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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/28/2024 and 4/24/2025 were received and placed in the record on file. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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:
“current application control unit” in claims 1-9
“detection sensor configured to detect a displaced amount of the actuator” in claims 3 and 6
“projecting optical system configured to project a luminous flux to the subject eye while the air is being sprayed from the nozzle to the subject eye” in claim 8
“receiving optical system configured to receive reflected light of the luminous flux reflected at the subject eye and outputs an applanation signal while the air is being sprayed from the nozzle to the subject eye” in claim 8
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.
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.
The identified claim limitations identified as invoking 35 USC 112(f) will be interpreted as follows:
“current application control unit…”: described in paragraph [0074] as any control device and may be configured as firmware, software, and hardware or combination thereof; or equivalents thereof.
“detection sensor configured to detect a displaced amount of the actuator” described in paragraph [0074] as an angle detection sensor (element 34i) which detects position of the actuator via rotation angle of solenoid 34g, or equivalents thereof
“projecting optical system configured to project a luminous flux to the subject eye while the air is being sprayed from the nozzle to the subject eye” described in paragraph [0047]-[0051] as the optical elements for projecting light onto the eye, or equivalents thereof
“receiving optical system configured to receive reflected light of the luminous flux reflected at the subject eye and outputs an applanation signal while the air is being sprayed from the nozzle to the subject eye” described in paragraphs [0054]-[0058] as the optical elements for receiving light and determining applanation of the eye, or equivalents thereof
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yano et al (US 5,107,851).
Regarding claims 1, 2 and 7-10; Yano discloses a contactless ophthalmotonometer, comprising:
a cylinder (elements 33);
a piston (elements 32) movably provided inside the cylinder (column 5, lines 38-44; figures 4 and 6);
an actuator (solenoid; element 31) configured to move the piston (elements 32) inside the cylinder (elements 33) with current applied to the actuator to compress air inside the cylinder with the piston (column 5, lines 38-44; figures 4 and 6);
a nozzle (element 34) in communication with the inside of the cylinder, the nozzle configured to spray the air compressed with the piston to a subject eye (column 5, lines 38-44; figures 4 and 6); and
a current application control unit (elements 54) configured to apply the current to the actuator (column 5, lines 1-28), wherein the current application control unit performs first application processing for applying the current of a first current value to the actuator and, when a predetermined switching condition is satisfied while the first application processing is being performed, the first application processing is switched to second application processing for applying the current of a second current value higher than the first current value to the actuator (wherein controller applies a first lower current application, and if applanation is not detecting in applied the pressure range, then system then switches so as to apply a second higher current application than the first to the solenoid in order to explore for applanation at a higher pressure range; column 5, lines 1-37, column 5, line 65 – column 6, line 51, column 7, lines 10-29; figures 3a-6).
Further regarding claim 2; Yano discloses the nozzle (element 34) is in communication with the inside of the cylinder through a chamber in communication with the inside of the cylinder (wherein element 33 can be identified as a cylinder part wherein the piston cannot reach [i.e. top portion of element 33] and a chamber part where the piston operates [lower portion of element 33]), the contactless ophthalmotonometer further comprises a pressure sensor (element 35) configured to detect pressure inside the chamber (column 5, lines 44-45), and the current application control unit determines whether the switching condition is satisfied or not based on whether the pressure detected by the pressure sensor achieves a predetermined pressure threshold (wherein MPU determines if the switching condition is satisfied if the a IOC is not within the lower measured pressure range [i.e. a predetermined pressure threshold being the upper bound of the range] and switches analog switch element 53 to apply a higher current to the solenoid element 1 to test with a higher pressure range; column 5, lines 1-37, column 5, line 65 – column 6, line 51, column 7, lines 10-29; figures 3a-6).
Further regarding claim 7; the current application control unit stops the second application processing when a defined period of time determined in advance passes from start of the first application processing (wherein the examiner notes Yano meets the BRI of stopping the second application a period of time determined in advance from the start of the first application processing in that Yano discloses the system automatically changes [step 103] and applies pressure at the higher pressure range using the MPU [step 104] and finishes the second application processing [step 106] when performed on a single eye, thus being the predetermined time it takes for the system to run the loop which is determined by the programming ahead of time).
Further regarding claim 8; Yano discloses a projecting optical system (combined element 45, 44, 39) configured to project a luminous flux to the subject eye while the air is being sprayed from the nozzle to the subject eye (column 5, lines 56-59); and a receiving optical system (combined elements 40, 46, 47) configured to receive reflected light of the luminous flux reflected at the subject eye and outputs an applanation signal while the air is being sprayed from the nozzle to the subject eye (column 5, line 59-63), wherein the current application control unit stops the second application processing when a peak of the applanation signal output from the receiving optical system is detected while the second application processing is being performed (wherein system stops applanation tests after a peak applanation signal is detected; column 6, lines 45-51 and column 7, lines 27-29).
Further regarding claim 9; Yano discloses the actuator (solenoid element 31) is a rotary actuator configured to cause the piston (element 32) to move inside the cylinder through a crank mechanism (element 2) (wherein examiner notes that although the 2nd embodiment in figures 4 and 6 does not show crank element 2, Yano discloses figure 3A as depicting the second embodiment, where figure 3a depicts the rotary solenoid element 1 which drives piston element 3 via crank element 2; see figure 3a).
Further regarding claim 10; Yano discloses a method for actuating a contactless ophthalmotonometer, the contactless ophthalmotonometer including:
a cylinder (elements 33);
a piston (elements 32) movably provided inside the cylinder (column 5, lines 38-44; figures 4 and 6);
an actuator (solenoid; element 31) configured to move the piston (elements 32) inside the cylinder (elements 33) with current applied to the actuator to compress air inside the cylinder with the piston (column 5, lines 38-44; figures 4 and 6);
a nozzle (element 34) in communication with the inside of the cylinder, the nozzle configured to spray the air compressed with the piston to a subject eye (column 5, lines 38-44; figures 4 and 6);
the method including:
performing first application processing for applying the current of a first current value to the actuator when the current is to be applied to the actuator (step of providing a first current value to the solenoid to apply a first lower pressure range; column 5, lines 1-37, column 5, line 65 – column 6, line 51, column 7, lines 10-29; figures 3a-6); and
switching the first application processing to second application processing for applying the current of a second current value higher than the first current value to the actuator when a predetermined switching condition is satisfied while the first application processing is being performed (step of switching to apply a second current value to the solenoid to apply a second higher pressure range when an applanation condition is not met in the lower applied pressure range; column 5, lines 1-37, column 5, line 65 – column 6, line 51, column 7, lines 10-29; figures 3a-6).
Claims 1, 3 and 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dobashi (US 2013/0331679 A1).
Regarding claims 1, 3 and 7-10; Dobashi discloses a contactless ophthalmotonometer, comprising:
a cylinder (element 43; figure 2);
a piston (element 40) movably provided inside the cylinder (paragraph [0045]; figure 2);
an actuator (element 42) configured to move the piston (element 40) inside the cylinder (element 43) with current applied to the actuator to compress air inside the cylinder with the piston (paragraphs [0045] and [0056]; figure 2);
a nozzle (element 22) in communication with the inside of the cylinder (via tube element 44), the nozzle configured to spray the air compressed with the piston to a subject eye (paragraph [0039]; figure 2); and
a current application control unit (elements 301 and 310) configured to apply the current to the actuator, wherein the current application control unit performs first application processing for applying the current of a first current value to the actuator and, when a predetermined switching condition is satisfied while the first application processing is being performed, the first application processing is switched to second application processing for applying the current of a second current value higher than the first current value to the actuator (wherein a minute current is applied to solenoid element 42 to move the piston element 40 to the desired starting position [i.e. predetermined switching condition] in step S100, and upon reaching the starting position, controller element 301 increases the solenoid drive current measure intraocular pressure by applanation of the eye in step S101; paragraphs [0082]-[0083]; figure 8).
Further regarding claim 3; Dobashi discloses a detection sensor (element 47) configured to detect a displaced amount of the actuator (wherein position of dog element 46 inherently detects the position of the actuator), wherein the current application control unit determines whether the switching condition is satisfied or not based on whether the displaced amount detected by the detection sensor achieves a predetermined displaced amount threshold (wherein current application control unit determines switching condition is satisfied when detection switch 47 detects that the piston is in the correction location in order to increase drive current and test intraocular pressure; paragraphs [0046]-[0047] and [0082]-[0083]; figures 6a-c and 8).
Further regarding claim 7; Dobashi discloses the current application control unit stops the second application processing when a defined period of time determined in advance passes from start of the first application processing (wherein the current is only applied to drive the solenoid for a predetermined period of time in situations where the eye does not experience applanation, i.e. when the IOC is more than 30, the system stops applying current and resets to do another test, thus meeting the BRI as the controller includes a situation where the second application processing is stopped a defined period of time from the start of the first application processing; paragraphs [0082]-[0089]; figure 8).
Further regarding claim 8; Dobashi discloses a projecting optical system (elements 37, 36, 25) configured to project a luminous flux to the subject eye while the air is being sprayed from the nozzle to the subject eye; and a receiving optical system (elements 34, 33, 32 and 31) configured to receive reflected light of the luminous flux reflected at the subject eye and outputs an applanation signal while the air is being sprayed from the nozzle to the subject eye, wherein the current application control unit stops the second application processing when a peak of the applanation signal output from the receiving optical system is detected while the second application processing is being performed (wherein drive current to solenoid is interrupted when the corneal shape changing signal measured by optical system is at its first maximum value; paragraphs [0058]-[0059]; figure 5 and 12)
Further regarding claim 9; Dobashi discloses the actuator is a rotary actuator (element 42) configured to cause the piston (element 40) to move inside the cylinder (element 43) through a crank mechanism (element 41) (paragraphs [0045] and [0055]; figures 2, 4a-c, 6a-c).
Further regarding claim 10; Dobashi discloses a cylinder (element 43; figure 2);
a piston (element 40) movably provided inside the cylinder (paragraph [0045]; figure 2);
an actuator (element 42) configured to move the piston (element 40) inside the cylinder (element 43) with current applied to the actuator to compress air inside the cylinder with the piston (paragraphs [0045] and [0056]; figure 2);
a nozzle (element 22) in communication with the inside of the cylinder (via tube element 44), the nozzle configured to spray the air compressed with the piston to a subject eye (paragraph [0039]; figure 2); and
the method including:
performing first application processing for applying the current of a first current value to the actuator when the current is to be applied to the actuator (applies minute current to get piston into desired position; step S100; paragraph [0082]); and
switching the first application processing to second application processing for applying the current of a second current value higher than the first current value to the actuator when a predetermined switching condition is satisfied while the first application processing is being performed (switching to measurement mode and increasing the drive current to drive the piston to blow air into the eye in order to measure IOC; step S101; paragraph [0083]).
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.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Yano as applied to claims 1 and 2 above, and further in view of Hideshima (US 4,996,990).
Yano is described in the rejection of claim 1 and 2 above; however Yano does not explicitly disclose the current application control unit increases the second current value in a stepwise manner while the second application processing is being performed.
Hideshima teaches a similar non-contact tonometer which blows air into the eye using a current controller to drive a solenoid to move a piston within a cylinder to drive air out of a nozzle to applanate the eye wherein the system wherein the current control unit can increase the current value in a stepwise manner in order to compensate for changes in the compression chamber and ensure the correct pressure/force is expelled from the nozzle (column 4, line 39 – column 5, line 31; figure 2)
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Yano’s tonometer and current application control unit to include compensation circuitry that causes the increase of the current value in a stepwise manner while measuring intraocular pressure as taught by Hideshima in order to compensate for any changes/irregularities in the compression chamber and ensure proper pressure application.
Further regarding claim 5; Yano discloses the claim limitations of claim 5 as described in the rejection of claim 2 above. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Yano/Hideshima combination would also include the same features for controlling current application to the second current value in a stepwise manner in accordance with an increase in pressure detected by a pressure sensor.
Claims 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dobashi as applied to claims 1 and 3 above, and further in view of Hideshima.
Dobashi is described in the rejection of claims 1 and 3 above; however, Dobashi does not explicitly disclose the current application control unit increases the second current value in a stepwise manner while the second application processing is being performed.
Hideshima teaches a similar non-contact tonometer which blows air into the eye using a current controller to drive a solenoid to move a piston within a cylinder to drive air out of a nozzle to applanate the eye wherein the system wherein the current control unit can increase the current value in a stepwise manner in order to compensate for changes in the compression chamber and ensure the correct pressure/force is expelled from the nozzle (column 4, line 39 – column 5, line 31; figure 2)
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Dobashi’s tonometer and current application control unit to include compensation circuitry that causes the increase of the current value in a stepwise manner while measuring intraocular pressure as taught by Hideshima in order to compensate for any changes/irregularities in the compression chamber and ensure proper pressure application.
Further regarding claim 6; Dobashi discloses the claim limitations of claim 6 as described in the rejection of claim 3 above. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Dobashi/Hideshima combination would also include the same features for controlling current application in a stepwise manner accordance with an increase in the displaced amount detected by the detection sensor while the second application processing is being performed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 6,159,148 to Luce; discloses a non-contact tonometer having non-linear pressure ramp.
US 5,947,898 to Suzuki et al; discloses a non-contact type tonometer.
US 2022/0095916 A1 to Ishikura et al; discloses a ophthalmologic apparatus.
US 2014/0257076 A1 to Shimozato; discloses a non-contact ophthalmologic apparatus and control method for the same.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791