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, 6-7, 9-10, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US Pub No.: 2006/0015180) in view of Lang (US Pub No.: 2002/0120329).
Regarding claim 1, Peyman (US Pub No.: 2006/0015180) teaches a multi-lens intraocular lens (IOL) system (an IOL with multiple lenses in [0064] and figures 21-24) comprising: a first lens (152 in [0064]); a second lens (156 in [0064]) rigidly connected to the first lens by at least one rigid member such that the second lens is a fixed distance, d (shown in figure 24, where the first and second lenses 152 and 156 are attached to each other. This is done via the struts defined in [0068]) from the first lens along an axis (lenses 152 and 156 are spaced apart from each other in figure 24 by a distance); a third lens (154 in figure 24) positioned between the first lens and the second lens (shown in figure 24) and adapted to move linearly along the axis anteriorly in a direction of the first lens or posteriorly in a direction of the second lens to change an optical power of the system (as the struts are disclosed to be telescopic in [0049], with telescoping in an IOL disclosed in [0077]);
However, Peyman does not teach an articulating actuator configured to move the third lens linearly along the axis in response to a force applied by a capsular bag of an eye.
Instead, Lang (US Pub No.: 2002/0120329) does teach an articulating actuator configured to move the third lens linearly along the axis in response to a force applied by a capsular bag of an eye (Lang discloses a lever arm for axial movement of an optic in [0006] that is connected to a capsular bag in [0064]). 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 lever of Lang into the device of Peyman for the actuation of an IOL optic for the purpose of allowing for a changing of the accommodation of a lens (as disclosed in [0064] of Lang) that would be beneficial for the intraocular lens of Peyman as this would allow for the natural anatomy of the eye to directly affect the accommodation of the eye.
Regarding claim 6, Peyman in view of Lang teach the IOL system of claim 1, wherein Peyman discloses that the distance d is between 3.00 mm and 4.00 mm, inclusive (Peyman teaches a distance between lenses being 0.5 to 5mm apart in [0038]).
Further regarding claim 6, it should be noted that the range provided here is for a different embodiment than the three lens system of Peyman first disclosed in [0065]. However, with respect to this embodiment (which is detailed from [0065]-[0077]), no distance between the lenses is provided. As the distance d is between the first and the second lens and as the embodiment of [0038] shows the distance from the most anterior and most posterior lens in that embodiment, it is seen that one of skill in the art would find it obvious to incorporate the distance provided here into the later embodiment within Peyman.
Regarding claim 7, Peyman in view of Lang teach the IOL system of claim 1, wherein Peyman discloses the optical power of the IOL system has a range of between 6 diopters and 34 diopters, inclusive (in [0043], the lenses can have an optical power of +/- 25 diopters, which can lead to the system having an optical power between 6 and 34 diopters. Additionally, in [0022] of Lang, it is disclosed that the system of Lang can have an optical power of 15 to 30 diopters).
Regarding claim 9, Peyman in view of Lang teach the IOL system of claim 1, wherein Lang teaches that the articulating actuator is adapted to move the third lens posteriorly toward the second lens when the capsular bag contracts (the lever arm of Lang in [0006] would move a lens as per [0006], which would allow for a posterior movement as an axial movement is present here. When the equatorial diameter of the capsular bag increases, posterior movement of the IOL occurs in [0064]).
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 lever of Lang into the device of Peyman for the actuation of an IOL optic for the purpose of allowing for a changing of the accommodation of a lens (as disclosed in [0064] of Lang) that would be beneficial for the intraocular lens of Peyman as this would allow for the natural anatomy of the eye to directly affect the accommodation of the eye.
Regarding claim 10, Peyman in view of Lang teach the IOL system of claim 1, wherein Lang teaches the articulating actuator is configured to move the third lens anteriorly toward the first lens when the capsular bag relaxes (the lever arm of Lang in [0006] would move a lens as per [0006], which would allow for a posterior movement as an axial movement is present here).
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 lever of Lang into the device of Peyman for the actuation of an IOL optic for the purpose of allowing for a changing of the accommodation of a lens (as disclosed in [0064] of Lang) that would be beneficial for the intraocular lens of Peyman as this would allow for the natural anatomy of the eye to directly affect the accommodation of the eye.
Regarding claim 13, Peyman teaches an intraocular lens (IOL) system (an IOL with multiple lenses in [0064] and figures 21-24), comprising: a first lens (152 in [0064]); a second lens (156 in [0064]) rigidly connected to the first lens by at least one rigid member such that the second lens is a fixed distance, d, (shown in figure 24, where the first and second lenses 152 and 156 are attached to each other. This is done via the struts defined in [0068]) from the first lens along an axis (lenses 152 and 156 are spaced apart from each other in figure 24); a third, moveable lens (154 in figure 24) positioned between the first lens and the second lens (shown in figure 24) and adapted to move linearly along the axis in a first direction towards the first lens and in a second direction towards the second lens to change an optical power of the system (as the struts are disclosed to be telescopic in [0049], with telescoping in an IOL disclosed in [0077]); a first articulating actuator configured to contact the third, moveable lens on a first side and to move the third (the first articulating actuator is taken to be the struts connected to the middle lens in figure 24. Figure 26 is taken to show the system of figure 24, wherein the articulating actuator would be the strut 212, as defined in [0087]), and a second articulating actuator configured to contact the third (the second articulating actuator is taken to be the struts connected to the middle lens in figure 24. Figure 26 is taken to show the system of figure 24, wherein the articulating actuator would be the strut 214, as defined in [0087]), moveable lens on a second side (shown in figure 6) and to move the third, moveable lens linearly along the axis in response to the force applied by the eye.
However, Peyman does not specifically teach that the struts would be able to move the lens linearly along the axis in response to a force applied by the eye. Instead, Lang (US Pub No.: 2002/0120329) does teach an articulating actuator configured to move the third lens linearly along the axis in response to a force applied by a capsular bag of an eye (Lang discloses a lever arm for axial movement of an optic in [0006] that is connected to a capsular bag in [0064]). Here, it is argued that two lever arms can be incorporated on either end of the third lens of Peyman.
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 lever of Lang into the device of Peyman for the actuation of an IOL optic for the purpose of allowing for a changing of the accommodation of a lens (as disclosed in [0064] of Lang) that would be beneficial for the intraocular lens of Peyman as this would allow for the natural anatomy of the eye to directly affect the accommodation of the eye.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US Pub No.: 2006/0015180) in view of Lang (US Pub No.: 2002/0120329) in further view of Peyman 2 (US Pub No.: 2006/0206206).
Regarding claim 2, Peyman in view of Lang teach the IOL system of claim 1, wherein Lang teaches that the articulating actuator comprises: a lever point (being the lever arm in [0064] that would have a lever point at the end of the arm. Said arm is equivalent to part 14 in figures 2 and 5 of Lang); a contact adapted to contact an interior surface of the capsular bag when the IOL system is implanted in the eye (as the lever arm is contacting a capsular bag in [0064]) when the IOL system is implanted in the eye (the lever of Lang would attach to the capsular bag when inserted in the eye).
However, Lang does not teach a first arm located between the lever point and the third lens and adapted to contact the third lens; a second arm located between the contact and the lever point, wherein the first and second arms form an angle θ.
Instead, Peyman 2 (US Pub No.: 2006/0206206) teaches a lever point (being the bend in part 136 in figure 19), wherein a first arm located between the lever point and the third lens (being the part of part 136 in figure 19 between the lens 132 and the bend of 136) and adapted to contact the third lens (being part 132 in figure 19); a second arm located between the contact and the lever point, wherein the first and second arms form an angle θ (the second lever arm would be the part 130, defined as a strut in [0049] that can connect to the lens in figure 20). Here, the angle between the arms can be defined as [Symbol font/0x71]). 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 lever with two arms and a lever point like the one presented of Peyman 2 into the combination of Peyman and Lang as the structure of this lever would not change the function of the device of Lang. In Lang, it is assumed that the lever just consists of one arm connecting to the optic and the capsulary bag as per [0064]. With respect to Peyman 2, the structure of the lever is seen as a different type of lever that can be used in an intraocular lens. From it is argued that this lever structure can be incorporated into Lang such that the structure of Lang will be different but the function of Lang (which will be to move the optical portion of Lang due to movement of the capsular bag) will remain the same.
Regarding claim 14, Peyman in view of Lang teach the IOL system of claim 13.
However, Peyman does not teach wherein the first articulating actuator comprises: a lever point; a first arm operably connecting the lever point and the third, moveable lens; a contact adapted to contact an interior surface of the eye; and a second arm located between the contact and the lever point; wherein the first articulating actuator is configured such that the first arm pivots around the lever point to move the third, moveable lens.
Instead, Peyman 2 teaches does not teach wherein the first articulating actuator comprises: a lever point (being the bend in part 136 in figure 19); a first arm operably connecting the lever point and the third, moveable lens (being the part of part 136 in figure 19 between the lens 132 and the bend of 136); a contact adapted to contact an interior surface of the eye (being part 132 in figure 19); and a second arm located between the contact and the lever point (being the part of part 136 between the bend and part 130 in figure 19); wherein the first articulating actuator is configured such that the first arm pivots around the lever point to move the third, moveable lens (shown in the movement of part 136 between figure 19 to figure 20).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US Pub No.: 2006/0015180) in view of Lang (US Pub No.: 2002/0120329) in further view of Gross (US Patent No.: 5,928,283).
Regarding claim 3, Peyman in view of Lang teach the IOL system of claim 1, wherein: Peyman discloses the first lens has a positive focal length (lens 152, as per [0066], can be biconvex. This will make the focal length positive); the second lens has a negative focal length (as per [0067], the central portion of the second lens 154); and the moveable lens has a positive focal length.
However, Peyman does not teach that the moveable lens has a positive focal length. Instead, Gross does disclose a central lens in a three lens system having a positive focal length in figure 6 thereof (being lens 70 in figure 6, which is assumed to be positive as per the shape of the lens). It is argued that a positive lens like the one presented in Gross can be incorporated in place of the third lens of Peyman.
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 positive lens of Gross into the device of Peyman as Peyman will teach a three lens system wherein the third lens (being part 70 in figure 6) can have a positive focal length. This is due to the fact that Peyman is seen to disclose a three lens IOL system wherein the middle lens has a positive focal length. As such, it is seen that the device of Peyman can incorporate a positive lens as taught by Gross with knowable results. Therefore, it is seen that one of obvious skill in the art would incorporate a lens with a positive focal length like the one taught in Gross into the device of Peyman.
Regarding claim 4, Peyman in view of Lang and Gross teach the IOL system of claim 3, wherein Peyman teaches that the first lens has a first focal length, the second lens has a second focal length, and the third lens has a third focal length(as parts 152, 154, and 156 are lenses in an implanted IOL, they will all have a defined focal length. The three lenses can have an optical power of +/- 25 diopters); wherein the optical power of the system is a function of the first focal length, the second focal length, and the third focal length (the optical power of an IOL system will depend on the focal lengths of the lenses therein. As such, an optical power will be provided by the device of Peyman); a nominal system optical power (a nominal system power is seen as the optical power before a movement of the third lens. While not defined in Peyman, it stands to reason that a nominal optical power will be provided by the device of Gross presented in figure 6); and a nominal distance ti between a center of the third lens and the first lens along the axis (while not defined, it stands to reason that there will be a distance between the first and third lens of Peyman as shown visually in figure 24).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman Peyman (US Pub No.: 2006/0015180) in view of Lang (US Pub No.: 2002/0120329) and Gross (US Patent No.: 5,928,283) in further view of Shu (US Pub No.: 2004/0148023) and Hauger (US Pub No.: 2009/0257065).
Regarding claim 5, Peyman in view of Lang and Gross teach the IOL system of claim 4. However, Peyman does not teach wherein the first focal length is between 18 mm and 28 mm, inclusive, the second focal length is between -4.5 mm and -8.5 mm, inclusive, and the third focal length is between 5 mm and 15 mm, inclusive.
Instead, Shu does teach a two lens system with a positive focal length between 5 to 12 mm and a negative focal length between -5 to -12 mm. These lengths are seen to satisfy the second and third focal lengths. From here, Hauger teaches an IOL with a focal length of 20.7mm and 23.1mm in [0103] therein, which would cover the first focal length. These lengths can be incorporated into the lenses of Gross.
As the device of Gross does teach three lenses for an IOL system while remaining silent, it is seen as obvious to incorporate the focal lengths defined in Shu and Hauger to cover the three lenses of Gross. As these focal lengths are disclosed in the prior art, it is argued that having lenses that provide for these focal lengths are known in the art. As a result, it is seen that one may seek to incorporate lenses of these focal lengths into the device of Gross as Gross itself does not teach any specific focal lengths for lenses 70, 74, and 76. As a result, 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 focal lengths of the lenses of Shu and Hauger into the device of Gross.
Allowable Subject Matter
Claims 8, 11-12, and 15-16 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.
With respect to claim 8, the references of Peyman (US Pub No.: 2006/0015180), Gross (US Patent No.: 5,928,283), Lang (US Pub No.: 2002/0120329), Peyman (US Pub No.: 2006/0206206), Shu (US Patent No.: 2004/0148023), Hauger (US Pub No.: 2009/0257065) and Zhang (US Pub No.: 2005/0209692) are seen to be the best combination of art to teach the distance to between the center of the moveable lens and the first lens along the axis changes by between 0.1 mm and 0.3 mm, inclusive, in response to a movement of the articulating actuator. Here, said combination of references above are not seen to teach how much a lens will move based off of the contraction or relaxation of the capsular bag. From here, Sohn (US Pub No.: 2014/0309734) does disclose a movement of between 0.5 and 2.0 mm of a lens via an actuation means in [0505]. This was the range that was found closest to the presented in claim 8, but this range does not cover the range presented therein. Additionally, while this movement is controlled by a lever mechanism (disclosed as part 50 in [0385], best shown in figure 2B), this lever is seen as being internal to the device as opposed to the lever required in claim 1 that extends from the lens to the capsular bag. As a result, Sohn was not seen as an ideal reference to teach what was in claim 8. As Sohn was the closest reference to teach the presented range and the cited references (mentioned above) did not teach a range of movement analogous to the ti distance in claim 8, claim 8 is seen as being allowable over the prior art.
Regarding claims 11 12, 15, and 16, the references of Peyman (US Pub No.: 2006/0015180), Gross (US Patent No.: 5,928,283), Lang (US Pub No.: 2002/0120329), Peyman (US Pub No.: 2006/0206206), Shu (US Patent No.: 2004/0148023), Hauger (US Pub No.: 2009/0257065) and Zhang (US Pub No.: 2005/0209692) are seen to be the best combination of art to teach what is presented here. However, said references do not teach an instance wherein the articulating actuator is adapted such that the first arm pivots around the lever point to form a more acute angle with the second arm when the capsular bag tightens and to move the moveable lens posteriorly towards the second lens as a result or wherein the articulating actuator is adapted such that the first arm pivots around the lever point to form a more obtuse angle with the second arm when the capsular bag relaxes and to move the moveable lens anteriorly towards the first lens as a result. Here, Lang and Peyman 2 are seen as the two closest references that teach this that were cited above. However, while Lang and Peyman 2 together seen to teach a lever with two arms and a pivoting joint between them, there is nothing claimed to suggest that the angle between these arms will become more acute or obtuse as the capsular bag tightens or relaxes. While this might be able to be argued, there is not any basis for this arguments that are presented within Lang and Peyman. As such, an argument that says Lang and Peyman 2 will teach claims 11 and 12 will not be seen as convincing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Portney (US Patent No.: 5,196,028) considered for a multi lens system in figure 2 Dudee (US Pub No.: 2016/0184089) considered for an intraocular lens with multiple lenses in figure 5A.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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