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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/17/26 has been entered.
Response to Arguments
Applicant's arguments filed 03/17/26 have been fully considered but they are not persuasive.
On pages 8-9 Applicant argues amendments overcome the rejections and objections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 30, 32, 60, 64-65, 67 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ferrari (US 20130331936).
Regarding claim 30 Ferrari discloses an IOL (Figure 8) for reducing negative dysphotopsia (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Ferrari discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0016] IOLs provide angle kappa correction by tilting an optic; Applicant’s specification [0007] indicates that providing a tilt adjustment of an optical axis of an optic of an IOL with respect to a platform based on measurements of an angle kappa reduces negative dysphotopsia) comprising:
an optic (Figure 8 item 7) having centered on an optical axis (Figure 10 item V), and
a platform coupled to the optic (Figure 8 item 8) configured to support the optic ([0045] haptics support a platform with the capsular bag) and which extends in an orientation plane (Annotated Figure 8),
wherein a tilt of the optical axis is adjustable with respect to the platform such that the optical axis extends at an angle that is not perpendicular with the orientation plane, and wherein the tilt is adapted to provide angle kappa correction in an individual’s eye ([0014], [0016]; the tilt of the optical axis is adjusted so it provides the kappa correction. See also Figure 10).
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Regarding claim 32 Ferrari discloses the IOL of claim 30 substantially as is claimed,
wherein Ferrari further discloses a portion of the optic or platform is configured to be laser ablated to allow the optical axis of the optic to tilt with respect to the platform (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Ferrari was considered capable of performing the cited intended use of being ablated. A portion of the optic or platform is understood to be capable of being laser ablated if desired, in a manner that would tilt the optical axis.).
Regarding claim 60 Ferrari discloses the IOL of claim 30 substantially as is claimed,
wherein Ferrari further discloses a tilt of the optic is adjustable with respect to the platform such that the optic extends in a plane not parallel with the orientation plane (See Annotated Figure 8 where the adjusted optic tilt of the inventive lens along line P is seen lying not parallel with the orientation plane. The Examiner also notes that the optic extends in many planes, since it extends in three-dimensional space. Many are not parallel with the orientation plane.).
Regarding claim 64 Ferrari discloses the IOL of claim 30 substantially as is claimed,
wherein Ferrari further discloses the platform includes haptics (Figure 8 items 80, 81).
Regarding claim 65 Ferrari discloses the IOL of claim 30 substantially as is claimed,
wherein Ferrari further discloses the optic comprises a multifocal lens (Abstract).
Regarding claim 67 Ferrari discloses the IOL of claim 30 substantially as is claimed,
wherein Ferrari further discloses the platform is adapted to center the center of the optic such that the optical axis extends through with respect to a pupillary axis of the individual’s eye (the Examiner notes that this appears to depend entirely upon the method of implantation of the claimed IOL as well as the specific geometry of the eye into which the IOL is implanted, as opposed to further structurally limiting the claimed IOL.).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 31 and 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrari as is applied above in view of Jahn et al. (US 6443984 B1) hereinafter known as Jahn.
Regarding claim 31 Ferrari discloses the IOL of claim 30 substantially as is claimed,
wherein a coupling allows the optical axis of the optic to tilt with respect to the platform (the optic and platform are inherently coupled via a “coupling”),
but is silent with regards to the coupling comprising a screw.
However, regarding claim 31 Jahn teaches an IOL which attaches a haptic (Figures 6a-b item 3) to an optic (Figures 6a-b item 1) via a screw coupling (Figures 6a-b item 37). Ferrari and Jahn are involved in the same field of endeavor, namely IOLs. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the IOL of Ferrari so that the coupling includes a screw such as is taught by Jahn in order to allow the adjustment of the haptic/optic angle before implantation, thus ensuring the IOL can be optimally adjusted for each particular patient before implantation.
Regarding claim 66 the Ferrari Jahn Combination teaches the IOL of claim 31 substantially as is claimed,
wherein the Combination further teaches the screw coupling is configured to be rotated in a first direction to vary an amount of the tilt of the optical axis in one direction with respect to the platform and to be rotated in a second opposite direction to vary the tilt of the optical axis with respect to the platform in the opposite direction (this is stated as a functional limitation (see the explanation in the rejection to claim 30 above. See also Figures 6a-6b and Column 4 lines 16-18).
Claims 33, 35, 53, 58-59, 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 20110153014 A1) hereinafter known as Zhang in view of Akinay et al. (US 20200323626 A1) hereinafter known as Akinay.
Regarding claim 33, Zhang discloses an intraocular lens (Figure 17) for reducing negative dysphotopsia (This is stated as a functional limitation (see the explanation regarding functional limitations in the rejection to claim 30 above). See also Figure 17 and [0061] of Zhang which describes how the optical axis can be tilted, and Applicant’s specification [0007] which states tilting the optical axis can reduce negative dysphotopsia) comprising:
an optic (Figure 17 item 226) centered on an optical axis (Figure 17 item 256), and
a platform coupled to the optic (Figures 15, 17 items 228/240/242/244/230) and configured to support the optic (Figures 5, 17) the platform including haptics (Figure 17 item 228), the haptics each including an inner portion coupled to the optic (Figures 15, 17 items 228/240/242/244 is the inner portion which couples to the center optic 226), and the haptics each including an outer periphery (Figures 15, 17 item 230), wherein the outer periphery of each of the haptics extend in a single orientation plane (Figure 17 the plane parallel to 262),
wherein the optical axis is tilted with respect to the platform such that the optical axis extends at an angle that is not perpendicular with the orientation plane (Figure 17; [0061]), and
wherein the tilt of the optical axis is adapted to provide angle kappa correction in an individual's eye (this is stated as a functional limitation of the tilted optical axis (see the explanation in the rejection to claim 30 above regarding functional limitations). Since Applicant’s specification [0007] indicates the tilted optical axis provides an angle kappa correction in an individual’s eye, the tilted optical axis of the claimed invention is understood to meet this functional limitation),
but is silent with regards to the inner portion and outer periphery of each of the haptics together all extend in a single orientation plane.
However, regarding claim 33 Akinay teaches that the inner part of a haptic (Figure 1b item 50a) that connects to an optic (Figure 1b item 20a) can extend all together and in the same, single orientation plane (Figure 1b, vertical plane) as the haptic outer periphery (Figure 1b item 40a) as an alternative to extending in various planes (Figure 7). Zhang and Akinay are involved in the same field of endeavor, namely IOLs. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the IOL of Zhang so the inner portion of the haptic that connects to the lens extends in the same plane as the outer periphery as is taught by Akinay since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). The haptics’ inner/outer portions extending in the same plane or different plane as each other are considered obvious alternatives in the art which are both understood equally likely to succeed. As long as Zhang’s periphery maintains the oblique lower surface (Figure 17 item 262), the relative plane(s) the remainder of the elements are positioned in are obvious to try.
Regarding claim 35, the Zhang Akinay Combination teaches the lens of claim 33 substantially as is claimed,
wherein Zhang further discloses that a degree of tilt of the optical axis is set based on an angle kappa of one or more individuals' eyes (this appears to be drawn towards a method of production or an intention behind the axis tilt as opposed to structurally limiting the lens itself).
Regarding claim 53, the Zhang Akinay Combination teaches the lens of claim 33 substantially as is claimed,
wherein Zhang further discloses that the optic is tilted with respect to the platform (Figure 17 shows the optic 226 which is horizontal and the platform which has an angle non-perpendicular thereto see at 262) to provide angle kappa correction in the individual's eye (this is stated as a functional limitation of the tilted optical axis (see the explanation in the rejection to claim 30 above regarding functional limitations). Since Applicant’s specification [0007] indicates the tilted optical axis provides an angle kappa correction in an individual’s eye, the tilted optical axis of the claimed invention is understood to meet this functional limitation).
Regarding claim 58, the Zhang Akinay Combination teaches the lens of claim 33 substantially as is claimed,
wherein Zhang further discloses that the single orientation plane comprises a plane that the haptics position the optic in within an eye (Figure 13).
Regarding claim 59, the Zhang Akinay Combination teaches the lens of claim 33 substantially as is claimed,
wherein the Combination teaches that the tilt of the optical axis centers the optic with respect to a visual axis of the individual's eye (this appears to depend on the anatomy and the user into which the lens is implanted (and its visual axis), as opposed to the claimed lens itself.).
Regarding claim 69, the Zhang Akinay Combination teaches the lens of claim 33 substantially as is claimed,
wherein Zhang further discloses each of the haptics has a same length ([0061] the arms are equal in length, Figures 15-16).
Claim 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang and Akinay as is applied above, further in view of Ferrari as is applied above.
Regarding claim 55, the Zhang Akinay Combination teaches the lens of claim 33 substantially as is claimed,
but is silent with regards to the optic comprising a multifocal lens.
However, regarding claim 55 Ferrari teaches that an IOL can include a multifocal lens (Abstract). Zhang and Ferrari are involved in the same field of endeavor, namely IOLs. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the IOL of the Zhang Akinay Combination so that the lens was multifocal as is taught by Ferrari in order to allow the lens to work for users who require the ability to see multiple distances.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/15/26
