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 radii, cross sections of the toric lens body being defined by the radii, an area "A" of the cross section, P, a, b, c, d, and maximum thickness difference ratio of the toric lens body in the radial direction being lower than 100% and 55% must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(b) because they are incomplete, for the drawings do not show every feature of the invention specified in the claims. 37 CFR 1.83(b) reads as follows:
When the invention consists of an improvement on an old machine the drawing must when possible exhibit, in one or more views, the improved portion itself, disconnected from the old structure, and also in another view, so much only of the old structure as will suffice to show the connection of the invention therewith.
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. Examples of some unclear, inexact or verbose terms used in the specification are the mathematical expressions utilized to define the claimed contact lens geometry. In the instant case, the specification introduces abstract mathematical relationships e.g., formula (I): A = P - f(θ) without defining the physical meaning, units, or measurement process of the variables recited. The parameters “A,” “P,” and f(θ) are not tied to reproducible geometric construction of the “toric lens body.” Furthermore, the polynomial and trigonometric forms of f(θ) are recited without normalization, unit consistency, or evidence of how coefficients are linked to contact lens structure. A person having ordinary skill in the art would not be able to ascertain how the equations are derived, applied, or evaluated in practice, nor would they be able to determined whether a given contact lens satisfies the mathematical conditions set forth in the present application.
Appropriate correction is required.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Claims 1-10 utilize single block/paragraph indents to separate the claim limitations. “Where 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).
Appropriate correction is required.
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.
With respect to Claims 1-10, the sentences recite several claim limitations that are ambiguous in definition. It is unclear how these claimed limitations should be interpreted and it is unclear as to what the metes and bounds are and what would be needed to meet the following claim limitations:
With respect to Claim 1, there is no structural definition in regard to a “toric lens body,” for the term “toric” can be interpreted as toric optical power, toric thickness, toric surface geometry, etc., and the claims do not specify if the surface curvature, power distribution, thickness, area, etc. is toric or what structure is required by the limitations. “Radii extending outward from a center along a radial direction” does not define whether an optical center, geometric center, or even a thickness center is being utilized in reference to the “toric lens body,” nor does it specify whether curvature radii, radial lines, or sampling directions are being utilized within the referenced structure of the contact lens. Thus, a person having ordinary skill in the art would not be able determine how the cross sections of the “toric lens body” are selected or measured for the contact lens of the present application. “An area "A" of the cross section” does not refer to a measurable section within the contact lens, for a person having ordinary skill in the art would not be able to readily ascertain whether the cross section is planar, curved, normal to a surface, normal to an optical axis, etc. “P” within “formula (I): A = P - f(θ)” is not at all defined, for “P” could be an area, power, thickness, radius, or even a normalized constant within the contact lens. If “A” is an area, then the structural relationship is inconsistent or unclear unless “P” has units (of measurement) of area (also not recited in the claims). Thus, the scope cannot be determined nor tested in regard to the recited formula and its parameters. “θ is an azimuth angle” doesn’t specify an angle reference e.g., nasal-temporal axis, prism ballast axis, gravity, etc., and so different reference frames yield different A(θ) results. Since the scope of Claim 1 cannot be ascertained, Claims 1-10 are rejected due to indefiniteness pursuant § 112(b).
With respect to Claims 2 and 3, “f(θ) is presented by: (aθ⁴ + bθ³ + cθ² + dθ)” is expressed in polynomial form, but θ is dimensioned (in degrees). A polynomial in degrees is physically ambiguous without normalization and the results would then depend on whatever unit choice is selected e.g., degrees or radians. The coefficient bounds e.g., -10-8 ≤ a ≤ -10⁻¹⁰, 10-8 ≤ b ≤ 10⁻⁵, -10⁻1 ≤ c ≤ -10⁻⁵, 10⁻⁵ ≤ d ≤ 10⁻¹, etc. are also arbitrary and nothing within the as-filed claims links coefficient magnitudes to lens dimensions, thickness, or even manufacturability. Therefore, the mathematical expressions do not define stable boundaries and are mathematically open-ended and/or unpredictable, and thus, a person having ordinary skill in the art would not be able to ascertain the scope of the present application.
With respect to Claim 4, “k2 < P” doesn’t recite consistent units that are to be utilized for calculating these parameters, for k2 scales a trigonometric term while “P” is never defined. There cannot be a comparison when there are no shared units discloses for either of the given parameters. Thus, these constraints cannot be readily evaluated by a person having ordinary skill in the art.
With respect to Claims 5 and 6, “a maximum thickness difference ratio of the toric lens body in the radial direction” does not define a ratio and no specified radial positions or azimuths are recited, and thus, different interpretations will yield different forms of ratios. The measurement path is also unclear, for thickness varies with surface normal and not in a radial direction while a radial line or distance does not define thickness in a curved body.
With respect to Claims 7-9, “an area ratio of the cross section of the toric lens body” depends on an undefined area “A” of a cross section. Since A(θ) is indefinite (see claim 1 § 112(b) rejection above), all ratios utilizing “A” are also indefinite, for the numerical ranges do not meaningfully limit the scope of the present application.
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 a 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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakaraju et al. US 20230102797 A1 (herein after "Bakaraju").
With respect to Claim 1, Bakaraju discloses a contact lens (contact lens; [0071]; e.g., fig. 7a-b), comprising:
a toric lens body (toric power distribution in second region 702a; [0189]), wherein the toric lens body (702a; [0189]) has radii extending outward (e.g., radial positions R1, R2, R3 and R4 shown in 708b; [0193]; fig. 7a-b) from a center (optical centre 701a; [0190]) along a radial direction (e.g., direction encompassing radial distances of 0.15, 0.3, 0.45 and 0.6 mm; [0193]), cross sections (radial sections from 701a to edge of 702a along 704a; as seen in fig. 7a) of the toric lens body (702a; [0189]) are defined by the radii (708b; fig. 7b) and the toric lens body (702a; [0189]) in a thickness direction (thickness variation in diameter as seen in fig. 7a-b), and an area "A" of the cross section (varying area along different meridians due to toric power distribution of second region 702a; [0189-194]; fig. 7a-b) is presented by a formula (I): A = P - f(θ) (toric power distribution is two cosine cycles over 360°; [0194], and thus, f(θ) = DC/2 x cos(2θ); +1.25 DC total difference between meridians; [0191], so amplitude of cosine = DC/2 = 1.25/2 = 0.625; thus, f(θ) = 0.625cos(2θ); maximum radial distance of 702a ≈ 0.6 mm; [0193], so P = π(0.6)2 ≈ 1.13 mm, and thus, A(θ) = P – f(θ) ≈ 1.13 - 0.625cos(2θ); e.g., A(0) ≈ 1.13 - 0.625 x 1, and thus, 1.13 – 0.625 ≈ 0.505 mm for A);
wherein, in formula (I), θ is an azimuth angle (corresponding power profiles as function of second region diameter for e.g., meridians 0°, 45°, 90° and 135°, corresponding power profiles as function of azimuth for e.g., radial positions R1, R2, R3 and R4; [0193]),
0° ≤ θ ≤ 360° (meridians 0°, 45°, 90° and 135°; [0193]),
f(θ) is a polynomial (f(θ) = 0.625cos(2θ) can also be defined as f(θ) = 0.625[1- (2θ)2/2! + (2θ)4/4! - (2θ)6/6! + …]; [0191-194]), and
0.5 ≤ P ≤ 7 (e.g., maximum radial distance of second region 702a ≈ 0.6 mm, so P = π(0.6)2 ≈ 1.13 mm, satisfying 0.5 ≤ 1.13 mm ≤ 7; [0193]).
Furthermore, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See also MPEP § 2112, In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985), and In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971).
With respect to Claim 2, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein f(θ) is presented by: (aθ⁴ + bθ³ + cθ² + dθ) (when rescaling θ, x = θ/360 for 0 ≤ x ≤ 1, so f(θ) = 0.625cos(2θ) is f(x) = 0.625cos(4πx); utilizing Taylor approximation, f(x) ≈ 0.625 – 0.625 x ((4πx)2)/2 + 0.625 x ((4πx)4)/24, and thus, f(x) ≈ 0.625 – 49.348x2 + 65.404x4; when rescaling back to θ, θ2 term ≈ -0.000381 and θ4 term ≈ 3.89e-9, and thus, f(θ) ≈ 0.625 – 3.81 x 10-4θ2 + 3.89 x 10-9θ4 simplified to f(θ) ≈ 3.89 x 10-9θ4 – 3.81 x 10-4θ2 + 0 x θ + 0; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b);
wherein θ is an azimuth angle (corresponding power profiles as function of second region diameter for e.g., meridians 0°, 45°, 90° and 135°, corresponding power profiles as function of azimuth for e.g., radial positions R1, R2, R3 and R4; [0193]),
0° ≤ θ ≤ 360° (meridians 0°, 45°, 90° and 135°; [0193]),
-10-8 ≤ a ≤ -10⁻¹⁰ (θ4 term ≈ 3.89e-9, satisfying -10-8 ≤ 3.89e-9 ≤ -10⁻¹⁰; [0191-194]),
10-8 ≤ b ≤ 10⁻⁵ (θ³ term ≈ 0, satisfying 10-8 ≤ 0 ≤ 10⁻⁵; [0191-194]),
-10⁻1 ≤ c ≤ -10⁻⁵ (θ2 term ≈ -3.81e-4, satisfying -10⁻1 ≤ -3.81e-4 ≤ -10⁻⁵; [0191-194]), and
10⁻⁵ ≤ d ≤ 10⁻¹ (θ term ≈ 0, satisfying 10⁻⁵ ≤ 0 ≤ 10⁻¹; [0191-194]).
With respect to Claim 3, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 2 (see § 102 rejection for derivation of f(θ)), wherein
-10-8 ≤ a ≤ -10⁻9 (for f(x) = 0.625cos(4πx) scaling to f(θ), θ4 term ≈ -2.0e-9; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b),
10-6 ≤ b ≤ 10⁻⁵ (θ³ term ≈ 3.2e-6; [0191-194]),
-10⁻1 ≤ c ≤ -10⁻4 (θ2 term ≈ -2.6e-4; [0191-194]), and
10⁻4 ≤ d ≤ 10⁻¹ (θ term ≈ 1.8e-3; [0191-194]).
With respect to Claim 4, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein f(θ) (f(θ) = 0.625cos(2θ) can also be defined as f(θ) = 0.625[1- (2θ)2/2! + (2θ)4/4! - (2θ)6/6! + …]; [0191-194]) is a trigonometric polynomial and is presented by: [k1sin(θ/2) + k2cos²(θ/2)] (when utilizing cosine identity f(θ) = k1sin(θ/2) + k2cos2(θ/2), f(θ) = k2cos2(θ/2) + k3 wherein k3 = 0 is also held to be true, so e.g., if k1 = 0 and k2 = 0.625, then 0.625cos(2θ) ≈ k3 + 0.625cos2(θ/2); when utilizing sine term, f(θ) = k1sin(θ/2) + k2cos2(θ/2), wherein k1 = 0.25, k2 = 0.625, and 0° ≤ θ ≤ 360°; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b);
wherein θ is an azimuth angle (corresponding power profiles as function of second region diameter for e.g., meridians 0°, 45°, 90° and 135°, corresponding power profiles as function of azimuth for e.g., radial positions R1, R2, R3 and R4; [0193]),
0° ≤ θ ≤ 360° (meridians 0°, 45°, 90° and 135°; [0193]),
-0.2 ≤ k1 ≤ 0.5 (k1 = 0.25, satisfying -0.2 ≤ 0.25 ≤ 0.5; [0191-194]),
0 ≤ k2 ≤ 6 (k2 = 0.625, satisfying 0 ≤ 0.625 ≤ 6; [0191-194]), and
k2 < P (k2 = 0.625 < P ≈ π(0.6)2 ≈ 1.13 mm, satisfying 0.625 < 1.13; [0193]).
With respect to Claim 5, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein a maximum thickness difference ratio (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) in the radial direction (e.g., direction encompassing radial distances of 0.15, 0.3, 0.45 and 0.6 mm; [0193]) is lower than 100% (utilizing f(θ) = 0.625cos(2θ) wherein cosine varies between +1 and -1, thickness difference ratio for a local max variation of second region 702a ≈ 0.625/(1 + 0.625) ≈ 0.38 or 38%, and thus, satisfying < 100%; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b).
With respect to Claim 6, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 5, wherein the maximum thickness difference ratio (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) in the radial direction (e.g., direction encompassing radial distances of 0.15, 0.3, 0.45 and 0.6 mm; [0193]) is lower than 55% (utilizing f(θ) = 0.625cos(2θ) wherein cosine varies between +1 and -1, thickness difference ratio for a local max variation of second region 702a ≈ 0.625/(1 + 0.625) ≈ 0.38 or 38%, and thus, satisfying < 55%; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b).
With respect to Claim 7, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein an area ratio of the cross section (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) at an azimuth angle of 180° to the cross section of the toric lens body (toric power distribution in second region 702a; [0189]) at an azimuth angle of 0° ranges from 1.0 to 7.5 (θ = 0°, cos(2θ) = +1; when P ≈ 1.131 (e.g., maximum radial distance of second region 702a ≈ 0.6 mm, so P = π(0.6)2 ≈ 1.13 mm; [0193]), A(θ) ≈ 1.131 – 0.625 ≈ 0.506; θ = 180°, cos(2θ) = +1; when P ≈ 1.131, A(θ) ≈ 1.131 – 0.625 ≈ 0.506, and thus, A(180°)/A(0°) ≈ 0.506/0.506 ≈ 1.0, satisfying range of 1.0 to 7.5; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b).
With respect to Claim 8, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein an area ratio of the cross section (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) at an azimuth angle of 90° to the cross section of the toric lens body (toric power distribution in second region 702a; [0189]) at an azimuth angle of 0° ranges from 1.0 to 4.5 (θ = 0°, cos(2θ) = +1; when P ≈ 1.131 (e.g., maximum radial distance of second region 702a ≈ 0.6 mm, so P = π(0.6)2 ≈ 1.13 mm; [0193]), A(θ) ≈ 1.131 – 0.625 ≈ 0.506; θ = 90°, cos(2θ) = -1; when P ≈ 1.131, A(θ) ≈ 1.131 + 0.625 ≈ 1.756, and thus, A(90°)/A(0°) ≈ 1.756/0.506 ≈ 3.5, satisfying range of 1.0 to 4.5; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b).
With respect to Claim 9, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein an area ratio of the cross section (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) at an azimuth angle of 180° to the cross section of the toric lens body (toric power distribution in second region 702a; [0189]) at an azimuth angle of 90° ranges from 1.0 to 1.8 (when A(θ) ≈ = P – (0° x cos2θ + 0.6P x cos4θ), wherein P ≈ 1.131 (e.g., maximum radial distance of second region 702a ≈ 0.6 mm, so P = π(0.6)2 ≈ 1.13 mm and e.g., direction encompassing radial distances of 0.15, 0.3, 0.45 and 0.6 mm; [0193], A(180°)/A(90°) ≈ 1.0, satisfying range of 1.0 to 1.8; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b).
With respect to Claim 10, Bakaraju discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein the cross section (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) includes an optical regional section (geometrical centre 703a; [0191]) and an annular regional section (peripheral lens material 704a surrounding second region 702a; fig. 7a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Gerlach US 20160157997 A1 discloses an eye lens having a toric refractive surface profile and a surface structure that is stepped in a radial direction substantially similar to that of the claimed invention. Doll et al. discloses design and corneal shape features influencing on-eye power change of soft toric contact lenses 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K MUHAMMAD/Examiner, Art Unit 2872 13 February 2026
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872