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 .
Election/Restrictions
The Applicant's election with traverse of species A1 (FIGS. 3-4) and B2 (the light source comprises a light element and a collimating lens) in the reply filed on 4/22/2026 is acknowledged. The Applicant traverses on the following grounds.
First, with respect to the election of the first group of species, the Applicant asserts that the Office failed to provide a description of the mutually exclusive characteristics of each species or grouping of species. This is not found persuasive. The names of the species A1-G1 themselves provide the description of the mutually exclusive characteristics. For example, species A1 is drawn to the embodiment of FIGS. 3-4 with a one-dimensional, linear sensor array which is simply not the same as, for example, the species B1 drawn to the embodiment of FIG. 5 with a one-dimensional, linear sensor array; the species C1 drawn to the embodiment of FIG. 5 with the two-dimensional, linear sensor array; the species D1 drawn to the embodiment of FIG. 6 with a one-dimensional, linear sensor array; the species E1 drawn to the embodiment of FIG. 7 with a one-dimensional, linear sensor array; the species F1 drawn to the embodiment of FIG. 7 with a two-dimensional, linear sensor array; or the species G1drawn to the embodiment of FIG. 8 with a two-dimensional, linear sensor array. The same is true for each species of the first group relative to others. The listing of the figures along with their respective sensor arrays are the description of the mutually exclusive characteristics.
Second, with respect to the election of the first group of species, the Applicant asserts that “one-dimensional, linear sensor array” is generic to a “two-dimensional, linear sensor array.” In particular, the Applicant asserts that a “two-dimensional, linear sensor array” consists of multiple "one-dimensional, linear sensor array[s]”. This is not found persuasive. Two dimensions are different from one dimension and, by definition, mutually exclusive. If an array is one-dimensional, it is precluded from being two dimensional. If an array is two dimensional, it is precluded from being one-dimensional.
Third, with respect to the election of the first group of species, the Applicant asserts:
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This is not found persuasive. Just because all the species have some features in common does not negate the fact that there are different structural differences that will need to be searched and examined with respect to the statutory requirements of 35 USC 112, 101, 102, and 103. Also, the species have physical attributes that are different from each other. The searching for each species will involve different strategies and search terms because different terms are necessarily used to describe different physical attributes. Searching for one set of physical attributes using one set of search terms would not necessarily involve or encompass a different set of physical attributes that is described with different terms. Furthermore, the examination process is made burdensome by the analysis of multiple structures with respect to the statutory requirements of 35 USC 112, 101, 102, and 103.
Fourth, with respect to the election of the first group of species, the Applicant asserts claims 2-20 are generic or read on the elected species. This is not persuasive. For example, claims 6-7 and 13 do not read on the elected species A1 and are not generic.
Fifth, with respect to the election of the second group of species, the Applicant asserts that the Office fails to "provide a description of the mutually exclusive characteristics of each species or grouping of species. This is not found persuasive. The names of the species A2-C2 themselves provide the description of the mutually exclusive characteristics. For example, species B2 is drawn to the embodiment with the light source comprising a light element and a collimating lens configured to collimate the beam of light along at least one axis which is simply not the same as, for example, the species A2 drawn to the embodiment with a laser light source or the species C1 with the collimating lens is disposed adjacent to the linear optical sensor. The same is true for each species of the second group relative to others. The listing of the species are, by their very nature, the description of the mutually exclusive characteristics.
Sixth, with respect to the election of the second group of species, the Applicant asserts:
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This is not found persuasive. Just because all the species have some features in common does not negate the fact that there are different structural differences that will need to be searched and examined with respect to the statutory requirements of 35 USC 112, 101, 102, and 103. Also, the species have physical attributes that are different from each other. The searching for each species will involve different strategies and search terms because different terms are necessarily used to describe different physical attributes. Searching for one set of physical attributes using one set of search terms would not necessarily involve or encompass a different set of physical attributes that is described with different terms. Furthermore, the examination process is made burdensome by the analysis of multiple structures with respect to the statutory requirements of 35 USC 112, 101, 102, and 103.
Seventh, with respect to the election of the second group of species, the Applicant asserts claims 2-20 are generic or read on the elected species. This is not persuasive. For example, claim 4-5 do not read on the elected species B2 and are not generic.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the drug delivery module of claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The drug delivery module 140 is interpreted to be a dispensing nozzle for producing a stream or mist of a pharmaceutical agent (paragraph 0044 of the specification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 8 is objected to because of the following informalities:
in claim 8, line 6: “an intraocular pressure” should be “the intraocular pressure”.
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 3, 14, and 18-19 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.
Claim 3 recites “along at least one axis” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a first axis” of claim 1, lines 4-5 or “a second axis” of claim 1, line 7. Clarification is required.
Claim 14 recites “the visible spectrum” in which there is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites “the determining the timing of the applanation of the cornea” in lines 1-2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “a first period of time” in line 3 and “a second time” in line 6, but it is not clear if either of these recitations is the same as, related to, or different from “a period of time” of claim 16, line 4. Clarification is required.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 3,304,769 (Stauffer).
With respect to claim 1, Stauffer teaches a system for determining an intraocular pressure (IOP) of an eye, the system comprising:
a pump (the air-puff generator 46 of Stauffer) configured to generate a puff of air;
a nozzle (the air passage 44 of Stauffer) in communication with the pump and configured to direct the puff of air along a first axis toward the eye;
a light source (the lamp 8, the condensing lens 14, and the optical prism 16 of Stauffer) disposed distal of the nozzle and directed to emit a beam of light toward a first linear optical sensor (the second prism 20, the focusing lens system 26, the first aperture 28, the second aperture 36, the lens 38, and the photo-multiplier tube 40 of Stauffer) along a second axis transverse to the first axis (see FIG. 1 of Stauffer),
wherein the beam of light comprises a width in the first axis such that a first portion of the beam of light illuminates a lateral surface of the eye and a second portion of the beam of light passes in front of the eye (col. 2, lines 9-65 and col. 3, lines 30-50 of Stauffer); and
the first linear optical sensor (the second prism 20, the focusing lens system 26, the first aperture 28, the second aperture 36, the lens 38, and the photo-multiplier tube 40 of Stauffer) disposed distal of the nozzle and configured to receive the second portion of the beam of light (see FIG. 1 of Stauffer).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 8, and 14-18 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 CN 106901688 (Shao). Citations to Shao will refer to the machine English translation that accompanies this Office Action.
Shao teaches a system for determining an intraocular pressure (IOP) of an eye, the system comprising: a pump (the air pump 111 for the pressing unit 100 along the direction A1 of Shao) configured to generate a puff of air; a nozzle (the gas nozzle 117 in the pressing unit 100 along the direction A1 of Shao) in communication with the pump and configured to direct the puff of air along a first axis toward the eye; a light source (the light source 120 along the direction A2 of Shao), and a first linear optical sensor (the imaging sensing unit 130 along the direction A3 of Shao)(see FIGS. 1-2 of Shao). Shao also teaches that the first direction A1 can range from 0 degrees to 90 degrees from the normal of the target surface 52 (page 5 of Shao), the angle between the first direction A1 and the second direction A2 ranges between 90 degrees to 0 degrees (page 5 of Shao), the angle between the first operation A1 and the third direction A3 ranges between 90 degrees to 0 degrees (page 5 of Shao), and the angle between the second direction A2 and the third direction operation A3 ranges between 180 degrees to 0 degrees (page 5 of Shao). Thus, given the values of the angles in which the first direction A1 is 90 degrees from the normal of the target surface 52, the angle between the first direction A1 and the second direction A2 is 90 degrees, the angle between the first operation A1 and the third direction A3 is 90 degrees, and the angle between the second direction A2 and the third direction operation A3 ranges between 180 degrees to 0 degrees, Shao anticipates that the claimed second axis (the second direction A2 and the third direction A3 of Shao) is transverse to the claimed first axis (the first direction A1 of Shao). Further, the illumination and detection of the light is of a spread-out nature and designed to hit a portion of eye (see FIG. 3A of Shao and the light spot 60) such that, given the values of the angles in which the first direction A1 is 90 degrees from the normal of the target surface 52, the angle between the first direction A1 and the second direction A2 is 90 degrees, the angle between the first operation A1 and the third direction A3 is 90 degrees, and the angle between the second direction A2 and the third direction operation A3 ranges between 180 degrees to 0 degrees, Shao anticipates that the second claimed axis (the second direction A2 and the third direction A3 of Shao) would result in a first portion of the beam of light illuminates a lateral surface of the eye and a second portion of the beam of light passes in front of the eye.
Alternatively, Shao teaches that the first direction A1 can range from 0 degrees to 90 degrees from the normal of the target surface 52 (page 5 of Shao), the angle between the first direction A1 and the second direction A2 ranges between 90 degrees to 0 degrees (page 5 of Shao), the angle between the first operation A1 and the third direction A3 ranges between 90 degrees to 0 degrees (page 5 of Shao), and the angle between the second direction A2 and the third direction operation A3 ranges between 180 degrees to 0 degrees (page 5 of Shao). This suggests that the positions of the pressing unit 100, the direction A1, the light source 120, the direction A2, the imaging sensing unit 130, and the direction A3 are subject to change based on desired results, operation, and spacing requirements. As such, the positions of the pressing unit 100, the direction A1, the light source 120, the direction A2, the imaging sensing unit 130, and the direction A3 are results-effective variables that would have been optimized through routine experimentation based on the desired results, operation, and spacing requirements. 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 positions of the pressing unit 100, the direction A1, the light source 120, the direction A2, the imaging sensing unit 130, and the direction A3 so as to obtain the desired results, operation, and spacing requirements. Thus, the features of “a second axis transverse to the first axis” and “wherein the beam of light comprises a width in the first axis such that a first portion of the beam of light illuminates a lateral surface of the eye and a second portion of the beam of light passes in front of the eye” would have been obvious.
With respect to claim 1, Shao teaches or suggests a system for determining an intraocular pressure (IOP) of an eye, the system comprising:
a pump (the air pump 111 of Shao) configured to generate a puff of air;
a nozzle (the gas nozzle 117 of Shao) in communication with the pump and configured to direct the puff of air along a first axis (the direction A1 of Shao) toward the eye;
a light source (the light source 120 of Shao) disposed distal of the nozzle and directed to emit a beam of light toward a first linear optical sensor (the imaging sensing unit 130 of Shao) along a second axis transverse to the first axis (the directions A2 and A3 of Shao),
wherein the beam of light comprises a width in the first axis such that a first portion of the beam of light illuminates a lateral surface of the eye and a second portion of the beam of light passes in front of the eye (see the above anticipatory and obviousness analyses with respect to this feature); and
the first linear optical sensor (the imaging sensing unit 130 of Shao) disposed distal of the nozzle and configured to receive the second portion of the beam of light (see the above anticipatory and obviousness analyses which would result in this feature).
With respect to claim 2, Shao teaches or suggests that the first linear optical sensor comprises a linear array of sensor elements disposed along a third axis (the imaging sensing unit 130 comprises a one-dimensional CCD; pages 6-7 of Shao).
With respect to claim 8, Shao teaches or suggests a processor (the processing unit 150 of Shao) configured to: receive, from the first linear optical sensor, a first plurality of displacement measurements obtained over a first period of time (the processing unit 150 receiving the measurements; pages 3, 5, and 7-8 of Shao); and determine, based on the first plurality of displacement measurements and the first period of time, an intraocular pressure of the eye (the processing unit 150 determining IOP; pages 3, 5, 7-8, and 12 of Shao).
With respect to claim 14, Shao teaches or suggests that the light source is configured to emit light having a center wavelength in the visible spectrum (the visible spectrum by the light source 120 of Shao; page 6 of Shao).
With respect to claim 15, Shao teaches or suggests a method for measuring intraocular pressure (IOP) of an eye of a patient, comprising:
generating a puff of air directed in a first axis (the direction A1 of Shao) toward a cornea of the eye, wherein the puff of air comprises a pressure (using the air pump 111 of Shao; pages 3, 5, 7-8, and 12 of Shao);
emitting, by a light source, a beam of light (using the light source 120 of Shao; pages 3, 5, 7-8, and 12 of Shao) toward a first optical sensor array along a second axis (the directions A2 and A3 of Shao) transverse to the first axis, wherein the beam of light comprises a width in the first axis such that a first portion of the beam of light illuminates a lateral surface of the eye and a second portion of the beam of light passes in front of the eye (see the above anticipatory and obviousness analyses with respect to this feature);
detecting, by the first optical sensor array, a width of the second portion of the beam of light (using the imaging sensing unit 130 of Shao; pages 3, 5, 7-8, and 12 of Shao); and
determining, based on the detected width of the second portion of the beam of light and the pressure of the puff of air, the IOP of the eye (determining IOP using the spot size and shape measurements; pages 3, 5, 7-8, and 12 of Shao).
With respect to claim 16, Shao teaches or suggests that the detecting the width of the second portion of the beam of light comprises: receiving, from the first optical sensor array, a first plurality of displacement measurements over a period of time (using the imaging sensing unit 130 of Shao; pages 3, 5, 7-8, and 12 of Shao); and wherein the determining the IOP is based on the first plurality of displacement measurements (determining IOP using the spot size and shape measurements; pages 3, 5, 7-8, and 12 of Shao).
With respect to claim 17, Shao teaches or suggests that the determining the IOP comprises: determining an applanation of the cornea; and wherein the determining the IOP is based on a timing of the applanation of the cornea (determining IOP using the spot size and shape measurements in time necessarily includes determining the applanation; pages 3, 5, 7-8, and 12 of Shao).
With respect to claim 18, Shao teaches or suggests that the determining the timing of the applanation of the cornea comprises determining a maximum displacement based on the first plurality of displacement measurements (determining IOP using the spot size and shape measurements in time necessarily includes determining any displacement; pages 3, 5, 7-8, and 12 of Shao).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Shao in view of U.S. Patent Application Publication No. 2018/0055358 (Nakajima). Citations to Shao will refer to the machine English translation that accompanies this Office Action.
Shao teaches or suggests that the first direction A1 is 90 degrees from the normal of the target surface 52, the angle between the first direction A1 and the second direction A2 is 90 degrees, the angle between the first operation A1 and the third direction A3 is 90 degrees, and the angle between the second direction A2 and the third direction operation A3 ranges between 180 degrees to 0 degrees. Nakajima teaches that a collimator lens 25 may be part of the light focusing aspects of the light source so as to better channel the light to a desired location (paragraphs 0050 and 0052 of Nakajima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a collimator lens 25 of Nakajima as part of the light source of Shao since it permits a better focus of light to desired location.
With respect to claim 3, the combination teaches or suggests that the light source comprises a light element (the light source 120 of Shao) and a collimating lens (the collimator lens 25 of Nakajima) configured to collimate the beam of light along at least one axis.
Claims 9 and 19 are is rejected under 35 U.S.C. 103 as being unpatentable over Shao in view of U.S. Patent Application Publication No. 2020/0300236 (Samakar). Citations to Shao will refer to the machine English translation that accompanies this Office Action.
Shao teaches or suggests the imaging sensing unit 130 comprises a one-dimensional CCD (pages 6-7 of Shao). Samakar teaches that a noncontact tonometer used for making IOP measurements can also be used for detecting when a patient has blinked and, once a blink is detected, the system triggers the pump to create a puff of air immediately following the blink for the IOP measurement (paragraphs 0041, 0046, and 0059 of Samakar). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the CCD camera of Shao and the control regime based on the patient’s blink of Samakar in the method and system of Shao since it discourages blinking from occurring during the IOP measurements.
With respect to claim 9, the combination teaches or suggests that the processor (the processing unit 150 of Shao as modified by Samakar) is further configured to: receive, from the first linear optical sensor, a second plurality of displacement measurements obtained over a second period of time preceding the first period of time (the readings from the CCD camera of Shao before the IOP measurements); detect, based on the second plurality of displacement measurements and the second period of time, a blink (the detection of the blink of Samakar); and cause the first linear optical sensor to obtain, based on detecting the blink, the first plurality of displacement measurements (performing the IOP measurements after the blink of Samakar).
With respect to claim 19, the combination teaches or suggests: receiving, from the first optical sensor array, a second plurality of displacement measurements obtained over a first period of time (the readings from the CCD camera of Shao before the IOP measurements); detecting, based on the second plurality of displacement measurements, a blink (the detection of the blink of Samakar); and causing the first optical sensor array to obtain, based on detecting the blink, the first plurality of displacement measurements at a second time subsequent to the first period of time (performing the IOP measurements after the blink of Samakar).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shao in view of U.S. Patent Application Publication No. 2021/0145278 (Von Bunau). Citations to Shao will refer to the machine English translation that accompanies this Office Action.
Shao teaches or suggests that the IOP measurements are used as indications to provide medicine and therapeutic treatments (page 12 of Shao). Von Bunau teaches a drug administration unit 322, 422 incorporated into an air-puff tonometer 300, 400 (FIGS. 3-4 of Von Bunau). The drug administration unit includes a control unit that controls the drug administration (paragraphs 0035, 0040-0041, 046-0047, 0054-0055, and 0069 of Von Bunau). The subsequent measurements and analyses may take into account the drug administration and monitoring adherence to the treatment plan and the effectiveness of the drugs and their dosages (paragraphs 0035 and 0069-0070, 0073, and 0076-0078 of Von Bunau). Shao also teaches the monitoring of the effectiveness of a treatment (page 8 of Shao). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a drug administration unit 322, 422, the control unit, and the subsequent analyses of Von Bunau and Shao in the air-puff tonometer of Shao since it provides effective treatments to the eye and permits the monitoring of the progress of the treatment.
With respect to claim 10, the combination teaches or suggests that a drug delivery module (the drug administration unit 322, 422 of Von Bunau) positioned and oriented to eject a stream of a pharmaceutical agent into the eye, wherein the processor is further configured to: cause the drug delivery module to eject the stream of the pharmaceutical agent into the eye (the control unit 322, 422 of Von Bunau); receive, from the first linear optical sensor, a third plurality of displacement measurements obtained over a third period of time (the subsequent monitoring of Von Bunau); and determine, based on the third plurality of displacement measurements whether the stream of the pharmaceutical agent reached the eye (the determining of effectiveness of the treatment of Von Bunau and Shao).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shao in view of WO 2006/066876 (Weber). Citations to Shao and Weber will refer to the machine English translations that accompany this Office Action.
Weber teaches a contactless tonometer comprising a detection device (131, 132, 133) which is used to automatically determine the position of the cornea of the eye and an alignment device (160) which automatically adjusts or actuates the measuring axis of the measuring system which is predefined or can be predefined in a vertical manner in relation to the cornea corresponding to the detection of the position (abstract of Weber). The detection system uses optical beams with a transmitter 131 and a receiver 132 that are processed by the measuring unit 150 to ensure proper alignment or positioning (pages 10-11 of Weber). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the optical sensor system and the processing unit for the optical sensor system of Weber in the system of Shao since it ensures proper alignment.
With respect to claim 11, the combination teaches or suggests a third optical sensor (the optical sensor system of Weber) directed toward the first axis, wherein the processor is configured to determine, based on a proximity measurement from the third optical sensor, whether the eye is disposed within measurement range of the nozzle (the processing unit of Weber performs an alignment determination).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Shao in view of U.S. Patent Application Publication No. 2024/0130615 (Gonzalez Garcia). Citations to Shao will refer to the machine English translation that accompanies this Office Action.
Shao teaches a first linear optical sensor in the form of a one-dimensional CCD or other photosensitive elements (pages 6-7 of Shao). Gonzalez Garcia teaches that an array of photodiodes are a suitable substitution for a CCD (paragraph 0026 of Gonzalez Garcia or paragraph 0028 of US Application No. 63/157028 from which Gonzalez Garcia claims priority). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a one-dimensional array of photodiodes in place of the one-dimensional CCD of Shao since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) Shao teaches that other photosensitive elements may be used and the optical sensor system and Gonzalez Garcia teaches such elements.
With respect to claim 12, the combination teaches or suggests that the first linear optical sensor comprises a one- dimensional array of photodiodes (the one-dimensional array of photodiodes of the combination).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shao in view of U.S. Patent Application Publication No. 2021/0022608 (Narkiss). Citations to Shao will refer to the machine English translation that accompanies this Office Action.
Narkiss teaches an air-puff pressure sensor in the nozzle of the tonometer so as to gauge the pressure applied to the eye and adjust the operational parameters if necessary or desired (paragraphs 0017, 0077, 0080, and 0088 of Narkiss). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an air-puff pressure sensor in the nozzle of the tonometer so as to gauge the pressure applied to the eye and adjust the operational parameters if necessary or desired.
With respect to claim 20, the combination teaches or suggests detecting, by a pressure sensor, the pressure of the puff of air (detecting the air-puff pressure using the pressure sensor of Narkiss).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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