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 .
Examiner’s Comments
In view of the amendments, the objection of claim 1 is withdrawn.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 7, 10 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Norton et al. (“Refractive State of Tree Shrew Eyes Measured with Cortical Visual Evoked Potentials” 2003), hereinafter “Norton”.
Regarding claim 1, Norton discloses a method for objectively determining an optimal correction of an ophthalmic refraction of a subject (Abstract), comprising the steps of: a) providing an eye of the subject with successive distinct lens powers and recording the corresponding successive neural signals of the subject while said eye of the subject receives a visual stimulus through each lens power (Pg. 3, “Visual Stimuli”, Lines 1-2; Pg. 4, “Trial Lenses”, Lines 1-4), until the recorded neural signal corresponding to one of the lens power shows a maximum neural activity as compared to all the other recorded neural signals (Pg. 4, “Trial Lenses”, Lines 1-4), and b) determining that the optimal correction of ophthalmic refraction of the subject is a lens power with which the subject exhibits a neural signal showing a given reduced neural activity as compared to the maximum neural activity of step a) (Pg. 14, Fig. 3, Pg. 17, Fig. 6).
Regarding claim 2, Norton discloses wherein in step b), the given reduced neural activity is determined by correcting the maximum neural activity based on a predetermined factor k associated with a start of accommodation response of said eye of the subject (Pg. 4, “Data Analysis”).
Regarding claim 7, Norton discloses wherein in step b) the neural signal showing the reduced neural activity is one of the recorded neural signals or is extrapolated from said recorded neural signals (Pg. 4, “Data Analysis”, “Statistics”).
Regarding claim 10, Norton discloses wherein the neural activity of the subject, associated with one lens power, is determined by extracting at least one feature of the neural signal recorded for said lens power (Pg. 14, Fig. 3).
Regarding claims 4 and 17, Norton discloses wherein in step a), each successive lens power provided to said eye of the subject is chosen based on a reference lens power that is a rough estimate of the optimal correction of the subject (Pg. 4, “Trial Lenses”, Pg. 7, “Two-Diopter Trial Lens Steps”).
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.
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 3, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Norton (“Refractive State of Tree Shrew Eyes Measured with Cortical Visual Evoked Potentials” 2003) in view of Suzuki et al. (USPG Pub No. 2016/0242670), hereinafter “Suzuki”.
Regarding claims 3 and 16, Norton discloses wherein in step a): the lens powers provided to the eye of the subject are successively smaller and smaller (Pg. 4, “Trial Lenses”, Pg. 7, “Two-Diopter Trial Lens Steps”), the neural activity of the last recorded neural signal is compared to the neural activity of a directly previously recorded neural signal (Pg. 4, “Trial Lenses”, Pg. 7, “Two-Diopter Trial Lens Steps”), step a) stops when the directly previously recorded neural signal shows more neural activity than the last recorded neural signal, said directly previously recorded neural signal being the one that shows the maximum neural activity (Pg. 4, “Trial Lenses”, Pg. 7, “Two-Diopter Trial Lens Steps”). Norton discloses the claimed invention, but does not specify a first lens power provided to the eye being one that blurs the vision of the subject. In the same field of endeavor, Suzuki discloses a first lens power provided to the eye being one that blurs the vision of the subject (Paragraph 97, Lines 15-28). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Norton with a first lens power provided to the eye being one that blurs the vision of the subject of Suzuki for the purpose of objectively evaluating time-dependent change in visual perception and providing a calculation method (Paragraph 13).
Regarding claim 18, Norton further discloses wherein in step a), each successive lens power provided to said eye of the subject is chosen based on a reference lens power that is a rough estimate of the optimal correction of the subject (Pg. 4, “Trial Lenses”, Pg. 7, “Two-Diopter Trial Lens Steps”).
Claims 5, 6, 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Norton (“Refractive State of Tree Shrew Eyes Measured with Cortical Visual Evoked Potentials” 2003) in view of Bernard et al. (USP No. 4,697,598), hereinafter “Bernard”.
Regarding claim 5, Norton discloses the claimed invention, but does not specify wherein each lens power is given in diopter (D) and wherein a step of diopters between two consecutive lens powers is smaller when the lens powers are close to the reference lens power than when the lens powers are distant from the reference lens power. In the same field of endeavor, Bernard discloses wherein each lens power is given in diopter (D) and wherein a step of diopters between two consecutive lens powers is smaller when the lens powers are close to the reference lens power than when the lens powers are distant from the reference lens power (Col. 4, Lines 7-17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Norton with wherein each lens power is given in diopter (D) and wherein a step of diopters between two consecutive lens powers is smaller when the lens powers are close to the reference lens power than when the lens powers are distant from the reference lens power of Bernard for the purpose of providing a system producing highly accurate refractive lens prescription (Col. 1, Lines 30-31).
Regarding claim 6, Norton discloses the claimed invention, but does not specify wherein step a) is implemented by a brain-computer interface, the lens power being automatically changed based on the analysis of the neural activity of the a previously recorded neural signal. In the same field of endeavor, Bernard discloses wherein step a) is implemented by a brain-computer interface, the lens power being automatically changed based on the analysis of the neural activity of the a previously recorded neural signal (Col. 5, Lines 54-58). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Norton with wherein step a) is implemented by a brain-computer interface, the lens power being automatically changed based on the analysis of the neural activity of the a previously recorded neural signal of Bernard for the purpose of providing a system producing highly accurate refractive lens prescription (Col. 1, Lines 30-31).
Regarding claim 12, Norton discloses a device for objectively determining an optimal correction of an ophthalmic refraction of a subject (Abstract), comprising at least one neuro-sensor (“electrode”) for detecting a neural signal originating from at least one area of a brain of the subject (Pg. 2, “Electrode Implantation”, Lines 1-2, Pg. 3, “Recording”, Lines 1-2), said neural signal being linked to visual acuity of eyes of the subject (Pg. 4, “Trial Lenses”, Lines 2-4), adapted to a) record successive neural signals of the subject while at least one eye of the subject receives a visual stimulus through successive distinct lens powers (Pg. 3, “Visual Stimuli”, Lines 1-2; Pg. 4, “Trial Lenses”, Lines 1-4), until one of the recorded neural signal shows a maximum neural activity as compared to all the other recorded neural signals (Pg. 4, “Trial Lenses”, Lines 1-4), and b) determine that the optimal correction of the ophthalmic refraction of the subject corresponds to a lens power with which the subject exhibits a neural signal showing a given reduced neural activity as compared to the maximum neural activity obtained in a) (Pg. 14, Fig. 3, Pg. 17, Fig. 6). Norton discloses the claimed invention, but does not specify control circuitry. In the same field of endeavor, Bernard discloses control circuitry (30) (see Fig. 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 provide the device of Norton with control circuitry of Bernard for the purpose of providing a system producing highly accurate refractive lens prescription (Col. 1, Lines 30-31). In addition, it has been held that the recitation that an element is “adapted to” perform a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.
Regarding claim 13, Norton discloses further comprising the power of the lens through which the eye of the subject receives the visual stimulus depending on analysis of neural activity of previously recorded neural signal(s) (Pg. 4, “Trial Lenses”). Norton and Bernard teach the device set forth above for claim 12, Bernard further discloses an automated refractometer (80) controlled by the control circuitry (30/170) to automatically change the power of the lens (see Fig. 2, Col. 3, Line 68 – Col. 4, Line 3). It would have been obvious to one of ordinary skill to provide the device of Norton with the teachings of Bernard for at least the same reasons as those set forth above with respect to claim 12.
Regarding claim 15, Norton discloses wherein the device for providing said distinct lens powers through which the eye of the subject receives the visual stimulus depending on analysis of neural activity of previously recorded neural signal(s) (Pg. 4, “Trial Lenses”). Norton and Bernard teach the device set forth above for claim 12, Bernard further discloses further comprises at least one active power lens (80) whose power is driven by the control circuitry (30/170) (see Fig. 2, Col. 3, Line 68 – Col. 4, Line 3). It would have been obvious to one of ordinary skill to provide the device of Norton with the teachings of Bernard for at least the same reasons as those set forth above with respect to claim 12.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Norton (“Refractive State of Tree Shrew Eyes Measured with Cortical Visual Evoked Potentials” 2003) in view of Suzuki et al. (USPG Pub No. 2015/0133811), hereinafter “Suzuki ‘811”.
Regarding claim 11, Norton discloses the claimed invention, but does not specify wherein the feature is amplitude in a spectral signal derived from the recorded neural signal, and wherein a higher neural activity matches with higher amplitude in the spectral signal. In the same field of endeavor, Suzuki ‘811 discloses wherein the feature is amplitude in a spectral signal derived from the recorded neural signal, and wherein a higher neural activity matches with higher amplitude in the spectral signal (see Fig. 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 provide the method of Norton with wherein the feature is amplitude in a spectral signal derived from the recorded neural signal, and wherein a higher neural activity matches with higher amplitude in the spectral signal of Suzuki ‘811 for the purpose of objectively evaluating lenses suitable for a user and to design lenses using evaluation (Paragraph 6).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Norton (“Refractive State of Tree Shrew Eyes Measured with Cortical Visual Evoked Potentials” 2003) in view of Bernard et al. (USP No. 4,697,598) as applied to claim 12 above, and further in view of Schmidt et al. (USP No. 4,706,679), hereinafter “Schmidt”.
Regarding claim 14, Norton and Bernard disclose the claimed invention except for wherein the neuro-sensor further comprises at least 3 electrodes positioned on back of the a head of the subject and that are embedded into a head rest of a chair in order to record neural signals originating from an occipital area of the brain of the subject. In the same field of endeavor, Schmidt discloses wherein the neuro-sensor further comprises at least 3 electrodes (300) positioned on back of the a head of the subject and that are embedded into a head rest of a chair (600) in order to record neural signals originating from an occipital area of the brain of the subject (see Figs. 1, 9, Col. 2, Lines 53-55). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the device of Norton and Bernard with wherein the neuro-sensor further comprises at least 3 electrodes positioned on back of the a head of the subject and that are embedded into a head rest of a chair in order to record neural signals originating from an occipital area of the brain of the subject of Schmidt for the purpose of providing a non-invasive EEG head set that is easy and quick to apply to the head of a patient (Col. 1, Lines 49-,52, 58-59).
Allowable Subject Matter
Claims 8 and 9 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.
The following is a statement of reasons for the indication of allowable subject matter: none of the references, alone or in combination, disclose or teach the method of claim 2, and specifically comprising the steps of determining factor k including selecting a group of subjects whose optimal correction is known and for each subject recording successive neural signals while at least one eye of the subject receives a visual stimulus through successive distinct lens powers, including the lens power of the optimal correction, analyzing the neural activity of each recorded neural signal, and deduce which recorded neural signal shows the maximum neural activity, comparing the maximum neural activity with the neural activity of the neural signal recorded for the lens power of the optimal correction, and deducing factor k from the comparison implemented for each subject as recited in dependent claim 8.
Response to Arguments
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive. Applicant argued that Norton does not disclose or teach the claims as presented.
As presented above with respect to independent claims 1 and 12, Norton teaches a method and device for objectively determining an optimal correction of an ophthalmic refraction of a subject. Applicant argued that Norton does not disclose the limitation “b) determining that the optimal correction of the ophthalmic refraction of the subject is a lens power with which the subject exhibits a neural signal showing a given reduced neural activity as compared to the maximum neural activity of step a)”, as presented in claim 1 and similarly in claim 12.
Fig. 3 of Norton, along with the corresponding disclosure (see Pg. 5, “Results: Normal Eyes” - Paragraph 3, and caption of Fig. 3), teaches that based on the visual evoked potentials (VEP), interpreted as the recited neural activity, recorded during the testing and measuring process, the best trials lens power was determined to be -1.5 D (and -1.0 D in Fig. 4). The determination is based on the change in the P1 amplitude which is obtained with differing trial lenses and results of said lenses (see Pg. 4, “Data Analysis”). The measurements, calculations, and plots, as gathered in Norton, are analyzed and compared with respect to varied neural activity, including maximum and reduced VEP, to extract the desired value or parameter from said measurements, calculations and plots. The claim language does not exclude any additional steps taken in the determination step, such as additional mathematical processes. For these reasons, the claims remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MAHIDERE S SAHLE/Primary Examiner, Art Unit 2872 6/9/2026
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