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 filed 10/08/2025 have been fully considered but they are not persuasive.
Regarding arguments to claim 1, it is stated that Hong does not teach “EDOF features having a first region that is non-decreasing in curvature as a function of increasing radial position from the optical axis to an outer edge of the first region to achieve powers greater than the base power at the outer edge.” Here, examiner still maintains that Hong teaches a non-decreasing curvature as regions with the “same base curvature” in are disclosed in figure 2 and [0007]. While examiner does acknowledge that a modification of a base curvature is present in [0047], the modification of a curvature was present as a means to provide for a smooth transition between profiles, where the modification of a base curvature is presented with a modification of various coefficients as means to possibly achieve the smooth transition. As such, while a modification of a curvature is allowed for in Hong, it is not seen as being required for the operation of Hong. The phrase “may provide” in [0047] also implies that an embodiment where a smooth transition is not provided is also present.
Regarding arguments to claim 31, it is stated that Hong does not describe an intraocular lens “a power profile that, in a first region, is non-decreasing as a function of increasing radial position from the optical axis to an outer edge of the first region to achieve a lens power greater than the base power at the outer edge.” Examiner disagrees. As mentioned above, the modifications taught in Hong in [0047]-[0049], use the phrase “may provide” which imply that an embodiment where a smooth transition is not provided is also present. As such, while there are parts of Hong that teach away from the limitations of claim 31, said limitations are seen as being in embodiments that are not required for the device taught in Hong.
Regarding arguments to claim 32, it is stated that Weeber does not teach “refractive features within a 1.4 mm radial distance of the optical axis.” Examiner agrees that the cited portion of Weeber did not teach the radial distance. Upon further consideration, a new ground(s) of rejection is made in view of Weeber (US Pub No.: 2009/0187242) in view of Weeber (US Pub No.: 2017/0156849).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6, 20-24 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong (US Pub No.: 2019/0307553).
Regarding claim 1, Hong (US Pub No.: 2019/0307553) discloses an intraocular lens providing an extended depth of focus (in [0002] and [0006]), the lens having an optical axis (part 108 is an optical axis, as per [0015] and figure 1A) and a base power at the optical axis (being the power at the inner region 116 in figure 1A. inner region defined as 116 in [0014] and [0026])
for achieving distance vision (distance optical power in [0003]. It also stands to reason that, as the lens of Hong provides a distance vision, a base power has to be provided by the lens), the lens comprising: an optic having a surface with a sagittal surface profile defined in-part by EDOF features (being the sagittal surface of the lens in figure 1A and 1B, with EDOF features disclosed in [0006]), the sagittal surface profile having a first region that is non-decreasing in curvature (being the regions with the “same base curvature” in figure 2 and [0007]. Said same base curvature is along the sagittal surface ) as a function of increasing radial position from the optical axis to an outer edge of the first region to achieve powers greater than the base power at the outer edge (shown in the equation in [0016] that is defined in [0015] as being for a first region and defining a first phase shift step, where said phase shifts extend a depth of focus in [0012]. Increasing a radial position, being r in equation 2 in [0016] (r defined in [0017]) increases the Zbase value), and the sagittal surface profile having a second region extending radially outward from the outer edge (being the outer region of the regions with the same base curvature in [0007], where said outer region is part 114 in figure 1A in [0014]) that is non-increasing in curvature as a function of increasing radial position from the outer edge to achieve powers less than the base power thereby defining a non-increasing portion (shown in the equation in [0016] that is defined in [0015] as being for a phase shift step, where said phase shifts extend a depth of focus in [0012]. Increasing a radial position, being r in equation 2 in [0016] (r defined in [0017]) increases the Zbase value. As per [0031] the sag profile constant is disclosed in equations 1-4 are defined as being the same for the first and second zones), the curvatures in the second region then non-decreasing to achieve the base power and then maintaining substantially the base power over at least 30% of the radial distance corresponding to a pupil of a user's eye for photopic vision conditions (as the inner and outer region have the same optical power, as per paragraph [0004] and in claim 2 of the claims of Hong, the base power is over at least 30% over the entire radial distance of the lens that is then placed over a pupil of the eye of the user. Pupil placement disclosed in [0004]).
Regarding claim 2, Hong discloses the lens of claim 1, wherein the first region is increasing in curvature as a function of increasing radial position from the optical axis to the outer edge of the first region (shown in equations 1-2 and figure 2 of Hong), the second region is decreasing in curvature as a function of increasing radial position from the outer edge to achieve the powers less than the base power (as per figure 2, the Sag in millimeters is lower in part 114 than it is in part 112 (said parts defined as separate zones in [0014]) where the decreased sag causes a decrease in curvature as a radial position increases), and then increasing in curvature as a function of radial position to achieve the base power (increase in sag in a first optic zone 112 shown in figure 2).
Regarding claim 5, Hong discloses the lens of claim 1, wherein substantially the base power is maintained in the second region over a radial distance of at least 0.3 mm (in Hong, being when the sag in figure 2 is constant for at least 0.3 mm in region 2, being the regions noted by label 114).
Regarding claim 6, Hong discloses the lens of claim 1, wherein substantially the base power is maintained in the second region over a radial distance of at least 0.6 mm (in Hong, being when the sag in figure 2 is constant for at least 0.6 mm in region 2, being the regions noted by label 114).
Regarding claim 20, Hong discloses the lens of claim 1, wherein the surface is an anterior surface or a posterior surface (being either posterior surface 106 or anterior surface 104 in figures 1A-1B, defined in [0014]. In this instance, the surface of Hong is the anterior surface 104), and wherein the non-increasing curvature portion is characterized by a discontinuity located at the outer edge (being outer region 118, defined in [0014]), such that the outer edge and the location of minimum lens power are substantially radially coincident (the outer edge 118 is radially coincident with parts 114 and 120 in figure 1B and 2).
Regarding claim 21, Hong discloses the lens of claim 1, wherein the surface is an anterior surface or a posterior surface (shown in figure 1B of Hong), and wherein the non-increasing curvature portion varies smoothly as a function of radius such that the distance from the outer edge of the first region to a radial location of a minimum lens power is less than 0.4 mm (the region with the lowest sag in figure 2 extends for less than 0.4mm).
Regarding claim 22, Hong discloses the lens of claim 1, wherein substantially the base power is maintained in the second region over a radial distance of at least 0.3 mm (in Hong, being when the sag in figure 2 is constant for at least 0.3mm in region 2, being the regions noted by label 114).
Regarding claim 23, Hong discloses the lens of claim 1, wherein substantially the base power is maintained in the second region over a radial distance of at least 0.6 mm (in Hong, being when the sag in figure 2 is constant for at least 0.6 mm in region 2, being the regions noted by label 114).
Regarding claim 24, Hong discloses the lens of claim 1, wherein the lens is monofocal (monofocal disclosed in [0003], where the MTF values In figure 3 imply that the lens of Hong is monofocal).
Regarding claim 31, Hong discloses an intraocular lens providing an extended depth of focus (in [0002] and [0006]), the lens having an optical axis (part 108 is an optical axis, as per [0015] and figure 1A) and a base power at the optical axis for achieving distance vision (distance optical power in [0003]. It also stands to reason that, as the lens of Hong provides a distance vision, a base power has to be provided by the lens), the lens comprising: an optic characterized by a power profile that, in a first region, is non-decreasing (being the regions with the “same base curvature” in figure 2 and [0007]) as a function of increasing radial position from the optical axis to an outer edge of the first region to achieve a lens power greater than the base power at the outer edge (shown in the equation in [0016] that is defined in [0015] as being for a first region and defining a first phase shift step, where said phase shifts extend a depth of focus in [0012]. Increasing a radial position, being r in equation 2 in [0016] (r defined in [0017]) increases the Zbase value), and, in a second region extending radially outward from the outer edge (being the outer region of the regions with the same base curvature in [0007], where said outer region is part 114 in figure 1A in [0014]) the power profile is non-increasing as a function of increasing radial position from the outer edge to achieve a minimum lens power that is less than the base power thereby defining a non-increasing portion (shown in the equation in [0016] that is defined in [0015] as being for a phase shift step, where said phase shifts extend a depth of focus in [0012]. Increasing a radial position, being r in equation 2 in [0016] (r defined in [0017]) increases the Zbase value. As per [0031] the sag profile constant is disclosed in equations 1-4 are defined as being the same for the first and second zones), and then non-decreasing as a function of increasing radial position to achieve the base power, the second region then maintaining substantially the base power over at least 30% of the radial distance corresponding to a pupil of a user's eye for photopic vision conditions (as the inner and outer region have the same optical power, as per paragraph [0004] and in claim 2 of the claims of Hong, the base power is over at least 30% over the entire radial distance of the lens that is then placed over a pupil of the eye of the user. Pupil placement disclosed in [0004]).
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) 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong (US Pub No.: 2019/0307553) in view of Weeber (US Pub No.: 2009/0187242).
Regarding claim 25, Hong discloses the lens of claim 1. However, Hong does not teach wherein the sagittal surface profile is further defined by a diffractive profile superimposed on the surface.
Instead, Weeber (US Pub No.: 2009/0187242) teaches wherein the sagittal surface profile is further defined by a diffractive profile superimposed on the surface (a diffractive pattern is imposed on at least one of the first shape or second shape in [0007], wherein the shapes are part of the intraocular lens body in [0008]). 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 diffractive profile that is superimposed on a surface of a lens as presented as Weeber into Hong for the purpose of providing a pattern in additional to the lens of an intraocular lens that can increase the depth of focus of a lens (in [0010]).
Regarding claim 26, Hong in view of Weeber teaches the lens of claim 25, wherein Weeber teaches the diffractive profile is configured to produce a depth of focus (in [0010]) having a first peak in MTF and a second peak in MTF myopically disposed relative to the first peak (multiple peak MTF values shown in figures like figure 11), and wherein the EDOF features increases the MTF between the first peak and the second peak (disclosed in [0078]-[0079], where the depth of focus will increase the MTF curve), wherein the MTF is specified using the ISO I model eye (in [0159]-[0160]), and wherein the MTF is specified for a spatial frequency of 50 lp/mm at the retina (in [0109]-[0110]), at 546 nm light (the eye model is evaluated at 546 nm), for a 3 mm diameter pupil (a pupil with a radius of 1.5mm is present in [0066]), and when the lens is immersed in aqueous humor having a refractive index of 1.336 at 546 nm (in [0166]-[0168]). 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 diffractive profile that is superimposed on a surface of a lens as presented as Weeber into Hong for the purpose of providing a pattern in additional to the lens of an intraocular lens that can increase the depth of focus of a lens (in [0010]).
Regarding claim 27, Hong in view of Weeber teach the lens of claim 26, wherein Weeber teaches the EDOF features increases the MTF only between the first peak and the second peak (the MTF only increases within the depth of focus area, as per [0077]-[0079]). 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 diffractive profile that is superimposed on a surface of a lens as presented as Weeber into Hong for the purpose of providing a pattern in additional to the lens of an intraocular lens that can increase the depth of focus of a lens (in [0010]).
Regarding claim 28, Hong in view of Weeber teach the lens of claim 26, wherein Weeber teaches that the diffractive profile is a bifocal diffractive profile (in [0083]). 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 diffractive profile that is superimposed on a surface of a lens as presented as Weeber into Hong for the purpose of providing a pattern in additional to the lens of an intraocular lens that can increase the depth of focus of a lens (in [0010]).
Regarding claim 29, Hong in view of Weeber teach the lens of claim 26, wherein Weeber teaches that the maximum MTF value is equal to or greater than 0.35 (shown in figure 11, and in later figures like 14 and 15). 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 diffractive profile that is superimposed on a surface of a lens as presented as Weeber into Hong for the purpose of providing a pattern in additional to the lens of an intraocular lens that can increase the depth of focus of a lens (in [0010]).
Regarding claim 30, Hong in view of Weeber teach the lens of claim 29, wherein Weeber teaches the first peak in the MTF and the second peak are separated by about 2.5 diopters (approximate separation by 2.5 diopters in figure 11 and 14), and the EDOF features provide a depth of focus continuous with the first peak that maintains an MTF of 0.15 or greater for at least about 1.25 diopters, in the myopic direction from the first peak (in figures 11, 14, and 15). 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 diffractive profile that is superimposed on a surface of a lens as presented as Weeber into Hong for the purpose of providing a pattern in additional to the lens of an intraocular lens that can increase the depth of focus of a lens (in [0010]).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weeber (US Pub No.: 2009/0187242) in view of Weeber (US Pub No.: 2017/0156849).
Regarding claim 32 Weeber discloses an intraocular lens having an optical axis (disclosed in [0038]) and providing an extended depth of focus using refractive features within a 1.4 mm radial distance (ranges between 1.35 to 1.48mm in [0108] 1.4mm in [0056]) of the optical axis to generate a through-focus MTF characterized by a first peak having an absolute maximum MTF value in excess of 0.35 (shown in figure 11, 14 and 15) and a region continuous with the first peak maintaining an MTF value of greater than 0.15 to achieve a depth of focus of at least about 1.25 diopters extending in the myopic direction from the first peak (in figures 11, 14, and 15), wherein the MTF is specified using the ISO 1 model eye (in [0159]-[0160]), and wherein the MTF is specified for a spatial frequency of 50 lp/mm at the retina, at 546 nm light, for a 3 mm diameter pupil (a pupil with a radius of 1.5mm is present in [0066]), when the lens is immersed in aqueous humor having a refractive index of 1.336 at 546 nm (in [0166]-[0168]).
Additionally, Weeber (US Pub No.: 2017/0156849) does teach providing an extended depth of focus using refractive features within a 1.4 mm radial distance (range of radial distances r shown in figure 4, ranging between 0mm to 2mm in [0077]. Extended depth of focus in [0012] and [0081]-[0083]).
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 radial distance ranges of Weeber 2017 into Weeber for the purpose of providing a range of distances that allow for a range of total sag to be implemented into a concave lens.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong (US Pub No.: 2019/0307553) in view of Weeber (US Pub No.: 2009/0187242).
Regarding claim 33, Hong discloses the lens of claim 1. However, Hong does not teach wherein the lens is toric.
Instead, Bogaert (US Pub No.: 2016/0100938) teaches wherein the lens is toric (in the abstract). 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 toric intraocular element of Bogaert into Hong for the purpose of providing an intraocular element that is design for “correcting astigmatism” as disclosed in the abstract of Bogaert.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding dependent claims 3 and 16, prior art such as Hong (US Pub No.: 2019/0307553), Weeber (US Pub No.: 2009/0187242), Tiwari (US Pub No.: 2018/0132996), Abe (US Pub No.: 2023/0301755), Holmstrom (US Pub No.: 2020/0209649), Choi (US Patent No.: 10/675,146), Fernandez Gutierrez (US Patent No.: 10/226,327) and Qureshi (US Pub No.: 2018/0360596) were considered to teach the equations presented in claims 3 and 14. However, said prior art does not teach equations in claims 3 and 16 stating respectively
z
r
=
r
2
(
R
+
R
2
-
1
+
c
r
2
-
1
+
α
m
r
*
r
m
in claim 3 or
z
r
=
r
2
(
R
+
R
2
-
1
+
c
r
2
-
1
+
E
D
O
F
f
e
a
t
u
r
e
s
s
a
g
i
t
t
a
l
p
r
o
f
i
l
e
t
e
r
m
in claim 16. Here, while equations presented in the prior art, including but not limited to the Z(r) equation in [0133] of Weeber, the Zbase equations in [0016] and [0021] of Hong, the equation between [0073]-[0074] of Abe, and the equation in column 6 line 55 of Fernandez Gutierrez were considered close to the equations presented in claims 3 and 16, but, as said equations were not the same, and as there is no teaching to take the presented equations of the prior art and modify it to teach the equations in claims 3 and 16, said equations are not read upon by cited prior art. Additionally, while the inventor of the current invention has cited these equations or equations similar to these equations in other documents and patent applications (like US Pub No.: 2022/0287826 that corresponds to this current application and US Pub No.: 2023/0017040 that was cited on patents.justia.com), the publication date of said applications are after the date of the provisional patent that this case claims priority to. As such, claims 3 and 16, if written in independent form, will be allowable over prior art.
Claims 3 and 16 with their dependent claims 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. Tiwari (US Pub No.: 2018/0132996) considered for an intraocular lens with a refractive index value of 1.336 at 546nm in [0049]. Abe considered for the equation to teach a sag height in paragraph [0073]
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774