DETAILED ACTION
This action is pursuant to claims filed on 11/03/2025. Claims 1-25 and 28-29 are pending. A first action on the merits of claims 1-25 and 28-29 is as follows.
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 .
Election/Restrictions
Claims 7-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claim Objections
Claims 1-6 and 28-29are objected to because of the following informalities:
In claim 1, line 3, “the cornea” should read “a cornea”, as there is a lack of antecedent basis
In claim 2, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
In claim 3, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
In claim 4, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
In claim 5, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
In claim 6, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
In claim 6, lines 2-3, “according to claim 1, the separation” should read “according to claim 1, wherein the separation”
In claim 28, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
In claim 29, lines 1-2, “a reflex tear secretion” should read “the reflex tear secretion”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 28-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation “conventional techniques” in line 12. “Conventional techniques” is a relative term, therefore it is unclear what constitutes as a conventional technique. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any type of technique that can be considered conventional will teach on this limitation. Claims 2-6 and 28-29 are also rejected due to their dependence on claim 1.
Further regarding claim 1, the claim recites the limitation “especially for dry eye disease” in lines 13-14. The use of the word “especially” makes it unclear if this method is required to be used for dry eye disease, or if that is optional. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as not being required for use with dry eye disease. Claims 2-6 and 28-29 are also rejected due to their dependence on claim 1.
Regarding claim 29, the claim recites the limitation “a preset time” in line 3. It is unclear if this is meant to refer to the preset from claim 5, line 3, or a different preset time. If it is referring to the preset time from claim 5, it needs to refer back to it. If it is referring to a different preset time, it needs to be distinguished from the preset time from claim 5. For purposes of examination, it is being interpreted as referring to the preset time from claim 5.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, and 29 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Belmonte (WO 9412104). 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 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 the cornea of the an eye of a subject by applying to towards the said cornea a controlled jet or puff of a gas mixture with a CO2 content of at least 99% CO2 (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) 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”) while maintaining a separation distance between the gas outlet nozzle and a corneal surface equal to or greater than 1 mm (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 CO2 with the H20 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, especially for dry eye disease (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, Belmonte 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 (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, Belmonte 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 (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, Belmonte 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 (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, Belmonte teaches the method for generating a reflex tear secretion according to claim 5, 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 of 4 seconds (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, 4, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Belmonte as applied to claim 1 above, and further in view of Buisan (EP 3583889).
Regarding claim 2, Belmonte teaches the method for generating a reflex tear secretion according to claim 1.
However, Belmonte 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 and Buisan are analogous arts as they are both devices that provide a puff of air to a user’s cornea to test their eye.
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 Belmonte as Belmonte is silent to the pressure used, and Buisan discloses a suitable pressure in an analogous device.
Regarding claim 4, Belmonte teaches the method for generating a reflex tear secretion according to claim 1.
However, Belmonte is silent on the flow rate of the gas.
Buisan teaches wherein the jet or puff of gas is applied towards the corneal surface with a flow rate equal to or greater than 150 ml / minute.
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 from Buisan into the method from Belmonte as Belmonte is silent on the flow rate, and Buisan discloses a suitable flow rate in an analogous device.
Regarding claim 28, the Belmonte/Buisan combination teaches the method for generating a reflex tear secretion according to claim 4, wherein the flow rate is 200 ml / minute (Buisan, Table 1 shows flow rates ranging from 102 ml/min-410 ml/min).
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791