As such, the CO2 concentration is a results-effective variable that would have been optimized through routine experimentation based on the desired effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the CO2 concentration so as to obtain the desired effect. Alternatively, the 98.5% concentration of CO2 is considered to be interpretated to be 99% concentration by interpreting the term by conventional rounding up for more convenient reference).
Regarding claim 40, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 31, wherein the jet or puff of gas is a puff of a short duration applied in the direction of the corneal surface for a preset time comprised between 2 and 6 seconds (Belmonte, Page 3: “Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”).
Regarding claim 41, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 31, wherein the separation distance is equal to or greater than 10 mm (Belmonte, Page 3: “One of the valve outlets was connected to a 0.5 mm diameter silicone tube and taken to a universal lens holder for graduation tests. The end of this tube was placed in the center of the lens holder by means of a stereoscopic vision lens, placing it perpendicularly to the center of the cornea and at a distance of 8-10 mm from the corneal surface”).
Regarding claim 42, the Belmonte/Situ combination teaches the method for generating a reflex tear secretion according to claim 40, wherein the preset time is 4 seconds (Belmonte, Page 3: “Gas flows continuously through this outlet except when the electronic valve momentarily changes the direction of flow to the surface of the cornea, for a pre-established period of time (0.1-10 s)”).
Claims 2 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over the Belmonte/Situ combination as applied to claim 1 above, and further in view of Buisan (EP 3583889).
Regarding claim 2, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 1.
However, the Belmonte/Situ combination is silent on the pressure of the gas.
Buisan teaches a handheld aesthesiometer. Specifically, Buisan teaches wherein an outlet pressure of the jet or puff of gas applied towards the corneal surface is higher than atmospheric pressure ([0036]: “the pressure of the gas 3 can be approximately 5-7 bar.” Atmospheric pressure is approximately 1 bar, therefore a pressure of 5-7 bar is higher than atmospheric pressure.). Belmonte, Situ, and Buisan are analogous art as they are both related to methods of using esthesiometers.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure from Buisan into the method from the Belmonte/Situ combination as the combination is silent to the pressure used, and Buisan discloses a suitable pressure in an analogous device.
Regarding claim 38, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 31.
However, the Belmonte/Situ combination is silent on the pressure of the gas.
Buisan teaches wherein an outlet pressure of the jet or puff of gas applied towards the corneal surface is higher than atmospheric pressure ([0036]: “the pressure of the gas 3 can be approximately 5-7 bar.” Atmospheric pressure is approximately 1 bar, therefore a pressure of 5-7 bar is higher than atmospheric pressure.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure from Buisan into the method from the Belmonte/Situ combination as the combination is silent to the pressure used, and Buisan discloses a suitable pressure in an analogous device.
Claims 30, 34-37, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over the Belmonte/Situ combination as applied to claim 1 above, and further in view of Huth (US 20080273171).
Regarding claim 30, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 1.
However, the Belmonte/Situ combination does not teach what conventional techniques can be used.
Huth teaches methods for measuring tear film and diagnosing tear disorders. Specifically, Huth teaches wherein the conventional techniques comprises a Schirmer test ([0011]: “The Schirmer test measures the amount of aqueous tears that can be produced by the eye in 5 minutes. If too little aqueous tears are produced, this is indicative of an aqueous deficient dry eye. If enough tears are produced, but symptoms of dry eye exist, this is indicative of an evaporative dry eye for example due to a lipid deficiency, blepharitis or Rosacea. In the Schirmer test, a 35 mm.times.5 mm filter paper strip is placed into the lower cul-de-sac of the eye and allowed to wet over its length over 5 minutes. Schirmer tests are performed without and with prior application of an anesthetic eyedrop. When an anesthetic eyedrop is not used, the test is considered to measure basal+reflex tear secretion. When an anesthetic eyedrop is used, the test is considered to measure only basal tear secretion.”). Belmonte, Situ, and Huth are analogous art as they are all related to the same field of endeavor of evaluating a user’s eye and determining possible conditions.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the conventional techniques including a Schirmer test from Huth into the Belmonte/Situ combination as the combination is silent on what conventional techniques are used, and Huth discloses a suitable technique in an analogous device.
Regarding claim 34, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 30, wherein the content of the gas used comprises a percentage of 99% of CO2 (Belmonte, Abstract: “The method comprises: (a) applying to the cornea or conjunctiva of the eye, whose sensitivity is to be determined, a flow of gas which contains CO2 and air in variable concentrations”; Page 3: “Mixtures of C0 .sub.2 contained in separate containers in 8 individuals were used. Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”. This limitation describes the gas mixture having a CO2 concentration of 98.5%, which can be interpreted as teaching on the gas mixture being 99% CO2, the prior art limitation is close enough such that one skilled in the art would have expected them to have the same properties (MPEP 2144.05(i).; Alternatively, Belmonte teaches that the concentrations are subject to change. The CO2 concentration would depend upon the desired effect. As such, the CO2 concentration is a results-effective variable that would have been optimized through routine experimentation based on the desired effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the CO2 concentration so as to obtain the desired effect. Alternatively, the 98.5% concentration of CO2 is considered to be interpretated to be 99% concentration by interpreting the term by conventional rounding up for more convenient reference).
Regarding claim 35, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 30, wherein the jet or puff of gas is a puff of a short duration applied in the direction of the corneal surface for a preset time comprised between 2 and 6 seconds (Belmonte, Page 3: “Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”).
Regarding claim 36, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 30, wherein the separation distance is equal to or greater than 10 mm (Belmonte, Page 3: “One of the valve outlets was connected to a 0.5 mm diameter silicone tube and taken to a universal lens holder for graduation tests. The end of this tube was placed in the center of the lens holder by means of a stereoscopic vision lens, placing it perpendicularly to the center of the cornea and at a distance of 8-10 mm from the corneal surface”).
Regarding claim 37, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 35, wherein the preset time is 4 seconds (Belmonte, Page 3: “Gas flows continuously through this outlet except when the electronic valve momentarily changes the direction of flow to the surface of the cornea, for a pre-established period of time (0.1-10 s)”).
Regarding claim 48, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 30.
However, the Belmonte/Situ combination does not teach wherein the tear secretion disturbances comprise dry eye disease.
Situ teaches wherein the tear secretion disturbances comprise dry eye disease ([0004]: “Accumulating evidence suggests that adaptation and sensitization of the sensory system play an important role in contact lens-induced discomfort and dryness”: [0016]: “a hypothesis is depicted that the main sensory cause of contact lens-induced symptoms of dryness and discomfort is an imbalance of the sensory response. A test of the hypothesis is to determine whether a difference in the balance between sensitization and adaptation occurs in symptomatic and asymptomatic contact lens wearers. The present disclosure studied a symptomatic group and an asymptomatic group and determined that they generally exhibited different sensory responses to a cooling mechanical stimulus as well as the ability to adapt to repetitive cooling mechanical stimuli”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include evaluating dry eye disease from Situ into the Belmonte/Situ combination as the combination is silent on the specific diseases being evaluated, and Situ discloses a suitable disease in an analogous device.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over the Belmonte/Situ/Huth combination as applied to claim 30 above, and further in view of Buisan.
Regarding claim 33, the Belmonte/Situ/Huth combination teaches the method for generating the reflex tear secretion according to claim 30.
However, the Belmonte/Situ/Huth combination is silent on the pressure of the gas.
Buisan teaches wherein an outlet pressure of the jet or puff of gas applied towards the corneal surface is higher than atmospheric pressure ([0036]: “the pressure of the gas 3 can be approximately 5-7 bar.” Atmospheric pressure is approximately 1 bar, therefore a pressure of 5-7 bar is higher than atmospheric pressure.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure from Buisan into the method from the Belmonte/Situ/Huth combination as the combination is silent to the pressure used, and Buisan discloses a suitable pressure in an analogous device.
Claims 32 and 44-47are rejected under 35 U.S.C. 103 as being unpatentable over the Belmonte/Situ combination as applied to claim 1 above, and further in view of Kinoshita (US 20070282012).
Regarding claim 32, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 1.
However, the Belmonte/Situ combination does not teach wherein the tear secretion disturbances comprise Sjögren syndrome.
Kinoshita discloses methods for evaluating dry eyes of a user. Specifically, Kinoshita teaches wherein the tear secretion disturbances comprise Sjögren syndrome ([0070]: “The "dry eye" herein is defined as "a disorder of cornea and conjunctiva epithelium, which is caused by qualitative and quantitative abnormalities of the tear (film)" … The former includes Sjogren syndrome”). Belmonte, Situ, and Kinoshita are analogous art as they are all related to the same field of endeavor of evaluating a user’s eye and determining possible conditions.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include evaluating Sjögren syndrome from Kinoshita into the Belmonte/Situ combination as the combination is silent on the specific diseases being evaluated, and Kinoshita discloses a suitable disease in an analogous device.
Regarding claim 44, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 32, wherein the content of the gas used comprises a percentage of 99% of CO2 (Belmonte, Abstract: “The method comprises: (a) applying to the cornea or conjunctiva of the eye, whose sensitivity is to be determined, a flow of gas which contains CO2 and air in variable concentrations”; Page 3: “Mixtures of C0 .sub.2 contained in separate containers in 8 individuals were used. Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”. This limitation describes the gas mixture having a CO2 concentration of 98.5%, which can be interpreted as teaching on the gas mixture being 99% CO2, the prior art limitation is close enough such that one skilled in the art would have expected them to have the same properties (MPEP 2144.05(i).; Alternatively, Belmonte teaches that the concentrations are subject to change. The CO2 concentration would depend upon the desired effect. As such, the CO2 concentration is a results-effective variable that would have been optimized through routine experimentation based on the desired effect. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the CO2 concentration so as to obtain the desired effect. Alternatively, the 98.5% concentration of CO2 is considered to be interpretated to be 99% concentration by interpreting the term by conventional rounding up for more convenient reference).
Regarding claim 45, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 32, wherein the jet or puff of gas is a puff of a short duration applied in the direction of the corneal surface for a preset time comprised between 2 and 6 seconds (Belmonte, Page 3: “Pulses of 3 seconds duration and increasing concentrations (0, 35, 50, 65, 80 and 98.5%) were sequentially applied at the cornea at 1 minute intervals with the gas flow adjusted 0.5 mg below of the ecological threshold.”).
Regarding claim 46, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 32, wherein the separation distance is equal to or greater than 10 mm (Belmonte, Page 3: “One of the valve outlets was connected to a 0.5 mm diameter silicone tube and taken to a universal lens holder for graduation tests. The end of this tube was placed in the center of the lens holder by means of a stereoscopic vision lens, placing it perpendicularly to the center of the cornea and at a distance of 8-10 mm from the corneal surface”).
Regarding claim 47, the Belmonte/Situ/Huth combination teaches the method for generating a reflex tear secretion according to claim 45, wherein the preset time is 4 seconds (Belmonte, Page 3: “Gas flows continuously through this outlet except when the electronic valve momentarily changes the direction of flow to the surface of the cornea, for a pre-established period of time (0.1-10 s)”).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over the Belmonte/Situ/Kinoshita combination as applied to claim 32 above, and further in view of Buisan.
Regarding claim 43, the Belmonte/Situ combination teaches the method for generating the reflex tear secretion according to claim 32.
However, the Belmonte/Situ/Kinoshita combination is silent on the pressure of the gas.
Buisan teaches wherein an outlet pressure of the jet or puff of gas applied towards the corneal surface is higher than atmospheric pressure ([0036]: “the pressure of the gas 3 can be approximately 5-7 bar.” Atmospheric pressure is approximately 1 bar, therefore a pressure of 5-7 bar is higher than atmospheric pressure.). Belmonte, Situ, and Buisan are analogous art as they are both related to methods of using esthesiometers.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure from Buisan into the method from the Belmonte/Situ/Kinoshita combination as the combination is silent to the pressure used, and Buisan discloses a suitable pressure in an analogous device.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over the Belmonte/Situ/Huth combination as applied to claim 30 above, and further in view of Kinoshita.
Regarding claim 49, the Belmonte/Situ/Huth combination teaches the method for generating the reflex tear secretion according to claim 30.
However, the Belmonte/Situ/Huth combination does not teach wherein the tear secretion disturbances comprise Sjögren syndrome.
Kinoshita teaches wherein the tear secretion disturbances comprise Sjögren syndrome ([0070]: “The "dry eye" herein is defined as "a disorder of cornea and conjunctiva epithelium, which is caused by qualitative and quantitative abnormalities of the tear (film)" … The former includes Sjogren syndrome”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include evaluating Sjögren syndrome from Kinoshita into the Belmonte/Situ/Huth combination as the combination is silent on the specific diseases being evaluated, and Kinoshita discloses a suitable disease in an analogous device.
Response to Arguments
Applicant has amended the claims to overcome the claim objections and 112(b) rejections, however the newly added claim 49 has introduced a new claim objection.
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive. Applicant argues that Belmonte does not teach the claimed method, as Belmonte does not explicitly state it is intended to be sued to induce maximal reflex tear secretion. However, Belmonte discloses all the same steps as the method, except of the flow rate which is taught by Situ, therefore Belmonte is capable of performing the method for inducing a maximal reflex tear secretion, and therefore teaches on the claims, making this argument unpersuasive.
Applicant additionally argues that Belmonte does not disclose applying 99% CO2 gas to the human subject. However, as stated in the 103 rejection above, Belmonte does disclose this limitation, as this concentration is the gas that is applied during the test (Belmonte, Page 3: “In one part of the studies on human sensations, the same calibrated mixtures of gases used in animal experiments were used (0, 35, 50, 65, 80 and 98.5%). In another group of experiments, it they obtained varying concentrations of C0 2 by mixing the contents of two tanks filled with 98.5% C0 2 and air.”), therefore this argument is not persuasive. Applicant cites the limitation stating in another group of experiments as saying the CO2 was mixed with air and therefore is not the 98.5% concentration applied to the eye, however as emphasized here, that is another group of experiments separate from the first part of the studies on humans, which uses the 98.5% CO2 mixture.
Applicant additionally argues that Belmonte does not disclose performing the technique on humans, however as stated in the 103 rejection above, the experiments were also performed on humans, therefore this argument is not persuasive (Belmonte, Page 3: “In one part of the studies on human sensations, the same calibrated mixtures of gases used in animal experiments were used (0, 35, 50, 65, 80 and 98.5%).).
Applicant’s arguments with respect to the flow rate 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.
The Declaration by Dr. Martinez is not persuasive. Although the explanation of the experiments were helpful in understanding the invention, the Declaration did not provide a basis for distinguishing the method that is obvious from prior art from the invention as currently claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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