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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju et al. US 2020/0073147 in view of Zheleznyak et al. US 2018/0243082.
Regarding claim 1, Bakaraju teaches an ophthalmic lens configured to inhibit progression of myopia in an eye or reduce myopia in the eye (see title, abstract and para 0005: teaches that spectacle lens may provide a stop signal to a myopic eye using chromatic cues to decelerate the rate of myopia progression), the ophthalmic lens comprising: a subsurface optical structure, wherein the ophthalmic lens is formed from a transparent material having a lens material refractive index (see para 0229: the refractive index of the one or more micro lenslets or ROEs may be higher than the refractive index of the material substantially surrounding, which infers the lens is formed from transparent material having a refractive index), to provide a chromatic alteration to reduce a rate of axial growth of the eye or decrease an axial length of the eye (see para 0006, 0042 and Figs. 3A-3H: teaches lenses including optical structures embedded in the lens material, such as refractive optical element (ROE) or diffractive optical elements (DOE) for producing chromatic cues at the retinal plane to control eye growth).
Bakaraju fails to teach: wherein the subsurface optical structure comprises refractive indices that differ from the lens material refractive index.
In the same field of endeavor, Zheleznyak teaches modifying refractive indices within optical polymer materials to form refractive optical structures inside ophthalmic device (see title, abstract and para. 0002), more particularly teaches irradiating selected regions of optical polymer material with focused laser pulses to produce localized refractive index changes relative to surrounding material, thereby forming internal refractive structures or gradient-index layers within the contact lens (see para 0009-0011). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the ophthalmic lens of Bakaraju by forming the embedded optical structures as subsurface refractive index structures within the lens material as taught by Zheleznyak, since Zheleznyak provides a known method for implementing optical structures inside transparent ophthalmic polymer while maintaining the chromatic optical functionality used by Bakaraju to control eye growth and inhibit myopia progression.
Regarding claim 2, the combination of Bakaraju teaches the ophthalmic lens of claim 1, and Zheleznyak further teaches wherein the subsurface optical structure comprises a diffractive structure configured to provide the chromatic alteration (see para 0180: “sub-surface phase changes that may be tailored to the specific optical and physical properties of the lens, e.g. combinations of toric or cylindrical subsurface refractive index change corrections with diffractive multifocal patterns utilizing refractive index changes, all within a ballasted contact lens to maintain proper orientation to the eye”).
Regarding claim 3, the combination of Bakaraju teaches the ophthalmic lens of claim 2, Zheleznyak further teaches wherein the subsurface optical structure is configured to provide a subsurface optical structure diffractive and/or refractive wavefront alteration (see title, abstract and paras. 0002-0004: teaches forming subsurface optical structures within the ophthalmic polymer materials by locally modifying the refractive index of the material, para 0005, 0011 and 0180: further teaches that such internal structures may include gradient-index (GRIN) layers and Fresnel-type or diffractive wavefront structures within the lens material that modify the optical phase and wavefront of transmitted light).
Regarding claim 4, the combination of Bakaraju teaches the ophthalmic lens of claim 3, and Bakaraju further teaches comprising an exterior shape configured to provide an exterior shape refractive wavefront alteration (see para 0006, 0042 and Figs. 3A-3H: teaches lenses including optical structures embedded in the lens material, such as refractive optical element (ROE) or diffractive optical elements (DOE) for producing chromatic cues at the retinal plane to control eye growth i.e., such spectacles lenses inherently include exterior lens surface that retract incoming light and therefore provide refractive wavefront alteration).
Regarding claim 5, the combination of Bakaraju teaches the ophthalmic lens of claim 4, and Zheleznyak further teaches wherein the subsurface optical structure diffractive and/or refractive wavefront alteration and the exterior shape refractive wavefront alteration jointly provide a combined wavefront alteration that provides 0 diopter of optical power (para 0005 and 0011: teaches forming subsurface refractive-index structures withing the ophthalmic lens materials that modify optical wavefront and provide refractive or diffractive corrections). Accordingly, it would have been obvious to one of ordinary skill in the art to combine the subsurface wavefront alteration taught by Zheleznyak with the exterior refractive shape of the ophthalmic lens of Bakaraju such that the combined wavefront alteration provides a desired net optical power, including 0 diopter, which is a known design choice in ophthalmic lenses.
Regarding claim 6, the combination of Bakaraju teaches the ophthalmic lens of claim 4, and Zheleznyak further teaches wherein the subsurface optical structure diffractive and/or refractive wavefront alteration and the exterior shape refractive wavefront alteration jointly provide a positive diopter combined wavefront alteration (see para 0006: optical structures may provide positive or negative power correction).
Regarding claim 7, the combination of Bakaraju teaches the ophthalmic lens of claim 4, and Zheleznyak further teaches wherein the subsurface optical structure diffractive and/or refractive wavefront alteration and the exterior shape refractive wavefront alteration jointly provide a negative diopter combined wavefront alteration (see para 0006: optical structures may provide positive or negative power correction).
Regarding claim 8, the combination of Bakaraju teaches the ophthalmic lens of claim 1, and Zheleznyak further teaches comprising an exterior shape configured to provide a zero diopters refractive wavefront alteration (para 0006 teaches: forming subsurface refractive-index structures within ophthalmic lens materials and further tache that such optical structures may provide positive or negative power corrections). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the exterior shape of the ophthalmic lens of Bakaraju to provide a desired optical power, including zero diopters, since selecting the magnitude of optical power including zero is a routine design choice in ophthalmic lens design.
Regarding claim 9, the combination of Bakaraju teaches the ophthalmic lens of claim 8, and Bakaraju further teach wherein the subsurface optical structure is configured to provide a subsurface optical structure diffractive and/or refractive wavefront alteration see para 0006, 0042 and Figs. 3A-3H: teaches lenses including optical structures embedded in the lens material, such as refractive optical element (ROE) or diffractive optical elements (DOE) for producing chromatic cues at the retinal plane to control eye growth.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju and Zheleznyak as applied to claim 1 above, and further in view of Futhey et al. US Patent No. 5,229,797.
Regarding claim 10, the combination of Bakaraju teaches the ophthalmic lens of claim 1, but fails to teach wherein: the subsurface optical structure provides a wavefront alteration comprising piston regions of different constant whole number optical phase in waves with respect to a reference wavelength and optical phase discontinuity regions; each of the optical phase discontinuity regions extends between and separates respective two immediately adjacent instances of the piston regions; and the subsurface optical structure provides the chromatic alteration for wavelengths that differ from the reference wavelength.
In the same field of endeavor, Futhey teaches a multifocal ophthalmic lens having a diffractive zone plate with a central zone and concentric annular zones each zone separated from an adjacent zone by an optical step having an optical height defined relative to a design wavelength (see col. 3 lines 13-21). Futhey further teaches that adjacent annular zones differ in optical path length by a fraction of the design wavelength and discusses that wavelength dependence of diffractive chromatic aberration (see col. 4 lines 10-43). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to implement the subsurface diffractive optical structure of Bakaraju and Zheleznyak using the wavelength-referenced diffractive zone structure taught by Futhey, since Futhey teaches phases zones separated by optical discontinuities in an ophthalmic lens to provide wavelength-dependent wavefront alteration, thereby yielding the claimed piston-region and phase-discontinuity arrangement.
Claim(s) 11, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju and Zheleznyak as applied to claim 1 above, and further in view of Ho et al. WO 2018/152596
Regarding claims 11 and 12, the combination of Bakaraju teaches the ophthalmic lens of claim 1, except for configured to defocus one or more blue-light wavelengths.
In the same field of endeavor, Ho teaches an ophthalmic lens system that medium wavelength may be focused at or near the retina, longer wavelengths may be focused at or near the retina, longer wavelengths may be focused to introduce myopic defocus, and short wavelengths, such as blue light may be focused substantially on or behind the retain (see para 0008-0021). Ho, further teaches that the lens system may be used to reduce progression of myopia and/or reduce progression of axial growth (para 0030), and also teaches having different powers for longer, shorter, and medium wavelength including blue (para 0018). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the ophthalmic lens of Bakaraju and Zhelenzyak to defocus one or more blue light wavelengths as taught by Ho, since Ho expressly teaches wavelength-dependent focal positioning, including blue-light positioning, to reduce myopia progression and axial growth.
Regarding claim 14, the combination of Bakaraju teaches the ophthalmic lens of claim 1, except for wherein the subsurface optical structure is configured to: decrease a focal length of a red-light wavelength relative to a focal length of a reference wavelength; and increase a focal length of a blue-light wavelength relative to the focal length of the reference wavelength.
In the same field of endeavor, Ho teaches an ophthalmic lens system for controlling longitudinal chromatic aberration and teaches wavelength-dependent focal positioning in which medium wavelengths may be focused at or near the retina, longer wavelengths such as red may be focused to introduced myopic defocus, and shorter wavelength such as blue may be focused substantially on or behind the retina (see para 0008-0021). Further teaches that the lens system may be used to reduce progression of myopia and/or reduce progression of axial growth (para 0030), and also teaches having different powers for longer, shorter, and medium wavelength including blue (para 0018). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the subsurface optical structure of the ophthalmic lens of Bakaraju and Zhelenzyak to decrease the focal length of red light and increase the focal length of blue light relative to a reference wavelength as taught by Ho, since Ho expressly teaches wavelength-dependent focal shifting of red, blue, and reference wavelength for myopia control chromatic effect.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju, Zheleznyak and Ho as applied to claim 14 above, and further in view of Hong et al. US 2007/0182924
Regarding claims 15-17, the combination of Bakarasu teaches the ophthalmic lens of claim 14, however, fails to teach wherein the subsurface optical structure is configured is configured to provide at least a 3.0 diopter diffractive wave front (claim 15), at least a 6.0 diopter diffractive wave front (claim 16), at least a 9.0 diopter diffractive wave front (claim 17) that provides the chromatic alteration.
In the same field of endeavor, Hong teaches ophthalmic lenses having diffractive patterns that provide optical power by diffraction (see para 0034), the diffractive structures provide optical power corresponding to near and intermediate focal regions, where the near focus provides an ad power in a range of about 3 to 9 diopters, and the intermediate focus provides an add power in a range of about 1.5 to 4.5 diopters (para 0007), see also para 0051 describing near-focus add power in a range of about 3-9 diopters generated by the diffractive structures.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the subsurface optical structure of the lens of Bakaraju, Zheleznyak and Ho to provide a diffractive front having a selected optical power within 3 to 9 diopter range as taught by Hong, since Hong expressly teaches that diffractive ophthalmic patterns may be designed to provide add powers in that range.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju and Zheleznyak as applied to claim 1 above, and further in view of Matsuoka et al. US 2022/0244573
Regarding claim 18, the combination of Bakaraju teaches the ophthalmic lens of claim 1, except for wherein the subsurface optical structure is configured to increase a focal length of a red-light wavelength and decrease the focal length of a blue-light wavelength.
In the same field of endeavor, Matsuoka teaches an ophthalmic lens having positive longitudinal chromatic aberration produced by diffraction structure with blaze wavelength on the short-wavelength side of visible light (see abstract, para 0042-0045, 0054-0058 and 0067). Matsuoka further teaches that, in positive longitudinal chromatic aberration, the power is stronger for the short wavelength than the long wavelength, while negative longitudinal chromatic aberration is the opposite (para 0052-0053). Matsuoka also teaches that a light ray on the short wavelength side moves to the overfocus side after the diffraction structure is provided (para 0063). Since stronger optical power corresponds to shorter focal length, and weaker optical power corresponds to longer focal length, Matsuoka teaches decreasing the focal length of blue light and increasing the focal length of red light. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the subsurface optical structure of the ophthalmic lens of Bakarajsu and Zheleznyak to increase the focal length of red light and decrease the focal length of the blue light as taught by Matsuoka since Matsuoka expressly teaches short wavelength side diffraction structures that provide longitudinal chromatic aberration for myopia control purposes.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju, Zheleznyak and Matsuoka as applied to claim 18 above, and further in view of Hong et al. US 2007/0182924
Regarding claim 19, the combination of Bakaraju teaches the ophthalmic lens of claim 18, except for wherein the subsurface optical structure is configured to provide at least a -3.0-diopter diffractive wave front that provides the chromatic alteration.
In the same field of endeavor, Hong teaches ophthalmic lenses having diffractive patterns shat provide optical power by diffraction (see para 0007). Hong further teaches that the optic surface includes diffractive structures forming concentric annular zones that diffract incident light into different diffraction orders to generate multiple focal regions (see para 0034: describing diffractive structures forming annular diffractive zones that diffract incident light into multiple diffraction orders). Hong further teaches that the diffractive structures provide optical power corresponding to near and intermediate focal regions, where the near focus provides an ad power in a range of about 3 to 9 diopters, and the intermediate focus provides an add power in a range of about 1.5 to 4.5 diopters (para 0007), see also para 0051 describing near-focus add power in a range of about 3-9 diopters generated by the diffractive structures. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the subsurface optical structure of the lens of Bakaraju, Zheleznyak and Ho to provide a diffractive front having a selected optical power within 3 to 9 diopter range as taught by Hong, since Hong expressly teaches that diffractive ophthalmic patterns may be designed to provide add powers in that range.
Claim(s) 20-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju, and Zheleznyak as applied to claim 1 above, and further in view of Hong et al. US 2007/0182924
Regarding claim 20, the combination of Bakaraju and Zheleznyak teaches the ophthalmic lens of claim 1, and Zheleznyak further teaches wherein: each of sub-volumes of the subsurface optical structure has a respective refractive index spatial distribution (see para 0063: “the spatial distribution of the refractive index change within the micromachined region was a small-scale gradient-index structure”) so that the subsurface optical structure provides a wavefront correction.
However, the combination of Bakaraju fails to teach: piston regions of different constant whole number optical phase in waves with respect to a reference wavelength and optical phase discontinuity regions; and each of the optical phase discontinuity regions extends between and separates respective two immediately adjacent instances of the piston regions.
In the same field of endeavor, Hong teaches multifocal ophthalmic lenses having annular diffractive zone formed by diffractive structures separated at zone boundaries by step heights defined with respect to a design wavelength (para 0036-0042). Hong further teaches that the optical phase associated with diffraction orders exhibits a discontinuity at the zone boundaries, and that similar phase discontinuities occur at successive zone boundaries (para 0075, see also Fig. 8). Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the subsurface optical structure of the ophthalmic lens of Bakaraju and Zheleznyak to include wavelength referenced phase regions and phase discontinuities as taught by Hong, since Hong expressly teaches diffractive ophthalmic structures having design-wavelength phase steps and discontinuities between adjacent zones for wavefront shaping.
Regarding claim 21, the combination of Bakaraju teaches the ophthalmic lens of claim 20, and Hong further teaches wherein the subsurface optical structure provides no optical power alteration for the reference wavelength (paras. 0007, 0014 and 0036: teaches that the optic surface is characterized by a base reference curve that provides the refractive power corresponding to the far focus, para 0075 and Fig. 8 also teaches that the optical phase associated with the 0th diffraction order remains substantially constant as the square radial distance changes). Thus, Hong teaches that, at the reference/design wavelength, the diffractive structure can be configured so that no additional optical power alteration is introduced by the diffractive patter itself i.e., the optical power remains that of the base refractive curve.
Regarding claim 22, the combination of Bakaraju teaches the ophthalmic lens of claim 20, and Hong further teaches wherein: the piston regions comprise a central piston region and annular piston regions that surround the central piston region; and each of the central piston region and the annular piston regions is configured to have a different constant whole number optical phase in waves with respect to the reference wavelength (para 0034: teaches diffractive optical structures comprising a plurality of concentric annular diffractive zone disposed about an optical axis of the optic, and para 0036-0042, 0075 and Fig. 8: further teaches tht the diffractive zones are defined with respect to a design wavelength and provide phase structures separated by zone boundaries exhibiting optical phase discontinuities).
Regarding claim 23, the combination of Bakaraju teaches the ophthalmic lens of claim 22, and Hong further teaches wherein the annular piston regions comprise six of the annular piston regions (see para 0050: that the number of diffractive zones can vary from 3 to 30 zones).
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bakaraju, Zheleznyak and Hong as applied to claim 22 above, and further in view of Portney US 2007/0258143
Regarding claim 26, the combination of Bakaraju teaches the ophthalmic lens of claim 22, except for wherein each of the optical phase discontinuity regions provides a one optical wave discontinuity with respect to the reference wavelength.
In the same field of endeavor, Portney teaches a multifocal diffractive ophthalmic lens in which constructive interference occurs when light from adjacent regions is shifted by an integer number of wavelengths relative to a design wavelength. In particular, the reference explains that the first diffraction order is produced by a phase of one wavelength shift between each adjacent blaze, while higher diffraction orders are produced by phase shifts of multiple wavelengths between adjacent blaze regions (see para 0009). Thus, Portney teaches adjacent diffractive regions separated by a one-wave phase discontinuity with respect to a design/reference wavelength. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date to configure the phase discontinuity regions of the subsurface optical structure of BAkarazu, Zhleznyak, and Hong to provide a one optical wave discountinuity as taught by Portney, since Protney expressly teaches wavelength-referenced one-wave phase shifts between adjacent diffractive regions in an ophthalmic lens.
Regarding claim 27, the combination of Bakaraju teaches the ophthalmic lens of claim 26, and Portney further teaches wherein the central piston region provides zero waves with respect to the reference wavelength (para 0009 teaches that zero-order diffraction corresponds to zero phase shift between light coming from adjacent blaze zones, while first-order diffraction corresponds to a one-wavelength phase shift between adjacent blaze zone, and this establishes that design-wavelength phase convention in which a region having zero phase shift serves as the reference phase region, while adjacent regions introduce integer wavelength phase steps relative to that reference).
Conclusion
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/EPHREM Z MEBRAHTU/ Primary Examiner, Art Unit 2872