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 .
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerligand et al. (PGPUB 20130077045, of record) in view of Jubin et al. (PGPUB 20160363782, of record).
Regarding claim 1 (please see the examiner’s note at the bottom of this action), Gerligand discloses a toric contact lens ([0027]), comprising:
a first surface and a second surface opposite of the first surface ([0026] front and back);
the lens having a horizontal thickness differential between the first surface and the second surface along a horizontal center axis (Fig. 5A is a thickness plot that indicates a difference of thicknesses along at least the horizontal and vertical axes), and a vertical thickness differential between the first surface and the second surface along a vertical center axis orthogonal to the horizontal center axis (Fig. 5A is a thickness plot that indicates a difference of thicknesses along at least the horizontal and vertical axes);
an optic zone disposed around an optical axis intersecting the horizontal center axis and the vertical center axis ([0039] and Fig. 5A center); and
a lens periphery surrounding the optic zone and extending between the optic zone and a lens edge (Fig. 5A), the lens periphery comprising:
a first stabilization zone on a first side of the lens periphery between the optic zone and the lens edge (Fig. 5A), the first stabilization zone having:
a first thickness profile comprising a plurality of first contour lines each at a varying thickness between the first surface and the second surface (Fig. 5A); and
a second stabilization zone on a second side of the lens periphery opposite the first side (Fig. 5A), the second stabilization zone between the optic zone and the lens edge, the second stabilization zone having:
a second thickness profile comprising a plurality of second contour lines each at a varying thickness between the first surface and the second surface (Fig. 5A).
Gerligand does not explicitly disclose wherein a first contour line of the plurality of first contour lines oriented to a target upper eyelid margin shape of a target upper eyelid of an average patient wearer configured to be substantially contained within a resting boundary of the target upper eyelid margin, having first thickness between approximately 73% - 80% of a meridian thickness differential of the difference between the horizontal thickness differential and the vertical thickness differential; and
a second contour line of the plurality of second contour lines oriented to the target upper eyelid margin shape configured to be substantially contained within the resting boundary of the target upper eyelid margin, having second thickness between approximately 73% - 80% of the meridian thickness differential.
However, Jubin teaches a toric contact lens having stabilization features wherein the thickness differential is in a range of 50-80% ([0039] and Fig. 5).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine Gerligand and Jubin such that a first and second contour line has a between approximately 73% - 80% of a meridian thickness differential of the difference between the horizontal thickness differential and the vertical thickness differential motivated by reducing lens awareness ([0042]).
Regarding claim 2, modified Gerligand discloses wherein the target upper eyelid margin shape is asymmetric about the vertical center axis ([0086] of Gerligand).
Regarding claim 3, modified Gerligand discloses wherein:
the first stabilization zone does not intersect the horizontal center axis; and the second stabilization zone does not intersect the horizontal center axis (as shown in Fig. 5A).
Regarding claim 4, modified Gerligand discloses wherein:
the first stabilization zone and the second stabilization zone are symmetrical to each other about the horizontal center axis (See Fig. 5A).
Regarding claim 5, modified Gerligand discloses wherein:
the first stabilization zone comprises a first active zone intersecting the plurality of first contour lines, the first active zone configured to intersect with an upper eyelid margin of a patient wearer (Fig. 5A where the active zones are understood to be functional zones); and
the second stabilization zone comprises a second active zone intersecting the plurality of second contour lines, the second active zone configured to intersect with the upper eyelid margin of the patient wearer (Fig. 5A where the active zones are understood to be functional zones).
Regarding claim 6, modified Gerligand discloses wherein:
the first active zone having a first thickness gradient across the plurality of first contour lines (Fig. 5A where the active zones are understood to be functional zones and the figure shows a plurality of contour lines throughout the functional zones of the lens); and
the second active zone having a second thickness gradient across the plurality of second contour lines (Fig. 5A where the active zones are understood to be functional zones and the figure shows a plurality of contour lines throughout the functional zones of the lens).
Regarding claim 7, modified Gerligand discloses the first thickness gradient of the first active zone is in a direction substantially orthogonal to the target upper eyelid margin shape (Fig. 5A where the contour lines define a thickness parallel to the optical axis and the plane on which the eyelid rests is orthogonal to the optical axis); and
a second thickness gradient of the first stabilization zone is in a direction substantially orthogonal to the target upper eyelid margin shape (Fig. 5A where the contour lines define a thickness parallel to the optical axis and the plane on which the eyelid rests is orthogonal to the optical axis).
Regarding claim 8, modified Gerligand discloses wherein:
the first contour line in the first active zone is substantially parallel to the target upper eyelid margin shape; and the second contour line in the second active zone is substantially parallel to the target upper eyelid margin shape (See Fig. 5A where 0.15 and 0.2 contour lines include tangent lines parallel to the eyelid).
Regarding claim 9, modified Gerligand discloses wherein:
each of the plurality of first contour lines in the first active zone is substantially parallel to the target upper eyelid margin shape; and each of the plurality of second contour lines in the second active zone is substantially parallel to the target upper eyelid margin shape (See Fig. 5A where 0.15 and 0.2 contour lines include tangent lines parallel to the eyelid).
Regarding claim 10, modified Gerligand discloses wherein:
each of the plurality of first contour lines in the first active zone is substantially not concentric with the lens edge; and each of the plurality of second contour lines in the second active zone is substantially not concentric with the lens edge (See Fig. 5A where the contour lines are not parallel with the lens edge).
Regarding claim 11, modified Gerligand discloses wherein:
each of the plurality of first contour lines outside the first active zone is substantially not concentric with the lens edge; and each of the plurality of second contour lines outside the second active zone is substantially not concentric with the lens edge (See Fig. 5A where the contour lines are not parallel with the lens edge).
Regarding claim 12, modified Gerligand discloses wherein:
the first active zone and the second active zone are symmetrical to each other about the vertical center axis (See Fig. 5A).
Regarding claim 13, modified Gerligand discloses wherein:
the first stabilization zone further comprises a third active zone having the first thickness gradient across the plurality of first contour lines (See Fig. 5A where each of the zones defined by the heights 0.2, 0.25, 0.3 and 0.35 may be considered individual active zones and are symmetric);
the second stabilization zone further comprises a fourth active zone having the second thickness gradient across the plurality of second contour lines (See Fig. 5A where each of the zones defined by the heights 0.2, 0.25, 0.3 and 0.35 may be considered individual active zones and are symmetric);
the first active zone and the third active zone are symmetrical to each other about the horizontal center axis (See Fig. 5A where each of the zones defined by the heights 0.2, 0.25, 0.3 and 0.35 may be considered individual active zones and are symmetric); and
the second active zone and the fourth active zone are symmetrical to each other about the horizontal center axis (See Fig. 5A where each of the zones defined by the heights 0.2, 0.25, 0.3 and 0.35 may be considered individual active zones and are symmetric).
Regarding claim 14, modified Gerligand discloses wherein:
a third contour line of the plurality of first contour lines oriented to a target lower eyelid margin shape of a target lower eyelid of an average patient wearer configured to be substantially contained within a resting boundary of the target lower eyelid margin, having first thickness between approximately 73% - 80% of a meridian thickness differential of the difference between the horizontal thickness differential and the vertical thickness differential; and a fourth contour line of the plurality of second contour lines oriented to the target lower eyelid margin shape configured to be substantially contained within the resting boundary of the target lower eyelid margin, having second thickness between approximately 73% - 80% of the meridian thickness differential ([0039] and Fig. 5 of Jubin).
Regarding claim 15, modified Gerligand discloses wherein:
the first thickness is approximately 77% of the meridian thickness differential; and the second thickness is approximately 77% of the meridian thickness differential ([0039] and Fig. 5 of Jubin).
Regarding claim 16, modified Gerligand does not disclose wherein:
the first contour line defines 0.23 millimeter (mm) thickness between the first surface and the second surface of the lens; and the second contour line defines 0.23 mm thickness between the first surface and the second surface of the lens.
However, due to the nature of optics/optical engineering the process of lens design includes manipulation of known result effective variables such as index or refraction, focal length, lens surface radii and other optical variables in order to make a lens meet its particular utility. This manipulation would normally be considered routine experimentation since the results are known optics/physics equations (unless the particular range of values meets secondary considerations). Further the court has determined that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to adjust the first contour height to be 0.03 mm higher, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955). In this case, one of ordinary skill in the art would have adjusted the first contour height to be 0.23 motivated be improving lens stabilization performance.
Regarding claim 17, modified Gerligand discloses wherein:
the first thickness profile varies from 0.2 millimeters (mm) thickness to 0.365 mm thickness between the first surface and the second surface of the lens; and the second thickness profile varies from 0.2 mm thickness to 0.365 mm thickness between the first surface and the second surface of the lens (Fig. 5A where the range varies from 0.2-0.35).
Regarding claim 18, modified Gerligand discloses wherein:
wherein:the first thickness profile has a first maximum thickness between the first surface and the second surface of the lens of 0.365 millimeters (mm); and the second thickness profile has a second maximum thickness between the first surface and the second surface of the lens of 0.365 mm (Fig. 5A where the range varies from 0.2-0.35).
Regarding claim 19, modified Gerligand discloses, further comprising a thin zone is contained in an inferior region and a superior region of the lens outside the first stabilization zone and outside the second stabilization zone (Fig. 5A).
Regarding claim 20, modified Gerligand discloses wherein:
the first thickness profile varies from 0.2 millimeters (mm) thickness to 0.365 mm thickness between the first surface and the second surface of the lens; the second thickness profile varies from 0.2 mm thickness to 0.365 mm thickness between the first surface and the second surface of the lens; and the thin zone varies has a third maximum thickness of 0.2 millimeters (mm) (Fig. 5A where the range varies from 0.2-0.35).
Regarding claim 21. Modified Gerligand discloses wherein the target upper eyelid margin shape is derived from data from one or more images of one or more eyelid profiles of patients ([0036]).
Regarding claim 22, modified Gerligand discloses method of fabricating a toric contact lens according to the toric contact lens of claim 1, comprising:
forming a lens from a volume of lens material, the lens comprising:
a first surface and a second surface opposite of the first surface ([0026] front and back);
the lens having a horizontal thickness differential between the first surface and the second surface along a horizontal center axis (Fig. 5A is a thickness plot that indicates a difference of thicknesses along at least the horizontal and vertical axes), and a vertical thickness differential between the first surface and the second surface along a vertical center axis orthogonal to the horizontal center axis (Fig. 5A is a thickness plot that indicates a difference of thicknesses along at least the horizontal and vertical axes);
an optic zone disposed around an optical axis intersecting the horizontal center axis and the vertical center axis ([0039] and Fig. 5A center); and
a lens periphery surrounding the optic zone and extending between the optic zone and a lens edge (Fig. 5A), the lens periphery comprising:
a first stabilization zone on a first side of the lens periphery between the optic zone and the lens edge (Fig. 5A), the first stabilization zone having:
a first thickness profile comprising a plurality of first contour lines each at a varying thickness between the first surface and the second surface (Fig. 5A); and
a second stabilization zone on a second side of the lens periphery opposite the first side (Fig. 5A), the second stabilization zone between the optic zone and the lens edge, the second stabilization zone having:
a second thickness profile comprising a plurality of second contour lines each at a varying thickness between the first surface and the second surface (Fig. 5A);
wherein
a first contour line of the plurality of first contour lines oriented to a target upper eyelid margin shape of a target upper eyelid of an average patient wearer configured to be substantially contained within a resting boundary of the target upper eyelid margin, having first thickness between approximately 73% - 80% of a meridian thickness differential of the difference between the horizontal thickness differential and the vertical thickness differential ([0039] and Fig. 5 of Jubin); and
a second contour line of the plurality of second contour lines oriented to the target upper eyelid margin shape configured to be substantially contained within the resting boundary of the target upper eyelid margin, having second thickness between approximately 73% - 80% of the meridian thickness differential ([0039] and Fig. 5 of Jubin).
Examiner’s Note
With respect to claim 1, the examiner is requesting clarification regarding the measurement of the 73%-80% thickness differential. This appears to be understood in the art, but the calculation of this value is not provided as far as the examiner can determine. The language states that the thickness is approximately 73-80% of a meridian thickness differential of the difference between the horizontal thickness differential and the vertical thickness differential. Looking at applicant’s Fig. 4A, it appears V1 changes from 0.3, at C1, to 0.16 and then H1 changes from .03, at C1, to 0.33. That is ΔV1 = 0.13 and ΔH1 = 0.30 and the difference (ΔH1 - ΔV1) is 0.17. Applicant’s specification states that 410(1) and 412(1) both satisfy this limitation, but looking at the drawing, the values of these two contour lines is 0.23, which is obviously greater than 73-80% of 0.17. For 0.23 to be within the 73-80% range, the difference of the vertical and horizontal thickness differentials would need to be in the range of 0.276 to 0.2921. The examiner is unsure how one would arrive at a value within that range given Fig. 4A.
Jubin does not give a contour map to compare with applicants, but specifically discusses the same differential values. Since this appears to be known in the art, the examiner believes there is unlikely to be a clarity issue within the claims, but rather with their understanding of the method that these values are measured.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVIS S FISSEL whose telephone number is (313)446-6573. The examiner can normally be reached 9AM-5PM.
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/TRAVIS S FISSEL/Primary Examiner, Art Unit 2872