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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Response to Amendment
The amendments to the claims, in the submission dated 01/28/2026, are acknowledged and accepted. Claims 1, 12, 15, 18 are amended. Claims 37-39 are new without the addition of new matter. Claims 1-2, 4-5, 7, 9, 11-13, 15, 18, 20 and 33-39 are pending.
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.
Claims 1-2, 4-5, 7, 9, 11, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Fujikado et al. US PGPub 2015/0219926 A1 (hereinafter, “Fujikado”) in view of Guillot et al. EP 3561578 A1 (of record, see Office action dated 05/14/2025, hereinafter, “Guillot”), Roffman et al. US PGPub 2012/0075579 A1 (of record, see Office action dated 05/14/2025, hereinafter, “Roffman”), and Franklin et al. US PGPub 2017/0123231 A1 (hereinafter, “Franklin”).
Regarding amended independent claim 1, Fujikado discloses a contact lens (refer to at least title and abstract disclosing a contact lens) comprising:
a front surface (Fig. 2, contact lens 10 has front surface 20, par. [0064]);
a back surface (Fig. 2, contact lens 10 has back surface 22, par. [0064]);
an optical centre (Fig. 2, contact lens 10 has geometric center 38, par. [0078]);
an optical axis (Fig. 2, contact lens 10 optical axis center 30, par. [0067]);
an optical zone comprising:
a first region, configured with a single vision power for correction of a myopic eye (Fig. 2, contact lens 10 has optical part 24 with central region 32 with refractive correction power, par. [0067]); and
a second region (Fig. 2, contact lens 10 has optical part 24 with peripheral region 34, par. [0068]), configured with a power map characterised by a plurality of meridional power distributions and a plurality of azimuthal power distributions, about its geometric centre (Fig. 2 shows contact lens 10 with concentric regions 32, 34, and 36, where central region 32 has refractive power, and peripheral region 34 with additional power, par. [0068], and Fig. 4 shows lens radius in millimeters against lens power differential in diopters, explaining an additional power set in an optical part of the contact lens 10 shown in Fig. 2, showing examples of changing refractive power of the lens along a meridian, with and without steps, par. [0054], where the additional refractive power is set to change continuously and gradually without steps from the optical axis center 30 toward the peripheral region 34 on the outer peripheral side in the radial direction to provide optical part 24 with a positive spherical aberration and as a result, the amount of correction of focal error is made to increase toward the front as it goes to the outer peripheral side, par. [0069], thereby disclosing meridional and azimuthal power distributions about the geometric center 38 of lens 10);
wherein the second region is decentered from the optical centre (Fig. 2, peripheral region 34 is off-center from geometric center 38, par. [0078]); and
a non-optical peripheral carrier zone about the optical zone (Fig. 2, peripheral part 26 extends in annular shape around optical part 24, par. [0065]).
Fujikado does not disclose the non-optical peripheral carrier zone (i.e., peripheral part 26) comprises a plurality of azimuthal thickness distributions about the optical axis, wherein at least one of the azimuthal power distributions is variant and is devoid of mirror symmetry, within the decentred second region, at least one of the meridional power distributions is variant and is devoid of mirror symmetry, within the decentred second region. Fujikado also does not disclose the power map provides a foveal correction for the myopic eye, and therefore Fujikado does not disclose the power map provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression, and Fujikado does not disclose at least one of the azimuthal thickness distributions is uniform to facilitate on-eye rotation of the contact lens on the myopic eye, and Fujikado does not disclose that the lens is configured to rotate when on-eye, comprising rotation responsive to blinking action by 90 degrees at least once per day of lens wear and at least 20 degrees within 2 hours of lens wear.
In the same field of invention, Guillot discloses a lens element intended to be worn in front of an eye, refer to at least par. [0001] thereof, with an optical zone (Guillot Fig. 1, the area of lens element 10 with optical power is an optical zone, par. [0071] thereof) comprising a first region, configured with a single vision power for correction of a myopic eye (Guillot Fig. 1, lens element 10 has prescription portion 12 that provides optical power to correct abnormal refraction of an eye of the wearer, pars. [0024-25] thereof, such as myopia, par. [0034] thereof); and a second region, configured with a power map characterised by a plurality of meridional power distributions and a plurality of azimuthal power distributions, about its geometric centre (Guillot Fig. 1, lens element 10 has a plurality of optical elements 14, pars. [0024], [0080], [0086] thereof, see also Guillot Fig. 12 showing optical elements 14 distributed about the center of lens element 10, and the shape of elements 14 provides the equivalent of a plurality of meridional power distributions and a plurality of azimuthal power distributions around the geometric center of element 14, as best understood by the Examiner), wherein second region is decentered from the optical centre (Guillot Fig. 1, each of optical elements 14 is not centered on the center of lens element 10), with at least one of the azimuthal power distributions that is variant and is devoid of mirror symmetry (Guillot Fig. 18, optical elements have a constant optical power and a discontinuous first derivative between two contiguous optical elements, and Fig. 19, optical elements have a varying optical power and a continuous first derivative between two contiguous optical elements, refer to Tables 2-3, par. [0109] of Guillot), within the decentred second region (Guillot Fig. 1, elements 14 have variable azimuthal power distributions due to their shape). Guillot further teaches at least one of the meridional power distributions is variant and is devoid of mirror symmetry (Guillot Fig. 1, quadrants Q1-Q4 have progressive addition dioptric function, par. [0075] thereof, refer to at least Table 1, see also Figs. 12 and 15 of Guillot, depicting an embodiment of lens element 10 with radial optical elements which can be constant or varying adding asymmetry to each quarter of meridional power, pars. [0075], [0103], [0110] thereof), within the decentred second region (refer to at least Figs. 1 and 12 of Guillot showing elements 14 have variable meridional power distributions due to their shape), and Guillot teaches the power map provides a foveal correction for the myopic eye (Guillot Fig. 1, prescription portion 12, par. [0024] thereof, provides optical power based on prescription of the wearer for correction of vision aberrations including foveal vision, par. [0025] thereof, and myopia, par. [0034] thereof), and provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression (the optical element disclosed by Guillot reduces the deformation of the retina of the eye of the wearer in peripheral vision to slow down the progression of the abnormal refraction of the eye of the person wearing the lens element, including myopia, refer to at least pars. [0008], [0082], [0091], [0185] thereof, and refer to claim 1 of Guillot).
Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the teachings of Guillot to the disclosure of Fujikado and modified contact lens 10 to have the non-optical peripheral carrier zone comprising a plurality of azimuthal thickness distributions about the optical axis because Guillot teaches such configuration allows compensation of accommodative lag when the person looks at near vision distances (Guillot, par. [0076]), and to have modified lens 10 of Fujikado to have at least one of the azimuthal power distributions that is variant and is devoid of mirror symmetry, within the decentred second region as Guillot teaches such configuration increases the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and to have modified Fujikado lens 10 to have at least one of the meridional power distributions that is variant and is devoid of mirror symmetry, within the decentred second region as Guillot teaches such configuration increases the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and to have modified Fujikado lens 10 to have the power map that provides a foveal correction for the myopic eye, and provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression, as Guillot teaches the disclosed lens element provides for foveal vision correction (Guillot, par. [0200]).
The prior art combination of Fujikado in view of Guillot does not disclose at least one of the azimuthal thickness distributions is uniform to facilitate on-eye rotation of the contact lens on the myopic eye and the lens is configured to rotate when on-eye, and the prior art combination does not disclose the lens comprising rotation responsive to blinking action by 90 degrees at least once per day of lens wear and at least 20 degrees within 2 hours of lens wear.
In the same field of invention, Roffman discloses a contact lens (see title and at least par. [0010] thereof), such as lens 10, shown in at least Fig. 2 thereof, with pseudotruncation 21 that is, as best understood by the Examiner, equivalent to a non-optical peripheral carrier zone surrounding optical zone 14 of lens 10 with lenticular portion bevel junction 18 and bevel portion 12 (Roffman par. [0062]), that have differing azimuthal thickness distributions about the optical axis. Roffman teaches it is desirable for corrective lenses to have a contact lens with a non-optical peripheral carrier zone, such as pseudotruncation 21, about the optical zone, such as optical zone 14, with the non-optical peripheral carrier zone comprising a plurality of azimuthal thickness distributions about the optical axis such as lenticular portion bevel junction 18 and bevel portion 12, and Roffman teaches at least one of the azimuthal thickness distributions is substantially invariant to facilitate a specific fit on the eye (maximum radial thickness region is symmetrical around meridian 110, pars. [0094-95], see also Figs. 1 and 2 of Roffman). Roffman further teaches the lenses disclosed therein can include features to orient the lens for stabilization (refer to at least par. [0090] thereof). Therefore, in order to reach a stable orientation when worn, the contact lenses of Roffman must be capable of rotating on-eye to reach the stabilized orientation for optimal correction of vision.
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the contact lens 10 disclosed by Fujikado according to the teachings of Roffman in order to provide improved wearing comfort (Roffman, par. [0009]), and Roffman teaches it is advantageous to construct a translating contact lens with asymmetric optics and pseudotruncation which matches the lid position, in order to better engage the contact lens and enable vertical translation (Roffman, par. [0060]).
The prior art combination of Fujikado in view of Guillot and Roffman does not disclose comprising rotation responsive to blinking action by 90 degrees at least once per day of lens wear and at least 20 degrees within 2 hours of lens wear.
In the same field of invention, Franklin discloses a contact lens (refer to at least title and abstract thereof disclosing a contact lens, and see Fig. 3 illustrating contact lens 300, par. [0034] thereof), and Franklin teaches in Fig. 4 evaluations of lens orientation versus time after insertion into a wearer’s eye (par. [0026] thereof), where a total of six test lenses were evaluated for on-eye orientation over a three hour wear time (par. [0037] thereof), and the data presented in Fig. 4 demonstrates lenses disclosed by Franklin rotated over time (par. [0037] thereof), where at least one lens rotated 30 degrees within two hours of insertion and another rotated 120 degrees within two hours of insertion. Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the teachings of Franklin to the disclosure of Fujikado and modified contact lens 10 with surface modified zones that maintain orientation and stability performance while providing the comfort of a single vision lens (Franklin, par. [0014]).
Regarding dependent claim 2, Fujikado in view of Guillot, Roffman and Franklin (hereinafter, “modified Fujikado”) disclose the contact lens of the claim 1, but the prior art combination does not explicitly disclose wherein only one of the plurality of meridional power distributions has mirror symmetry about the geometric centre of the decentered second region; and none of the plurality of azimuthal power distributions has mirror symmetry about the geometric centre of the decentered second region.
However, Guillot does disclose radial and concentric optical elements in Figs. 12 and 15, and teaches that some, or all, of the optical elements can either be constant or varying in optical power and can have a variety of continuous or discontinuous derivatives between contiguous elements (Guillot pars. [0108-110]). Guillot further teaches that opposing quarters Q2 and Q4 could have a progressive power change from the top of Q2 to the bottom of Q4. Thus, Guillot teaches the options to create a lens that has an asymmetrical change in optical power across quadrants Q1-Q4, and a symmetrical change in radial optical power across opposing quarters, for example Q2 and Q4 (Guillot par. [0075]). Therefore, a person having ordinary skill the art would have been able to optimize the lens disclosed by Fujikado according to the teachings of Guillot such that only one of the pluralities of the meridional power distributions has mirror symmetry along the optical zone and none of the pluralities of the azimuthal power distributions has mirror symmetry about the optical axis, for the purpose of increasing the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and improve ease of manufacturing (Guillot par. [0089]).
Regarding dependent claim 4, modified Fujikado discloses the contact lens of claim 1, and Roffman further discloses wherein the at least one of the azimuthal power distributions is defined using a cosine distribution of half (1/2) of a frequency defined with two cosine cycles over 360° or 2p radians (Roffman teaches lenticular portion 15, bevel portion 12, and flange portion 20 are described by a sin2 function, par. [0094], where the trigonometric identity
sin
2
x
=
1
-
c
o
s
(
2
x
)
2
is equivalent to a cosine distribution of half (1/2) of a frequency defined with two cosine cycles over 360° or 2p radians).
Regarding dependent claim 5, modified Fujikado discloses the contact lens of claim 1, and Guillot further discloses wherein a surface area of the second region within the optical zone comprises at least 10% and no greater than Guillot in at least Fig. 1 shows optical elements 14 comprise at least 10% of the area of lens element 10 as determined from diameters of the respective elements).
Guillot does not disclose wherein the surface area of the second region within the optical zone is between 5 and 25 square millimeters. Rather, in at least par. [0073], Guillot discloses central zone 16 has a diameter greater than or equal to 4 mm and smaller than or equal to 22 mm, which from these values gives an area for central zone 16 of between 13 and 380 square millimeters, or for each element 14 of zone 16, an area of between 3 and 95 square millimeters.
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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP §2144.05(I) first paragraph. Thus, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to choose parameters for the surface area of the second region of Fujikado contact lens 10 such that an area would be between 3 and 95 square millimeters, which overlaps the disclosed range of between 5 and 25 square millimeters, since 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP §2144.05(I) first paragraph. In the current instance, areas of optical elements are art recognized results effective variables in that optical elements have specific sizes for their functions as taught by Guillot in at least par. [0096]. Thus, one would have been motivated to optimize the area of the second region of an optical element because it is an art-recognized result-effective variable and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See MPEP §2144.05(II)(B) “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a personal of ordinary skill in the art to experiment to reach another workable product or process.” Furthermore, one of ordinary skill in the art would have a reasonable expectation of success when making this modification because modifying sizes of optical elements is a routine activity in lens design.
Regarding dependent claim 7, modified Fujikado discloses the contact lens of claim 1, and Guillot further discloses wherein the geometric centre of the second region is located at least 1.5 mm away from the optical center of the contact lens (Guillot discloses central zone 16 has a diameter greater than or equal to 4 mm and less than or equal to 22 mm, par. [0073], therefore the geometric center of element 14 is at least 1.5 mm from the optical center of lens element 10, for a diameter of 4 mm, and up to 8 mm from the optical center for a diameter of 22 mm, as best determined by the Examiner from the geometry of the device presented in at least Fig. 1 of Guillot).
Regarding dependent claim 9, modified Fujikado discloses the contact lens of claim 7, and Guillot further discloses wherein the second region of the optical zone comprises primary spherical aberration between +0.5 D to -0.5 D, defined over a minimum diameter of the second region (Guillot discloses the two optical powers are considered different when the difference between the two optical powers is greater than or equal to 0.5 D, par. [0063], therefore Guillot teaches at least one of the regions, such as element 14, has a different power of at least 0.5 D, either positive or negative relative to the first region of lens element 10, and since spherical aberration is one of the vision disorder aberrations that can be corrected by a contact lens, such as lens element 10 of Guillot, the prior art teaches second region of the optical zone comprises primary spherical aberration between +0.5 D to -0.5 D, defined over a minimum diameter of the second region, because a minimum diameter of the second region would be required for the region to provide corrective refractive power for a user to perceive the correction).
Regarding dependent claim 11, modified Fujikado discloses the contact lens of claim 1, and Roffman further discloses wherein a difference between a thickest point and a thinnest point within the plurality of azimuthal thickness distributions of the non-optical peripheral carrier zone about the optical axis provides a peak-to-valley thickness (Roffman, Fig. 7, discloses a thickest section of pseudotruncation 21, par. [0081], therefore there must exist a thinnest section of pseudotruncation 21 in comparison to the thickest section, and as such, Roffman inherently discloses a peak-to-valley thickness); wherein the peak-to-valley thickness is between 5 mm and 45 mm providing substantial invariance (Roffman teaches maximum radial thickness is symmetrical such that peak-to-valley thickness approaches zero, i.e., substantially invariant, in the context of the maximum difference of bevel flange 19 being 179 mm, par. [0095]).
Regarding dependent claim 33, modified Fujikado discloses the contact lens of claim 1, and Guillot further discloses wherein the at least one of the partially variant meridional power distributions is radially variant (Guillot, Fig. 1, the prescription portion of lens element 10 has a progressive addition dioptric function extending between quadrants Q2 and Q4, par. [0075]).
The prior art combination does not disclose the radial power variation in the at least one of the partially variant meridional power distributions is between 0 and -1 D.
However, Guillot does disclose radial and concentric optical elements in Figs. 12 and 15, and teaches that some, or all, of the optical elements can either be constant or varying in optical power and can have a variety of continuous or discontinuous derivatives between contiguous elements, pars. [0108-110]. Guillot further teaches that opposing quarters Q2 and Q4 could have a progressive power change from the top of Q2 to the bottom of Q4. Thus, Guillot has the ability to create a lens that has an asymmetrical change in optical power across quadrants Q1-Q4, and a symmetrical change in radial optical power across opposing quarters, for example Q2 and Q4, (par. [0075]).
Therefore, a person having ordinary skill the art would have been able to optimize the lens disclosed by Fujikado according to the teachings of Guillot, such that only one of the pluralities of the meridional power distributions has mirror symmetry along the optical zone and none of the pluralities of the azimuthal power distributions has mirror symmetry about the optical axis, for the purpose of increasing the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and improve ease of manufacturing (Guillot par. [0089]).
Regarding dependent claim 34, modified Fujikado discloses the contact lens of claim 1, and Guillot further discloses wherein the at least one of the plurality of the partially variant meridional power distributions is radially invariant (Guillot teaches an embodiment wherein quadrant Q4 has an optical power different from the first optical power corresponding to the refraction area, par. [0074]).
Regarding dependent claim 35, modified Fujikado discloses the contact lens claim 1, but the prior art combination does not disclose wherein the difference between a maximum power and a minimum power within the meridionally varying power distributions across the second region, and the azimuthally varying power distributions about the geometric centre of the second region, provides a delta power; wherein the delta power is between +0.5 D and +2.75 D.
However, optimizing focal power, or a change in focal power, is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In this case, Guillot teaches in Tables 1-3 a maximum change in power meridionally and azimuthally of approximately 0.5 diopters, which is a variable which achieves a recognized result. Therefore, the prior art teaches adjusting the optical power of a corrective lens and identifies said sizes and ratios as result-effective variables. Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the change in focal power, since it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding dependent claim 36, modified Fujikado discloses the contact lens of claim 1, but the prior art combination does not disclose wherein the plurality of azimuthal thickness distributions are defined with a desired width spanning a range of arbitrary radial distances in the non-optical peripheral carrier zone, wherein the desired width is between 3.5 mm and 7.2 mm, of the non-optical peripheral carrier zone.
However, optimizing radial distance is well within the bounds of normal experimentation. See MPEP 2144.05 II (A). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, “[a] particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.” In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). In this case, Roffman teaches radial distance in the form of lenticular portion, which is disclosed to be about 2.625 mm (Roffman, par. [0094]) as a variable which achieves a recognized result.
Therefore, the prior art teaches adjusting the radial distance of the thickness distributions and identifies said sizes and ratios as result-effective variables. Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the radial distance since it is not inventive to discover the optimum or workable ranges by routine experimentation.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fujikado in view of Guillot and Roffman.
Regarding amended independent claim 15, Fujikado discloses a contact lens (refer to at least title and abstract disclosing a contact lens) comprising:
a front surface (Fig. 2, contact lens 10 has front surface 20, par. [0064]);
a back surface (Fig. 2, contact lens 10 has back surface 22, par. [0064]);
an optical centre (Fig. 2, contact lens 10 has geometric center 38, par. [0078]);
an optical axis (Fig. 2, contact lens 10 optical axis center 30, par. [0067]);
an optical zone comprising:
a first region, configured with a single vision power for correction of a myopic eye (Fig. 2, contact lens 10 has optical part 24 with central region 32 with refractive correction power, par. [0067]); and
a second region (Fig. 2, contact lens 10 has optical part 24 with peripheral region 34, par. [0068]), configured with a power map characterised by a plurality of meridional power distributions and a plurality of azimuthal power distributions, about its geometric centre (Fig. 2 shows contact lens 10 with concentric regions 32, 34, and 36, where central region 32 has refractive power, and peripheral region 34 with additional power, par. [0068], and Fig. 4 shows lens radius in millimeters against lens power differential in diopters, explaining an additional power set in an optical part of the contact lens 10 shown in Fig. 2, showing examples of changing refractive power of the lens along a meridian, with and without steps, par. [0054], where the additional refractive power is set to change continuously and gradually without steps from the optical axis center 30 toward the peripheral region 34 on the outer peripheral side in the radial direction to provide optical part 24 with a positive spherical aberration and as a result, the amount of correction of focal error is made to increase toward the front as it goes to the outer peripheral side, par. [0069], thereby disclosing meridional and azimuthal power distributions about the geometric center 38 of lens 10);
wherein the second region is decentered from the optical centre (Fig. 2, peripheral region 34 is off-center from geometric center 38, par. [0078]); and
a non-optical peripheral carrier zone about the optical zone (Fig. 2, peripheral part 26 extends in annular shape around optical part 24, par. [0065]).
Fujikado does not disclose at least one of the azimuthal power distributions is variant and is devoid of mirror symmetry, within the decentred second region, nor does Fujikado disclose at least one of the meridional power distributions is variant and is devoid of mirror symmetry, within the decentred second region. Fujikado does not disclose the power map provides a foveal correction for the myopic eye, and therefore Fujikado does not disclose the power map provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression. Fujikado also does not disclose the lens is configured to rotate when on-eye, nor does Fujikado disclose the regional conoid of partial blur is not a regular conoid of Sturm and is irregular, and Fujikado does not disclose the regional conoid of partial blur has a depth of at least 0.5 mm at the retina of the eye, the regional conoid of partial blur spans at a para macular region of the retina of the myopic eye; wherein the regional conoid of partial blur is at least within 15 degrees field of the retina of the myopic eye.
In the same field of invention, Guillot discloses a lens element intended to be worn in front of an eye, refer to at least par. [0001] thereof, with an optical zone (Guillot Fig. 1, the area of lens element 10 with optical power is an optical zone, par. [0071] thereof) comprising a first region, configured with a single vision power for correction of a myopic eye (Guillot Fig. 1, lens element 10 has prescription portion 12 that provides optical power to correct abnormal refraction of an eye of the wearer, pars. [0024-25] thereof, such as myopia, par. [0034] thereof); and a second region, configured with a power map characterised by a plurality of meridional power distributions and a plurality of azimuthal power distributions, about its geometric centre (Guillot Fig. 1, lens element 10 has a plurality of optical elements 14, pars. [0024], [0080], [0086] thereof, see also Guillot Fig. 12 showing optical elements 14 distributed about the center of lens element 10, and the shape of elements 14 provides the equivalent of a plurality of meridional power distributions and a plurality of azimuthal power distributions around the geometric center of element 14, as best understood by the Examiner), wherein second region is decentered from the optical centre (Guillot Fig. 1, each of optical elements 14 is not centered on the center of lens element 10), with at least one of the azimuthal power distributions that is variant and is devoid of mirror symmetry (Guillot Fig. 18, optical elements have a constant optical power and a discontinuous first derivative between two contiguous optical elements, and Fig. 19, optical elements have a varying optical power and a continuous first derivative between two contiguous optical elements, refer to Tables 2-3, par. [0109] of Guillot), within the decentred second region (Guillot Fig. 1, elements 14 have variable azimuthal power distributions due to their shape). Guillot further teaches at least one of the meridional power distributions is variant and is devoid of mirror symmetry (Guillot Fig. 1, quadrants Q1-Q4 have progressive addition dioptric function, par. [0075] thereof, refer to at least Table 1, see also Figs. 12 and 15 of Guillot, depicting an embodiment of lens element 10 with radial optical elements which can be constant or varying adding asymmetry to each quarter of meridional power, pars. [0075], [0103], [0110] thereof), within the decentred second region (refer to at least Figs. 1 and 12 of Guillot showing elements 14 have variable meridional power distributions due to their shape), and Guillot teaches the power map provides a foveal correction for the myopic eye (Guillot Fig. 1, prescription portion 12, par. [0024] thereof, provides optical power based on prescription of the wearer for correction of vision aberrations including foveal vision, par. [0025] thereof, and myopia, par. [0034] thereof), and provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression (the optical element disclosed by Guillot reduces the deformation of the retina of the eye of the wearer in peripheral vision to slow down the progression of the abnormal refraction of the eye of the person wearing the lens element, including myopia, refer to at least pars. [0008], [0082], [0091], [0185] thereof, and refer to claim 1 of Guillot).
Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the teachings of Guillot to the disclosure of Fujikado and modified contact lens 10 to have the non-optical peripheral carrier zone comprising a plurality of azimuthal thickness distributions about the optical axis because Guillot teaches such configuration allows compensation of accommodative lag when the person looks at near vision distances (Guillot, par. [0076]), and to have modified lens 10 of Fujikado to have at least one of the azimuthal power distributions that is variant and is devoid of mirror symmetry, within the decentred second region as Guillot teaches such configuration increases the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and to have modified Fujikado lens 10 to have at least one of the meridional power distributions that is variant and is devoid of mirror symmetry, within the decentred second region as Guillot teaches such configuration increases the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and to have modified Fujikado lens 10 to have the power map that provides a foveal correction for the myopic eye, and provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression, as Guillot teaches the disclosed lens element provides for foveal vision correction (Guillot, par. [0200]).
The prior art combination of Fujikado in view of Guillot does not disclose at least one of the azimuthal thickness distributions is uniform to facilitate on-eye rotation of the contact lens on the myopic eye and the lens is configured to rotate when on-eye, and the prior art combination does not disclose the regional conoid of partial blur is not a regular conoid of Sturm and is irregular and the prior art combination does not disclose the regional conoid of partial blur has a depth of at least 0.5 mm at the retina of the eye, the regional conoid of partial blur spans at a para macular region of the retina of the myopic eye; wherein the regional conoid of partial blur is at least within 15 degrees field of the retina of the myopic eye.
In the same field of invention, Roffman discloses a contact lens (see title and at least par. [0010] thereof), such as lens 10, shown in at least Fig. 2 thereof, with pseudotruncation 21 that is, as best understood by the Examiner, equivalent to a non-optical peripheral carrier zone surrounding optical zone 14 of lens 10 with lenticular portion bevel junction 18 and bevel portion 12 (Roffman par. [0062]), that have differing azimuthal thickness distributions about the optical axis. Roffman teaches it is desirable for corrective lenses to have a contact lens with a non-optical peripheral carrier zone, such as pseudotruncation 21, about the optical zone, such as optical zone 14, with the non-optical peripheral carrier zone comprising a plurality of azimuthal thickness distributions about the optical axis such as lenticular portion bevel junction 18 and bevel portion 12, and Roffman teaches at least one of the azimuthal thickness distributions is substantially invariant to facilitate a specific fit on the eye (maximum radial thickness region is symmetrical around meridian 110, pars. [0094-95], see also Figs. 1 and 2 of Roffman). Roffman further teaches the lenses disclosed therein can include features to orient the lens for stabilization (refer to at least par. [0090] thereof). Therefore, in order to reach a stable orientation when worn, the contact lenses of Roffman must be capable of rotating on-eye to reach the stabilized orientation for optimal correction of vision.
It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the contact lens 10 disclosed by Fujikado according to the teachings of Roffman in order to provide improved wearing comfort (Roffman, par. [0009]), and Roffman teaches it is advantageous to construct a translating contact lens with asymmetric optics and pseudotruncation which matches the lid position, in order to better engage the contact lens and enable vertical translation (Roffman, par. [0060]).
The prior art combination of Fujikado in view of Guillot and Roffman does not disclose the regional conoid of partial blur is not a regular conoid of Sturm and is irregular and the prior art combination does not disclose the regional conoid of partial blur has a depth of at least 0.5 mm at the retina of the eye, the regional conoid of partial blur spans at a para macular region of the retina of the myopic eye; wherein the regional conoid of partial blur is at least within 15 degrees field of the retina of the myopic eye
With regard to the limitations regarding the regional conoid of partial blur is not a regular conoid of Sturm and is irregular; and the regional conoid of partial blur has a depth of at least 0.5 mm at the retina of the eye, the regional conoid of partial blur spans at a para macular region of the retina of the myopic eye; wherein the regional conoid of partial blur is at least within 15 degrees field of the retina of the myopic eye, as best understood by the Examiner, the claims recite functions of the claimed contact lens (i.e., the shape and disposition of the light passing through the claimed contact lens to generate regional conoid of partial blur, depth of the regional conoid of partial blur, the span of the regional conoid of partial blur) in which the prior art is capable of performing. Because the structure of the claimed system, as identified above and in the original action, is the same as that claimed, it must inherently perform the same function and produce the regional conoid of partial blur that is not a regular conoid of Sturm and is irregular; and the regional conoid of partial blur has a depth of at least 0.5 mm at the retina of the eye, the regional conoid of partial blur spans at a para macular region of the retina of the myopic eye; wherein the regional conoid of partial blur is at least within 15 degrees field of the retina of the myopic eye. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). MPEP §2114. In this case, the conoids of partial blur must be a result of the claimed structural elements and arrangement of the claimed structural elements in the claimed contact lens, because the regional conoids of partial blur must be the inherent result of light passing through the optical elements claimed, and because the prior art has been cited and mapped to the structures claimed, the prior art combination must be capable of producing regional conoids of partial blur that satisfy the claimed limitations.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fujikado in view of Guillot.
Regarding amended independent claim 18, Fujikado discloses a contact lens (refer to at least title and abstract disclosing a contact lens) comprising:
a front surface (Fig. 2, contact lens 10 has front surface 20, par. [0064]);
a back surface (Fig. 2, contact lens 10 has back surface 22, par. [0064]);
an optical centre (Fig. 2, contact lens 10 has geometric center 38, par. [0078]);
an optical axis (Fig. 2, contact lens 10 optical axis center 30, par. [0067]);
an optical zone comprising:
a first region, configured with a single vision power for correction of a myopic eye (Fig. 2, contact lens 10 has optical part 24 with central region 32 with refractive correction power, par. [0067]); and
a second region (Fig. 2, contact lens 10 has optical part 24 with peripheral region 34, par. [0068]), configured with a power map characterised by a plurality of meridional power distributions and a plurality of azimuthal power distributions, about its geometric centre (Fig. 2 shows contact lens 10 with concentric regions 32, 34, and 36, where central region 32 has refractive power, and peripheral region 34 with additional power, par. [0068], and Fig. 4 shows lens radius in millimeters against lens power differential in diopters, explaining an additional power set in an optical part of the contact lens 10 shown in Fig. 2, showing examples of changing refractive power of the lens along a meridian, with and without steps, par. [0054], where the additional refractive power is set to change continuously and gradually without steps from the optical axis center 30 toward the peripheral region 34 on the outer peripheral side in the radial direction to provide optical part 24 with a positive spherical aberration and as a result, the amount of correction of focal error is made to increase toward the front as it goes to the outer peripheral side, par. [0069], thereby disclosing meridional and azimuthal power distributions about the geometric center 38 of lens 10);
wherein the second region is decentered from the optical centre (Fig. 2, peripheral region 34 is off-center from geometric center 38, par. [0078]); and
a non-optical peripheral carrier zone about the optical zone (Fig. 2, peripheral part 26 extends in annular shape around optical part 24, par. [0065]).
Fujikado does not disclose at least one of the azimuthal power distributions is variant and is devoid of mirror symmetry, within the decentred second region, nor does Fujikado disclose at least one of the meridional power distributions is variant and is devoid of mirror symmetry, within the decentred second region. Fujikado does not disclose the power map provides a foveal correction for the myopic eye, and therefore Fujikado does not disclose the power map provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression. Fujikado also does not disclose the lens is configured to rotate when on-eye, and Fujikado does not disclose the regional conoid of partial blur includes a sagittal plane and a tangential plane; wherein and the tangential plane is located in front of the retina for at least one location within 40 degrees field of the retina of the myopic eye; for at least one location within 40 degrees field of the retina of the myopic eye the sagittal plane is located in front of or close to the retina of the myopic eye.
In the same field of invention, Guillot discloses a lens element intended to be worn in front of an eye, refer to at least par. [0001] thereof, with an optical zone (Guillot Fig. 1, the area of lens element 10 with optical power is an optical zone, par. [0071] thereof) comprising a first region, configured with a single vision power for correction of a myopic eye (Guillot Fig. 1, lens element 10 has prescription portion 12 that provides optical power to correct abnormal refraction of an eye of the wearer, pars. [0024-25] thereof, such as myopia, par. [0034] thereof); and a second region, configured with a power map characterised by a plurality of meridional power distributions and a plurality of azimuthal power distributions, about its geometric centre (Guillot Fig. 1, lens element 10 has a plurality of optical elements 14, pars. [0024], [0080], [0086] thereof, see also Guillot Fig. 12 showing optical elements 14 distributed about the center of lens element 10, and the shape of elements 14 provides the equivalent of a plurality of meridional power distributions and a plurality of azimuthal power distributions around the geometric center of element 14, as best understood by the Examiner), wherein second region is decentered from the optical centre (Guillot Fig. 1, each of optical elements 14 is not centered on the center of lens element 10), with at least one of the azimuthal power distributions that is variant and is devoid of mirror symmetry (Guillot Fig. 18, optical elements have a constant optical power and a discontinuous first derivative between two contiguous optical elements, and Fig. 19, optical elements have a varying optical power and a continuous first derivative between two contiguous optical elements, refer to Tables 2-3, par. [0109] of Guillot), within the decentred second region (Guillot Fig. 1, elements 14 have variable azimuthal power distributions due to their shape). Guillot further teaches at least one of the meridional power distributions is variant and is devoid of mirror symmetry (Guillot Fig. 1, quadrants Q1-Q4 have progressive addition dioptric function, par. [0075] thereof, refer to at least Table 1, see also Figs. 12 and 15 of Guillot, depicting an embodiment of lens element 10 with radial optical elements which can be constant or varying adding asymmetry to each quarter of meridional power, pars. [0075], [0103], [0110] thereof), within the decentred second region (refer to at least Figs. 1 and 12 of Guillot showing elements 14 have variable meridional power distributions due to their shape), and Guillot teaches the power map provides a foveal correction for the myopic eye (Guillot Fig. 1, prescription portion 12, par. [0024] thereof, provides optical power based on prescription of the wearer for correction of vision aberrations including foveal vision, par. [0025] thereof, and myopia, par. [0034] thereof), and provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression (the optical element disclosed by Guillot reduces the deformation of the retina of the eye of the wearer in peripheral vision to slow down the progression of the abnormal refraction of the eye of the person wearing the lens element, including myopia, refer to at least pars. [0008], [0082], [0091], [0185] thereof, and refer to claim 1 of Guillot).
Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the teachings of Guillot to the disclosure of Fujikado and modified contact lens 10 to have the non-optical peripheral carrier zone comprising a plurality of azimuthal thickness distributions about the optical axis because Guillot teaches such configuration allows compensation of accommodative lag when the person looks at near vision distances (Guillot, par. [0076]), and to have modified lens 10 of Fujikado to have at least one of the azimuthal power distributions that is variant and is devoid of mirror symmetry, within the decentred second region as Guillot teaches such configuration increases the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and to have modified Fujikado lens 10 to have at least one of the meridional power distributions that is variant and is devoid of mirror symmetry, within the decentred second region as Guillot teaches such configuration increases the efficiency of the abnormal refraction control in peripheral vision with even more effect in horizontal axis (Guillot, par. [0078]), and to have modified Fujikado lens 10 to have the power map that provides a foveal correction for the myopic eye, and provides a regional conoid of partial blur, serving as a directional cue, or an optical signal, at the retina of the myopic eye for at least one of slowing, retarding, or reducing myopia progression, as Guillot teaches the disclosed lens element provides for foveal vision correction (Guillot, par. [0200]).
The prior art combination of Fujikado in view of Guillot does not disclose the regional conoid of partial blur includes a sagittal plane and a tangential plane; wherein and the tangential plane is located in front of the retina for at least one location within 40 degrees field of the retina of the myopic eye; for at least one location within 40 degrees field of the retina of the myopic eye the sagittal plane is located in front of or close to the retina of the myopic eye.
With regard to the limitations regarding the regional conoid of partial blur includes a sagittal plane and a tangential plane; wherein and the tangential plane is located in front of the retina for at least one location within 40 degrees field of the retina of the myopic eye; for at least one location within 40 degrees field of the retina of the myopic eye the sagittal plane is located in front of or close to the retina of the myopic eye, as best understood by the Examiner, the claims recite functions of the claimed contact lens (i.e., the shape and disposition of the light passing through the claimed contact lens to generate regional conoid of partial blur, depth of the regional conoid of partial blur, the span of the regional conoid of partial blur) which the prior art is capable of performing. Because the structure of the claimed system, as identified above and in the original action, is the same as that claimed, it must inherently perform the same function and produce the regional conoid of partial blur includes a sagittal plane and a tangential plane; wherein and the tangential plane is located in front of the retina for at least one location within 40 degrees field of the retina of the myopic eye; for at least one location within 40 degrees field of the retina of the myopic eye the sagittal plane is located in front of or close to the retina of the myopic eye. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). MPEP §2114. In this case, the conoids of partial blur must be a result of the claimed structural elements and arrangement of the claimed structural elements in the claimed contact lens, because the regional conoids of partial blur must be the inherent result of light passing through the optical elements claimed, and because the prior art has been cited and mapped to the structures claimed, the prior art combination must be capable of producing regional conoids of partial blur that satisfy the claimed limitations.
Allowable Subject Matter
Claims 12-13, 20, and 37-39 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.
Regarding amended dependent claim 12, modified Fujikado discloses the contact lens of claim 1, but the prior art combination does not disclose wherein the lens is configured to rotate when on-eye by 180 degrees at least thrice per 8 hours of lens wear, and at least 15 degrees within 1 hour of lens wear (Franklin in Fig. 4 discloses lens orientation in degrees varying over time after insertion in minutes, but does not teach or disclose the lens disclosed therein rotates by 180 degrees when worn on-eye at least thrice per 8 hours of wear).
Regarding dependent claim 13, modified Fujikado discloses the contact lens of claim 1, comprising at least one rotation assisting feature; wherein the at least one rotation assisting feature is represented using a periodic function with a periodicity; wherein the periodic function is a saw-tooth profile, a sinusoidal profile, a sum of sinusoidal profiles, or a quasi-sinusoidal profile; wherein the periodicity of the periodic function is no less than 6 defined over 0 to 2p radians, and the rate of thickness change is different for the increase than for the decrease and wherein the maximum thickness variation within the at least one rotation assisting feature is between 10 mm to 45 mm.
Regarding amended dependent claim 20, modified Fujikado discloses the contact lens of claim 1, comprising at least one rotation assisting feature, wherein the at least one rotation assisting feature is configured to increase rotation on the myopic eye and in combination with the at least partially variant meridional and azimuthal power distribution within the second region, offers a temporally and spatially varying stop signal for the myopic eye such that the efficacy of the directional signal remains substantially consistent over time.
Regarding new dependent claim 37, modified Fujikado discloses the contact lens of claim 1, wherein the lens is configured to rotate when on-eye by more than 180 degrees.
Regarding new dependent claim 38, Fujikado in view of Guillot and Roffman discloses the contact lens of claim 15, wherein the lens is configured to rotate when on-eye by more than 180 degrees.
Regarding new dependent claim 39, Fujikado in view of Guillot discloses the contact lens of claim 18, wherein the lens is configured to rotate when on-eye by more than 180 degrees.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Fujikado is cited as a primary reference, while Guillot and Roffman are cited as supporting references for features and limitations not explicitly or specifically disclosed by Fujikado. Further, Franklin is cited to explicitly teach on-eye rotation of a contact lens, with data supporting degrees of rotation over time as worn. The prior art cited in the rejection above teaches the contact lens as currently claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Justin W Hustoft whose telephone number is (571)272-4519. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM Eastern Time.
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/JUSTIN W. HUSTOFT/ Examiner, Art Unit 2872
/THOMAS K PHAM/ Supervisory Patent Examiner, Art Unit 2872