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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 03/09/2026 has been entered.
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.
Claims 1-2, 5-11, 13, 15-19, 22-23, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rafaeli et al. US PGPub 2020/0166777 A1 (of record, see IDS dated 04/26/2021, hereinafter, “Rafaeli”).
Regarding independent claim 1, Rafaeli discloses a contact lens (Fig. 1A depicts dynamic contact lens 100, par. [0076]) comprising:
an optical portion (Fig. 1A, dynamic contact lens 100 includes dynamic portion 101, par. [0076], and the dynamic portion and the optical portion can be aligned with the optical axis of the dynamic contact lens, par. [0247], and Rafaeli teaches a dynamic lens can have a standard optical transparency, par. [0398]), wherein the optical portion comprises an optical posterior base curvature (Fig. 1A, dynamic contact lens 100 includes dynamic anterior surface 103 and dynamic posterior surface 104 which comprises a curvature, par. [0076]); and
an optical center (Fig. 1A, dynamic contact lens 100 has a geometric axis of the lens 112 par. [0076], and the dynamic portion 101 comprises a center thickness 112, par. [0077], therefore dynamic contact lens 100 has an optical center);
a peripheral portion, wherein the peripheral portion comprises a peripheral posterior base curvature and an anterior peripheral surface (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102 with a base curvature and dynamic portion 101 includes a dynamic anterior surface 103, par. [0076]); and
a transition zone coupling the optical portion and the peripheral portion (Fig. 1A, dynamic portion 101 and peripheral portion 102 are coupled at interface 108, also referred to as the transition zone, par. [0076]),
wherein, when worn on the eye of a patient, the optical portion is characterized by a first quasi-stable configuration and a second quasi-stable configuration (Rafaeli discloses when dynamic contact lens 100 is applied to a cornea, the dynamic portion can assume two or more quasi-stable configurations, par. [0084]),
wherein interaction of the contact lens with eye movement causes a transition between the first quasi-stable configuration and the second quasi-stable configuration (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]),
wherein the eye movement comprises a change in a gaze position of the eyeball (Rafaeli discloses a dynamic contact lens can comprise features configured to induce a change in conformation of the dynamic portion upon application of pressure by an eyelid such as changing a gaze angle, pars. [0137-138]),
wherein during the transition, a thickness of the optical portion does not change (Rafaeli discloses the dynamic portion is characterized by a substantially uniform thickness, par. [0079], and further discloses in certain dynamic contact lenses, the optical power of the dynamic portion does not change when the configuration of the dynamic portion changes, par. [0256], therefore as best understood by the Examiner, the thickness of the dynamic contact lens 100 does not change during the transition from one conformation to another), and
wherein the lens comprises one or more depressions disposed in the anterior peripheral surface and a fenestration coupled to each of the one or more depressions (one or more protrusions, where protrusions are thickened areas in the anterior surface of a lens designed to create mechanical forces when there is dynamic contact between the protrusion and the eyelid, can include surface features that increase friction such as grooves, depressions, and ridges, pars. [0172], [0175], and a groove or channel can be coupled to one or more fenestrations, par. [0079], refer also to at least pars. [0099-100], [0102], [0109], [0181], [0304-308], [0384], [0388], and [0401]),
wherein the optical portion, the peripheral portion, or both the optical portion and the peripheral portion comprise at least one mechanism configured to transport tear fluid into and out of an optical tear volume formed between an optical posterior surface and an anterior surface of the cornea, when worn on the eye of the patient (Figs. 1A and 1B, the peripheral posterior surface comprises cavities 109, which when placed on the cornea fill with tear fluid to provide tear fluid reservoirs, pars. [0076], [0078], and the transition zone can be configured facilitate flow of tear fluid to a tear lens formed between the dynamic posterior surface and a cornea when the dynamic lens is applied to an eye, pars. [0090-91], and a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, pars. [0098-100], and when tear fluid flows under the dynamic portion such as induced by a gaze change or lid pressure, the as-fabricated SAG assumes some or all of the as-fabricated SAG height, causing the dimensions of the tear lens to change and thereby change the optical power of the dynamic portion, pars. [0108-109]), and
wherein the optical tear volume is configured to have a maximum of 1 mL (Rafaeli discloses a volume of a tear lens can be, for example, within a range from 0.001 µL to 0.01 µL, from 0.001 µL to 0.1 µL, from 0.01 µL to 10 µL, from 0.02 µL to 8 µL, from 0.05 µL to 7 µL, from 0.1 µL to 6 µL, from 0.1 µL to 5 µL, from 0.5 µL to 4 µL, or within a range from 1 µL to 3 µL, par. [0238], where the disclosed range of 0.001 µL to 0.01 µL anticipates the claimed range of a tear volume of a maximum of 1 µL).
Per MPEP 2131.03(I), a specific example in the prior art which is within a claimed range anticipates the range. In this case, the range between 0.001 and 0.01 µL disclosed by Rafaeli is within the claimed range of no greater than 1 µL. "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original). Therefore, Rafaeli anticipates the claimed range of tear volume.
Regarding dependent claim 2, Rafaeli discloses the contact lens of claim 1, wherein the optical portion comprises an optical posterior surface (Fig. 1A, dynamic contact lens 100 includes dynamic posterior surface 104, par. [0076]);
wherein the peripheral portion comprises a peripheral posterior surface (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102 with a base curvature and dynamic portion 101 includes a dynamic anterior surface 103, par. [0076]);
wherein the contact lens is configured such that when worn on the eye of a patient, the optical portion can assume a plurality of configurations in response to a pressure applied to the optical portion (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]);
wherein when a negative pressure is applied to the optical posterior surface by an eyelid or a change in gaze angle, the optical posterior surface assumes one or more substantially conforming configurations with respect to the anterior surface of the cornea (dynamic contact lens can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084], and a dynamic contact lens can comprise one or more features configured to induce a change in conformation of the dynamic portion, par. [0137]); and
wherein in the absence of a negative pressure, the optical posterior surface assumes a neutral configuration to provide a tear volume between the optical posterior surface and the anterior surface of the cornea (Figs. 1A and 1B, the peripheral posterior surface comprises cavities 109, which when placed on the cornea fill with tear fluid to provide tear fluid reservoirs, pars. [0076], [0078], and Rafaeli discloses a non-conforming configuration, the dynamic portion is not adhering to the cornea, where the dynamic portion extends above or bulges away from the surface of the cornea to provide a lenticular volume between the posterior surface of the dynamic portion and the cornea where the lenticular volume can fill with tear fluid to form a tear lens, par. [0123]).
Regarding dependent claim 5, Rafaeli discloses the contact lens of claim 2, wherein, the peripheral posterior base curvature is from 7.5 mm to 9.5 mm (the peripheral portion can be characterized by base curvature, i.e., the curvature of the anterior surface within a range, for example, from 7 mm to 10 mm, from 7.2 mm to 9.8 mm, from 7.4 mm to 9.6 mm, from 7.6 mm to 9.4 mm, from 7.8 mm to 9.2 mm, or from 8 mm to 9 mm, par. [0240]); and the difference between the peripheral posterior base curvature and the optical posterior base curvature is greater than 0.1 mm (Rafaeli discloses that in the conforming configuration the dynamic base curvature can be substantially the same as the peripheral base curvature, par. [0206], and that the dynamic portion 115, see at least Fig. 1A, can be characterized by a diameter within a range, for example, from 1 mm 7 mm, from 1.5 mm to 6 mm, from 1.5 mm to 5 mm, from 2 mm to 5 mm, from 2 mm to 4 mm, or from 2.5 mm to 3.5 mm, par. [0232], where Rafaeli defines substantially as ±10% of a value, par. [0066], thus a 10% difference between curvatures of 7.6 mm to 9.4 mm is 0.76 mm to 0.94 mm, satisfying the limitation that the difference in curvatures be greater than 0.1 mm).
Per MPEP 2131.03(I), a specific example in the prior art which is within a claimed range anticipates the range. In this case, the ranges between 7.6 mm to 9.4 mm, from 7.8 mm to 9.2 mm, or from 8 mm to 9 mm disclosed by Rafaeli are within the claimed range of 7.5 mm to 9.5 mm "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original). Therefore, Rafaeli anticipates the claimed range of peripheral posterior base curvature.
Regarding dependent claim 6, Rafaeli discloses the contact lens of claim 1, wherein the transition zone comprises one or more discontinuities extending across the transition zone (the surface properties of the posterior surface can be continuous or discontinuous, par. [0196], thereby disclosing at least one discontinuity).
Regarding dependent claim 7, Rafaeli discloses the contact lens of claim 6, wherein the one or more discontinuities comprises one or more posterior grooves in the posterior surface of the peripheral portion and extending into the optical portion (Fig. 5A, wedge-shaped cavities 507 are disposed around deformable dynamic portion 501, par. [0295], on the posterior surface of the dynamic lens).
Regarding dependent claim 8, Rafaeli discloses the contact lens of claim 7, wherein of the one or more posterior grooves are coupled to a fenestration (one or more fenestrations can be fluidly coupled to one or more cavities, such as wedge-shaped cavities 507 shown in Fig. 5A, and the fenestrations can allow tear fluid to flow from the anterior surface of the dynamic contact lens into one or more cavities, which can facilitate the transition of the dynamic portion between different configurations, par. [0307]).
Regarding dependent claim 9, Rafaeli discloses the contact lens of claim 7, comprising one or more anterior grooves in the peripheral anterior surface (dynamic contact lens can comprise one or more protrusions in the peripheral anterior surface, par. [0079], where the one or more protrusions can include surface features that increase friction such as grooves, depressions, and ridges, par. [0175]).
Regarding dependent claim 10, Rafaeli discloses the contact lens of claim 9, wherein the one or more anterior grooves are connected to one or more posterior grooves (at least one of the channels can be coupled to one or more fenestrations extending through the peripheral anterior surface, par. [0099]).
Regarding dependent claim 11, Rafaeli discloses the contact lens of claim 9, wherein the one or more anterior grooves are not connected to one or more posterior grooves (see at least Fig. 35B showing a cross-sectional view of dynamic contact lens with the protrusions not aligned with cavities, par. [0312], demonstrating an embodiment in which anterior grooves are not connected to posterior grooves).
Regarding dependent claim 13, Rafaeli discloses the contact lens of claim 1, wherein, when worn on the eye of a patient, the optical portion is characterized by the first quasi-stable configuration and the second quasi-stable configuration (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]);
the contact lens comprises one or more fenestrations connecting the peripheral posterior surface to the anterior surface (a groove or channel can be coupled to one or more fenestrations, par. [0079], and a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, par. [0099]); and
fluidly coupling one or more fenestrations to a tear meniscus causes a change in the optical power of an optical lens system comprising the optical portion of the contact lens, a tear film, and a lenticular optical tear volume (lenticular volumes between the posterior surface of the dynamic portion and the anterior surface of the cornea can fill with tear fluid to form a tear lens, par. [0253], and the first and second configurations correspond to different optical powers imparted by the tear lens, par. [0254], and the fenestrations can allow tear fluid to flow from the anterior surface of the dynamic contact lens into one or more cavities, which can facilitate the transition of the dynamic portion between different configurations, par. [0307]).
Regarding dependent claim 15, Rafaeli discloses the contact lens of claim 1, wherein the transport of tear fluid into and out of the optical tear volume is associated with the transition between the first quasi-stable configuration of the optical portion and the second quasi-stable configuration of the optical portion (dynamic contact lenses can be fabricated with a dynamic portion that can transition between two or more configurations on the eye where each of the two or more configurations provides a different optical power, and a lenticular volume is formed between the anterior surface of the cornea and the posterior surface of the dynamic portion of the dynamic contact lens which can fill with tear fluid to form a tear lens for correcting vision, par. [0072]).
Regarding dependent claim 16, Rafaeli discloses the contact lens of claim 1, wherein the at least one mechanism comprises a posterior groove, an anterior groove, a fenestration (dynamic tear lens can be fluidly coupled to at least one fenestration to facilitate tear fluid movement from and to the space between the lens and the eye, par. [0181]), a tear fluid reservoir (tear fluid reservoir, par. [0156]), a protrusion (one or more protrusions can include surface features that increase friction such as grooves, depressions, and ridges, par. [0175]), a depression, a valve, a fenestration comprising a valve, a geometry of the optical portion, a geometry of the peripheral portion, or a combination of any of the foregoing.
Regarding dependent claim 17, Rafaeli discloses the contact lens of claim 1, wherein interaction of tear fluid in the tear meniscus with the optical tear volume induces the transition between the first quasi-stable configuration of the optical portion and the second quasi-stable configuration of the optical portion (Figs. 1A and 1B, the peripheral posterior surface comprises cavities 109, which when placed on the cornea fill with tear fluid to provide tear fluid reservoirs, pars. [0076], [0078], and the transition zone can be configured facilitate flow of tear fluid to a tear lens formed between the dynamic posterior surface and a cornea when the dynamic lens is applied to an eye, pars. [0090-91], and a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, pars. [0098-100], and when tear fluid flows under the dynamic portion such as induced by a gaze change or lid pressure, the as-fabricated SAG assumes some or all of the as-fabricated SAG height, causing the dimensions of the tear lens to change and thereby change the optical power of the dynamic portion, pars. [0108-109]), maintains the first quasi stable configuration of the optical portion, maintains the second quasi-stable configuration of the optical portion, or a combination of any of the foregoing.
Regarding dependent claim 18, Rafaeli discloses the contact lens of claim 1, wherein motion of the eye, an eyelid, or a combination thereof, induces the transition between the first quasi-stable configuration of the optical portion and the second quasi-stable configuration of the optical portion, maintains the first quasi-stable configuration of the optical portion, maintains the second quasi-stable configuration of the optical portion, or a combination of any of the foregoing (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]).
Regarding dependent claim 19, Rafaeli discloses the contact lens of claim 1, wherein interaction of tear fluid in the tear meniscus with at least two of the optical portion, the peripheral portion, and the at least one mechanism, induces the transition between the first quasi-stable configuration of the optical portion and the second quasi-stable configuration of the optical portion, maintains the first quasi-stable configuration of the optical portion, maintains the second quasi-stable configuration of the optical portion, or a combination of any of the foregoing (Figs. 1A and 1B, the peripheral posterior surface comprises cavities 109, which when placed on the cornea fill with tear fluid to provide tear fluid reservoirs, pars. [0076], [0078], and dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084], and the transition zone can be configured facilitate flow of tear fluid to a tear lens formed between the dynamic posterior surface and a cornea when the dynamic lens is applied to an eye, pars. [0090-91], and a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, pars. [0098-100], and when tear fluid flows under the dynamic portion such as induced by a gaze change or lid pressure, the as-fabricated SAG assumes some or all of the as-fabricated SAG height, causing the dimensions of the tear lens to change and thereby change the optical power of the dynamic portion, pars. [0108-109]).
Regarding dependent claim 22, Rafaeli discloses the contact lens of claim 1, comprising one or more anterior grooves disposed in the peripheral anterior surface (one or more protrusions, where protrusions are thickened areas in the anterior surface of a lens designed to create mechanical forces when there is dynamic contact between the protrusion and the eyelid, can include surface features that increase friction such as grooves, depressions, and ridges, pars. [0172], [0175], and a groove or channel can be coupled to one or more fenestrations, par. [0079], refer also to at least pars. [0099-100], [0102], [0109], [0181], [0304-308], [0384], [0388], and [0401]) and one or more fenestrations connected to each of the one or more anterior grooves (a groove or channel can be coupled to one or more fenestrations, par. [0079]), wherein the at least one fenestration connects the anterior groove to the peripheral posterior surface (a groove or channel can be coupled to one or more fenestrations, par. [0079], and a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to the tear film between the peripheral posterior surface of the lens and the cornea, par. [0099]).
Regarding dependent claim 23, Rafaeli discloses the contact lens of claim 1, comprising: a plurality of radially disposed posterior grooves (channels can be disposed in the posterior surface, par. [0092], and each of the one or more channels can extend radially outward from the dynamic portion, par. [0093]); and one or more fenestrations, wherein one or more fenestrations is coupled to each of the plurality of radially disposed posterior grooves (at least one of the channels can be coupled to one or more fenestrations extending through the peripheral anterior surface, par. [0099]).
Regarding independent claim 27, Rafaeli discloses a contact lens (Fig. 1A depicts dynamic contact lens 100, par. [0076]) comprising:
an optical portion (Fig. 1A, dynamic contact lens 100 includes dynamic portion 101, par. [0076], and the dynamic portion and the optical portion can be aligned with the optical axis of the dynamic contact lens, par. [0247], and Rafaeli teaches a dynamic lens can have a standard optical transparency, par. [0398]),
wherein the optical portion comprises an optical posterior base curvature (Fig. 1A, dynamic contact lens 100 includes dynamic anterior surface 103 and dynamic posterior surface 104 which comprises a curvature, par. [0076]) and an optical center (Fig. 1A, dynamic contact lens 100 has a geometric axis of the lens 112 par. [0076], and the dynamic portion 101 comprises a center thickness 112, par. [0077], therefore dynamic contact lens 100 has an optical center);
a peripheral portion (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102, par. [0076]),
wherein the peripheral portion comprises a peripheral posterior base curvature (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102 with a base curvature and dynamic portion 101 includes a dynamic anterior surface 103, par. [0076]); and
a transition zone coupling the optical portion and the peripheral portion (Fig. 1A, dynamic portion 101 and peripheral portion 102 are coupled at interface 108, also referred to as the transition zone, par. [0076]),
wherein, when worn on the eye of a patient, the optical portion is characterized by a first quasi-stable configuration and a second quasi-stable configuration (Rafaeli discloses when dynamic contact lens 100 is applied to a cornea, the dynamic portion can assume two or more quasi-stable configurations, par. [0084]),
wherein interaction of the contact lens with eye movement causes a transition between the first quasi-stable configuration and the second quasi-stable configuration (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]),
wherein the eye movement comprises a change in a gaze position of the eyeball (Rafaeli discloses a dynamic contact lens can comprise features configured to induce a change in conformation of the dynamic portion upon application of pressure by an eyelid such as changing a gaze angle, pars. [0137-138]),
wherein the optical portion comprises an optical posterior surface (Fig. 1A, dynamic contact lens 100 includes dynamic anterior surface 103 and dynamic posterior surface 104 which comprises a curvature, par. [0076]);
wherein the peripheral portion comprises a peripheral posterior surface (dynamic contact lens can comprise a peripheral portion comprising a peripheral posterior surface, par. [0205]);
wherein the contact lens is configured such that when worn on the eye of a patient, the optical portion can assume a plurality of configurations in response to a pressure applied to the optical portion (the one or more non-conforming configurations can comprise a single non-conforming configuration, two or more discrete non-conforming configurations, or a plurality of quasi-stable non-conforming configurations, which can be continuous or discrete, pars. [0121], [0129]);
wherein when a negative pressure is applied to the optical posterior surface by an eyelid or a change in gaze angle, the optical posterior surface assumes one or more substantially conforming configurations with respect to the anterior surface of the cornea (dynamic contact lens can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084], and a dynamic contact lens can comprise one or more features configured to induce a change in conformation of the dynamic portion, par. [0137]); and
wherein in the absence of a negative pressure, the optical posterior surface assumes a neutral configuration to provide a tear volume between the optical posterior surface and the anterior surface of the cornea (Figs. 1A and 1B, the peripheral posterior surface comprises cavities 109, which when placed on the cornea fill with tear fluid to provide tear fluid reservoirs, pars. [0076], [0078], and Rafaeli discloses a non-conforming configuration, the dynamic portion is not adhering to the cornea, where the dynamic portion extends above or bulges away from the surface of the cornea to provide a lenticular volume between the posterior surface of the dynamic portion and the cornea where the lenticular volume can fill with tear fluid to form a tear lens, par. [0123]),
wherein the lens comprises one or more depressions disposed in an anterior peripheral surface and a fenestration coupled to each of the one or more depressions configured to provide a volume for tear fluid to flow into (one or more protrusions, where protrusions are thickened areas in the anterior surface of a lens designed to create mechanical forces when there is dynamic contact between the protrusion and the eyelid, can include surface features that increase friction such as grooves, depressions, and ridges, pars. [0172], [0175], and a groove or channel can be coupled to one or more fenestrations, par. [0079], refer also to at least pars. [0099-100], [0102], [0109], [0181], [0304-308], [0384], [0388], and [0401], and Figs. 1A and 1B, the peripheral posterior surface comprises cavities 109, which when placed on the cornea fill with tear fluid to provide tear fluid reservoirs, pars. [0076], [0078], and the transition zone can be configured facilitate flow of tear fluid to a tear lens formed between the dynamic posterior surface and a cornea when the dynamic lens is applied to an eye, pars. [0090-91], and a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, pars. [0098-100], and when tear fluid flows under the dynamic portion such as induced by a gaze change or lid pressure, the as-fabricated SAG assumes some or all of the as-fabricated SAG height, causing the dimensions of the tear lens to change and thereby change the optical power of the dynamic portion, pars. [0108-109]).
Regarding independent claim 28, Rafaeli discloses a contact lens (Fig. 1A depicts dynamic contact lens 100, par. [0076]) comprising:
an optical portion (Fig. 1A, dynamic contact lens 100 includes dynamic portion 101, par. [0076], and the dynamic portion and the optical portion can be aligned with the optical axis of the dynamic contact lens, par. [0247], and Rafaeli teaches a dynamic lens can have a standard optical transparency, par. [0398]),
wherein the optical portion comprises an optical posterior base curvature (Fig. 1A, dynamic contact lens 100 includes dynamic anterior surface 103 and dynamic posterior surface 104 which comprises a curvature, par. [0076]); and
an optical center (Fig. 1A, dynamic contact lens 100 has a geometric axis of the lens 112 par. [0076], and the dynamic portion 101 comprises a center thickness 112, par. [0077], therefore dynamic contact lens 100 has an optical center);
a peripheral portion (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102, par. [0076]),
wherein the peripheral portion comprises a peripheral posterior base curvature (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102 with a base curvature and dynamic portion 101 includes a dynamic anterior surface 103, par. [0076]); and
a transition zone coupling the optical portion and the peripheral portion (Fig. 1A, dynamic portion 101 and peripheral portion 102 are coupled at interface 108, also referred to as the transition zone, par. [0076]),
wherein, when worn on the eye of a patient, the optical portion is characterized by a first quasi-stable configuration and a second quasi-stable configuration (Rafaeli discloses when dynamic contact lens 100 is applied to a cornea, the dynamic portion can assume two or more quasi-stable configurations, par. [0084]),
wherein interaction of the contact lens with eye movement causes a transition between the first quasi-stable configuration and the second quasi-stable configuration (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]),
wherein the eye movement comprises a change in a gaze position of the eyeball (Rafaeli discloses a dynamic contact lens can comprise features configured to induce a change in conformation of the dynamic portion upon application of pressure by an eyelid such as changing a gaze angle, pars. [0137-138]),
wherein during the transition, an optical power of the optical portion does not change (Rafaeli discloses the dynamic portion is characterized by a substantially uniform thickness, par. [0079], and further discloses in certain dynamic contact lenses, the optical power of the dynamic portion does not change when the configuration of the dynamic portion changes, par. [0256], therefore as best understood by the Examiner, the thickness of the dynamic contact lens 100 does not change during the transition from one conformation to another),
wherein the lens comprises one or more depressions disposed in an anterior peripheral surface and a fenestration coupled to each of the one or more depressions configured to provide a source of tear fluid (one or more protrusions, where protrusions are thickened areas in the anterior surface of a lens designed to create mechanical forces when there is dynamic contact between the protrusion and the eyelid, can include surface features that increase friction such as grooves, depressions, and ridges, pars. [0172], [0175], and a groove or channel can be coupled to one or more fenestrations, par. [0079], refer also to at least pars. [0099-100], [0102], [0109], [0181], [0304-308], [0384], [0388], and [0401]).
Regarding dependent claim 29, Rafaeli discloses the contact lens of claim 1, wherein the first quasi-stable configuration provides a first optical power that focuses a first image on the fovea from a first distance and the second quasi-stable configuration provides a second optical power that focuses a second image on the fovea from a second distance (dynamic contact lenses can be fabricated with a dynamic portion that can transition between two or more configurations on the eye where each of the two or more configurations provides a different optical power, par. [0072], and the first optical power may be zero, and the optical power can be within a range, for example, from O D to ±6 D, from 0 D to ±4 D, from 0 D to ±3D, from 0 D to ±2 D, or from O D to ±1 D, par. [0119], and the second optical power in the non-conforming configuration can be more or less than the optical power in the conforming configuration, for example, the second optical power can be less than ±1 D, less than ±2 D, less than ±3 D, less than ±4 D, less than ±5 D, or less than ±6 D of the first optical power, par. [0124]).
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 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rafaeli as applied to claim 1, in view of Pugh et al. US PGPub 2017/0299893 A1 (hereinafter, “Pugh ‘893”).
Regarding dependent claim 20, Rafaeli discloses the contact lens of claim 1, wherein, the contact lens comprises at least one fenestration connecting the peripheral posterior surface to the anterior surface (a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, pars. [0098-100]).
Rafaeli does not disclose at least one of the fenestrations comprises a valve.
In the same field of invention, Pugh ‘893 discloses a contact lens (see at least Figs. 1A-1B thereof), wherein the contact lenses include pumps that may be used to move tear fluid proximate to a user’s eye surface (par. [0055] thereof), where channels may be formed to include flow directing aspects, such as flap valves or profiled surface which may favor one direction of flow rather than another (par. [0056] thereof), and Pugh teaches very small features may be molded into the hydrogel to form these channels and the analog of flow check valves into the shape of the channels (par. [0056] thereof), where Examiner understands a flow check valve to be equivalent to a unidirectional valve.
Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the teachings of Pugh ‘893 to the disclosure of Rafaeli and included a flow check valve formed into fenestrations disclosed by Rafaeli, to direct and control an appropriate level of flow direction in the channels to pump fluid along a network of channels exchanging fluid from external regions to internal regions (Pugh ‘893, par. [0058]).
Regarding dependent claim 21, Rafaeli in view of Pugh ‘893 discloses the contact lens of claim 20, and Rafaeli further discloses wherein the valve comprises a capillary valve (Rafaeli teaches structural features of the dynamic lens contribute to imparting a restoring force to the dynamic portion in the anterior direction and away from the cornea that produces a pumping force to pull tear fluid beneath the dynamic portion to form a tear lens in a quasi-stable non-conforming configuration, par. [0109], and mechanical forces within the lens can cause the dynamic portion to transition between configurations, par. [0139], where the mechanical forces can be capillary forces, par. [0140], therefore the valve would function by the application of capillary forces and would satisfy the limitation of being a capillary valve).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Rafaeli in view of Pugh ‘893.
Regarding independent claim 26, Rafaeli discloses a contact lens (Fig. 1A depicts dynamic contact lens 100, par. [0076]) comprising:
an optical portion (Fig. 1A, dynamic contact lens 100 includes dynamic portion 101, par. [0076], and the dynamic portion and the optical portion can be aligned with the optical axis of the dynamic contact lens, par. [0247], and Rafaeli teaches a dynamic lens can have a standard optical transparency, par. [0398]),
wherein the optical portion comprises an optical posterior base curvature (Fig. 1A, dynamic contact lens 100 includes dynamic anterior surface 103 and dynamic posterior surface 104 which comprises a curvature, par. [0076]) and an optical center (Fig. 1A, dynamic contact lens 100 has a geometric axis of the lens 112 par. [0076], and the dynamic portion 101 comprises a center thickness 112, par. [0077], therefore dynamic contact lens 100 has an optical center);
a peripheral portion (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102, par. [0076]),
wherein the peripheral portion comprises a peripheral posterior base curvature (Fig. 1A, dynamic contact lens 100 includes peripheral portion 102 with a base curvature and dynamic portion 101 includes a dynamic anterior surface 103, par. [0076]);
a transition zone coupling the optical portion and the peripheral portion (Fig. 1A, dynamic portion 101 and peripheral portion 102 are coupled at interface 108, also referred to as the transition zone, par. [0076]),
wherein, when worn on the eye of a patient, the optical portion is characterized by a first quasi-stable configuration and a second quasi-stable configuration (Rafaeli discloses when dynamic contact lens 100 is applied to a cornea, the dynamic portion can assume two or more quasi-stable configurations, par. [0084]),
wherein interaction of the contact lens with eye movement causes a transition between the first quasi-stable configuration and the second quasi-stable configuration (Rafaeli discloses dynamic contact lens 100 can be configured such that the dynamic portion can transition between the two or more quasi-stable states by pressure applied to the dynamic contact lens by the eyelids, par. [0084]),
wherein the eye movement comprises a change in a gaze position of the eyeball (Rafaeli discloses a dynamic contact lens can comprise features configured to induce a change in conformation of the dynamic portion upon application of pressure by an eyelid such as changing a gaze angle, pars. [0137-138]); and
at least one fenestration connecting a peripheral posterior surface of the contact lens to an anterior surface of the contact lens (a fenestration can be configured to fluidly couple a tear layer or the anterior surface of the lens to a channel or to the tear film between the peripheral posterior surface of the lens and the cornea, pars. [0098-100]),
wherein the lens comprises one or more depressions disposed in an anterior peripheral surface and a fenestration coupled to each of the one or more depressions (one or more protrusions, where protrusions are thickened areas in the anterior surface of a lens designed to create mechanical forces when there is dynamic contact between the protrusion and the eyelid, can include surface features that increase friction such as grooves, depressions, and ridges, pars. [0172], [0175], and a groove or channel can be coupled to one or more fenestrations, par. [0079], refer also to at least pars. [0099-100], [0102], [0109], [0181], [0304-308], [0384], [0388], and [0401]).
Rafaeli does not disclose wherein the at least one fenestration comprises a unidirectional valve (Rafaeli in at least Fig. 4A shows a view of a dynamic contact lens illustrating the direction of tear flow movement from the tear fluid reservoirs toward the dynamic portion when force is applied to the tear fluid reservoirs by the lower eyelid when gazing down, par. [0032], but does not specify the direction of flow is exclusively one-way).
In the same field of invention, Pugh ‘893 discloses a contact lens (see at least Figs. 1A-1B thereof), wherein the contact lenses include pumps that may be used to move tear fluid proximate to a user’s eye surface (par. [0055] thereof), where channels may be formed to include flow directing aspects, such as flap valves or profiled surface which may favor one direction of flow rather than another (par. [0056] thereof), and Pugh teaches very small features may be molded into the hydrogel to form these channels and the analog of flow check valves into the shape of the channels (par. [0056] thereof), where Examiner understands a flow check valve to be equivalent to a unidirectional valve.
Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the teachings of Pugh ‘893 to the disclosure of Rafaeli and included a flow check valve formed into the channels and/or fenestrations disclosed by Rafaeli, to direct and control an appropriate level of flow direction in the channels to pump fluid along a network of channels exchanging fluid from external regions to internal regions (Pugh ‘893, par. [0058]).
Allowable Subject Matter
Claims 3, 4, and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding dependent claim 3, Rafaeli discloses the contact lens of claim 2, but does not disclose wherein the negative pressure is from 5 Pa to 1,500 Pa (Rafaeli discloses forces ranging from 0.1 gm-force to 10 gm-force, par. [0157], but does not disclose areas over which these forces are applied, therefore a comparison of the pressures in the prior art and the instant application is not feasible).
Regarding dependent claim 4, Rafaeli discloses the contact lens of claim 2, but does not disclose wherein the negative pressure is from 10 Pa to 250 Pa (Rafaeli discloses forces ranging from 0.1 gm-force to 10 gm-force, par. [0157], but does not disclose areas over which these forces are applied, therefore a comparison of the pressures in the prior art and the instant application is not feasible).
Regarding dependent claim 25, Rafaeli discloses the contact lens of claim 1, wherein, the peripheral portion comprises a depression in the peripheral anterior surface (protrusions can be disposed on the anterior surface of the peripheral portion of the dynamic contact lens, par. [0170], and the one or more protrusions can include surface features that increase friction such as grooves, depressions, and ridges, par. [0175]); and
a fenestration coupled to the depression (one or more protrusions, where protrusions are thickened areas in the anterior surface of a lens designed to create mechanical forces when there is dynamic contact between the protrusion and the eyelid, can include surface features that increase friction such as grooves, depressions, and ridges, pars. [0172], [0175], and a groove or channel can be coupled to one or more fenestrations, par. [0079]); and
a posterior groove (Figs. 24A-24C, dynamic lens includes cavities 2406 in the posterior surface of the dynamic lens, par. [0179]) coupled to the fenestration (one or more fenestrations can be fluidly coupled to one or more cavities to allow tear fluid to flow from the anterior surface of the dynamic contact lens into one or more cavities, which can facilitate the transition of the dynamic portion between different configurations, par. [0307]), but Rafaeli does not disclose wherein the posterior groove extends into the optical portion (Rafaeli does not teach or suggest posterior grooves extend into the optical portion of dynamic lens disclosed therein).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Justin W Hustoft whose telephone number is (571)272-4519. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM Eastern Time.
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/JUSTIN W. HUSTOFT/ Examiner, Art Unit 2872
/THOMAS K PHAM/ Supervisory Patent Examiner, Art Unit 2872
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