DETAILED ACTION
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or 120 as follows:
The priority or continuity claim has not been entered because it was not filed during the required time period. Applicant may wish to consider filing a petition to accept an unintentionally delayed claim for priority. See 37 CFR 1.55 or 1.78. Applicant’s petition filed on April 29, 2026 under 1.78 is noted and will be considered.
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) 31-47 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al (US20170209259A1) "Choi".
Regarding Claim 31, the first embodiment of Choi discloses a multifocal intraocular lens (IOL) (IOL 100, par. [0016], Fig. 1) comprising, at least one diffractive surface (diffractive element 102, par. [0016], Fig. 1) including a plurality of discrete, adjacent, diffractive, concentric Fresnel zones (zones x.sub.i, par. [0021], Fig. 2);
said Fresnel zones comprise a first zone (zone x0 to x1, par. [0019], Fig. 2) having a repetitive pattern of a first diffractive profile and a second zone (zone x1 to x2, par. [0019], Fig. 2) having a repetitive pattern of a second diffractive profile, wherein said first zone is centrally disposed with respect to said IOL (par. [0019], zones are ordered along radial axis and start from closest to center of axis to farthest, Fig. 2) and said second zone is peripherally disposed around said first zone (par. [0019], zones are ordered along radial axis and start from closest to center of axis to farthest, Fig. 2), but does not disclose five diffractive orders from -2 to +2 with -2 and +2 having the highest energy fluxes.
However, another embodiment of Choi discloses said first and second diffractive profiles each produce an energy flux distribution over five diffractive orders: -2, -1, 0, +1 and +2 (par. [0027], diffractive lens could be five-order and may start between -4 and -1), including vision-providing orders comprising at least said -2 order providing far vision, said +2 order providing near vision, and said 0 order providing a first intermediate vision (pars. [0013], [0024], [0027], some embodiments may have far-intermediate ranges for vision);
wherein from said first zone, the -2 order and +2 order have two highest energy fluxes of said five diffractive orders (par. [0027], Claim 9, lowest diffractive order has flux of at least 40% and highest order had flux of at least 20%, while intermediate orders have flux between 10-20%);
and from said second zone, energy flux decreases with increasing order number of said vision- providing orders (par. [0024], decreases from 0th order to 2nd order, Fig. 9). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include five diffractive orders from -2 to +2 with -2 and +2 having the highest energy fluxes, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, par. [0006]).
Regarding Claim 32, the first embodiment of Choi does not disclose the -2 order and +2 order having the highest and second highest flux. However, another embodiment of Choi teaches the multifocal IOL according to claim 31, wherein from said first zone, the -2 order has the highest energy flux of said five diffractive orders and the +2 order has the second highest energy flux of said five diffractive orders (par. [0027], Claim 9, lowest diffractive order has flux of at least 40% and highest order had flux of at least 20%, while intermediate orders have flux between 10-20%). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include the -2 order and +2 order having the highest and second highest flux, as taught by another embodiment of Choi, in order to better approximate the full range of working vision for a patient without a presbyopic condition (Choi, par. [0022]).
Regarding Claim 33, the first embodiment of Choi does not disclose the +1 order providing second intermediate vision. However, another embodiment of Choi teaches the multifocal IOL according to claim 31, wherein from said first zone, said +1 order provides a second intermediate vision (par. [0027], energy distribution between orders varies and diffractive lens could be five-order and may start between -4 and -1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include the +1 order providing second intermediate vision, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, par. [0006]).
Regarding Claim 34 the first embodiment of Choi does not disclose the -1 order being suppressed. However, another embodiment of Choi teaches the multifocal IOL according to claim 33, wherein from said first zone, said -1 order is suppressed (pars. [0013] and [0027], -1 order may be intermediate order and at least one intermediate order will be suppressed). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include the -1 order being suppressed, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, par. [0006]).
Regarding Claim 35, the first embodiment of Choi does not disclose the -1 and +1 orders being suppressed. However, another embodiment of Choi teaches the multifocal IOL of claim 34, wherein from said second zone, said -1 and +1 orders are suppressed (pars. [0013], [0024], 0027], -1 order may be intermediate order and at least one intermediate order will be suppressed, additionally because the 2nd order is suppressed in an embodiment, and embodiment with more diffractive orders can shift or change the suppression so that the third highest order can be +1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include the -1 and +1 orders being suppressed, as taught by another embodiment of Choi, in order better correspond the constructive interference with the different ranges of vision (Choi, par. [0006]).
Regarding Claim 36, the first embodiment of Choi does not disclose an efficiency of 90% or greater for five diffractive orders. However, another embodiment of Choi teaches the multifocal IOL according to claim 31, with an efficiency of greater than 90% in said five diffractive orders (par. [0027], Claim 9, lowest diffractive order has flux of at least 40% and highest order had flux of at least 20%, while intermediate orders have flux between 10-20%). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include an efficiency of 90% or greater for five diffractive orders, as taught by another embodiment of Choi, in order to better approximate the full range of working vision for a patient without a presbyopic condition (Choi, par. [0022]).
Regarding Claim 37, the first embodiment of Choi does not disclose an efficiency of at least 93%. However, another embodiment of Choi teaches the multifocal IOL according to claim 36, wherein said efficiency is at least 93% (Claim 9, Figs. 9-11). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include an efficiency of at least 93%, as taught by another embodiment of Choi, in order to better approximate the full range of working vision for a patient without a presbyopic condition (Choi, par. [0022]).
Regarding Claim 38, the first embodiment of Choi discloses a multifocal intraocular lens (IOL) (IOL 100, par. [0016], Fig. 1) comprising, at least one diffractive surface (diffractive element 102, par. [0016], Fig. 1) including a plurality of discrete, adjacent, diffractive, concentric Fresnel zones (zones x.sub.i, par. [0021], Fig. 2),
wherein said diffractive surface produces an asymmetrical distribution of energy flux over more than three consecutive diffractive orders (par. [0027], Figs. 3-11);
said Fresnel zones comprise a first zone (zone x0 to x1, par. [0019], Fig. 2) having a repetitive pattern of a first diffractive profile and a second zone (zone x1 to x2, par. [0019], Fig. 2) having a repetitive pattern of a second diffractive profile, wherein said first zone is centrally disposed with respect to said IOL (par. [0019], zones are ordered along radial axis and start from closest to center of axis to farthest, Fig. 2) and said second zone is peripherally disposed around said first zone (par. [0019], zones are ordered along radial axis and start from closest to center of axis to farthest, Fig. 2);
from said first zone, said lowest of said more than three consecutive orders and said highest of said more than three orders consecutive orders have two highest energy fluxes, of said more than three consecutive orders (par. [0027], Figs. 3-11), but does not disclose the lowest order providing a far focus, the highest order producing a near focus, the 0th order providing intermediate focus, and a decreasing energy flux with increasing order.
However, another embodiment of Choi teaches said first and second diffractive profiles each produce an energy flux distribution over said more than three consecutive orders, including vision-providing orders comprising at least a lowest of said more than three consecutive orders providing a far focus of said IOL (par. [0022], the distance focus (used to describe far focus) represents the zero-order, which is the lowest order in the referenced main embodiment, Figs. 3-8), a highest of said more than three consecutive orders providing a near focus of said IOL (par. [0027], highest order may be near focus while other orders are intermediate), and a refractive 0th order providing a first intermediate focus of said IOL (par. [0027], when an order starts between -4 and -1, the 0th order may be intermediate);
and from said second zone, energy flux decreases with increasing order number of said vision- providing orders (par. [0024], decreases from 0th order to 2nd order, Fig. 9). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include the lowest order providing a far focus, the highest order producing a near focus, the 0th order providing intermediate focus, and a decreasing energy flux with increasing order, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, par. [0006]).
Regarding Claim 39, the first embodiment of Choi does not disclose an odd number of orders greater than three. However, another embodiment of Choi teaches the multifocal IOL according to claim 38, wherein said more than three orders consist of an odd number of orders (par. [0027], diffractive lens could be five-order). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include an odd number of orders greater than three, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, pars. [0006] and [0027]).
Regarding Claim 40, Choi further discloses the multifocal IOL of claim 38, wherein from said first zone, the lowest order has the highest energy flux, and the highest order has the second highest energy flux of said more than three consecutive diffractive orders from said first zone (par. [0027], Figs. 3-11).
Regarding Claim 41, the first embodiment of Choi does not disclose an additional intermediate focus. However, another embodiment of Choi teaches the multifocal IOL according to claim 38, wherein from said first zone, said vision- producing orders included among said more than three consecutive diffractive orders further comprise at least one additional intermediate focus (par. [0027]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include an additional intermediate, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, pars. [0006] and [0027]).
Regarding Claim 42, Choi further discloses the multifocal IOL according to claim 41, wherein said more than three consecutive orders produced by said first zone comprise suppressed orders consisting of a first suppressed order (par. [0022], Figs. 3-8).
Regarding Claim 43, the first embodiment of Choi does not disclose a first and second suppressed order. However, another embodiment of Choi teaches multifocal IOL according to claim 42, wherein said more than three orders produced by said second zone further comprise said first suppressed order and at least one second suppressed order (pars. [0013], [0024], 0027], -1 order may be intermediate order and at least one intermediate order will be suppressed, additionally because the 2nd order is suppressed in an embodiment, and embodiment with more diffractive orders can shift or change the suppression so that the third highest order can be +1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include a first and second suppressed order, as taught by another embodiment of Choi, in order to better correspond the constructive interference with the different ranges of vision (Choi, pars. [0006], [0013] and [0027]).
Regarding Claim 44, Choi further discloses the multifocal IOL according to claim 38, wherein said first diffractive profile is asymmetrical (par. [0027], Figs. 3-11).
Regarding Claim 45, Choi further discloses the multifocal IOL according to claim 38, wherein said first diffractive profile has an asymmetrical double-peaked geometry (par. [0027], Figs. 3-11).
Regarding Claim 46, Choi further discloses the multifocal IOL according to claim 38, wherein said diffractive surface comprises diffractive steps (diffractive steps 104, par. [0016], Fig. 1).
Regarding Claim 47, Choi further discloses the multifocal IOL according to claim 46, wherein said diffractive steps are partially inside and partially outside a base curvature of the IOL (par. [0016], zones may be semicircular or sectored zones).
Regarding Claim 50, the first embodiment of Choi does not disclose an efficiency greater than 90%. However, another embodiment of Choi teaches the multifocal IOL according to claim 38, with an efficiency of greater than 90% in said more than three diffractive orders (Claim 9, Figs. 9-11). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Choi to include an efficiency greater than 90% for more than three diffractive orders, as taught by another embodiment of Choi, in order to better approximate the full range of working vision for a patient without a presbyopic condition (Choi, par. [0022]).
4. Claim(s) 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al (US20170209259A1) “Choi” in view of Portney (WO 2007019389 A1) “Portney”.
Regarding Claim 48, Choi does not disclose an IOL with variable thickness and a maintained curvature. However, Portney, in the same field of art, teaches a diffractive intraocular lens (intraocular lens implant 100, par. [0040], Fig. 6), wherein a thickness of the IOL is variable and a curvature of the IOL is maintained among said steps (pars. [0043] and [0045], Claim 9, curvature is the same along the yz plane, thickness t of lens body 110 varies, Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Choi to include variable thickness and a maintained curvature, as taught by Portney, in order for the curvature to have less impact on the grating of the optical surface, which can produce interference patterns on the base surface, and for the thinner parts of the lens body that are more compliant to be reshaped as needed (Portney, pars. [0026] and [0045]).
Regarding Claim 49, Choi does not disclose an IOL with variable thickness and variable curvature. However, Portney, in the same field of art, teaches a diffractive intraocular lens (intraocular lens implant 100, par. [0040], Fig. 6), wherein a thickness of the IOL is variable and a curvature of the IOL is variable among said steps (pars. [0043] and [0045], Claim 8, curvature changes along the xz plane, thickness t of lens body 110 varies, Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Choi to include variable thickness and variable curvature, as taught by Portney, in order to have controllable impact on the refractive power of the lens body, and for the thinner parts of the lens body that are more compliant to be reshaped as needed (Portney, pars. [0025] and [0045]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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