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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 28, 2026 has been entered.
The amended claims submitted July 28, 2026 in response to the office action mailed April 28, 2026 are under examination. Claims 1-21 are pending and either amended or new.
Claim Objections
The claim objections of the previous office action have been overcome by the amendments to the claims.
Claim 7 is objected to because of the following informalities: line 2, “constituted” should be “constitute”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-8, 11-19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. JP 2022167769 A (hereafter Lee, where reference will be made to the attached machine translation).
Regarding claim 1, Lee teaches “An ophthalmic lens (paragraph [0001]: “a contact lens for myopia control” and paragraph [0047]: “measurements were taken of actual products of the present invention, as shown in Figures 7 and 8. This product is similar to the embodiment shown in Figure 3”), comprising:
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a central zone (the portion of the first optical zone 10 interior to the second local minima in power as depicted in Fig. 8 and the portion of Fig. 7 that crosses through area 21, see region marked with the solid line double arrow in the examiner’s markup of a portion of Fig. 7 above) having a first region (the centermost region thereof radially interior to the first local minima in optical power, see dashed double arrow examiner’s markup of a portion of Fig. 7 above) characterized by a substantially constant first optical power (This is met in at least two ways. First, an ordinary skilled artisan would reasonably consider this interior-most area to have a substantially constant first optical power of about -3.2. Second, the type of power distribution that this actual lens is approximating is shown in Fig. 4, where the entire first optical zone has a constant first optical power, which happens to be -1D.) and a second region disposed radially outward of the first region (a second portion of zone 10 that includes the first local minima and the first local maxima in optical power, see examiner’s markup of a portion of Fig. 7 above) having in a radial direction a maximum corresponding to a positive deviation in power relative to the substantially constant first power as a function of radial position (Consider the right-hand side of the line graph in Fig. 7 that shows the power as a function of radius, along a chord that passes through defocus control zone 21 included in the examiner’s markup above. After the first minima in power, there is a first maximum in power relative to the first power. Note that this is also true in Fig. 8, where the solid line appears to depict a circumferential average of the power as a function of radius.) and a minimum corresponding to a negative deviation in power relative to the substantially constant first power (Consider the right-hand side of the line graph in Fig. 7 that shows the power as a function of radius, along a chord that passes through defocus control zone 21. There is a first local minimum immediately outside of the first region. Note that this is also true in Fig. 8, where the solid line appears to depict a circumferential average of the power as a function of radius.); and
a peripheral zone (second optical zone 20, third optical zone 30 and fourth optical zone 40, plus the outermost portion of zone 10 that contains the second local minimum as a function of radius, see the examiner’s markup of a portion of Fig. 7 above) disposed radially outward of the central zone (see e.g. Figs. 7 and 8), the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region (This is met in at least two ways. Consider the right-hand side of the line graph in Fig. 7 that shows the power as a function of radius, along a chord that passes through defocus control zone 21. That the average optical power is greater than the first optical power is self-evident, because, even at the local minima in zone 30, the optical power is greater than the first optical power. That the average optical power is increasing throughout zones 20-40 is evident from the fact that each successive local maximum is higher in power than the previous maximum, and each local minima is also higher in power than the previous minimum. Thus, if one determines the average optical power in an analogous manner to the DC component of an electrical power signal, it is increasing throughout zones 20-40. The same conclusions are reached when considering the solid line of the graph on the right-hand side of Fig. 8.),
the peripheral zone having maxima in optical power as a function of radial position (there are two such maxima in the line the subtends defocus control area 21, see paragraphs [0050]-[0051] “the first peripheral defocus control area 21 is a high intensity defocus area, and its diopter is +2.80D compared to the diopter of the first optical area 10… compared to the diopters of the first optical region 10, the diopters of the fourth optical region 40 are +3.5D”. These are marked as the second and third local maxima in the examiner’s markup of Fig. 7 above.) each of the maxima corresponding to a positive deviation relative to the increasing average optical power (+2.8D and +3.5D are the peaks relative to the average power considered over a full period of oscillation.) and having minima in optical power as a function of radial position (There are three such minima in the portion of Fig. 7 that passes through area 21, the 2nd local minimum at the end of zone 10, the 3rd local minimum in the center of zone 30 and the 4th local minimum at the end of zone 40. There are two such minima in Fig. 8, one at the end of zone 10 and one in the center of zone 30.) each of the minima corresponding to a negative deviation relative to the increasing average optical power (each of these minima is relative to the average power considered over a full period of oscillation).”
Regarding claim 2, Lee teaches “The lens of claim 1, wherein the substantially constant first optical power of the first region, the positive deviation and the negative deviation of the second region, and the positive deviations and negative deviations of peripheral zone constitute a power profile (see right-hand side graphs of Figs. 7 and 8, paragraph [0048] distribution of diopters.), and
wherein the power profile has no discontinuities in power (there are no discontinuities in the measured power profiles of Figs. 7 and 8).”
Regarding claim 3, Lee teaches “The lens of claim 1, wherein the diameter of the central zone is at least 2mm (paragraph [0015]: “the diameter range of the first optical region is 2.0 mm to 4.0 mm” see also paragraphs [0023]-[0024]).”
Regarding claim 4, Lee teaches “The lens of claim 1, wherein the diameter of the central zone is at least 3mm (paragraphs [0023]-[0024]: “The diameter range of the first optical zone 10 provides pupil sizes that correspond to the light rays necessary for normal learning and viewing… the appropriate diameter range for the first optical region 10 is 2.0 mm to 4.0 mm” Given that the overlap between the claimed range and the disclosed range is the entire upper half of the disclosed range, Lee is considered to teach the claimed range with sufficient specificity to anticipate the range.).”
Regarding claim 5, Lee teaches “The lens of claim 1, wherein the central zone and the peripheral zone are rotationally symmetric (the zones themselves are a circle and annulus, which are rotationally symmetric shapes. Note that the claim does not explicitly recite that the optical power within the central zone and the peripheral zone are rotationally symmetric).”
Regarding claim 6, Lee teaches “The lens of claim 1, wherein the lens is contact lens (e.g. paragraph [0001]: “a contact lens for myopia control”).”
Regarding claim 7, Lee teaches “The lens of claim 1, wherein the positive deviations and negative deviations in power and the peripheral zone constituted a periodic function as a function of radius (The peaks and valleys of the central and peripheral zones are a periodic function as a function of radius in the sense that peaks and valleys alternate with one another as a function of radius. Note that the claim does not specifically recite “having a fixed period” and the comment in the specification, paragraph [0049]: “periodically (i.e., a repeating pattern having a fixed period)” can reasonably be construed as an explanation, not a specific definition.).”
Regarding claim 8, Lee teaches “The lens of claim 1, wherein the area above the constant first power and the average power that is encompassed by the positive deviations of the second region and the peripheral zone is less than 20% different than the area below the constant first power and the average power that is encompassed by the negative deviations of the second region and the peripheral zone (This is met as follows. The deviations within the second region are both similar to one another and negligibly small relative to the deviations from the average power in the periphery and thus cannot constitute a 20% difference in area. Within the peripheral region, by definition, an average power is mathematically determined by the relative areas above and below the average. Thus the areas encompassed by the positive and negative deviations from the average power differ by 0%.).”
Regarding claim 11, Lee teaches “The lens of claim 1, wherein the positive deviations and the negative deviations in the peripheral zone have an amplitude in the range of 0.5 - 12.0 diopters (the amplitude of the positive and negative deviations within the peripheral zone for Fig. 7 through 21 are both approximately 0.5*2.8D=1.4 diopters which is in the claimed range. See also Fig. 4A with amplitudes of about 1 diopter and Fig. 8 with amplitudes of about 1.05 and 1.7 diopters.).”
Regarding claim 12, Lee teaches “The lens of claim 1, wherein the positive deviations and the negative deviations in the second region and the peripheral zone are determined by variations in surface curvature (see Figs. 6A and 6B and descriptions thereof in paragraphs [0045]-[0046]).”
Regarding claim 13, Lee teaches “The lens of claim 2, wherein the lens is contact lens (e.g. paragraph [0001]: “a contact lens for myopia control”).”
Regarding claim 14, Lee teaches “The lens of claim 13, wherein the central zone and the peripheral zone are rotationally symmetric (the zones themselves are a circle and annulus, which are rotationally symmetric shapes. Note that the claim does not explicitly recite that the optical power within the central zone and the peripheral zone are rotationally symmetric).”
Regarding claim 15, Lee teaches “The lens of claim 14, wherein the diameter of the central zone is at least 2mm (paragraph [0015]: “the diameter range of the first optical region is 2.0 mm to 4.0 mm” see also paragraphs [0023]-[0024]).”
Regarding claim 16, Lee teaches “The lens of claim 15, wherein the positive deviations and negative deviations in power and the peripheral zone constituted a periodic function as a function of radius (The peaks and valleys of the central and peripheral zones are a periodic function as a function of radius in the sense that peaks and valleys alternate with one another as a function of radius. Note that the claim does not specifically recite “having a fixed period” and the comment in the specification, paragraph [0049]: “periodically (i.e., a repeating pattern having a fixed period)” can reasonably be construed as an explanation, not a specific definition.).”
Regarding claim 17, Lee teaches “The lens of claim 16, wherein the area above the constant first power and the average power that is encompassed by the positive deviations of the second region and the peripheral zone is less than 20% different than the area below the constant first power and the average power that is encompassed by the negative deviations of the second region and the peripheral zone (This is met as follows. The deviations within the second region are both similar to one another and negligibly small relative to the deviations from the average power in the periphery and thus cannot constitute a 20% difference in area. Within the peripheral region, by definition, an average power is mathematically determined by the relative areas above and below the average. Thus the areas encompassed by the positive and negative deviations from the average power differ by 0%.).”
Regarding claim 18, Lee teaches “The lens of claim 17, wherein the positive deviations and the negative deviations in the peripheral zone have an amplitude in the range of 0.5 - 12.0 diopters (the amplitude of the positive and negative deviations within the peripheral zone for Fig. 7 through 21 are both approximately 0.5*2.8D=1.4 diopters which is in the claimed range. See also Fig. 4A with amplitudes of about 1 diopter and Fig. 8 with amplitudes of about 1.05 and 1.7 diopters.).”
Regarding claim 19, Lee teaches “The lens of claim 18, wherein the positive deviations and the negative deviations in the second region and the peripheral zone are determined by variations in surface curvature (see Figs. 6A and 6B and descriptions thereof in paragraphs [0045]-[0046]).”
Regarding claim 21, Lee teaches “An ophthalmic lens (paragraph [0001]: “a contact lens for myopia control” and paragraph [0047]: “measurements were taken of actual products of the present invention, as shown in Figures 7 and 8. This product is similar to the embodiment shown in Figure 3”), comprising:
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a central zone (the portion of the first optical zone 10 interior to the second local minima in power as depicted in Fig. 8 and the portion of Fig. 7 that crosses through area 21, see region marked with the solid line double arrow in the examiner’s markup of a portion of Fig. 7 above) having a first region (the centermost region thereof radially interior to the first local minima in optical power, see dashed double arrow examiner’s markup of a portion of Fig. 7 above) characterized by a substantially constant first optical power (This is met in at least two ways. First, an ordinary skilled artisan would reasonably consider this interior-most area to have a substantially constant first optical power of about -3.2. Second, the type of power distribution that this actual lens is approximating is shown in Fig. 4, where the entire first optical zone has a constant first optical power, which happens to be -1D.) and a second region disposed radially outward of the first region (a second portion of zone 10 that includes the first local minima and the first local maxima in optical power, see examiner’s markup of a portion of Fig. 7 above) having in a radial direction a maximum corresponding to a positive deviation in power relative to the substantially constant first power as a function of radial position (Consider the right-hand side of the line graph in Fig. 7 that shows the power as a function of radius, along a chord that passes through defocus control zone 21 included in the examiner’s markup above. After the first minima in power, there is a first maximum in power relative to the first power. Note that this is also true in Fig. 8, where the solid line appears to depict a circumferential average of the power as a function of radius.) and a minimum corresponding to a negative deviation in power relative to the substantially constant first power (Consider the right-hand side of the line graph in Fig. 7 that shows the power as a function of radius, along a chord that passes through defocus control zone 21. There is a first local minimum immediately outside of the first region. Note that this is also true in Fig. 8, where the solid line appears to depict a circumferential average of the power as a function of radius.); and
a peripheral zone (second optical zone 20, third optical zone 30 and fourth optical zone 40, plus the outermost portion of zone 10 that contains the second local minimum as a function of radius, see the examiner’s markup of a portion of Fig. 7 above) disposed radially outward of the central zone (see e.g. Figs. 7 and 8), the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region (This is met in at least two ways. Consider the right-hand side of the line graph in Fig. 7 that shows the power as a function of radius, along a chord that passes through defocus control zone 21. That the average optical power is greater than the first optical power is self-evident, because, even at the local minima in zone 30, the optical power is greater than the first optical power. That the average optical power is increasing throughout zones 20-40 is evident from the fact that each successive local maximum is higher in power than the previous maximum, and each local minima is also higher in power than the previous minimum. Thus, if one determines the average optical power in an analogous manner to the DC component of an electrical power signal, it is increasing throughout zones 20-40. The same conclusions are reached when considering the solid line of the graph on the right-hand side of Fig. 8.),
the peripheral zone having at least one maximum in optical power as a function of radial position (there are two such maxima in the line the subtends defocus control area 21, see paragraphs [0050]-[0051] “the first peripheral defocus control area 21 is a high intensity defocus area, and its diopter is +2.80D compared to the diopter of the first optical area 10… compared to the diopters of the first optical region 10, the diopters of the fourth optical region 40 are +3.5D”. These are marked as the second and third local maxima in the examiner’s markup of Fig. 7 above.) the maximum corresponding to a positive deviation relative to the increasing average optical power (+2.8D and +3.5D are the peaks relative to the average power considered over a full period of oscillation.) and having at least one minimum in optical power as a function of radial position (There are three such minima in the portion of Fig. 7 that passes through area 21, the 2nd local minimum at the end of zone 10, the 3rd local minimum in the center of zone 30 and the 4th local minimum at the end of zone 40. There are two such minima in Fig. 8, one at the end of zone 10 and one in the center of zone 30.) the minimum corresponding to a negative deviation relative to the increasing average optical power (each of these minima is relative to the average power considered over a full period of oscillation).”
Claims 1-7, 11, 13-16 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. US 2018/0373059 A1 (hereafter Lin).
Regarding claim 1, Lin teaches (16th example, Fig. 20, Table 24) “An ophthalmic lens (the contact lens of the 16th example), comprising:
a central zone (the zone within about 2.8667 mm of the center in Fig. 20 and Table 24) having a first region (the region within 2 mm of the center in Fig. 20 and Table 24) characterized by a substantially constant first optical power (see Fig. 20 and Table 24 the diopter within 2 mm of the center is a constant value of -6.00) and a second region (the region between 2 and about 2.8667 mm from the center in Fig. 20 and Table 24) disposed radially outward of the first region (the second region is radially outward with radial positions of 2 mm to 2.8667 mm of the first region that is within 2 mm) having in a radial direction a maximum (e.g. Table 24 [radius, diopter] pair [2.6,-6.0] which is a local maxima relative to -6.00) corresponding to a positive deviation in power relative to the substantially constant first power as a function of radial position (the maxima at radii of 2.6 is a positive deviation relative to -6.00) and a minimum (e.g. Table 24 [radius, diopter] pairs [2.2,-6.5] and [2.8,-7] which are local minima) corresponding to a negative deviation in power relative to the substantially constant first power (e.g. Table 24 [radius, diopter] pairs [2.2,-6.5] and [2.8,-7] are negative deviations from -6.00); and
a peripheral zone (the zone from about 2.8667 mm to 4 mm) disposed radially outward of the central zone (the zone beginning at about 2.8667 is radially outward from the central zone), the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region (It is possible to closely approximate the average optical power as a function of radius in an analogous fashion to determining the average DC power under the following approximations/assumptions. (1) Approximate each decreasing or increasing segment in Lin Fig. 20 as linear. This allows you to determine each radius at which -6.0 diopters is crossed, namely at radii of 2.3, 2.72, 2.8667, 3.133 and 3.246) (2) Estimate the areas above and below -6.0 diopters by triangles with the base defined by the radii at which -6D is crossed and the heights defined by the maxima or minima (3) Calculate the average over a full period as the area under the curve of a positive deviation triangle plus the area of an adjacent negative deviation triangle divided by the length. These reasonable and necessary approximations yield the result that the average optical power is actually increasing throughout the zone with radii greater than 2.3 mm, see table below.),
the peripheral zone having at least one maximum in optical power as a function of radial position the maximum corresponding to a positive deviation relative to the increasing average optical power (the maxima at radius, diopter pairs of [3.0,-4] and [3.6,4] in Fig. 20 and Table 4), and having at least one minimum in optical power as a function of radial position the minimum corresponding to a negative deviation relative to the increasing average optical power (the minima at radius, diopter pairs of [3.2,-7.5] and [4.0, 2] in Fig. 20 and Table 4).”
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Regarding claim 2, Lin teaches “The lens of claim 1, wherein the substantially constant first optical power of the first region, the positive deviation and the negative deviation of the second region, and the positive deviations and negative deviations of peripheral zone constitute a power profile (the power profile of Fig. 20 and Table 24), and
wherein the power profile has no discontinuities in power (Fig. 20 depicts a continuous power profile with no discontinuities).”
Regarding claim 3, Lin teaches “The lens of claim 1, wherein the diameter of the central zone is at least 2mm (see Fig. 20 and Table 24 the central zone diameter is 6 mm which is in the claimed range).”
Regarding claim 4, Lin teaches “The lens of claim 1, wherein the diameter of the central zone is at least 3mm (see Fig. 20 and Table 24 the central zone diameter is 6 mm which is in the claimed range).”
Regarding claim 5, Lin teaches “The lens of claim 1, wherein the central zone and the peripheral zone are rotationally symmetric (see Fig. 1 and e.g. paragraph [0173]: “The annular region symmetrically surrounds the central region. The peripheral region symmetrically surrounds the annular region.”).”
Regarding claim 6, Lin teaches “The lens of claim 1, wherein the lens is contact lens (e.g. paragraph [0173]: “contact lens”).”
Regarding claim 7, Lin teaches “The lens of claim 1, wherein the positive deviations and negative deviations in power and the peripheral zone constituted a periodic as a function of radius (between 2.4 mm and 3.2 mm from the center, the peaks and valleys are periodically spaced in intervals of 0.2mm, see Table 24. These periodic positive and negative deviations of power are in parts of both the second region and the peripheral zone. Furthermore, the peaks and valleys of the central and peripheral zones are a periodic function as a function of radius in the sense that peaks and valleys alternate with one another as a function of radius. Note that the claim does not specifically recite “having a fixed period” and the comment in the specification, paragraph [0049]: “periodically (i.e., a repeating pattern having a fixed period)” can reasonably be construed as an explanation, not a specific definition.).”
Regarding claim 11, Lin teaches “The lens of claim 1, wherein the positive deviations and the negative deviations in the peripheral zone have an amplitude in the range of 0.5 - 12.0 diopters (One can calculate the positive and negative deviations from the increasing average power within the peripheral zone using the values above.
radius
diopter
calculated average relative to -6D
amplitude
3.0
-4
0.4677
1.532
3.2
-7.5
0.4797
-1.9797
3.6
4
3.6099
6.3901
4
2
not well defined
not well defined
Thus, the amplitude of the deviations includes values between 1.532 and 6.3901 which are in the claimed range).”
Regarding claim 13, Lin teaches “The lens of claim 2, wherein the lens is contact lens (e.g. paragraph [0173]: “contact lens”).”
Regarding claim 14, Lin teaches “The lens of claim 13, wherein the central zone and the peripheral zone are rotationally symmetric (see Fig. 1 and e.g. paragraph [0173]: “The annular region symmetrically surrounds the central region. The peripheral region symmetrically surrounds the annular region.”).”
Regarding claim 15, Lin teaches “The lens of claim 14, wherein the diameter of the central zone is at least 2mm (see Fig. 20 and Table 24 the central zone diameter is 6 mm which is in the claimed range).”
Regarding claim 16, Lin teaches “The lens of claim 15, wherein the positive deviations and negative deviations in power and the peripheral zone constituted a periodic as a function of radius (between 2.4 mm and 3.2 mm from the center, the peaks and valleys are periodically spaced in intervals of 0.2mm, see Table 24. These periodic positive and negative deviations of power are in parts of both the second region and the peripheral zone. Furthermore, the peaks and valleys of the central and peripheral zones are a periodic function as a function of radius in the sense that peaks and valleys alternate with one another as a function of radius. Note that the claim does not specifically recite “having a fixed period” and the comment in the specification, paragraph [0049]: “periodically (i.e., a repeating pattern having a fixed period)” can reasonably be construed as an explanation, not a specific definition.).”
Regarding claim 21, Lin teaches (16th example, Fig. 20, Table 24) “An ophthalmic lens (the contact lens of the 16th example), comprising:
a central zone (the zone within about 3.246 mm of the center in Fig. 20 and Table 24) having a first region (the region within 2 mm of the center in Fig. 20 and Table 24) characterized by a substantially constant first optical power (see Fig. 20 and Table 24 the diopter within 2 mm of the center is a constant value of -6.00) and a second region (the region between 2 and about 3.246 mm from the center in Fig. 20 and Table 24) disposed radially outward of the first region (the second region is radially outward with radial positions of 2-3.246 mm of the first region that is within 2 mm) having in a radial direction a maximum (e.g. Table 24 [radius, diopter] pairs [2.6,-6.0] and [3.0,-4] which are local maxima relative to -6.00) corresponding to a positive deviation in power relative to the substantially constant first power as a function of radial position (the maxima at radii of 2.6 and 3.0 are positive deviations relative to -6.00) and a minimum (e.g. Table 24 [radius, diopter] pairs [2.2,-6.5]; [2.8,-7] and [3.2, -7.5] which are local minima) corresponding to a negative deviation in power relative to the substantially constant first power (e.g. Table 24 [radius, diopter] pairs [2.2,-6.5]; [2.8,-7] and [3.2, -7.5] are negative deviations from -6.00); and
a peripheral zone (the zone from about 3.246 mm to 4 mm) disposed radially outward of the central zone (the zone beginning at about 3.246 is radially outward from the central zone), the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region (As admitted by the applicant in lines 15-18 of page 8 of 10 of the remarks filed March 30, 2026, the average optical power that is increasing as a function of radius relative to the first optical power beginning at about 3.3 mm. It is possible to closely approximate the average optical power as a function of radius under the following approximations/assumptions. (1) Approximate each decreasing or increasing segment in Lin Fig. 20 as linear. This allows you to determine each radius at which -6.0 diopters is crossed, namely at radii of 2.3, 2.72, 2.8667, 3.133 and 3.246) (2) Estimate the areas above and below -6.0 diopters by triangles with the base defined by the radii at which -6D is crossed and the heights defined by the maxima or minima (3) Calculate the average over a full period as the area under the curve of a positive deviation triangle plus the area of an adjacent negative deviation triangle divided by the length. These reasonable and necessary approximations yield the result that the average optical power is actually increasing throughout the zone with radii greater than 2.3 mm, see table below. Thus it can be definitively stated that the average optical power is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region defined as starting at 3.246 mm),
the peripheral zone having at least one maximum in optical power as a function of radial position the maximum corresponding to a positive deviation relative to the increasing average optical power (the maxima at 3.6 mm of 4 diopters in Fig. 20 and Table 4), and having at least one minimum in optical power as a function of radial position the minimum corresponding to a negative deviation relative to the increasing average optical power (the final minima at 4 mm of 2 diopters in Fig. 20 and Table 4).”
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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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. US 2018/0373059 A1 (hereafter Lin) as applied to claim 1 above, and further in view of Hovinga et al. US 2022/0137432 A1 (cited in an IDS, hereafter Hovinga).
Regarding claim 12, Lin teaches the lens of claim 1 however Lin fails to explicitly teach “wherein the positive deviations and the negative deviations in the second region and the peripheral zone are determined by variations in surface curvature.”
Hovinga teaches (claim 1) “An ophthalmic lens (ophthalmic lens 100), comprising:
a central zone (central optical zine 110) … characterized by a substantially constant first optical power (e.g. paragraph [0036]: “the central zone may have only a single power” or Fig. 2A,2C -3.0 diopters) … and
a peripheral zone (peripheral zone 120, 220, 230) disposed radially outward of the central zone (see Figs. 1 and 2A,2C), the peripheral zone having positive and negative deviations as a function of radial position (see Figs. 2A, 2C and e.g. paragraph [0044]: “A radial power profile of the peripheral zone can have any of a variety of shapes comprising maxima and minima.”), relative to an average optical power (paragraph [0045]: “The base power in the peripheral zone … may vary (increase… ) in the radial direction with the spatial modulation causing offsets from the base power at a given location.”) from the substantially constant first optical power (e.g. paragraph [0047]: “An add power offset between the first power and the base power of the peripheral zone will typically be in the range of 0.5 diopters to 5 diopters.”).”
(claim 12) “wherein the positive deviations and the negative deviations in… the peripheral zone are determined by variations in surface curvature (paragraph [0043]: “Radial power may be varied using localized variations in surface curvature”).”
Lin teaches the lens of claim 12 except for the manner in which the radial power variations are achieved being by variations in the surface curvature. Hovinga teaches that “Radial power may be varied using localized variations in surface curvature or localized variations in index of refraction.” (paragraph [0043]).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize surface curvature variations which is one of two known methods for achieving radial power variations as taught by Hovinga in the lens of Lin because Lin teaches creating such radial power variations but is silent as to how they should be produced, thus an ordinary skilled artisan would look to Hovinga to decide how to achieve them.
Allowable Subject Matter
Claims 9-10 and 20 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.
The following is a statement of reasons for the indication of allowable subject matter:
Reference will be made to Lee et al. JP 2022167769 A (hereafter Lee, where reference will be made to the attached machine translation), Lin et al. US 2018/0373059 A1 (hereafter Lin) and Saw et al. WO 2013015743 A1 (hereafter Saw).
Regarding claim 9, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole: (claim 1) “a minimum corresponding to a negative deviation in power relative to the substantially constant first power” and (claim 9) “wherein the deviation amplitudes relative to the average optical power of the peripheral zone is equal to the deviation amplitudes relative to the substantially constant first power in the second region.”
In particular, Lee and Lin anticipate claim 1, however, neither teaches “wherein the deviation amplitudes relative to the average optical power of the peripheral zone is equal to the deviation amplitudes relative to the substantially constant first power in the second region.”
Saw teaches (claim 1) “An ophthalmic lens (Figure 3 shows a contact lens having ten optic zones), comprising:
a central zone (CZ1, DZ1, CZ2 and DZ2) having a first region (CZ1) characterized by a substantially constant first optical power (Fig. 3 -2D) and a second region (DZ1, CZ2 and DZ2) disposed radially outward of the first region (see Fig. 3) having in a radial direction a maximum (0.5D and 1D in DZ1 and DZ2) corresponding to a positive deviation in power relative to the substantially constant first power as a function of radial position (0.5D and 1D are positive deviations relative to -2D) and a minimum (-1.5D in CZ2) corresponding to a negative deviation in power (-1.5D is a negative deviation from 0.5D and 1.5D in annuli adjacent thereto); and
a peripheral zone (the remaining optic zones CZ3-CZ5 and DZ3-DZ5) disposed radially outward of the central zone (see Fig. 3), the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region (the average power is linearly increasing by 0.5D over each period that includes a minima and a maxima),
the peripheral zone having at least one maximum in optical power as a function of radial position the maximum corresponding to a positive deviation relative to the increasing average optical power (the maxima in DZ3-DZ5), and having at least one minimum in optical power as a function of radial position the minimum corresponding to a negative deviation relative to the increasing average optical power (the minima in CZ3-CZ5).”
(claim 9) “wherein the deviation amplitudes relative to the average optical power of the peripheral zone is equal to the deviation amplitudes relative to the substantially constant first power in the second region (the amplitude of the deviations relative to the linearly increasing average optical power is a constant throughout the contact lens).”
However, Saw fails to teach (claim 1) “a minimum corresponding to a negative deviation in power relative to the substantially constant first power.”
Although, each individual limitation is taught by the prior art, this, by itself, does not constitute a prima facie case of obviousness.
In the instant case, it would not have been obvious to modify Lee of Lin to change the amplitude of the deviations in the second region or the peripheral zone to be the same as taught by Saw for at least the following reasons. (1) Saw does not provide any explicit motivation for doing so. (2) Such a modification would be a substantial change from the functional forms in Lee and Lin which both include amplitudes in the peripheral zone greatly exceeding the amplitudes in the second region.
Further, it would not have been obvious to modify Saw in view of Lee or Lin to make the first local minimum in the second region to be a negative deviation from the first optical power for at least the following reasons. (1) Neither Lee nor Lin explain any benefit stemming from the relative diopter of this first minimum. (2) Saw consistently teaches a linearly increasing average dioptric power throughout the contact lens, which would reasonably be considered to teach away from such a modification, absent a strong motivation to do so.
Regarding claims 10 and 20, the prior art taken either singly or in combination fails to teach or reasonably suggest the following limitation when taken in context of the claim as a whole: (claim 1) “a minimum corresponding to a negative deviation in power relative to the substantially constant first power” and (claims 10 or 20) “wherein the average optical power in the peripheral zone increases linearly.”
In particular, Lee and Lin anticipate claim 1, however, neither teaches “wherein the average optical power in the peripheral zone increases linearly.”
Saw teaches (claim 1) “An ophthalmic lens (Figure 3 shows a contact lens having ten optic zones), comprising:
a central zone (CZ1, DZ1, CZ2 and DZ2) having a first region (CZ1) characterized by a substantially constant first optical power (Fig. 3 -2D) and a second region (DZ1, CZ2 and DZ2) disposed radially outward of the first region (see Fig. 3) having in a radial direction a maximum (0.5D and 1D in DZ1 and DZ2) corresponding to a positive deviation in power relative to the substantially constant first power as a function of radial position (0.5D and 1D are positive deviations relative to -2D) and a minimum (-1.5D in CZ2) corresponding to a negative deviation in power (-1.5D is a negative deviation from 0.5D and 1.5D in annuli adjacent thereto); and
a peripheral zone (the remaining optic zones CZ3-CZ5 and DZ3-DZ5) disposed radially outward of the central zone (see Fig. 3), the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially constant first optical power as a function of radius throughout the peripheral region (the average power is linearly increasing by 0.5D over each period that includes a minima and a maxima),
the peripheral zone having at least one maximum in optical power as a function of radial position the maximum corresponding to a positive deviation relative to the increasing average optical power (the maxima in DZ3-DZ5), and having at least one minimum in optical power as a function of radial position the minimum corresponding to a negative deviation relative to the increasing average optical power (the minima in CZ3-CZ5).”
(claim 10) “wherein the average optical power in the peripheral zone increases linearly (the average optical power, averaged over a period of one CZ zone and one DZ zone increases linearly throughout the contact lens by 0.5D over each period).”
However, Saw fails to teach (claim 1) “a minimum corresponding to a negative deviation in power relative to the substantially constant first power.”
Although, each individual limitation is taught by the prior art, this, by itself, does not constitute a prima facie case of obviousness.
In the instant case, it would not have been obvious to modify Lee of Lin to make the average optical power increase linearly in the peripheral zone as taught by Saw for at least the following reasons. (1) Saw does not provide any explicit motivation for doing so. (2) Such a modification would be a substantial change from the functional form in Lin which shows a dramatic increase in the rate of increase in the average optical power in the peripheral region. (3) Such a modification would also be a substantial change from the functional form in Lee where the average shows obvious deviations from a linear increase.
Further, it would not have been obvious to modify Saw in view of Lee or Lin to make the first local minimum in the second region to be a negative deviation from the first optical power for at least the following reasons. (1) Neither Lee nor Lin explain any benefit stemming from the relative diopter of this first minimum. (2) Saw consistently teaches a linearly increasing average dioptric power throughout the contact lens, which would reasonably be considered to teach away from such a modification, absent a strong motivation to do so.
Response to Arguments
Applicant's arguments filed July 28, 2026 have been fully considered but they are not persuasive.
Under the heading “Status of Claims” on page 7 of 9, the applicant summarizes the previous rejections and the claims which have been amended or are new.
Under the heading “Summary of Examiner Interview” on page 7 of 9, the applicant notes that no agreement was reached regarding whether or not Lin has positive and negative deviations relative to the average power in the peripheral zone. This is accurate. The applicant secondly notes that the Examiner suggested that a difference between the present invention and Lin is a peripheral region in which average optical power was increasing throughout the peripheral zone. This is also accurate. However, this suggestion was based on the assumption that the characterizations by the applicant in the page 8 of 10 of the remarks filed March 30, 2026 regarding the average optical power of Lin integrated over a period, from which they deduced that the power was not increasing until outside of about 3.3 mm were accurate. However, to verify the applicant’s assertions, the examiner conducted a more detailed mathematical analysis, calculating the average optical power by the area under the curve divided by the length of the period in an analogous manner to a DC-component of an electrical signal. As explained in the new grounds of rejection above, to perform these area calculations the examiner had to make two approximations (1) that the crossing point of the -6D diopter line could be found by assuming the functional form between two points, one above and one below -6D is linear and (2) that the areas could be reasonably approximated by triangles (area=1/2*base*height). Under these minor but necessary approximations, the average power at any peak or valley can be obtained by summing the area of the current deviation triangle with the area of the interiorly adjacent deviation triangle and dividing by the period length in mm. As noted and tabulated in the rejection above, these calculated averages increase as a function of radius starting at least at a 2.6 mm radius, contrary to the undisclosed calculations by the applicant in the remarks filed March 30, 2026.
Under the heading “Claim Objections” on page 7 of 9 of the applicant’s remarks the applicant notes that the objection to claim 1 has been overcome by the amendments to the claims. The examiner agrees, however a new claim objection of claim 7 has been raised by the amendments.
Under the heading “Rejection of Claims 1-7, 10-11, and 13-16 under 35 U.S.C. Q 102(a)(1) over Lin” on page 8 of 9 of the applicant’s remarks the applicant argues that the rejection over Lin has been overcome by the amendment to claim 1 to further recite “the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially first optical power as a function of radius throughout the peripheral region, the peripheral zone having maxima in optical power as a function of radial position .... and minima in optical power as a function of radial position". As explained above, upon further more detailed analysis, this feature was found to be taught by Lin.
In the rest of page 8 of 9 of the applicant’s remarks the applicant argues that claims 2-20 are patentable for at least the same reasons as claim 1. The argument with respect to claim 1 has been addressed above.
Under the heading “Regarding New Claim 21” on page 9 of 9 of the applicant’s remarks the applicant points out that new claim 21 recites “the peripheral zone having in the radial direction an average optical power that is greater than and increases relative to the substantially first optical power as a function of radius throughout the peripheral region, the peripheral zone having at least one maximum in optical power as a function of radial position ... and having at least one minimum in optical power as a function of radial position.” and that accordingly claim 21 is patentable over Lin. This argument is not persuasive for at least the following reasons. First, the calculations presented for claim 1 equally apply to claim 21. Furthermore, even assuming that the applicant’s characterization from page 8 of 10 of the remarks filed March 30, 2026 regarding the average optical power were correct, there is still one maximum at 3.6 mm and one minimum at 4 mm in the peripheral zone so defined.
The request for an interview with the examiner on page 9 of 9 of the applicant’s remarks is denied. The nature and number of the outstanding issues of patentability are such that it does not appear that an interview would result in expediting allowance of the application at this time. See MPEP §713.01 (IV) “An interview should be had only when the nature of the case is such that the interview could serve to develop and clarify specific issues and lead to a mutual understanding between the examiner and the applicant, and thereby advance the prosecution of the application. … Where a complete reply to a first action includes a request for an interview, the examiner, after consideration of the reply, should grant such an interview request if it appears that the interview would result in expediting the allowance of the application.”
In the interest of compact prosecution, the examiner notes the above identified allowable subject matter. Furthermore, the subject matter of claims 7 and 16 could easily be narrowed to positively recite “wherein the positive deviations and negative deviations in power and the peripheral zone constitute[[d]] a periodic function as a function of radius having a fixed period” in keeping with the explanation in paragraph [0049] of the specification. Many readers might already have read paragraph [0049] as a definition, but the examiner did not do so in light of the discussion of “a constant period” in the interview, see the examiner’s interview summary mailed 7/17/2026, which the applicant rejected as too limiting. Other possibly distinguishing features include having at least three maxima in the peripheral zone or having a sinusoidal functional form. Although these features are taught by both Saw and Hovinga, neither Saw nor Hovinga can be reasonably modified to meet the current limitations of claim 1 as explained above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARA E RAKOWSKI whose telephone number is (571)272-4206. The examiner can normally be reached 9AM-4PM ET M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky L Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARA E RAKOWSKI/Primary Examiner, Art Unit 2872
Prosecution Insights