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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/15/2025 has been considered by the Examiner and made of record in the application file.
Response to Amendment
The amendment filed 11/06/2025 has been entered. Claims 1-20 have been amended.
Response to Arguments
Applicant's arguments filed 11/06/2025 have been fully considered but they are not persuasive.
Regarding the rejections under 35 U.S.C. § 101, applicant’s arguments have been fully considered and are appreciated. However, the examiner respectfully disagrees.
With respect to Step 2A, Prong One, applicant argues that the claims are not directed to an abstract idea because they recite a specific geometric parameterization and numerical procedure for shaping a physical optical surface. Applicant additionally states “this is a concrete engineering rule set for shaping a lens surface at per-meridian resolution”. However, an “engineering rule set” is still an abstract idea. Computing angles and selecting positions and depths of different points is a process that can be done mentally or with the aid of pen and paper. Designing a product using math is a mental process. In Enfish, the claims were directed towards improving a computer’s functionality. However, in the instant application, a computer is just used to perform the calculations. In McRO, there was interaction with the real world by changing an image on a screen. The instant application has no real world interaction. In Diehr, the claims pertained to real world interaction as well, such as steps involving installing rubber in a press, closing the mold, etc. The instant application does not have any real world interaction such as in Diehr.
With respect to Step 2A, Prong Two, applicant argues the claims integrate calculation steps into a practical application that configures a physical optical surface. However, a physical lens is not being constructed in these claims. The process pertains to coming up with the parameters for a contact lens, not making the contact lens. It is a design process. Designing a product using math is a mental process.
With respect to 2B, applicant argues “the claims as a whole transform corneal measurements into a concrete lens-surface specification through a particular, non-conventional sequence of technical steps.” However, there is no real world change as a result of these calculations. The calculations merely determine parameters and values for designing a lens, but there is no lens crafted. There is no physical, tangible lens as a result of the claims, but rather a design for a lens.
Regarding the rejections under 35 U.S.C. § 112(b), applicant’s arguments have been fully considered and are appreciated. However, the examiner respectfully disagrees.
With respect to claim 1, applicant argues that the amended claim now provides objective metes and bounds for how the add location and add power are selected. However, the rejection is not overcome. Claim 1 is unclear due to the language of “is selected to correspond to a desired…” and “is selected to achieve a desired….” This language is vague and indefinite and makes it unclear whether the limitation being claimed is a motivation, a process of designing, or the desires of the person making the contact lens.
With respect to claim 2, applicant’s arguments in combination with the amendments are persuasive and the rejection is withdrawn.
With respect to claim 3, applicant argues that the amendment to overcomes the rejection of record due to providing a definite geometric region from which the CP6 selection is derived. However, similarly to claim 1, the language of “is selected according to a selected area of the volume control zone” is vague and indefinite. It is unclear whether the limitation being claimed is a motivation, a process of designing, or the desires of the person making the contact lens.
With respect to claim 6, applicant argues that the amendment overcomes the rejection of record due to anchoring the angle to an explicit reference plane and axis, removing ambiguity. However, the limitations of claim 6 appear to be definitions. The claim defines the volume control zone by geometric control points, angles, and lines, but without any ranges included. Further, the volume control zone was previously defined in claim 1. It is unclear if this is changing the definition of the volume control zone.
With respect to claims 7, 8, and 15, applicant’s arguments in combination with the amendments are persuasive and the rejection is withdrawn.
Regarding the rejections under 35 U.S.C. § 112(d), applicant’s arguments in combination with the amendments are persuasive and the rejection is withdrawn.
Regarding the rejections under 35 U.S.C. § 102/103, applicant’s arguments have been fully considered and are appreciated. However, the examiner respectfully disagrees.
Applicant argues Gifford does not disclose the claimed squeeze-angle geometry or mid-peripheral add control, Gifford’s geometry does not provide independent control of the squeeze angle, and the missing elements are not taught or suggested by Gifford and adding secondary art would not render them obvious. However, these are not physical limitations. These are steps and definitions used in the process of designing a lens, and motivations used in the process of designing a lens. The limitations are drawn to a product by process and it fails to further limit the subject matter of the claims. Citing In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” See MPEP § 2113. Gifford discloses a similar contact lens with the same structure, therefore it is capable of performing the same function. Due to the contact lens of Gifford and the contact lens of the instant application having the same structure, these definitions and processes are functional equivalents.
The double patenting rejections are withdrawn.
Claim Objections
Claims 1, 4, 8, and 15 are objected to because of the following apparent inadvertent typographical errors:
In the last two paragraphs of claim 1, examiner suggests:
“witihin” should read “within”
“withhin” should read “within”
“th saggital” should read “the sagittal”
In claim 4 line 2, examiner suggests “cetnral” should read “central”
In the second to last paragraph of claim 8, examiner suggests “to correspond to a”
In the second to last paragraph of claim 15, examiner suggests “to correspond to a”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1:
“a local slope of a most peripheral aspect of the volume control zone is defined by a predetermined squeeze angle having an apex at a deepest point of the secondary compression zone”
“wherein the predetermined squeeze angle is the included angle between (i) a line representing a local slope of the posterior surface at a most-peripheral point of the volume control zone, and (ii) a line representing a local slope of the posterior surface at a deepest-sagittal-depth point of the secondary compression zone on the same semi-meridian, the deepest-sagittal-depth point being defined relative to a reference plane coincident with the anterior corneal apex”
Claims 8 and 15:
“generating a posterior surface having a plurality of semi-meridians”
“defining the volume control zone and the secondary compression zone using a set of geometric control points on the semi-meridians at predetermined chord positions measured from the central axis”
“determining a deepest-sagittal-depth point of the secondary compression zone relative to an anterior reference plane coincident with an anterior corneal apex”
“computing a predetermined squeeze angle as an included angle between (i) a line representing a local slope of the posterior surface at a most-peripheral point of the volume control zone and (ii) a line representing a local slope of the posterior surface at the deepest-sagittal-depth point of the secondary compression zone”
“selecting a semi-chord radial distance of a geometric control point CP4 on a first semi-meridian within the secondary compression zone to correspond a desired mid-peripheral add location”
“selecting a sagittal depth of a geometric control point CP6 on a second semi-meridian within the volume control zone is selected to achieve a desired mid-peripheral add power”
Claims 9 and 16:
“selecting a sagittal depth of the secondary compression zone at the geometric control point CP4, measured relative to an anterior reference plane coincident with an anterior corneal apex, the sagittal depth being determined from a sagittal height of the pretreatment cornea at the semi-chord radial distance of the geometric control point CP4”
Claims 10 and 17:
“selecting the sagittal depth of the geometric control point CP6 on the second semi-meridian of the volume control zone comprises selecting the sagittal depth, measured relative to the anterior reference plane, based on a selected area of the volume control zone”
Claims 13 and 20:
“defining the volume control zone by the geometric control point CP4 and a geometric control point CP3 that is medial to CP4”
“positioning CP3 to define a predetermined angle between (i) a line connecting CP3 and CP4 and (ii) a line that lies in the anterior reference plane, passes through CP4, and is orthogonal to the central axis”
Claim 14:
“defining the volume control zone and the secondary compression zone as contiguous portions of a single continuous spline, along each semi-meridian, fitted through geometric control points spanning both zones”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 8-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) a method to design a contact lens (stored on one or more non-transitory machine-readable storage media). This judicial exception is not integrated into a practical application because the claim limitations are directed to designing a contact lens, which is a mental process that can be performed mentally or with the aid of pen and paper, see MPEP 2106.04(a)(2)(III). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as set forth in the analysis below following the current subject matter guidance.
Step
Analysis
1: Statutory Category?
Yes. The claims recite a product.
2A – Prong 1: Judicial Exception Recited?
Yes. The claims recite the limitations of designing a contact lens, which can be performed in the human mind or with the aid of pen and paper. The claims recite designing steps of defining a posterior surface, defining each of the zones of the posterior surface, selecting a semi-chord radial distance, and selecting a sagittal location, which are all directed to the judicial exception of an abstract idea (mental processes). Other than reciting “non-transitory machine-readable storage media,” nothing in the claim precludes the method from practically being performed in the human mind. Except for the “non-transitory machine-readable storage media,” the claim encompasses the user manually performing the operations to define each zone. The limitation is a mental process.
2A – Prong 2: Integrated into a Practical Application?
No. The method is recited at a high level of generality, i.e., as a generic method of defining the zones of the contact lens. The abstract idea is now integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to the abstract idea.
2B: Claim provides an Inventive Concept?
No. The claims as a whole merely require the abstract mental design step (on non-transitory machine-readable storage media). Thus, even viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea. The claims are ineligible.
Further dependent claims 9-14 do not include additional elements that are sufficient to amount to significantly more than the judicial exception following the current subject matter guidance similar to the analysis above.
Claims 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) a method to design a contact lens (on a computer). This judicial exception is not integrated into a practical application because the claim limitations are directed to designing a contact lens, which is a mental process that can be performed mentally or with the aid of pen and paper, see MPEP 2106.04(a)(2)(III). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as set forth in the analysis below following the current subject matter guidance.
Step
Analysis
1: Statutory Category?
Yes. The claims recite a process.
2A – Prong 1: Judicial Exception Recited?
Yes. The claims recite the limitations of designing a contact lens, which can be performed in the human mind or with the aid of pen and paper. The claims recite designing steps of defining a posterior surface, defining each of the zones of the posterior surface, selecting a semi-chord radial distance, and selecting a sagittal location, which are all directed to the judicial exception of an abstract idea (mental processes). Other than reciting “computer-implemented,” nothing in the claim precludes the method from practically being performed in the human mind. Except for the “computer-implemented,” the claim encompasses the user manually performing the operations to define each zone. The limitation is a mental process.
2A – Prong 2: Integrated into a Practical Application?
No. The method is recited at a high level of generality, i.e., as a generic method of defining the zones of the contact lens. The abstract idea is now integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to the abstract idea.
2B: Claim provides an Inventive Concept?
No. The claims as a whole merely require the abstract mental design step (on non-transitory machine-readable storage media). Thus, even viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea. The claims are ineligible.
Further dependent claims 16-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception following the current subject matter guidance similar to the analysis above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “wherein a semi-chord radial distance of a geometric control point CP4, on a first semi-meridian, within the secondary compression zone, is selected to correspond to a desired mid-peripheral add location; and wherein a sagittal depth of a geometric control point CP6, on a second semi-meridian, within the volume control zone is selected to achieve a desired mid-peripheral add power, wherein the sagittal depth of the CP6 is measured relative to an anterior reference plane coincident with the anterior corneal apex” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
The language “selected to correspond to a desired” and “selected to achieve a desired” is unclear and is not a definite phrasing. It is unclear what is being claimed here – whether the limitation is claiming a motivation, if it claiming the benefit of the device without claiming the actual size ranges or physical features of the device, if it is claiming a method of designing a contact lens, or if it is claiming the desires of the person making the contact lens. Despite the wording of the amended limitation, there is no change in scope and the scope is vague and indefinite. For purposes of examination examiner assumes that as long as the structure is the same, then it was designed to be as desired. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955), see MPEP 2144.05.
Therefore, for the purposes of examination, examiner assumes that if the contact lens has the same structure and function, that this is an inherent limitation.
Claims 2-7 are dependent on claim 1 and therefore inherit the same issues.
Regarding claim 2, the limitation “a sagittal depth of the secondary compression zone at the geometric control point CP4, measured relative to an anterior reference plane coincident with the anterior corneal apex, is determined from a sagittal height of the pretreatment cornea at the semi-chord radial distance of CP4” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
The limitation is incomplete for omitting essential elements/steps. The limitation indicates that the sagittal depth of the lens is determined from and therefore related to the sagittal height of the pretreatment cornea. However, it is unclear what the relation is and how one would obtain the sagittal depth from the sagittal height – for example, whether the sagittal depth is the same as, different, bigger smaller, etc. compared to the sagittal height. ¶0049 states the sagittal depth of the secondary compression zone is a function of the sagittal height of the pretreatment cornea, however, no information is given about the function, such as whether it is geometric, exponential, logarithmic, etc. There are also no ranges included. Since this limitation is just saying that the sagittal height of the secondary compression zone is related to the sagittal height of the pretreatment cornea without any metes and bounds to further limit it, this claim is just stating a definition and/or fact, which is inherent.
For the purposes of examination, examiner assumes that since this is just stating a definition and/or fact, that this claim limitation is inherent.
Regarding claim 3, the limitation “the sagittal depth of the geometric control point CP6 on the second semi-meridian within the volume control zone, measured relative to the anterior reference plane, is selected according to a selected area of the volume control zone.” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
This limitation is substantially similar to the limitations in claim 1, and has the same issues as described above in the 112(b) rejection of claim 1. Therefore, for the same reasons, examiner assumes that if the contact lens has the same structure and function, that this is an inherent limitation.
Regarding claim 6, the limitation “the volume control zone is defined by the geometric control point CP4 and a geometric control point CP3 that is medial to the CP4; and the CP3 is positioned to define a predetermined angle between (i) a line connecting the CP3 and the CP4 and (ii) a line that lies in the anterior reference plane, passes through the CP4, and is orthogonal to the central axis” raises clarity issues. It is unclear how this limitation should be interpreted and it is unclear as to what the metes and bounds of the above claim limitations are and would be needed to meet the above claim limitations.
It is unclear what the further limitation is. The claim appears to be defining terms, saying that the volume control zone is defined by geometric control points, and that the geometric control points define certain angles and lines. However, there are no ranges included or any metes and bounds to further limit the claimed invention, therefore this claim is just stating a definition and/or fact, which is inherent. Additionally, the volume control zone was previously defined in claim 1, so it is unclear if this claim is changing the definition of the volume control zone.
For the purposes of examination, examiner assumes that since this is just stating a definition and/or fact, that this claim limitation is inherent.
Claims 8 and 15 recite the limitation "the posterior surface model" in at the end of the third paragraph of both claims. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, examiner assumes “generating a posterior surface model” at the beginning of the third paragraph of each claim.
Claims 1-2, 6, 8, 13, 15, and 20 recite the limitations “the CP3” “the CP4” “the CP6” “CP3” “CP4” “CP6” throughout the claims. There is insufficient antecedent basis for this limitation in the claims. It is unclear for each if it is a new element or if it is the same as “the geometric control point CP3/CP4/CP6”. For the purposes of examination, examiner assumes “CP3” and “the CP3” as “the geometric control point CP3”, “CP4” and “the CP4” as “the geometric control point CP4”, and “CP6” and “the CP6” as “the geometric control point CP6”. See below for each instance:
“the CP6” in the second to last line of claim 1
“of CP4” in the last two lines of claim 2
“the CP3” and “the CP4” throughout the entirety of claim 6
“of CP6” in the second to last line of claim 8
“the CP3” and “the CP4” throughout the entirety of claim 13
“of CP6” in the second to last line of claim 15
“the CP3” and “the CP4” throughout the entirety of claim 20
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
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-10, 13-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gifford et al. (US 20200041816 A1), hereinafter Gifford.
Regarding independent claim 1, Gifford discloses a contact lens for reshaping a pretreatment cornea of an eye of a patient, comprising:
an anterior surface (14; Figs. 1-2; ¶0216); and
a posterior surface (16; Figs. 1-2; ¶0216) having a plurality of semi-meridians (Figs. 1-2, 9) angularly spaced about a central axis of the lens (Figs. 1-2, 9), each semi-meridian (Figs. 1-2, 9) extending from a lens center toward an edge terminus (38; Fig. 9; ¶0242) (inherent, a semi-meridian can be defined along any radius of the lens; Figs. 1-2), the plurality of semi-meridians (Figs. 1-2, 9) defining multiple zones (12, 1, 2, 3, 4, 5; Figs. 1-2; ¶0216-¶0222) comprising:
a central compression zone (12; Figs. 1-2, 9; ¶0222) to contact the pretreatment cornea (Fig. 9),
a volume control zone (1-2; Figs. 1-2; ¶0217-¶0218) peripheral to the central compression zone (12) (Figs. 1-2),
a secondary compression zone (between zones 2 and 3; Figs. 1-2, 9; ¶0218) to contact the pretreatment cornea (Fig. 9), wherein the secondary compression zone (between zones 2 and 3) is peripheral to the volume control zone (1-2) (Figs. 1-2) (while Gifford does not specifically state this zone is a compression zone, because the structure of the claimed system, as identified above, is the same as that claimed, it must inherently perform the same function and apply pressure)1,
a peripheral relief zone (3; Figs. 1-2, 9; ¶0218) peripheral to the secondary compression zone (between zones 2 and 3) (Figs. 1-2, 9),
a landing zone (4-5; Figs. 1-2, 9; ¶0219-¶0220) to contact the pretreatment cornea (Fig. 9), wherein the landing zone (4-5) is peripheral to the peripheral relief zone (3) (Figs. 1-2), and
the edge terminus (38) peripheral to the landing zone (4-5) (Figs. 1-2, 9), wherein a local slope of a most peripheral aspect of the volume control zone (1-2) is defined by a predetermined squeeze angle having an apex at a deepest point of the secondary compression zone (between zones 2 and 3) (Figs. 1-2, 9; this is a definition and the contact lens of Gifford is functionally equivalent – this limitation is being interpreted under 112(f), see above);
wherein the predetermined squeeze angle is the included angle between (i) a line representing a local slope of the posterior surface (16) at a most-peripheral point of the volume control zone (1-2), and (ii) a line representing a local slope of the posterior surface (16) at a deepest-sagittal-depth point of the secondary compression zone (between zones 2 and 3) on the same semi-meridian, the deepest-sagittal-depth point being defined relative to a reference plane coincident with the anterior corneal apex (Figs. 1-2, 9; this is a definition and the contact lens of Gifford is functionally equivalent – this limitation is being interpreted under 112(f), see above);
wherein the volume control zone (1-2) and secondary compression zone (between zones 2 and 3) are defined by a set of geometric control points (Fig. 2) on each semi-meridian (Figs. 1-2, 9) at predetermined chord positions measured from the central axis (inherent that positions would have been chosen; Fig. 2);
wherein a semi-chord radial distance of a geometric control point CP4 (Fig. 2), on a first semi-meridian, within the secondary compression zone (between zones 2 and 3), is selected to correspond to a desired mid-peripheral add location (inherent, see 112(b) rejection above); and
wherein a sagittal depth of a geometric control point CP6 (Fig. 2), on a second semi-meridian, within the volume control zone (1-2) is selected to achieve a desired mid-peripheral add power (inherent, see 112(b) rejection above), wherein the sagittal depth of the CP6 (Fig. 2) is measured relative to an anterior reference plane coincident with the anterior corneal apex (inherent, this is just defining where sagittal depth is being measured from; Figs. 2, 9).
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Regarding claim 2, Gifford discloses the contact lens of claim 1, as set forth above. Gifford further discloses: a sagittal depth of the secondary compression zone (between zones 2 and 3) at the geometric control point CP4 (Fig. 2), measured relative to an anterior reference plane coincident with the anterior corneal apex, is determined from a sagittal height of the pretreatment cornea at the semi-chord radial distance of CP4 (inherent, see 112(b) rejection above).
Regarding claim 3, Gifford discloses the contact lens of claim 1, as set forth above. Gifford further discloses: the sagittal depth of the geometric control point CP6 (Fig. 2) on the second semi-meridian within the volume control zone (1-2) (Figs. 1-2, 9), measured relative to the anterior reference plane, is selected according to a selected area of the volume control zone (1-2) (inherent, see 112(b) rejection above).
Regarding claim 6, Gifford discloses the contact lens of claim 1, wherein: the volume control zone (1-2) is defined by the geometric control point CP4 and a geometric control point CP3 (Fig. 2) that is medial to the CP4 (Fig. 2); and the CP3 is positioned to define a predetermined angle between (i) a line connecting the CP3 and the CP4 (Fig. 2) and (ii) a line that lies in the anterior reference plane, passes through the CP4 (Fig. 2), and is orthogonal to the central axis (inherent, see 112(b) rejection above).
Regarding claim 7, Gifford discloses the contact lens of claim 1, wherein: the volume control zone (1-2) and the secondary compression zone (between zones 2 and 3) are contiguous portions of a single continuous spline (Figs. 2, 9), along each semi-meridian (Figs. 1-2, 9) fitted through geometric control points spanning both zones (Figs. 2, 9).
Regarding independent claim 8, Gifford discloses one or more non-transitory machine-readable storage media (¶0152) encoded with instructions that, when executed by one or more hardware processors of a computing system (¶0152), cause the computing system to perform operations to design a contact lens for reshaping a pretreatment cornea of an eye of a patient (¶0156), the operations comprising:
receiving corneal topography data of the pretreatment cornea (¶0154) and a target mid-peripheral add power (implicit from ¶0152 and ¶0156);
generating a posterior surface (16; Figs. 1-2; ¶0216) having a plurality of semi-meridians (Figs. 1-2, 9) angularly spaced about a central axis of the lens (Figs. 1-2, 9), each semi-meridian (Figs. 1-2, 9) extending radially from a lens center toward an edge terminus (38; Fig. 9; ¶0242) (inherent, a semi-meridian can be defined along any radius of the lens; Figs. 1-2), the posterior surface model defining multiple zones (12, 1, 2, 3, 4, 5; Figs. 1-2; ¶0216-¶0222) comprising:
a central compression zone (12; Figs. 1-2, 9; ¶0222) to contact the pretreatment cornea (Fig. 9),
a volume control zone (1-2; Figs. 1-2; ¶0217-¶0218) peripheral to the central compression zone (12) (Figs. 1-2),
a secondary compression zone (between zones 2 and 3; Figs. 1-2, 9; ¶0218) to contact the pretreatment cornea (Fig. 9), wherein the secondary compression zone (between zones 2 and 3) is peripheral to the volume control zone (1-2) (Figs. 1-2) (while Gifford does not specifically state this zone is a compression zone, because the structure of the claimed system, as identified above, is the same as that claimed, it must inherently perform the same function and apply pressure),
a peripheral relief zone (3; Figs. 1-2, 9; ¶0218) peripheral to the secondary compression zone (between zones 2 and 3) (Figs. 1-2, 9),
a landing zone (4-5; Figs. 1-2, 9; ¶0219-¶0220) to contact the pretreatment cornea (Fig. 9), wherein the landing zone (4-5) is peripheral to the peripheral relief zone (3) (Figs. 1-2), and
the edge terminus (38) peripheral to the landing zone (4-5) (Figs. 1-2, 9);
defining the volume control zone (1-2) and the secondary compression zone (between zones 2 and 3) using a set of geometric control points on the semi-meridians (Figs. 1-2, 9) at predetermined chord positions measured from the central axis (inherent that positions would have been chosen; Fig. 2);
for each semi-meridian, determining a deepest-sagittal-depth point of the secondary compression zone (between zones 2 and 3) relative to an anterior reference plane coincident with an anterior corneal apex (inherent that a depth would be determined in the designing process);
for each semi-meridian, computing a predetermined squeeze angle as an included angle between (i) a line representing a local slope of the posterior surface (16) at a most-peripheral point of the volume control zone (1-2) and (ii) a line representing a local slope of the posterior surface (16) at the deepest-sagittal-depth point of the secondary compression zone (between zones 2 and 3) (Figs. 1-2, 9; this is a definition and the contact lens of Gifford is functionally equivalent – this limitation is being interpreted under 112(f), see above);
selecting a semi-chord radial distance of a geometric control point CP4 (Fig. 2) on a first semi-meridian (Figs. 1-2, 9) within the secondary compression zone (between zones 2 and 3) to correspond a desired mid-peripheral add location (inherent, see 112(b) rejection above); and
selecting a sagittal depth of a geometric control point CP6 (Fig. 2) on a second semi-meridian (Figs. 1-2, 9) within the volume control zone (1-2) is selected to achieve a desired mid-peripheral add power (inherent, see 112(b) rejection above); the sagittal depth of CP6 (Fig. 2) being measured relative to the anterior reference plane (inherent, this is just defining where sagittal depth is being measured from; Figs. 2, 9).
Regarding independent claim 15, Gifford discloses a computer-implemented method to design a contact lens for reshaping a pretreatment cornea of an eye of a patient, the method comprising:
receiving corneal topography data of the pretreatment cornea (¶0154) and a target mid-peripheral add power (implicit from ¶0152 and ¶0156);
generating a posterior surface (16; Figs. 1-2; ¶0216) having a plurality of semi-meridians (Figs. 1-2, 9) angularly spaced about a central axis of the lens (Figs. 1-2, 9), each semi-meridian (Figs. 1-2, 9) extending radially from a lens center toward an edge terminus (38; Fig. 9; ¶0242) (inherent, a semi-meridian can be defined along any radius of the lens; Figs. 1-2), the posterior surface model defining multiple zones (12, 1, 2, 3, 4, 5; Figs. 1-2; ¶0216-¶0222) comprising:
a central compression zone (12; Figs. 1-2, 9; ¶0222) to contact the pretreatment cornea (Fig. 9),
a volume control zone (1-2; Figs. 1-2; ¶0217-¶0218) peripheral to the central compression zone (12) (Figs. 1-2),
a secondary compression zone (between zones 2 and 3; Figs. 1-2, 9; ¶0218) to contact the pretreatment cornea (Fig. 9), wherein the secondary compression zone (between zones 2 and 3) is peripheral to the volume control zone (1-2) (Figs. 1-2) (while Gifford does not specifically state this zone is a compression zone, because the structure of the claimed system, as identified above, is the same as that claimed, it must inherently perform the same function and apply pressure),
a peripheral relief zone (3; Figs. 1-2, 9; ¶0218) peripheral to the secondary compression zone (between zones 2 and 3) (Figs. 1-2, 9),
a landing zone (4-5; Figs. 1-2, 9; ¶0219-¶0220) to contact the pretreatment cornea (Fig. 9), wherein the landing zone (4-5) is peripheral to the peripheral relief zone (3) (Figs. 1-2), and
the edge terminus (38) peripheral to the landing zone (4-5) (Figs. 1-2, 9);
defining the volume control zone (1-2) and the secondary compression zone (between zones 2 and 3) using a set of geometric control points on the semi-meridians (Figs. 1-2, 9) at predetermined chord positions measured from the central axis (inherent that positions would have been chosen; Fig. 2);
for each semi-meridian, determining a deepest-sagittal-depth point of the secondary compression zone (between zones 2 and 3) relative to an anterior reference plane coincident with an anterior corneal apex (inherent that a depth would be determined in the designing process);
for each semi-meridian, computing a predetermined squeeze angle as an included angle between (i) a line representing a local slope of the posterior surface (16) at a most-peripheral point of the volume control zone (1-2) and (ii) a line representing a local slope of the posterior surface (16) at the deepest-sagittal-depth point of the secondary compression zone (between zones 2 and 3) (Figs. 1-2, 9; this is a definition and the contact lens of Gifford is functionally equivalent – this limitation is being interpreted under 112(f), see above);
selecting a semi-chord radial distance of a geometric control point CP4 (Fig. 2) on a first semi-meridian (Figs. 1-2, 9) within the secondary compression zone (between zones 2 and 3) to correspond a desired mid-peripheral add location (inherent, see 112(b) rejection above); and
selecting a sagittal depth of a geometric control point CP6 (Fig. 2) on a second semi-meridian (Figs. 1-2, 9) within the volume control zone (1-2) is selected to achieve a desired mid-peripheral add power (inherent, see 112(b) rejection above); the sagittal depth of CP6 (Fig. 2) being measured relative to the anterior reference plane (inherent, this is just defining where sagittal depth is being measured from; Figs. 2, 9).
Regarding claims 9 and 16, Gifford discloses the one or more non-transitory machine-readable storage media of claim 8 and the computer-implemented method of claim 15, as set forth above. Gifford further discloses the operations and method further comprising: selecting a sagittal depth of the secondary compression zone (between zones 2 and 3) at the geometric control point CP4 (FIG. 2), measured relative to an anterior reference plane coincident with an anterior corneal apex (inherent, this is just defining where sagittal depth is being measured from; Figs. 2, 9), the sagittal depth being determined from a sagittal height of the pretreatment cornea at the semi-chord radial distance of the geometric control point CP4 (Fig. 2) (Figs. 1, 2, 9; ¶0049-¶0058; functionally equivalent – this limitation is being interpreted under 112(f), see above).
Regarding claims 10 and 17, Gifford discloses the one or more non-transitory machine-readable storage media of claim 8 and the computer-implemented method of claim 15, as set forth above. Gifford further discloses the storage media and method further comprising: selecting the sagittal depth of the geometric control point CP6 (Fig. 2) on the second semi-meridian of the volume control zone (1-2) comprises selecting the sagittal depth, measured relative to the anterior reference plane, based on a selected area of the volume control zone (1-2) (Figs. 1, 2, 9; ¶0049-¶0058; functionally equivalent – this limitation is being interpreted under 112(f), see above).
Regarding claims 13 and 20, Gifford discloses the one or more non-transitory machine-readable storage media of claim 8 and the computer-implemented method of claim 15, as set forth above. Gifford further discloses the operations and method further comprising: defining the volume control zone (1-2) by the geometric control point CP4 (Fig. 2) and a geometric control point CP3 (Fig. 2) that is medial to CP4 (Fig. 2) (inherent, Figs. 1, 2, 9; ¶0049-¶0058; this limitation is being interpreted under 112(f), see above); and positioning CP3 (Fig. 2) to define a predetermined angle between (i) a line connecting CP3 and CP4 (Fig. 2) and (ii) a line that lies in the anterior reference plane, passes through CP4 (Fig. 2), and is orthogonal to the central axis (inherent, Figs. 1, 2, 9; ¶0049-¶0058; functionally equivalent – this limitation is being interpreted under 112(f), see above).
Regarding claim 14, Gifford discloses the one or more non-transitory machine-readable storage media of claim 8, as set forth above. Gifford further discloses the operations further comprising: defining the volume control zone (1-2) and the secondary compression zone (between zones 2 and 3) as contiguous portions of a single continuous spline, along each semi-meridian, fitted through geometric control points spanning both zones (Fig. 2; functionally equivalent – this limitation is being interpreted under 112(f), see above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4-5, 11-12, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford (US 20200041816 A1).
Regarding claim 4, Gifford discloses the contact lens of claim 1, as set forth above. Gifford does not specifically disclose a semi-chord radial distance, measured from the central axis, of the geometric control point CP4 (Fig. 2) is within a range from 2.6 mm to 5.2 mm.
Gifford teaches a semi-chord radial distance, measured from the central axis, of the geometric control point CP4 (Fig. 2) is within a range of 1.6 mm to 6.5 mm (¶0215-¶0220). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05. One would be motivated to have a semi-chord radial distance of the first geometric control point CP4 in a range of 2.6 mm to 5.2 mm for the purpose of effectively controlling the shape of the contact lens to apply pressure to the cornea to reshape the eye.
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for one to choose the semi-chord radial distance of the first geometric control point CP4 in the overlapping range as disclosed by Gifford to be in the claimed range for the purpose of effectively controlling the shape of the contact lens to apply pressure to the cornea to reshape the eye.
Regarding claim 5, Gifford discloses the contact lens of claim 1, as set forth above. Gifford does not explicitly disclose the secondary compression zone (between zones 2 and 3) has, along each semi-meridian, a radial width between its proximal and distal boundaries within a range of 0.2 mm to 0.8 mm (however, this range is suggested by Fig. 2 and ¶0215-¶0220)2.
Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955), see MPEP 2144.05. In this case Gifford has a central compression zone, a volume control zone (1-2), a secondary compression zone (between zones 2 and 3), a peripheral relief zone (3), a landing zone (4-5), and an edge terminus (38), fulfilling the general conditions of the claim. One would be motivated to make the width of the secondary compression zone between 0.2 mm and 0.8 mm for the purpose of effectively applying pressure to the cornea through the secondary compression zone to reshape the eye.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the secondary compression zone to have a width in a range of 0.2 mm to 0.8 mm for the purpose of effectively applying pressure to the cornea through the secondary compression zone to reshape the eye and since it has been held that discovering the optimum or workable ranges only involves routine skill in the art.
Regarding claims 11 and 18, Gifford discloses the one or more non-transitory machine-readable storage media of claim 8 and the computer-implemented method of claim 15, as set forth above. Gifford does not specifically disclose selecting a semi-chord radial distance, measured from the central axis, of the geometric control point CP4 (Fig. 2) to be within a range from 2.6 mm to 5.2 mm.
Gifford teaches a semi-chord radial distance, measured from the central axis, of the geometric control point CP4 (Fig. 2) is within a range of 1.6 mm to 6.5 mm (¶0215-¶0220). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); see MPEP 2144.05. One would be motivated to have a semi-chord radial distance of the first geometric control point CP4 (Fig. 2) in a range of 2.6 mm to 5.2 mm for the purpose of effectively controlling the shape of the contact lens to apply pressure to the cornea to reshape the eye.
Therefore, it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention for one to choose the semi-chord radial distance of the first geometric control point CP4 (FIG. 2) in the overlapping range as disclosed by Gifford to be in the claimed range for the purpose of effectively controlling the shape of the contact lens to apply pressure to the cornea to reshape the eye.
Regarding claims 12 and 19, Gifford discloses the one or more non-transitory machine-readable storage media of claim 8 and the computer-implemented method of claim 15, as set forth above. Gifford does not explicitly disclose selecting a radial width of the secondary compression zone (between zones 2 and 3), along each semi-meridian, between its proximal and distal boundaries, to be within a range from 0.2 mm to 0.8 mm (however, this range is suggested by Fig. 2 and ¶0215-¶0220).
Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955), see MPEP 2144.05. In this case Gifford has a central compression zone, a volume control zone (1-2), a secondary compression zone (between zones 2 and 3), a peripheral relief zone (3), a landing zone (4-5), and an edge terminus (38), fulfilling the general conditions of the claim. One would be motivated to make the width of the secondary compression zone between 0.2 mm and 0.8 mm for the purpose of effectively applying pressure to the cornea through the secondary compression zone to reshape the eye.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the secondary compression zone to have a width in a range of 0.2 mm to 0.8 mm for the purpose of effectively applying pressure to the cornea through the secondary compression zone to reshape the eye and since it has been held that discovering the optimum or workable ranges only involves routine skill in the art.
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 NATASHA NIGAM whose telephone number is (571)270-5423. The examiner can normally be reached Monday - Friday 8-5.
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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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/NATASHA NIGAM/Examiner, Art Unit 2872 January 22nd, 2026
/RICKY L MACK/Supervisory Patent Examiner, Art Unit 2872
1 While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997)).
2 It has been held the drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979), see MPEP 2125.