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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/12/2026 has been entered.
Response to Amendment
The Amendment filed 01/26/2026 has been entered. Claim 1 has been amended.
Response to Arguments
Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive.
Applicant argues that neither Gifford nor Lieberman, either alone or in combination, teach the limitations required by claim 1 that “two or more geometric control points” including “a second control point to independently produce a predetermined squeeze angle between the lens surface and the corneal surface and having an apex at a deepest point of the secondary compression zone,” because Gifford lacks control points and therefore cannot independently vary the volume and the squeeze angle. However, the examiner respectfully disagrees.
Examiner notes that limitations such as “a radial position of a first control point is selected to separate a first region of the volume control zone and a second region of the volume control zone…and to set a sagittal depth of the first control point to independently produce a predetermined tear volume between the lens surface and the corneal surface” and “a second control point to independently produce a predetermined squeeze angle between the lens surface and the corneal surface” are directed towards decisions made by a user during a design process. Processes and methods of designing a device do not hold patentable weight. The act of choosing and deciding what values to set for each property (the radius, width, height, etc.) is not patentable. At best, these limitations can be considered product by process limitations. The same contact lens could have been made using a different process of decision making to arrive at the same structure, therefore these limitations fail to further limit the subject matter the claim. 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. Therefore, these limitations are considered met by any contact lens with the same structure.
Applicant argues it is not possible to use the teachings of Gifford to achieve the surface shape and volume of the present invention because the claimed invention of the instant application uses geometric control points to determine widths and heights and Gifford is limited by spherical and aspherical curves. However, both are directed towards decision making processes which pertains to a method of designing a contact lens that can result in an unlimited amount of different structures. There are no ranges included or any metes and bounds to limit the structure of the claimed invention.
Applicant argues neither Gifford nor Lieberman teach volume control. As far as it is understood, “volume control” is directed towards a process of a user determining a tear volume between the lens surface and the corneal surface. The act of choosing, or a decision making process is a thought process and is not given patentable weight. The contact lens of Gifford has the same structure and a zone that corresponds to the “volume control zone” wherein a tear volume would be produced between the lens surface and the corneal surface simply due to the shape of the lens. The actual structure of the contact lens as claimed in the instant application is disclosed by Gifford. Applicant argues that the terms “volume” and area” are not found in Gifford’s specification. However, the examiner notes the elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990) MPEP § 2131. The structure of the contact lens of Gifford is the same as that of the instant application, therefore, there must be a “volume”.
Regarding applicant’s arguments that Gifford “teaches away” from the claimed invention, the examiner is unpersuaded. A reference may be directed to an entirely different problem than the one addressed by the inventor, or may be from an entirely different field of endeavor than that of the claimed invention, yet the reference is still anticipatory if it explicitly or inherently discloses every limitation recited in the claims, since it has been held "Arguments that the alleged anticipatory prior art is ‘nonanalogous art’ or ‘teaches away from the invention’ or is not recognized as solving the problem solved by the claimed invention, [are] not ‘germane’ to a rejection under section 102." Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) see MPEP 2131.05. Applicant argues that “since the radius of the second peripheral zone is dependent on the selected height of the point joining the zones and the sagittal height of the cornea model, then the angle of incidence is also dependent and cannot be independently controlled.” However, examiner notes again that the act of “controlling” these values is directed towards a method of designing a contact lens and is not given patentable weight.
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 and 6-7 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 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 (Figs. 1-2, 9) 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 (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
an edge terminus (38; Fig. 9; ¶0242) peripheral to the landing zone (4-5) (Figs. 1-2, 9),
wherein the volume control zone (1-2; Figs. 1-2; ¶0217-¶0218) is defined by two or more geometric control points (any points within the region 1-2, such as 1a, 1b, and the next point; see modified Fig. 2) on a semi-meridian of the contact lens (Figs. 1-2, 9), and a radial position of a first control point (1b; see modified Fig. 2) is selected to separate a first region of the volume control zone (1; Figs. 1-2; ¶0217) and a second region of the volume control zone (2; Figs. 1-2; ¶0218) peripheral to the first region of the volume control zone (1) (Figs. 1-2; ¶0217-¶0218), and to set a sagittal depth (¶0057-¶0058) of the first control point (see modified Fig. 2) to independently produce a predetermined tear volume between the lens surface and the corneal surface (the volume control zone 1-2 has the same structure/shape as the volume control zone of the instant application, therefore a tear volume must be produced; Fig. 2), and wherein a local slope of a most peripheral aspect of the volume control zone (1-2) comprises a second control point (point between zones 2 and 3; see modified Fig. 2) to independently produce a predetermined squeeze angle between the lens surface and the corneal surface (Fig. 9) and having an apex at a deepest point of the secondary compression zone (Figs. 2, 9) (the structure of the contact lens including the secondary compression zone of Gifford is the same as that of the instant application, therefore there must be a squeeze angle between the lens surface and the corneal surface; Figs. 2, 9).
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Regarding claim 6, Gifford discloses the contact lens of claim 1, wherein: the sagittal elevations of the control points (Figs. 2, 9) are based on sagittal elevations of the pretreatment cornea at the control points (¶0049-¶0060).
Regarding claim 7, Gifford discloses the contact lens of claim 1, wherein: the sagittal elevations of the control points (Figs. 2, 9) are based on biometric mean data (¶0109; and implicit from stock lenses in ¶0144)2.
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) 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Gifford (US 20200041816 A1) in view of Lieberman (US 5570142 A).
Regarding claim 2, Gifford discloses the contact lens of claim 1, as set forth above. Gifford further discloses the volume control zone (1-2) is defined by the one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose geometric control points at the same semi-chord radial distance on the at least two of the multiple semi-meridians have different sagittal elevations.
However, Lieberman discloses an asymmetric aspheric contact lens wherein points (S, T; Figs. 2-3; col. 7 line 63 – col. 8 line 13) at the same semi-chord radial distance (C; Figs. 2-3; col. 7 line 63 – col. 8 line 13) on at least two of the multiple semi-meridians (Figs. 2-3; col. 7 line 63 – col. 8 line 13) have different sagittal elevations (difference in elevation G; Figs. 2-3; col. 7 line 63 – col. 8 line 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gifford to incorporate the asymmetry of the contact lens of Lieberman to make the geometric control points at the same semi-chord radial distance on at least two of the multiple semi-meridians have different sagittal elevations for the purpose of making a contact lens that more accurately mimics the surface of the cornea and thus achieve a better fit and better vision correction.
Regarding claim 3, Gifford discloses the contact lens of claim 1, as set forth above. Gifford further discloses the secondary compression zone (between zones 2 and 3; Figs. 1-2, 9) is defined by the one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose geometric control points at the same semi-chord radial distance on the at least two of the multiple semi-meridians have different sagittal elevations.
However, Lieberman discloses an asymmetric aspheric contact lens wherein points (S, T; Figs. 2-3; col. 7 line 63 – col. 8 line 13) at the same semi-chord radial distance (C; Figs. 2-3; col. 7 line 63 – col. 8 line 13) on at least two of the multiple semi-meridians (Figs. 2-3; col. 7 line 63 – col. 8 line 13) have different sagittal elevations (difference in elevation G; Figs. 2-3; col. 7 line 63 – col. 8 line 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gifford to incorporate the asymmetry of the contact lens of Lieberman to make the geometric control points at the same semi-chord radial distance on at least two of the multiple semi-meridians have different sagittal elevations for the purpose of making a contact lens that more accurately mimics the surface of the cornea and thus achieve a better fit and better vision correction.
Regarding claim 4, Gifford discloses the contact lens of claim 1, as set forth above. Gifford further discloses the peripheral relief zone (3) is defined by the one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose geometric control points at the same semi-chord radial distance on the at least two of the multiple semi-meridians have different sagittal elevations.
However, Lieberman discloses an asymmetric aspheric contact lens wherein points (S, T; Figs. 2-3; col. 7 line 63 – col. 8 line 13) at the same semi-chord radial distance (C; Figs. 2-3; col. 7 line 63 – col. 8 line 13) on at least two of the multiple semi-meridians (Figs. 2-3; col. 7 line 63 – col. 8 line 13) have different sagittal elevations (difference in elevation G; Figs. 2-3; col. 7 line 63 – col. 8 line 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gifford to incorporate the asymmetry of the contact lens of Lieberman to make the geometric control points at the same semi-chord radial distance on at least two of the multiple semi-meridians have different sagittal elevations for the purpose of making a contact lens that more accurately mimics the surface of the cornea and thus achieve a better fit and better vision correction.
Regarding claim 5, Gifford discloses the contact lens of claim 1, as set forth above. Gifford further discloses the landing zone (4-5) is defined by the one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose geometric control points at the same semi-chord radial distance on the at least two of the multiple semi-meridians have different sagittal elevations.
However, Lieberman discloses an asymmetric aspheric contact lens wherein points (S, T; Figs. 2-3; col. 7 line 63 – col. 8 line 13) at the same semi-chord radial distance (C; Figs. 2-3; col. 7 line 63 – col. 8 line 13) on at least two of the multiple semi-meridians (Figs. 2-3; col. 7 line 63 – col. 8 line 13) have different sagittal elevations (difference in elevation G; Figs. 2-3; col. 7 line 63 – col. 8 line 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gifford to incorporate the asymmetry of the contact lens of Lieberman to make the geometric control points at the same semi-chord radial distance on at least two of the multiple semi-meridians have different sagittal elevations for the purpose of making a contact lens that more accurately mimics the surface of the cornea and thus achieve a better fit and better vision correction.
Conclusion
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 March 6th, 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 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), see MPEP 2112.