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) 1-2, 9-11, 18-20, 22-23, 26-28 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).
Regarding claim 1, Brodie (US Pub No.: 2021/0315687) discloses an implantable device for supporting an artificial intraocular lens (AIOL) in an eye (as per the abstract with a supporting disclosed in [0012]), the device comprising: a posterior platform comprising an anterior-facing surface and an inner wall defining (being the ring in figure 1, which has an inner wall, anterior surface, and a posterior platform depicted in figures 2-3. The anterior surface and posterior platform will be the anterior and posterior side of the ring), at least in part, a central aperture, wherein when the device is implanted in the eye and supports the AIOL (the aperture being the opening in the ring, where the IOL is placed within in figures 1-3), light passes through an optical portion of the AIOL and the central aperture of the posterior platform towards a retina of the eye (as the device has an IOL in the abstract and [0001], and as per the placement of the device in figures 4-7, it stands to reason that light will pass through the lens toward a retina); and a plurality of radially extending structures for stabilizing the device within the eye, preventing limiting rotation of the device within the eye after implantation and positioning of the device, and aiding in centration of the device relative to an optical axis of the eye (being the haptics with haptic ends in figures 1-3), wherein each of the plurality of radially extending structures comprises a radially outermost portion adapted for sutureless positioning 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 (being the haptic ends of the device in figures 1-3), the device resides posterior of an iris of the eye and no portion of the device rests external to a sclera of the eye after implantation (Brodie discloses implantation posterior to the iris and cornea in [0019] with the capsule placed in the posterior chamber in [0030]. Atraumatic scleral fixation details in [0005]-[0007]).
However, Brodie does not teach at least one awning positioned over the anterior-facing surface of the posterior platform, wherein the at least one awning forms at least one recess anterior to the posterior platform, the at least one recess adapted to receive a portion of at least one haptic of the AIOL.
Instead, Kojima teaches at least one awning positioned over the anterior-facing surface of the posterior platform (being bag portion 15 in figures 1-2, defined in [0101]-[0102]), wherein the at least one awning forms at least one recess anterior to the posterior platform (being the opening 18 to which parts 15 form around), the at least one recess adapted to receive a portion of at least one haptic of the AIOL (a lens can be housed within part 18 as per [0107]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 2, Brodie in view of Kojima teach the device of claim 1, wherein Kojima discloses the at least one awning positioned over the anterior-facing surface of the posterior platform defines an anterior opening (parts 15 of Kojima can be implemented over the posterior platform of Brodie, where parts 15 define an opening as per figures 3A-3B 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 a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 9, Brodie in view of Kojima teach the device of claim 1, wherein Brodie discloses, during use, at least a portion of the intraocular lens is positioned within the at least one recess (in figures 2-3 of Brodie) against the anterior-facing surface (the IOL will be aligned to the anterior-facing surface of Brodie).
Regarding claim 10, Brodie in view of Kojima teach the device of claim 9, wherein Kojima teaches an external surface of the at least one awning has a smooth geometry (part 15 is depicted as being flat and smooth in figures 1-3) to protect the iris from the intraocular lens upon implantation of the device (as part 15 is defined as a bag portion in [0101] and as the bag portion is used to hold an intraocular lens in place, the holding of the lens protects the iris of the user). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 11, Brodie in view of Kojima teaches the device of claim 9, wherein Kojima discloses an internal surface of the at least one awning provides counter pressure to a haptic of the intraocular lens upon positioning of the intraocular lens on the anterior-facing surface (as part 15 is defined as a bag portion in [0101] and as the bag portion is used to hold an intraocular lens in place, the holding of the lens will counter a pressure on the haptic of the intraocular lens as both the haptics and part 15 are used to hold a lens. The internal surface will be the edge parts of part 15 in figure 3A that is close to part 20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 18, Brodie in view of Kojima teach the device of claim 1, wherein Brodie discloses the posterior platform 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), wherein each of the plurality of radially extending structures is coupled to the device at an angle to the first plane (shown in figure 1, where the haptic arms extend from a posterior surface of the ring element at an angle with respect to a first plane).
Regarding claim 19, Brodie in view of Kojima teach the device of claim 18, wherein Brodie discloses the radially outermost portion of each of the plurality of radially extending structures is anterior of the first plane (shown in figure 1, where the haptic arms extend from a posterior surface of the ring element).
Regarding claim 20, Brodie in view of Kojima teach the device of claim 19, wherein Kojima teaches that the at least one awning projects anterior to the radially outermost portion (Kojima’s awning portion part 15 will project anterior to the outermost portion of the support 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 a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 22, Brodie in view of Kojima teach the device of claim 1, wherein Kojima teaches that the posterior platform further comprises one or more cut-outs peripheral to the central aperture (slits part 14 shown in figures 3A-3B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place, where the slits part 14 will reduce the breakage risk of the IOL in [0103]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 23, Brodie in view of Kojima teach the device of claim 22, Kojima teaches wherein Kojima teaches the posterior platform is sized and shaped to support a central optic of the intraocular lens on an anterior-facing surface of the posterior platform and the one or more cut-outs are sized and shaped to receive at least a portion of a haptic of the intraocular lens when the intraocular lens is implanted within the at least one recess of the device (it stands to reason that the haptics on the IOL of Brodie in figure 2 can slot within the openings part 14 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 a bag portion part 15 of Kojima into the device to provide a means to hold an intraocular lens in place. As part 15 is placed over foam elements part 16 in figures 3A and B, the bag part 15 can be implemented over the anterior facing surface of the ring member of Brodie with results that would be obvious to one of ordinary skill in the art.
Regarding claim 26, Brodie in view of Kojima teach a system with Brodie comprising the device of claim 1 and the AIOL (being the IOL in figures 2-3 of Brodie. [0017] discloses that the device is able to “accommodate a wide variety of intraocular lenses”.
Regarding claim 27, Brodie in view of Kojima teach the system of claim 26, wherein Brodie discloses the device is configured to receive the AIOL forming the system before the system is implanted into the eye (shown visually in figures 2-3 of Brodie).
Regarding claim 28, Brodie in view of Kojima teach the system of claim 27, wherein Brodie discloses the AIOL is a one-piece intraocular lens or a multi-piece intraocular lens (one piece lens with haptics shown in figures 2-3).
Claim(s) 3-8 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) in further view of de Juan Jr. (US Pub No.: 2019/0269500).
Regarding claim 3, Brodie in view of Kojima teaches the device of claim 2. However, said prior art does not teach wherein the at least one awning comprises a visualization feature that projects inward from the at least one awning so as to narrow a dimension of the anterior opening.
Instead, de Juan Jr. (US Pub No.: 2019/0269500) teaches wherein the at least one awning comprises a visualization feature that projects inward from the at least one awning so as to narrow a dimension of the anterior opening (de Juan teaches markers 1100 in [0159] and in figure 1A-1B that can be implemented into the awning of Brodie in view 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 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 4, Brodie in view of Kojima and de Juan teach the method of claim 3, with de Juan wherein, in use, the visualization feature is directly visualized through a pupil of 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.
Regarding claim 5, Brodie in view of Kojima and de Juan teach the device of claim 3, wherein Kojima teaches the device has an elongate shape comprising a long axis and a short axis, wherein the dimension of the anterior opening that is narrowed is a distance between central-most edges of the anterior opening along the long axis of the device (a long axis being from the top end of figure 12 to the bottom end of figure 12 would extend along the elongate sides of the device of figure 12, with the short axis extending from the left to right end of the device along the short sides of the device of figure 12). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate details with respect to a thickness provided in Kojima into the device of Brodie for the purpose of providing additional structural details within the device of Kojima that would provide dimensional details required for a device that is inserted into the eye of a user.
Regarding claim 6, Brodie in view of Kojima and de Juan teach the device of claim 5, with Kojima teaching wherein the distance is at least about 5.0 mm up to about 7.0 mm (in [0158]-[0160] of Kojima).
Regarding claim 7, Brodie in view of Kojima and de Juan teach the device of claim 5, wherein the visualization feature projects at least about 2.5 mm to about 3 mm away from a central axis through the central aperture (the visualization marker of de Juan can be placed 2.5 to 3mm away from the central axis of Brodie. .
Regarding claim 8, Brodie in view of Kojima and de Juan teach the device of claim 5, wherein the distance is greater than a diameter of the central aperture (as per figure 12, the distance between the central most edges of the anterior opening of part 2 is greater than the diameter of the central aperture within the device of part 1).
Regarding claim 29, Brodie in view of Kojima teach the system of claim 28. However, Brodie does not teach wherein the one-piece intraocular lens is selected from a group consisting of a unifocal lens, a toric lens, a multi-focal lens, an extended-depth-of- focus lens, and an accommodating intraocular lens.
Instead, de Juan (US Pub No.: 2019/0269500) teaches wherein the one-piece intraocular lens is selected from a group consisting of a unifocal lens, a toric lens, a multi-focal lens, an extended-depth-of- focus lens, and an accommodating intraocular lens (toric lenses in [0101], multi-focal lenses in [0093]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a toric or multi-focal lens as presented in de Juan into Brodie in order to provide specific lenses into Brodie that are used to compensate for visual aberrations as per [0101] of de Juan.
Claim(s) 12-14, 21, and 24-25 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 12, Brodie in view of Kojima teach the device of claim 1. However, said combination does not teach a further comprising of one or more posterior stabilization features.
Instead, Wanders (US Pub No.: 2018/0263757) teaches one or more posterior stabilization features (supports in [0014] are used to fix the IOL into an opening, as per [0042], the posterior stabilization features provide a support for the IOL is provided). 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 13, Brodie in view of Kojima and Wanders teach the device of claim 12, wherein Wanders teaches the one or more posterior stabilization features extend posteriorly from a posterior surface of the posterior platform (shown in figure 1 with the supports part 5 and 5’ defined in [0104]-[0107]), the one or more posterior stabilization features are configured to engage with at least a portion of a capsular bag (anterior support engaging with a capsular bag in [0014]). 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 14, Brodie in view of Kojima and Wanders teach the device of claim 13, wherein the posterior stabilization feature comprises a first portion projecting posteriorly from a posterior surface of the posterior platform and a second portion projecting laterally outward from the first portion (as 5 and 5’ extend out in opposite directions of each other in figures 1-2, 5 can be defined as a posterior projection and 5’ can be defined as a lateral projection). 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 21, Brodie in view of Kojima teach the device of claim 1. However, said combination does not teach wherein an anterior segment of the capsular bag provides support for the device 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 24, Brodie in view of Kojima teach the device of claim 1. However, said combination does not further comprise one or more stabilization features configured to engage with at least a portion of the capsular bag.
Instead, Wanders further comprises one or more stabilization features configured to engage with at least a portion of the capsular bag (anterior support engaging with a capsular bag in [0014]). 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 25, Brodie in view of Kojima teach the device of claim 24, wherein the one or more stabilization features extend posterior to the at least one recess or anterior to the at least one recess.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: with respect to independent claim dependent claim 15 with claims 16-17, prior art, such as Brodie (US Pub No.: 2021/0315687) in view of Kojima (US Pub No.: 2020/0000575), de Juan (US Pub No.: 2019/0269500), Wanders (US Pub No.: 2018/0263757), 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 15 stating “wherein the posterior platform comprises an outer perimeter that is substantially non-circular and an inner perimeter that is substantially circular” 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. As a result, a “non-circular” shaped of the posterior platform, which is equivalent to the non-circular structure in 16/988,519, was not found in prior art before the effective filing date of the current application. 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.
Claims 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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