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 .
Response to Arguments
Applicant’s arguments, see remarks, filed 5/6/2026, with respect to the rejection(s) of claim(s) 1-9 under 35 U.S have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ellis, Beer, and Akinay.
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.
Claim(s) 1-3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis (2020/0345481) "Ellis" in view of Beer (US 20180055626 A1) "Beer".
Regarding Claim 1, Ellis discloses: A two-piece intraocular lens (IOL) (par. [0034], FIGS. 4- 6) having an optical axis (par. [0032], FIG. 2, optical axis CA) extending in an anterior-posterior direction (par. [0032], FIG. 2), an equator (par. [0032], FIG. 2, equator E) extending in a plane substantially perpendicular to the optical axis (par. [0032], FIG. 2), an accommodated state, a dis-accommodated state, and states therebetween (par. [0013]),
and an anterior shape-changing exchangeable optic (Abstract, FIGS. 1-3, shape-changing optic 12) comprising: an elastic anterior face (Abstract, FIGS. 1-3, elastic anterior face 12) located anterior to the equator and having a periphery (Abstract, FIGS. 1-3, periphery 20);
a posterior face (Abstract, posterior face 22);
an elastic side wall (Abstract, elastic side wall 30) extending from the anterior face to the posterior face (Abstract);
and a chamber (par. [0013], chamber 32) located between the anterior face and the posterior face and containing material (par. [0013]),
but does not disclose: the IOL comprising: a base comprising a plurality of actuating haptics, and an attachment member, etc. However, Beer, in the same field of art, discloses an IOL (par. [0086], Fig. 1A) comprising: a base (par. [0086], FIG. 1A, optic 105) comprising a plurality of actuating haptics (par. [0086], FIG. 1A, haptics 100), each having a lateral end (par. [0086], Fig. 1A, capture zone 120), a medial end (par. [0086], Fig. 1A, flexion zone 110), and an intermediate section (par. [0086], Fig. 1A, haptic arms 115) extending between the lateral end and the medial end;
an attachment member (par. [0086], Figs. 1A and 5B, restraining tabs 130) located about the periphery or extending from the periphery and releasably connected to the medial end of at least some of the plurality of actuating haptics (pars. [0103] and [0127], Figs. 1A and 5B, restraining tabs connected to haptics through sutures that can later be laser cut and thus release the haptics). 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 Ellis to include a base with the stated components and an attachment member releasably connected to the actuating haptics, as disclosed by Beer, in order to more securely hold the optic and allow for easier transition between accommodative and dis-accommodative states (Beer, par. [0086]).
Regarding Claim 2, Ellis does not teach that the attachment member comprises: a plurality of anterior arms extending from the periphery of the anterior face, etc. However, Beer discloses an IOL (par. [0086], Fig. 1A) wherein the attachment member (par. [0086], Figs. 1A and 5B, restraining tabs 130) comprises: a plurality of anterior arms (par. [0086], Figs. 1A and 5B, plurality of restraining tabs 130 connected to plurality of haptic arms 115) extending from the periphery of the anterior face and each having a medial end (par. [0086], Fig. 1A, section of tabs restraining tabs 30 protruding from optic ring 135) extending from the anterior face and a lateral end (par. [0086], Figs. 5A and 5B, section of restraining tabs 30 touching flexion zone 110) releasably connected to the medial end of a respective one of the plurality of actuating haptics (pars. [0103] and [0127], Figs. 1A and 5B, restraining tabs connected to haptics through sutures that can later be laser cut and thus release the haptics), and an intermediate section (par. [0086], Figs. 5A and 5B, section of restraining tabs 30 not touching optic ring 135 or flexion zone 110) between the medial end and the lateral end. 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 Ellis to include an attachment member with arms connected to the actuating haptics in order to more securely hold the optic and allow for easier transition between accommodative and dis-accommodative states (Beer, par. [0086]).
Regarding Claim 3, Ellis further discloses the IOL of claim 1 (par. [0034], FIGS. 4-6), wherein the anterior face (anterior face 14) is more resistant to deformational change than the material (par. [0013]).
Regarding Claim 8, Ellis does not disclose that the medial end of one or more of the plurality of actuating haptics and the lateral end of a respective one or more of the plurality of anterior arms comprises interlocking projections to releasably attach the medial end of the one or more plurality of actuating haptics and the lateral end of the respective one or more of the plurality of arms. However, Beer discloses the IOL of claim 2 (par. [0086], Fig. 1A), wherein the medial end of one or more of the plurality of actuating haptics (par. [0086], FIG. 1A, haptics 100) and the lateral end of a respective one or more of the plurality of anterior arms (par. [0086], Figs. 1A and 5B, plurality of restraining tabs 130 connected to plurality of haptic arms 115) comprises interlocking projections to releasably attach the medial end of the one or more plurality of actuating haptics and the lateral end of the respective one or more of the plurality of arms (pars. [0020] and [0086], restraining tab or mechanism connected to haptics 100 may be in the form of restraining rings or sutures that would therefore interlock with the haptics). 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 Ellis, as taught by Beer, to include interlocking projections between the actuating haptics and anterior arms in order for the haptics and other IOL components to be properly secured and to allow for easier transition between accommodative and dis-accommodative states (Beer, par. [0086]).
Claim(s) 4-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis (2020/0345481) "Ellis" in view of Beer (US 20180055626 A1) "Beer," and further in view of Akinay et al (2020/0323626) "Akinay".
Regarding Claim 4, Ellis and Beer do not disclose at least two opposing stabilizing, non-actuating haptics connected to a respective lateral end of at least two of the plurality of actuating haptics. However, Akinay discloses a two-piece IOL (par. [0064]) comprising at least two opposing stabilizing, non-actuating haptics (par. [0064], See Annotated Fig. 1A, below, haptic junctions 50a) connected to a respective lateral end of at least two of the plurality of actuating haptics (par. 0064], See Annotated Fig. 1A, below, haptics 30a and arms 40a). 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 Ellis and Beer to include opposing stabilizing, non- actuating haptics connected to actuating haptics in order for the haptics and other IOL components to be properly secured and assembled within the eye during surgery (Akinay, par. [0064]).
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Regarding Claim 5, Ellis and Beer do not disclose a posterior optic located between the at least two opposing stabilizing, non-actuating haptics. However, Akinay discloses a two-piece IOL (par. [0064]) comprising a posterior optic (par. [0067], IOL can be moved anteriorly or posteriorly) located between the at least two opposing stabilizing, non-actuating haptics (par. [0064], See Annotated Fig. 1A, above, haptic junctions 50a). 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 Ellis and Beer to include a posterior optic with opposing stabilizing, non-actuating haptics in order for the haptics and other IOL components to be properly secured and assembled within the eye during surgery (Akinay, par. [0064]).
Regarding Claim 6, Ellis further discloses the IOL (par. [0034], FIGS. 4-6) of claim 5, wherein the posterior optic (posterior face 22) comprises a spherical, aspheric, toric, toroidal, multifocal, diffractive, extended depth of focus lens, or combinations thereof (par. [0034]).
Regarding Claim 7, Ellis further discloses shape-changing optic (par. [0034]) of claim 5, wherein the posterior optic (posterior face 22) comprises a fixed power(s) lens (Claim 5).
Regarding Claim 9, Ellis further discloses the IOL (par. [0034]) of claim 4, wherein at least one or more of the plurality of actuating haptics (haptic 34), the attachment member, one or more of the stabilizing haptics, or combinations thereof comprises a therapeutic agent (par. [0031]: for any component that is resistant to deformational change, which includes one of the actuating haptics, par. [0038], the force applied to it will not be strong enough to cause breakage of the component and cause the component's loss of its therapeutic purpose, thus implying there is a therapeutic agent comprised within the component).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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