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 . Claims 1-20 are pending and examined below.
Response to Arguments
Applicant's arguments filed 08/19/2025 have been fully considered but they are not persuasive.
Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 8-10) and that the dependent claims rise and fall with the same arguments (pages 11-12). Applicant's arguments are moot due to the additional reference applied to the newly added limitations, as detailed in the rejection below. Please see the rejection below.
Claim Objections
Claims 1, 3, 8, 10, & 14 objected to because of the following informalities:
Claims 1, 8, & 14 recites the limitation "the cornea" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "a cornea" in line 3 from the bottom. It is unclear if this is the same or different “cornea” from line 3. For the purpose of examination, they are regarded as the same.
Claim 3 appears to repeat the same disorders from lines 2-3 in lines 4-7.
Claim 10 recites the limitation " the fenestration" in line 2. It is unclear if this is the same or different from “at least one fenestration” from claim 8 of which claim 10 depends from. For the purpose of examination, they are regarded as the same.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 8-9, 11-12, 14-15, & 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Volk (US 5347326 A).
Regarding claim 1, Volk teaches a method of wearing a scleral lens (60, Fig. 3), which comprises: obtaining the scleral lens (60, Fig. 3), comprising:
an optic zone (70, Fig. 4) that extends over the cornea of an eyeball of a wearer upon wearing of the scleral lens (The scleral portion 66 facilitates positioning of the diagnostic or therapeutic contact lens 60 on the cornea 12, Figs. 3-4, col. 10 line 35-36);
a landing zone (66, Figs. 3 & 4) that is configured to land at a conjunctiva corresponding to a scleral surface of the eyeball upon wearing of the scleral lens (66, Figs. 3 & 4, col. 10 lines 33-34); and
a transition zone (the area between 66 and 70, Fig. 4) that connects the optic zone and the landing zone and is configured to be located above a limbus when associated with the eyeball upon wearing of the scleral lens (Figs. 3 & 4, col. 10 lines 33-34), wherein the optic zone comprises:
an annular zone (see annotated Fig. 10 below) in which a plurality of pockets (98, Fig. 10) is provided, the annular zone having an inner circumference and an outer circumference (see annotated Fig. 10 below) and being disposed on a posterior surface (96, Fig. 10) of the optic zone, wherein each of the plurality of pockets (98, Fig. 10) is located between the inner circumference and the outer circumference, and each of the plurality of pockets has an opening in the posterior surface of the optic zone and without penetrating an anterior surface of the optic zone (col. 10 lines 46-48 & col. 13 lines 49-54); and
at least one fenestration (97, Fig. 10) located radially outward from the outer circumference and not located in the transition zone (see annotated Fig. 10 below), and wherein each of the plurality of pockets (98, Fig. 10) is configured to retain gas bubbles near the at least one fenestration (97, col. 13 lines 52-54), and wherein the number of pockets in the annular zone is at least 2 times more than the number at least one fenestration (Fig. 10); and
placing the scleral lens over the eyeball (Fig. 3), wherein the eyeball has a cornea (Fig. 3) and wherein the scleral lens is configured to allow delivery of a fluid (tear fluid, col. 13 lines 34-36) from the outside of the scleral lens to the cornea while wearing the scleral lens (col. 13 lines 34-36).
Regarding claim 2, Volk teaches
wherein the wearer suffers from an ocular disease or disorder (col. 2 lines 8-9).
Regarding claim 3, Volk teaches
wherein the ocular disease or disorder comprises Stevens-Johnson syndrome, keratoconjunctivitis sicca, graft rejection, ocular cicatricial pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular cornea, spherical cornea, irregular astigmatism, or a combination thereof. pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular astigmatism, or a combination thereof (col. 1 lines 33-35).
Regarding claim 6, Volk teaches
wherein the fluid comprises tears or eye drops (tear fluid, abstract).
Regarding claim 8, Volk teaches a method of using a scleral lens (60, Fig. 3), which comprises: obtaining the scleral lens (60, Fig. 3) comprising:
an optic zone (70, Fig. 4) that extends over the cornea of an eyeball of a user upon wearing of the scleral lens (The scleral portion 66 facilitates positioning of the diagnostic or therapeutic contact lens 60 on the cornea 12, Figs. 3-4, col. 10 line 35-36);
ii. a landing zone (66, Figs. 3 & 4) that is configured to land at a conjunctiva corresponding to a scleral surface of the eyeball upon wearing of the scleral lens (66, Figs. 3 & 4, col. 10 lines 33-34); and
iii. a transition zone (the area between 66 and 70, Fig. 4) that connects the optic zone and the landing zone and is configured to be located above a limbus when associated with the eyeball upon wearing of the scleral lens (Figs. 3 & 4, col. 10 lines 33-34), wherein the optic zone comprises:
(1) an annular zone (see annotated Fig. 10 below) in which a plurality of pockets is provided, the annular zone having an inner circumference and an outer circumference (see annotated Fig. 10 below) and being disposed on a posterior surface of the optic zone, wherein each of the plurality of pockets is located between the inner circumference and the outer circumference, and each of the plurality of pockets has an opening in the posterior surface of the optic zone and without penetrating an anterior surface of the optic zone (col. 10 lines 46-48 & col. 13 lines 49-54); and
(2) at least one fenestration (97, Fig. 10) located radially outward from the outer circumference and not located in the transition zone (see annotated Fig. 10 below), and wherein
each of the plurality of pockets is configured to retain gas bubbles near the at least one fenestration (col. 13 lines 52-54), wherein the depth d of at least one pocket is within the range of 0.05 mm to 0.3 mm (0.2 mm, col. 12 line 33) and the opening of at least one pocket has a maximum dimension t ranging from 0.2 mm to 1 mm (Volk discloses the diameter of hole 98 to be “very small” and discloses lens 40 to be less than or equal to 10mm, so the diameter of the holes would inherently be less when looking at the holes 98 shown in Fig. 10, col. 13 lines 63-65), and wherein t>2d, or the horizontal cross-section of the at least one fenestration has a maximum dimension ranging from 0.2 mm to 1 mm (Volk discloses the radius ranging from 0.3 to 5.0 mm, then inherently the maximum dimension would fall with the range as well, col. 11 lines 35-38); and
treating an ocular disease or disorder by placing the scleral lens over the eyeball (Fig. 3), wherein the scleral lens is configured to allow fluid to enter a corneal clearance between the scleral lens and the cornea during wearing of the scleral lens (col. 13 lines 34-36).
Regarding claim 9, Volk teaches
wherein the ocular disease or disorder comprises Stevens-Johnson syndrome, keratoconjunctivitis sicca, graft rejection, ocular cicatricial pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular astigmatism, or a combination thereof (col. 1 lines 33-35).
Regarding claim 11, Volk teaches
wherein the diameter of the inner circumference of the annular zone ranges from 5.0 mm to 13.5 mm (Volk teaches a lens with diameter 10.0 mm, so it would be inherent that the diameter of the inner circumference of the annular zone ranges from 5.0 mm to 13.5 mm, col. 10 lines 16-17).
Regarding claim 12, Volk teaches
wherein the fluid comprises tears or eye drops (tear fluid, abstract).
Regarding claim 14, Volk teaches a method of treating an ocular disease or disorder in an individual in need thereof (abstract), which comprises: providing a scleral lens (60, Fig. 3) comprising:
an optic zone (70, Fig. 4) that extends over the cornea of an eyeball of the individual upon wearing of the scleral lens (The scleral portion 66 facilitates positioning of the diagnostic or therapeutic contact lens 60 on the cornea 12, Figs. 3-4, col. 10 line 35-36);
ii. a landing zone (66, Figs. 3 & 4) that is configured to land at a conjunctiva corresponding to a scleral surface of the eyeball upon wearing of the scleral lens (66, Figs. 3 & 4, col. 10 lines 33-34); and
iii. a transition zone (the area between 66 and 70, Fig. 4) that connects the optic zone and the landing zone and is configured to be located above a limbus when associated with the eyeball upon wearing of the scleral lens (Figs. 3 & 4, col. 10 lines 33-34), wherein the optic zone comprises :
(1) an annular zone (see annotated Fig. 10 below) in which a plurality of pockets is provided, the annular zone having an inner circumference and an outer circumference (see annotated Fig. 10 below) and being disposed on a posterior surface of the optic zone, wherein each of the plurality of pockets is located between the inner circumference and the outer circumference, and each of the plurality of pockets has an opening in the posterior surface of the optic zone and without penetrating an anterior surface of the optic zone (col. 10 lines 46-48 & col. 13 lines 49-54); and
(2) at least one fenestration (97, Fig. 10) located radially outward from the outer circumference and not located in the transition zone (see annotated Fig. 10 below), and
wherein each of the plurality of pockets (98, Fig. 10) is configured to retain gas bubbles near the at least one fenestration (97, col. 13 lines 52-54), and wherein the number of pockets in the annular zone is at least 2 times more than the number of at least one fenestration (Fig. 10); and
administering a fluid (tear fluid, col. 13 lines 34-36) to a corneal clearance between the scleral lens and the cornea, wherein the scleral lens is configured to provide a fluid reservoir located on the cornea (precorneal region, col. 13 lines 54-55).
Regarding claim 15, Volk teaches
wherein the ocular disease or disorder comprises Stevens-Johnson syndrome, keratoconjunctivitis sicca, graft rejection, ocular cicatricial pemphigoid, persistent corneal epithelial injury, irregular cornea, spherical cornea, keratoconus, pellucid marginal corneal degeneration, irregular astigmatism, or a combination thereof (col. 1 lines 33-35).
Regarding claim 18, Volk teaches
wherein the fluid comprises tears or eye drops (tear fluid, abstract).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4-5, 10, & 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volk in view of De Juan (US 20150055081 A1), hereinafter, Juan.
Regarding claims 4, 10, & 16, Volk is not specific in the measurements of the at least one fenestration to the geometric center of the scleral lens. However, Juan teaches ophthalmic lenses for correcting refractive error of an eye (abstract, Juan)
wherein the distance from the geometric center of the at least one fenestration to the geometric center of the scleral lens is in the range of 4.0 mm to 7.0 mm (about 3.5 mm to about 4.5 mm, ¶0107, Juan).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Volk by incorporating the teaching above as taught by Juan in order to decrease optical artifacts of the fenestrations (¶0107, Juan).
Regarding claims 5 & 17, Volk teaches
wherein the diameter of the inner circumference of the annular zone ranges from 5.0 mm to 13.5 mm (Volk teaches a lens with diameter 10.0 mm, so it would be inherent that the diameter of the inner circumference of the annular zone ranges from 5.0 mm to 13.5 mm, col. 10 lines 16-17).
Claim(s) 7, 13, & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volk in view of Michelson (US 4709996 A).
Regarding claims 7, 13, & 19, Volk does not teach the scleral lens configured to allow metabolites to be discharged. However, Michelson teaches a device for forming a fluid lens when immersed in a liquid medium (abstract, Michelson)
wherein the scleral lens is further configured to allow metabolites generated on an ocular surface under the scleral lens to be discharged (col. 2 lines 37-40, Michelson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Volk by incorporating the teaching above as taught by Michelson in order to permit the maximum exchange of gases, nutrients and metabolites between cornea, lachrymal fluid and the atmosphere, thus minimally compromising normal physiology (col. 2 lines 37-40, Michelson).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volk in view of Thompson (US 20160131924 A1).
Regarding claim 20, Volk does not teach artificial tears. However, Thompson teaches a contact lens system (abstract, Thompson)
wherein the fluid comprises artificial tears (¶0024, Thompson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Volk by incorporating the teaching above as taught by Thompson in order to provide additional moisture and lubrication to the corneal surface (¶0024, Thompson).
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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 KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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