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 .
Applicant's amendments and remarks, filed, 12/16/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 21-30 are under examination.
Claims 1-20 have been cancelled.
Priority
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(a)-(d) is acknowledged. This application is the National Stage filing under 35 USC 371 of PCT/EP2019/083724, filed on 12/04/2019. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Withdrawn Rejection
The rejected of claims 21-25, 27-30 under 35 U.S.C. 103(a) as being unpatentable over Swital et al. (WO2015/173388) is withdrawn in view of applicant’s amendments.
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 21-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Step 1
The instantly claimed invention (claim 1 being representative) requires performing a series of process steps. As such, the claims fall into one of the four statutory categories.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 21, 27, 30, the following limitations constitute the abstract idea for the following reasons:
predicting…an evolution over time of a vision related parameter of the person from said obtained successive values by using a prediction model, wherein the prediction model is configured such that interchanging a temporal order of individual values within at least a part of said successive values affects said predicted evolution and based on said predicted evolution…;
Mental Processes
Under the broadest reasonable interpretation, the above “predicting” step (and the associated sub-steps) falls within the mental process groupings of abstract ideas for the following reasons. In particular, one of ordinary skill in the art would recognize that the “predicting” step generally involves analyzing data (using a prediction model). Furthermore, a review of the specification [page 10] clearly describes algorithmic processes for performing the above functions using conventional computer. Accordingly, the specification provides sufficient evidence that the claims are directed to an abstract idea since the specific descriptions provided for accomplishing these tasks include only data reception and analysis. Therefore, the above steps fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III. [Step 2A, Prong 1: YES].
Mathematical Concept
Given the plain meaning, the above steps also recite a mathematical concept. In particular, the “predicting” step requires using prediction model associated with various parameters. While no specific equation is being claimed, this still amounts to a mathematical calculation and/or mathematical relationship (i.e. calculating a value for a parameter). Applicant is reminded that there is no particular word or set of words that indicates a claim recites a mathematical calculation. See MPEP 2106.04(a)(2). Therefore, when read in light of the specification, the claimed predicting step also encompasses a mathematical concept. [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim includes any additional steps/elements that integrate the recited judicial exception into a practical application of the exception. In this case, the additional steps/elements that are not part of the abstract idea are as follows:
obtaining…successive values for a person corresponding to repeated measurements over time of at least one parameter relating to a lifestyle or activity of the person;
based on said predicted evolution, triggering the device to provide a prompt to the person…, the prompt instructing the person to perform a vision-protective activity comprising at least one of: (i) increasing the near-vision distance between the person's eyes and the text being read; and (ii) increasing a time duration the person spends outdoors, the prompt being provided via at least one of a vibration of the device, an audio reminder, or a visual prompt on a display of the device;
and in response to the prompt, the person performing the vision-protective activity, thereby administering a vision therapy regimen that treats or reduces the risk of myopia onset or progression.
With regards to the additional “obtaining” step, this step is not limited to any particular techniques or devices and results in obtaining data for use by the abstract idea. Therefore, this step amounts to insignificant extra-solution activity and is not indicative of an integration into a practical application. See MPEP 2106.05(g).
With regards the limitation “by using a prediction model…”, this limitation merely indicates a field of use or technological environment in which the judicial exception is performed. Although the additional element “using a prediction model” limits the identified judicial exception, this type of limitation merely confines the use of the abstract idea to a particular technological environment and thus fails to add an inventive concept to the claims. See MPEP 2106.05(h).
With regards to the additional “triggering”, this step requires providing a “prompt” to a person to encourage activity, wherein the prompt merely provides instructions and is not limited to any physical acts. Accordingly, this step does not result in administering any particular treatment but merely amounts to insignificant extra-solution activity (e.g. outputting information or advice), as discussed in MPEP § 2106.05(g), and/or generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
With regards to a person “performing the vision activity”, the activity broadly encompasses a visual prompt to move the text closer to the eyes or go outside and therefore does not amount to administering a particular treatment or prophylaxis for a disease or medical condition. See MPEP 2106.04(d)(2). For example, consider a claim that recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step recites a particular dosage and type of medication and it integrates the mental analysis step into a practical application. For this reason, the phrase “thereby administering a vision therapy regimen that treats or reduces the risk of myopia onset or progression” also does not amount to a particular treatment. See MPEP 2106.04(d)(2). Unlike Vanda, claim 21 does not recite a specific method of treating disease using an improved set of doses in light of this discovery of an underlying condition. Therefore, after careful consideration, this limitation amounts to mere instructions to “apply” the exception in a generic way or generally linking the judicial exception to field-of-use. MPEP 2106.04(d)(2). Consequently, the claimed invention does not integrate the abstract idea into a “practical application.”
With regard to the claimed processor, “device”, and sensors, these features are generically recited and merely used as tools to obtain information and perform the abstract idea. Moreover, applicant is reminded that “generic computer components such as a computer and database do not satisfy the inventive concept requirement.” See MPEP 2106.05(f) and 2106.05(h). Therefore, the additionally recited steps/elements amount to insignificant extra-solution activity that does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Even when viewed in combination, these additional steps/elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO]
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons:
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity or field of use. Moreover, methods/system for obtaining measurement data from a subject over time are routine and conventional in the art. For example, Wahl et al. (Proc. ACM Interact. Mob. Wearable Ubiquitous Technol., 2, 3, Article 139 (September 2018), pp.1-28) teaches methods, processors, and sensors for predicting sleep timing in human subjects based on measurements associated with human circadian data sets [Section 1]. Wahl additionally teaches displaying prompts to a user as well as alarm indicators [Figure 9, page 14]. Alternatively, Swital et al. (WO2015/173388) teaches a system for monitoring and analyzing the visual behavior of a user, wherein the system includes sensors, functionality for triggering sound or vibrational alerts or recommendations based on user measurements, as well as smart phone devices [see at least pages 6 and 8]; as well as providing suggestions to the user based on different visual conditions and/or stimuli including text [pages 6, 8]. Accordingly, it is the examiner’s position that the additionally recited steps/elements appended to the judicial exception were well understood, routine, and conventional in the art. See MPEP 2106.05(d)(Part II). Thus, the independent claims as a whole do not amount to significantly more than the exception itself.
Dependent Claims
Dependent claims 22-26, 28-29 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) 22-23, 28, these claims further limit the specificity of parameter (i.e. the abstract idea). Accordingly, these claims are also abstract ideas that are not patent eligible for reasons discussed above (Step 2A, analysis). Regarding claim(s) 24-26, these claims further limit when the prompt is provided (claim 24) and further limit the nature of the prompt in generic and unconventional ways (i.e. vibration, audio reminder, visual prompt on a display) without any particular specific relationship to the abstract idea (i.e. they do not make use of the predicted evolution of a vision-related parameter). As an example of insignificant extra-solution activity, in Flook the Supreme Court decided that adjusting an alarm limit according to a mathematical formula was “post-solution activity” and insufficient to confer eligibility. Flook, 437 U.S. at 590, 596–98. Therefore, under the BRI, these steps amount to insignificant activity (i.e. presenting information in some unspecified way) and/or merely indicating a field of use in which to apply a judicial exception for reasons discussed above (Step 2A, prong 2, and Step 2B analysis). See MPEP 2106.05(g) and 2106.05(h). Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Response to Arguments
Applicant’s arguments, filed 12/16/2025, have been fully considered but are not persuasive for the following reasons.
Applicant generally argues that the amended claims now require administering a particular treatment. In response, as set forth above, the step of “performing the vision activity” broadly encompasses a visual prompt (to move the text closer to the eyes or go outside) and therefore does not amount to administering a particular treatment or prophylaxis for a disease or medical condition. See MPEP 2106.04(d)(2). Similarly, with regards to the phrase “thereby administering a vision therapy regimen that treats or reduces the risk of myopia onset or progression”, the “vision therapy” is generically recited (i.e. not associated with any particular dosage and type of medication) and thus does not amount to administering a particular treatment. See MPEP 2106.04(d)(2). Unlike Vanda, claim 21 does not recite a specific method of treating disease using an improved set of doses in light of this discovery of an underlying condition. Therefore, after careful consideration, this limitation amounts to mere instructions to “apply” the exception in a generic way or generally linking the judicial exception to field-of-use. MPEP 2106.04(d)(2). Consequently, the examiner maintains that the claimed invention does not integrate the abstract idea into a “practical application.” For at least these reasons, the rejection is maintained.
Claim rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
This is a written description rejection.
Claims 21-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement is separate and distinct from the enablement requirement. The specification must: (1) describe the claimed invention in a manner understandable to a person of ordinary skill in the art, and (2) show that the inventor actually invented the claimed subject matter. In this case, the specification fails to provide written description support for the following steps:
predicting, by at least one processor, an evolution over time of a vision-related parameter of the person from said obtained successive values by using a prediction model, wherein the prediction model is configured such that interchanging a temporal order of individual values within at least a part of said successive values affects said predicted evolution, the vision-related parameter comprising at least one of: (i) a time duration spent outdoors by the person, and (ii) a near-vision distance between the person's eves and a text being read;
In this case, the above predicting step requires the use of a generically recited “prediction model” that is merely described using functional language specifying desired results and/or specific functions. One of ordinary skill in the art would understand that the practicing these steps requires that such a model be well-defined (mathematically) and validated (to achieve functionality). A review of the specification fails to provide any evidence that applicant has knowledge of such a model for the full scope of what is being claimed. The specification does generally disclose the invention can be implemented using a “machine learning model” and various self-reported parameters that will, in turn, modify the prediction model [page 11] and as well as curves associated with myopia level evolution and onset risk [page 12, Figures 2, 6]. However, such teachings are not commensurate in scope than what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Moreover, such a generic disclosure does not amount to significant details of how the claimed prediction model is mathematically defined in order to achieve the claimed function, i.e. it amounts to nothing more than using a model as a ‘black box’ with inputs/outputs at a basic level and does not clarify the structure of the prediction model or provide a sufficient disclosure for a model that is “configured such that interchanging a temporal order of individual values within at least a part of said successive values affects said predicted evolution, the vision-related parameter comprising at least one of: (i) a time duration spent outdoors by the person, and (ii) a near-vision distance between the person's eves and a text being read”. One of ordinary skill in the art would recognize that such limitations are not trivial. For example, Brennan et al. (AU2018202725) teaches a method and computer program product for estimating future axial elongation of an individual's eye as a way to predict and track refractive error progression of an individual. Unlike the instant claims, Brennan teaches a well-defined prediction model to achieve the claimed function that is based on specific equations and model parameters [0011-0018, 0037-0042]. In addition, Swital et al. (WO2015/173388) teaches a system for monitoring and analyzing the visual behavior of a user [Abstract]. In particular, Swital teaches various models that can be employed to model the relationship between variables [pages 11-12], including interpolation models to perform prediction based on values within the set of collected data used for model-fitting while extrapolation can be employed to perform prediction based on values outside the set of collected data [pages 11-12]. Therefore, the specification does not establish a reasonable structure-function correlation between the prediction model and the claimed function (predicting an evolution over time of a vision-related parameter) for the full scope of what is being claimed.
For the reasons discussed above, the specification does not provide information to demonstrate to one of ordinary skill in the art that the inventor possessed the invention at the time the application was filed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
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 21-30 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 21, 27, 30 is/are also rejected due to said dependency. Claims 21, 27, 30 recite the term “near-vision distance between the person’s eyes and a text being read” (throughout). It is unclear as to the metes and bounds of “near-vision distance”. A review of the specification does not provide any limiting definition such that the artisan would know how to avoid infringement. Clarification is requested via amendment. For purposes of examination, this term is broadly interpreted to mean “distance”.
Claims 21, 27, 30 recite “and in response to the prompt, the person performing the vision-protective activity, thereby administering a vision therapy regimen that treats or reduces the risk of myopia onset or progression.” In this case, it is unclear as to the metes and bounds of the term “vision therapy regimen”. A review of the specification does not provide any limiting definition that would serve to clarify the scope. In addition, applicant is reminded that the following are examples of language that may raise a question as to the limiting effect in a claim: (A) statements of intended use or field of use, (B) “adapted to” or “adapted for” clauses, (C) “wherein” clauses, or (D)“thereby”/”whereby”. See MPEP § 2111.04. As a result, it is unclear what positive limitation of the claimed process is intended by the above “thereby” clause. Clarification is requested via amendment. This rejection could be overcome, for example, by amending the ‘thereby' clause to positively recite an active method step.
Claims 21, 27, 30 recite “wherein the prediction model is configured such that interchanging a temporal order of individual values within at least a part of said successive values affects said predicted evolution”. It remain unclear what limiting effect of the “prediction model” is intended by the above “wherein” clause. More specifically, it is unclear in what way the claimed prediction model is “configured such that interchanging a temporal order of individual values within at least a part of said successive values affects said predicted evolution”. In addition, it is unclear in what way said “interchanging” of the order of values “affects said prediction evolution”. A review of the specification does not provide any specific computational operations, equations, or algorithms that would serve to clarify the scope. Therefore, the claim(s) is/are indefinite for failing to point out the requisite computational techniques that are included or excluded by the claim language, such that the artisan would know how to avoid infringement. Clarification is again requested via amendment. Applicant’s response has not provided any illuminating arguments or clarifying amendments that would serve to correct the issue.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619