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 .
Election/Restrictions
Applicant’s election without traverse of invention II in the reply filed on 10/27/2025 is acknowledged.
Drawings
The drawings are objected to because figures 1-4, 10-10b, 16, 23-28, and 30-31 include text, the drawings shall not contain text matter, except a single word or words, when absolutely indispensable (MPEP 1825).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the tabs, the second interior ring, the convex pillars, and the shelves must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The text of the disclosure must be dark black ink that is plainly and legible, having a form of sufficient clarity and contrast (MPEP 608 (6.32.01)).
Claims 11-12 recite “a shelf,” but the term “shelf” is not described in the disclosure.
Appropriate correction is required.
Claim Objections
Claims 7-8, 10, 16, and 17 objected to because of the following informalities:
Claim 7 recites “the eye capsule” but should recite “an eye capsule”
Claim 7 recites “the capsule” but should recite “a capsule”
Claim 7 recites “intersecting said anterior, said posterior ring, said interior ring” but should recite “intersecting said anterior ring, said posterior ring, said interior ring”
Claim 8 recites “the ciliary muscle” but should recite “a ciliary muscle”
Claim 8 recites “and to extend” but should recite “to extend”
Claim 10 recites “claim 7 wherein” but should recite “claim 7, wherein”
Claim 10 recites “around scaffold” but should recite “around the scaffold”
Claim 16 recites “claim 15 wherein” but should recite “claim 15, wherein”
Claim 17 recites “prescribe optical meridian” but should recite “prescribed optical meridian,” the limitation also changes from singular to plural.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-23 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “said outer edge” without antecedent basis
Claim 10 recites “said flexing” without proper antecedent basis. Check dependency, claim 8 recites a basis for flexing.
Claim 10 recites “said eye capsule shrinking” without proper antecedent basis. Check dependency, claim 9 recites a basis for eye capsule shrinking.
Claim 16 recites “an appropriate vertical fenestration” but is unclear on what qualifies a fenestration as “appropriate”
Dependent claims are likewise rejected
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(s) 7-9, 11-12, 18-20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20160220355 A1) in view of Sarfarzi (US 7662179 B2), Currie (US 20140277437 A), Argento (US 20200008931 A1), and Zaldivar (US 20160095699 A1).
Regarding claim 7, Lee teaches an implant for an ocular capsular bag to replace a human lens of the eye capsule (abstract) removed during cataract surgery ([0002]) said implant comprising: a scaffold (fig 2a/3a), said scaffold comprising: an anterior ring (abstract); a posterior ring positioned away from said anterior ring (abstract, fig 2a/3a); a plurality of pillars coupling said anterior ring and said posterior ring (sidewall 206, fig 2a/3a); a primary lens permanently secured to one of said posterior ring or said anterior ring (see fig 6, [0033], primary lens secured to two rings via haptic); a plurality of vertical fenestrations between said pillars (orifices 220, fig 2a/3a), said vertical fenestrations intersecting said anterior ring and posterior ring (see fig 2a/3a) said vertical fenestrations enabling aqueous humor circulation (structure is capable of this, [0008], [0032]);
Lee fails to teach the interior ring. Sarfarazi teaches an intraocular lens (abstract) with at least one interior ring with a lens positioned between said posterior ring and said anterior ring (see outer edge of lens, or middle ring, in figure 13). By applying the teachings of Sarfarzi, Lee is modified to be doubled, having another two-ring design as seen in figure 2a in addition to the two rings present, with a total of four rings. The combination of Lee and Sarfarazi teaches a plurality of pillars coupling said interior ring (the device would include sidewall pillars between all the rings), said interior ring enabling aqueous humor circulation (structure is capable of this, Sarfarazi: [0008]), and a secondary lens (a lens would be present in the additional two rings) having one or more anchoring mechanisms extending outwardly from said secondary lens (Lee: see fig 6, element 606) and said secondary lens being removably attached to one of said anterior ring, said posterior ring, or said at least one interior ring with said anchoring mechanisms being inserted into one of said vertical fenestrations or onto said tabs (Lee: see fig 6), wherein said attachment of said secondary lens defines open volumes within said scaffold on either side of said secondary lens (modified structure would have open volumes, see fig 2a).
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 Lee by applying the teachings of the multiple lens and ring design of Sarfaraz in order to add an additional lens to the device to allow for vision to be varied to suit a particular patient’s circumstances (col 44-58, and col 12, lines 9-38)
Lee in view of Sarfaraz fails to teach the details of the horizontal fenestrations. Currie teaches an intraocular lens (abstract) with a plurality of horizontal fenestration located within the inner edge of a posterior ring (see element 18 of figure 2) to provide aqueous humor circulation within the capsule through two non-equatorial regions of the ocular capsular bag (structure is capable of this); said posterior ring and said horizontal fenestrations enabling aqueous humor circulation (structure is capable of this), said vertical fenestrations intersecting said horizontal fenestrations (the combination of Lee in view of Sarfaraz and Currie would have intersecting fenestrations).
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 Lee in view of Sarfaraz by applying the teachings of lens fenestrations, as taught by Currie, in order to structurally separate the lens optic from the haptic allowing for independence ([0282]).
Lee in view of Sarfaraz and Currie does not exactly teach the details of the tabs. Argento teaches an intraocular lens (abstract) wherein a plurality of tabs are positioned at the inner edge of a ring (for example see fig 25c or 51a/c, or 52a/c);
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 Lee in view of Sarfaraz and Currie by applying the teachings of tabs, as taught by Argento, in order to create an additional mating surface to add further guidance and connection to the lens placement ([0255], [0365])
Lee in view of Sarfaraz, Currie, and Argento does not exactly teach the details of the lens fenestrations. Zaldivar teaches an intraocular lens (abstract) with a lens having a plurality of fenestrations located near said outer edge of the lens ([0044], [0049]); thereby maintaining said circulation of the aqueous humor on either side of the lens through said secondary lens fenestrations (structure is capable of this).
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 Lee in view of Sarfaraz, Currie, and Argento by applying the teachings of the lens fenestrations, as taught by Zaldivar, in order to permit aqueous flow ([0044]).
Regarding claim 8, Lee further teaches where said posterior ring or said anterior ring flexes ([0026]) in response to movements of the ciliary muscle of the eye after implantation via zonules, thereby changing the curvature and power of said primary lens and to extend the depth of focus of said primary lens ([0004]).
Regarding claim 9, Lee further teaches wherein said posterior ring and said anterior ring are shaped to allow said eye capsule to shrink around said posterior ring and said anterior ring (structure is capable of this), thereby precluding migrations of epithelial cells within said eye capsule ([0008]).
Regarding claim 11, Lee does not exactly teach the details of a shelf. Argento teaches an intraocular lens (abstract) wherein a plurality of tabs creates a shelf and are positioned at the inner edge of a ring with a lens being attached to (for example see fig 25c or 51a/c, or 52a/c);
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 interior ring taught by Lee in view of Sarfaraz by applying the teachings of a shelf, as taught by Argento, in order to create an additional mating surface to add further guidance and connection to the lens placement ([0255], [0365])
Regarding claim 12, Lee in view of Sarfaraz further teaches wherein said scaffold comprises at least two interior rings (see rejection in claim 1, 4 rings total, 2 would be interior).
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 Lee by applying the teachings of the multiple lens and ring design of Sarfaraz in order to add an additional lens to the device to allow for vision to be varied to suit a particular patient’s circumstances (col 44-58, and col 12, lines 9-38)
Lee in view of Sarfaraz does not exactly teach the details of a shelf. Argento teaches an intraocular lens (abstract) wherein a plurality of tabs creates a shelf and are positioned at the inner edge of a ring with a lens being attached to (for example see fig 25c or 51a/c, or 52a/c).
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 interior rings as taught by Lee in view of Sarfaraz by applying the teachings of a shelf, as taught by Argento, in order to create an additional mating surface to add further guidance and connection to the lens placement ([0255], [0365])
Regarding claim 18, Lee further teaches wherein said secondary lens is concave ([0033], any suitable optic).
Regarding claim 19, Lee further teaches wherein said secondary lens is convex ([0033], any suitable optic).
Regarding claim 20, Lee further teaches wherein said secondary lens is flat ([0033], any suitable optic).
Regarding claim 22, Lee in view of Sarfaraz further teaches wherein the diameter of said interior ring provides a concave curvature to said pillars (the combination teaches an interior ring, see above, Lee: [0024]).
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 Lee by applying the teachings of the multiple lens and ring design of Sarfaraz in order to add an additional lens to the device to allow for vision to be varied to suit a particular patient’s circumstances (col 44-58, and col 12, lines 9-38)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20160220355 A1) in view of Sarfarzi (US 7662179 B2), Currie (US 20140277437 A), Argento (US 20200008931 A1), and Zaldivar (US 20160095699 A1) and in further view of Pinchuk (US 20100283164 A1).
Regarding claim 10, Lee in view of Sarfaraz, Currie, Argento, and Zaldivar does not exactly teach where shrinking occurs around the device. Pinchuk teaches an intraocular lens (abstract) wherein said flexing of said anterior or said posterior ring is in response to said eye capsule shrinking around scaffold ([0047]), thereby allowing said implant to have a secure fit for any variable size of said eye capsule (structure is capable of this).
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 Lee in view of Sarfaraz, Currie, Argento, and Zaldivar, by applying the teachings of capsular bag shrinkage, as taught by Pinchuk, to understand that natural shrinkage occurs within a capsule and allows for an intraocular ring to “hold on” and “change” ([0047]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20160220355 A1) in view of Sarfarzi (US 7662179 B2), Currie (US 20140277437 A), Argento (US 20200008931 A1), and Zaldivar (US 20160095699 A1) and in further view of Bumbalough (US 8034108 B2).
Regarding claim 13, Lee in view of Sarfaraz, Currie, Argento, and Zaldivar fails to exactly teach an asymmetric arrangement. Bumbalough teaches and intraocular lens (abstract) wherein asymmetry is utilized (col 5, lines 20-40).
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 Lee in view of Sarfaraz, Currie, Argento, and Zaldivar, by applying the teachings of asymmetry, as taught by Bumbalough in order to allow for a non-uniform distribution of forces (col 5, lines 20-40).
Claim(s) 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20160220355 A1) in view of Sarfarzi (US 7662179 B2), Currie (US 20140277437 A), Argento (US 20200008931 A1), Zaldivar (US 20160095699 A1), and Bumbalough (US 8034108 B2) and in further view of Hayes (WO 2016014940 A1).
Regarding claim 14, Lee in view of Sarfaraz, Currie, Argento, and Zaldivar fails to teach five horizontal fenestrations. Hayes teaches an intraocular lens (abstract) wherein there are at least five horizontal fenestrations (pg. 12, lines 27-30).
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 Lee in view of Sarfaraz, Currie, Argento, Zaldivar, and Bumbalough by applying the teachings of a plurality of fenestrations, as taught by Hayes in order to complete a simple design substitution according to design intent (pg. 12, lines 27-30).
Regarding claim 15, Lee further teaches wherein there are at least 10 vertical fenestrations (see fig 2a/b or 3a/b).
Regarding claim 16, Lee further teaches wherein said secondary lens is associated with a prescribed optical meridian and inserted in an appropriate vertical fenestration for addressing astigmatism correction (structure is capable of this, [0018], [0033]).
Regarding claim 17, Lee further teaches wherein said secondary lens has an optical meridian, said secondary lens optical meridian being set off-axis of one of said prescribe optical meridians of said vertical fenestration when attached to said scaffold (structure is capable of this, the structure can be rotated depending which fenestration the haptic is place in, [0018], [0033]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20160220355 A1) in view of Sarfarzi (US 7662179 B2), Currie (US 20140277437 A), Argento (US 20200008931 A1), and Zaldivar (US 20160095699 A1) and in further view of Stenger (US 20120078364 A1).
Regarding claim 21, Lee in view of Sarfaraz, Currie, Argento, and Zaldivar fails to exactly teach a convex curvature. Stenger teaches an intraocular lens (abstract) wherein the diameter of said interior ring provides a convex curvature to said pillars (fig 1).
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 Lee in view of Sarfaraz, Currie, Argento, and Zaldivar, by applying the teachings of convex pillars, as taught by Stenger in order to complete a simple substitution of one known element design for another to obtain predictable results of safe implantation in an eye (MPEP 2143).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20160220355 A1) in view of Sarfarzi (US 7662179 B2), Currie (US 20140277437 A), Argento (US 20200008931 A1), and Zaldivar (US 20160095699 A1) and in further view of Anna (WO 2013102041 A1).
Regarding claim 23, Lee in view of Sarfaraz, Currie, Argento, and Zaldivar fails to exactly teach a rectilinear relationship. Anna teaches an intraocular lens (abstract) wherein the diameter of said interior ring is rectilinear to said pillars (fig 1).
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 Lee in view of Sarfaraz, Currie, Argento, and Zaldivar, by applying the teachings of a rectilinear relationship, as taught by Anna in order to complete a simple substitution of one known element design for another to obtain predictable results of safe implantation in an eye ((MPEP 2143).
Conclusion
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, Thomas Barrett can be reached at (571) 272-4746. 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
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