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 .
Response to Arguments
Applicant's argument s filed 14 May 2026 have been fully considered but they are not persuasive. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Please see response to arguments below in the present Office action.
In response to the applicant's argument that "The specification is objected to as not giving specific definitions, physical meanings…Applicant respectfully submits that the objection to the specification has been overcome," the Examiner traverses. See specification new matter objection(s) and § 112(a) claim rejection(s) below in the present Office action, necessitated by amendment.
In response to the applicant's argument that "The drawings are objected to because of not indicating every feature specified in the claims…being lower than 100% and 55% in claims 5 and 6, and thus the objections to the drawings have been overcome," the Examiner traverses. Many of these claimed elements are still unsupported, for merely labeling a radial direction axis as “r” does not disclose the limitation “the toric lens body has radii extending outward from a geometric center of the toric lens body.” Examiner submits that “Applicant respectfully presents that the radii r and the cross section of the tonic lens body defined by the radii have been shown in the original FIGS. 2, 3 and 6-8” is incorrect. The as-filed specification and drawings do not indicate that “r” is for the radii and the drawings illustrate an arrow (i.e., indicating a direction) for “r,” that extends beyond the toric lens body. The claim requires a defined geometric relationship to a specific center of the toric lens body while the drawings depict an unlabeled graph axis identified only as “r” representing any radial coordinate, normalized distance, or independent variable. Furthermore, the absence of disclosure of P cannot be remedied by adding new matter to the specification and characterizing P as a “selectable design base.” Graphs depicting axes labeled “r” and “z” without numerical values, scales, or reference dimensions do not disclose that “a maximum thickness difference ratio of the toric lens body in the radial direction is lower than 100%” and “the maximum thickness difference ratio of the toric lens body in the radial direction is lower than 55%.” Such ratios require quantitative information that includes at least the maximum and minimum thickness values. A person having ordinary skill in the art would not be able determine whether the claim thresholds are met without these values. The mere mention of a thickness profile in the specification and claims does not clearly link any particular percentage limitations within unlabeled graphs within the drawings, for numerous profiles of varying magnitudes could produce the same qualitative graph shape(s). Thus, drawings lacking numerical (e.g., radial direction is lower than 100%) and unsupported context (e.g., “the radii r”) do not show the specific limitations recited in the claims.
In response to the applicant's argument that "Claims 1-10 are rejected under 35 U.S.C. @ 112(b)…based on the above amendments, Applicant respectfully submits that the 35 U.S.C. § 112 rejection to the claims has been overcome," the Examiner traverses. See § 112(b) rejection(s) below in the present Office action, necessitated by amendment.
In response to the applicant's argument that "In the Office Action, the polynomial f(0) represented by [k1sin(0/2) + k2cos2(0/2)]…Bakaraju in fact fails to disclose or suggest the recited trigonometric polynomial for defining a cross-sectional area of the toric lens body," the Examiner traverses. Per the last Office action, “cross sections (radial sections from 701a to edge of 702a along 704a; as seen in fig. 7a) of the toric lens body (702a; [0189])” was already mapped and cited (See Non-final Rejection dated 20 February 2026). Examiner reminds the applicant that the claims are directed to a contact lens product and they define that product utilizing prominent toric lens structure recitation and mathematical relationships. The patentability of this contact lens application is about whether the prior art lens structure satisfies the claimed structural limitations, rather than whether the prior art expressly used the same mathematical characterization or intended use. Examiner submits that a prior art product is not distinguished merely because the applicant describes the same structure using different equations. Bakaraju does not need to explicitly identify the recited trigonometric polynomial where such calculations and values are inherent to the disclosed structure and are derivable through routine analysis by a person having ordinary skill in the art. The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
In response to the applicant's argument that "According to paragraph [0194] of Bakaraju, the cosine function of Bakaraju…the physical meaning of such trigonometric function is substantially different from the function of the area "A" of the present application," the Examiner traverses. Applicant’s argument is unpersuasive, for Bakaraju describing a cosine function as representing a sphero-cylindrical power distribution does not establish that the disclosed toric lens body lacks the claimed geometric characteristics. A prior art structure is not patentably distinguished merely because it is described using a different mathematical framework or attributed a different physical meaning. Applicant has failed to provide evidence that the disclosed toric geometry cannot satisfy the claimed area function. Applicant assumes that refractive power and cross-sectional areas are unrelated, but the claimed coefficients are broad and were derived directly from the disclosed embodiment using routine mathematical analysis well within ordinary skill in the art. Re-expressing a known structural variation using an alternative trigonometric basis does not impart patentable distinction to the underlying contact lens product. Furthermore, the claims do not recite a method of generating a function, deriving coefficients, or assigning a particular physical meaning to the recited math. Examiner reminds the applicant that 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). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In response to the applicant's argument that "In addition, regarding the derivation of the power distribution function proposed in the Office Action…its refractive power function as a cross-sectional area function of the entire toric lens body, either," the Examiner traverses. In response to applicant's argument that "Applicant respectfully submits that the ability to mathematically derive a similar expression does not constitute a teaching or suggestion of the claimed use," a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP § 2111. Applicant attempts to import process limitations into a product claim by arguing that Bakaraju does not teach using its refractive power function as a cross-sectional area function. The claims do not recite a method of deriving the equations, measuring the lens, performing the calculations, or generating the coefficients, for they merely define the lens by resulting mathematical relationships. Furthermore, the applicant has failed to establish that the claimed parameters produce a structurally distinct lens. See previous arguments above and claim rejection(s) below in the present Office action for further details and guidance.
In response to the applicant's argument that "Furthermore, as indicated above, even a person having ordinary skill in the art tries to manipulate the mathematical expression disclosed in Bakaraju…is not predictable or routine under the principles for determining obviousness," the Examiner traverses. Counsel's assertion is merely an argument unaccompanied by evidentiary support, and, thus, is insufficient to rebut Examiner's findings. Arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). MPEP § 2145, 716.01(c). The ranges for P, k1, and k2 encompass values directly derivable from the disclosed embodiment of Bakaraju. Fourier-type decompositions and trigonometric representations of symmetric toric profiles are well-known analytical tools in the art as well. Examiner submits that expressing a known toric distribution utilizing an alternative but mathematically related trigonometric basis would have been a routine design choice and does not amount to a redesign absent evidence or critically or unexpected results. Examiner reminds the applicant that “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
In response to the applicant's argument that "Moreover, according to lines 1-4 of paragraph [0193] of Bakaraju, it is understood that the calculation…should be different from the calculation of the second region 702a," the Examiner traverses. Examiner reminds the applicant that the claims do not require that the mathematical relationship be derived from or describe the entirety of the optic zone. The recited claims merely recite a toric lens body having surface curvature and cross sections with areas satisfying the claimed function. The allegation that Bakaraju characterizes the toric second region 702a rather than the entire optical zone 700a does not establish that the claimed limitations are absent. The second region 702a is itself a part of the disclosed toric lens structure and embodies the very toric characteristics relied upon to derive the claimed parameters. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., calculation for the whole optic zone, and optic zone not even being recited at all in Claim 1, calculation of zones being different, etc.) are not recited in the rejected claim(s). 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). Applicant has failed to provide evidence demonstrating that the whole optic zone fails to satisfy the claimed relationships and would alter the claimed ranges. Arguments that calculations for the entire optic zone “should be different” is speculative and unsupported by technical evidence. Examiner submits that even if the whole optic zone, which is not recited at all in independent Claim 1, were represented by a modified expression, extending a localized toric distribution to the broader lens structure through routine geometric analysis would have been well within ordinary skill in the art and does not establish a patentable distinction. Applicant’s argument merely identifies a difference in the region(s) from which the mathematical characterization originates, not a structural difference in the claimed contact lens itself, and thus, does not rebut the finding(s) that Bakaraju discloses the claimed limitations. See MPEP § 2145, 716.01(c).
In response to the applicant's argument that "Also, Applicant further submits that, the selection of the range of the parameters P, k1 and k2 is not arbitrary…such selection cannot be dismissed as a matter of design choice," the Examiner traverses. Examiner reminds the applicant that the current and previous Office action (See Non-final Rejection dated 20 February 2026) never asserted that the claimed parameters constitute a matter of design choice. The recited values were derived from the express disclosures of a Bakaraju embodiment and have been shown to fall within the broadly claimed ranges. Bakaraju discloses a toric second region having a cosine power distribution with two axes of mirror symmetry and a toric magnitude of +1.25 DC ([0191]; figs. 7a-b). The disclosed mirror symmetry supports k1 = 0, which satisfies the claimed range of -0.2 ≤ k1 ≤ 0.5. The +1.25 DC toric magnitude yields a cosine amplitude of 1.25/2 = 0.625, thereby supporting k2 = 0.625, which satisfies the claimed range of 0 ≤ k2 ≤ 6. Furthermore, and utilizing the express disclosed representative radial position of 0.6 mm, P is approximated as π(0.6)2 ≈ 1.13 mm2 , satisfying both 0.5 ≤ P ≤ 7 and k2 < P. Examiner submits that the identified values were not arbitrarily selected, but instead come directly from the disclosed toric lens geometry and mathematical characteristics of the prior art of Bakaraju. Applicant has failed to provide objective evidence demonstrating that Bakaraju also lacks the asserted properties relating to thickness distribution, mechanical stability, or manufacturability. Applicant’s assertion that the claimed parameters provide technical effects does not rebut the fact that the prior art of Bakaraju expressly or inherently discloses values within the claimed limitations. Since no evidence of criticality or unexpected results has been attributed to the claimed ranges, the applicant has not persuasively established a patentable distinction over Bakaraju. Examiner also reminds the applicant that the fact that the inventor has recognized another advantage (e.g., “generate a defined structural configuration. In fact, such configuration produces technical effects”) which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to the applicant's argument that "Accordingly, Applicant respectfully presents that Bakaraju at least fails to disclose…as recited in the amended claim 1 of the present application. (Emphasis added)," the Examiner traverses. See previous arguments above and claim rejection(s) below in the present Office action for further details and guidance. Examiner notes that the asserted distinction argued over the prior art of Bakaraju appears to reside primarily in the recitation of mathematical relationships and formulas utilized to characterize the claimed contact lens product. To the extent that patentability is predicated on such mathematical concepts alone, without identifying a structural distinction in the claimed article itself, the claims may implicate subject matter eligibility concerns under 35 USC § 101. Mathematical relationships, formulas, and calculation are recognized judicial exceptions that can be performed in the human mind or with pen and paper. See MPEP § 2106.04(a)(2). The purported point of novelty should be a structurally distinct lens, rather than mere mathematical descriptions of a lens. As the Federal Circuit explained, “methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’” 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)).
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which they think 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 fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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, P, 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 as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “the radii r” (See Arguments/Remarks Made in an Amendment, Specification, and Drawings dated 14 May 2026 and 08 April 2024).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “basic area parameter P” (See Arguments/Remarks Made in an Amendment, Specification, and Drawings dated 14 May 2026 and 08 April 2024; See specification objection(s) below for new matter).
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 amendment filed 14 May 2026 is objected to under 35 U.S.C. 132 (a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “f(θ) and a basic area parameter P. From the formula (I), it is known that the unit of the basic area parameter P is the same as the area A. In some embodiments, the area A and the basic area parameter P are standardized and are unitless. as will be described below” (See para. [0042] in as-filed specification dated 14 May 2026) and “In addition, it is observed that in some examples, the value of f(θ) equals to zero, and thus A = P. Therefore, in some embodiments, the value of the basic area parameter P is selected as a design base of the area A of the contact lens” (See para. [0087] in as-filed specification dated 14 May 2026).
The amendments introduce new subject matter of parameter P that is not reasonably conveyed by the original disclosure, for assertions that P is a basic parameter and can be selected as a design base of the area of the contact lens attribute new functional significance and design of the contact lens. Although a person having ordinary skill in the art could infer that P must have units compatible with A if A is an area, this does not provide written description support for redefining P as a fundamental design parameter or characterizing P as a selectable design base. Thus, these amendments constitute new matter because they introduce functional roles of the variables rather than merely explaining what was originally disclosed.
Applicant is required to cancel the new matter in the reply to this Office action.
Claim Objections
Claims 1, and 5-10 are objected to because of the following informalities:
Claims 1, and 5-10 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(a)
The following is a quotation of 35 U.S.C. 112(a) :
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112 :
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, and 5-10 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112 , the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to Claim 1, the recitation “P is a basic area parameter” in line 7 is considered new subject matter because the amendment does not merely clarify existing subject matter and is not supported by the original disclosure. Instead, the amendment introduces a new characterization and functional role for P that was not reasonably conveyed by the original disclosure. Although a person having ordinary skill in the art may recognize that P has dimensions compatible with area, such recognition does not provide written description support for treating P as a fundamental design parameter of the lens geometry. As stated in the specification objection(s) above in the present Office action, these amendments constitute new matter because they introduce functional roles of the variables rather than merely claiming what was originally disclosed.
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, and 5-10 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 Claim 1, the recitation “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. The orientation of the angular coordinate system is not specified, and thus, a person having ordinary skill in the art would not be able to determine with reasonable certainty which cross sections correspond to particular values of θ, which renders the scope of the claimed area function unclear. Since the metes and the bounds of Claim 1 cannot be ascertained, Claims 1-10 are rejected due to indefiniteness pursuant § 112(b).
With respect to Claims 5 and 6, the recitation “herein the toric lens body includes an optical region and an annular region, a thickness difference ratio of the toric lens body is calculated by dividing a thickness difference at boundaries between the optical region and the annular region by a thickness of an edge of the optical region; wherein a maximum thickness difference ratio of the toric lens body in the radial direction is lower than 100%...wherein the maximum thickness difference ratio of the toric lens body in the radial direction is lower than 55%” is indefinite and unclear. A person having ordinary skill in the art would not be able to ascertain: what defines the optical region and the annular region, what differentiates each region from the other, whether the boundaries are discernable, what the thickness difference looks like at each boundary, etc. Examiner notes that there appears to be one circular boundary between the two claimed regions on the surface of the lens within the submitted drawings. If this is the only boundary illustrated, then it is unclear where the other boundaries are located. It is also unclear whether they have different values that would affect the ratio or not. The undefined measurement basis for the thickness difference is also unclear, for there is no clarity in regards to whether the thickness is sag difference, axial thickness along an optical axis, surface separation, etc. It is also unclear where on the edge, and in what direction, thickness is measured. Examiner submits that the functional scope uncertainty makes it unclear whether these limitations are directed to a design constraint, measurement method, or a property of a manufactured lens, which affects how infringement would even be evaluated. Each of these limitations have multiple interpretations which would change the scope of the claims compared to the state of the art. Therefore, one of ordinary skill in the art would not be apprised as to the scope of the invention. See MPEP § 2173.05(b)). Examiner further submits that the graphs within the drawings depicting axes labeled “r” and “z” without numerical values, scales, or reference dimensions do not disclose that “a maximum thickness difference ratio of the toric lens body in the radial direction is lower than 100%” and “the maximum thickness difference ratio of the toric lens body in the radial direction is lower than 55%.” Such ratios require quantitative information that includes at least the maximum and minimum thickness values. A person having ordinary skill in the art would not be able determine whether the claim thresholds are met without these values.
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 or 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, and 5-10 are rejected under 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bakaraju et al. US 20230102797 A1 (herein after "Bakaraju") in view of Fricker "Zernike polynomials, MATLAB Central File Exchange" (Published 2008, pgs. 1-10).
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]) having a toric surface curvature (adjacent surface curvatures; [0027]), 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 geometric center (optical centre 701a; [0190]) of the toric lens body (toric power distribution in second region 702a; [0189]) 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 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)] (due to two axes of mirror-symmetry, sin(θ/2) =/= sin[360°-θ)/2], and thus, k1 = 0; [0194], when utilizing cosine identity cos2(θ/2) = [1+cos(θ)]/2, there is a cosine amplitude of k2 = 0.625; [0191], when substituting the values, f(θ) = [0sin(θ/2) + 0.625cos2(θ/2)], hence f(θ) = k1sin(θ/2) + k2cos2(θ/2), wherein k1 = 0, k2 = 0.625, and 0° ≤ θ ≤ 360°; derived from toric power distribution for second region 702a profile data within [0191-194]; fig. 7a-b) P is a basic area parameter (e.g., P = π(0.6)2 ≈ 1.13 mm2; [0189-194]; fig. 7a-b), -0.2 ≤ k1 ≤ 0.5 (k1 = 0, satisfying -0.2 ≤ 0 ≤ 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 mm2, satisfying 0.625 < 1.13; [0193]);
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]) with reference (fig. 7a-b) to the geometric center (optical centre 701a; [0190]),
0° ≤ θ ≤ 360° (meridians 0°, 45°, 90° and 135°; [0193]), and
0.5 ≤ P ≤ 7 (e.g., maximum radial distance of second region 702a ≈ 0.6 mm2, so P = π(0.6)2 ≈ 1.13 mm2, satisfying 0.5 ≤ 1.13 mm2 ≤ 7; [0193]).
Although Bakaraju does not appear to explicitly recite the equation(s) A = P - f(θ) wherein f(θ) is a trigonometric polynomial and is presented by: [k1sin(θ/2) + k2cos2(θ/2)], a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:…(C) Show that a characteristic not disclosed in the reference is inherent. 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. See MPEP §§ 2131 & 2112.
Thus, in the same 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
)
(equation 2, pg. 3). For example, if a general Fourier series is
f
θ
=
a
0
+
∑
n
[
a
n
cos
n
θ
+
b
n
s
i
n
(
n
θ
)
], then utilizing the cosine identity cos2(θ/2) = [1+cos(θ)]/2 provides f(θ) = k2/2 + (k2/2)cos(θ) + k1sin(θ/2), which is just a truncated trigonometric expansion and low-order Fourier representation.
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 Bakaraju in view of Fricker to include the technical feature of representing an area function in numerous ways. By representing data in this way (i.e.,
f
r
,
θ
=
∑
n
=
0
∞
∑
m
=
-
n
n
a
n
m
Z
n
m
(
r
,
θ
)
,
f
θ
=
a
0
+
∑
n
[
a
n
cos
n
θ
+
b
n
s
i
n
(
n
θ
)
], etc.), one has the advantage of summarizing a complicated structural deformation or aberration in terms of a small number of coefficients associated with the dominant Zernike modes, as taught by Fricker (pg. 3). 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); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
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). Examiner reminds the applicant that 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. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977).
With respect to Claim 5, Bakaraju in view of Fricker discloses the contact lens (contact lens; [0071]; e.g., fig. 7a-b) according to claim 1, wherein the toric lens body (toric power distribution in second region 702a; [0189]) includes an optical region (optical zone of the contact lens; [0023-25]) and an annular region (non-optical peripheral carrier zone; [0029]), a thickness difference ratio (fig. 7a-b) of the toric lens body (toric power distribution in second region 702a; [0189]) is calculated by dividing a thickness difference at boundaries (fig. 7a-b) between the optical region (optical zone of the contact lens; [0022-25]) and the annular region (non-optical peripheral carrier zone; [0029]) by a thickness of an edge (second region comprising edge of optical zone, non-optical peripheral carrier zone connects or lies between second region and remainder of surrounding optic zone; [0027]) of the optical region (blending zone between optic zone and peripheral carrier zone; [0029]); 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 in view of Fricker 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 in view of Fricker 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 in view of Fricker 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 in view of Fricker 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 in view of Fricker 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
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 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 12 June 2026
/SHARRIEF I BROOME/Primary Examiner, Art Unit 2872
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