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 method steps (A01), (A02), (A03), (A04), (A05), calculation steps (1), (2), (3), (4), (5), axis of said central optical zone with the center of the circle of the contact lens as the reference point, and external axis of said central optical zone 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.
Claim Objections
Claims 5-8 objected to because of the following informalities:
With respect to Claim 5, “the design of the design of different curvature changes” is unclear, for “the design” is either a duplicated term or is grammatically incorrect given the context of the claims presented in the as-filed application.
With respect to Claims 6-8, the recitations “wherein
R
0
is the curvature of the highest point on said at least one radial curve of said central optical zone, the
p
=
1
-
e
2
, the
e
is the eccentricity, and the
y
0
is the radius of said central optical zone; the edge b (bordering) of said central optical zone” in Claim 6, “the function z can be any function” in Claim 7, “Q is the any point a, and this equation (3) is the Zernike formula” in Claim 8 are in improper claim form, for they include reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
With respect to Claim 7, “the A1, A2, A3~An, etc.” recites variables not consistent with the variables utilized in the equation “
Z
=
C
X
2
1
+
1
-
(
K
+
1
)
C
2
X
2
+
A
1
X
+
A
2
X
2
+
A
3
X
3
+
…
+
A
n
X
n
.”
With respect to Claims 7 and 8, the equations are not of sufficient quality, for “
Z
=
C
X
2
1
+
1
-
(
K
+
1
)
C
2
X
2
+
A
1
X
+
A
2
X
2
+
A
3
X
3
+
…
+
A
n
X
n
” and “
W
r
,
θ
=
∑
n
,
m
C
n
m
Z
n
m
(
r
,
θ
)
” are illegible. “The specification, including the claims, may contain chemical and mathematical formulae, but shall not contain drawings or flow diagrams…Chemical and mathematical formulas and tables must be presented in compliance with § 1.52(a) and (b).” See 37 CFR 1.58 and MPEP § 608.
With respect to Claim 8, the recitation “on the surface of said central optical zone of the function z. This equation (3) calculates the aspheric angle (θ) of the function z =
f
(
θ
)
” is improper formatting of the claim(s). “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations. See Fressola v.Manbeck, 36 USPQ2d 1211 (D.D.C. 1995).” See MPEP § 608.
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.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception without reciting significantly more, and therefore the claims are patent ineligible subject matter.
The claimed invention is directed to a judicial exception: a combination of mental processes and mathematical concepts without significantly more. The claim(s) recite(s) “optical design method the steps of…planning at least one predetermined position…designing the curvature value of said at least one annular curve…performing a numerical design of the curvature…completing the power distribution design of said central optical zone of said contact lens” in Claim 1, “carrying out the numerical design of the curvature of said at least one annular curve…using said first point and the curvature of said at least one annular curve to calculate the end point through a functional equation…to gradually complete the design of the design of different curvature changes” in Claim 5, “at least one radial curvature is obtained on said at least one annular curve” in Claim 9, and “a constant periodic continuous function along the axis of said central optical zone, which can be a sine wave, a square wave or a sawtooth wave and other periodic functions, and the curvature design of said at least one radial curve is performed by rotating clockwise or counterclockwise” in Claim 10.
The claim(s) further recite(s) “said at least one radial curve of said central optical zone is calculated, and the calculation is done by equation (1) (which is the sag equation): Sag =
R
0
-
R
0
2
-
y
0
2
p
p
(mm)” in Claim 6, “an equation (2) for calculating the different changes in the curvature of said at least one radial curve on the surface of said central optical zone, the function:
Z
=
C
X
2
1
+
1
-
(
K
+
1
)
C
2
X
2
+
A
1
X
+
A
2
X
2
+
A
3
X
3
+
…
+
A
n
X
n
(mm)” in Claim 7, and “wherein the equation calculates the curvature of said at least one radial curve of said central optical zone through equation (3):
W
r
,
θ
=
∑
n
,
m
C
n
m
Z
n
m
(
r
,
θ
)
(mm)” in Claim 8, for “mathematical formulas are considered to be a judicial exception as they express a scientific truth, but have been labelled by the courts as both abstract ideas and laws of nature”. See MPEP § 2106.04.
The mathematical concepts and mental processes (e.g., planning positions, designing curvature using periodic functions, performing numerical calculations including sag equations, functional equations, Zernike polynomials to determine lens geometry, etc.) are recited at a high level of generality without requiring any particular machine or transformation, and thus, falls within abstract idea groupings. “A principle, in the abstract, is a fundamental truth; an original cause; a motive; these cannot be patented, as no one can claim in either of them an exclusive right.” See Le Roy v. Tatham, 55 U.S. (14 How.) 156, 175 (1852). The claimed method(s) of optical design and equation calculation falls within the abstract idea category of data analysis and interpretation, and thus, is held ineligible under 101. Furthermore, ‘holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea);’ Examiner also reminds the applicant that ‘Claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. See Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);’ See MPEP § 2106.04(a)(2).
This judicial exception is not integrated into a practical application because the claims merely use the mathematical calculations to design or complete a contact lens without reciting how the design is applied in a meaningful way to manufacture, improve, or otherwise implement the contact lens in a technological process. The recitation of a contact lens is nominal does not impose any meaningful limit on the abstract idea. In other words, although the claim recites e.g., a contact lens, a central optical zone, a peripheral positioning zone, etc., these elements are merely claimed as sections of a contact lens comprised within an optical design. The optical design method and calculations for designing features of a contact lens perform no improvement to themselves or to the operation of the optical design and/or non-orthogonal and non-symmetric contact. Therefore, the claim(s) do not recite any improvement to the underlying functioning of designing a contact lens, calculating a design of a contact lens, or forming a non-orthogonal and non-symmetric contact lens, for the claim instead recites the application of known zone region positioning, calculations, equations, and judgments to an optical design and/or non-orthogonal and non-symmetric contact lens.
The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they only recite generic and conventional mathematical operations and result-oriented contact lens design steps without any specific or unconventional technological implementation. See MPEP § 2106.05(f). Thus, there is no transformation of a physical object, no improved technological performance, and no meaningful limitation confining the abstract idea (involving mental processes, mathematical modeling, and data analysis in an optical design lens context) to a particular implementation beyond generic mathematical calculations and design steps. See MPEP § 2106.05(d). ‘Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include: i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea…, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (See MPEP § 2106.05(f)); ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (See MPEP § 2106.05(d));’ See MPEP § 2106.05. Accordingly, Claims 1-10 are rejected under 35 U.S.C. 101.
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 1-10 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.
The as-filed claims are replete with limitations lacking antecedent basis:
Claim 1 recites the limitation "the steps." Claim 1 recites the limitation " the range of said central optical zone." Claims 1 and 3 recite the limitation "the curvature value." Claim 1 recites the limitation "the change in the curvature value." Claims 1, 5, 7-8, and 10 recite the limitation "the curvature." Claim 1 recites the limitation "the power distribution design."
Claims 2, 3, 5-7, and 9 recite the limitation "the/said center of the circle." Claim 4 and 7-8 recite the limitation "the function."
Claims 5 and 10 recite the limitation "the axis of said central optical zone." Claim 5 recites the limitation "the position of said at least one annular curve on the surface." Claim 5 recites the limitation "the design of the first point on the surface." Claims 5 and 10 recite the limitation "the curvature design." Claim 5 and 7 recite the limitation "the end point." Claim 5 recites the limitation "the non-orthogonal and non-symmetric annular design." Claim 5 recites the limitation "the design of the design of different curvature changes."
Claim 6 and 7 recite the limitation "the calculation." Claim 6 recites the limitation "the sag equation." Claim 6 recites the limitation "the curvature of the highest point." Claim 6 recites the limitation "the eccentricity." Claim 6 recites the limitation "the radius." Claims 6 and 7 recite the limitation "the edge." Claims 6 and 7 recite the limitation "the circumferential edge." Claim 6 recites the limitation "the diameter." Claim 6 recites the limitation "the peripheral curvature."
Claim 7 recites the limitation "the different changes in the curvature of said at least one radial curve on the surface." Claim 7 recites the limitation "the radius of curvature of the aspherical surface vertex." Claim 7 recites the limitation "the major axis." Claim 7 recites the limitation "the ellipse." Claim 7 recites the limitation "the minor axis." Claim 7 recites the limitation "the A1, A2, A3~An." Claim 7 recites the limitation "the high-order coefficients of the aspheric surface." Claim 7 recites the limitation "the distance."
Claim 8 recites the limitation "the aspheric surface angle." Claim 8 recites the limitation "the coordinate position of any point a on the aspheric surface." Claim 8 recites the limitation "the Zernike formula." Claim 9 recites the limitation "the adjacent intersection position."
Claim 10 recites the limitation "the surface of the contact lens." Claim 10 recites the limitation "the front surface." Claim 10 recites the limitation "the outer surface." Claim 10 recites the limitation "the eyeball." Claim 10 recites the limitation "the back surface." Claim 10 recites the limitation "the surface that is attached to the eyeball." Claim 10 recites the limitation "the external axis."
There is insufficient antecedent basis for these limitations in the claim(s). This is not an exhaustive list. Since the claims are replete with inconsistent terminology and lack of antecedent basis for several claimed elements, the Examiner has mapped the rejections following the exact formatting of the as-filed claims in the present Office action.
With respect to Claims 1-10, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011), Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005).
For example, “planning at least one predetermined position within said central optical zone of said contact lens” in Claim 1 and “at least one radial curvature is obtained on said at least one annular curve from said center of the circle to the adjacent intersection position of said central optical zone” in Claim 9, recite an apparatus and methods of using the apparatus. Thus, it is unclear whether infringement occurs when one creates a system that allows planning a predetermined position and obtaining a radial curvature, or whether infringement occurs when a predetermined position is actually planned and a radial curvature is actually obtained. See Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) & MPEP § 2173(p).
With respect to Claims 5-8, the phrase “carrying out the numerical design of the curvature of said at least one annular curve” in Claim 5 includes relative terminology which renders the claim indefinite. The term “carrying out the numerical design” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The design of the contact lens, the design of the curvature, and all other limitations of Claims 5-8 are also rendered indefinite by the use of the term “carrying out the numerical design.” Examiner notes that it is also unclear as to who or what is “carrying out the numerical design.”
With respect to Claims 9 and 10, and 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).
In the current instance, “at least one radial curvature is obtained on said at least one annular curve” in Claim 9 and “the curvature design of said at least one radial curve is performed by rotating clockwise or counterclockwise” in Claim 10 recite functional language, for the claim limitation(s) merely recite a description of a problem to be solved or a function or result achieved by the invention. For example, “the curvature design of said at least one radial curve is performed by rotating clockwise or counterclockwise” merely describes how the curvature design is performed through a process of rotating rather than reciting any definite structural characteristics of the contact lens itself. There is no defined geometry, parameters, or physical configuration of the radial curve, and thus, these limitations are purely functional and result-oriented. 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).
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 optical design method and contact 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.
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 1-7, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tung WO 2021252808 A1 (see machine translation; utilizing US 20230229021 A1 for mapped citations of WO 2021252808 A1 herein).
With respect to Claim 1, Tung discloses an optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) comprising a central optical zone (central optical zone 22; [0084]), a peripheral positioning zone (alignment zone 26; [0068]) surrounding (fig. 3) said central optical zone (central optical zone 22; [0084]), and a peripheral curve zone (peripheral zone 28; [0068]) surrounding (fig. 3) said peripheral positioning zone (alignment zone 26; [0068]), the optical design method (method for making contact lenses; [0067]) the steps of:
(A01) planning at least one predetermined position (back curves within quadrants 60 of alignment zone 26 between adjacent sub-axes are connected for annular alignment curve of back surface of contact lens 20, optical zone 22 and its base curve(s) 30; [0010], [0049], [0071]) within said central optical zone (central optical zone 22; [0084]) of said contact lens (contact lens 20; [0068]), and designing at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) at said at least one predetermined position (back curves within quadrants 60 of alignment zone 26 between adjacent sub-axes are connected for annular alignment curve of back surface of contact lens 20, optical zone 22 and its base curve(s) 30; [0010], [0049], [0071]);
(A02) within the range of said central optical zone (central optical zone 22; [0084]), designing the curvature value (derive ocular sagittal heights by measured corneal curvatures and shape factors, usually check 4 quadrants up to maximum reliable annular zone; [0093]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) surrounding (fig. 3) said central optical zone (central optical zone 22; [0084]);
(A03) based on the change (lens will exert planned forces via base curve portion of contact lens 20, to change corneal shape; [0079]) in the curvature value (derive ocular sagittal heights by measured corneal curvatures and shape factors, usually check 4 quadrants up to maximum reliable annular zone; [0093]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) surrounding (fig. 3) said central optical zone (central optical zone 22; [0084]), performing a numerical design of the curvature (adjust sagittal height of scleral contact lens 20 for forming proper tear space between posterior surface of contact lens 20 and front surface of cornea 12; [0088]) of a non-orthogonal and non-symmetric ([0115]) radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) within the range of said central optical zone (central optical zone 22; [0084]);
(A04) repeating step (A03) to form a non-orthogonal and non-symmetric curved surface design ([0115]) in said central optical zone (central optical zone 22; [0084]); and
(A05) completing the power distribution design (adjust astigmatism axis and/or power to grind on front or back surface of central portion of contact lens 20; [0108]) of said central optical zone (central optical zone 22; [0084]) of said contact lens (contact lens 20; [0068]).
Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). See also MPEP § 2112.02.
With respect to Claim 2, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 1, wherein in step (A01), based on the center of the circle (geometric center of contact lens; [0075]) of said contact lens (contact lens 20; [0068]), said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) is planned to surround (fig. 3) said center of the circle (geometric center of contact lens; [0075]) in a clockwise or counterclockwise (counterclockwise; [0046]) manner within said central optical zone (central optical zone 22; [0084]).
With respect to Claim 3, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 2, wherein the curvature value (derive ocular sagittal heights by measured corneal curvatures and shape factors, usually check 4 quadrants up to maximum reliable annular zone; [0093]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) is designed along said center of the circle (geometric center of contact lens; [0075]) of said contact lens (contact lens 20; [0068]) as a reference point (value on elevation map represents height of analyzed corneal surface with respect to reference surface; [0048]) with a constant periodic continuous function or a non-constant periodic continuous function (plurality of sets of alignment curves of alignment zone blended into an uneven but rather smooth, continuous annular alignment zone; [0088]).
With respect to Claim 4, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 3, wherein said constant periodic continuous function (plurality of sets of alignment curves of alignment zone blended into an uneven but rather smooth, continuous annular alignment zone; [0088]) is a sine wave, square wave, or sawtooth wave (progressive, alignment curvatures can be blended for an uneven but smooth and continuous annular alignment zone 26; [0078] & [0088], optical zone 22 and its base curve(s) designed as not conforming to central cornea shape while still controlling lens orientation with peripheral alignment zone 26; [0010]); any point (a) in the function of non-constant periodic continuous function (plurality of sets of alignment curves of alignment zone blended into an uneven but rather smooth, continuous annular alignment zone; [0088]) is an equation of polynomial, exponential function, Fourier, gaussian, sum of sine or Weibull (plurality of sets of alignment curves of alignment zone 26 blended into an uneven but rather smooth, continuous annular alignment zone, and thus, continuity of z =
f
(
θ
)
at any point of alignment curves, standard aspheric lens equation derived by sagittal height equation; [0063], [0088]).
With respect to Claim 5, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 2, wherein the contact lens (contact lens 20; [0068]) is rotated clockwise or counterclockwise (counterclockwise; [0046]) along the axis (Z-axis, i.e., optical axis; [0024]) of said central optical zone (central optical zone 22; [0084]) with the center of the circle (geometric center of contact lens; [0075]) of the contact lens (contact lens 20; [0068]) as the reference point (value on elevation map represents height of analyzed corneal surface with respect to reference surface; [0048]) to obtain the curvature (optical zone 22 and its base curve(s) 30; [0010], [0049]) of said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) within the range of said central optical zone (central optical zone 22; [0084]) on said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) in said central optical zone (central optical zone 22; [0084]), which is implemented through the following calculation (sagittal height equation; [0063]) steps:
(1) first determining the position (back curves within quadrants 60 of alignment zone 26 between adjacent sub-axes are connected for annular alignment curve of back surface of contact lens 20, optical zone 22 and its base curve(s) 30; [0010], [0049], [0071]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) on the surface of said central optical zone (central optical zone 22; [0084]) of said contact lens (contact lens 20; [0068]);
(2) carrying out the numerical design of the curvature (adjust sagittal height of scleral contact lens 20 for forming proper tear space between posterior surface of contact lens 20 and front surface of cornea 12; [0088]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]);
(3) obtaining the design of the first point on the surface (edge thickness can be calculated; [0038], converting lens sagittal height to the P-Qdrt alignment curve(s); [0103]) of said central optical zone (central optical zone 22; [0084]) (i.e., said center of the circle (geometric center of contact lens; [0075]) of said contact lens (contact lens 20; [0068])) and the curvature design (ocular information needed for designing contact lenses 20 or peripheral zone usually measured corneal information e.g., corneal curvatures (KM), shape factors (e-value, p-value, or q-value; [0097]), as well as elevation height obtained from elevation map; [0097]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]);
(4) using said first point and the curvature (edge thickness can be calculated; [0038], converting lens sagittal height to the P-Qdrt alignment curve(s); [0103]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) to calculate the end point ([0038], [0103]) through a functional equation (standard aspheric lens equation derived by sagittal height equation; [0063]), so as to obtain said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) within the range of said central optical zone (central optical zone 22; [0084]) of the non-orthogonal and non-symmetric annular design ([0115]) along said central optical zone (central optical zone 22; [0084]); and
(5) repeating the above step (4) to gradually complete the design of the design of different curvature changes (corneal sagittal height with sub-axes derived to form lens axial thickness with plurality of sets of sub-axes at peripheral portion of contact lens; [0102-103]; fig. 5-8) of said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) presented from ~360° (counterclockwise from 0° to 360°; [0046]) within said central optical zone (central optical zone 22; [0084]).
With respect to Claim 6, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 5, wherein said central optical zone (central optical zone 22; [0084]) is a curvature design (ocular information needed for designing contact lenses 20 or peripheral zone usually measured corneal information e.g., corneal curvatures (KM), shape factors (e-value, p-value, or q-value; [0097]) method (central optical zone is freed up and can be predetermined freely in any geometric possible shape; [0067]) of one or more segments (central optical zone 22 and its base curves; [0010]) on said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]), and said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) of said central optical zone (central optical zone 22; [0084]) is calculated, and the calculation (sagittal height equation; [0063]) is done by equation (1) (which is the sag equation):
Sag =
R
0
-
R
0
2
-
y
0
2
p
p
(mm) (S = R/P − SQRT((R/P)2 − (D/2)2/P); [0063]),
wherein
R
0
is the curvature of the highest point ([0063]) on said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) of said central optical zone (central optical zone 22; [0084]), the
p
=
1
-
e
2
(derived by P=1−sign(e)*e2; [0063]), the
e
is the eccentricity (e-value of surface; [0063]), and the
y
0
is the radius (D is zone diameter of surface, and thus, D ≈ 2
y
; [0063]) of said central optical zone (central optical zone 22; [0084]); the edge b (bordering) of said central optical zone (central optical zone 22; [0084]) (the circumferential edge connected to said peripheral positioning zone (alignment zone 26; [0068])) is calculated back by the diameter of said contact lens (contact lens 20; [0068]) and the peripheral curvature (diameter of optical zone 22 or contact lens 20 and radii of curvature for base curve 30, optical zone 22 has curvature that is defined by base curve 30; [0072-73]).
With respect to Claim 7, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 5, wherein the equation is designed to calculate (plurality of curvatures having particular e-value or forming one or more defined curvatures such as an aspheric curve or S curve; [0060] & [0103]) different changes in the curvature (lens will exert planned forces via base curve portion of contact lens 20, to change corneal shape; [0079]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) in said central optical zone (central optical zone 22; [0084]), and the calculation method is the function z =
f
(
x
)
of the curvature ([0060] & [0103]) and angle (orientation angles between 0° and 360°; [0046]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]), that is, any point a (of alignment curves; [0088] & [0103]) in the function
f
(
x
)
conforms to equation (2):
lim
θ
→
a
+
f
(
θ
)
=
f
(
a
)
and
lim
θ
→
a
-
f
(
θ
)
=
f
(
a
)
(plurality of sets of alignment curves of alignment zone 26 blended into an uneven but rather smooth, continuous annular alignment zone, and thus, continuity of z =
f
(
θ
)
at any point of alignment curves; [0088]),
where the function z can be any function z =
f
(
θ
)
(curves can be 4 sets of aspheric curves, or mixing spherical and aspheric curves; [0103]); the function z ([0060] & [0103]) is provided as an equation (2) for calculating (standard aspheric lens equation derived by sagittal height equation; [0063]) the different changes in the curvature (lens will exert planned forces via base curve portion of contact lens 20, to change corneal shape; [0079]) of said at least one radial curve on the surface (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) of said central optical zone (central optical zone 22; [0084]), the function:
Z
=
C
X
2
1
+
1
-
(
K
+
1
)
C
2
X
2
+
A
1
X
+
A
2
X
2
+
A
3
X
3
+
…
+
A
n
X
n
(mm) (standard aspheric lens equation derived by sagittal height equation (S): S = R/P − SQRT((R/P)2 − (D/2)2/P), where R is measured central curvature of spherical or aspheric surface; [0063], wherein Ss=Rs/Ps−SQRT((Rs/Ps)2−(D/2)2/Ps) and Sf=Rf/Pf−SQRT((Rf/Pf)2−(D/2)2/Pf); [0097]; p-value (POZ) is required if optical zone 22 is predetermined aspheric, SOZ = BC/POZ − SQRT((BC/POZ)2 − (OZ/2)2/POZ); [0098]; K1, K2, K3, K4 are factors for fine tuning sagittal height; [0099], forming aspheric alignment zone 26 using e-value derived by formula of eaz = SQRT(Rb2 − Ra2)/(Zonea + Zoneb), wherein Ra and Rb are radii of curvature of two alignment zones fused having zone width of Zonea and Zoneb respectively, aspheric alignment zone 26 formed having radii of curvature Ra, zone width (Zonea + Zoneb), and e-value of eaz, four sets of alignment zone AC1, AC2, AC3, AC4 for each sub-axis converted from sagittal height values of Saz1, Saz2, Saz3, and Saz4; [0103]),
in the function z: "
C
= 1/
R
,
R
is the radius of curvature of the aspherical surface vertex ([0063]),
K
= 1 -
e
,
e
is the eccentricity ([0063); when
K
= 1, it represents a hyperboloid (K1 ~K4 factors used to correct unwanted corneal bearing, conjunctiva pinching or excessive edge-lift in scleral contact lens 20; [0099]); when
K
= -1, it represents a paraboloid ([0099]); when 0 >
K
> -1, it represents a semi-elliptical sphere symmetrical to the major axis of the ellipse ([0099]); when
K
> 0, it represents a semi-elliptical sphere symmetrical to the minor axis of the ellipse ([0099]); when
K
= 0, it represents a sphere ([0099]); the
A
1
,
A
2
,
A
3
~
A
n
, etc. are the high-order coefficients of the aspheric surface (alignment curves AZ1, AZ2, AZ3, AZ4 for forming the alignment zone 26 of the P-Qdrt ortho-k contact lens 20; [0100]); using equation (2) to calculate the distance (x1) between the curvature (vertical distance measured; [0053]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) and said center of the circle (geometric center of contact lens; [0075]) along said central optical zone (central optical zone 22; [0084]), the end point of the edge b (bordering) ([0038], [0103]) of said central optical zone (central optical zone 22; [0084]) (the circumferential edge connected to said peripheral positioning zone (alignment zone 26; [0068])) is obtained ([0060] & [0103]).
With respect to Claim 9, Tung discloses a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]), comprising a central optical zone (central optical zone 22; [0084]), a peripheral positioning zone (alignment zone 26; [0068]) surrounding (fig. 3) said central optical zone (central optical zone 22; [0084]) and an peripheral curve zone (peripheral zone 28; [0068]) surrounding (fig. 3) said peripheral positioning zone (alignment zone 26; [0068]), wherein said central optical zone (central optical zone 22; [0084]) is located around the center of the circle (geometric center of contact lens; [0075]) of the contact lens (contact lens 20; [0068]), and at least one radial curvature is obtained (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) on said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) from said center of the circle (geometric center of contact lens; [0075]) to the adjacent intersection position (geometric center of contact lens intersects geometric center of corneal apex for an upright and tangential position; [0058]) of said central optical zone (central optical zone 22; [0084]) and said peripheral positioning zone (alignment zone 26; [0068]) to form a non-orthogonal, non-symmetric curved surface ([0115]).
With respect to Claim 10, Tung discloses the non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 9, wherein said central optical zone (central optical zone 22; [0084]) is an optical design of spherical, aspheric, astigmatism, multifocal astigmatism or free-form surface (central optical zone is freed up and can be predetermined freely in any geometric possible shape; [0067]), and the surface of the contact lens (contact lens 20; [0068]) is the front surface (the outer surface that is not attached to the eyeball) or the back surface (the surface that is attached to the eyeball) (center thickness is distance between front and back surfaces of contact lens, at geometric center of contact lens; [0034]), and is planned to rotate clockwise or counterclockwise (counterclockwise; [0046]) along the external axis (Z-axis, i.e., optical axis; [0024]) of said central optical zone (central optical zone 22; [0084]) to design the curvature (ocular information needed for designing contact lenses 20 or peripheral zone usually measured corneal information e.g., corneal curvatures (KM), shape factors (e-value, p-value, or q-value; [0097]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]); a regular or irregular surface (uneven lens axial thickness with plurality of sets of sub-axes at peripheral portion, [0102]) forming a non-orthogonal, non-symmetric curvature ([0115]) of said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) on said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]), and the curvature ([0097]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) is a constant periodic continuous function (plurality of sets of alignment curves of alignment zone blended into an uneven but rather smooth, continuous annular alignment zone; [0088]) along the axis (Z-axis, i.e., optical axis; [0024]) of said central optical zone (central optical zone 22; [0084]), which can be a sine wave, a square wave or a sawtooth wave and other periodic functions (progressive, alignment curvatures can be blended for an uneven but smooth and continuous annular alignment zone 26; [0078] & [0088], optical zone 22 and its base curve(s) designed as not conforming to central cornea shape while still controlling lens orientation with peripheral alignment zone 26; [0010]), and the curvature design ([0097]) of said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) is performed by rotating clockwise or counterclockwise (counterclockwise; [0046]).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tung WO 2021252808 A1 (see machine translation; utilizing US 20230229021 A1 for mapped citations of WO 2021252808 A1 herein) in view of Fricker "Zernike polynomials, MATLAB Central File Exchange".
With respect to Claim 8, Tung discloses the optical design method (method for making contact lenses; [0067]) for designing a non-orthogonal and non-symmetric contact lens (in off-centered keratoconus or PMD cases, asymmetry extends beyond cornea margin, design P-Qdrt lenses for loosening peripheral zone 28 in one or two quadrants to accommodate; [0115]) as claimed in claim 5, wherein the equation calculates (standard aspheric lens equation derived by sagittal height equation; [0063]) the curvature (optical zone 22 and its base curve(s) 30; [0010], [0049]) of said at least one radial curve (alignment zone 26, adjacent to and radially outward from outer margin of optical zone 22; [0088]) of said central optical zone (central optical zone 22; [0084]) through equation (3):
W
r
,
θ
=
∑
n
,
m
C
n
m
Z
n
m
(
r
,
θ
)
(mm) (be any of conventional contact lens design, aspheric contact lens or incorporating dual geometric or reverse geometric designs; [0107], software comprises database portion and set of logic calculation components; [0120]; fig. 8, measured corneal/ocular surface information including corneal curvatures, e-value, elevation map, corneal size, other data utilized in generating and calculating lens specification, and thus, calculating precisely engineered surface shape and obtaining advanced aberration-correcting design; [0121]),
the aspheric surface angle (θ) of the function z =
f
(
θ
)
is calculated (orientation angles between 0° and 360° in conjunction with axial thickness, and thus, utilizing thickness as a function of aspheric angle; [0046] & [0079]), where
Q
is the coordinate position of any point a (coordinate system described by the X-axis 41, Y-axis 42, and Z-axis 43 is a Cartesian coordinate system; [0069]) on the aspheric surface (aspheric alignment zone; [0103]) of said at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) on the surface of said central optical zone (central optical zone 22; [0084]) of the function z ([0060] & [0103]). This equation (3) calculates the aspheric angle (θ) of the function z =
f
(
θ
)
(orientation angles between 0° and 360° in conjunction with axial thickness, and thus, utilizing thickness as a function of aspheric angle; [0046] & [0079]), wherein, the coordinate position of any point a [
Q
(
x
1
,
Y
1
)
, Cartesian coordinates;
Q
(
r
,
θ
)
, polar coordinates] (coordinate system described by the X-axis 41, Y-axis 42, and Z-axis 43 is a Cartesian coordinate system; [0069]) on the at least one annular curve (four sets of alignment curves composing annular peripheral portion of contact lens 20; [0049], [0071]) of the surface of the central optical zone (central optical zone 22; [0084]) of the function z,
Q
is the any point a ([0046], [0069], [0079]).
Although Tung does not appear to explicitly recite equation (3):
W
r
,
θ
=
∑
n
,
m
C
n
m
Z
n
m
(
r
,
θ
)
(mm) and equation (3) being a Zernike formula, “where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.” See MPEP §§ 2131 & 2112.
Thus, in another field of endeavor, Fricker teaches analyzing LASIK optical data using Zernike functions, wherein any function
f
r
,
θ
defined on a circle can be expressed as a sum of Zernike modes, just as sine and cosine functions are used in familiar 1-D Fourier analysis:
f
r
,
θ
=
∑
n
=
0
∞
∑
m
=
-
n
n
a
n
m
Z
n
m
(
r
,
θ
)
(pg. 3).
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 Tung to represent data in this way, for the purpose of summarizing a complicated structural deformation or aberration in terms of coefficients associated with the dominant Zernike modes, as taught by Fricker (pg. 3). Furthermore, and by representing data in this way, one can summarize a complicated structural deformation or aberration in terms of a small number of coefficients associated with the dominant Zernike modes. See Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (948 F.2d at 1268, 20 USPQ at 1749-50); note that as long as there is evidence of record establishing inherency, failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Lo-Yu et al. discloses an investigation of the relationship between contact lens design parameters and refractive changes in Ortho-K substantially similar to that of the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to K MUHAMMAD whose telephone number is (571)272-4210. The examiner can normally be reached Monday - Thursday 1:00pm - 9:30pm EDT.
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/K MUHAMMAD/Examiner, Art Unit 2872 17 March 2026
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872