DETAILED ACTION
Priority
1. Receipt is acknowledged of papers submitted under 35 U.S.C. 119 (a) — (d), which papers have been placed of record in the file. Oath/Declaration
Oath/Declaration
2. Oath and declaration filed 12/25/2024 on is accepted.
Information Disclosure Statement
3. The prior art documents submitted by application in the Information Disclosure Statement filed on 6/20/2025 and 3/17/2026 and 12/25/2024 and 1/23/2025 have all been considered and made of record (note the attached copy of form PTO – 1449).
Claim Rejections - 35 USC § 112
4. 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 1-17 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.
Regarding claim 1, (“the accommodative regulation area (A2) has a first diopter distribution with N spherical aberration changes in a radial direction (Dr) , and Nis a positive integer”): a spherical aberration may be defined by a symmetric polynomial expression in Dr comprising terms with any even order above 2. By analysing such a high order spherical aberration the skilled in person cannot determine whether the local variations of the first and second derivatives of the power profile are the result of actual “spherical aberration changes” ,i.e., changes of the functional form defining the spherical aberration , or if such variations are rather comprised within one single complex spherical aberration as intended in the design of the contact lens and thus no “spherical aberration change” occurs. Therefore, the skilled in the person cannot determine how many spherical aberration changes actually occur without knowing how the lens was originally designed. And (“a maximum diopter of the second diopter distribution is obtained by adding a defocus variable to the predetermined diopter , and the defocus variable to the predetermined diopter and the defocus variable satisfies the following equation: Y=a*X2+b*X+ c, followed by the ranges of values for a,b and c ): from a single contact lens showing a local maximum of power at a radial position different than Dr= 0 it cannot be determined, at least for a large range of values of this maximum of power, whether the local maximum of power is the result of this particular function or any other. Therefore, claim make indefinite.
Claims 2-15 depends on claim 1, inherently claims 2-15 makes indefinite.
Claim Rejections - 35 USC § 102
4. 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.
Claim(s) 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakaraju et al (10,209,535 B2).
Regarding claim 1, Bakaraju et al discloses, a myopia control contact lens, comprising: a central correction area providing a predetermined diopter; an accommodative regulation area surrounding the central correction area, wherein the accommodative regulation area has a first diopter distribution with N spherical aberration changes in a radial direction, and N is a positive integer; a defocus area surrounding the accommodative regulation area, wherein the defocus area has a second diopter distribution in the radial direction (column 1, line 35; see power profile of any of figure 17-“ defocus variable of approx. 2 diopter , figure 19- “ defocus variable” of approx.. 1.5 diopters , figure 20, “ defocus variable of approx. 1.5 diopters figure 25 , , defocus variable of approx. 2 diopters, figure 29- “defocus variable “ of approx. 2 , figure 25 , or figure 52 –” “defocus variable” of approx. 1.5 diopters).
Regarding claim 2, Bakaraju et al discloses wherein each of diopters of the first diopter distribution is greater than the predetermined diopter (see figs. 17,19,20,25,29 or 52).
Regarding claim 3, Bakaraju et al discloses wherein the first diopter distribution has one or more regional maxima and one or more regional minima with a total quantity of M, wherein M is an integer and equal to N minus 1 when N is an odd, or equal to N when N is an even (see figs. 17,19,20,25,29 or 52).
Regarding claim 4, Bakaraju et al discloses wherein the second diopter distribution sequentially includes an increasing diopter area and a decreasing diopter area along the radial direction (see figs. 17,19,20,25,29 or 52).
Regarding claim 5, Bakaraju et al discloses wherein the second diopter distribution includes a regional maximum diopter, and the increasing diopter area and the decreasing diopter area use the regional maximum diopter as a dividing point (see figs. 17,19,20,25,29 or 52).
Regarding claim 6, Bakaraju et al discloses wherein a maximum variation of the N spherical aberration changes of the accommodative regulation area is within a range of the defocus variable multiplied by a first predetermined magnification that ranges from 0.01 to 0.9. (see figs. 17,19,20,25,29 or 52).
Regarding claim 7, Bakaraju et al discloses wherein the central correction area is located within a first radius range, the accommodative regulation area is located within the first radius range and a second radius range, and the defocus area is located within the second radius range and a third radius range (see figs. 17,19,20,25,29 or 52).
Regarding claim 8, Bakaraju et al discloses wherein the first radius range is between 0 mm to 0.5 mm. (see figs. 17,19,20,25,29 or 52).
Regarding claim 9, Bakaraju et al discloses wherein the second radius range includes the first radius range and a second outer diameter range, and the second outer diameter range is between 0.5 mm to 2 mm (see figs. 17,19,20,25,29 or 52).
Regarding claim 10, Bakaraju et al discloses wherein the third radius range includes the second radius range and a third outer diameter range, and the third outer diameter range is greater than 2 mm (see figs. 17,19,20,25,29 or 52).
Regarding claim 11, Bakaraju et al discloses wherein the diopters of the central correction area, the accommodative regulation area and the defocus area vary continuously (see figs. 17,19,20,25,29 or 52).
Regarding claim 12, Bakaraju et al discloses wherein a ranges from 0 and 5, b ranges from 0 and 5, and c ranges from 0.5 and 15 (see figs. 17,19,20,25,29 or 52).
Regarding claim 13, Bakaraju et al discloses, wherein the central correction area has a circular shape, and the accommodative regulation area and the defocus area each have a generally annular shape (see figs. 17,19,20,25,29 or 52).
Regarding claim 14, Bakaraju et al discloses, wherein the accommodative regulation area is used to adjust an accommodation lag of a to-be-adjusted eye and reduce a variation of an accommodative microfluctuation of the to-be-adjusted eye (see figs. 17,19,20,25,29 or 52).
Regarding claim 15, Bakaraju et al discloses, wherein the defocus area is used to adjust a defocus characteristic of a to-be-adjusted eye to a myopic defocus state (see figs. 17,19,20,25,29 or 52).
Regarding claim 16, Bakaraju et al discloses, wherein the defocus characteristic corresponds to a nasal peripheral region of the to-be-adjusted eye, and the nasal peripheral region is located within a range of a retinal eccentricity being less than 0 degrees (see figs. 17,19,20,25,29 or 52).
Regarding claim 17, Bakaraju et al discloses, wherein the defocus variable changes with the predetermined diopter in the defocus area, and the defocus variable falls within a range of 1 to 30 times the predetermined diopter (see figs. 17,19,20,25,29 or 52).
Regarding claim 18, Bakaraju et al discloses, wherein the central correction area has the predetermined diopter for completely correcting a myopia degree of a to-be-adjusted eye (see figs. 17,19,20,25,29 or 52).
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED A HASAN whose telephone number is (571)272-2331. The examiner can normally be reached M-TH 6 AM -4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bumsuk Won can be reached at 571-272-2713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED A HASAN/Primary Examiner, Art Unit 2872 7/26/2026
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