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 Amendment
The Amendment filed 06/12/2026 has been entered. Claims 1-7 have been amended.
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
Regarding the 102 rejections, applicant’s arguments have been fully considered and are appreciated. However, the examiner respectfully disagrees. Applicant argues the currently applied prior art does not disclose the amended limitations of “the volume control zone is defined by at least four geometric control points on a semi-meridian of the contact lens, the at least four geometric control points being connected by one of: a spline, a polynomial, or a combination of conic sections and uncurved segments to define a surface contour of the volume control zone” and “the predetermined squeeze angle is defined between a line connecting the second control point and the deepest point of the secondary compression zone and a horizontal line through the deepest point of the secondary compression zone”. Applicant additionally argues that amended claim 1 is not merely a design decision or product-by-process limitation, and instead recites the resulting lens structure.
Regarding the limitation of the predetermined squeeze angle, this is a definition and does not further limit the claim. It states what to consider the predetermined squeeze angle and this is met by the structure of Gifford.
Regarding the limitation of the volume control zone and the at least four geometric control points, applicant argues the disclosure of Gifford is materially different from the posterior surface geometry because Gifford describes conventional zone-by-zone construction. However, any points within the region 1-2 of Gifford can be considered geometric control points of the volume control zone, therefore there can be at least four. Further, the limitation that the at least four geometrical control points are “connected by one of: a spline, a polynomial, or a combination of conic sections and uncurved segments to define a surface contour of the volume control zone” encompasses nearly every possible shape as to the structure of the posterior surface. Due to how broadly the contact lens is claimed, with nearly infinite possibilities as to the actual structure, the contact lens of Gifford can easily satisfy the limitations, regardless of how it was designed. Other than the limitations which indicate the compression zones to contact the cornea, there are no metes and bounds (i.e. ranges with actual values or shapes) to limit the shape of the posterior surface geometry.
Regarding applicant’s argument that amended claim 1 does not rely on a mental act of choosing values of on a method of designing the lens, the examiner disagrees. A geometric control point does not have any physical, material, or structural characteristics that would be distinguishable on a physical contact lens. The resulting contact lens of claim 1 is one which has the listed zones, wherein the central compression zone and the secondary compression zone contact the pretreatment cornea, with a squeeze angle, and with a volume control zone geometry that can be fit by or defined by any number of possible functions. Besides this, there are no further metes and bounds as to the structure of the resulting contact lens. The contact lens of Gifford discloses all the features of the physical contact lens that results from the process of designing it.
Regarding the 103 rejections, applicant’s arguments have been fully considered and are appreciated. However, the examiner respectfully disagrees. Applicant argues that teaches conformance of the posterior lens surface to an irregular corneal surface to reduce gaps, rendering the combination improper. Applicant additionally argues that Lieberman does not teach the geometric control point surface architecture, and that the proposed motivation to combine is insufficient.
Regarding the propriety of the combination, the examiner disagrees. Although Lieberman teaches conforming the lens to the cornea to reduce gaps, the concept of Lieberman is to account for an asymmetric corneal topography and modify the lens topography to match it. Gifford already teaches having gaps between the lens and the cornea for the purpose of applying pressure to reshape the eye. Lieberman is only applied to account for the rotational asymmetry of a cornea and adjust the lens sagittal elevations to have different elevations at different points with the same radial distances on the lens. Applicant’s own stated issue is to design lenses with elevation differences intended to correspond to the irregular elevation of an asymmetric cornea (¶0011), which is what the contact lens of Lieberman is directed towards. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). It is further noted that “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” and in addition it has been further held that "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle" and taking into account "the inferences and creative steps that a person of ordinary skill in the art would employ." KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007), see MPEP 2141.
Regarding the geometric control point surface architecture, these limitations are directed towards a product-by-process and the resulting contact lens structure regarding the geometric control points is taught by Gifford, as stated above.
Regarding the proposed modification to combine, applicant argues that “the stated rationale merely identifies a general benefit of asymmetric fitting, it does not provide an articulated reason why a person of ordinary skill would have modified Gifford’s orthokeratology-style, multi-zone reshaping lens to include the specific claimed geometric control-point architecture in each of the zones”. Firstly, Lieberman is not used to teach the specific geometric control points, it is used to teach the rotational asymmetry of the contact lens to account for rotationally asymmetric corneal topography. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The rationale given is the motivation of the asymmetric contact lens of Lieberman – one would be motivated to use the rotationally asymmetric contact lens concept of Lieberman for the purpose of having a contact lens with a better fit and better vision correction (col. 2 line 63 – col. 3 line 3).
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 at least four geometric control points (any points within the region 1-2, such as 1a, 1b, and more can be defined; see modified Fig. 2) on a semi-meridian of the contact lens (Figs. 1-2, 9), the at least four geometric control points being connected by one of: a spline, a polynomial, or a combination of conic sections and uncurved segments to define a surface contour of the volume control zone (this leads to an infinite number of possibilities as to the actual curvature of the surface contour, therefore the lens of Gifford can meet this limitation, see Fig. 2; further any of these functions can be used to fit the surface curvature of the volume control zone of Gifford), 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), wherein the predetermined squeeze angle is defined between a line connecting the second control point and the deepest point of the secondary compression zone and a horizontal line through the deepest point of the secondary compression zone (this is just a definition defining what to consider the squeeze angle and this can be met by the lens of Gifford, see modified Fig. 9 below; further regarding the term “horizontal”, it is not interpreted to mean a particular direction since no frame of reference is established).
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Regarding claim 6, Gifford discloses the contact lens of claim 1, wherein: the sagittal elevations of the geometric control points (Figs. 2, 9) are based on sagittal elevations of the pretreatment cornea at the same radial distance as the geometric control points (¶0049-¶0060).
Regarding claim 7, Gifford discloses the contact lens of claim 1, wherein: the sagittal elevations of the geometric 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 at least four geometric control points (see modified Fig. 2) on each of the multiple semi-meridians (Figs. 1-2). Gifford does not disclose the at least four geometric control points at the same semi-chord radial distances 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 at least four 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 (col. 2 line 63 – col. 3 line 3 of Lieberman).
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 one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose the volume control zone is defined by at least four 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 at least four 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 (col. 2 line 63 – col. 3 line 3 of Lieberman).
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 one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose the volume control zone is defined by at least four 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 at least four 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 (col. 2 line 63 – col. 3 line 3 of Lieberman).
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 one or more geometric control points (see modified Fig. 2) on the multiple semi-meridians (Figs. 1-2). Gifford does not disclose the volume control zone is defined by at least four 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 at least four 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 (col. 2 line 63 – col. 3 line 3 of Lieberman).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Legerton (US 8083346 B2), Davis et al. (US 6511179 B1), Lieberman et al. (US 6340229 B1) disclose similar contact lenses wherein the lenses are rotationally asymmetric and/or the sagittal heights of the lens are varied to account for corneal topography.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 July 7th, 2026
/George G. King/Primary 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.
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