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 Objections
Claim 7 objected to because of the following informalities: "shape-changing optic" should be changed to "IOL". Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an attachment member in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure for the attachment member is disclosed in the specification as an “an anterior arm” or “a ring of the anterior face of the anterior optic” (see paragraph [0027]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ellis (2020/0345481) "Ellis" in view of Akinay et al (2020/0323626) "Akinay".
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, Akinay discloses:
the IOL (pars. [0067], See Annotated Fig. 1A, below, IOL 10a) comprising: a base (pars. [0067] and [0068], FIG. 2B, optic 20a, base 110) comprising a plurality of actuating haptics (pars. [0067], See Annotated Fig. 1A, below, haptics 30a and arm 40a), each having a lateral end (See Annotated Fig. 1A, below), a medial end (See Annotated Fig. 1A, below), and an intermediate section (See Annotated Fig. 1A, below) extending between the lateral end and the medial end;
an attachment member (par. [0067], haptic junction 50a) 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 (See Annotated Fig. 1A, below). 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 in order to more securely hold the optic and to allow for haptics and other IOL components to be individually inserted and assembled within the eye during surgery (Akinay, par. [0064]).
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Regarding Claim 2, that the attachment member comprises: a plurality of anterior arms extending from the periphery of the anterior face, etc. However, Akinay discloses a two-piece IOL (par. [0064]) wherein the attachment member (par. [0067], haptic junction 50a) comprises: a plurality of anterior arms (par. [0067], See Annotated Fig. 1A, above, haptic junction 50a) extending from the periphery of the anterior face and each having a medial end (See Annotated Fig. 1A, above) extending from the anterior face and a lateral end (See Annotated Fig. 1A, above) releasably connected to the medial end of a respective one of the plurality of actuating haptics (See Annotated Fig. 1A, above, haptics 30a and arm 40a), and an intermediate section (See Annotated Fig. 1A, above) 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 for the haptics and other IOL components to be individually inserted and assembled within the eye during surgery (Akinay, par. [0064]).
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 4, Ellis does 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, above, 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, above, 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 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]).
Regarding Claim 5, Ellis does 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 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 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, Akinay discloses the IOL of claim 2 (par. [0067], See Annotated Fig. 1A, above), wherein the medial end of one or more of the plurality of actuating haptics (haptics 30a and arms 40a, See Annotated Fig. 1A, above) and the lateral end of a respective one or more of the plurality of anterior arms (haptic junctions 50a, See Annotated Fig. 1A, above) 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 (par. [0064]). 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 interlocking projections between the actuating haptics and anterior arms in order for the haptics and other IOL components to be individually inserted and properly secured and assembled within the eye during surgery (Akinay, par. [0064]).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIE N THOMAS/ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774