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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/29/2023 was considered by the examiner.
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 5, 17, 18, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “… period of time shorter than 48 hours or shorter than 24 hours.” in claims 5, 17, 18, and 19 is a relative term which renders the claim indefinite. The term “… period of time shorter than 48 hours or shorter than 24 hours.” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, examiner assumes that the phrase should have been written “… period of time shorter than 48 hours.”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 9, 10, and 13-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kubota et al. (US 2021/0382325).
Regarding Claim 1, Kubota discloses an eyewear for a subject having an eye provided with a myopia control solution (Fig. 1A, Paragraph 0047, lines 1-4), said myopia control solution inducing a temporal variation (Paragraph 0119, line 5, duration of treatment each day, Paragraph 0123, line 5, time of day of treatment, Paragraph 0129, lines 2-3, range of times of treatment, Paragraph 0049, lines 6-11, the display 72 comprises pixels which are selectively activated to provide stimulus to the retina, alternatively or in combination the projection units 12 can be used), of an ocular feature (Fig. 3, projection units 12, displays 72, or light sources 30 can be used, Paragraph 0087, lines 8-11) of said eye, said eyewear (Fig. 1A, Fig. 1B, Fig. 1C, spectacles 70) comprising:
at least one ophthalmic lens (Fig. 1A, Fig. 1B, Fig. 1C, spectacles 70, Paragraph 0053, lines 13-14, corrective lens) having an adjustable optical feature (Paragraph 0049, lines 6-11, the display 72 comprises pixels which are selectively activated to provide stimulus to the retina, alternatively or in combination the projection units 12 can be used), to be placed in front of said eye of said subject for improving vision of the subject;
control circuitry (Paragraph 0202, lines 7-8, microprocessors and/or microcontrollers have circuitry) having one or more memories (Paragraph 0200, line 7, memory device, Paragraph 0201, lines 1-12, memory) and one or more processors (Paragraph 0202, lines 7-8, microprocessors), adapted to control said ophthalmic lens by setting said adjustable optical feature to a current value (Paragraph 0087, lines 15-21, the processor controls the light sources 30, projection units 12, and the displays 72, the programmed value being the current value),
said one or more memories having in memory data relative to said temporal variation of said ocular feature of said eye (Paragraph 0053, lines 22-25, the display can be programmed to selectively activate pixels 94, Paragraph 0182, lines 1-6, duration of activation, Paragraph 0031, lines 6-7, appropriate time being an elapsed time or the temporal variation), and
said one or more processors being programmed (Paragraph 0178, lines 1-17, Paragraph 0179, lines 1-8) to determine said current value of said adjustable optical feature based on said data (Paragraph 0179, lines 1-8, the programmable myopic defocus according to the programming data can adjust the stimulation apparatus, Paragraph 0181, lines 1-9, and Paragraph 0182, lines 1-6, Paragraph 0183, lines 11-14, the programmed value being the current value, Paragraph 0182, lines 1-6, duration of activation, Paragraph 0031, lines 6-7, appropriate time being an elapsed time or the temporal variation).
Regarding Claim 2, Kubota discloses as is set forth above and further discloses wherein said data are representative of a status of said ocular feature of said eye after an elapsed time since providing said myopia control solution to said eye (Paragraph 0131, lines 7-10, user is prompted again at an appropriate time, Paragraph 0119, lines 12-14, duration and time of treatment).
Regarding Claims 3 and 16, Kubota discloses as is set forth above and further discloses wherein said current value of said adjustable optical feature is determined such as to correct a variable defect of the vision of the subject caused by said temporal variation of said ocular feature of said eye (Paragraph 0169, lines 1-5, Paragraph 0182, lines 1-6, duration of activation, Paragraph 0031, lines 6-7, appropriate time being an elapsed time or the temporal variation).
Regarding Claim 4, Kubota discloses as is set forth above and further discloses wherein said defect of the vision is one of the following: sensitivity to glare; inappropriate refractive power of said eye (Paragraph 0047, lines 1-3, partially reverse myopia (i.e. nearsightedness) progression); and lack of accommodative response of said eye.
Regarding Claims 5, 17, 18, and 19, Kubota discloses as is set forth above and further discloses wherein said data are representative of a period of time shorter than 48 hours or shorter than 24 hours (Paragraph 0043, lines 1-6, and Paragraph 0044, lines 1-5, one-hour defocus sessions).
Regarding Claim 9, Kubota discloses as is set forth above and further discloses wherein said adjustable optical feature of said ophthalmic lens comprises at least one of a dioptric feature and a light transmittance feature (Paragraph 0169, lines 1-5, programmable control over the dioptric magnitude of the peripheral defocus stimulus).
Regarding Claim 10, Kubota discloses as is set forth above and further discloses wherein said ocular feature of said eye comprises one of the following: a pupil diameter of said eye; a pupil responsiveness of said eye (Paragraph 0183, lines 1-11, sensor to measure the pupil size); a curvature of a cornea of said eye; an accommodation capacity of said eye; and a refraction of said eye.
Regarding Claim 13, Kubota discloses as is set forth above and further discloses wherein said eyewear further comprises at least a sensor adapted to detect viewing conditions or to measure said ocular feature of the eye (Paragraph 0183, lines 1-11, sensor to measure the pupil size) and wherein said processor is further programmed to determine said current value taking into account an output of said sensor.
Regarding Claim 14, Kubota discloses as is set forth above and further discloses wherein said eyewear further comprises an input circuit adapted to receive information from the subject (Paragraph 0131, lines 1-6, user can accept treatment) and wherein said one or more processors is further programmed to determine said current value based on said information inputted in said input circuit (Paragraph 0140, lines 1-3, a computing device or processor can perform the steps of Fig. 17).
Regarding Claim 15, Kubota discloses a method for determining a current value of an adjustable optical feature (Paragraph 0087, lines 15-21, the processor controls the light sources 30, projection units 12, and the displays 72) of an ophthalmic lens (Fig. 1A, Fig. 1B, Fig. 1C, spectacles 70, Paragraph 0053, lines 13-14, corrective lens) to be placed in front of an eye of a subject for improving vision of the subject, said eye of the subject being provided with a myopia control solution (Fig. 1A, Paragraph 0047, lines 1-4) inducing a temporal variation (Paragraph 0179, lines 1-8, the programmable myopic defocus according to the programming data can adjust the stimulation apparatus, Paragraph 0181, lines 1-9, and Paragraph 0182, lines 1-6, Paragraph 0183, lines 11-14, the programmed value being the current value) of an ocular feature of said eye (Paragraph 0053, lines 22-25, the display can be programmed to selectively activate pixels 94), said method comprising:
providing the subject with an eyewear having said ophthalmic lens (Fig. 1A, Fig. 1B, Fig. 1C, spectacles 70, Paragraph 0053, lines 13-14, corrective lens);
determining data relative to said temporal variation (Paragraph 0119, line 5, duration of treatment each day, Paragraph 0123, line 5, time of day of treatment, Paragraph 0129, lines 2-3, range of times of treatment, Paragraph 0050, lines 6-11, the display 72 comprises pixels which are selectively activated to provide stimulus to the retina, alternatively or in combination the projection units 12 can be used) of said ocular feature of said eye; and
determining said current value of said adjustable optical feature (Paragraph 0087, lines 15-21, the processor controls the light sources 30, projection units 12, and the displays 72, the programmed value being the current value, Paragraph 0182, lines 1-6, duration of activation, Paragraph 0031, lines 6-7, appropriate time being an elapsed time or the temporal variation) of said ophthalmic lens based on said data.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kubota et al. (US 2021/0382325) in view of Bakaraju et al. (US 2023/0176399).
Regarding Claim 6, Kubota discloses as is set forth above but doesn’t specifically disclose wherein said data are based on a statistical model relative to said temporal variation of said ocular feature of said eye, said statistical model taking into account a physiological response of the subject or of a reference population or both to said myopia control solution.
However, Bakaraju, in the same field of endeavor, teaches wherein said data are based on a statistical model relative to said temporal variation of said ocular feature of said eye (Paragraph 0104, Fig. 2, virtual retinal model, lines 8-9, comprising temporal sequence, Paragraph 0107, simulations are modelled by mathematical equations), said statistical model taking into account a physiological response of the subject (Paragraph 0108, lines 1-12, response to photoreceptor cells) or of a reference population or both to said myopia control solution, for the purpose of evaluating different therapeutic approaches to myopia control.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have the eyewear of Kubota with the wherein said data are based on a statistical model relative to said temporal variation of said ocular feature of said eye, said statistical model taking into account a physiological response of the subject or of a reference population or both to said myopia control solution, of Bakaraju, for the purpose of evaluating different therapeutic approaches to myopia control.
Allowable Subject Matter
Claims 7, 8, 11, and 12 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: with respect to the allowable subject matter, none of the prior art either alone or in combination disclose or teach of the claimed combination of limitations to warrant a rejection under 35 USC 102 or 103.
Specifically, with respect to claim 7, none of the prior art either alone or in combination disclose or teach eyewear including, as the distinguishing feature(s) in combination with the other limitations, wherein said one or more processors is further programmed to start determining a current value of said adjustable optical feature based on an input of the subject or based on a predetermined schedule.
Specifically, with respect to claim 8, none of the prior art either alone or in combination disclose or teach eyewear including, as the distinguishing feature(s) in combination with the other limitations, wherein said current value is determined based on an affine function representative of evolution of said adjustable optical feature with time, said affine function being determined based on said data.
Specifically, with respect to claim 11, none of the prior art either alone or in combination disclose or teach eyewear including, as the distinguishing feature(s) in combination with the other limitations, wherein said myopia control solution comprises providing a drug to said eye and said data include at least one of the following: pharmacokinetic data on said provided drug, concentration of said provided drug, quantity of said provided drug.
Specifically, with respect to claim 12, none of the prior art either alone or in combination disclose or teach eyewear including, as the distinguishing feature(s) in combination with the other limitations, wherein said myopia control solution comprises applying temporarily a contact lens to said eye in order to reshape a cornea of said eye and said data include reshaping data representative of evolution of a shape of the cornea with time after removing said contact lens.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Neroev et al. (US 2014/0243583), Drobe (US 2016/0000314), Leahy et al. (US 2016/0338947), Frutiger et al. (US 2020/0073145), Kubota et al. (US 2021/0356767), Kubota et al. (US 11,320,674), Baranton et al. (US 2022/0283450), Linder (US 2019/0038123), Linder (US 11,000,186), Linder et al. (US 11,974,374), Linder et al. (US 2021/0329764), and Chehab et al. (US 2014/0036225) are cited to show similar eyewear and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R ALEXANDER whose telephone number is (571)270-7656. The examiner can normally be reached M-F 8:30 AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached on (571) 270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R ALEXANDER/ Primary Examiner, Art Unit 2872