DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
2. Applicant’s new arguments (see Remarks dated 11/14/2025) have been fully considered, but they are not persuasive regarding reference Bakaraju, which is maintained in the rejection below. The previous 102 rejections of claim 1, as anticipated by Brennan and Ho, respectively, have been withdrawn.
Applicant’s old arguments (see Remarks dated 08/19/2025) have not been considered where they address the claim 1 limitations “the treatment portion of the annular region of each of the at least one lenses having a width, wherein a normal to a surface of the treatment portion taken halfway across the width of the treatment portion crosses a normal taken at the centre of the central region, at the centre of the curvature of a surface of the central region, such that” (which are included in the claims dated 08/19/2025, but omitted from the claims dated 11/14/2025), but have otherwise been considered, and are not persuasive regarding Bakaraju.
Claim Rejections - 35 USC § 102
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
4. Claims 1, 3-4, 9-13, 15-18, and 20 are rejected under 35 USC 102(a)(1) as being anticipated by Bakaraju et al. (WO 2021056059 A1—of record).
Regarding claim 1, Bakaraju discloses a method of reducing progression of myopia (Abstract & [00115]), comprising:
providing at least one contact lens (Fig. 3, 300) having an optic zone (Fig. 3, 302) and a peripheral zone surrounding the optic zone (Fig. 3, outer region of 300 which is radially segmented into eighths), the optic zone comprising a central region (Fig. 3, 301) and an annular region that surrounds the central region (Fig. 3, 302 and its radially outer portion), wherein the central region focuses light from each distant point object to a focal point at a distal focal surface (Fig. 6A, to 604a), the annular region includes a treatment portion (Fig. 3, region 304) that is not rotationally symmetric about an optical axis of the lens ([00115]), and wherein the treatment portion has a centre of curvature that is a first distance from the optical axis (Fig. 3, 304 has a centre of curvature a first distance from the optical axis;) and the treatment portion focuses light from each distant point object to form a focused arc at a proximal focal surface (Figs. 3, as a result of 304 having an arc shape) that is closer to a posterior surface of the lens than the distal focal surface is to the posterior surface of the lens (Fig. 6A, 607a-612a are closer than 604a), the arc being outside of and surrounding a blur circle formed by light focused by the central region (Fig. 6A, 613a and 615a; [00123]); and
rotating about the optical axis, over time, the treatment portion of the at least one contact lens on the eye ([00115]), wherein the rotation reduces adaptation to a treatment stimulus by the person over time (wherein rotation of the lens inherently reduces an eye’s adaptation to a shape of the lens, as opposed to a case where the lens is not rotated).
Regarding claims 3 and 4, Bakaraju discloses wherein rotating the treatment portion over time comprises rotating the treatment portion in discrete rotation steps of 90° about the optical axis of the lens and relative to the lens wearer's retina (Figs. 8, 11, and 14).
Regarding claim 9, Bakaraju discloses providing a contact lens that that is configured to rotate in response to a force when worn by a wearer, and wherein the step of rotating comprises subjecting the lens to a force imparted by the lens wearer, wherein the force results in rotation of the treatment portion ([00115]).
Regarding claim 10, Bakaraju discloses wherein the step of rotating comprises a lens wearer blinking, thereby imparting a force on the lens ([00115]).
Regarding claim 11, Bakaraju discloses wherein the peripheral zone of each of the at least one lenses comprises a variation in thickness configured to promote rotation of the lens ([00105]-[00106]).
Regarding claim 12, Bakaraju discloses wherein the thickness profile of the peripheral zone of each of the at least one lenses has no axis of mirror symmetry or is rotationally asymmetric ([00115]).
Regarding claim 13, Bakaraju discloses wherein the thickness of the peripheral zone varies periodically around the lens (Figs. 2-3, segmented eighths).
Regarding claim 15, Bakaraju discloses providing at least two lenses ([00220]), wherein a first lens provides a treatment portion that is configured to span a first region of the lens wearer's eye ([00220], first lens on first eye), and wherein at least one additional lens provides a treatment portion that is configured to span a different region of the lens wearer's eye ([00220], second lens on a second eye), and wherein the step of rotating comprises a wearer wearing the first lens and then each of the at least one additional lenses in succession ([00220], multiple occasions of 30 minute sessions).
Regarding claim 16, Bakaraju discloses wherein the peripheral zone of each lens has a varying thickness profile that is configured to control rotation of the lens ([00106]), and wherein the first lens has a treatment portion rotationally positioned relative to the peripheral zone thickness profile, at a first angle (Fig. 3, 304 of a first lens), and the each of the at least one additional lenses has a treatment portion that is rotationally positioned, relative to the peripheral zone thickness profile at a different angle (Fig. 3, 304 of a second lens).
Regarding claim 17, Bakaraju discloses wherein rotating the treatment portion comprises a lens wearer removing and replacing the first lens with one of the additional lenses after a day ([00116], “throughout a day of lens wear”; [00118], “per day”).
Regarding claim 18, Bakaraju discloses wherein rotating the treatment portion comprises a lens wearer alternating between wearing a first lens and each one of the additional lenses ([00220]).
Regarding claim 20, Bakaraju discloses providing a lens wearer with a set of 7 lenses for wearing on each day of the week, wherein the step of rotating the treatment zone comprises wearing each of the lenses on successive days ([00203], “worn alternating daily between left and right eyes”).
Claim Rejections - 35 USC § 103
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 2 and 14 are rejected under 35 USC 103 as being unpatentable over Bakaraju.
Regarding claim 2, Bakaraju fails to explicitly disclose wherein the treatment portion of each of the at least one lenses spans less than 50% of the annular region.
However, due to the nature of optics/optical engineering, the process of lens design includes manipulation of variables such as index of refraction, lens surface radii, lens thickness, lens distances, and other shape concerns, in order to allow a lens system to meet its particular utility (usually based on focal length, but also on aberration elimination). This manipulation would normally be considered routine experimentation since the results are governed by known optics/physics equations and are known to be result-effective (unless the particular range of values meets secondary considerations).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust Bakaraju’s device such that the treatment portion of the lenses was to span <50% of the annular region, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955). In this case, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to change the proportions of the areas such that the expression was satisfied, motivated by improving image aberration correction.
Regarding claim 14, Bakaraju fails to explicitly disclose wherein the periodic variation is a sinusoid, triangular or sawtooth waveform.
However, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to adjust Bakaraju such that the periodic variation was a sinusoid/triangular/sawtooth waveform, since it has been held that a mere change in shape of an element is general recognized as being within the level of ordinary skill in the art when the change in shape is not significant to the function of the combination, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). One would have been motivated to select a sinusoid, triangular, or sawtooth waveform, for the purpose of improving image aberration correction
7. Claim 5 is rejected under 35 USC 103 as being unpatentable over Bakaraju in view of Dalal ("Soft Toric Contact Lens." SlideShare, 16 Jun 2017, https://www.slideshare.net/slideshow/soft-toric-contact-lens-77017455/77017455#2—of record).
Regarding claim 5, Bakaraju fails to explicitly disclose wherein each rotation step is a rotation by 10° about the optical axis of the lens and relative to the lens wearer’s retina.
However, Dalal teaches rotatable lenses (slide 21), and discloses wherein each rotation step is a rotation by 10° about the optical axis of the lens and relative to the lens wearer’s retina (slide 21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Bakaraju and Dalal such that each rotation step was a rotation by 10° about the optical axis, motivated by allowing for more precise accommodation of a wearer.
8. Claim 8 is rejected under 35 USC 103 as being unpatentable over Bakaraju in view of Brennan et al (US 10901237 B2—of record).
Regarding claim 8, Bakaraju fails to explicitly disclose wherein the treatment portion of each of the at least one lenses has a characteristic that reduces the contrast of an image that is formed by light passing through the central region and the treatment portion, compared to an image of an object that would be formed by light passing through only the central region.
However, Brennan teaches lenses for addressing myopia (Abstract), and discloses wherein a treatment portion of a lens has a characteristic that reduces the contrast of an image that is formed by light passing through a central region and the treatment portion, compared to an image of an object that would be formed by light passing through only the central region (column 10 lines 64-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Bakaraju and Brennan such that contrast was adjusted, motivated by addressing sensitive vision of a wearer.
9. Claim 19 is rejected under 35 USC 103 as being unpatentable over Bakaraju in view of Frutiger et al. (US 20200073145 A1—of record).
Regarding claim 19, Bakaraju fails to explicitly disclose providing a lens wearer with a prescription schedule indicating the order in which the first lens and each of the at least one additional lenses should be worn and/or how long each lens should be worn for.
However, Frutiger teaches a similar contact lens ([0002]), and discloses providing a lens wearer with a prescription schedule indicating the order in which the first lens and each of the at least one additional lenses should be worn and/or how long each lens should be worn for ([0005] & [0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine Bakaraju and Frutiger such that a wearer was provided with a prescription schedule, motivated by allowing a wearer to target a vision treatment need.
Conclusion
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daniel Jeffery Jordan whose telephone number is 571-270-7641. The examiner can normally be reached 9:30a-6:00p.
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/D. J. J./Examiner, Art Unit 2872
/STEPHONE B ALLEN/Supervisory Patent Examiner, Art Unit 2872