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 . Claims 21-46 are pending and examined below.
Claim Objections
Claims 39-41 and 44-46 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim 39-41 recite dependency on any of the claims 1, 10, 21, or 30. They must depend from either claim 21 or 30 because claims 1-20 have been canceled. Claims 44-46 state dependency on any of the claims 1 to 43, 1 to 44, or 1 to 45. They must have definite dependency from only previous claims starting from claim 21. See MPEP § 608.01(n). Accordingly, the claims 39-41 and are treated as dependent from claim 21.
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.
Claim(s) 21-25, 30, 33, 39, 41-43, and 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (US 20150320547 A1) "Rosen".
Regarding Claim 21, the first embodiment of Rosen teaches an intraocular lens (intraocular lens 100, par. [0095], Fig. 2) comprising: a lens body (optic 102, par. [0095], Fig. 2), but does not disclose a certain refractive index, diopter power label, and power shape factor. However, another embodiment of Rosen teaches the lens body comprising: a refractive index between 1.40 and 1.50 inclusive (par. [0243], lens can be made from PMMA, which has a refractive index within the above mentioned range), a diopter label power between 23 D and 30 D (par. [0190]), inclusive, and a power shape factor that is less than or equal to −0.2 and greater than or equal to −1 (par. [0137], Fig. 14, shape factor may be -1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include a certain refractive index, diopter power label, and power shape factor, as taught by another embodiment of Rosen, in order to help with correction of certain aberrations and to include deformable materials that can respond appropriately to various ocular forces (Rosen, pars. [0137], [0190], and [0243]).
Regarding Claim 22, the first embodiment of Rosen does not disclose a diopter power label between 24 D and 29 D. However, another embodiment of Rosen teaches the intraocular lens according to claim 21, wherein the lens comprises a diopter label power that is between 24 D and 29 D, inclusive (par. [0190]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include a diopter power label between 24 D and 29 D, as taught by another embodiment of Rosen, in order to help with correction of certain aberrations (Rosen, par. [0190]).
Regarding Claim 23, the first embodiment of Rosen does not disclose a power shape factor between -0.8 and -0.3. However, another embodiment of Rosen teaches the intraocular lens according to claim 22, wherein the power shape factor is less than or equal to −0.3 and greater than or equal to −0.8 (par. [0137], Fig. 14, shape factor may be greater than -1 in the above mentioned range). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include a power shape factor between -0.8 and -0.3, as taught by another embodiment of Rosen, in order to help with correction of certain aberrations (Rosen, pars. [0137] and [0190]).
Regarding Claim 24, Rosen further discloses the intraocular lens according to claim 21, wherein the lens comprises a central thickness that is between 0.62 mm and 1.0 mm (par. 0217]).
Regarding Claim 25, Rosen further discloses the intraocular lens according to claim 22, wherein the lens comprises a central thickness that is between 0.70 mm and 0.90 mm (par. [0217]).
Regarding Claim 30, the first embodiment of Rosen teaches an intraocular lens (intraocular lens 100, par. [0095], Fig. 2) comprising: a lens body (optic 102, par. [0095], Fig. 2), but does not disclose a certain refractive index, diopter power label, and power shape factor. However, another embodiment of Rosen teaches the lens body comprising: a refractive index between 1.50 and 1.60 inclusive (par. [0243], lens can be made from polystyren, which has a refractive index within the above mentioned range), a diopter label power between 23 D and 35 D (par. [0190], 20-24 D overlap with stated range), inclusive, and a power shape factor that is less than or equal to −0.2 and greater than equal to −1 (par. [0137], Fig. 14, shape factor may be -1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include a certain refractive index, diopter power label, and power shape factor, as taught by another embodiment of Rosen, in order to help with correction of certain aberrations and to include deformable materials that can respond appropriately to various ocular forces (Rosen, pars. [0137], [0190], and [0243]).
Regarding Claim 33, Rosen further discloses the intraocular lens according to claim 30, wherein the lens comprises a central thickness that is between 0.45 mm and 1.0 mm (par. [0217]).
Regarding Claim 39, Rosen further discloses the intraocular lens of any of claim 1, 10, 21 or 30, wherein the power shape factor is calculated using paraxially defined curvature radii of the first surface and the second surface (pars. [0021] and [0128]).
Regarding Claim 41, the first embodiment of Rosen does not disclose a power shape factor calculated by ray tracing techniques. However, another embodiment of Rosen teaches the intraocular lens of any of claim 1, 10, 21 or 30, wherein the power shape factor is calculated by ray tracing techniques applied to the intraocular lens (par. [0153]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include a power shape factor calculated by ray tracing techniques, as taught by another embodiment of Rosen, in order to determine the effects of the shape factor on the correction of certain aberrations (Rosen, par. [0153]).
Regarding Claim 42, the first embodiment of Rosen does not disclose ray tracing techniques that utilize a specific aperture size. However, another embodiment of Rosen teaches the intraocular lens of claim 41, wherein the ray tracing techniques comprise utilizing a specific aperture size (pars. [0142] and [0156]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include ray tracing techniques that utilize a specific aperture size, as taught by another embodiment of Rosen, in order to achieve the maximum or optimum effect of the lens (Rosen, par. [0142]).
Regarding Claim 43, the first embodiment of Rosen does not disclose specific ray tracing techniques. However, another embodiment of Rosen teaches the intraocular lens of claim 41, wherein the ray tracing techniques comprise utilizing a specific aperture size, a best focus position and spherical aberration effects on the power shape factor (pars. [0138], [0153], and [0156]. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include specific ray tracing techniques, as taught by another embodiment of Rosen, in order to achieve the maximum or optimum effect of the lens and order to determine the effects of the shape factor on the correction of certain aberrations (Rosen, pars. [0142] and [0153]).
Regarding Claim 45, the first embodiment of Rosen does not disclose IOL correction as specified in ISO 11979-2 2014, Eye model #2. However, another embodiment of Rosen teaches the intraocular lens according to any of claims 1 to 44, wherein the intraocular lens corrects for the average corneal spherical aberration as specified in ISO 11979-2 2014, Eye model #2 (pars. [0180] and [0244]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include IOL correction as specified in ISO 11979-2 2014, Eye model #2, as taught by another embodiment of Rosen, in order to help with correction of certain aberrations (Rosen, par. [0180]).
Regarding Claim 46, the first embodiment of Rosen does not disclose a surface that is aspheric. However, another embodiment of Rosen teaches the intraocular lens according to any of claims 1 to 45, wherein the lens comprises an anterior surface that is aspheric, or wherein the lens comprises a posterior surface that is aspheric, or wherein the lens comprises a posterior surface and an anterior surface that are aspheric (pars. [0018] and [0151]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosen to include a surface that is aspheric, as taught by another embodiment of Rosen, in order to help with correction of certain aberrations and improve vision relative to IOLs with typical surface geometries (Rosen, par. [0018]).
Claim(s) 26-27, 31-32, 34-36, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (US 20150320547 A1) "Rosen A" in view of Rosen et al (US 20170258578 A1) "Rosen B".
Regarding Claim 26, Rosen A teaches the intraocular lens according to claim 21, further comprising an anterior haptic (haptics 104, par. [0095], Fig. 2) connected to the lens body (optic 102, par. [0095], Fig. 2), but does not disclose a vault height that is between 0.34 mm and 0.65 mm. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), wherein the lens comprises a vault height that is between 0.34 mm and 0.65 mm (par. [0059]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include a vault height that is between 0.34 mm and 0.65 mm, as taught by Rosen B, in order to have certain surface geometries for reducing aberrations (Rosen B, par. [0059]).
Regarding Claim 27, Rosen A teaches the intraocular lens according to claim 22, further comprising an anterior haptic (haptics 104, par. [0095], Fig. 2) connected to the lens body (optic 102, par. [0095], Fig. 2), but does not disclose a vault height that is between 0.40 mm and 0.60 mm. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), wherein the lens comprises a vault height that is between 0.40 mm and 0.60 mm (par. [0059]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include a vault height that is between 0.40 mm and 0.60 mm, as taught by Rosen B, in order to have certain surface geometries for reducing aberrations (Rosen B, par. [0059]).
Regarding Claim 31, Rosen A does not disclose a diopter label power is between 25 D and 35 D. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), wherein the diopter label power is between 25 D and 35 D, inclusive (par. [0063]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include a diopter label power is between 25 D and 35 D, as taught by Rosen B, in order to help correct for astigmatism and provide visual acuity for central vision (Rosen B, pars. [0081] and [0082]).
Regarding Claim 32, Rosen A does not disclose a power shape factor less than or equal to −0.40 and greater than or equal to −0.95. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), wherein the power shape factor is less than or equal to −0.40 and greater than or equal to −0.95 (par. [0073], range of -2 to -0.9 overlaps with given range). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include a power shape factor less than or equal to −0.40 and greater than or equal to −0.95, as taught by Rosen B, in order to reduce refractive errors and thus improve vision (Rosen B, Abstract).
Regarding Claim 34, Rosen A further discloses the intraocular lens according to claim 31, wherein the lens comprises a central thickness that is between 0.55 mm and 0.90 mm (par. [0217]).
Regarding Claim 35, Rosen A teaches the intraocular lens according to claim 30, further comprising an anterior haptic (haptics 104, par. [0095], Fig. 2) connected to the lens body (optic 102, par. [0095], Fig. 2), but does not disclose a vault height that is between 0.30 mm and 0.65 mm. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), wherein the lens comprises a vault height that is between 0.30 mm and 0.65 mm (par. [0059]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include a vault height that is between 0.30 mm and 0.65 mm, as taught by Rosen B, in order to have certain surface geometries for reducing aberrations (Rosen B, par. [0059]).
Regarding Claim 36, Rosen A teaches the intraocular lens according to claim 21, further comprising an anterior haptic (haptics 104, par. [0095], Fig. 2) connected to the lens body (optic 102, par. [0095], Fig. 2), but does not disclose a vault height that is between 0.35 mm and 0.60 mm. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), wherein the lens comprises a vault height that is between 0.35 mm and 0.60 mm (par. [0059]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include a vault height that is between 0.35 mm and 0.60 mm, as taught by Rosen B, in order to have certain surface geometries for reducing aberrations (Rosen B, par. [0059]).
Regarding Claim 44, Rosen A does not disclose an MTF value of at least 0.7 at a spatial frequency of 50 cycles/mm for a 5 mm pupil in green light. However, Rosen B, in the same field of art, teaches an intraocular lens (IOL 100, par. [0049], Fig. 1), having an MTF value of at least 0.7 at a spatial frequency of 50 cycles/mm for a 5 mm pupil in green light (Fig. 9A). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen A to include an MTF value of at least 0.7 at a spatial frequency of 50 cycles/mm for a 5 mm pupil in green light, as taught by Rosen B, in order to provide good on-axis image quality (Rosen B, par. [0065]).
Claim(s) 28-29, 37, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (US 20150320547 A1) "Rosen" in view of Tabernero et al (US 20070093891 A1) "Tabernero".
Regarding Claim 28, Rosen does not disclose certain surface curvatures. However, Tabernero, in the same field of art, teaches an intraocular lens (aberrated lens 81 and 91, par. [0015], Figs. 8 and 9) designed to reduce spherical aberration, wherein the lens comprises a first surface having an anterior surface curvature greater than 0 mm.sup.−1 and less than 0.120 mm.sup.−1 and a second surface having a posterior surface curvature greater than −0.367 mm.sup.−1 and less than −0.130 mm.sup.−1 (Fig. 14). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen to include certain surface curvatures, as taught by Tabernero, in order for the lens to have a specific shape factor and other dimensions to correct vision as needed (Tabernero, pars. [0079] and [0119]).
Regarding Claim 29, Rosen does not disclose certain surface curvatures. However, Tabernero, in the same field of art, teaches an intraocular lens (aberrated lens 81 and 91, par. [0015], Figs. 8 and 9) designed to reduce spherical aberration, wherein the lens comprises a first surface having an anterior surface curvature greater than 0 mm.sup.−1 and less than 0.12 mm.sup.−1 and a second surface having a posterior surface curvature greater than −0.36 mm.sup.−1 and less than −0.130 mm.sup.−1 (Fig. 14). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen to include certain surface curvatures, as taught by Tabernero, in order for the lens to have a specific shape factor and other dimensions to correct vision as needed (Tabernero, pars. [0079] and [0119]).
Regarding Claim 37, Rosen does not disclose certain surface curvatures. However, Tabernero, in the same field of art, teaches an intraocular lens (aberrated lens 81 and 91, par. [0015], Figs. 8 and 9) designed to reduce spherical aberration, wherein the lens comprises a first surface having an anterior surface curvature greater than 0.00 mm.sup.−1 and less than 0.082 mm.sup.−1 and a second surface having a posterior surface curvature greater than −0.179 mm.sup.−1 and less than −0.081 mm.sup.−1 (Fig. 14). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen to include certain surface curvatures, as taught by Tabernero, in order for the lens to have a specific shape factor and other dimensions to correct vision as needed (Tabernero, pars. [0079] and [0119]).
Regarding Claim 40, Rosen does not disclose a power shape factor formula of (Power. Sub.ant -Power.sub.post)/(Power.sub.ant + Power.sub.post). However, Tabernero, in the same field of art, teaches an intraocular lens (aberrated lens 81 and 91, par. [0015], Figs. 8 and 9) designed to reduce spherical aberration, wherein the power shape factor is calculated according to the formula (Power. Sub.ant - Power.sub.post)/(Power.sub.ant + Power.sub.post) (par. [0119], Fig. 22, although the formula used in Tabernero is the inverse of the above formula, Fig. 22 shows the same relationship for the shape factor as the relationship claimed in the application). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosen to include a power shape factor formula, as taught by Tabernero, in order for the lens to have a specific shape factor and other dimensions to correct vision as needed (Tabernero, pars. [0079] and [0119]).
Claim(s) 38 is rejected under 35 U.S.C. 103 as being unpatentable over Rosen et al (US 20150320547 A1) "Rosen A" in view of Rosen et al (US 20170258578 A1) "Rosen B" in further view of Tabernero et al (US 20070093891 A1) "Tabernero".
Regarding Claim 38, Rosen does not disclose certain surface curvatures. However, Tabernero, in the same field of art, teaches an intraocular lens (aberrated lens 81 and 91, par. [0015], Figs. 8 and 9) designed to reduce spherical aberration, wherein the lens comprises a first surface having an anterior surface curvature greater than 0.01 mm.sup.−1 and less than 0.082 mm.sup.−1 and a second surface having a posterior surface curvature greater than −0.179 mm.sup.−1 and less than −0.081 mm.sup.−1 (Fig. 14, anterior surface curvature of 0.009 is only 0.001 mm.sup.-1 outside of range, and may be rounded to 0.01). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ranges of Rosen since it has been held that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”, see MPEP 2144.05 - Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Conclusion
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774