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 .
Claim Status
Claims 1-14 are pending for examination in the application filed 10/11/2024.
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, as explained in MPEP §2181, subsection I (note that the list of generic placeholders below is not exhaustive, and other generic placeholders may invoke 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 Generic Placeholder (A Term That Is Simply A Substitute for “Means”)
With respect to the first prong of this analysis, a claim element that does not include the term “means” or “step” triggers a rebuttable presumption that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply. When the claim limitation does not use the term “means,” examiners should determine whether the presumption that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6 does not apply is overcome. The presumption may be overcome if the claim limitation uses a generic placeholder (a term that is simply a substitute for the term “means”). The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f) or pre- AIA 35 U.S.C. 112, paragraph 6: “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for.” Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media,161 F.3d at 704, 48 USPQ2d at 1886–87; Mas- Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir.1998). This list is not exhaustive, and other generic placeholders may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6.
Such claim limitations are:
An intelligent optometry and glasses fitting assistance system (claims 1-7)…
comprising an optometry and glasses fitting assistance system (claim 1) and a detection module (claims 1 and 8) ...wherein, said optometry and glasses fitting assistance system comprises:
a corneal topography preliminary module… (claims 1 and 8)
a corneal topography optimization module… (claims 1-2, and 8)
a model construction module… (claims 1 and 8)
and a model evaluation module… (claims 1 and 8)
([pg. 6 ln. 3-13] Please refer to FIGS. 1 to 5, which are a functional block diagram of the intelligent optometry and glasses fitting assistance system of the present invention, a proportional diagram of the initial corneal topography of the present invention, a proportional diagram of the corneal optimized topography of the present invention, a dimensional diagram of the interaction model of the lens and cornea of the present invention and a dimensional diagram of the fluorescent tear fluid model of the present invention. As can be clearly seen from the figures, the intelligent optometry and glasses fitting assistance system of the present invention mainly comprises: a detection module 1 and an optometry and glasses fitting assistance system 2. The optometry and glasses fitting assistance system 2 refers to a personal computer (PC), a notebook computer (Notebook), a tablet computer (Table PC) or a smartphone).
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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.
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 1-2, 7-9 and 14 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.
Claims 1 and 8 recite the limitation “the evaluation calculation method is to calculate the contact area between the lens and the cornea, and output an evaluation result” and “the evaluation calculation method calculates the contact area between the lens and the cornea, and outputs an evaluation result”, respectively. There is insufficient antecedent basis for “the contact area” in the claims. It is unclear whether “the contact area” is the same as the previously claimed “lens alignment zone contact area AZ” and/or the previously claimed “lens optical zone contact area” OZ. Please clarify.
Claims 2 and 9 recite the limitation “the value of the optimization function being able to be linear programming (LP), mixed integer linear programming (MILP), quadratic programming (QP), second-order pyramid programming (SOCP), nonlinear programming (NLP), constrained linear least squares, nonlinear least squares and nonlinear equations”, and “said optimization function being able to be linear programming (LP), mixed integer linear programming (MILP), quadratic programming (QP), second-order pyramid programming (SOCP), nonlinear programming (NLP), constrained linear least squares, nonlinear least squares and nonlinear equations”, respectively. In claim 2, it is unclear what “the value of the optimization function” is, as linear programming (LP), mixed integer linear programming (MILP), quadratic programming (QP), second-order pyramid programming (SOCP), nonlinear programming (NLP), constrained linear least squares, nonlinear least squares and nonlinear equations are optimization techniques, not explicit values. Further, in claims 2 and 9 it is unclear if the optimization function is able to be one of: linear programming (LP), mixed integer linear programming (MILP), quadratic programming (QP), second-order pyramid programming (SOCP), nonlinear programming (NLP), constrained linear least squares, nonlinear least squares and nonlinear equations. Please clarify.
Claim 7 recites the limitation “wherein the prefer operation of said corneal reshaping lens evaluation auxiliary model is to obtain the satisfied constraints and the minimized or maximized target parameters through the approximation algorithm”. Examiner is interpreting the claims to read “the preferred operation”, for the sake of compact prosecution. The phrase "prefer operation" renders the claim indefinite because it makes the intended scope of the claim unclear. MPEP § 2173.05(d) states: “Description of examples or preferences is properly set forth in the specification rather than the claims”.
Claims 7 and 14 recite the limitation “obtain(s) the satisfied constraints and the minimized or maximized target parameters through the approximation algorithm, and the method for obtaining the minimized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is positive (f"(x)＞0), then the point is the local minimum, and the method for obtaining the maximized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is negative (f"(x)＜0), then the point is the local maximum”. There is insufficient antecedent basis for “the maximized or minimized target parameters” in the claims. There is insufficient antecedent basis for “the point” in the claims. Please clarify.
Claim limitations “a detection module used to obtain an optometry parameter and a corneal characteristic parameter of the patient” of claim 1 and “a detection module to obtain an optometry parameter and a corneal characteristic parameter of the patient through detection” of claim 8 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. MPEP §2181 II. DESCRIPTION NECESSARY TO SUPPORT A CLAIM LIMITATION WHICH INVOKES 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, SIXTH PARAGRAPH reads:
A. The Corresponding Structure Must Be Disclosed In the Specification Itself in a Way That One Skilled In the Art Will Understand What Structure Will Perform the Recited Function
The proper test for meeting the definiteness requirement is that the corresponding structure (or material or acts) of a means- (or step-) plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function. See Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999).
The specification sets forth the corresponding structure for the glasses fitting assistance system 2, which includes the corneal topography preliminary module, corneal topography optimization module, model construction module, and model evaluation module in ([pg. 6 ln. 3-13] Please refer to FIGS. 1 to 5, which are a functional block diagram of the intelligent optometry and glasses fitting assistance system of the present invention, a proportional diagram of the initial corneal topography of the present invention, a proportional diagram of the corneal optimized topography of the present invention, a dimensional diagram of the interaction model of the lens and cornea of the present invention and a dimensional diagram of the fluorescent tear fluid model of the present invention. As can be clearly seen from the figures, the intelligent optometry and glasses fitting assistance system of the present invention mainly comprises: a detection module 1 and an optometry and glasses fitting assistance system 2. The optometry and glasses fitting assistance system 2 refers to a personal computer (PC), a notebook computer (Notebook), a tablet computer (Table PC) or a smartphone). However, the specification fails to set forth the corresponding structure, material, or acts in compliance with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, for the detection module and the claim limitation cannot "be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof”.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. MPEP §2181 Section IV. DETERMINING WHETHER 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, FIRST PARAGRAPH SUPPORT EXISTS reads:
“When a claim containing a computer-implemented 35 U.S.C. 112(f) claim limitation is found to be indefinite under 35 U.S.C. 112(b) for failure to disclose sufficient corresponding structure (e.g., the computer and the algorithm) in the specification that performs the entire claimed function, it will also lack written description under section 112(a). See MPEP § 2163.03, subsection VI.”
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Fan (Fan, Yuzhuo, et al. "Machine learning algorithm improves accuracy of ortho-K lens fitting in vision shaping treatment." Contact Lens and Anterior Eye 45.3 (2022): 101474) in view of Tung (US20240310657A1).
Regarding claim 1, Fan teaches an intelligent optometry assistance system for orthokeratology lenses based on corneal topography ([2.2. Materials] All patients underwent a standard anterior eye and refractive status assessment prior to wearing ortho-k lenses, including measurement of baseline corneal topography using a corneal topographer (Siris, CSO, Italy). [3.3. Efficiency of the machine learning method] the run time of the machine learning model is only 1.15 ± 0.54 s (Intel(R) Core(TM) i7-8565U CPU @1.80–1.99 GHz with Windows 10)),
comprising an optometry and glasses fitting assistance system and a detection module used to obtain an optometry parameter and a corneal characteristic parameter of the patient, wherein, said optometry and glasses fitting assistance system comprises: a corneal topography preliminary module provided for drawing a corneal preliminary topography map according to said optometry parameter and said corneal characteristic parameter ([2.2. Materials] All patients underwent a standard anterior eye and refractive status assessment prior to wearing ortho-k lenses, including measurement of baseline corneal topography using a corneal topographer (Siris, CSO, Italy). The final selected corneal topographic map was sampled without upper or lower eyelid occlusion, with over 95% coverage of the cornea and 90% confidence, and confirmed by the consistency with the corneal K values sampled by an IOLMaster and computer refractometer (differences between different machines are less than 0.25D));
a corneal topography optimization module provided for performing reconstruction, optimization adjustment and resampling according to said corneal preliminary topography map to obtain a corneal optimized topography map ([2.2. Materials] The final selected corneal topographic map was sampled without upper or lower eyelid occlusion, with over 95% coverage of the cornea and 90% confidence, and confirmed by the consistency with the corneal K values sampled by an IOLMaster and computer refractometer (differences between different machines are less than 0.25D));
a model construction module provided for obtaining a corneal reshaping lens evaluation auxiliary model according to a predetermined corneal reshaping lens parameter combined with said optometry parameter, said corneal characteristic parameter and said corneal optimized topography map, said corneal reshaping lens evaluation auxiliary model calculating a lens alignment zone contact area AZ of said corneal reshaping lens parameter ([4.1 The need for machine learning models] Clinically, AC is one of the most important parameters of VST orthokeratology lenses because it reflects the alignment with the peripheral cornea and plays a very important role in lens centration and movement. An appropriate AC parameter means that an ideal lens sagittal height can ensure excellent clinical performance, i.e., an ideal lens centration, sufficient tear exchange and comfort levels, and good daily visual acuity. Appropriate lens fitting under dynamic fluorescein is illustrated by a “bull’s eye” pattern with an adequate central treatment zone entrapped by a tear reservoir enclosed by the alignment zone. [4.2 The advantages of machine learning models] Therefore, this study established a machine learning model for precisely predicting AC1K1, AC1K2 and AC2K1. This method only requires a few simple corneal parameters and basic patient information to calculate accurate AC parameters (sex, age, HVID, S, C, e value, flat K, steep K, ACD, and AL). This model can accurately estimate the toricity needed for toric lens design. The reason why AC2K2 was not included in this study is that the upper cornea of some patients sometimes cannot be fully exposed due to eyelid occlusion when corneal topography is performed),
and a model evaluation module provided for performing evaluation calculation on said corneal reshaping lens evaluation auxiliary model according to a predetermined evaluation index, wherein the evaluation calculation method is to calculate the contact area between the lens and the cornea, and output an evaluation result ([2.5 Machine learning method] For each task, four kinds of machine learning algorithms were implemented in the experimental analysis based on robust linear regression models, support vector machine (SVM) regression models with linear kernel functions, bagging decision trees, and Gaussian processes. Five evaluation metrics, including the coefficient of determination (R2), R value, mean absolute error (MAE), mean squared error (MSE), and root mean squared error (RMSE), were used to evaluate the performance of the above algorithms in predicting the targeted AC1K1, AC1K2 and AC2K1 values. The best-performing algorithm was further applied to predict AC1K1, AC1K2 and AC2K1. All the experiments were implemented in MATLAB 2020a (The MathWorks, Inc., USA)).
Fan does not explicitly teach an optometry and glasses fitting assistance system for orthokeratology lenses; the implementable range of said lens alignment zone contact area AZ being between (DIA-C1)/2 and (DIA-OZ-C2)/2; wherein DIA is the lens diameter; OZ is the lens optical zone contact area, which is provided by said corneal reshaping lens parameter; C1 is the first calculation parameter; and C2 is the second calculation parameter.
Tung, in the same field of endeavor of orthokeratology lenses, teaches an optometry and glasses fitting assistance system for orthokeratology lenses ([Abstract] A contact or spectacle lens for correcting peripheral ocular defocus which has a center zone in a central portion for correcting refractive errors and an aspheric, annular anti-defocus zone adjacent to and extending radially outwardly from the center zone. [0162] These objects of the present invention can be achieved by providing an apparatus and method for correcting the refractive error with a peripheral ocular defocus condition in a patient's eye. In accordance with a method of the present invention, an anti-defocus (ADF) orthokeratology contact lens 10 (as shown for example in FIGS. 6-9) is fitted to a cornea of a patient's eye, the contact lens 10 having a back surface with plurality of zones);
the implementable range of said lens alignment zone contact area AZ (28) being between (DIA-C1)/2 and (DIA-OZ-C2)/2; wherein DIA is the lens diameter (10); OZ is the lens optical zone contact area (20), which is provided by said corneal reshaping lens parameter; C1 is the first calculation parameter; and C2 is the second calculation parameter ([0162] In accordance with a method of the present invention, an anti-defocus (ADF) orthokeratology contact lens 10 (as shown for example in FIGS. 6-9) is fitted to a cornea of a patient's eye, the contact lens 10 having a back surface with plurality of zones that includes a central optical zone having front and back surfaces (20a, 20b) with corresponding curves (30a, 30b) respectively; an ADF zone 21 with an ADF base curve 31b, an intermediate zone 24 (plateau zone in hyperopic lenses), a connecting or fitting zone 26, and an alignment zone and/or a peripheral zone 28. An ADF base curve 21b is carefully created to flatten or steepen the mid-peripheral cornea curvature to cause the cornea 12 to have an anti-defocus mid-peripheral portion surrounding the central zone created by the base curve 20b of the optical zone 20 for far vision. The target power of the optical zone 20 for correction of the far vision can be determined by an eye care practitioner for fitting orthokeratology lenses. The shape of the ADF zone (21a, 21b) can be derived from testing the ocular defocus with an ADF testing spectacle lens or an ADF testing contact lens as aforementioned. [0163] In accordance with an apparatus of the present invention, a contact lens 10 is provided having a optical zone curve (30a, 30b) portion of the lens, an ADF curve (31a, 31b) portion of the lens circumscribing and coupled to the optical zone curve portion, a plateau curve in an intermediate zone 24 and/or a fitting curve in a connecting zone 26 portion of the lens circumscribing and coupled to the ADF curve (31a, 31b) portion, and an alignment curve and/or a peripheral curve in a peripheral zone 28 portion of the lens circumscribing and coupled to the intermediate zone 24 or connecting zone 26 portion. [0164] The diameter of the central optical zone 20 of the contact lens 10 can preferably be varied from 1.0-3.0 mm for different purposes of correcting myopia, hyperopia or presbyopia. The zone width of the ADF zone 21 can preferably be varied from 1.0 to 4.0 mm for reshaping the predetermined myopic or hyperopic peripheral ocular defocus on a corneal surface. The total diameter of the optical zone 20 and ADF zone 21 together is preferred to be 4.0-8.0 mm, which can be merged for an aspheric optical-ADF curve with an eccentricity value of −0.1 e to −3.0 e for a H-ADF orthokeratology contact lens 10 to mold off hyperopic ocular defocus, or +0.1 e to +3.0 e for a M-ADF orthokeratology lens 10 to mold off myopic ocular defocus on the cornea 12 of the eye 14).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the time of filing to modify the system of Fan with the teachings of Tung to use an optometry and glasses fitting assistance system for orthokeratology lenses where the implementable range of said lens alignment zone contact area AZ being between (DIA-C1)/2 and (DIA-OZ-C2)/2 "for correcting the refractive error with a peripheral ocular defocus condition in a patient's eye" [0162] because "The different radii used to define the base curves (30a, 30b) in contact lens 10 and the ADF curves (31a, 31b), as well as the curves for the intermediate zone 24, the connecting zone 26, and the peripheral zone 28 and their relative thicknesses, are calculated after careful examination of a patient's eye 14 and the associated ocular tissue. The corneal curvature must be measured, the proper contact lens power defined, and the anticipated physiological response to the contact lenses 10 must be determined" [0167].
Regarding claim 3, Fan and Tung teach the system of claim 1. Fan further teaches wherein said corneal reshaping lens parameter is obtained by selecting the parameter that is closest to said optometry parameter and said corneal characteristic parameter ([2.2. Materials] The final selected corneal topographic map was sampled without upper or lower eyelid occlusion, with over 95% coverage of the cornea and 90% confidence, and confirmed by the consistency with the corneal K values sampled by an IOLMaster and computer refractometer (differences between different machines are less than 0.25D). [2.3. Research framework] This novel fitting algorithm is deemed the “calculation method” in this study. After all data and information were collected, AC1K1 (flat K reading of AC1), AC1K2 (steep K reading of AC1) and AC2K1 (flat K reading of AC2) were estimated with the calculation method. Based on these AC values and ocular parameters, a machine learning method for estimating the values corresponding to AC1K1, AC1K2 and AC2K1 was implemented, and the results were compared with the final ordered parameters).
Regarding claim 4, Fan and Tung teach the system of claim 1. Fan further teaches wherein said corneal reshaping lens evaluation auxiliary model comprises a lens and corneal interaction model and a fluorescent tear fluid model ([2.2 Materials] The final ordered lens parameters, as confirmed by both fluorescein staining at lens delivery and an ideal “bull’s eye” corneal topography pattern after lens treatment, were prescribed by the same doctor. The lens was not dispensed if the fluorescein pattern was deemed unacceptable. Lenses with excessive central clearance, inadequate edge lift or inadequate bearing at the alignment curve were regarded as unacceptable. No severe corneal complications were observed during follow-up assessments. [4.1 The need for machine learning models] Appropriate lens fitting under dynamic fluorescein is illustrated by a “bull’s eye” pattern with an adequate central treatment zone entrapped by a tear reservoir enclosed by the alignment zone).
Regarding claim 8, Fan teaches an intelligent optometry assistance method for orthokeratology lenses based on corneal topography ([2.2. Materials] All patients underwent a standard anterior eye and refractive status assessment prior to wearing ortho-k lenses, including measurement of baseline corneal topography using a corneal topographer (Siris, CSO, Italy). [3.3. Efficiency of the machine learning method] the run time of the machine learning model is only 1.15 ± 0.54 s (Intel(R) Core(TM) i7-8565U CPU @1.80–1.99 GHz with Windows 10)), comprising the steps of:
Step S1: Patient parameter reading, which is to provide a detection module to obtain an optometry parameter and a corneal characteristic parameter of the patient through detection ([2.2. Materials] All patients underwent a standard anterior eye and refractive status assessment prior to wearing ortho-k lenses, including measurement of baseline corneal topography using a corneal topographer (Siris, CSO, Italy). The final selected corneal topographic map was sampled without upper or lower eyelid occlusion, with over 95% coverage of the cornea and 90% confidence, and confirmed by the consistency with the corneal K values sampled by an IOLMaster and computer refractometer (differences between different machines are less than 0.25D));
Step S2: Corneal topography reconstruction and analysis, which is to provide a corneal topography preliminary module to draw a corneal preliminary topography map according to said optometry parameter and said corneal characteristic parameter, and to provide a corneal topography optimization module to perform reconstruction, optimization adjustment and resampling based on said corneal preliminary topography map to obtain a corneal optimized topography map ([2.2. Materials] The final selected corneal topographic map was sampled without upper or lower eyelid occlusion, with over 95% coverage of the cornea and 90% confidence, and confirmed by the consistency with the corneal K values sampled by an IOLMaster and computer refractometer (differences between different machines are less than 0.25D));
Step S3: Lens and cornea model construction, which is to provide a model construction module to obtain a corneal reshaping lens evaluation auxiliary model according to a predetermined corneal reshaping lens parameter combined with said optometry parameter, said corneal characteristic parameter and said corneal optimized topography map ([4.1 The need for machine learning models] Clinically, AC is one of the most important parameters of VST orthokeratology lenses because it reflects the alignment with the peripheral cornea and plays a very important role in lens centration and movement. An appropriate AC parameter means that an ideal lens sagittal height can ensure excellent clinical performance, i.e., an ideal lens centration, sufficient tear exchange and comfort levels, and good daily visual acuity. Appropriate lens fitting under dynamic fluorescein is illustrated by a “bull’s eye” pattern with an adequate central treatment zone entrapped by a tear reservoir enclosed by the alignment zone. [4.2 The advantages of machine learning models] Therefore, this study established a machine learning model for precisely predicting AC1K1, AC1K2 and AC2K1. This method only requires a few simple corneal parameters and basic patient information to calculate accurate AC parameters (sex, age, HVID, S, C, e value, flat K, steep K, ACD, and AL). This model can accurately estimate the toricity needed for toric lens design. The reason why AC2K2 was not included in this study is that the upper cornea of some patients sometimes cannot be fully exposed due to eyelid occlusion when corneal topography is performed);
Step S4: Constraint setting, which is to set the number of iterations of said corneal reshaping lens evaluation auxiliary model, and calculate a lens alignment zone contact area AZ of said corneal reshaping lens parameter ([3.3. Efficiency of the machine learning method] In addition, the number of lens fitting trials was compared between the traditional method, which uses flat K readings and e values to estimate the AC radius, and the machine learning method. The numbers of lens fitting trials required from the first trial lens to the final order were recorded for a sample of 100 people. The average number of trials required with the traditional method was 1.86 ± 0.55, and the average number of trials required with the machine learning method was only 1.18 ± 0.45. [3.1. Prediction results of the machine learning model] As indicated in Table 2, in the four machine learning approaches, the best R-squared value for AC1K1 estimation based on the linear SVM machine learning model was 0.91, which indicated that the AC curvature values were highly correlated with the input parameters…We then select the best performing method among the four methods for the subsequent predictions of AC1K1 (Linear SVM), AC1K2 (Gaussian process regression) and AC2K1 (Gaussian process regression), and collectively referred to as the final optimized machine learning methods);
Step S5: Optimization function creation, which is to provide a model evaluation module to perform an evaluation calculation on said corneal reshaping lens evaluation auxiliary model according to a predetermined evaluation index, and the evaluation calculation method calculates the contact area between the lens and the cornea, and outputs an evaluation result ([2.5 Machine learning method] For each task, four kinds of machine learning algorithms were implemented in the experimental analysis based on robust linear regression models, support vector machine (SVM) regression models with linear kernel functions, bagging decision trees, and Gaussian processes. Five evaluation metrics, including the coefficient of determination (R2), R value, mean absolute error (MAE), mean squared error (MSE), and root mean squared error (RMSE), were used to evaluate the performance of the above algorithms in predicting the targeted AC1K1, AC1K2 and AC2K1 values. The best-performing algorithm was further applied to predict AC1K1, AC1K2 and AC2K1. All the experiments were implemented in MATLAB 2020a (The MathWorks, Inc., USA)).
Fan does not explicitly teach an optometry and glasses fitting assistance method for orthokeratology lenses; the implementable range of said lens alignment zone contact area AZ is between (DIA-C1)/2 and (DIA-OZ-C2)/2, wherein DIA is the lens diameter; OZ is the lens optical zone contact area, which is provided by said corneal reshaping lens parameter, C1 is the first calculation parameter, and C2 is the second calculation parameter.
Tung, in the same field of endeavor of orthokeratology lenses, teaches an optometry and glasses fitting assistance method for orthokeratology lenses ([Abstract] A contact or spectacle lens for correcting peripheral ocular defocus which has a center zone in a central portion for correcting refractive errors and an aspheric, annular anti-defocus zone adjacent to and extending radially outwardly from the center zone. [0162] These objects of the present invention can be achieved by providing an apparatus and method for correcting the refractive error with a peripheral ocular defocus condition in a patient's eye. In accordance with a method of the present invention, an anti-defocus (ADF) orthokeratology contact lens 10 (as shown for example in FIGS. 6-9) is fitted to a cornea of a patient's eye, the contact lens 10 having a back surface with plurality of zones);
the implementable range of said lens alignment zone contact area AZ (28) is between (DIA-C1)/2 and (DIA-OZ-C2)/2; wherein DIA is the lens diameter (10), OZ is the lens optical zone contact area (20), which is provided by said corneal reshaping lens parameter, C1 is the first calculation parameter, and C2 is the second calculation parameter ([0162] In accordance with a method of the present invention, an anti-defocus (ADF) orthokeratology contact lens 10 (as shown for example in FIGS. 6-9) is fitted to a cornea of a patient's eye, the contact lens 10 having a back surface with plurality of zones that includes a central optical zone having front and back surfaces (20a, 20b) with corresponding curves (30a, 30b) respectively; an ADF zone 21 with an ADF base curve 31b, an intermediate zone 24 (plateau zone in hyperopic lenses), a connecting or fitting zone 26, and an alignment zone and/or a peripheral zone 28. An ADF base curve 21b is carefully created to flatten or steepen the mid-peripheral cornea curvature to cause the cornea 12 to have an anti-defocus mid-peripheral portion surrounding the central zone created by the base curve 20b of the optical zone 20 for far vision. The target power of the optical zone 20 for correction of the far vision can be determined by an eye care practitioner for fitting orthokeratology lenses. The shape of the ADF zone (21a, 21b) can be derived from testing the ocular defocus with an ADF testing spectacle lens or an ADF testing contact lens as aforementioned. [0163] In accordance with an apparatus of the present invention, a contact lens 10 is provided having a optical zone curve (30a, 30b) portion of the lens, an ADF curve (31a, 31b) portion of the lens circumscribing and coupled to the optical zone curve portion, a plateau curve in an intermediate zone 24 and/or a fitting curve in a connecting zone 26 portion of the lens circumscribing and coupled to the ADF curve (31a, 31b) portion, and an alignment curve and/or a peripheral curve in a peripheral zone 28 portion of the lens circumscribing and coupled to the intermediate zone 24 or connecting zone 26 portion. [0164] The diameter of the central optical zone 20 of the contact lens 10 can preferably be varied from 1.0-3.0 mm for different purposes of correcting myopia, hyperopia or presbyopia. The zone width of the ADF zone 21 can preferably be varied from 1.0 to 4.0 mm for reshaping the predetermined myopic or hyperopic peripheral ocular defocus on a corneal surface. The total diameter of the optical zone 20 and ADF zone 21 together is preferred to be 4.0-8.0 mm, which can be merged for an aspheric optical-ADF curve with an eccentricity value of −0.1 e to −3.0 e for a H-ADF orthokeratology contact lens 10 to mold off hyperopic ocular defocus, or +0.1 e to +3.0 e for a M-ADF orthokeratology lens 10 to mold off myopic ocular defocus on the cornea 12 of the eye 14).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the time of filing to modify the method of Fan with the teachings of Tung to use an optometry and glasses fitting assistance system for orthokeratology lenses where the implementable range of said lens alignment zone contact area AZ being between (DIA-C1)/2 and (DIA-OZ-C2)/2 "for correcting the refractive error with a peripheral ocular defocus condition in a patient's eye" [0162] because "The different radii used to define the base curves (30a, 30b) in contact lens 10 and the ADF curves (31a, 31b), as well as the curves for the intermediate zone 24, the connecting zone 26, and the peripheral zone 28 and their relative thicknesses, are calculated after careful examination of a patient's eye 14 and the associated ocular tissue. The corneal curvature must be measured, the proper contact lens power defined, and the anticipated physiological response to the contact lenses 10 must be determined" [0167].
Regarding claim 10, Fan and Tung teach the method of claim 8. Fan further teaches wherein in Step S3, said corneal reshaping lens parameter is obtained by selecting the parameter that is closest to said optometry parameter and said corneal characteristic parameter ([2.2. Materials] The final selected corneal topographic map was sampled without upper or lower eyelid occlusion, with over 95% coverage of the cornea and 90% confidence, and confirmed by the consistency with the corneal K values sampled by an IOLMaster and computer refractometer (differences between different machines are less than 0.25D). [2.3. Research framework] This novel fitting algorithm is deemed the “calculation method” in this study. After all data and information were collected, AC1K1 (flat K reading of AC1), AC1K2 (steep K reading of AC1) and AC2K1 (flat K reading of AC2) were estimated with the calculation method. Based on these AC values and ocular parameters, a machine learning method for estimating the values corresponding to AC1K1, AC1K2 and AC2K1 was implemented, and the results were compared with the final ordered parameters).
Regarding claim 11, Fan and Tung teach the method of claim 8. Fan further teaches wherein in step S3, said corneal reshaping lens evaluation auxiliary model comprises a lens and corneal interaction model and a fluorescent tear fluid model ([2.2 Materials] The final ordered lens parameters, as confirmed by both fluorescein staining at lens delivery and an ideal “bull’s eye” corneal topography pattern after lens treatment, were prescribed by the same doctor. The lens was not dispensed if the fluorescein pattern was deemed unacceptable. Lenses with excessive central clearance, inadequate edge lift or inadequate bearing at the alignment curve were regarded as unacceptable. No severe corneal complications were observed during follow-up assessments. [4.1 The need for machine learning models] Appropriate lens fitting under dynamic fluorescein is illustrated by a “bull’s eye” pattern with an adequate central treatment zone entrapped by a tear reservoir enclosed by the alignment zone).
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Tung and Martínez-Plaza (Martínez-Plaza, Elena, et al. "Orthokeratology effect on the corneoscleral profile: Beyond the bull's eye." Ophthalmic and Physiological Optics 44.4 (2024): 757-768).
Regarding claim 7, Fan and Tung teach the system of claim 1. Fan does not explicitly teach wherein the prefer operation of said corneal reshaping lens evaluation auxiliary model is to obtain the satisfied constraints and the minimized or maximized target parameters through the approximation algorithm, and the method for obtaining the minimized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is positive (f"(x)＞0), then the point is the local minimum, and the method for obtaining the maximized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is negative (f"(x)＜0), then the point is the local maximum.
Martinez-Plaza, in the same field of endeavor of orthokeratology lenses, teaches wherein the prefer operation of said corneal reshaping lens evaluation auxiliary model is to obtain the satisfied constraints and the minimized or maximized target parameters through the approximation algorithm ([Introduction] Recent technology, used as part of the CL fitting process allows for non-invasive assessment of the corneoscleral profile. The Eye Surface Profiler (ESP) (eaglet-eye.com) provides reliable measurements of corneal and scleral parameters. Using this device, several studies have obtained evidence of corneoscleral profile modifications in subjects wearing soft and scleral CLs for a 5- to 8-h time period… Consequently, the aim of the present study was to assess the effect of ortho-k CL wear for myopia on the corneoscleral profile over a short-term follow-up period. [Corneoscleral profile] The following parameters were automatically calculated by the ESP software: simulated keratometry in the steep (SimKs) and flat (SimKf) meridians and sagittal height measurements for 13-, 14- and 15-mm chord lengths, including average sagittal height (ASH), difference between the temporal and nasal sagittal heights (T-NSH), minimum and maximum sagittal height (MinSH and MaxSH), including all available meridians and minimum and maximum sagittal height of the largest orthogonal difference (MinSH90° and MaxSH90°, respectively),
and the method for obtaining the minimized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is positive (f"(x)＞0), then the point is the local minimum, and the method for obtaining the maximized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is negative (f"(x)＜0), then the point is the local maximum ([Corneoscleral profile] The following parameters were automatically calculated by the ESP software: simulated keratometry in the steep (SimKs) and flat (SimKf) meridians and sagittal height measurements for 13-, 14- and 15-mm chord lengths, including average sagittal height (ASH), difference between the temporal and nasal sagittal heights (T-NSH), minimum and maximum sagittal height (MinSH and MaxSH), including all available meridians and minimum and maximum sagittal height of the largest orthogonal difference (MinSH90° and MaxSH90°, respectively).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the time of filing to modify the system of Fan with the teachings of Martinez-Plaza to obtain the minimized or maximized target parameters through the approximation algorithm because "the raw height data were used to obtain sagittal height and slope data in polar format (Figure 1). This new method can be performed using modelling software that allows for the management of a large quantity of data and the calculation of basic trigonometry functions. It allowed the description and comparison of a representative area of corneoscleral geometry between visits using a manageable quantity of data. The sagittal height and slope parameters provide valuable information that is comparable with the elevation and curvature data obtained by commercial topographers" [Discussion].
Regarding claim 14, Fan and Tung teach the method of claim 8. Fan does not explicitly teach wherein in step S6, the approximation algorithm obtains the satisfied constraints and the minimized or maximized target parameters, and the method for obtaining the minimized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is positive (f"(x)＞0), then the point is the local minimum, and the method for obtaining the maximized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is negative (f"(x)＜0), then the point is the local maximum.
Martinez-Plaza, in the same field of endeavor of orthokeratology lenses, teaches wherein in step S6, the approximation algorithm obtains the satisfied constraints and the minimized or maximized target parameters, ([Introduction] Recent technology, used as part of the CL fitting process allows for non-invasive assessment of the corneoscleral profile. The Eye Surface Profiler (ESP) (eaglet-eye.com) provides reliable measurements of corneal and scleral parameters. Using this device, several studies have obtained evidence of corneoscleral profile modifications in subjects wearing soft and scleral CLs for a 5- to 8-h time period… Consequently, the aim of the present study was to assess the effect of ortho-k CL wear for myopia on the corneoscleral profile over a short-term follow-up period. [Corneoscleral profile] The following parameters were automatically calculated by the ESP software: simulated keratometry in the steep (SimKs) and flat (SimKf) meridians and sagittal height measurements for 13-, 14- and 15-mm chord lengths, including average sagittal height (ASH), difference between the temporal and nasal sagittal heights (T-NSH), minimum and maximum sagittal height (MinSH and MaxSH), including all available meridians and minimum and maximum sagittal height of the largest orthogonal difference (MinSH90° and MaxSH90°, respectively),
and the method for obtaining the minimized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is positive (f"(x)＞0), then the point is the local minimum, and the method for obtaining the maximized target parameter is to make the first-order derivative of the point be zero (f'(x)=0), and if the second-order derivative of the point is negative (f"(x)＜0), then the point is the local maximum ([Corneoscleral profile] The following parameters were automatically calculated by the ESP software: simulated keratometry in the steep (SimKs) and flat (SimKf) meridians and sagittal height measurements for 13-, 14- and 15-mm chord lengths, including average sagittal height (ASH), difference between the temporal and nasal sagittal heights (T-NSH), minimum and maximum sagittal height (MinSH and MaxSH), including all available meridians and minimum and maximum sagittal height of the largest orthogonal difference (MinSH90° and MaxSH90°, respectively).
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Therefore, it would have been obvious to a person of ordinary skill in the art before the time of filing to modify the method of Fan with the teachings of Martinez-Plaza to obtain the minimized or maximized target parameters through the approximation algorithm because "the raw height data were used to obtain sagittal height and slope data in polar format (Figure 1). This new method can be performed using modelling software that allows for the management of a large quantity of data and the calculation of basic trigonometry functions. It allowed the description and comparison of a representative area of corneoscleral geometry between visits using a manageable quantity of data. The sagittal height and slope parameters provide valuable information that is comparable with the elevation and curvature data obtained by commercial topographers" [Discussion].
Allowable Subject Matter
Claims 2, 5-6, 9, and 12-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims once all rejections and objections are overcome.
Regarding claims 2 and 9, the following limitations were not found to be taught in the art: wherein the optimization adjustment of said corneal topography optimization module is to establish an optimization function, and the formula for obtaining the value of the optimization function is: ∫w1×OZ-w2×AZ; wherein w1 is the first weighting factor; w2 is the second weighting factor; OZ is the lens optical zone contact area (Optical Zone); AZ is the lens alignment zone contact area (Alignment Zone), the value of the optimization function being able to be linear programming (LP), mixed integer linear programming (MILP), quadratic programming (QP), second-order pyramid programming (SOCP), nonlinear programming (NLP), constrained linear least squares, nonlinear least squares and nonlinear equations.
Regarding claims 5 and 12, Newman (US20210031471A1) teaches wherein the parameter range of C1 is between 0.5mm and 1.5mm ([0062] Adjacent to the alignment zone 34, a peripheral zone 36 any number of edge geometries can be formed to create an appropriate edge lift at the peripheral cornea. The peripheral zone 36 can have a width from 0.1 mm to 0.6 mm). The following limitations were not found to be taught in the art: wherein the parameter range of C1 is between 0.5mm and 1.5mm, and the initial value is 0.8mm.
Regarding claims 6 and 13, Tung teaches wherein the parameter range of C2 is between 1mm and 2mm ([0171] Center power: −1.25 D (Myopia) [0172] Center-ADF zone 20-21: BOZ (zone width) 8.5 mm, [0173] BOZR (radius of curvature) 9.0 mm [0174] FOZR (Center front curve): 9.54 mm [0175] Front ADP: +10 D [0176] Horizontal front e-value −1.11 (p=2.23) [0177] Intermediate zone 24-26: half zone width 1.16 mm, radius of curvature 7.28 mm [0178] Peripheral zone 28: half zone width 1.0 mm, radius of curvature 9.8 mm). The following limitations were not found to be taught in the art: wherein the parameter range of C2 is between 1mm and 2mm, and the initial value is 1.2mm.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wang (US20180210229A1) teaches orthokeratology lens fitting.
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/JACQUELINE R ZAK/Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
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