DETAILED ACTION
Priority
1. Receipt is acknowledged of papers submitted under 35 U.S.C. 119 (a) — (d), which papers have been placed of record in the file. Oath/Declaration
Oath/Declaration
2. Oath and declaration filed on 1/26/2023 is accepted.
Information Disclosure Statement
3. The prior art documents submitted by application in the Information Disclosure Statement filed on 7/29/202 and 10/14/2022 and 4/3/2025 have all been considered and made of record ( note the attached copy of form PTO – 1449).
Claim Objections
4.Claim 17 is objected to because of the following informalities: “ A computer program comprising program instructions for causing a computer to perform” , “ A computer program “ should be written “ a computer readable storage medium” Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
Claim 4 is 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 4, using the phrase “preferably four ocular parameters selected from refraction” make claim indefinite. Specially using word “preferably” did not specify mention what kind of parameter value use, make the claim indefinite.
Claim Rejections - 35 USC § 103
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al (2018/0140181 A1) in view of Burton (2021/0169417 A1).
Regarding claim 1, Brennan et al discloses (refer to figures 1-10) a computer implemented method of determining ocular biometric status of a patient during a period of analysis, comprising the steps of: inputting into a computational model the age of the patient and a plurality of measurements of at least one ocular parameter obtained from the patient during a period of analysis , in which the at least one ocular parameter is selected from refraction, axial length, corneal radius, corneal keratometric power, axial length to corneal radius (ALCR) ratio and myopia progression; generating in the computational model a comparison of each of the plurality of measurements and the age of the patient ; converting, by the computational model, each of the plurality of measurements into an age-specific centile parameter; generating a refractogram which shows the change in the age-specific centile parameters for the at least one ocular parameter over the period of analysis; and providing in the refractogram, a measurement of the ocular biometric status of the patient based on the progression of the age-specific centile parameters of the at least one ocular parameter over the period of analysis (paragraph 0035 -0072).
Brennan et al discloses all of the claimed limitations except at least one ocular parameter and computational model.
Burton discloses computer implemented method (paragraph 3214) and ocular parameters (paragraph 1956) and computational model.
It would have been obvious to one of ordinary skill in the art at the time of invention was made to provide of teaching one ocular parameter and computational model in to the Brennan et al a computer implemented method for monitoring or computing system or analysing physiological parameters or neurological parameter as taught by Burton et al (paragraph 0105).
Regarding claim 2, Brennan et al discloses comprising the steps of: inputting into a computational model a plurality of measurements of a plurality of ocular parameters obtained from the patient during the period of analysis; comparing, by the computational model, each of the plurality of measurements and the age of the patient with population data for each of the plurality of ocular parameters; converting, by the computational model, each of the plurality of measurements into an age-specific centile parameter; and plotting in a graph the change in the age-specific centile parameters for each of the plurality of ocular parameters over the period of analysis (paragraph 0035-0072).
Regarding claim 3, Brennan et al discloses wherein the converting of each of the plurality of measurements into an age-specific centile parameter comprises the step of applying a sigmoid function to the plurality of measurements to account for non-linearity of a biometric parameter to centile relationship (paragraph 0035-0072).
Regarding claim 4, Brennan et al discloses in which the plurality of ocular parameters includes at least three and preferably four ocular parameters selected from refraction, axial length, corneal radius, corneal keratometry power, ALCR ratio and myopia progression (paragraph 0035-0072).
Regarding claim 5, Brennan et al discloses in which the population data for the at least one ocular parameter employed in the comparison step comprises age and sex matched population data (paragraph 0035-0072).
Regarding claim 6, Brennan et al discloses in which the population data for the at least one ocular parameter employed in the comparison step comprises ethnicity, age and sex matched population data (paragraph 0035-0072).
Regarding claim 7, Brennan et al discloses which is a method of monitoring effectiveness of myopia control therapy over the period of time and optionally assist a healthcare professional prescribe an alternative for the patient (paragraph 0035-0072).
. Regarding claim 8, Brennan et al discloses which is a method of predicting risk of developing myopia in a patient (paragraph 0035-0072).
Regarding claim 9, Brennan et al discloses which is a method of predicting risk of developing severe myopia in a patient (paragraph 0035-0072).
Regarding claim 10, Brennan et al discloses which is a method of predicting severity of myopia in a patient.
Regarding claim 11, Brennan et al discloses(refer to figures 1-10) a computer implemented system to determine ocular biometric status of a patient undergoing myopia control therapy and comprising: a computational model configured to: receive as an input the age of the patient and a plurality of measurements for an ocular parameter selected from refraction, axial length, corneal radius, corneal keratometric power, axial length to corneal radius (ALCR) ratio and myopia progression obtained from the patient; compare each of the plurality of measurements and the age of the patient with population data for the at least one ocular parameter and generate a plurality of age- specific centile parameter for the at least one ocular parameter; and graphically represent in a refractogram the change in the age-specific centile parameters of the at least one ocular parameter over the period of therapy, and a display system to display the refractogram (paragraph 0035-0072).
Brennan et al discloses all of the claimed limitations except at least one ocular parameter and computational model.
Burton discloses computer implemented method (paragraph 3214) and ocular parameters (paragraph 1956) and computational model.
It would have been obvious to one of ordinary skill in the art at the time of invention was made to provide of teaching one ocular parameter and computational model in to the Brennan et al a computer implemented method for monitoring or computing system or analysing physiological parameters or neurological parameter as taught by Burton et al (paragraph 0105) .
Regarding claim 12, Brennan et al discloses including a determination system for obtaining from the patient the plurality of measurements for the ocular parameter (paragraph 0035-0072).
Regarding claim 13, Brennan et al discloses including a storage system for storing ocular parameter measurements and optionally population data for the ocular parameter (paragraph 0035-0072).
Regarding claim 14, Brennan et al discloses in which the computational model is configured to: receive as an input the age of the patient and the plurality of measurements for each of the plurality of ocular parameters; compare each of the plurality of measurements and the age of the patient with population data for ocular parameters and generate a plurality of age-specific centile parameters for each of ocular parameters; and graphically represent in a refractogram the change in the age-specific centile parameters for each of the ocular parameters over the period of therapy (paragraph 0035-0072).
Regarding claim 15, Brennan et al discloses in which the plurality of ocular parameters includes at least three ocular parameters selected from refraction, axial length, corneal radius, corneal keratometric power, ALCR ratio and myopia progression (paragraph 0035-0072).
Regarding claim 16, Brennan et al discloses, the plurality of ocular parameters includes refraction, axial length, corneal radius, corneal keratometric power, ALCR ratio and myopia progression ocular parameters (paragraph 0035-0072).
Regarding claim 17, Brennan et al discloses (refer to figures 1-11) a method comprising the steps of: inputting into a computational model the age of the patient and a plurality of measurements of at least one ocular parameter obtained from the patient during a period of therapy, in which the at least one ocular parameter is selected from refraction, axial length, corneal radius, corneal keratometric power, axial length to corneal radius (ALCR) ratio and myopia progression; comparing, by the computational model, each of the plurality of measurements and the age of the patient with population data for the at least one ocular parameter; converting, by the computational model, each of the plurality of measurements into an age-specific centile parameter; plotting in a refractogram the change in the age-specific centile parameters for the at least one ocular parameter over the period of therapy; and display the refractogram on a screen or printed format (paragraph 0035-0075).
Brennan et al discloses all of the claimed limitations except at least one ocular parameter and computational model.
Burton discloses computer implemented method (paragraph 3214) and ocular parameters (paragraph 1956) and computational model.
It would have been obvious to one of ordinary skill in the art at the time of invention was made to provide of teaching one ocular parameter and computational model in to the Brennan et al a computer implemented method for monitoring or computing system or analysing physiological parameters or neurological parameter as taught by Burton et al (paragraph 0105).
Regarding claim 18, Brennan et al discloses on a record medium (paragraph 0035-0075).
Regarding claim 19, Brennan et al discloses on a carrier signal (paragraph 0035-0075).
Regarding claim 20, Brennan et al discloses on a read-only memory (paragraph 0035-0075).
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED A HASAN whose telephone number is (571)272-2331. The examiner can normally be reached M-TH 6 AM -4 PM.
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/MOHAMMED A HASAN/Primary Examiner, Art Unit 2872 3/28/2026
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