DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 26 August 2026.
Claim(s) 1 and 15 is/are amended.
Claim(s) 1 and 8-16 is/are currently pending and have been examined.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claims 1 and 8-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 15, which is representative of claim 1, recites a method for determining a modification or a change of an initial myopia control solution used by a myopic subject, comprising:
providing statistical data relative to a statistical evolution of said eye state parameter with time while said initial myopia control solution is implemented;
computing an expected ulterior value of a magnitude linked to said eye state parameter at said ulterior time based on said statistical data relative to the statistical evolution of said eye state parameter with time while said initial myopia control solution is implemented, and a real ulterior value of said magnitude;
comparing said real ulterior value of said magnitude with said expected ulterior value of said magnitude;
determining said modification or change to said initial myopia control solution for said subject based on the result of this comparison; and
generating a signal indicating that said modification or change is recommended, said modification or change of said initial myopia control solution comprising a modification of at least one implementation parameter selected from: a concentration, a dosage, and/or a frequency of instillation of a drug in the eye, a sphere, an addition, a cut-off level of wavelength filter, a distribution of power in a periphery, a location and/or power of micro-lenses, a dimension of scattering components, and/or a duration of wear of an ophthalmic lens, and a curvature profile and/or a duration of wear of a lens for corneal reshaping, wherein
the method comprises: determining a high threshold value of statistically usual values for said magnitude at said ulterior time; comparing said real ulterior value of the magnitude with said high threshold value; and determining said modification or change of said initial myopia control solution taking into account the result of this comparison; and when said real ulterior value of the magnitude is comprises between said expected ulterior value and said high threshold value, the method comprises: when said magnitude increases when myopia degree of the eye increases, determining said modification or change of said initial myopia control solution as comprising a modification of at least one implementation parameter of said initial myopia control solution; or when said real ulterior value of the magnitude is higher than said high threshold value, the method comprises: when said magnitude increases when the myopia degree of the eye increases, determining said modification or change of said initial myopia control solution as comprising a change from said initial myopia control solution to a different myopia control solution, and when said magnitude decreases when the myopia degree of the eye increases, determining said modification or change of said initial myopia control solution as comprising a modification of at least an implementation parameter of said initial myopia control solution or a change to no myopia control solution, or
the method comprises: determining a high threshold value of statistically usual values for said magnitude at said ulterior time; comparing said real ulterior value of the magnitude with said high threshold value; and
determining said modification or change of said initial myopia control solution taking into account the result of this comparison; and when said real ulterior value of the magnitude is comprised between said expected ulterior value and said high threshold value, the method comprises: when said magnitude increases when the myopia degree of the eye increases, determining said modification or change of said initial myopia control solution as comprising a modification of at least one implementation parameter of said initial myopia control solution; or when said real ulterior value of the magnitude is higher than said high threshold value, the method comprises: when said magnitude increases when the myopia degree of the eye increases, determining said modification or change of said initial myopia control solution as comprising a change from said initial myopia control solution to a different myopia control solution, and when said magnitude decreases when the myopia degree of the eye increases, determining said modification or change of said initial myopia control solution as comprising a modification of at least an implementation parameter of said initial myopia control solution or a change to no myopia control solution.
These limitations describe a concept of comparing a change in eye parameters over time to an expected change in eye parameters to determine and outputting an adjustment to a treatment for myopia. This concept describes a process that an eye care provider should follow to determine and output how to adjust treatment for myopia. This concept is similar to the examples of “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions” and “assigning hair designs to balance head shape“ given in MPEP 2106.04(a)(2)(II)(C) as examples of the managing personal behavior sub-grouping of the methods of organizing human activity grouping. As such, these limitation set forth a method of organizing human activity. Alternatively, the identified concept is analogous to the examples of “observation”, “evaluation”, “judgement”, and “opinion” given in MPEP 2106.04(a)(2)(III) and can be performed in the human mind or with pen and paper. As such, these limitations set forth a mental process. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claim 1 recites a system comprising: one or more memories and one or more processors. This additional element is recited at an extremely high level of generality, and may be interpreted as a generic computing device used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not integrate the abstract idea into a practical application.
Claim 1 recites the additional element of a device that includes circuitry to measure a real initial value and real ulterior value of an eye state parameter representative of a myopia degree of an eye of the subject at an initial time and at an ulterior time. Claim 15 recites the additional element of a similar measurement step. This additional element reflects no improvement in the functioning of a computer or another technology. Further, this additional element does use the judicial exception with a particular machine or manufacture. This additional element does not meaningfully limit the claim and instead amounts to necessary data gathering for the abstract idea. As such, this additional element is considered insignificant extra-solution activity. As such, this additional element does not integrate the abstract idea into a practical application.
As indicated above, the claim recites the limitation “generating a signal indicating that said modification or change is recommended, said modification or change of said initial myopia control solution comprising a modification of at least one implementation parameter selected from: a concentration, a dosage, and/or a frequency of instillation of a drug in the eye, a sphere, an addition, a cut-off level of wavelength filter, a distribution of power in a periphery, a location and/or power of micro-lenses, a dimension of scattering components, and/or a duration of wear of an ophthalmic lens, and a curvature profile and/or a duration of wear of a lens for corneal reshaping.” This limitation is considered part of the abstract idea identified above. However for the purposes of compact prosecution, the analysis will consider the impact if this limitation were an additional element. The limitation is so broad as to encompass any outputting of the determined modification or change. Thus the limitation amounts to necessary data output, indicating that it is insignificant extra-solution activity. Further, this limitation does not put any meaningful limitation on the abstract idea. As such, this limitation would be considered insignificant extra-solution activity. Insignificant extra-solution activity does not integrate an abstract idea into a practical application. As such, this limitation, if it were an additional element, would not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements and the signal generation limitation amount to instructions to implement the abstract idea and insignificant extra-solution activity with a computing device. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore the independent claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, claim 1 recites additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more.
As previously noted, the claims recite an additional element of a device that includes circuitry to measure a real initial value and real ulterior value of an eye state parameter representative of a myopia degree of an eye of the subject at an initial time and at an ulterior time or an equivalent measuring step. Shammas (US 2015/0216410 A1) demonstrates (“Measurements for the ophthalmic parameters AL, AND, RND, and NT in equations (1a) or (1b) may be obtained using the well-known LENSTAR LS 900.RTM. biometer.” [0055]) that such devices and measurements were well known before the priority date of the claimed invention. At Step 2B, the fact that an additional element is well-known supports a determination that the additional element is insignificant extra-solution activity. This additional element continues to be understood as necessary data gathering for the abstract idea. As such, this additional element does not amount to significantly more than the abstract idea.
As previously noted, the claims recite the limitation of generating a signal. Again, for the purposes of compact prosecution, the analysis will consider the impact if this limitation were an additional element. Per MPEP 2106.05(d)(II), transmitting data over a network has been recognized by the courts to be a conventional computer function. Transmitting data over a network is an example of generating a signal. At Step 2B, the fact that an additional element is well-known supports a determination that the additional element is insignificant extra-solution activity. Thus this limitation would still be understood as necessary data output for the abstract idea. As such, this limitation would not amount to significantly more than the abstract idea.
There are no further additional elements. When considered as a combination, the additional elements and the signal generation limitation amount to instructions to implement the abstract idea and insignificant extra-solution activity with a computing device. As such, the combination of additional elements does not amount to significantly more than the abstract idea.
Therefore, when considered individually and as a combination, any additional elements of the independent claims do not amount to significantly more than the judicial exception. Thus the independent claims are not patent eligible.
Dependent claim 8-14 and 16 further describes the abstract idea set forth by the claim, but these claims are determined to continue to recite an abstract idea, albeit a narrowed one. Dependent claims 8-14 and 16 recite no further additional elements. The previously identified additional elements, individually and as a combination, for the same reasons as articulated above, fail to integrate the narrowed abstract idea into a practical application. Therefore the claims remain directed to an abstract idea. At Step 2B, the previously identified additional elements, individually and as a combination, for the same reasons as articulated above, do not amount to significantly more than the narrowed abstract idea. Thus as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 1 and 8-16:
Taking Claim 1 as an example, this claim has been further amended to recite iv) generating a signal indicating that said modification or change is recommended, said modification or change of said initial myopia control solution comprising a modification of at least one implementation parameter selected from… . … Such features, along with other features of the claimed invention, cannot be categorized under any of the abstract idea categories.
As previously explained, the pending claims are not (and cannot be) directed to “organizing human activity” because the features recited therein are not directed to “fundamental economic principles,” “commercial or legal interactives,” or “managing personal behavior.” Again, in order for the claims to fall into the “organizing human activity” category, the claims must actually be directed to the aforementioned practices. However, this is simply not the case in the present application.
The claims also cannot be directed to a “mental process” because the claims features cannot practically be performed in the human mind. For example, the human mind is physically incapable of generating an electronic or technical signal.
Furthermore, the claimed invention does not relate to a general or abstract clinical decision but rather to a concrete modification of specific physical, structural, or chemical parameters.”
The system of Claim 1 does not merely compute or compare data to reach an intellectual conclusion. Instead, the one or more processors is specifically programmed to transform the analytical results into a tangible technical action, namely generating a signal that directly governs physical, structure, or chemical adjustments. This integration produces a highly useful and concrete technical effect.
It is believed the claims are also directed to “significantly more” at least … because the recited features as not “well-understood, routine, or conventional.” Further evidence of this is given by the fact that the claims are novel over the prior art as no art-based rejections have been set forth.
Claim 1 provides significantly more than conventional, routine activity or mere data gathering. The tight coupling of physical eye measurements, statistical evolution analysis, and the automated generation of a signal to modify specific physical, structural, or chemical structure constitutes an inventive concept that improves the determination of a myopia control solution.
Examiner’s Response: Applicant's arguments filed 26 August 2026 have been fully considered but they are not persuasive.
Applicant’s remarks do not appear to articulate a basis for the assertion that the identified limitation cannot be categorized under any of the abstract idea categories. Examiner notes the extreme breadth of the phrase “generating a signal.” The definition of “signal” encompasses both “a detectable physical quantity or impulse (such as a voltage, current, or magnetic field strength) by which messages or information can be transmitted” and “something (such as a sound, gesture, or object) that conveys notice or warning”. The specification does not specify the signal’s mode, so the broadest reasonable interpretation of “generating a signal” encompasses one person telling another that the modification or change is recommended or one person writing instructions on a piece of paper instructing that a modification or change is recommended. Thus the broadly claimed “generating a signal” falls within the scope of methods of organizing human activity and mental processes.
Examiner appreciates the clarity with which Applicant understands the claims to not be directed to any of the abstract idea groupings but the unexplained assertion remains unpersuasive.
Examiner notes that the present claims do not recite either an “electronic” or “technical” signal.
Examiner is unaware of guidance differentiating “general or abstract clinical decisions” from “concrete modification of specific physical, structural or chemical parameters.” However, in order to advance prosecution, examiner notes 3 points. A) The recitation of, for example, “a modification of at least one implementation parameter selected from … a dosage” specifies neither drug nor magnitude of change and thus does not appear to be “concrete” in any meaningful sense. B) The claims of Mayo v. Prometheus included limitations such as “wherein the level of 6-thioguanine greater than about 400 pmol per 8x10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject” which did not make those claims eligible despite an indication to a modification of dosage. C) “Modification of specific physical, structure, or chemical parameters” does not appear to exclude a claim from reciting a mental process as any doctor is capable of thinking and writing “I’m changing the dosage of acetaminophen from 1000 mg/day to 2000 mg/day” which is a “modification of specific chemical parameters.”
Applicant’s argument appears to be grounded in out-of-date subject matter eligibility jurisprudence. er MPEP 2106(I), “eligibility should not be evaluated based on whether the claim recites a ‘useful, concrete, and tangible result,’ … as this test has been superseded.”
Applicant’s argument from novelty and non-obviousness is contrary to current guidance. Per MPEP 2106.05, “the search for an inventive concept should not be confused with a novelty or non-obviousness determination.”
Examiner notes that Applicant’s argument regarding conventionality appears to only address the claim as a whole and applicant does not appear to argue the conventionality of specific additional elements (e.g., a device that includes circuitry to measure a real initial value and real ulterior value of an eye state parameter representative of a myopia degree of an eye of the subject at an initial time and at an ulterior time). It is unclear why applicant considers the claimed measurement and analysis to be “tight[ly] coupled.” The analysis appears to simply use the measurement as a data input and then outputs the results with an entirely generic signal. One of ordinary skill in the art would not consider either this input or output to be part of any technical solution. Per MPEP 2106.05(a), “It is important to note, the judicial exception alone cannot provide the improvement.” Here, the asserted improvement lies in the abstract idea rather than any additional element or in combination with an additional element.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 14 October 2025.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-09-05
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