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 with respect to claim(s) 1-10 and 31-33 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
Claims 1-10 and 31-40 are examined below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 and 31-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento (US 2018/0177589 A1) in view of Brady (US 2018/0271645 A1).
Regarding claim 1, Argento teaches An accommodating intraocular lens (1800, AIOL, fig. 18A) comprising:
a base lens (1840, accommodating structure, fig. 18B) having-
an anterior base lens component (1840a, first component, fig. 18B) having a first optical portion (1810, first optical component, fig. 18B) and a first haptic portion (1803a, first bellows structure, fig. 18C) at least partially surrounding the first optical portion;
an optical axis (see annotated fig. 18C, below);
a posterior base lens component (1840b, second component, fig. 18B) coupled to the anterior base lens component and having a second optical portion (1850, second optical component, fig. 18B) aligned with the first optical portion along the optical axis and a second haptic portion (1803b, second bellows structure, fig. 18C) at least partially surrounding the second optical portion and aligned with the first haptic portion in a direction parallel to the optical axis (fig. 18C);
an optical chamber (1805, fluid chamber, fig. 18C) between the first optical portion and the second optical portion; and
a haptic reservoir (1803, outer reservoir, fig. 18A) between the first haptic portion and the second haptic portion (¶ [0503]), the haptic reservoir in fluid communication with the optical chamber (¶ [0501]); and
a fixed lens (1830, fixed lens, fig. A) configured to be removably coupled with the base lens (¶ [0013]), the fixed lens having-
a lens portion (1836, optical portion, fig. 18A) having an anterior face (see annotated fig. 18C, below) and a posterior face (see annotated fig. 18C, below), the lens portion providing a fixed optical power (¶ [0499]) and configured to be aligned with the first and second optical portions when the fixed lens is coupled to the base lens (fig. 18C).
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Argento fails to teach a plurality of retaining structures, a plurality of flow-through features and a plurality of tabs configured to enter the plurality of retain structures and be positioned circumferentially between two of the plurality of flow-through features. However, Brady teaches an accommodating intraocular lens that includes
a plurality of retaining structures formed in one or both of the anterior base lens component and the posterior base lens component (fig. 11B, ¶ [0151], the area below tabs 1160), the plurality of retaining structures open toward the optical axis (fig. 11D);
a plurality of flow-through features formed in one or both of the anterior base lens component and the posterior base lens component (1140, cutouts, fig. 11B), wherein each of the flow-through features separate individual ones of the retaining structures (fig. 11B); and
a plurality of tabs extending radially outward from the lens portion (1150, fins, fig. 11B), each tab being configured to enter one of the plurality of retaining structures and be positioned circumferentially between two of the plurality of flow-through features when the fixed lens is coupled to the base lens (¶ [0151], fig. 11D).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the accommodating intraocular lens of Argento to include a plurality of retaining structures, a plurality of flow-through features and a plurality of tabs configured to enter the plurality of retain structures and be positioned circumferentially between two of the plurality of flow-through features as taught by Brady in order to receive one or more fins extending from the lens and secure the power lens to the base assembly (Brady, ¶ [0151]).
Regarding claim 2, Argento further teaches the anterior face of the fixed lens is positioned posterior of an anterior-most edge of the anterior base lens component when the fixed lens is coupled to the base lens (fig. 18C).
Regarding claim 3, Argento fails to teach a hole through on of the tabs. However, Brady further teaches a hole through one of the tabs (¶ [0151], manipulation holes), the hole being configured to receive a portion of a tool for manipulating the fixed lens with respect to the base lens (¶ [0151]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the tabs of the lens to include a hole as taught by Brady in order to allow a user to insert a tool to assist in rotating the power lens (Brady, ¶ [0151]).
Regarding claim 4, Argento further teaches the anterior base lens component includes a first annular mating portion (see annotated fig. 18B, below) surrounding the first optical portion; the posterior base lens component includes a second annular mating portion (1858, wall, fig. 18B) surrounding the second optical portion; the first annular mating portion includes a plurality of protrusions (1855, standoff, fig. 18B) configured to mate with the second annular mating portion (¶ [0496]); and wherein circumferential gaps (1857, recesses, fig. 18B) between the plurality of protrusions at least partially define fluid flow paths between the haptic reservoir and the optical chamber (¶ [0496] and ¶ [0501]).
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Regarding claim 5, Argento further teaches the anterior base lens component includes a first annular mating portion (see annotated fig. 18B, below) surrounding the first optical portion; the posterior base lens component includes a second annular mating portion (see annotated fig. 18B, below) surrounding the second optical portion; the second annular mating portion includes a plurality of protrusions (1871, mid-bellows attachment features, fig. 18B) configured to mate with the first annular mating portion (¶ [0353]); and wherein circumferential gaps (¶ [0353-0354]) between the plurality of protrusions at least partially define fluid flow paths between the haptic reservoir and the optical chamber (¶ [0354]).
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Regarding claim 6, Argento further teaches one or more indentations in an anterior-most surface of the anterior base lens component (1881, outer flow-through features, fig. 18A).
Regarding claim 7, Argento fails to teach a radial indentation. However, Brady further discloses at least one of the plurality of flow-through features is defined at least partially by a radial indentation in a radially-outermost surface of one or both of the anterior base lens component and the posterior base lens component (167, opening, fig. 3C), and wherein the radial indentations is circumferentially aligned and in communication with at least one of the one or more indentations (fig. 3A). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the accommodating intraocular lens of Argento to include a radial indentation as taught by Brady in order to provide enhanced flexibility in the anterior segment of the haptic (Brady, ¶ [0114]).
Regarding claim 8, Argento further teaches a fluid chamber between the fixed lens and the first optical portion of the anterior base lens component when the fixed lens is coupled with the base lens (1841, chamber, fig. 18C), wherein circumferential gaps (1820, passages, fig. 18C) between the tabs of the fixed lens allow fluid to pass around fixed lens into and out from the fluid chamber (¶ [0504]).
Regarding claim 31, Argento teaches an accommodating intraocular lens (1800, AIOL, fig. 18A) comprising:
a base lens (1840, accommodating structure, fig. 18B) having
an anterior base lens component (1840a, first component, fig. 18B) having a first optical portion (1810, first optical component, fig. 18B) and a first haptic portion (1803a, first bellows structure, fig. 18C) at least partially surrounding the first optical portion;
an optical axis (see annotated fig. 18C, below);
a posterior base lens component (1840b, second component, fig. 18B) coupled to the anterior base lens component and having a second optical portion (1850, second optical component, fig. 18B) aligned with the first optical portion along the optical axis and a second haptic portion (1803b, second bellows structure, fig. 18C) at least partially surrounding the second optical portion and aligned with the first haptic portion in a direction parallel to the optical axis (fig. 18C);
an optical chamber (1805, fluid chamber, fig. 18C) between the first optical portion and the second optical portion; and
a haptic reservoir (1803, outer reservoir, fig. 18A) between the first haptic portion and the second haptic portion (¶ [0503]), the haptic reservoir in fluid communication with the optical chamber (¶ [0501]); and
a fixed lens (1830, fixed lens, fig. A) configured to be removably coupled with the base lens (¶ [0013]), the fixed lens having-
a lens portion (1836, optical portion, fig. 18A) having an anterior face (see annotated fig. 18C, below) and a posterior face (see annotated fig. 18C, below), the lens portion being aligned with the first and second optical portions when the fixed lens is coupled to the base lens (fig. 18C).
Argento fails to teach a plurality of cavities, a plurality of slots and a plurality of tabs positioned along a plane extending perpendicular to the optical axis. However, Brady teaches an accommodating intraocular lens that includes
a plurality of cavities formed in one or both of the anterior base lens component and the posterior base lens component(¶ [0151, area below tab 1160), the plurality of cavities open toward the optical axis (fig. 11B);
a plurality of slots, each slot adjacent one of the plurality of cavities (1140, cutouts, fig. 11B);
a plurality of tabs (1150, fins, fig. 11B), wherein each of the plurality of tabs extending radially outward from the lens portion to define a length that terminates at an end configured to be received by a corresponding one of the plurality of cavities (fig. 11D);
wherein-
each tab is configured to fit into one of the slots when the fixed lens is initially translated into a position in which the fixed lens is at least partially surrounded by the haptic reservoir (¶ [0151]); and
each tab is configured enter one of the plurality of cavities when the fixed lens is rotated about the optical axis after the tabs are positioned in the slots (¶ [0151]), such that the length of each of the plurality of tabs, the lens portion, the plurality of slots, and the plurality of cavities are positioned along a plane extending perpendicular to the optical axis (fig. 11D).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the accommodating intraocular lens of Argento to include a plurality of cavities, a plurality of slots and a plurality of tabs positioned along a plane extending perpendicular to the optical axis as taught by Brady in order to secure the power lens to the base assembly (Brady, ¶ [0151]).
Regarding claim 32, Argento further discloses comprising a plurality of radially-inward protrusions (1855, standoffs, fig. 18B) at interfaces between the slots and the cavities, the protrusions configured to flex radially-outward when the fixed lens is rotated about the optical axis after the tabs are positioned in the slots (The phrase “the protrusions configured to flex radially-outward when the fixed lens is rotated about the optical axis after the tabs are positioned in the slots” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the standoffs are considered to be capable of flexing radially-outward when the fixed lens is rotated about the optical axis after the tabs are positioned in the slots), wherein the protrusions inhibit movement of the tabs from the cavities to the slots under forces of an eye of a patient (The phrase “the protrusions inhibit movement of the tabs from the cavities to the slots under forces of an eye of a patient” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the standoffs is considered to be capable of inhibiting movement of the tabs from the cavities to the slots under forces of an eye of a patient).
Regarding claim 33, Argento further discloses a plurality of steps at interfaces between the slots and the cavities (¶ [0500], where the cavity transitions to the slot), wherein the steps inhibit movement of the tabs from the cavities to the slots under forces of an eye of a patient (The phrase “the steps inhibit movement of the tabs from the cavities to the slots under forces of an eye of a patient” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the steps where the cavity transition to the slot are considered to be capable of inhibiting movement of the tabs from the cavities to the slots under forces of an eye of a patient).
Regarding claim 34, Argento teaches an accommodating intraocular lens (1800, AIOL, fig. 18A) comprising:
a base lens (1840, accommodating structure, fig. 18B) having-
an anterior base lens component (1840a, first component, fig. 18B) having a first optical portion (1810, first optical component, fig. 18B) and a first haptic portion (1803a, first bellows structure, fig. 18C) at least partially surrounding the first optical portion;
an optical axis (see annotated fig. 18C, below);
a posterior base lens component (1840b, second component, fig. 18B) coupled to the anterior base lens component and having a second optical portion (1850, second optical component, fig. 18B) aligned with the first optical portion along the optical axis and a second haptic portion (1803b, second bellows structure, fig. 18C) at least partially surrounding the second optical portion and aligned with the first haptic portion in a direction parallel to the optical axis (fig. 18C);
an optical chamber (1805, fluid chamber, fig. 18C) between the first optical portion and the second optical portion; and
a haptic reservoir (1803, outer reservoir, fig. 18A) between the first haptic portion and the second haptic portion (¶ [0503]), the haptic reservoir in fluid communication with the optical chamber (¶ [0501]); and
a fixed lens (1830, fixed lens, fig. A) configured to be removably coupled with the base lens (¶ [0013]), the fixed lens having-
a lens portion (1836, optical portion, fig. 18A) having an anterior face (see annotated fig. 18C, below) and a posterior face (see annotated fig. 18C, below); and
wherein, when the fixed lens is coupled with the base lens-
the lens portion is aligned with the first and second optical portions (fig. 18C).
Argento fails to teach a plurality of retaining structures and plurality of tabs positioned along a plane extending perpendicular to the optical axis. However, Brady teaches an accommodating intraocular lens that includes
a plurality of retaining structures formed in one or both of the anterior base lens component and the posterior base lens component (fig. 11B, ¶ [0151], the area below tabs 1160), the plurality of retaining structures open toward the optical axis (fig. 11D);
a plurality of tabs (1150, fins, fig. 11B), wherein each of the plurality of tabs extending radially outward from the lens portion to define a length that terminates at an end configured to be received by a corresponding one of the plurality of retaining structures (fig. 11D),
wherein, when the fixed lens is coupled with the base lens-
each of the plurality of tabs is positioned within the corresponding one of the plurality of retaining structures such that the length of each of the plurality of tabs, the lens portion, and the plurality of retaining structures are positioned along a plane extending perpendicular to the optical axis (fig. 11D).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the accommodating intraocular lens of Argento to include a plurality of retaining structures and plurality of tabs positioned along a plane extending perpendicular to the optical axis as taught by Brady in order to secure the power lens to the base assembly (Brady, ¶ [0151]).
Regarding claim 35, Argento further teaches the anterior face of the fixed lens is positioned posterior of an anterior-most edge of the anterior base lens component when the fixed lens is coupled to the base lens (fig. 18C).
Regarding claim 36, Argento further teaches the lens portion of the fixed lens is configured to provide a fixed optical power (¶ [0499]).
Regarding claim 37, Argento further teaches a shape and/or volume of the optical chamber is adjustable in response to a change in force on the base lens (¶ [0041]).
Regarding claim 38, Argento further teaches the optical chamber and the haptic reservoir are filled with a fluid, and wherein the base lens is configured to change a distribution of the fluid within the optical chamber and the haptic reservoir in response to a change in force on the base lens (¶ [0041] and ¶ [0054]).
Regarding claim 39, Argento further teaches the fixed lens defines circumferential gaps between each of the plurality of tabs (1820, passages, fig. 18C), and when the fixed lens is coupled to the base lens-
the AIOL further includes a fluid chamber defined at least partially between the fixed lens and the first optical portion of the anterior base lens component (1841, chamber, fig. 18C), and
the circumferential gaps are in communication with the fluid chamber to allow fluid to pass around fixed lens and flow into and/or out from the fluid chamber (¶ [0504]).
Regarding claim 40, Argento further teaches the anterior base lens component defines: a radially outermost surface of the base lens (see annotated fig. 18C, below); an anterior-most surface of the base lens (see annotated fig. 18C, below).
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Argento fails to teach a flow feature defined by recces in the radially outermost surface and the anterior-most surface. However, Brady further teaches a flow feature defined by (i) a first surface portion that extends parallel to the optical axis and includes a radially inwardly recessed portion of the radially outermost surface (see annotated fig. 11B, below) and (ii) a second surface portion that extends perpendicular to the optical axis and includes a posteriorly recessed portion of the anterior-most surface (see annotated fig. 11B, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the accommodating intraocular lens of Argento to include a flow feature as taught by Brady in order to permit the haptic to be radially compressed, radially expanded, or both (Brady, ¶ [0138]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Argento in view of Brady as applied to claim 1 above, and further in view of Peyman (US 5,697,973 A).
Regarding claim 9, Argento further teaches an outer wall of the base lens (see annotated fig. 18D, below).
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Argento in view of Brady fails to teach a channel. However, Peyman teaches an intraocular lens that includes a channel in an outer wall of the base lens (see annotated fig. 5, below), the channel extending along an entire perimeter of the base lens (fig. 3, col 4 lines 48-56). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Argento and Brady to include a channel as taught by Peyman in order to receive the periphery of the iris or an opening in the capsular bag independent of additional support means (col 1 line 51 - col 2 line 10, Peyman).
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Regarding claim 10, Argento further discloses a seam between the anterior base lens component and the posterior base lens component (1801, seam fig. 18C).
Argento in view of Brady and Peyman fail to teach the channel is positioned at a seam. However, the channel is on the outer wall of the base lens component, so it is either positioned on the seam or not. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the device of Argento, Brady and Peyman to include positioning the channel at a seam as it would be obvious to try in order to ensure channel is able to receive the periphery of the iris or an opening in the capsular bag independent of additional support means.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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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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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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