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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/1/24 is being considered by the examiner.
Priority
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection (US 20220409434 is an intervening reference since its publication date of 12/29/2022 is not more one year of the filing date of DE102023111634.7 since there is a common Applicant and Inventor) because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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 7-9 and 16-17 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.
In claim 7, the limitation of “by which one of the first and second astigmatism values identical in sign” seems unclear. If only one of the first and second astigmatism values is selected, it remains unclear what identical in sign is referring to. Is this the first and second astigmatism values identical in sign or in comparison to something else? For the purposes of examination, identical in sign will be meant as a positive or negative value.
Claims 16-17 do not recite any transitional phrase. MPEP 2111.03 states the following: The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. The determination of what is or is not excluded by a transitional phrase must be made on a case-by-case basis in light of the facts of each case. The scope of claims 16-17 are unclear since there is no transitional phrase recited that would determine whether the claims should be interpreted as inclusive/open-ended. For the purpose of examination, the claims should be interpreted as open-ended.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 19 is rejected under 35 U.S.C. 101 as not falling within one of the four statutory categories of invention and thus fails as eligible subject matter. Claim 19 characterizes the invention as “a computer-readable medium for storing a computer program.” A broadest reasonable interpretation of this language typically covers forms of non-transitory tangible media and transitory propagating signals per se, which are not patentable under 35 U.S.C. 101. Claims that cover both statutory and non-statutory embodiments under the broadest reasonable interpretation of the claims when read in light of the specification and in view of one skilled in the art, embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. The claim is considered to be broad enough to cover a transitory propagating signal that carries a programmed instruction set. Furthermore, even when the claim is directed to one of the four statutory categories of invention, the claim must not be wholly directed to subject matter encompassing a judicially recognized exception without a particular practical application. In the instant case, in addition to failing to fall within one of the four statutory categories of invention, the claim recites only instructions, i.e. an algorithm that is not limited to a particular practical application. It is suggested to add “non-transitory” to the claim. For the purpose of examination, it is assumed to read “a non-transitory computer readable storage medium.”
Claims 1-17 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-17 and 20 are directed to statutory subject matter as the claims recite a method, control device, and a treatment apparatus. As recited above and for the purposes of this 101 analysis, claim 19 will be assumed to read “a non-transitory computer-readable medium.”
Step 2A, Prong One
Regarding claim 1, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claim 1, the limitations of “determining first astigmatism values from predetermined visual disorder data of a patient, wherein the visual disorder data provides a measured refraction of the patient; determining second astigmatism values from predetermined measurement data of a cornea of the patient, wherein the measurement data provides a morphology of the cornea; ascertaining astigmatism correction data for astigmatism correction of the cornea, wherein the first and second astigmatism values are combined by a combination rule for ascertaining the astigmatism correction data; and providing the control data for the ophthalmological laser, which includes the ascertained astigmatism correction data” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to review a print out of a patient’s visual disorder data for first astigmatism values, review a print out of a patient’s measurement data for second astigmatism values, combining the first and second astigmatism values, and providing the combined value for the astigmatism correction data.
Step 2A, Prong Two
For claim 1, the judicial exception is not integrated into a practical application. In particular, claim 1 recites “an ophthalmological laser and a control device.” The ophthalmological laser amounts to nothing more than pre-solution activity of data gathering. The control device is recited at a high-level of generality and amount to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of an ophthalmological laser amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the ophthalmological laser is recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20190060121 (¶3-an examination apparatus is conventional in ophthalmological laser therapy), US 20220280338 (¶3-conventional in ophthalmological laser therapy), and US 20140243805 (¶79-an ophthalmological laser slit lamp, a link system for conventional ophthalmological biomicroscopes, fundus camera systems or, also, OCT systems). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-17 and 19, the limitations of claim 1 further define the limitations already indicated as being directed to the abstract idea.
Regarding claim 2, the limitations of “wherein a difference between the first and second astigmatism values is determined, and wherein the combination rule is provided depending on the difference” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to take the difference of the first and second values and use it for the combination rule.
Claims 3-5 are further directed to the abstract idea.
Regarding claim 6, the limitations of “wherein a difference between the first and second astigmatism values is determined, and wherein the first combination rule is used if the difference between the first and second astigmatism values is below a preset threshold value” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to take the difference of the first and second values and using it for the first combination rule if the difference between the first and second astigmatism values is below a preset threshold value.
Regarding claim 7, the limitations of “wherein a second combination rule is provided as the combination rule, by which one of the first and second astigmatism values identical in sign, and having a magnitude closer to zero, is selected” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to providing a second combination rule when one of the first and second astigmatism values identical in sign, and having a magnitude closer to zero, is selected.
Regarding claim 8, the limitations of “wherein the second combination rule includes that the cardinal astigmatism is provided by a maximum of J0,R and J0,K, if both are less than zero, and by a minimum of J0,R and J0,K, if both are greater than zero, and by zero for all further cases, and wherein the oblique astigmatism is provided by a maximum of J45,R and J45,K, if both are less than zero, and by a minimum of J45,R and J45,K if both are greater than zero, and by zero for all further cases” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to provide the second combination rule based on the cardinal astigmatism and oblique astigmatism value meeting the criteria when compared to threshold values.
Regarding claim 9, the limitations of “wherein a difference between the first and second astigmatism values is determined, and wherein the second combination rule is used if the difference between the first and second astigmatism values is above a preset threshold value” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to take the difference of the first and second values and using it for the second combination rule if the difference between the first and second astigmatism values is above a preset threshold value.
Regarding claim 10, the limitations of “wherein a third combination rule is provided as the combination rule, by which the first and second astigmatism values are combined such that the cardinal astigmatism is considered as higher than the oblique astigmatism for the astigmatism correction” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to provide a third combination rule when the first and second astigmatism values are combined such that the cardinal astigmatism is considered as higher than the oblique astigmatism for the astigmatism correction.
Regarding claim 11, the limitations of “wherein the third combination rule includes that the cardinal astigmatism is provided by a maximum of J0,R and J0,K, if both are less than zero, and by a minimum of J0,R and J0,K if both are greater than zero, and by zero for all further cases, and wherein the oblique astigmatism is calculated by (J45,R + J45,K)/2” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to provide the third combination rule based on the cardinal astigmatism and oblique astigmatism value meeting the criteria when compared to threshold values.
Regarding claim 12, the limitations of “wherein a difference between the first and second astigmatism values is determined, and wherein the third combination rule is used if the difference between the first and second astigmatism values is above a preset first threshold value, and it is further determined that a residual astigmatism above a preset second threshold value remains in the cornea after the treatment” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional using pen and paper to subtracting first and second astigmatism values and using the third combination rule when the difference is above a threshold and a residual astigmatism above a preset second threshold value remains in the cornea after the treatment.
Regarding claim 13, wherein the measured refraction is determined by a refractometer and/or a phoropter and/or an aberrometer amounts to pre-solution activity of data gathering. The refractometer, phoropter, or aberrometer is well-understood, routine, and conventional activity as evidenced by US 5612754 (col. 1 and lines 24-25-a conventional eye-refractometer), US 20120188512 (¶7-conventional phoropters), and US 20150313463 (¶7-conventional aberrometers).
Regarding claim 14, wherein the morphology of the cornea is determined by a topography device, and/or a tomography device amounts to pre-solution activity of data gathering. A topography or tomography device is well-understood, routine, and conventional activity as evidenced by US 20020082590 (¶57-a conventional topographer), US 20170216090 (¶52-conventional OCT), and US 6149609 (col. 16 and lines 5-6-conventional corneal topographic scanning devices).
Regarding claim 15, the ophthalmological laser amounts to nothing more than pre-solution activity of data gathering and is well-understood, routine, and conventional activity as stated above for claim 1. The transferring step amounts to post-solution activity of data gathering.
Regarding claim 16, a control device is recited at a high-level of generality and amount to nothing more than a part of a generic computer.
Regarding claim 17, the ophthalmological laser amounts to nothing more than pre-solution activity of data gathering and is well-understood, routine, and conventional activity as stated above for claim 1. The control device is recited at a high-level of generality and amount to nothing more than a part of a generic computer.
Regarding claim 19, a computer program is recited at a high-level of generality and amounts to nothing more than a part of a generic computer.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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, 4, 14-17, and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Arba Mosquera (US 20210361486 filed on 5/20/21), hereinafter referred to as Arba.
Regarding claim 1, Arba teaches a method for providing control data for an ophthalmological laser of a treatment apparatus for correcting an astigmatism, wherein the method comprises the following steps performed by a control device: determining first astigmatism values from predetermined visual disorder data of a patient (¶5- ascertaining a lenticule geometry of the lenticule to be separated, which includes a lenticule height, from predetermined visual disorder data of a human or animal eye), wherein the visual disorder data provides a measured refraction of the patient (¶5-wherein the lenticule geometry is defined by means of a refractive power value); determining second astigmatism values from predetermined measurement data of a cornea of the patient (¶34-generated based on predetermined visual disorder data, in particular from a previously measured topography and/or pachymetry and/or the morphology of the cornea), wherein the measurement data provides a morphology of the cornea (¶34-morphology of the cornea); ascertaining astigmatism correction data for astigmatism correction of the cornea (¶10-the correction value is ascertained; ¶22-the mentioned control datasets are usually generated based on a measured topography and/or pachymetry and/or morphology of the cornea to be treated and the type of the visual disorder to be corrected), wherein the first and second astigmatism values are combined by a combination rule for ascertaining the astigmatism correction data (¶14-an average value from refractive power deviations at different points of time, wherein the achieved refractive power value is determined after an application of the treatment apparatus. In other words, the correction value, which is ascertained from a deviation of the expected and the achieved lenticule height, can be combined with a refractive power correction value, wherein the refractive power correction value is ascertained from a deviation of the planned and the achieved refractive power value. Therein, the refractive power correction value can preferably be determined by means of the same statistical approaches as the correction value. By this form of configuration, the advantage arises that a deviation of the refractive power value can be additionally taken into account in ascertaining the deformation geometry; ¶6-the visual disorder data can for example describe ametropia, thus deviation of the refractive power of an eye or a cornea from the ideal value, for example myopia, hyperopia or astigmatism); and providing the control data for the ophthalmological laser, which includes the ascertained astigmatism correction data (¶22-wherein the control dataset or datasets include control data for positioning and/or for focusing individual laser pulses in the cornea, and can comprise at least one beam device for beam guidance and/or beam shaping and/or beam deflection and/or beam focusing of a laser beam of the laser. Therein, the mentioned control datasets are usually generated based on a measured topography and/or pachymetry and/or morphology of the cornea to be treated and the type of the visual disorder to be corrected; ¶20-treatment apparatus with at least one eye surgical laser).
Regarding claim 4, Arba teaches the method according to claim 1, wherein a first combination rule is provided as the combination rule, by which an average value between the first and second astigmatism values is determined (¶14-an average value from refractive power deviations at different points of time, wherein the achieved refractive power value is determined after an application of the treatment apparatus. In other words, the correction value, which is ascertained from a deviation of the expected and the achieved lenticule height, can be combined with a refractive power correction value, wherein the refractive power correction value is ascertained from a deviation of the planned and the achieved refractive power value. Therein, the refractive power correction value can preferably be determined by means of the same statistical approaches as the correction value. By this form of configuration, the advantage arises that a deviation of the refractive power value can be additionally taken into account in ascertaining the deformation geometry).
Regarding claim 14, Arba teaches the method according to claim 1, wherein the morphology of the cornea is determined by a topography device, and/or a tomography device (¶22-control datasets are usually generated based on a measured topography and/or pachymetry and/or morphology of the cornea to be treated and the type of the visual disorder to be corrected).
Regarding claim 15, Arba teaches a method for controlling a treatment apparatus, wherein the method comprises the following steps: providing control data for an ophthalmological laser of a treatment apparatus according to the method of claim 1 (¶5-providing control data of an eye surgical laser of a treatment apparatus), and transferring the provided control data to the ophthalmological laser of the treatment apparatus (¶5-providing control data for controlling the eye surgical laser is effected by the control device; ¶6-the visual disorder data can be effected by retrieving the visual disorder data from a data storage or data server, or the visual disorder data can for example be received from a measuring appliance performing measurements).
Regarding claim 16, Arba teaches a control device, which is configured to perform a respective method according to claim 1 (¶31-control device 20).
Regarding claim 17, Arba teaches a treatment apparatus with at least one ophthalmological laser for configured to perform separation of a corneal volume with predefined interfaces of a human or animal eye by optical breakdown (¶31-a treatment apparatus 10 with an eye surgical laser 18 for the separation of a corneal volume/cornea volume predefined by a lenticule geometry of a cornea of a human or animal eye 36, thus a lenticule 12, which can also be referred to as volume body, with predefined interfaces 14, 16 by means of photodisruption), and at least one control device according to claim 16 (¶31-control device 20).
Regarding claim 19, Arba teaches a computer-readable medium for storing a computer program, the computer program comprising commands which cause a treatment apparatus to execute the method according to claim 1 (¶24-a computer program including instructions, which cause the treatment apparatus according to the third inventive aspect to execute the method steps).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Shraiki (US 20220409434 filed on 6/16/22).
Regarding claim 1, Shraiki teaches a method for providing control data for an ophthalmological laser of a treatment apparatus for correcting an astigmatism (¶20-correction for astigmatism), wherein the method comprises the following steps performed by a control device (¶41-control device 20): determining first astigmatism values from predetermined visual disorder data of a patient (¶20-. the term astigmatism is in particular also known as cornea curvature, which has a refractive error of the eye. Thus, it is a visual disorder of the patient), wherein the visual disorder data provides a measured refraction of the patient (¶22-the refractive index of the cornea are patient-specific and the anterior target interface can thus be individually determined by considering in the mathematical model such that corresponding individual visual disorders); determining second astigmatism values from predetermined measurement data of a cornea of the patient (¶29-this data in particular corresponds to the preset parameter. In particular, control datasets are generated at least by providing topographic and/or pachymetric and/or morphologic data of the untreated cornea and providing topographic and/or pachymetric and/or morphologic data of the pathological and/or unnaturally altered area to be removed within the cornea or considering corresponding optical corrections for eliminating the visual disorders), wherein the measurement data provides a morphology of the cornea (¶29-morphologic data of the untreated cornea); ascertaining astigmatism correction data for astigmatism correction of the cornea (¶52-a correction for an astigmatism and/or a correction for a spherical aberration can be determined; ¶41-a treatment apparatus 10 with an eye surgical laser 18 for the separation of a predefined corneal), wherein the first and second astigmatism values are combined by a combination rule for ascertaining the astigmatism correction data (¶14-this mathematical model now analytically describes the shape of the anterior target interface depending on the posterior actual interface. Now, based on this anterior target interface and based on the anterior actual interface, which can in particular also be already preset by the patient information, the shape of the volume body to be removed can be determined; ¶20); and providing the control data for the ophthalmological laser, which includes the ascertained astigmatism correction data (¶33-wherein the control dataset or datasets include(s) control data for positioning and/or focusing individual laser pulses in the cornea, and includes at least one beam device for beam guidance and/or beam shaping and/or beam deflection and/or beam focusing of a laser beam of the laser; ¶30-treatment apparatus with at least one eye surgical laser).
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 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Arba in view of Miller (US 20200345541 filed on 11/30/17).
Regarding claim 2, Arba teaches the method according to claim 1. However, Arba does not teach wherein a difference between the first and second astigmatism values is determined, and wherein the combination rule is provided depending on the difference.
Miller teaches wherein a difference between the first and second astigmatism values is determined (¶19-the laser treatment may be modified based on the difference between the first signal and the second signal), and wherein the combination rule is provided depending on the difference (¶19- if the difference is above the threshold, the signal processor 112 may transmit instructions to the treatment system 102 to cease treatment. If the difference is below the threshold or the difference is unclear based on an error in the detection of the responses or derivation of the signals, among other examples, the signal processor 112 may transmit instructions to the treatment system 102 to direct a subsequent pair of laser pulses in order to repeat the process).
Miller generally describes techniques to monitor efficacy of laser eye treatment through cell lysis determination (¶4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein a difference between the first and second astigmatism values is determined, and wherein the combination rule is provided depending on the difference of Miller in order to modify the laser treatment (Miller, ¶5).
Regarding claim 6, Arba teaches the method according to claim 4. However, Arba does not teach wherein a difference between the first and second astigmatism values is determined, and wherein the first combination rule is used if the difference between the first and second astigmatism values is below a preset threshold value.
Miller teaches wherein a difference between the first and second astigmatism values is determined (¶5-a difference between the first signal and the second signal), and wherein the first combination rule is used if the difference between the first and second astigmatism values is below a preset threshold value (¶19-if the difference is below the threshold or the difference is unclear based on an error in the detection of the responses or derivation of the signals, among other examples, the signal processor 112 may transmit instructions to the treatment system 102 to direct a subsequent pair of laser pulses in order to repeat the process).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein a difference between the first and second astigmatism values is determined, and wherein the first combination rule is used if the difference between the first and second astigmatism values is below a preset threshold value of Miller in order to modify the laser treatment (Miller, ¶5) or direct a subsequent pair of laser pulses in order to repeat the process (Miller, ¶19).
Claims 3, 5, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Arba in view of Verma (NPL “The art of nomograms” published in 2018).
Regarding claim 3, Arba teaches the method according to claim 1. However, Arba does not teach wherein the first and second astigmatism values are divided into two vector components, wherein the first astigmatism values comprise a vector J0,R for a cardinal astigmatism, in which cylinder axes of the astigmatism for 0° and 90° are perpendicular to each other, and a vector J45,R for an oblique astigmatism, in which cylinder axes for 45° and 135° are perpendicular to each other, wherein the second astigmatism values comprise a corresponding vector J0,K for the cardinal astigmatism and a corresponding vector J45,K for the oblique astigmatism.
Verma teaches wherein the first and second astigmatism values are divided into two vector components (page 3, right col.-Nomogram 5 section-cardinal and oblique astigmatism), wherein the first astigmatism values comprise a vector J0,R for a cardinal astigmatism, in which cylinder axes of the astigmatism for 0° and 90° are perpendicular to each other (page 3, right col., last ¶- the power of a Jackson crossed-cylinder with axes at 0 degree and 90 degrees; page 4, left col., last ¶- (separate cardinal and oblique components analyses)), and a vector J45,R for an oblique astigmatism, in which cylinder axes for 45° and 135° are perpendicular to each other (page 3, right col., last ¶-page 4, left col., ¶1-the power of a Jackson crossed-cylinder with axes at 45 degrees and 135 degrees; page 4, left col., last ¶- (separate cardinal and oblique components analyses)), wherein the second astigmatism values comprise a corresponding vector J0,K for the cardinal astigmatism and a corresponding vector J45,K for the oblique astigmatism (Table 2-Nom. 5 for 0 and 45 degree axis).
Verma relates to retrospectively analyse strategies for adjusting refractive surgery plans with reference to the preoperative manifest refraction (page 1, Background section).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein the first and second astigmatism values are divided into two vector components, wherein the first astigmatism values comprise a vector J0,R for a cardinal astigmatism, in which cylinder axes of the astigmatism for 0° and 90° are perpendicular to each other, and a vector J45,R for an oblique astigmatism, in which cylinder axes for 45° and 135° are perpendicular to each other, wherein the second astigmatism values comprise a corresponding vector J0,K for the cardinal astigmatism and a corresponding vector J45,K for the oblique astigmatism of Verma in order to evaluate the differences among systematic strategies for adjusting the surgical refractive plan (Verma, page 8, right col., ¶2).
Regarding claim 5, the combination of Arba and Verma teaches the method according to claim 3, wherein the first combination rule includes that the cardinal astigmatism is calculated by (J0,R + J0,K)/2 and the oblique astigmatism by (J45,R + J45,K)/2 (MPEP 2111.04: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim.” In this case, if the cardinal astigmatism and oblique astigmatism were calculated differently, the claim limitation is not required).
Regarding claim 10, the combination of Arba and Verma teaches the method according to claim 3, wherein a third combination rule is provided as the combination rule, by which the first and second astigmatism values are combined such that the cardinal astigmatism is considered as higher than the oblique astigmatism for the astigmatism correction (MPEP 2111.04: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim.” In this case, if the first and second astigmatism values were combined and the cardinal astigmatism was considered lower than the oblique astigmatism, the claim limitation is not required).
Regarding claim 11, the combination of Arba and Verma teaches the method according to claim 10, wherein the third combination rule includes that the cardinal astigmatism is provided by a maximum of J0,R and J0,K, if both are less than zero, and by a minimum of J0,R and J0,K if both are greater than zero, and by zero for all further cases, and wherein the oblique astigmatism is calculated by (J45,R + J45,K)/2 (MPEP 2111.04: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim.” In this case, if the cardinal astigmatism maximum and minimum are not less than zero and greater than zero, to meet the two respective definitions and the oblique astigmatism was calculated different, the claim limitation is not required).
Regarding claim 12, the combination of Arba and Verma teaches the method according to claim 10, wherein a difference between the first and second astigmatism values is determined, and wherein the third combination rule is used if the difference between the first and second astigmatism values is above a preset first threshold value, and it is further determined that a residual astigmatism above a preset second threshold value remains in the cornea after the treatment (MPEP 2111.04: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim.” In this case, if the difference between the first and second astigmatism values is below a preset first threshold value, and a residual astigmatism is below a preset second threshold value, the claim limitation is not required).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Arba in view of Verma as applied to claims 1 and 3 above, and further in view of Lin (CN 114077717 filed on 8/11/20).
Regarding claim 7, the combination of Arba and Verma teaches the method according to claim 3. However, the combination of Arba and Verma does not teach wherein a second combination rule is provided as the combination rule, by which one of the first and second astigmatism values identical in sign, and having a magnitude closer to zero, is selected.
Lin teaches wherein a second combination rule is provided as the combination rule, by which one of the first and second astigmatism values identical in sign, and having a magnitude closer to zero, is selected (page 3, ¶1-normalized intended refractive correction vector (NIRC): The magnitude is equal to the IRC and the vector angle is 0).
Lin relates to the analysis and evaluation of astigmatism correction results of a laser system for reshaping the cornea, and belongs to the technical field of ophthalmology (page 1, ¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein a second combination rule is provided as the combination rule, by which one of the first and second astigmatism values identical in sign, and having a magnitude closer to zero, is selected of Lin in order for correcting astigmatism (Lin, page 1, ¶6).
Regarding claim 8, the combination of Arba, Verma, and Lin teaches the method according to claim 7, wherein the second combination rule includes that the cardinal astigmatism is provided by a maximum of J0,R and J0,K, if both are less than zero, and by a minimum of J0,R and J0,K, if both are greater than zero, and by zero for all further cases, and wherein the oblique astigmatism is provided by a maximum of J45,R and J45,K, if both are less than zero, and by a minimum of J45,R and J45,K if both are greater than zero, and by zero for all further cases (MPEP 2111.04: “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim.” In this case, if the cardinal astigmatism maximum and minimum are not less than zero and greater than zero respectively, and the oblique astigmatism maximum and minimum are not less than zero and greater than zero respectively, the claim limitation is not required).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Arba in view of Verma and further in view of Lin as applied to claims 1, 3, and 7 above, and further in view of Gonzalez (US 20210244565 filed on 10/28/19).
Regarding claim 9, the combination of Arba, Verma, and Lin teaches the method according to claim 7. However, the combination of Arba, Verma, and Lin does not teach wherein a difference between the first and second astigmatism values is determined, and wherein the second combination rule is used if the difference between the first and second astigmatism values is above a preset threshold value.
Gonzalez teaches wherein a difference between the first and second astigmatism values is determined (¶33-an error term, which represents differences between pixel values of the undocked iris image at its pixel positions and pixel values of the docked iris image at the corresponding mapped pixel positions, is minimized), and wherein the second combination rule is used if the difference between the first and second astigmatism values is above a preset threshold value (¶57-pixels that have intensity differences greater than a predefined threshold).
Gonzalez relates to an iris registration method for an ophthalmic laser surgical procedure, and in particular, it relates to an iris registration method for registering corneal astigmatism measurement results to docked eye images (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein a difference between the first and second astigmatism values is determined, and wherein the second combination rule is used if the difference between the first and second astigmatism values is above a preset threshold value of Gonzalez in order to correct astigmatism of the eye (Gonzalez, ¶9) and to identify eyelids and reduce their deleterious effect on precision and convergence (Gonzalez, ¶57).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Arba in view of Trumm (US 20150313463 filed on 12/23/13).
Regarding claim 13, Arba teaches the method according to claim 1. However, Arba does not teach wherein the measured refraction is determined by a refractometer and/or a phoropter and/or an aberrometer.
Trumm teaches wherein the measured refraction is determined by a refractometer and/or a phoropter and/or an aberrometer (¶8-enable a reliable objective refraction measurement by means of an…aberrometer).
Trumm relates to a method and a device for stimulating the accommodation of at least one eye of a subject. In particular, the present invention thereby offers a particularly reliable option for determining a set of ophthalmological data of at least one eye of the subject and, in particular, for measuring the refractive error of the subject and for establishing an appropriate optical correction (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein the measured refraction is determined by a refractometer and/or a phoropter and/or an aberrometer of Trumm in order to increase the accuracy of the measured values or in order to reduce possible measurement errors (Trumm, ¶48).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Arba in view of Vinciguerra (US 20130083290 filed on 9/27/12).
Regarding claim 20, Arba teaches the method according to claim 14. However, Arba does not teach wherein the topography device is a keratograph, and the tomography device is an optical coherence tomograph, and/or a Scheimpflug tomograph.
Vinciguerra teaches wherein the topography device is a keratography (¶21-the topographical data to be calculated using a keratometer. The keratometer may for example be a video-keratograph), and the tomography device is an optical coherence tomograph, and/or a Scheimpflug tomograph (¶22-optical coherence tomography (OCT); ¶20-a Scheimpflug system).
Vinciguerra relates to an ophthalmological analysis method for measuring a curvature of an eye cornea using an analysis system consisting of a measuring device that is used to determine corneal topography data and an analysis device that is used to derive a curvature of the cornea from the corneal topography data (¶3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Arba to include wherein the topography device is a keratograph, and the tomography device is an optical coherence tomograph, and/or a Scheimpflug tomograph of Vinciguerra in order to suggest an ophthalmological analysis method with which a change in the curvature of the cornea may be measured (Vinciguerra, ¶6).
Conclusion
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/L.N.H./Examiner, Art Unit 3792 /AMANDA L STEINBERG/Examiner, Art Unit 3792