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 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) 1-13, 20-21, 24-26, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodie (US Pub No.: 2021/0315687) in view of Kojima (US Pub No.: 2020/0000575).
Regarding claim 1, Brodie (US Pub No.: 2021/0315687) discloses a method for supporting an artificial intraocular lens (IOL) in an eye (as per the abstract with a supporting disclosed in [0012]), the method comprising: positioning an artificial intraocular lens (IOL) within a lens support device (shown in figure 2 where the IOL is placed into the “artificial capsule” labeled in said figure), the IOL comprising a central optic and at least one haptic (shown in figure 2), the lens support device comprising: a central support axis (being any linear axis extending along the device of figure 1. It can be along a haptic down the middle of the device in figure 10); an outer perimeter wall (being the outer perimeter of the ring in figure 10 that would be closest to the front of the eye in figure 4); an anterior wall extending inwardly towards the central support axis from an anterior portion of the outer perimeter wall (shown in figure 4, wherein an upper segment is extending toward the center of the device from the anterior end of the ring defined in figure 10); a posterior wall extending inwardly towards the central support axis from a posterior portion of the outer perimeter wall, the posterior wall having an inner perimeter comprising a closed shape centered on the central support axis (being the part of the ring in figure 10 that is closest to the back of the eye (i.e. closest to the optic nerve) that extends towards the center of the device in figure 4); a central aperture (being the opening for the IOL in figures 1 and 2) extending through a full thickness of the lens support structure (shown in figures 1-2); and a recess bounded by a portion of the outer perimeter wall, a portion of the anterior wall (shown in figures 1-2), and a portion of the posterior wall, wherein said positioning comprises positioning a portion of the at least one haptic of the IOL within the recess to form an assembled device (shown in figure 2);
However, Brodie does not teach loading the assembled device into an injector system; and inserting the assembled device into an eye using the injector system.
Instead, Kojima (US Pub No.: 2020/0000575) teaches loading the assembled device into an injector system; and inserting the assembled device into an eye using the injector system (in the abstract under part b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the injector of Kojima into Brodie for the purpose of providing a means to insert the capsule of Brodie (disclosed in [0031]-[0034] of Brodie, in which the capsule holds the lens and the support device) not provided for in Brodie, with the injector of Kojima being specifically disclosed to inject fixing devices for intraocular lenses in [0074]-[0077] of Kojima. The injector of Kojima also provides the benefit of being biocompatible, non-toxic, and non-stimulatory in [0086] of Kojima.
Regarding claim 2, Brodie in view of Kojima teach the method of claim 1, wherein Brodie discloses said positioning comprises aligning a central axis of said central optic of said IOL with said central support axis of said lens support device (in figure 2 of Brodie, the central axis of the IOL and the support axis are lining up to form the arrangement shown in figure 3) .
Regarding claim 3, Brodie in view of Kojima teach the method of claim 1, wherein Brodie discloses inserting the assembled device in the eye comprises presenting the assembled device into an anterior chamber of the eye or a posterior chamber of the eye (placement of the capsule holding the IOL into a posterior chamber in [0030]).
Regarding claim 4, Brodie in view of Kojima teach the method of claim 3, wherein Kojima teaches inserting the assembled device in the eye comprises sequentially presenting portions of the assembled device from an injector system (as the injector of Kojima teaches a sequential injection in [0077], a sequential injection of the lens and the support means of Brodie via the injector of [0077] of Kojima is possible to one of ordinary skill in the art). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the injector of Kojima into Brodie for the purpose of providing a means to insert the capsule of Brodie (disclosed in [0031]-[0034] of Brodie, in which the capsule holds the lens and the support device) not provided for in Brodie, with the injector of Kojima being specifically disclosed to inject fixing devices for intraocular lenses in [0074]-[0077] of Kojima. The injector of Kojima also provides the benefit of being biocompatible, non-toxic, and non-stimulatory in [0086] of Kojima.
Regarding claim 5, Brodie in view of Kojima teach the method of claim 3, wherein Kojima discloses inserting the assembled device into the eye comprises presenting the assembled device in full from an injector system (in [0076] of Kojima). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the injector of Kojima into Brodie for the purpose of providing a means to insert the capsule of Brodie (disclosed in [0031]-[0034] of Brodie, in which the capsule holds the lens and the support device) not provided for in Brodie, with the injector of Kojima being specifically disclosed to inject fixing devices for intraocular lenses in [0074]-[0077] of Kojima. The injector of Kojima also provides the benefit of being biocompatible, non-toxic, and non-stimulatory in [0086] of Kojima.
Regarding claim 6, Brodie in view of Kojima teach the method of claim 5, wherein Brodie discloses that the assembled device is presented in full oriented with the anterior wall located anteriorly relative to the eye and the posterior wall located posteriorly relative to the eye (Brodie discloses implantation posterior to the iris and cornea in [0019] with the capsule placed in the posterior chamber in [0030]).
Regarding claim 7, Brodie in view of Kojima teach the method of claim 1, wherein Brodie discloses the lens support device further comprises three fixation arms (shown in figures 1-2 of Brodie). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the injector of Kojima into Brodie for the purpose of providing a means to insert the capsule of Brodie (disclosed in [0031]-[0034] of Brodie, in which the capsule holds the lens and the support device) not provided for in Brodie, with the injector of Kojima being specifically disclosed to inject fixing devices for intraocular lenses in [0074]-[0077] of Kojima. The injector of Kojima also provides the benefit of being biocompatible, non-toxic, and non-stimulatory in [0086] of Kojima.
Regarding claim 8, Brodie in view of Kojima teach the method of claim 7, wherein Brodie discloses, at rest, two of the three fixation arms are in a folded configuration, flexible, and are biased towards the folded configuration (as the fixation arms of Brodie are defined as haptics, a degree of flexibility is implied to be here. As such, a bending of the haptics to an origin point is implied to be possible within Brodie).
Regarding claim 9, Brodie in view of Kojima teach the method of claim 7, wherein Brodie discloses that each of the three fixation arms comprises an origin portion coupled to the outer perimeter wall of the lens support structure and a terminal portion comprising an anchor (the origin portion being the part of the haptic arm attached to the ring in figure 1 with the anchor being the haptic end in figure 1).
Regarding claim 10, Brodie in view of Kojima teach the method of claim 9, wherein Brodie discloses that the anchor of each of the three fixation arms is adapted for sutureless, trans-scleral fixation (disclosed in [0005]-[0006]).
Regarding claim 11, Brodie in view of Kojima teach the method of claim 10, with Brodie further comprising grasping the anchor of a first fixation arm and externalizing the anchor through and over a first portion of sclera (in [0027], as the three haptic arms are externalized trans-sclerally, an externalizing of the haptic arms including the haptic end anchors is present, with a grasping of an arm implied as said grasping by some means is required to place the device in the body).
Regarding claim 12, Brodie in view of Kojima teach the method of claim 11, with Brodie further comprising grasping the anchor of a second fixation arm, unfolding the folded configuration of the second fixation arm, and externalizing the anchor of the second fixation arm through and over a second portion of sclera (in [0027], as the three haptic arms are externalized trans-sclerally, an externalizing of the haptic arms including the haptic end anchors is present, with a grasping of an arm implied as said grasping by some means is required to place the device in the body. The second arm will be externalized over a second portion of the sclera as per the geometry of the device in figures 1-3).
Regarding claim 13, Brodie in view of Kojima teach the method of claim 12, with Brodie, further comprising grasping the anchor of a third fixation arm, tensioning the third fixation arm and externalizing the anchor of the third fixation arm through and over a third portion of sclera to locate and stabilize the assembled device within the eye (in [0027], as the three haptic arms are externalized trans-sclerally, an externalizing of the haptic arms including the haptic end anchors is present, with a grasping of an arm implied as said grasping by some means is required to place the device in the body. The third arm will be externalized over a second portion of the sclera as per the geometry of the device in figures 1-3).
Regarding claim 20, Brodie in view of Kojima teaches the method of claim 1, wherein Brodie discloses inserting the assembled device into the eye comprises inserting the assembled device posterior to an iris of the eye (implantation posterior to an iris in [0012]).
Regarding claim 21, Brodie in view of Kojima teach the method of claim 20, Brodie discloses wherein a posterior-facing surface of the posterior wall is positioned anteriorly to an anterior segment of the capsular bag of the eye (as the device of brodie is used to “provide support and centration for an intraocular lens (IOL) without use of the native capsular bag” in [0030], the device will be anterior to the posterior end of the capsular bag as the device is not relying on the bag for a support while providing a lens replacement).
Regarding claim 24, Brodie in view of Kojima teach the method of claim 1, wherein Brodie discloses the device further comprises a plurality of radially extending structures for stabilizing the device within the eye, preventing rotation of the device within the eye, and aiding in centration of the device relative to an optical axis of the eye (being the haptic arms with the haptic ends in figure 1).
Regarding claim 25, Brodie in view of Kojima teach the method of claim 24, wherein Brodie discloses each of the plurality of radially extending structures comprises a radially outermost portion adapted for sutureless positioning (sutureless positioning in the abstract and in [0005]-[0006]) of the device within the eye by providing contact with internal structures of the eye such that when the device is implanted in the eye (depicted in figures 4-5, transclera anchors for attachment in [0005]-[0007]), the device resides posterior of an iris of the eye (as the device of brodie is used to “provide support and centration for an intraocular lens (IOL) without use of the native capsular bag” in [0030], the device will be anterior to the posterior end of the capsular bag as the device is not relying on the bag for a support while providing a lens replacement) and no portion of the device rests external to a sclera of the eye after implantation (scleral fixation details in [0005]-[0007]).
Regarding claim 26, Brodie in view of Kojima teaches the method of claim 25, wherein Brodie discloses that the posterior wall lies within a first plane (the posterior wall of the device in figures 2-3 are on a plane defined by the device in said figures), and each of the plurality of radially extending structures is coupled to the device at an angle to the first plane so that a radially outermost portion of each of the plurality of radially extending structure lies anterior to the first plane (shown in figure 1, where the haptic arms extend from a posterior surface of the ring element).
Regarding claim 29, Brodie in view of Kojima teach the method of claim 1, with Kojima further comprising loading the assembled device into an injector system (in [0074]-[0076] of Kojima), wherein inserting the assembled device into the eye comprises using the injector system to insert the assembled device into the eye (in [0074]-[0076]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodie (US Pub No.: 2021/0315687) in view of Kojima (US Pub No.: 2020/0000575) in further view of Scharioth (US Pub No.: 2019/0076236).
Regarding claim 18, Brodie in view of Kojima teach the method of claim 1. However, said prior art does not teach wherein the closed shape of the inner perimeter of the posterior wall is smaller in diameter than a diameter of the central optic of the IOL (shown in figures 8-9). However, Brodie does not explicitly teach details with respect to a central optic diameter of the IOL.
Instead, Scharioth (US Pub No.: 2019/0076236) teaches a diameter of the central optic of the IOL (in [0041], the active lens has a diameter between 4 and 10 mm, such that the diameter of the lens of Scharioth may be larger than the diameter of the posterior wall of Brodie). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lens sizing of Scharioth into Brodie for the purpose of providing lens details not present in Brodie, to which the diameter of Scharioth provides a diameter that allows for a lens to fit within a capsular bag as per [0009]-[0010] of Scharioth.
Regarding claim 19, Brodie in view of Kojima and Scharioth teach the method of claim 18, wherein Brodie discloses the diameter of the closed shape is less than about 6.0 mm (a diameter of 5mm to 10mm in [0037]-[0039], which satisfies the diameter being less than 6mm).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodie (US Pub No.: 2021/0315687) in view of Kojima (US Pub No.: 2020/0000575) in view of de Juan Jr. (US Pub No.: 2019/0269500).
Regarding claim 22, Brodie in view of Kojima teach the method of claim 20. However, Brodie does not teach wherein the anterior wall comprises a visualization feature that projects inward to narrow a dimension of an anterior region of the central aperture.
Instead, de Juan Jr. (US Pub No.: 2019/0269500) teaches wherein the anterior wall comprises a visualization feature that projects inward to narrow a dimension of an anterior region of the central aperture (de Juan teaches markers 1100 in [0159] and in figure 1A-1B that can be implemented into the anterior region of the central aperture of Brodie). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the markers of de Juan into Brodie in order to enhance the visualization of the lens, as per [0159] of de Juan, providing the benefit of allowing a physician to take measurements of the lens to ensure a proper fit.
Regarding claim 23, Brodie in view of Kojima and de Juan teach the method of claim 22, with de Juan further comprising directly visualizing the visualization feature through the pupil of the eye during inserting of the assembled device into the eye (as the visualization markers are “easily identifiable with intra-ocular imaging techniques known to the art” in [0159], and as said imaging types will be outside of the body, an imaging of the pupil is present to visualize the markers of de Juan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the markers of de Juan into Brodie in order to enhance the visualization of the lens, as per [0159] of de Juan, providing the benefit of allowing a physician to take measurements of the lens to ensure a proper fit.
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brodie (US Pub No.: 2021/0315687) in view of Kojima (US Pub No.: 2020/0000575) in further view of Wanders (US Pub No.: 2018/0263757).
Regarding claim 27, Brodie in view of Kojima teach the method of claim 1. However, said prior art did not teach a further comprising of engaging at least a portion of an anterior segment of the capsular bag with one or more posterior stabilization features coupled to the device providing support along a Z-axis of the eye.
Instead, Wanders (US Pub No.: 2018/0263757) teaches engaging at least a portion of an anterior segment of the capsular bag (anterior support engaging with a capsular bag in [0014]) with one or more posterior stabilization features coupled to the device providing support along a Z-axis of the eye (as the supports are used to fix the IOL into an opening, as per [0042], the posterior stabilization features provide a support for the IOL device along what would be a Z-axis on the eye). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the support in the capsular bag as presented in Wanders into Brodie for the purpose of providing an additional support means for the intraocular lens that can clamp a capsular bag flap (in [0042]), allowing for the device of Brodie to be usable in patients where a capsular bag is still present.
Regarding claim 28, Brodie in view of Kojima and Wanders teach the method of claim 27, wherein Wanders teaches that the one or more posterior stabilization features extend posteriorly from a posterior surface of the device (shown in figure 1 with the supports part 5 and 5’ defined in [0104]-[0107]), wherein the posterior stabilization feature comprises a first portion projecting posteriorly from a posterior surface of the posterior wall and a second portion projecting laterally outward from the first portion (being shown in figure 1-2 of Wanders).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the support in the capsular bag as presented in Wanders into Brodie for the purpose of providing an additional support means for the intraocular lens that can clamp a capsular bag flap (in [0042]), allowing for the device of Brodie to be usable in patients where a capsular bag is still present.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: With respect to independent claim dependent claim 14 with claims 15-17, prior art, such as Brodie (US Pub No.: 2021/0315687) in view of Kojima (US Pub No.: 2020/0000575) and Aharoni (US Pub No.: 2014/0371852) and Ben Num (US Pub No.: 2013/0116781) are taken to be the best prior art to teach the limitations of claims 37 and 59. However, as per discussions and interviews for application number 16/988,519 (Patent No 11,759,309), the prior art did not teach details with respect to “said non-circular shape of said outer perimeter wall and (ii) said closed, non-circular shape of said inner perimeter of said anterior wall.” As such, the limitation in the present claim 14 stating “the outer perimeter wall is non-circular in shape” with the limitations of independent claim 1 was also not found in the prior art. In view of applicant’s arguments dated 03/17/2023 and the interview dated 03/10/2023 for application 16/988,519, it was agreed upon that the prior art would not teach recess details pertaining to the size and shape of the inner perimeter of the posterior wall with respect to the inner perimeter of the anterior wall. From here, prior art such as Aharoni and Ben Num were looked into to teach the difference in size and shape of the wall perimeters, but were found to not teach details with respect to a non-circular shape for said outer perimeter wall, or details with two awning portions in said outer perimeter wall.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aharoni (US Pub No.: 2014/0371852) discloses a capsular bag support with an interior opening at about axis 18. Ben Num (US Pub No.: 2013/0116781) discloses a support device 306 for an IOL lens.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774