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 Objections
Claim 8 is objected to because of the following informalities: redundant claim. Both claims 4 and 8 recite identical claim language and both depend from claim 1. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: redundant claim. Both claims 12 and 16 recite identical claim language and both depend from claim 11. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: redundant claim. Both claims 13 and 17 recite identical claim language and both depend from claim 11. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: redundant claim. Both claims 14 and 18 recite identical claim language and both depend from claim 11. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 9, 11, 12, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Koch et al. (WO 2017/149512 A1), hereinafter “Koch”, in view of Caballero et al. (WO 2018/055220 A1), hereinafter “Caballero”.
Regarding claim 1, Koch discloses a scleral contact lens for an eye of a patient (see Figs. 1, 2, Paragraph 42), the scleral contact lens comprising: an anterior surface (Paragraph 42); and a posterior surface (Paragraph 42), the posterior surface comprising: a central optic zone (210) defined by a base curve according to an apical radius of the cornea of the eye (see Fig. 2, Paragraphs 47, 48); a peripheral corneal zone (220) peripheral to the central optic zone (see Fig. 2, Paragraphs 47, 48), a clearance control zone (230) peripheral to the peripheral corneal zone (see Fig. 2, Paragraphs 47, 48), and a universal scleral landing zone (240) peripheral to the clearance control zone (Paragraph 49), the universal scleral landing zone having a single radius, landing zone angle and surface shape and a convex to the eye that is not controlled by modulating an angle (see Fig. 2, Paragraphs 42, 47-49, 63 – “edge contour zone” or “landing zone”); wherein the scleral contact lens is configured not to contact the cornea of the eye (Paragraphs 65, 103); wherein the universal scleral landing zone is configured to contact the eye (Paragraphs 65, 103); and wherein the central optic zone, the peripheral corneal zone, and the clearance control zone are configured not to contact the eye (Paragraphs 65, 103). Koch discloses the claimed invention except for radius less than 10 mm. In the same field of endeavor, Caballero discloses radius less than 10 mm (Paragraphs 36, 45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the lens of Koch with radius less than 10 mm of Caballero for the purpose of providing an optimized lens that meets the anatomical optical properties of the eye of the patient (Abstract). Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). 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 (CCPA 1955). Lastly, the method of forming the structure is not germane to the issue of patentability of the structure itself. Therefore, this limitation has not been given patentable weight.
Regarding claim 9, Koch further discloses wherein: the base curve of the optic zone is defined by at least one of a spherical radius, an aspherical radius with a conic constant, a torus, a multifocal shape, or a rotationally asymmetric shape (Paragraphs 42, 43).
Regarding claim 11, Koch discloses a method for defining a shape of a posterior surface of a scleral contact lens for an eye of a patient (see Figs. 1, 2, Paragraph 42), the method comprising: defining a base curve for a central optic zone (210) of the scleral contact lens according to an apical radius of the cornea of the eye (see Fig. 2, Paragraphs 47, 48); defining a peripheral corneal zone (220) peripheral to the central optic zone (see Fig. 2, Paragraphs 47, 48); defining a clearance control zone (230) peripheral to the peripheral corneal zone (see Fig. 2, Paragraphs 47, 48); and defining a universal scleral landing zone (240) peripheral to the clearance control zone according to a single radius, landing zone angle and surface shape and a convex to the eye that is not controlled by modulating an angle (see Fig. 2, Paragraphs 42, 47-49, 63 – “edge contour zone” or “landing zone”); wherein the scleral contact lens is configured not to contact the cornea of the eye (Paragraphs 65, 103); wherein the universal scleral landing zone is configured to contact the eye (Paragraphs 65, 103); and wherein the central optic zone, the peripheral corneal zone, and the clearance control zone are configured not to contact the eye (Paragraphs 65, 103). Koch discloses the claimed invention except for radius less than 10 mm. In the same field of endeavor, Caballero discloses radius less than 10 mm (Paragraphs 36, 45). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Koch with radius less than 10 mm of Caballero for the purpose of providing an optimized lens that meets the anatomical optical properties of the eye of the patient (Abstract). Furthermore, such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). 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 (CCPA 1955).
Regarding claims 2, 12 and 16, Koch further discloses wherein: the single surface shape of the scleral landing zone has a spherical geometry (Paragraphs 42, 49).
Regarding claim 19, Koch further discloses further comprising: defining the base curve of the optic zone according to at least one of a spherical radius, an aspherical radius with a conic constant, a torus, a multifocal shape, or a rotationally asymmetric shape (Paragraphs 42, 43).
Claims 3, 4, 8, 13, 14, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Koch (WO 2017/149512 A1) in view of Caballero (WO 2018/055220 A1) as applied to claims 1 and 11 above, and further in view of Legerton et al. (USPG Pub No. 2011/0153012), hereinafter “Legerton”.
Regarding claim 3, Koch and Caballero disclose the claimed invention, but do not specify wherein: the single surface shape of the scleral landing zone is defined by at least one knot of a spline. In the same field of endeavor, Legerton discloses wherein: the single surface shape of the scleral landing zone is defined by at least one knot of a spline (Paragraphs 34, 54). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the lens of Koch and Caballero with wherein: the single surface shape of the scleral landing zone is defined by at least one knot of a spline of Legerton for the purpose of obtaining the desired geometric configuration of the lens (Paragraph 34).
Regarding claims 4 and 8, Koch and Caballero disclose the claimed invention, but do not specify wherein: the single surface shape of the scleral landing zone is defined by part of a cubic spline, basis spline, or Bezier function. In the same field of endeavor, Legerton discloses wherein: the single surface shape of the scleral landing zone is defined by part of a cubic spline, basis spline, or Bezier function (Paragraphs 34, 54 – “spline mathematics” is inclusive). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the lens of Koch and Caballero with wherein: the single surface shape of the scleral landing zone is defined by part of a cubic spline, basis spline, or Bezier function of Legerton for the purpose of obtaining the desired geometric configuration of the lens (Paragraph 34).
Regarding claims 13 and 17, Koch and Caballero disclose the claimed invention, but do not specify further comprising: defining the single surface shape of the scleral landing zone according to at least one knot of a spline. In the same field of endeavor, Legerton discloses further comprising: defining the single surface shape of the scleral landing zone according to at least one knot of a spline (Paragraphs 34, 54). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Koch and Caballero with further comprising: defining the single surface shape of the scleral landing zone according to at least one knot of a spline of Legerton for the purpose of obtaining the desired geometric configuration of the lens (Paragraph 34).
Regarding claims 14 and 18, Koch and Caballero disclose the claimed invention, but do not specify further comprising: defining the single surface shape of the scleral landing zone according to part of a cubic spline, basis spline, or Bezier function. In the same field of endeavor, Legerton discloses further comprising: defining the single surface shape of the scleral landing zone according to part of a cubic spline, basis spline, or Bezier function (Paragraphs 34, 54 – “spline mathematics” is inclusive). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Koch and Caballero with further comprising: defining the single surface shape of the scleral landing zone according to part of a cubic spline, basis spline, or Bezier function of Legerton for the purpose of obtaining the desired geometric configuration of the lens (Paragraph 34).
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Koch (WO 2017/149512 A1) in view of Caballero (WO 2018/055220 A1) as applied to claims 1 and 11 above, and further in view of Ducharme (USP No. 5,452,031)
Regarding claim 10, Koch and Caballero disclose the claimed invention, but do not specify wherein: the peripheral corneal zone, the clearance control zone, and the scleral landing zone are defined by a spline having a plurality of knots and/or control points. In the same field of endeavor, Ducharme discloses wherein: the peripheral corneal zone, the clearance control zone, and the scleral landing zone are defined by a spline having a plurality of knots and/or control points (see Fig. 1, Col. 5, Lines 27-35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the lens of Koch and Caballero with wherein: the peripheral corneal zone, the clearance control zone, and the scleral landing zone are defined by a spline having a plurality of knots and/or control points of Ducharme for the purpose of providing a lens with a proper fit (Col. 2, Lines 45-51).
Regarding claim 20, Koch and Caballero disclose the claimed invention, but do not specify further comprising: defining the peripheral corneal zone, the clearance control zone, and the scleral landing zone according to a spline having a plurality of knots and/or control points. In the same field of endeavor, Ducharme discloses further comprising: defining the peripheral corneal zone, the clearance control zone, and the scleral landing zone according to a spline having a plurality of knots and/or control points (see Fig. 1, Col. 5, Lines 27-35). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method of Koch and Caballero with further comprising: defining the peripheral corneal zone, the clearance control zone, and the scleral landing zone according to a spline having a plurality of knots and/or control points of Ducharme for the purpose of providing a lens with a proper fit (Col. 2, Lines 45-51).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. Applicant argued that Koch in view of Caballero does not disclose the claimed invention as presented.
Figs. 1, 2, and the corresponding disclosure, of Koch teach a scleral contact lens (100) for an eye comprising a central optic zone (210), a peripheral corneal zone (220), a clearance control zone (230), and a scleral landing zone (240). Paragraph 49 teaches that the scleral landing zone (240) is capable of having a rotationally symmetric design, interpreted as having a ”universal” design. This design does not require modulating the shape since the shape is consistent. Paragraph 49 also teaches selecting a proper landing zone angle and the scleral landing zone design being at a 12.8 mm chord. Since a diameter can be interpreted as the longest chord, the radius of a 12.8 mm chord is 6.4 mm. In addition, an optimized final product that is symmetric and/or has parameters that are constant, is considered to have a “universal” design. Caballero provides further support with respect to the design of a scleral landing zone (see Paragraphs 36, 45). Such modifications is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1966) and In re Rose, 105 USPQ 237 (CCPA 1955). 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 (CCPA 1955). Thus, Koch, alone or in combination with Caballero, teach all of the limitations of the claims presented. Furthermore, the limitations do not produce a new and unexpected result.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MAHIDERE S SAHLE/Primary Examiner, Art Unit 2872 3/14/2026