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 § 112
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 and 14-20 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.
Claim 1 recites “an annular alignment zone surrounding the optical zone and extending radially outwardly from the optical zone, the alignment zone having a front surface and a back surface and providing orientation control to the contact lens.” However it is unclear how an alignment zone can “provide orientation control to the contact lens.” Specifically, this limitation is unclear as it recites functional language without providing a discernable boundary on what element/structure of the alignment zone performs the function and it is unclear if a specific material/structure/element must be present in the alignment zone to perform the function of “providing orientation control to the contact lens.” As such, the metes and bounds of the claim cannot be discerned and the claim is unclear. See Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc) (“Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim”) (MPEP § 2173.05(g)). For example, the “orientation control” provided could be a groove or hole to redistribute weight, a marking to indicate to a wearer the direction to place the contact lens, a region that is design to interact with a certain portion of the eye, etc. As such, it is unclear what structure is required by the claimed “alignment zone.”
For the purposes of examination, any annular alignment zone having sagittal heights reading on the structural requirements of the claim will be interpreted as reading on the claimed “annular alignment zone.”
Claims 2-12 and 14-20 are rejected as being dependent upon claim 1 and failing to cure the deficiencies of the rejected base claim.
Claim 12 recites that “the front surface of the peripheral zone the edge has a rotationally uniform edge thickness.” However, it is unclear whether the claim is referring to a front surface, the peripheral zone, the edge, or some combination of the terms. For the purposes of examination, any peripheral zone or edge having a rotationally uniform thickness will be interpreted as reading on the claimed limitation.
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.
Claim(s) 1-12 and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lieberman et al. (U.S. Patent No. 5,953,098; hereinafter – “Lieberman”).
Regarding claim 1, Lieberman teaches a contact lens comprising:
an optical zone (36) in a central portion of the lens extending radially outward from a center of the lens and having a front surface (28), a back surface (30), and a base curve (26), wherein the back surface of the optical zone has a curvature which is rotationally symmetrical (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49-67; C. 13, L. 29 – C. 14, L. 9); and
an annular alignment zone (34, 38) surrounding the optical zone and extending radially outwardly from the optical zone, the alignment zone having a front surface and a back surface and providing orientation control to the contact lens (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59),
wherein the contact lens comprises an X-axis and a Y-axis, the X-axis and Y-axis being orthogonal to an optical axis when the contact lens is worn on an eye of a subject and being in a plane of an edge of the contact lens (See e.g. Figs. 1, 7, and 10-11; C. 9, L. 22 – C. 10, L. 19; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59)
wherein the X-axis and Y-axis each comprise two opposed radial lines extending from the intersection of the X-axis and Y-axis (See e.g. Figs. 1, 7, and 10-11; C. 9, L. 22 – C. 10, L. 19; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59), thereby forming:
(i) a first sub-axis (56) having a first alignment curve and a first predetermined sagittal height in the alignment zone (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59);
(ii) a second sub-axis (58) having a second alignment curve and a second predetermined sagittal height in the alignment zone (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59);
(iii) a third sub-axis (68) having a third alignment curve and a third predetermined sagittal height in the alignment zone (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59); and
(iv) a fourth sub-axis (70) having a fourth alignment curve and a fourth predetermined sagittal height in the alignment zone (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59),
wherein the predetermined sagittal height in the alignment zone of one of the sub- axes is different from the predetermined sagittal height in the alignment zone of at least one other sub-axis, and wherein each sub-axis is orthogonal to adjacent sub-axes (See e.g. Figs. 1, 7, and 10-11; C. 6, L. 14-65; C. 7, L. 63 – C. 8, L. 9; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59).
Regarding claim 2, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the lens further comprises an intermediate zone (38) coupled to and extending radially outward from the optical zone (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59).
Regarding claim 3, Lieberman teaches the contact lens of claim 2, as above.
Lieberman further teaches that the optical zone (36) further comprises an inner additive optical zone in a central portion of the optical zone, and wherein the inner additive optical zone has an additive base curve which is steeper than the base curve (See e.g. Figs. 1, 7, and 10-11; C. 8, L. 49-67; C. 13, L. 29 – C. 14, L. 9).
Regarding claim 4, Lieberman teaches the contact lens of claim 2, as above.
Lieberman further teaches that the base curve is a single curvature and has a longer radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 14-15; C. 17, L. 31 – C. 18, L. 28).
Regarding claim 5, Lieberman teaches the contact lens of claim 4, as above.
Lieberman further teaches that the base curve is toric (See e.g. Figs. 14-15; C. 10, L. 20-39; C. 13, L. 29 – C. 14, L. 9; C. 17, L. 31 – C. 18, L. 28).
Regarding claim 6, Lieberman teaches the contact lens of claim 2, as above.
Lieberman further teaches that the base curve is a single curvature and has a shorter radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 14-15; C. 17, L. 31 – C. 18, L. 28).
Regarding claim 7, Lieberman teaches the contact lens of claim 3, as above.
Lieberman further teaches that the base curve is a single curvature and has a longer radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 14-15; C. 17, L. 31 – C. 18, L. 28).
Regarding claim 8, Lieberman teaches the contact lens of claim 3, as above.
Lieberman further teaches that the base curve is a single curvature and has a shorter radius than a central corneal curvature of the subject (See e.g. Figs. 14-15; C. 17, L. 31 – C. 18, L. 28).
Regarding claim 9, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the curvature of the front surface is one of a spherical, aspheric or toric curvature (See e.g. Figs. 10-11 and 14-15; C. 10, L. 20-39; C. 13, L. 29 – C. 14, L. 9; C. 17, L. 31 – C. 18, L. 28).
Regarding claim 10, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches a peripheral zone (34, 82) having a front surface and a back surface which is coupled to and extends radially outwardly from the alignment zone (See e.g. Figs. 1, 7, 10-11, and 14-15; C. 11, L. 42 – C. 12, L. 31).
Regarding claim 11, Lieberman teaches the contact lens of claim 10, as above.
Lieberman further teaches that the back surface of the peripheral zone has a rotationally uniform curvature (See e.g. Figs. 1, 7, 10-11, and 14-15; C. 11, L. 42 – C. 12, L. 31).
Regarding claim 12, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the front surface of the peripheral zone the edge has a rotationally uniform thickness (See e.g. Figs. 1, 7, 10-11, and 14-15; C. 11, L. 42 – C. 12, L. 31).
Regarding claim 14, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the lens is a rigid contact lens (C. 15, L. 57-67).
Regarding claim 15, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the lens is a soft contact lens (C. 15, L. 57-67).
Regarding claim 16, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the predetermined sagittal height in the alignment zone of three of the sub-axes are different from each other (See e.g. Figs. 1, 7, and 10-11; C. 6, L. 14-65; C. 7, L. 63 – C. 8, L. 9; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59).
Regarding claim 17, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches that the predetermined sagittal height in the alignment zone of all of the sub-axes are different from each other (See e.g. Figs. 1, 7, and 10-11; C. 6, L. 14-65; C. 7, L. 63 – C. 8, L. 9; C. 8, L. 49 – C. 9, L. 21; C. 10, L. 48 – C. 11, L. 32; C. 11, L. 42-59).
Regarding claim 18, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches a method of manufacturing the contact lens of claim 1 by using a computer to determine the data for use in orientation control, upright control, or peripheral alignment of the contact lens (See e.g. Fig. 2; C. 5, L. 7 – C. 6, L. 36), comprising:
determining manufacturing data by inputting data representative of at least one of the following data into said computer, said computer being adapted to calculate said data: corneal sagittal heights readings; corneal shape factors, p-value, e-value, or q-value; corneal curvature readings (KM); corneal size; specification of selected best-fit prototype contact lens; refractive error for correction or molding; and ocular surface information obtained by OCT, 3D map, or trial fitting set (See e.g. Fig. 2; C. 5, L. 7 – C. 6, L. 36);
based on at least one of the above-inputted data, generating data by said computer (See e.g. Fig. 2; C. 5, L. 7 – C. 6, L. 36);
based on predetermined processes, generating a manufacturing specification by said computer (See e.g. Fig. 2; C. 5, L. 7 – C. 6, L. 36);
transmitting said manufacturing specification into a predetermined manufacturing machine (See e.g. Fig. 2; C. 13, L. 1-10);
manufacturing by said manufacturing machine for one, or a set of, contact lenses (See e.g. Fig. 2; C. 13, L. 1-28).
Regarding claim 19, Lieberman teaches the method of claim 18, as above.
Lieberman further teaches that inputting is performed by a client processor and calculating is performed by the client processor or by a server connected to the client processor through a global data communication network (See e.g. Fig. 2; C. 5, L. 7 – C. 6, L. 36).
Regarding claim 20, Lieberman teaches the contact lens of claim 1, as above.
Lieberman further teaches a method of treating ametropia or a corneal disorder of a subject, comprising the step of applying the contact lens of claim 1 to the eye of the subject (See e.g. Figs. 14-15; C. 17, L. 31 – C. 18, L. 28).
Claim(s) 1-12, 14, and 16-20 is/are additionally rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford et al. (U.S. PG-Pub No. 2020/0041816; hereinafter – “Gifford”).
Regarding claim 1, Gifford teaches a contact lens comprising:
an optical zone (12) in a central portion of the lens extending radially outward from a center of the lens and having a front surface (14), a back surface (16), and a base curve (12), wherein the back surface of the optical zone has a curvature which is rotationally symmetrical (See e.g. Figs. 1-2 and 10; Paragraphs 0027, 0032, 0215-0216, 0222, and 0266-0268); and
an annular alignment zone (1-5) surrounding the optical zone and extending radially outwardly from the optical zone, the alignment zone having a front surface and a back surface and providing orientation control to the contact lens (See e.g. Figs. 1-2 and 10; Paragraphs 0028, 0097-0102, 0215-0221, 0234, and 0266-0269),
wherein the contact lens comprises an X-axis and a Y-axis, the X-axis and Y-axis being orthogonal to an optical axis when the contact lens is worn on an eye of a subject and being in a plane of an edge of the contact lens (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269)
wherein the X-axis and Y-axis each comprises two opposed radial lines extending from the intersection of the X-axis and Y-axis (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269), thereby forming:
(i) a first sub-axis (44) having a first alignment curve and a first predetermined sagittal height in the alignment zone (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269);
(ii) a second sub-axis (46) having a second alignment curve and a second predetermined sagittal height in the alignment zone (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269);
(iii) a third sub-axis (48) having a third alignment curve and a third predetermined sagittal height in the alignment zone (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269); and
(iv) a fourth sub-axis (49) having a fourth alignment curve and a fourth predetermined sagittal height in the alignment zone (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269),
wherein the predetermined sagittal height in the alignment zone of one of the sub- axes is different from the predetermined sagittal height in the alignment zone of at least one other sub-axis, and wherein each sub-axis is orthogonal to adjacent sub-axes (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269).
Regarding claim 2, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches that the lens further comprises an intermediate zone (1-5) coupled to and extending radially outward from the optical zone (See e.g. Figs. 1-2 and 10; Paragraphs 0028, 0097-0102, 0215-0221, 0234, and 0266-0269).
Regarding claim 3, Gifford teaches the contact lens of claim 2, as above.
Gifford further teaches that the optical zone (1) further comprises an inner additive optical zone in a central portion of the optical zone, and wherein the inner additive optical zone has an additive base curve which is steeper than the base curve (See e.g. Figs. 1-2 and 10; Paragraphs 0027, 0032, 0048-0061, 0215-0216, 0222-0225, and 0266-0268).
Regarding claim 4, Gifford teaches the contact lens of claim 2, as above.
Gifford further teaches that the base curve is a single curvature and has a longer radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 1-2 and 10; Paragraphs 0012-0013, 0027, 0030, 0032, 0044, 0048-0061, 0215-0216, 0222-0225, and 0242-0248).
Regarding claim 5, Gifford teaches the contact lens of claim 4, as above.
Gifford further teaches that the base curve is toric (Paragraphs 0017 and 0032).
Regarding claim 6, Gifford teaches the contact lens of claim 2, as above.
Gifford further teaches that the base curve is a single curvature and has a shorter radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 1-2 and 10; Paragraphs 0012-0013, 0027, 0030, 0032, 0044, 0046, 0048-0061, 0215-0216, 0222-0225, and 0242-0248).
Regarding claim 7, Gifford teaches the contact lens of claim 3, as above.
Gifford further teaches that the base curve is a single curvature and has a longer radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 1-2 and 10; Paragraphs 0012-0013, 0027, 0030, 0032, 0044, 0048-0061, 0215-0216, 0222-0225, and 0242-0248).
Regarding claim 8, Gifford teaches the contact lens of claim 3, as above.
Gifford further teaches that that the base curve is a single curvature and has a shorter radius than a radius of a central corneal curvature of the subject (See e.g. Figs. 1-2 and 10; Paragraphs 0012-0013, 0027, 0030, 0032, 0044, 0046, 0048-0061, 0215-0216, 0222-0225, and 0242-0248).
Regarding claim 9, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches that the curvature of the front surface is one of a spherical, aspheric or toric curvature (Paragraphs 0032-0034).
Regarding claim 10, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches a peripheral zone (4, 5, 38) having a front surface and a back surface which is coupled to and extends radially outwardly from the alignment zone (See e.g. Figs. 1-2 and 10; Paragraphs 0090-0102, 0132-0133, 0237-0238, 0251-0256, and 0266-0269).
Regarding claim 11, Gifford teaches the contact lens of claim 10, as above.
Gifford further teaches that the back surface of the peripheral zone has a rotationally uniform curvature (See e.g. Figs. 1-2 and 10; Paragraphs 0090-0102, 0132-0133, 0237-0238, 0251-0256, and 0266-0269).
Regarding claim 12, Gifford teaches the contact lens of claim 11, as above.
Gifford further teaches that the front surface of the peripheral zone the edge has a rotationally uniform thickness (See e.g. Figs. 1-2 and 10; Paragraphs 0090-0102, 0132-0133, 0237-0238, 0251-0256, and 0266-0269).
Regarding claim 14, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches that the lens is a rigid contact lens (Paragraph 0076).
Regarding claim 16, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches that the predetermined sagittal height in the alignment zone of three of the sub-axes are different from each other (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269).
Regarding claim 17, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches that the predetermined sagittal height in the alignment zone of all of the sub-axes are different from each other (See e.g. Figs. 1-2 and 10; Paragraphs 0097-0102, 0132-0133, and 0266-0269).
Regarding claim 18, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches a method of manufacturing the contact lens of claim 1 by using a computer to determine the data for use in orientation control, upright control, or peripheral alignment of the contact lens (See e.g. Figs. 11-13; Paragraphs 0064-0075, 0077-0089, 0158-0159, 0162, 0167, and 0270-0284), comprising:
determining manufacturing data by inputting data representative of at least one of the following data into said computer, said computer being adapted to calculate said data: corneal sagittal heights readings; corneal shape factors, p-value, e-value, or q-value; corneal curvature readings (KM); corneal size; specification of selected best-fit prototype contact lens; refractive error for correction or molding; and ocular surface information obtained by OCT, 3D map, or trial fitting set (See e.g. Figs. 11-13; Paragraphs 0065-0074, 0078-0087, 0135, 0162-0163, 0165-0167, 0239-0256, 0272-0273, 0277-0278, and 0282);
based on at least one of the above-inputted data, generating data by said computer (See e.g. Figs. 11-13; Paragraphs 0065-0074, 0078-0087, 0135, 0162-0163, 0165-0167, 0239-0256, 0272-0273, 0277-0278, and 0282);
based on predetermined processes, generating a manufacturing specification by said computer (See e.g. Figs. 11-13; Paragraphs 0064-0075, 0077-0089, 0158-0159, 0162, 0167, and 0270-0284);
transmitting said manufacturing specification into a predetermined manufacturing machine (See e.g. Figs. 11-13; Paragraphs 0075, 0088, 0197, 0239, 0270-0272, and 0292);
manufacturing by said manufacturing machine for one, or a set of, contact lenses (See e.g. Figs. 11-13; Paragraphs 0075, 0088, 0197, 0239, 0270-0272, and 0292).
Regarding claim 19, Gifford teaches the method of claim 18, as above.
Gifford further teaches that inputting is performed by a client processor and calculating is performed by the client processor or by a server connected to the client processor through a global data communication network (See e.g. Figs. 11-13; Paragraphs 0065-0074, 0078-0087, 0135, 0162-0163, 0165-0167, 0197, 0239-0256, 0272-0273, 0277-0278, 0282, and 0292).
Regarding claim 20, Gifford teaches the contact lens of claim 1, as above.
Gifford further teaches a method of treating ametropia or a corneal disorder of a subject, comprising the step of applying the contact lens of claim 1 to the eye of the subject (See e.g. Figs. 11-13; Paragraphs 0077-0089, 0112, 0125, 0136-0147, 0170-0182, and 0270-0284).
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(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gifford in view of Lieberman.
Regarding claim 15, Gifford teaches the contact lens of claim 1, as above.
Gifford fails to explicitly disclose that the lens is a soft contact lens.
However, Lieberman teaches a contact lens having an optical zone, an alignment zone, and a peripheral zone wherein the lens is a soft contact lens (C. 15, L. 57-67).
Lieberman teaches that this soft contact lens as a suitable material which “enables the lens to sit much more securely on the cornea and rotate less with respect to the cornea, than any lens of the prior art” (C. 15, L. 1-67) in order “to provide a contact lens that accounts for the natural tilt of the cornea” and “to rapidly and economically manufacture custom-fit contact lenses that provide increased visual acuity by aspherically and asymmetrically matching and/or conforming to a portion of the wearer's cornea” (C. 3, L. 26-41).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the contact lens of Gifford to be a soft contact lens as in Lieberman since it “enables the lens to sit much more securely on the cornea and rotate less with respect to the cornea, than any lens of the prior art” in order “to provide a contact lens that accounts for the natural tilt of the cornea” and “to rapidly and economically manufacture custom-fit contact lenses that provide increased visual acuity by aspherically and asymmetrically matching and/or conforming to a portion of the wearer's cornea,” as taught by Lieberman (C. 3, L. 26-41; C. 15, L. 1-67), and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (See MPEP 2144.07).
Response to Arguments
Applicant's arguments, see pages 7-8, filed 12/30/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 in view of Lieberman have been fully considered but they are not persuasive.
Applicant argues that “the different sagittal heights in the sub-axes of the present lens are not arbitrarily placed, but instead are placed orthogonally to one another in an alignment zone” and “although the lens of the Lieberman reference is asymmetric, such asymmetry is simply for the purpose of matching the outer contour of a subject’s eye” and therefor “Lieberman thus lacks orthogonal sub-axes in an alignment zone having different sagittal heights, as recited in claim 1.” However, Examiner respectfully disagrees.
Specifically, Lieberman’s peripheral zones that are designed such that the zone “asymmetrically and aspherically matches a corresponding peripheral portion of the cornea, which lies under the peripheral portion of the lens when the lens is worn in the wearer's eye” (e.g. C. 8, L. 54-57) read on the broadest reasonable interpretation of the claimed “alignment zone.”
No special definition of “alignment zone” is found in the present specification, and, absent a special definition, Examiner is obligated to take the broadest reasonable interpretation not in conflict with the specification. It is noted that the feature upon which applicant relies (i.e., “alignment zone”) has been given its broadest reasonable interpretation. 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). The examiner respectfully disagrees with applicant’s interpretation of, “alignment zone,” which states/seems to imply that the alignment zone must have some specific structure other than different sagittal heights. Rather, given that Lieberman’s different zones are designed to match a portion of the cornea, they must necessarily align with those portions of the cornea, reading on an “alignment zone.”
More compellingly, Lieberman explicitly discloses that these peripheral zones are designed such that “each local surface segment on the posterior surface in the optical portion of the lens conforms to the shape of the respective local portion of the cornea lying under the local surface segment” (C. 10, L. 8-11). Thus, each zone aligns with the shape of the cornea and reads on the claimed “alignment zone.”
As Applicant has not provided any structure of the “alignment zone” that Applicant believes to be a different structure than that of Lieberman, Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Applicant's arguments, see page 8, filed 12/30/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 in view of Gifford have been fully considered but they are not persuasive.
Applicant argues that “zone 1 of the Gifford lens has a rotationally symmetric curve” and “By contrast, the alignment zone extending radially outwardly from the optical zone of the present lens is divided into quadrants by the sub-axes defined in claim 1, and at least two of the sub-axes have different alignment curves and sagittal heights.” However, Examiner respectfully disagrees.
Specifically, Gifford defines multiple peripheral zones that read on the claimed “alignment zone” and explicitly teaches that “In its non rotationally symmetric form, the peripheral zones 3-5 outside of the central zone can be divided into equal sized quadrants 44, 46, 48, 49 each having different values so as to improve fit on asymmetric corneas” (Paragraph 0268, see also Paragraphs 0132-0133). Thus, contrary to Applicant’s assertion, the lens of Gifford has multiple quadrants that are not symmetric and have different alignment curves reading on the claimed invention.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas R Pasko whose telephone number is (571)270-1876. The examiner can normally be reached M-F 8 AM - 5 PM.
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Nicholas R. Pasko
Primary Examiner
Art Unit 2896
/Nicholas R. Pasko/Primary Examiner, Art Unit 2896