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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first annular structure, space defined between a half-ring, center points, reference point, a width of the first annular structure located on the nasal side is larger than a width of the first annular structure located on the bitemporal side, semi-circular curve and a semi-elliptic curve, first curve zone and a second curve zone that are continuously bent outward from the periphery of the base curve zone, sagittal depths, values of sagittal depths from points on an outer edge of the first curve zone to the base curve zone are the same, a difference between X2 and X1 is 0.1 mm to 0.4 mm, the distance from the outer edge of the first curve zone in the bitemporal side to the base curve zone is set to X3, and a ratio of X3 to X1 is 1/3, inner surface, and circular ring must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. The as-filed specification does not provide adequate written description support for the recited asymmetric orthokeratology lens parameters, including the claimed distances, ratios, sagittal depth values, and related numerical limitations (e.g., space defined between a half-ring of the first annular structure on a nasal side and a cornea is larger than space defined between a half-ring of the first annular structure on a bitemporal side and the cornea, a width of the first annular structure located on the nasal side is larger than a width of the first annular structure located on the bitemporal side, values of sagittal depths from points on an outer edge of the first curve zone to the base curve zone are the same, a difference between X2 and X1 is 0.1 mm to 0.4 mm, the distance from the outer edge of the first curve zone in the bitemporal side to the base curve zone is set to X3, and a ratio of X3 to X1 is 1/3, etc.). The as-filed specification does not disclose these specific values, corresponding ranges, examples, graphs, tables, or other supportive description, for it raises concerns as to if the as-filed specification provides sufficient disclosure to reasonably convey to one of ordinary skill in the art that applicant had possession of the claimed subject matter at the time of filing. Appropriate correction is required. No new matter should be entered.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
Claims 1-12 utilize paragraphs as indentations to separate the claim limitations. Examiner reminds the applicant that “[w]here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i).” See MPEP § 608.01(m).
With respect to Claims 4-5, and 11, the sentences recite “to enable” and it is unclear how the phrase “to enable” followed by functional language (e.g., “to enable the first annular structure to form a circular ring” in Claim 11) should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the claim limitations. “To enable” implies a hypothetical or conditional scenario without clarifying whether the enabling condition and/or claimed limitation is a necessary or optional aspect of the asymmetric orthokeratology lens. This creates uncertainty about whether the claimed elements and limitations are required or merely illustrative. Thus, this phrase does not establish the relationship between the enabling condition and the claimed invention. See 35 USC § 112(f) rejection for further details. Applicant should clarify the claim limitations as appropriate. Care should be taken during revision of the description and of any statements of problem or advantage, not to add subject-matter which extends beyond the content of the application (specification) as originally filed.
With respect to Claim 5, the recitation “the asymmetric orthokeratology lens according to claim 1, outer edges of the reverse curve zone…” does not provide sufficient antecedent basis and makes the grammatical scope of the claim unclear.
Appropriate correction is required.
Claim Interpretation – - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) are: “that are successively formed outward from a periphery of the base curve zone, wherein an outer edge of the base curve zone is combined with an outer edge of the reverse curve zone, to form a first annular structure” in Claim 1, “to enable a width of the first annular structure located on the nasal side to be greater than a width of the first annular structure located on the bitemporal side” in Claims 4 and 5, and “to enable the first annular structure to form a circular ring, and a curvature of an inner surface, located on the nasal side, of the circle is greater than a curvature of an inner surface, located on the bitemporal side, of the circle” in Claim 11.
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With respect to Claims 1-12, the limitations lack objective boundaries for measured values throughout the claims, such as distance, width, space, curvature, and sagittal depth. This is not an exhaustive list, for the claims are replete with terms and phrases that render the metes and bounds of the claims unclear.
With respect to Claim 1, “wherein an outer edge of the base curve zone is combined with an outer edge of the reverse curve zone, to form a first annular structure” is indefinite, for it is unclear whether “combined” means tangent, adjoining, intersecting, overlapping, sharing a boundary, or even integrally formed. Furthermore, the recitation “space defined between a half-ring of the first annular structure…” is indefinite because the term “space” makes it unclear whether it refers to radial distance, volumetric clearance, average gap, maximum gap, sagittal depth, or another measurement. “Half-ring” is also unclear because the claim nor as-filed specification defines where the annular structure is divided into halves or how much of the structure constitutes a half-ring.
With respect to Claim 2, “a central point of the outer edge of the reverse curve zone is offset facing the nasal side, with a center point of the base curve zone as a reference point, and a width of the first annular structure” is indefinite, for “a central point” of a circle or ellipse is unclear because an outer edge has infinitely many points. A person having ordinary skill in the art cannot reasonably ascertain whether this refers to the geometric center, centroid, apex, midpoint of a major axis, or another location within the curve zones. Furthermore, “offset facing the nasal side” is indefinite since the amount, direction, and measurement basis of the offset are not defined. “Width of the first annular structure” is also indefinite since it is unclear whether the width is measured radially, circumferentially, as an average width, a maximum width, or at a specified location since the location of the first annular structure is not adequately defined in the claims and as-filed specification.
With respect to Claims 4-7, “semi-circular curve and a semi-elliptic curve” (Claim 4) include relative terminology, for it is unclear what portion(s) of the curves are “semi,” where the “semi” portions begin and end and how they are joined together to surround the curve zone(s). “to enable a width of the first annular structure located on the nasal side to be greater than a width of the first annular structure located on the bitemporal side” (Claim 5) is merely functional language stating a desired result rather than positively reciting the structural features that achieve the result. Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234 (1942) See MPEP § 2173.05(g). Examiner reminds the applicant that “apparatus 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). “Continuously bent outward from the periphery of the base curve zone” (Claim 6) does not specify the manner, angle, radius, or degree of the outward bending and “wherein values of sagittal depths from points on an outer edge of the first curve zone to the base curve zone are the same” (Claim 7) makes it unclear which points on the outer edge are used to determine the sagittal depths.
For the prosecution on merits, examiner interprets the claimed subject matter described above as introducing optional elements, optional structural limitations, optional expressions, and optional functionality within an asymmetric orthokeratology lens.
Applicant should clarify the claim limitations as appropriate. Care should be taken during revision of the description and of any statements of problem or advantage, not to add subject-matter which extends beyond the content of the application (specification) as originally filed. If the language of a claim, considered as a whole in light of the specification and given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection of the claims under 35 U.S.C. 112, second paragraph, is appropriate. See MPEP 2173.05(a), MPEP 2143.03(I), and MPEP 2173.06.
Proper correction is required to ensure accuracy and consistency in the claims, for the language is so awkward that it renders the claims nearly incomprehensible. The primary purpose of the requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. See MPEP § 2173.
Claim Rejections - 35 USC § 102
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 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, and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. US 20210181529 A1 (herein after "Wang").
With respect to Claim 1, Wang discloses an asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]), comprising a base curve zone (base arc zone; [0005], [0067-70]), and a reverse curve zone (reversal arc zone; [0005], [0067-70]), an adaptation curve zone (adaptive arc zone; [0005], [0067-70]), and a peripheral curve zone (peripheral arc zone; [0005], [0067-70]) that are successively formed outward from a periphery (fig. 1) of the base curve zone (base arc zone; [0005], [0067-70]), wherein an outer edge (fig. 1) of the base curve zone (base arc zone; [0005], [0067-70]) is combined with an outer edge (fig. 1) of the reverse curve zone (reversal arc zone; [0005], [0067-70]), to form a first annular structure (annular reversal arc zone RC located radially outward of base arc zone BC; [0098]), and space defined (first region 110; [0049], [0164]) between a half-ring (diameter of radial widths of annular regions i.e., half of difference between outer diameter and inner diameter adjusted in accordance with size of patient's pupil, requirements for near vision clarity, etc.; [0136]) of the first annular structure (annular reversal arc zone RC located radially outward of base arc zone BC; [0098]; fig. 1) on a nasal side (right side of third region 130 within flat-raised-flat regions; [0164]; fig. 6) and a cornea (cornea is pressed at center to compress cornea cells toward both sides; [0164]) is larger (radius of curvature of second region is smaller than radius of curvature of first region; [0049], [0164]) than space defined (second region 120 having small radial width; [0049], [0164]) between a half-ring ([0136]) of the first annular structure (annular reversal arc zone RC located radially outward of base arc zone BC; [0098]) on a bitemporal side (left side of third region 130 within flat-raised-flat regions; [0164]; fig. 6) and the cornea (cornea is pressed at center to compress cornea cells toward both sides; [0164]).
With respect to Claim 6, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 1, wherein an inner surface (inner surface IS comprising a centrally located base arc zone; [0009], [0067]) of the base curve zone (base arc zone; [0005], [0067-70]) is flat (three regions of base arc zone are flat-raised-flat; [0164]), the reverse curve zone (reversal arc zone; [0005], [0067-70]) comprises a first curve zone (reversal arc zone having outer diameter; [0133]) and a second curve zone (reversal arc zone having inner diameter; [0133]) that are continuously bent outward from the periphery (fig. 1) of the base curve zone (base arc zone; [0005], [0067-70]), and a curvature of an inner surface (IS; fig.1) of the first curve zone (reversal arc zone having outer diameter; [0133]) is less than or equal to a curvature (reversal arc zone having an inner diameter of 6.5 mm and an outer diameter of 8.3 mm, curvature of larger diameter in reversal arc zone being less than curvature of smaller diameter in reversal arc zone; [0133]) of an inner surface (IS; fig.1) of the second curve zone (reversal arc zone having inner diameter; [0133]).
With respect to Claim 7, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 6, wherein values of sagittal depths (sagittal height at radius r: h′=h+Δh; [0107], if Δh = 0, then same sagittal depths as seen in fig. 1) from points on an outer edge (fig. 1) of the first curve zone (reversal arc zone having outer diameter; [0133]) to the base curve zone (base arc zone; [0005], [0067-70]) are the same (as seen in fig. 1).
With respect to Claim 8, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 6, wherein a distance from an outer edge (fig. 1) of the first curve zone (reversal arc zone having outer diameter; [0133]) in the bitemporal side (left side of third region 130 within flat-raised-flat regions; [0164]; fig. 6) to the base curve zone (base arc zone; [0005], [0067-70]) is equal to a distance (as seen in fig. 1) from an outer edge (fig. 1) of the first curve zone (reversal arc zone having outer diameter; [0133]) in the nasal side (right side of third region 130 within flat-raised-flat regions; [0164]; fig. 6) to the base curve zone (base arc zone; [0005], [0067-70]); a distance from an outer edge (fig. 1) of the second curve zone (reversal arc zone having inner diameter; [0133]) in the bitemporal side (left side of third region 130 within flat-raised-flat regions; [0164]; fig. 6) to the first curve zone (reversal arc zone having outer diameter; [0133]) is less than a distance from the outer edge (as seen in fig. 1) of the second curve zone (reversal arc zone having inner diameter; [0133]) in the nasal side (right side of third region 130 within flat-raised-flat regions; [0164]; fig. 6) to the first curve zone (reversal arc zone having outer diameter; [0133]).
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 2-5, and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. US 20210181529 A1 (herein after "Wang") in view of Spratt et al. US 20190258082 A1 (herein after "Spratt").
With respect to Claim 2, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 1.
Wang does not appear to explicitly teach the following limitation(s): wherein outer edges of the base curve zone, the adaptation curve zone, and the peripheral curve zone are all circles whose center points are coincident with each other, and a central point of the outer edge of the reverse curve zone is offset facing the nasal side, with a center point of the base curve zone as a reference point, and a width of the first annular structure located on the nasal side is larger than a width of the first annular structure located on the bitemporal side.
However, in the same field of endeavor, Spratt teaches a method for designing a lens shape and spectacle lens ([0041]), wherein an ophthalmic lens (60; [0181]; fig. 7) comprises outer edges (e.g., a periphery or outer edge 16 of ophthalmic lens 60; [0169]) of a base curve zone (within boundary line 18; [0173]; fig. 7), adaptation curve zone (within second boundary line 22 of the transition zone 64; [0173]; fig. 7), and peripheral curve zone (margin portion within width 23; [0170]; fig. 7) that are all circles (figs. 6-7, 9a) whose center points (e.g., carrier point 14; [0169]; figs. 6-7, 9a) are coincident with each other (figs. 6-7, 9a) and a central point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the outer edge (periphery of ophthalmic lens 60; figs. 6-7, 9a) of a reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) is offset facing the nasal side (frame line 19 on the nasal side, center of circular extension boundaries are displaced by 10 mm to nasal side of geometric center of lens; [0172-173], [0181]; figs. 6-7, 9a), with a central point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of base curve zone (within boundary line 18; [0173]; figs. 6-7) as a reference point (figs. 6-7, 9a), and a width of an annular structure (outer edge of boundary line 18 combined with outer edge of frame line 19, prescription zone within width 68; figs. 6-7, 9a) located on the nasal side (nasal side; fig. 9a) is larger than a width (thickness of lens normal to front surface at temporal edge of blank is about 8 mm without extension, with carrier extension that is reduced to under 5.0 mm; [0181]; fig. 9c) of the annular structure (figs. 6-7, 9a) located on the bitemporal side (temple side; fig. 9a).
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 modify the orthokeratology lens of Wang to include the technical feature of a central point of an outer edge of a curve zone being offset and facing a nasal side, for the purpose of retaining optimized optical design, blending surfaces smoothly within curve zones, achieving acceptability amongst most wearers, and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to rearrange a central point of an outer edge of a curve zone to be offset and facing a nasal side, since it has been held that rearranging parts of an invention involves only routine skill in the art In re Japikse, 86 USPQ 70. See MPEP § 2144. One of ordinary skill in the art would have a reasonable expectation of success when making this modification because Wang explicitly teaches that the diameter of the central region and the radial widths of the annular regions can be adjusted in accordance with size of the patient's pupil, requirements for near vision clarity, etc., and for the purpose of providing reversible correction based on activities of cornea cells ([0064], [0136]).
With respect to Claim 3, Wang in view of Spratt teaches the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 2.
Wang does not appear to explicitly teach the following limitation(s): wherein the outer edge of the reverse curve zone is a circle or an ellipse.
However, Spratt further teaches a method for designing a lens shape and spectacle lens ([0041]), the ophthalmic lens (60; [0181]; fig. 7), wherein an outer edge (the outer edge constructed via a quartic expansion or quartic polynomial of a circular extension; [0076], [0173], [0181], e.g., a periphery or outer edge 16 of ophthalmic lens 60; [0169]) of the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) is a circle or an ellipse (uncut finished spectacle lens is larger than finally edged ophthalmic lens for spectacles and uncut finished spectacle lens may be of circular or elliptical shape; [0096]).
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 modify the orthokeratology lens of Wang to include the technical feature of an outer edge of a curve zone being of circular or elliptical shape, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthokeratology lens of Wang to include the technical feature of an outer edge of a curve zone being of circular or elliptical shape, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in the art when the change in shape is not significant to the function of the combination, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), MPEP §2144. In the instant case, the change in shape does not appear to be significant to the function because Wang also explicitly teaches a curve zone having other shapes, such as elliptical, oval, etc., via an adjustment of radii of curvature within a curve zone, and for the purpose of achieving correction of the human eye ([0097], [0157]).
With respect to Claim 4, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 1.
Wang does not appear to explicitly teach the following limitation(s): wherein outer edges of the base curve zone, the adaptation curve zone, and the peripheral curve zone are all circles whose center points are coincident with each other, the outer edge of the reverse curve zone is surrounded by a semi-circular curve and a semi-elliptic curve, a center point of the semi-circular curve and a central point of the semi-elliptic curve coincide with a center point of the base curve zone, the semi-circular curve surrounds a side, facing the bitemporal side, of the base curve zone, the semi-elliptic curve surrounds a side, facing the nasal side, of the base curve zone, and a distance from a point on the semi-elliptic curve to the center point of the base curve zone is greater than or equal to a distance from a point on the semi-circular curve to the center point of the base curve zone, to enable a width of the first annular structure located on the nasal side to be greater than a width of the first annular structure located on the bitemporal side.
However, in the same field of endeavor, Spratt teaches a method for designing a lens shape and spectacle lens ([0041]), wherein an ophthalmic lens (60; [0181]; fig. 7) comprises outer edges (e.g., a periphery or outer edge 16 of ophthalmic lens 60; [0169]) of a base curve zone (within boundary line 18; [0173]; fig. 7), the adaptation curve zone (within second boundary line 22 of the transition zone 64; [0173]; fig. 7), and the peripheral curve zone (margin portion within width 23; [0170]; fig. 7) that are all circles (figs. 6-7, 9a) whose center points (e.g., carrier point 14; [0169]; figs. 6-7, 9a) are coincident with each other (figs. 6-7, 9a), the outer edge (periphery of ophthalmic lens 60; figs. 6-7, 9a) of the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) is surrounded by a semi-circular curve and a semi-elliptic curve (uncut finished spectacle lens is larger than finally edged ophthalmic lens for spectacles and uncut finished spectacle lens may be of circular or elliptical shape; [0096]; semi-circular and semi-elliptic curves surrounding frame line 19 as seen in figs. 6-7), a center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the semi-circular curve (figs. 6-7) and a central point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the semi-elliptic curve (figs. 6-7) coincide with a center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the base curve zone (within boundary line 18; [0173]; fig. 7), the semi-circular curve (figs. 6-7) surrounds a side, facing the bitemporal side (temple side; figs. 6-7, 9a), of the base curve zone (within boundary line 18; [0173]; fig. 7), the semi-elliptic curve (figs. 6-7) surrounds a side, facing the nasal side (nasal side; figs. 6-7, 9a), of the base curve zone (within boundary line 18; [0173]; fig. 7), and a distance from a point on the semi-elliptic curve (figs. 6-7) to the center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the base curve zone (within boundary line 18; [0173]; fig. 7) is greater than or equal to (distance 13 to first boundary line 18 measured from fitting cross 15 along 180 meridian of both semi-circular and semi-elliptical curves is equal; [0172]; as seen in figs. 6-7) a distance from a point on the semi-circular curve (figs. 6-7) to the center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the base curve zone (within boundary line 18; [0173]; fig. 7), to enable a width of an annular structure (outer edge of boundary line 18 combined with outer edge of frame line 19, prescription zone within width 68; figs. 6-7, 9a) located on the nasal side (nasal side; fig. 9a) to be greater than a width (thickness of lens normal to front surface at temporal edge of blank is about 8 mm without extension, with carrier extension that is reduced to under 5.0 mm; [0181]; fig. 9c) of the annular structure (figs. 6-7, 9a) located on the bitemporal side (temple side; fig. 9a).
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 modify the orthokeratology lens of Wang to include the technical feature of an outer edge of a curve zone being surrounded by circular and/or elliptical-shaped curves facing nasal and temporal sides, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthokeratology lens of Wang to include the technical feature of an outer edge of a curve zone being surrounded by circular and/or elliptical-shaped curves, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in the art when the change in shape is not significant to the function of the combination, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), MPEP §2144. In the instant case, the change in shape does not appear to be significant to the function because Wang also explicitly teaches a curve zone having other shapes, such as elliptical, oval, etc., via an adjustment of radii of curvature within a curve zone, and for the purpose of achieving correction of the human eye ([0097], [0157]).
With respect to Claim 5, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 1.
Wang does not appear to explicitly teach the following limitation(s): wherein outer edges of the reverse curve zone, the adaptation curve zone, and the peripheral curve zone are all circles whose center points are coincident with each other, an outer edge of the base curve zone is surrounded by a semi-circular curve and a semi-elliptic curve, a center point of the semi-circular curve and a central point of the semi-elliptic curve coincide with a center point of the reverse curve zone, the semi-circular curve is set facing the bitemporal side, the semi-elliptic curve is set facing the nasal side, and a distance from a point on the semi-elliptic curve to the center point of the reverse curve zone is less than or equal to a distance from a point on the semi-circular curve to the center point of the reverse curve zone, to enable a width of the first annular structure located on the nasal side to be greater than a width of the first annular structure located on the bitemporal side.
However, in the same field of endeavor, Spratt teaches a method for designing a lens shape and spectacle lens ([0041]), wherein an ophthalmic lens (60; [0181]; fig. 7) comprises outer edges (e.g., a periphery or outer edge 16 of ophthalmic lens 60; [0169]) of the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a), the adaptation curve zone (within second boundary line 22 of the transition zone 64; [0173]; fig. 7), and the peripheral curve zone (margin portion within width 23; [0170]; fig. 7) are all circles (figs. 6-7, 9a) whose center points (e.g., carrier point 14; [0169]; figs. 6-7, 9a) are coincident with each other (figs. 6-7, 9a), an outer edge (periphery of ophthalmic lens 60; figs. 6-7, 9a) of the base curve zone (within boundary line 18; [0173]; fig. 7) is surrounded by a semi-circular curve and a semi-elliptic curve (uncut finished spectacle lens is larger than finally edged ophthalmic lens for spectacles and uncut finished spectacle lens may be of circular or elliptical shape; [0096]; semi-circular and semi-elliptic curves surrounding frame line 19 as seen in figs. 6-7), a center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the semi-circular curve (figs. 6-7, 9a) and a central point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the semi-elliptic curve (figs. 6-7, 9a) coincide with a center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a), the semi-circular curve (figs. 6-7, 9a) is set facing the bitemporal side (temple side; figs. 6-7, 9a), the semi-elliptic curve (figs. 6-7, 9a) is set facing the nasal side (nasal side; fig. 9a), and a distance from a point on the semi-elliptic curve (figs. 6-7, 9a) to the center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) is less than or equal to (distance 13 to first boundary line 18 measured from fitting cross 15 along 180 meridian of both semi-circular and semi-elliptical curves is equal; [0172]; as seen in figs. 6-7) a distance from a point on the semi-circular curve (figs. 6-7, 9a) to the center point (e.g., carrier point 14; [0169]; figs. 6-7, 9a) of the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a), to enable a width (thickness of lens normal to front surface at temporal edge of blank is about 8 mm without extension, with carrier extension that is reduced to under 5.0 mm; [0181]; fig. 9c) of an annular structure (outer edge of boundary line 18 combined with outer edge of frame line 19, prescription zone within width 68; figs. 6-7, 9a) located on the nasal side (nasal side; fig. 9a) to be greater than a width (thickness of lens normal to front surface at temporal edge of blank is about 8 mm without extension, with carrier extension that is reduced to under 5.0 mm; [0181]; fig. 9c) of the annular structure (figs. 6-7, 9a) located on the bitemporal side (temple side; figs. 6-7, 9a).
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 modify the orthokeratology lens of Wang to include the technical feature of an outer edge of a curve zone being surrounded by circular and/or elliptical-shaped curves facing nasal and temporal sides, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the orthokeratology lens of Wang to include the technical feature of an outer edge of a curve zone being surrounded by circular and/or elliptical-shaped curves, since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in the art when the change in shape is not significant to the function of the combination, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), MPEP §2144. In the instant case, the change in shape does not appear to be significant to the function because Wang also explicitly teaches a curve zone having other shapes, such as elliptical, oval, etc., via an adjustment of radii of curvature within a curve zone, and for the purpose of achieving correction of the human eye ([0097], [0157]).
With respect to Claim 9, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 8.
Wang does not appear to explicitly teach the following limitation(s): wherein the distance from the outer edge of the second curve zone in the bitemporal side to the first curve zone is set to be X1, the distance from the outer edge of the second curve zone in the nasal side to the first curve zone is set to X2, and a difference between X2 and X1 is 0.1 mm to 0.4 mm.
However, in the same field of endeavor, Spratt teaches a method for designing a lens shape and spectacle lens ([0041]), and an ophthalmic lens (60; [0181]; figs. 5-7, 9a-9c) comprising: a distance from an outer edge of a second curve zone (Rin; [0042]; fig. 9a) of a reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) in the bitemporal side (temple side; figs. 6-7, 9a) to a first curve zone (Rout; [0042]; fig. 9a) of a reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) is set to be X1 (figs 5, 9a-9c), a distance from an outer edge of the second curve zone (Rin; [0042]; fig. 9a) of a reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) in the nasal side (nasal side; fig. 9a) to the first curve zone (Rout; [0042]; fig. 9a) of a reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a) is set to X2 (figs 5, 9a-9c), and a difference between X2 and X1 is 0.1 mm to 0.4 mm (predetermined width from inner radius to an outer radius within steps, steps not to be of equal length, each particular step preferably not larger than 0.5 mm, encompassing ≤ 0.5 mm; [0042]; figs 5, 9a-9c).
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 modify the orthokeratology lens of Wang to include the technical feature of differences between outer edge distances of curve zones being 0.1 mm to 0.4 mm, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, a change of size and proportion (e.g., a difference between distance X2 and distances X1 is 0.1 mm to 0.4 mm) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). See MPEP § 2144.04. One of ordinary skill in the art would have a reasonable expectation of success when making this modification because Wang explicitly teaches that the diameter of the central region and the radial widths of the annular regions can be adjusted in accordance with size of the patient's pupil, requirements for near vision clarity, etc., and for the purpose of providing reversible correction based on activities of cornea cells ([0064], [0136]).
With respect to Claim 10, Wang in view of Spratt teaches the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 9.
Wang does not appear to explicitly teach the following limitation(s): wherein the distance from the outer edge of the first curve zone in the bitemporal side to the base curve zone is set to X3, and a ratio of X3 to X1 is 1/3.
However, Spratt further teaches a method for designing a lens shape and spectacle lens ([0041]), the ophthalmic lens (60; [0181]; figs. 5-9c), wherein the distance from the outer edge of the first curve zone (Rout; [0042]; fig. 9a) in the bitemporal side (temple side; figs. 6-7, 9a) to the base curve zone (within boundary line 18; [0173]; fig. 7) is set to X3 (gradient of curvature may vary from 0.05 to 1.0 diopters per mm (D/mm); [0041], slope dZ/dR is determined; [0045]), and a ratio of X3 to X1 is 1/3 (predetermined width from inner radius to an outer radius within steps, steps not to be of equal length, each particular step preferably not larger than 0.5 mm, encompassing ≤ 0.5 mm; [0042]; figs 5, 9a-9c, e.g., X3/X1 slope ratio ≈ 1/3 when distance X1 ≈ 3 mm, distance X2 ≈ 3.1 mm, and distance X3 ≈ 1 mm; [0040-45], [0180]; fig. 8).
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 modify the orthokeratology lens of Wang to include the technical feature of a ratio between outer edge distances of curve zones being 1/3, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, a change of size and proportion (e.g., “distance from the outer edge of the first curve zone in the bitemporal side to the base curve zone is set to X3, and a ratio of X3 to X1 is 1/3”) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). See MPEP § 2144.04. One of ordinary skill in the art would have a reasonable expectation of success when making this modification because Wang explicitly teaches that the diameter of the central region and the radial widths of the annular regions can be adjusted in accordance with size of the patient's pupil, requirements for near vision clarity, etc., and for the purpose of providing reversible correction based on activities of cornea cells ([0064], [0136]).
With respect to Claim 11, Wang discloses the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 1.
Wang does not appear to explicitly teach the following limitation(s): wherein outer edges of the base curve zone, the reverse curve zone, the adaptation curve zone, and the peripheral curve zone are all circles whose center points are coincident with each other, to enable the first annular structure to form a circular ring, and a curvature of an inner surface, located on the nasal side, of the circle is greater than a curvature of an inner surface, located on the bitemporal side, of the circle.
However, in the same field of endeavor, Spratt teaches a method for designing a lens shape and spectacle lens ([0041]), wherein an ophthalmic lens (60; [0181]; fig. 7) comprises outer edges (e.g., a periphery or outer edge 16 of ophthalmic lens 60; [0169]) of the base curve zone (within boundary line 18; [0173]; fig. 7), the reverse curve zone (within frame line 19, prescription zone within width 68; [0170]; figs. 6-7, 9a), the adaptation curve zone (within second boundary line 22 of the transition zone 64; [0173]; fig. 7), and the peripheral curve zone (margin portion within width 23; [0170]; fig. 7) that are all circles (figs. 6-7, 9a) whose center points (e.g., carrier point 14; [0169]; figs. 6-7, 9a) are coincident with each other (figs. 6-7, 9a), to enable an annular structure (outer edge of boundary line 18 combined with outer edge of frame line 19, prescription zone within width 68; figs. 6-7, 9a) to form a circular ring (extension smoothly blended with central portion or prescription zone at radius Rin circle to ensure continuity of surface heights, slopes and curvatures at Rin boundary, center of ring defining carrier or carrier point is decentered in nasal direction relative to prism reference point (PRP) to limit presence of carrier extension to temporal side of edged and fitted lens; [0041]), and a curvature of an inner surface (inner surface at Rin; [0052]), located on the nasal side (nasal side; fig. 9a), of the circle (figs. 6-7, 9a) is greater than a curvature (curvature in radial direction at a 180 degree meridian; [0147]; curvature of inner surface on nasal side greater than curvature of inner surface at temporal side; as seen in figs. 9a-9b) of an inner surface (inner surface at Rin; [0052]), located on the bitemporal side (temple side; fig. 9a), of the circle (figs. 6-7, 9a).
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 modify the orthokeratology lens of Wang to include the technical feature of decentering a lens in a nasal direction to provide curvatures at a nasal side being greater than curvatures at a temporal side, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, a change of size and proportion (e.g., “a curvature of an inner surface, located on the nasal side, of the circle is greater than a curvature of an inner surface, located on the bitemporal side, of the circle.”) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). See MPEP § 2144.04. One of ordinary skill in the art would have a reasonable expectation of success when making this modification because Wang explicitly teaches that the diameter of the central region and the radial widths of the annular regions can be adjusted in accordance with size of the patient's pupil, requirements for near vision clarity, etc., and for the purpose of providing reversible correction based on activities of cornea cells ([0064], [0136]).
With respect to Claim 12, Wang in view of Spratt teaches the asymmetric (two or more regions being irregularly shaped; [0125], [0145]; fig. 2) orthokeratology lens (orthokeratology lens; [0005]) according to claim 11, wherein an inner surface (inner surface IS comprising a centrally located base arc zone; [0009], [0067]) of the base curve zone (base arc zone; [0005], [0067-70]) is flat (three regions of base arc zone are flat-raised-flat; [0164]), the reverse curve zone (reversal arc zone; [0005], [0067-70]) comprises a first curve zone (reversal arc zone having outer diameter; [0133]) and a second curve zone (reversal arc zone having inner diameter; [0133]) that are continuously bent outward from the periphery (fig. 1) of the base curve zone (base arc zone; [0005], [0067-70]), a curvature of an inner surface (IS; fig.1), located on the nasal side (right side of third region 130 within flat-raised-flat regions; [0164]; fig. 6), of the first curve zone (reversal arc zone having outer diameter; [0133]) is equal to (as seen in fig. 1) a curvature of an inner surface (IS; fig.1), located on the bitemporal side (left side of third region 130 within flat-raised-flat regions; [0164]; fig. 6), of the first curve zone (reversal arc zone having outer diameter; [0133]), OR a curvature of an inner surface (IS; fig.1), located on the nasal side (right side of third region 130 within flat-raised-flat regions; [0164]; fig. 6), of the second curve zone (reversal arc zone having inner diameter; [0133]) is greater than a curvature of an inner surface (IS; fig.1), located on the bitemporal side (left side of third region 130 within flat-raised-flat regions; [0164]; fig. 6), of the second curve zone (reversal arc zone having inner diameter; [0133]; Wang).
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 modify the orthokeratology lens of Wang to include the technical feature of decentering a lens in a nasal direction to provide curvatures at a nasal side being greater than curvatures at a temporal side, for the purpose of retaining optimized optical design and ensuring continuity of surface heights, slopes, and curvatures at particular boundaries, as taught by Spratt ([0041]). Furthermore, a change of size and proportion (e.g., “a curvature of an inner surface, located on the nasal side, of the circle is greater than a curvature of an inner surface, located on the bitemporal side, of the circle.”) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). See MPEP § 2144.04. One of ordinary skill in the art would have a reasonable expectation of success when making this modification because Wang explicitly teaches that the diameter of the central region and the radial widths of the annular regions can be adjusted in accordance with size of the patient's pupil, requirements for near vision clarity, etc., and for the purpose of providing reversible correction based on activities of cornea cells ([0064], [0136]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Paune Fabre US 20200133024 A1 discloses an orthokeratology contact lens for treating myopia substantially similar to that of the claimed invention.
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/K MUHAMMAD/Examiner, Art Unit 2872 30 March 2026
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872