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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/20/2026 has been considered by the examiner.
Response to Amendment
The Amendment filed 05/20/2026 has been entered. Claims 1-7, 11-14, and 49-52 remain pending in the application. Claims 8-10 and 15-20 have been cancelled. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 02/24/2026.
Response to Arguments
Applicant’s arguments, see pgs. 6-7, filed 05/08/2026, with respect to the rejection of
claims 1-6 under U.S.C. 102 and claims 7-14 under 35 U.S.C. 103 have been fully considered and are persuasive.
Therefore, the previous rejections have been withdrawn and new grounds of rejection have been set forth below as necessitated by applicant’s amendment received 05/20/2026.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1. Claims 1-7, 11, and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 20080269890 A1) in view of Angelopoulos et al. (KR 20190026986 A).
Regarding claim 1, Simpson discloses an intraocular lens (IOL) (10) comprising: a front surface (16) comprising a front optic surface located in the central portion of the front surface (fig. 2b annotated below illustrates a front optic surface located in the central portion of the front surface 16) and a front control surface located peripherally to the front optic surface (fig. 1b annotated below illustrates a front control surface 20 peripheral to a front optic surface 16); a back surface (18) comprising a back optic surface located in the central portion of the back surface (fig. 2b annotated below illustrates a back optic surface located in the central portion of the back surface 18) and a back control surface located peripherally to the back optic surface (fig. 1b annotated below illustrates a back control surface 22 peripheral to a back optic surface 18); an optic zone (¶ 0063 discloses an optic zone or image forming zone IL) defined by the front optic surface, the back optic surface, a thickness (which may be constant or vary radially or circumferentially) between front optic surface and the back optic surface, and at least one refractive index (fig. 2b annotated below illustrates an optic zone defined by a front optic surface and back optic surface, ¶ 0060 discloses a central optic region with a thickness, and ¶ 0058 discloses an optic comprising a requisite index of refraction); and a control zone (14) positioned peripherally relative to the optic zone and defined by the front control surface (20), the back control surface (22), and an edge (fig. 1b illustrates a control zone with a front surface, back surface, and edge); wherein the front optic surface has a first surface curvature and the front control surface has a second surface curvature different than the first surface curvature (fig. 1b illustrates a front optic surface 16 with a curvature and a front control surface 20 with a different curvature or flat configuration), and the back optic surface has a third surface curvature and the back control surface has a fourth surface curvature different than the third surface curvature (fig. 1b illustrates a back optic surface 18 with a curvature and a back control surface 22 with a different curvature or flat configuration); wherein the front optic surface (16) is a refracting surface (¶ 0058 discloses that the optic 12 is formed of biocompatible materials that have a requisite index of refraction) that is convex in an anterior direction (see fig. 1b and ¶ 0057 which discloses an optic 12 with bi-convex surfaces 16/18, i.e. comprises a convex optic surface 16 in an anterior direction); wherein the back optic surface (18) is a refracting surface (see ¶ 0058) that is convex in a posterior direction (see fig. 1b and ¶ 0057 which discloses an optic 12 with bi-convex surfaces 16/18, i.e. comprises a convex optic surface 18 in an posterior direction); wherein the back surface comprises at least one discontinuity in the form of a jump, ledge or step located either within the back control surface or at a junction of the back control surface and the back control surface (fig. 1b illustrates and ¶ 0059 discloses a front control surface 20 with discontinuities e.g. surface undulations 26. ¶ 0020 discloses that discontinuities/textured regions can be disposed on anterior and posterior surfaces.); and wherein the control zone is configured to reduce, minimize, or eliminate negative peripheral pseudophakic dysphotopsia (PPD) and/or reduce, minimize, and/or eliminate posterior capsular opacification (PCO) (The abstract discloses an intraocular lens comprising an optic and peripheral optic flange/control zone that inhibits dysphotosia. ¶ 0065 discloses that an intraocular lens may also be configured to minimize the potential of PCO).
Simpson fails to disclose that the front control surface has a curvature opposite in sign to the curvature of the front optic surface and that the back control surface has a curvature of the same sign as the curvature of the front optic surface.
Angelopoulos also discloses an intraocular lens (IOL) (100) comprising: a front (anterior) surface (104) and a front control surface located peripherally to the front optic surface (see fig. 3 below); a back (posterior) surface (106) and a back control surface located peripherally to the back optic surface (see fig. 3 below). Angelopoulos teaches that the front control surface has a curvature opposite in sign to the curvature of the front optic surface (fig. 3 below illustrates a front control surface that has a curvature in opposite sign to the curvature of the front optic surface, i.e. a front control surface with a convex curvature in a posterior direction) and that the back control surface has a curvature of the same sign as the curvature of the front optic surface (fig. 3 below illustrates a back control surface that has a curvature of the same sign as the curvature of the front optic surface, i.e. a back control surface with a convex curvature in an anterior direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IOL of Simpson to include that the front control surface has a curvature opposite in sign to the curvature of the front optic surface and that the back control surface has a curvature of the same sign as the curvature of the front optic, surface as taught by Angelopoulos, as the modification merely involves a combination of known IOL features that achieves predictable results of creating an IOL with features that reduce unwanted/negative visual effects (Angelopoulos ¶ 0007).
Regarding claim 2, Simpson discloses an intraocular lens (IOL) (10) comprising: an optic zone comprising a front optic surface, a back optic surface, a thickness, and a refractive index (fig. 2b annotated above illustrates an optic zone comprising a front optic surface and back optic surface, ¶ 0060 discloses a central optic region with a thickness, and ¶ 0058 discloses an optic comprising a requisite index of refraction); and a control zone positioned peripherally relative to the optic zone and comprising a front (anterior) control surface, a back (posterior) control surface, and an edge (fig. 1b illustrates a control zone 14 positioned peripherally relative to an optic zone with a front surface 20, back surface 22, and edge); wherein the front optic surface has a first surface curvature and the front control surface has a second surface curvature different than the first surface curvature (fig. 1b illustrates a front optic surface 16 with a curvature and a front control surface 20 with a different curvature or flat configuration), and the back optic surface has a third surface curvature and the back control surface has a fourth surface curvature different than the third surface curvature (fig. 1b illustrates a back optic surface 18 with a curvature and a back control surface 22 with a different curvature or flat configuration); wherein at least one of a control surface or a junction of the control zone and the optic zone comprises at least one discontinuity in the form of a jump, ledge or step (fig. 1b illustrates and ¶ 0059 discloses a front control surface 20 with discontinuities e.g. surface undulations 26. ¶ 0020 discloses that discontinuities/textured regions can be disposed on anterior and posterior surfaces.); and wherein the control zone is configured to reduce, minimize, and/or eliminate negative peripheral pseudophakic dysphotopsia (PPD) and/or reduce, minimize, and/or eliminate posterior capsular opacification (PCO) (The abstract discloses an intraocular lens comprising an optic and peripheral optic flange/control zone that inhibits dysphotosia. ¶ 0065 discloses that an intraocular lens may also be configured to minimize the potential of PCO).
Simpson’s embodiment in fig. 1b fails to disclose that and the back optic surface has a third surface curvature and the back control surface has a fourth surface curvature different than the third surface curvature and more specifically, of the same sign as the third surface curvature. Simpson teaches an alternate IOL embodiment (57) in fig. 5b in which the back optic surface has a third surface curvature and the back control surface has a fourth surface curvature different than the third surface curvature and more specifically, of the same sign as the third surface curvature (fig. 5b illustrates separate back optic and back control surfaces with the same sign, i.e. surfaces that are both convex in a posterior direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IOL of Simpson in fig. 1b to include that and the back optic surface has a third surface curvature and the back control surface has a fourth surface curvature different than the third surface curvature and more specifically, of the same sign as the third surface curvature, as taught by Simpson’s embodiment in fig. 5b, in order to provide optical power that is substantially the same as the central optic and/or to aid in focusing peripheral light rays incident thereon onto the retina such that together with the rays focused by the central optic would form a single image of a field of view (¶ 0073).
Simpson fails to disclose that the front optic surface has a first surface curvature and the front control surface has a second surface curvature different than the first surface curvature and more specifically, in opposite sign to the first surface curvature.
Angelopoulos also discloses an intraocular lens (IOL) (100) comprising: an optic zone comprising a front optic surface (104), a back optic surface (106), and a thickness (see fig. 3); and a control zone positioned peripherally relative to the optic zone and comprising a front control surface and a back control surface (see fig. 3 above). Angelopoulos teaches that the front optic surface has a first surface curvature and the front control surface has a second surface curvature different than the first surface curvature and more specifically, in opposite sign to the first surface curvature (fig. 3 above illustrates a front optic surface 104 with a first curvature and a front control surface with a second curvature in opposite sign to the curvature first surface, i.e. a front control surface/second surface with a convex curvature in a posterior direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IOL of Simpson to include that and the back optic surface has a third surface curvature and the back control surface has a fourth surface curvature different than the third surface curvature and more specifically, of the same sign as the third surface curvature as, taught by Angelopoulos, as the modification merely involves a combination of known IOL features that achieves predictable results of creating an IOL with features that reduce unwanted/negative visual effects (Angelopoulos ¶ 0007).
Regarding claim 3, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 1. Simpson further discloses that the control surface comprises a discontinuity with an optic surface (fig. 1b annotated below illustrates that the control surface 20/22 comprises a discontinuity with an optic surface 16/18 such as a ledge or flanged peripheral portion 14).
Regarding claim 4, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 1. Simpson further discloses that a control surface comprises at least one discontinuity within its surface profile whereby the at least one discontinuity sub-divides a control surface into segments or sub-regions, or sub-portions of the control surface (fig. 1b annotated below illustrates and ¶ 0059 discloses that a control surface 20 comprises discontinuities e.g. surface undulations with different ranges of amplitudes ranging from 0.2-2.0 micros thereby subdividing the control surface into segments).
Regarding claim 5, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 1. Simpson further discloses that the discontinuity is within the back control surface (¶ 0020 discloses that discontinuities/textured regions can be disposed on anterior and posterior surfaces).
Regarding claim 6, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 1. Simpson further discloses that the front comprises at least one discontinuity in the form of a jump, ledge or step (fig. 1b illustrates that the front comprises a ledge or flange 20).
Regarding claim 7, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 1. Simpson teaches an alternate embodiment (102) wherein a boundary between the optic zone and the control zone forms an optic-control junction and the discontinuity is at the optic-control junction (fig. 13a annotated below illustrates and ¶ 0095 discloses zone boundaries between an optic zone and control zone forming a junction between the two zones and that the junction comprises discontinuities).
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 intraocular lens 10 of Simpson to include a boundary between the optic zone and the control zone that forms an optic-control junction and the discontinuity is at the optic-control junction as taught by Simpson’s alternate embodiment 102 in order to modify the fraction of optical energy diffracted (Simpson ¶ 0095).
Regarding claim 11, Simpson in view of Angelopoulos discloses the invention as claimed as discussed with respect to claim 1. Simpson teaches an alternate embodiment (fig. 1c) wherein an angle of a sidewall formed by the discontinuity on a surface is at an angle or slope of between (inclusively) 0° and 80° degrees with respect to an axis of the intra-ocular lens, (¶ 0060 discloses that the angle of the sidewall can be slanted anteriorly or posteriorly relative to a central optic and fig. 1c illustrates a side wall with an angle of about 45 degrees with respect to the axis of the intraocular lens).
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 intraocular lens 10 of Simpson to include a sidewall angled with respect to an axis of the intra-ocular lens as taught by Simpson’s alternate embodiment 10’ in order to inhibit dysphotosia (Simpson ¶ 0060).
Regarding claim 49, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 1. Simpson further discloses that the control zone is configured to intercept a portion of oblique light rays passing through the pupil and redirect and/or redistribute the rays to a region on the retina that would otherwise be a dark band (¶ 0011 discloses that the IOL is configured to capture or redirect peripheral light rays entering the eye).
Regarding claim 50, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 49. Simpson teaches an alternate embodiment (fig. 2b) wherein the at least one discontinuity is configured to reduce, minimize, or eliminate PCO (¶ 0065 discloses that a discontinuity/flange may comprise a surface, e.g. a smooth/untextured surface, configured to minimize the potential of PCO).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IOL of Simpson in fig. 1b to include at least one discontinuity is configured to reduce, minimize, or eliminate PCO, as taught by Simpson’s embodiment in fig. 2b, in order to minimize the potential of posterior capsular opacification (¶ 0073).
Regarding claim 51, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 2. Simpson further discloses that the control zone is configured to intercept a portion of oblique light rays passing through the pupil and redirect and/or redistribute the rays to a region on the retina that would otherwise be a dark band (¶ 0011 discloses that the IOL is configured to capture or redirect peripheral light rays entering the eye).
Regarding claim 52, Simpson in view of Angelopoulos disclose the invention as claimed as discussed with respect to claim 51. Simpson teaches an alternate embodiment wherein the at least one discontinuity is configured to reduce, minimize, or eliminate PCO (¶ 0065 discloses that a discontinuity/flange may comprise a surface configured to minimize the potential of PCO).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the IOL of Simpson in fig. 1b to include at least one discontinuity is configured to reduce, minimize, or eliminate PCO, as taught by Simpson’s embodiment in fig. 2b, in order to minimize the potential of posterior capsular opacification (¶ 0073).
2. Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 20080269890 A1) in view of Angelopoulos et al. (KR 20190026986 A) as applied to claim 1 above, and further in view of Paul (US 6468306 B1).
Regarding claim 12, Simpson in view of Angelopoulos discloses the invention as claimed as discussed with respect to claim 1. Simpson fails to disclose that the height of a sidewall formed by the discontinuity is greater than 0 mm and less than or equal to 1 mm. Paul also discloses an intraocular lens (IOL) (20) comprising: a front (anterior) surface comprising a front optic surface (40 AF) located in the central portion of the front surface and a front control surface (46) located peripherally to the front optic surface; a back (posterior) surface comprising a back optic surface (40 PF) located in the central portion of the back surface (see fig. 3 annotated below). Paul teaches that that the height of a sidewall formed by the discontinuity (e.g., the at least one discontinuity) is greater than 0 mm and less than or equal to 1 mm (col. 8 table 1 and 2 disclose side wall heights between 0 mm-1 mm/0um and 750um). 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 intraocular lens of Simpson to include a sidewall formed by the discontinuity in which the height is greater than 0 mm and less than or equal to 1 mm as taught by Paul in order to reduce glare and PCO in intraocular lenses (Paul col. 8 lines 6-9).
Regarding claim 13, Simpson in view of Angelopoulos discloses the invention as claimed as discussed with respect to claim 1. Simpson further discloses that a profile of a sidewall formed by the discontinuity is straight. However, Simpson fails to disclose that the sidewall formed by the discontinuity is curved, or aspheric or tortuous or stepped or irregular. Paul also discloses an intraocular lens (IOL) (20). Paul teaches that a profile of a sidewall formed by a discontinuity is straight, or curved, or aspheric or tortuous or stepped or irregular (fig. 8 illustrates a sidewall/edge with a straight profile, fig. 19 illustrates a sidewall/edge with a curved profile, and figs. 18 and 20 illustrate side walls/edges with sawtooth or stepped profiles). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intraocular lens of Simpson to include a profile of a sidewall formed by a discontinuity that is straight, curved, or aspheric or tortuous or stepped, or irregular as taught by Paul in order to reduce glare and PCO (Paul col. 13 lines 59-66).
Regarding claim 14, Simpson in view of Angelopoulos discloses the invention as claimed as discussed with respect to claim 1. Simpson fails to disclose that a corner formed by a discontinuity may be radiused, or filleted, or beveled, or chamfered. Paul also discloses an intraocular lens (IOL) (20). Paul teaches that a corner formed by a discontinuity may be radiused, or filleted, or beveled, or chamfered (fig. 19 illustrates a radiused corner 264, fig. 16 illustrates a filleted corner 226b, fig. 20 illustrates a discontinuity with beveled surfaces 286/290 forming respective corners 282/284, and fig. 7 illustrates a discontinuity with a chamfered surface 96). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intraocular lens of Simpson to include a corner formed by a discontinuity that may be radiused, or filleted, or beveled, or chamfered as taught by Paul in order to help reduce glare (Paul – Abstract).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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