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
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) 1-19, 21-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawu (AU2014/202701A1) in view of Kingston (20100079723A1) in view of Gupta (2013/0261744).
In regard to claim 1, Lawu teaches a lens 14 configured for implantation into an eye of a human and to provide extended depth of field [0009: improve depth of focus, which refers to an extended depth of field], the lens comprising:
an optic (center of lens surface 10a which performs refraction, see fig 11A) comprising a transparent material [0062: PMMA; polymethyl methacrylate is a transparent material],
the optic (central surface of 10a) having an anterior surface and a posterior surface (see fig 11A),
each of the anterior surface and the posterior surface having a surface vertex [0061: anterior and posterior are aspheric; therefore have a surface vertex; also see figure 6D) the optic having an optical axis through the surface vertices [0091: optical axis; see fig 6D, the axis is present even though not labeled based on the properties and shape of the lens], and
at least one haptic disposed with respect to the optic to affix the optic in the eye when implanted therein [0061: haptics (not shown) may be provided],
wherein the anterior and posterior surfaces comprise aspheric surfaces [0061: aspheric lens surface 12; posterior surface may in addition be aspheric] that define in combination a wavefront exiting the optic (table 15: summarizes the wavefront spherical aberration [00101]),
and the posterior surface has an aspheric shape [0061: posterior surface may in addition be aspheric] to control spherical aberration (table 15: spherical aberration; [0088: 0049; 0054; this is controlling the aberration by modifying the amount]).
However, Lawu does not teach the curvature values as claimed or a biconic.
Kingston teaches a biconic perturbed by an aspheric higher order function of radial distance from the optical axis [0034: biconic; any suitable aspheric configuration] to control spherical aberration (see title).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the biconic function of Kingston in the lens of Lawu because the biconic function compensates for the asphericity and toricity of the eye.
Kingston teaches the posterior surface has a radius of curvature, Ry, a radius of curvature, Rx, a conic constant, ky, and a conic constant, kx,
wherein the posterior surface has an absolute value of ratio Rx/Ry between 0 and 100 and an absolute value of ratio kx/ky between 0 and 100 (table 1; [0049]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the ratio values of Kingston to control the lens shape of the lens of Lawu in order to optimize the power of the lens for the individual user. [0049]
Gupta teaches an aspheric optical element where the anterior surface has a conic constant between -1.0 and + 1.0 [0032; k=0 for a spherical shape; k>-1 for an ellipsoidal surface; k=+1 for a hyperboloidal surface].
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a conic constant in the range taught by Gupta in order to optimize the shape of the lens for the individual user’s eye since the constant corresponds to the lens shape. [0032]
In regard to claims 2-9, Lawru meets the claim limitations as discussed in the rejection of claim 1 but does not teach the Rx/Ry ratio as claimed.
Kingston further teaches the absolute value of the ratio Rx/Ry is between 0.5 and 10. [0049: Rx/Ry ranges from 0.606-0.915, table 1]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the ratio values of Kingston to control the lens shape of the lens of Lawu in order to optimize the power of the lens for the individual user. [0049]
In regard to claims 10-17, Lawru meets the claim limitations as discussed in the rejection of claim 1 but does not teach the kx/ky ratio as claimed.
Kingston further teaches the absolute value of the ratio kx/ky is between 0.5 and 10. [0049: absolute value of the ratio kx/ky ranges from about .07 to 0.82] It has been held that In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05I
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the conic constant of Lawru in view of Gupta as taught by Kingston in order to optimize the shape of the lens to the individual user’s needs since the conic constant corresponds to the shape of the lens.
In regard to claim 18, Lawru meets the claim limitations as discussed in the rejection of claim 1, but does not teach the exit pupil shape as claimed.
Gupta teaches that said optic comprises an exit pupil (0007: embodiments include an implantable ophthalmic device with an aspheric optical element, with negative spherical aberration varying across an exit pupil) and that that the aspheric surface has a radial power profile at the exit pupil that continuously increases from the optical axis (Paragraph 0032).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the aspheric lens surfaces of Lawru to incorporate the teachings of Gupta and provide wherein the optic comprises an exit pupil, and wherein the anterior and posterior surfaces are shaped to provide a radial power profile characterized by D(IF) = a + br2 + cr4 + dr6 + er8 for wavefront at the exit pupil of the optic for an object vergence of 0 to 2.5 Diopter (D), where r is the radial distance from the optical axis and a, b, c, d, and e are coefficients, in order to provide a radius of curvature that changes with distance from the optical axis which can be modified to make the lens more ellipsoidal or hyperboloidal as needed [0032].
In regard to claim 19, Lawru meets the claim limitations as discussed in the rejection of claim 1, wherein a thickness along said optical axis is between about 100-700 micrometers. [0062: center thickness greater than 0.56mm, which corresponds to 560 micrometers; also see table 10]
In regard to claims 21-22, Lawru meets the claim limitations as discussed in the rejection of claim 1, but does not teach the posterior surface radius of curvature Ry as claimed.
Kingston further teaches the posterior surface radius of curvature, Ry, is between 2 and 20 mm. (0049: Ry falls between 9.133 and 30 mm) It has been held that In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05I
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the posterior surface radius of curvature Ry as taught by Kingston in the lens of Lawru in order to optimize the lens shape to provide an appropriate power for the individual user [0049]
In regard to claims 23-24, Lawru meets the claim limitations as discussed in the rejection of claim 1, but does not teach the posterior surface radius of curvature Rx as claimed.
Kingston further teaches the posterior surface radius of curvature, Rx, is between 2 and 20 mm. [0049: Rx of the posterior surface is between 8.359 and 20.100mm] It has been held that In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05I
It would have been obvious to one of ordinary skill in the art at the time the invention was field to use the posterior surface radius of curvature Rx of Kingston in the posterior surface of the lens of Lawru in order to optimize the power of the posterior lens for the individual user’s needs. [0049]
In regard to claims 25-26, Lawru meets the claim limitations as discussed in the rejection of claim 1, but does not teach the posterior surface conic constant ky as claimed.
Kingston teaches the posterior surface conic constant, ky is between -20 to 20 or between -25-0. [0049: ky of the posterior surface is between -4.826 and 29.404]
Since the conic constant controls the shape of the lens, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the posterior surface constant of Kingston in the posterior surface of the lens of Lawru in order to optimize the shape of the posterior lens for the individual needs of the user and desired lens properties.
In regard to claim 27, Lawru meets the claim limitations as discussed in the rejection of claim 1, but does not teach the anterior surface conic constant is zero. A conic constant of zero corresponds to a spherical shape.
Gupta further teaches the anterior surface conic constant is 0. [0032: conic constant can be k=0 to provide a spherical surface]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the anterior surface constant of Gupta in the lens of Lawru in order to optimize the shape of the lens for the individual user’s eye since the constant corresponds to the lens shape. [0032]
In regard to claim 28, Lawru meets the claim limitations as discussed in the rejection of claim 1, but does not teach the anterior surface conic constant is -1.0. Z conic constant of -1.0 corresponds to a paraboloidal surface.
Gupta further teaches the anterior surface conic constant is -1.0. [0032: the conic constant can be -1.0 to provide a paraboloidal surface]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the anterior surface constant of Gupta in the lens of Lawru in order to optimize the shape of the lens for the individual user’s eye since the constant corresponds to the lens shape. [0032]
In regard to claims 29-30, Lawru meets the claim limitations as discussed in the rejection of claim 28, but does not teach the radius of curvature of the anterior surface as claimed.
Kingston further teaches the radius of curvature of the anterior surface is from -100 mm to 100 mm or from an absolute value of 10 mm to 100 mm. [0049: 8.150 to 20.756mm] It has been held that In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05I
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the anterior radius of curvature of Kingston in the invention of Lawru in order to control the lens profile of Lawu in order to optimize the power of the lens for the individual user. [0049]
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lawru (AU2014/202701A1) in view of Kingston (20100079723A1) in view of Gupta (2013/0261744) and further in view of Angelopoulos (2011/0184514A1).
In regard to claim 20, Lawru meets the claim limitations as discussed in the rejection of claim 1, and further teaches said anterior surface 12 is convex (see figures 11A).
However, Lawru does not teach said posterior surface is concave such that said optic is meniscus-shaped.
Angelopoulos teaches an IOL with an anterior surface that is convex and the posterior surface is concave such that the optic is meniscus shaped (figure 2B).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the lens of Lawru to be meniscus shaped as taught by Lawru in order to allow the lens to provide pseudo-accommodation (abstract).
Response to Arguments
In regard to the 112(a) rejection of claim 1, the amendment overcomes the rejection.
In regard to the 112b rejection of claims 29-30, the amendment has overcome the rejection.
In regard to the 103(a) rejection of claims 1-19 and 21-30 as unpatentable over Lawu (AU2014/202701A1) in view of Kingston (2010/0079723A1) and in view of Gupta (2013/0261744), the applicant’s arguments have been fully considered. The applicant argues that the posterior surface has an aspheric biconic shape perturbed by an aspheric higher order function of radial distance from the optical axis to control the spherical aberration and states this shape forms the extended depth of field. As stated in the nonfinal rejection dated 9/16/2025, Kingston was used to teach this feature. It appears that the applicant is arguing that the shape of Kingston is bispheric or toric and not aspheric. However, Kingston clearly states the lens may be aspheric [0011; 0013, etc.] The arguments regarding this are unclear. The applicant was called to clarify on 3/31/2026 but no reply was received.
In regard to the 103(a) rejection of claim 20 as unpatentable over Lawu (AU2014/202701A1) in view of Kingston (2010/0079723A1) and in view of Gupta (2013/0261744) and further in view of Angelopoulos (2011/0184514A1), no further arguments have been submitted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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