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 01/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
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 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite the abstract idea of collecting medical examination data, analyzing the data to identify patient characteristics, and adjusting subsequent examination and parameters based on the identified characteristics, which constitutes a mental process that can be performed in the human mind or using pen and paper. This judicial exception is not integrated into a practical application because additional elements merely implement the abstract idea on a generic computer and do not improve the functioning of a computer, improve a medical device, or effect a particular technological transformation. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited “computer implemented” features and electronic examinations are generic and perform well-understood, routine, and conventional functions of receiving, analyzing and adjusting data and modifying parameters based on the analysis. The claims do not recite any specific technological improvement to a computer, medical device, or examination system.
The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘Mental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978).
Claims 2-9 are dependent on claim 1 and therefore rejected for at least the same reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 10 and 11 are rejected under 35 U.S.C. § 103 as being unpatentable over Kerasidis et al. (US 2019/0246890, of record) in view of Hincapie Ordonez et al. (US 2023/0149716).
Regarding claim 1, Kerasidis discloses a computer-implemented method (title discloses: Systems And Methods For Neuro-Ophthalmology Assessments) comprising: receiving a set of neuro-ophthalmic examination results for a patient ([0065] discloses: numerical/qualitative results, are obtained from a clinician/user, for feedback with 8, test subject); identifying, from the set of neuro-ophthalmic examination results, a set of patient characteristics ([0046] discloses: eye movement tracking, accelerometer data; [0061] discloses: spatiotemporal locations etc., of 8, test subject, for processing, [0066]-[0069] discloses: including: yaw, pitch and roll, and calculating: displacement, total sway and root mean square movement; Examiner notes this location data is considered “a set of patient characteristics”); and adjusting subsequent electronic neuro-ophthalmic examinations based on the set of patient characteristics ([0048] discloses: balance, convergence, visual fields, VOR etc., assessment protocols; [0067]-[0068] discloses: assessments may be iterated and executed under different testing conditions; [0052] discloses: clinician or monitoring device may interact with system and execute different tests with different VR simulation/assessment imaging).
Kerasidis fails to disclose a method adjusting one or more parameters of examinations based on the set of patient characteristics. Kerasidis and Hincapie are related because both disclose user testing methods.
Hincapie teaches a method adjusting one or more parameters of examinations based on the set of patient characteristics (claim 1 teaches: using one or more characteristic parameters to adjust electrical stimulations as the patient changes posture).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Hincapie and provide a method adjusting one or more parameters of examinations based on the set of patient characteristics. Doing so would allow for effective target processing and response functions, thereby improving the overall functionality and efficiency of the optical system.
Regarding claim 10, Kerasidis discloses a system for generating a set of neuro-ophthalmic examinations, comprising: a display screen ([0068] discloses: display screen); and one or more processors ([0011] discloses: data processors) configured to execute a set of instructions that cause the one or more processors to: receive a set of neuro-ophthalmic examination results for a patient ([0065] discloses: numerical/qualitative results, are obtained from a clinician/user, for feedback with 8, test subject); identify, from the set of neuro-ophthalmic examination results, a set of patient characteristics ([0046] discloses: eye movement tracking, accelerometer data; [0061] discloses: spatiotemporal locations etc., of 8, test subject, for processing, [0066]-[0069] discloses: including: yaw, pitch and roll, and calculating: displacement, total sway and root mean square movement; Examiner notes this location data is considered “a set of patient characteristics”).
Kerasidis fails to disclose a system to adjust one or more parameters of the set of electronic neuro-ophthalmic examinations based on the set of patient characteristics. Kerasidis and Hincapie are related because both disclose user testing methods.
Hincapie teaches a system for adjusting one or more parameters of examinations based on the set of patient characteristics (claim 1 teaches: using one or more characteristic parameters to adjust electrical stimulations as the patient changes posture).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Hincapie and provide a system for adjusting one or more parameters of examinations based on the set of patient characteristics. Doing so would allow for effective target processing and response functions, thereby improving the overall functionality and efficiency of the optical system.
Regarding claim 11, Kerasidis discloses a computer-readable medium for generating a neuro-ophthalmic examination report, comprising: one or more processors ([0011] discloses: data processors); memory ([0080] discloses: results are calculated and stored locally in MCD memory); and a set of instructions stored in the memory that, when executed by the one or more processors, cause the one or more processors to: receive a set of neuro-ophthalmic examination results for a patient ([0065] discloses: numerical/qualitative results, are obtained from a clinician/user, for feedback with 8, test subject); identify, from the set of neuro-ophthalmic examination results, a set of patient characteristics ([0046] discloses: eye movement tracking, accelerometer data; [0061] discloses: spatiotemporal locations etc., of 8, test subject, for processing, [0066]-[0069] discloses: including: yaw, pitch and roll, and calculating: displacement, total sway and root mean square movement; Examiner notes this location data is considered “a set of patient characteristics”);
Kerasidis fails to disclose a system to adjust one or more parameters of the set of electronic neuro-ophthalmic examinations based on the set of patient characteristics. Kerasidis and Hincapie are related because both disclose user testing methods.
Hincapie teaches a system for adjusting one or more parameters of examinations based on the set of patient characteristics (claim 1 teaches: using one or more characteristic parameters to adjust electrical stimulations as the patient changes posture).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Hincapie and provide a system for adjusting one or more parameters of examinations based on the set of patient characteristics. Doing so would allow for effective target processing and response functions, thereby improving the overall functionality and efficiency of the optical system.
Claims 2-9 are rejected under 35 U.S.C. § 103 as being unpatentable over Kerasidis et al. (US 2019/0246890, of record) in view of Hincapie Ordonez et al. (US 2023/0149716), as applied to claim 1 above, in view of Seriani (US 2021/0251482).
Regarding claim 2, the modified Kerasidis discloses the computer-implement method of claim 1.
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises a patient neuro-ophthalmic diagnosis, a patient symptom, an imaging result, or a combination thereof, and wherein the one or parameters comprise a facial and limb sensation parameter, a visual acuity parameter, a visual field parameter, a double vision parameter, a color blindness parameter, an Amsler grid parameter, a cranial nerve recording parameter, a hearing test parameter, an arm or leg strength parameter, a gait parameter, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the set of neuro-ophthalmic examination results comprises a patient neuro-ophthalmic diagnosis, a patient symptom (in at least abstract discloses: communicating data with a customer), an imaging result ([0143] teaches: imaging data, for evaluations of customers), or a combination thereof, and wherein the one or parameters comprise a facial and limb sensation parameter, a visual acuity parameter, a visual field parameter, a double vision parameter, a color blindness parameter, an Amsler grid parameter, a cranial nerve recording parameter, a hearing test parameter, an arm or leg strength parameter, a gait parameter, or a combination thereof ([0135] teaches: visual acuity parameter).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises a patient neuro-ophthalmic diagnosis, a patient symptom, an imaging result, or a combination thereof, and wherein the one or parameters comprise a facial and limb sensation parameter, a visual acuity parameter, a visual field parameter, a double vision parameter, a color blindness parameter, an Amsler grid parameter, a cranial nerve recording parameter, a hearing test parameter, an arm or leg strength parameter, a gait parameter, or a combination thereof. Doing so would allow for integration of patient metrics into examination framework, thereby expanding the diagnostic scope of the system and enabling more comprehensive evaluation of the patients visual functions.
Regarding claim 3, the modified Kerasidis discloses the computer-implemented method of claim 1.
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, an eye dominance result, a glasses or contact lens wearing result, a type of eyeglasses, or a combination thereof, and wherein the one or more parameters comprise an instruction font size parameter, an object size parameter, a color plate parameter, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches disclose a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, an eye dominance result, a glasses or contact lens wearing result, a type of eyeglasses, or a combination thereof ([0039] teaches: customer diagnostic center for ordering and/or purchasing of eyeglasses and contact lenses), and wherein the one or more parameters comprise an instruction font size parameter, an object size parameter, a color plate parameter, or a combination thereof ([0099] teaches: size of objects for visual acuity measurement of customer).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, an eye dominance result, a glasses or contact lens wearing result, a type of eyeglasses, or a combination thereof, and wherein the one or more parameters comprise an instruction font size parameter, an object size parameter, a color plate parameter, or a combination thereof. Doing so would allow for integration of patient metrics into examination framework, thereby expanding the diagnostic scope of the system and enabling more comprehensive evaluation of the patients visual functions.
Regarding claim 4, the modified Kerasidis discloses the computer-implemented method of claim 1.
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, or a combination thereof, and wherein the one or more parameters comprise a focus of kinetic field test parameter, a focus of static visual field test parameter, a color plate location parameter, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, or a combination thereof ([0039] teaches: customer diagnostic center for ordering and/or purchasing of eyeglasses and contact lenses), and wherein the one or more parameters comprise a focus of kinetic field test parameter, a focus of static visual field test parameter, a color plate location parameter, or a combination thereof ([0118] teaches: Amsler grid, e.g., automated static threshold parameter).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, or a combination thereof, and wherein the one or more parameters comprise a focus of kinetic field test parameter, a focus of static visual field test parameter, a color plate location parameter, or a combination thereof. Doing so would allow for integration of patient metrics into examination framework, thereby expanding the diagnostic scope of the system and enabling more comprehensive evaluation of the patients visual functions.
Regarding claim 5, the modified Kerasidis discloses the computer-implemented method of claim 1.
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, an Amsler grid test result, a reaction speed test result, or a combination thereof, and wherein the one or more parameters comprise a static field test focus parameter, a test display location parameter, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result ([0099] teaches: size of objects for visual acuity measurement of customer), an Amsler grid test result, a reaction speed test result, or a combination thereof, and wherein the one or more parameters comprise a static field test focus parameter, a test display location parameter, or a combination thereof ([0118] teaches: Amsler grid, e.g., automated static threshold parameter; Seriani’s disclosure of automated static threshold testing corresponds to a static field test focus parameter, as such threshold testing determines focus or sensitivity within defined visual field regions).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, an Amsler grid test result, a reaction speed test result, or a combination thereof, and wherein the one or more parameters comprise a static field test focus parameter, a test display location parameter, or a combination thereof. Doing so would expand the diagnostic capability of the system by allowing inclusion of recognized visual field and acuity assessment results within the set of patient experimentation data, thereby proving a more comprehensive evaluation of the visual functions.
Regarding claim 6, the modified Kerasidis discloses the computer-implemented method of claim 1, wherein the one or more parameters comprise a test display location parameter, an eye movement test requirement parameter, a facial sensation test requirement parameter, or a combination thereof ([0046] discloses: eye movement tracking, accelerometer data; [0061] discloses: spatiotemporal locations etc., of 8, test subject, for processing).
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, an Amsler grid test result, a reaction speed test result, a kinetic visual field test result, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, an Amsler grid test result, a reaction speed test result, a kinetic visual field test result, or a combination thereof ([0118] teaches: Amsler grid, e.g., automated static threshold parameter; Seriani’s disclosure of automated static threshold testing corresponds to a static field test focus parameter, as such threshold testing determines focus or sensitivity within defined visual field regions).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, an Amsler grid test result, a reaction speed test result, a kinetic visual field test result, or a combination thereof. Doing so would expand the diagnostic capability of the system by allowing inclusion of recognized visual field and acuity assessment results within the set of patient experimentation data, thereby proving a more comprehensive evaluation of the visual functions.
Regarding claim 7, the modified Kerasidis discloses the computer-implemented method of claim 1, wherein the one or more parameters comprise an object orientation parameter, an eye movement test requirement parameter, a facial sensation test requirement parameter, a facial movement test requirement parameter, or a combination thereof ([0046] discloses: eye movement tracking, accelerometer data; [0061] discloses: spatiotemporal locations etc., of 8, test subject, for processing).
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, a reaction speed test result, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, a reaction speed test result, or a combination thereof ([0039] teaches: customer diagnostic center for ordering and/or purchasing of eyeglasses and contact lenses).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises a blind spot calibration result, a glasses or contact lens wearing result, a type of eyeglasses, a visual acuity result, a reaction speed test result, or a combination thereof. Doing so would allow for integration of patient metrics into examination framework, thereby expanding the diagnostic scope of the system and enabling more comprehensive evaluation of the patients visual functions.
Regarding claim 8, the modified Kerasidis discloses the computer-implemented method of claim 1.
Kerasidis fails to disclose a method wherein the set of neuro-ophthalmic examination results comprises patient questionnaire results, visual acuity results, or a combination thereof, and wherein the one or more parameters comprise a color plate color type parameter, a color scheme instruction parameter, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the set of neuro-ophthalmic examination results comprises patient questionnaire results, visual acuity results, or a combination thereof ([0099] teaches: size of objects for visual acuity measurement of customer), and wherein the one or more parameters comprise a color plate color type parameter, a color scheme instruction parameter, or a combination thereof ([0118] teaches: color testing, e.g., Ishihara or Farnsworth lantern).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the set of neuro-ophthalmic examination results comprises patient questionnaire results, visual acuity results, or a combination thereof, and wherein the one or more parameters comprise a color plate color type parameter, a color scheme instruction parameter, or a combination thereof. Doing so would allow for integration of patient metrics into examination framework, thereby expanding the diagnostic scope of the system and enabling more comprehensive evaluation of the patients visual functions.
Regarding claim 9, the modified Kerasidis discloses the computer-implemented method of claim 1.
Kerasidis fails to disclose a method wherein the subsequent electronic neuro- ophthalmic examinations comprise a neuro-ophthalmic patient questionnaire, a visual acuity test, an Amsler grid test, a kinetic visual field test, a static visual field test, a double vision test, a color plate test, or a combination thereof. Kerasidis and Seriani are related because both disclose optical systems.
Seriani teaches a method wherein the subsequent electronic neuro- ophthalmic examinations comprise a neuro-ophthalmic patient questionnaire, a visual acuity test, an Amsler grid test, a kinetic visual field test, a static visual field test, a double vision test, a color plate test, or a combination thereof ([0099] teaches: size of objects for visual acuity measurement of customer).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Kerasidis to incorporate the teachings of Seriani and provide a method wherein the subsequent electronic neuro- ophthalmic examinations comprise a neuro-ophthalmic patient questionnaire, a visual acuity test, an Amsler grid test, a kinetic visual field test, a static visual field test, a double vision test, a color plate test, or a combination thereof. Doing so would allow for integration of patient metrics into examination framework, thereby expanding the diagnostic scope of the system and enabling more comprehensive evaluation of the patients visual functions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Seriani (US 2020/0373016), Blum (US 2011/0082704) and Seriani et al. (US 2008/0198328) all disclose relevant optical systems.
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/J.C.S./Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872