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
Arguments regarding the drawing objections, abstract objection, and 112b rejections of record have been considered persuasive and the objections/rejections of record have been withdrawn.
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive. In response to applicant's argument that Wortz fails to show amended features of the invention, the examiner disagrees, see new rejection below.
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 recites “a exterior” but should recite “an exterior”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2-10 and 13-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites “forming a vertical interior wall between the first straight portion and the second straight portion” however the disclosure and drawings show a vertical wall between the first straight portion and the third straight portion as seen in figure 5 and 7, therefore the amendment introduces new matter.
Dependent claims are likewise rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2-9, 13, 15, and 19-20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wortz (US 10111746 B2).
Regarding Claim 2, Wortz teaches a prosthetic capsular device comprising: a housing structure (see annotated figure 25) comprising: an anterior portion comprising: an anterior opening; and an anterior sidewall connected to the anterior opening and extending laterally outward and posteriorly from the anterior opening, the anterior sidewall comprising a first exterior curved surface and a first interior surface comprising a first straight portion and a second straight portion, wherein the first straight portion extends to a first transition point of the first interior surface, and wherein the second straight portion extends from the first transition point of the first interior surface to a longitudinal center plane of the housing structure, and wherein the first straight portion is formed at an obtuse angle relative to the second straight portion; a posterior portion comprising (see annotated figure 25): a posterior opening; and a posterior sidewall connected to the posterior opening and extending laterally outward and anteriorly from the posterior opening, the posterior sidewall comprising a second exterior curved surface and a second interior surface comprising a third straight portion and a fourth straight portion, wherein the third straight portion extends to a first transition point of the second interior surface, and wherein the fourth straight portion extends from the first transition point of the second interior surface to the longitudinal center plane of the housing structure, and wherein the third straight portion is formed at an obtuse angle relative to the fourth straight portion (see annotated figure 25); an interior cavity formed between the anterior opening and the posterior opening (see annotated figure 25), the interior cavity configured to house an intraocular lens (col 48, lines 33-36); and a groove formed by the first straight portion and the second straight portion of the anterior sidewall of the anterior portion and the third straight portion and the fourth straight portion of the posterior sidewall of the posterior portion (see annotated figure 25), wherein the second straight portion and the fourth straight portion are colinear with each other forming a vertical interior wall between the first straight portion and the second straight portion (see annotated figure 25),, and wherein the groove is configured to hold the intraocular lens in place within the interior cavity of the housing structure (col 48, lines 33-36, ridge is part of groove).
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Annotated Figure 25
Regarding Claim 3, Wortz further teaches wherein the first exterior curved surface and the second exterior curved surface are continuous surfaces with no openings (see annotated figure 25).
Regarding Claim 4, Wortz further teaches wherein the first exterior curved surface and the second exterior curved surface connect at the longitudinal center plane of the housing structure (see annotated figure 25).
Regarding Claim 5, Wortz further teaches wherein the housing structure is symmetrical, such that the anterior portion and the posterior portion are mirror images (see annotated figure 25).
Regarding Claim 6, Wortz further teaches wherein the interior cavity is configured to house the intraocular lens of at least the following types: spherical, aspheric, wavefront, convex, concave, extended depth of focus, pinhole or small aperture, multifocal, toric, accommodative, ultraviolet (UV) filtering, diffractive chromatic aberration reducing, light adjustable, positive diopter, and negative diopter (col 10, lines 48-58).
Regarding Claim 7, Wortz further teaches wherein the prosthetic capsular device is made of silicone or silicone polymer (col 2, lines 16-18).
Regarding Claim 8, Wortz further teaches wherein the prosthetic capsular device is manufactured by compression molding, three-dimensional laser cutting, two photon lithography, additive manufacturing, or a combination of the above (col 14, lines 50-53).
Regarding Claim 9, Wortz further teaches wherein the prosthetic capsular device comprises a flexible or elastic material (col 2, lines 16-22), such that the prosthetic capsular device is foldable and self-expandable (col 2, lines 16-22).
Regarding Claim 13, Wortz further teaches wherein the first straight portion and the third straight portion are formed at a sidewall angle (the 1st and 3rd portion are formed at the sidewall, an angle is inherently present).
Regarding Claim 15, Wortz further teaches wherein the interior cavity comprises a volume for maintaining the shape and size of the natural capsular bag (col 37, lines 1-8, interior cavity is part of the device, the device as a whole maintains the shape).
Regarding Claim 19, as best understood based on the 35 U.S.C. 112(b) issues identified above, Wortz further teaches wherein the device comprises one or more ridges (extending longitudinally from the anterior opening to the posterior opening (col 50, lines 22-30).
Regarding Claim 20, Wortz further teaches wherein the one or more ridges are located intermittently around a circumference of an exterior of the device (col 50, lines 22-30).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wortz (US 10111746 B2) in view of Kahook (US 20180161153).
Regarding Claim 10, Wortz is silent about the dimension of the sidewall. Kahook teaches common sizing of modular intraocular lens systems (abstract) wherein a thickness of the anterior sidewall and the posterior sidewall is between about 0.1 mm and 1.0 mm ([0071], 0.2-0.7mm is between 0.1-1mm).
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 device taught by Wortz to include similar dimensions of another intraocular lens system, as taught in Kahook, in order to reasonably fit and shape the device within the eye.
Claims 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wortz (US 10111746 B2).
Regarding Claim 14, the Wortz embodiment in figure 25 is silent about the dimensions of the sidewall angle, however, Wortz teaches another embodiment wherein the sidewall angle is about 34 or about 57 (col 30, lines 52-60, 35 is about 34).
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 figure 19 embodiment taught by Wortz to include similar dimensions of another embodiment in order to fit and shape the device within the eye as desired.
Claims 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wortz (US 10111746 B2) in view of Ifland (US 20180055625 A1)
Regarding Claim 16, Wortz fails to teach the device further comprising notches. Ifland teaches a prosthetic capsular device (abstract) comprising one or more notches (element 906, fig 9A-D) located on an exterior surface of the housing structure (view orientation in fig 9A-D), protruding radially outward from the exterior surface (view orientation in fig 9A-D).
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 device taught by Wortz by including the notches, as taught by Ifland, in order to easily insert and secure the device within the capsular bag ([0250]).
Regarding Claim 17, Wortz fails to teach the device further comprising notches. Ifland teaches a prosthetic capsular device (abstract) wherein the one or more notches contact or engage a surface of a natural capsular bag of an eye ([0250]).
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 device taught by Wortz by including the notches, as taught by Ifland, in order to easily insert and secure the device within the capsular bag ([0250]).
Regarding Claim 18, Wortz fails to teach the device further comprising notches. Ifland teaches a prosthetic capsular device (abstract) wherein the one or more notches are located along the longitudinal center plane of the housing structure (view orientation in fig 9A-D, longitudinal plane goes lengthwise horizontally though the center of the device).
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 device taught by Wortz by including the notches, as taught by Ifland, in order to easily insert and secure the device within the capsular bag ([0250]).
Regarding Claim 21, Wortz fails to exactly teach details of a textured surface. Ifland teaches a prosthetic capsular device (Abstract) wherein an exterior surface of the housing comprises a textured surface ([0257]), the textured surface comprising an adhesive, nanostructures, or micro-structures formed on the exterior surface ([0257], pores).
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 device taught by Wortz by including the texture, as taught by Ifland, in order to promote fibrosis ([0257]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on (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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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799