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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/24/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 9-13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive.
Applicant argues that one of ordinary skill in the art would not have found it obvious to modify the passive payload of Lemoff with the functionalized inserts of Pugh R. Examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Para [0026] of Lemoff does not merely teach passive elements but both passive and active element which may be disposed in an insert of the lens. Since both Lemoff and Pugh R. disclose electronic contact lenses with inserts, it could be asserted that one of ordinary skill in the art could have used the teaching of Pugh R. to modify Lemoff for the purpose of customizing a lens for its desired use as shown in Para [0073] and Fig 6 of Pugh R. For these reasons examiner maintains the rejection under USC 103.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327).
Regarding claim 1, Lemoff discloses a scleral lens (see Fig 1) comprising: - a cover part suitable for covering the pupil, the iris and, at least partially, the sclera of an eye of an individual, the cover part comprising a transparent central portion (see Fig 1; Para [0025-0028]; an outer surface 132 and an inner surface of lens 136 cover the pupil, iris and the sclera as seen in Fig 1; a section of the two surfaces comprise an optical zone 120 of the contact lens 110 which is the portion transparent to light through which light passes on route to the retina);- at least one electronic component encapsulated in an encapsulation portion of the cover part (see Fig 1; Para [0026]; lens contains at least one electronic payload 114 and 112), wherein the form and/or the dimensions of the cover part are configured, at least locally, as a function of the arrangement of the electronic component or components (see Fig 2; Para [0037]; thickness of core depends on chosen payload), such that the pupil is totally visible through the transparent central portion of the cover part, when the scleral lens is worn by the eye (see Fig 1; Para [0027]; optical zone is 8mm in diameter thus sufficient to meet the typical pupil size at full dilation) wherein the encapsulation portion of the cover part is thicker than the rest of the cover part (see Fig 3; Para [0038]; the core portion which contains payload may have a thickness of 1mm which is thicker than the 200-micron thickness of the outer and inner layers). Lemoff does not disclose said encapsulation portion extending according to a non-circular form around the transparent central portion, such that the mass of the electronic component is distributed non-uniformly in the encapsulation portion so as to counteract gravity and prevent decentering of the scleral lens with respect to the pupil when the scleral lens is worn by the eye. Lemoff and Pugh R. are related because both disclose electronic components in a contact lens
Pugh R. discloses a contact lens (see Fig 3) wherein said encapsulation portion extending according to a non-annular form around the transparent central portion (see Fig 6; Para [0073]; 640 shows an example of a non-annular form insert).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff with wherein said encapsulation portion extending according to a non-annular form around the transparent central portion of Pugh R. for the purpose of improving functionality of the lens (Para [0073]).
Lemoff in view of Pugh R. does not disclose such that the mass of the electronic component is distributed non-uniformly in the encapsulation portion so as to counteract gravity and prevent decentering of the scleral lens with respect to the pupil when the scleral lens is worn by the eye. Lemoff in view of Pugh R. and Sindt are related because both disclose contact lenses.
Sindt discloses a contact lens (see Fig 5B) such that the mass of the electronic component is distributed non-uniformly in the encapsulation portion so as to counteract gravity and prevent decentering of the scleral lens with respect to the pupil when the scleral lens is worn by the eye (see Fig 5B; Para [0074]; Sindt discloses the use of non-uniform weighted elements to create a weighted prismatic lens to prevent decentering of the contact lens; Lemoff discloses the electronic component of the lens)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. with such that the mass of the electronic component is distributed non-uniformly in the encapsulation portion so as to counteract gravity and prevent decentering of the scleral lens with respect to the pupil when the scleral lens is worn by the eye of Sindt for the purpose of improving a user’s vision by allowing proper alignment of optical features of a lens with user’s eye (Para [0074])
Regarding claim 2, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1 (see Fig 1). Lemoff further discloses wherein the scleral lens is rigid or hybrid (see Fig 2; Para [0031]; scleral lens is made of a rigid gas permeable plastic thus a rigid lens).
Regarding claim 3, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1 (see Fig 1). Lemoff further discloses wherein the cover part is formed to delimit, between the cornea and the cover part, a free space (E) forming a reservoir (see Fig 1; Para [0025]; a tear fluid layer 108 is disposed between the inner layer 136 and the cornea 104).
Regarding claim 12, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1 (see Fig 1). Lemoff further discloses wherein the cover part is composed of two pucks assembled together defining the portion in which the electronic component or components is/are encapsulated (see Fig 2B; Para [0031]; cover part is composed of outer layer 202 and inner layer 206 defining a middle core layer 204), one and/or the other of the two pucks comprising, in their zone delimiting the transparent central portion, a bonding polymer material whose refractive index is chosen so as not to generate a diopter in said central portion (see Fig 2B; Para [0040-0041]; the outer layer 202 contains a glue layer 209 which is index matched with the outer layer to prevent the generation of a diopter in the central portion).
Claims 4-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327) as applied to claim 1, and further in view of Legerton (US 2010/0128224, of record).
Regarding claim 4, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1. Lemoff in view of Pugh R. and Sindt does not disclose wherein at least the inner face of the cover part has a general asymmetrical form. Lemoff in view of Pugh R. and Sindt and Legerton are related because both disclose lenses that rests on the eye.
Legerton discloses a lens that rests on the eye (see Fig 3) wherein at least the inner face of the cover part has a general asymmetrical form (see Figs 3 and 4; Para [0039-0041]; inner face of the lens has an asymmetrical form as seen in Figs 3 and 4)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein at least the inner face of the cover part has a general asymmetrical form of Legerton for the purpose of improving a patient’s comfort and visual acuity (Para [0014]).
Regarding claim 5, Lemoff in view of Pugh R., Sindt and Legerton discloses the scleral lens as claimed in claim 4 (Legerton: see Fig 3). Legerton further discloses wherein at least one of four quadrants of the cover part has a form distinct from the other quadrants (Legerton: see Fig 3; Para [0039-0041]; a lens 100 may be divided into four quadrants of the cover part that form four distinct quadrants as seen in Fig 3).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein at least one of four quadrants of the cover part has a form distinct from the other quadrants of Legerton for the purpose of improving patient comfort and visual acuity (Para [0014]).
Regarding claim 7, Lemoff in view of Pugh R., Sindt and Legerton discloses the scleral lens as claimed in claim 5 (Legerton: see Fig 3). Legerton further dislcoses wherein the cover part has at least one flat meridian (Legerton: see Fig 3; Para [0040]; a flat meridian is shown by junction 108’ between two zones of the lens) and at least one cambered meridian, arranged at 90˚ from the flat meridian (Legerton: see Fig 3; Para [0028]; a first meridian 114 is located at 90 degrees from a point intersecting the flat meridian).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein the cover part has at least one flat meridian and at least one cambered meridian, arranged at 90˚ from the flat meridian of Legerton for the purpose of improving patient comfort and visual acuity (Para [0014]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327) as applied to claim 1, and further in view of Bailey (US 2013/0278890, of record).
Regarding claim 6, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in one of claims 1. Lemoff in view of Pugh R. and Sindt does not disclose wherein at least the inner face of the cover part has, at least locally, a toric surface. Lemoff and Bailey are related because both disclose contact lenses.
Bailey discloses a contact lens (see Fig 1A) wherein at least the inner face of the cover part has, at least locally, a toric surface (see Fig 1A; Para [0094]; an inner surface of the contact lens may be made toric)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein at least the inner face of the cover part has, at least locally, a toric surface of Bailey for the purpose of treat a patient’s eye sight and improve vision (Para [0094])
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327) as applied to claim 1, and further in view of Rosenwald (US 4,484,922, of record).
Regarding claim 9, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1. Lemoff in view of Pugh R. and Sindt does not disclose wherein the encapsulation portion extends around the transparent central portion according to an elliptical form whose large axis is on the transverse axis of the eye. Lemoff in view of Pugh R. and Sindt and Rosenwald are related because both disclose contact lenses with inserts
Rosenwald discloses a contact lens (see Fig 2) wherein the encapsulation portion extends around the transparent central portion according to an elliptical form whose large axis is on the transverse axis of the eye (Rosenwald: see Fig 2; Col 4, line 59- Col 5, line 6; an encapsulated portion 10 may be elliptical in shape with a horizontal/transverse dimension of 12mm and a vertical dimension of 11mm).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein the encapsulation portion extends around the transparent central portion according to an elliptical form whose large axis is on the transverse axis of the eye of Rosenwald for the purpose of preventing intrusion with central elements (Col 4, line 59- Col 5, line 6).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327) as applied to claim 1, and further in view of Pugh (US 2010/0078838, of record).
Regarding claim 10, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1. Lemoff in view of Pugh R. and Sindt does not disclose wherein the encapsulation portion extending around the transparent central portion according to a general form in front view delimited by a ring apart from in a crescent-shaped zone opposite the upper zone of the pupil (P). Lemoff in view of Pugh R. and Sindt and Pugh are related because both disclose electronic contact lenses.
Pugh discloses an electronic contact lens (see Fig 1), wherein the encapsulation portion extending around the transparent central portion according to a general form in front view delimited by a ring apart from in a crescent-shaped zone opposite the upper zone of the pupil (P) (see Figs 2C and 7; Para [0056]; a media insert 213/712 may extend in a crescent shape around the transparent central zone and may be located opposite the upper zone of a pupil defined as the upper section of the transparent optical zone as seen in Fig 7).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein the encapsulation portion extending around the transparent central portion according to a general form in front view delimited by a ring apart from in a crescent-shaped zone opposite the upper zone of the pupil (P) of Pugh for the purpose of improved on-eye comfort and consistent location of components (Para [0110])
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327) as applied to claim 1, and further in view of Waite (US 2020/0012124, of record).
Regarding claim 11, Lemoff in view of Pugh R. and Sindt discloses the scleral lens as claimed in claim 1 (see Fig 1). Lemoff in view of Pugh R. and Sindt does not disclose wherein the encapsulation portion (13) extends around the transparent central portion according to a general form in front view delimited by a pear-shaped quartic. Lemoff in view of Pugh R. and Sindt and Waite are related because both disclose contact lenses with inserts.
Waite discloses the contact lens with insert (Waite: see Fig 1A), wherein the encapsulation portion (13) extends around the transparent central portion according to a general form in front view delimited by a pear-shaped quartic (Waite: see Fig 3B; Para [0257-0258]; An insert 140 which comprises the encapsulation portion extends according to a substantially droop/pear-shape quartic shape around the central portion of the lens as seen in Fig 4).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with wherein the encapsulation portion (13) extends around the transparent central portion according to a general form in front view delimited by a pear-shaped quartic of Waite for the purpose of containing materials within the lens while maintaining structural integrity (Para [0259])
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lemoff (US 2018/0224671, of record) in view of Pugh R. (US 2012/0242953, of record) and Sindt (US 2014/0192327) as applied to claim 1, and further in view of Mirjalili (US 2019/0377428, of record).
Regarding claim 13, Lemoff in view of Pugh R. and Sindt discloses at least one scleral lens as claimed in claim 1. Lemoff in view of Pugh R. and Sindt does not disclose an automatic system for detecting the direction of the gaze of an individual. Lemoff in view of Pugh R. and Sindt and Mirjalili are related because both disclose electronic contact lenses.
Mirjalili discloses an electronic contact lens (see Fig 1B) comprising an automatic system for detecting the direction of the gaze of an individual (see Fig 1B and 3; Para [0031, 0038]; an automated system as seen in Fig 3 can detect the position and orientation of an individual)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Lemoff in view of Pugh R. and Sindt with comprising an automatic system for detecting the direction of the gaze of an individual of Mirjalili for the purpose of maintaining a stable image while compensating for eye movement (Para [0022])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL ANDRES SANZ whose telephone number is (571)272-3844. The examiner can normally be reached Monday-Friday 8:30 am -5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached on (571) 270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.S./Examiner, Art Unit 2872
/WILLIAM R ALEXANDER/Primary Examiner, Art Unit 2872