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 .
DETAILED ACTION
Response to Amendment
The amendment and the Request for Continuing Examination filed on 09/23/2025 have been entered. Claims 14-29 are now pending in the application. Claim 1 has been amended and new claims 28 and 29 have been added by the Applicant. Previous claims 14-27 rejections on the ground of nonstatutory double patenting as being unpatentable over claims 14-27 of U.S. Patent No. 10901237 have been withdrawn in light of Applicant’s amendments to claim 14.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Priority
As required by e M.P.E.P. 210, 200, 214, acknowledgement is made of applicant’s claim for priority based on Continuation of 17195840 , filed 03/09/2021 and a Continuation of 17875752 , which is also a Continuation of 17195840 , filed 03/09/2021. (Data provided by applicant is not consistent with PTO record, as there is a discontinuity in the priority applications listed in Application Data Sheet).
Drawings
The applicant’s drawings submitted 09/15/2023 are acceptable for examination purposes.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 28-29 recite the claim limitation where “the at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees configured to direct an innermost ray relative to a cross section of the treatment zone to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens” in lines 11-13. However, this limitation is confusing because it is unclear how it can be treated, given that it is unclear how the tilt angle is defined and/or measured? For example is the tilt angle a certain angle of the treatment zone of the lens measured with respect to some axis or coordinate system, or is it related to some angle of light i.e. to central mid annulus ray of the treatment zone passing through intersection of retinal plane and principal axis and/or to rays passing through that zone crossing the axis at or in front of the fovea? The specification notes that tilt angles in the above range are relative to a zero-angle comparator, where the angle of tilt is designated as zero where a central (mid annulus) ray of the treatment zone passes through the intersection of the retinal plane and the central or principal axis, but offers no definition on how the angle is measured. Moreover, the limitation notes that tilt angle of the above range is configured to direct an innermost ray relative to a cross section of the treatment zone to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens, which also means that the tilt angle of the above range can direct the innermost ray at the intersection of principal axis and the retinal plane of a wearer of the ophthalmic lens, but that angle also corresponds to zero angle comparator (see e.g. paragraphs 117, 134 of the published application). The limitation above will be treated broadly such that some angle of the treatment zone can be within such range, or that tilt angle can be in the above range when as such directs an innermost ray relative to a cross section of the treatment zone to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens. It is suggested to amend the claim and provide explanations in order to remove the indefiniteness issues.
Claims 15-27 depend on claim 14 and therefore inherit the same deficiencies.
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 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.
Claim 14-29 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al. (hereafter Brennan) US 20160054588 A1 in view of Lau et al. (hereafter Lau) US 20160377884 A1, and further in view of Legerton et al. (hereafter Legerton) US 20110153012 A1.
In regard to independent claim 14, Brennan teaches (see Figs. 1-9) an ophthalmic lens for at least one of slowing, retarding or preventing myopia progression (i.e. ophthalmic lenses, including contact lenses designed to slow, retard, or prevent myopia progression, see Title, Abstract, paragraphs [02,07, 25-30, 42-46, 49-52, 55]), the ophthalmic lens comprising:
a center zone with a negative power for myopic vision correction (i.e. center zone with negative focal power to correct existing myopic distance vision condition, to point A, see Figs 6a-c, 8a-c and 906 center zone in Fig. 9, see paragraphs [45-46, 49-50]), the center zone having a principal axis orthogonal to a surface thereof and passing through a center of the ophthalmic lens (i.e. as central axis, e.g. axis of rotation of circular center zone A/906, as depicted in e.g. 9 applied to radial profiles in e.g. Figs. 6a-c, 8a-c, paragraphs [45-46, 49-51]); and
at least one treatment zone surrounding the center zone (i.e. at least one treatment zone(s) that surround the center zone A/906, as zones from A-B and B-C, enhanced treatment zones, i.e. peripheral zones 908, see Figs. 6-9, paragraphs [45-46, 49-50]), the at least one treatment zone (A-B, B-C, 908) having a power profile comprising a positive power relative to the center zone ( as treatment zone A-B, B-C, 908 carries a large amount of high add or high plus power relative to the power in the center zone A/906, as depicted in Figs. 6a-c, 8a-c, see paragraphs [45-46, 49-50, 52]), the at least one treatment zone having a surface shape comprising a portion of a generally toroidal shape (i.e. lenses are toric including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55]),
wherein the at least one treatment zone is arranged as to form a continuous surface with the center zone (i.e. as center and treatment zones arranged as continuous surface, as depicted in e.g. Figs. 6a-9, paragraphs [44, 46, 49-51]),
wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the center zone (i.e. as treatment zones A-B, B-C, enhanced treatment zones, and/or 908 zones, as depicted in Figs. 6a-c, 8a-c, 9 are concentric circular (or elliptical) zones with the center zone A, 906, as depicted in Figs. 6a-c, 8a-c, 9 sharing central common axis (of rotation), paragraphs [44-46, 49-51]).
But Brennan is silent that the at least one treatment zone (A-B, B-B, enhanced treatment zone(s), 906) with the surface shape comprising a portion of generally toroidal shape ( as noted above, since lenses are toric including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55]) is also projecting outwardly from a front surface of the ophthalmic lens, and
that at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees configured to direct an innermost ray relative to a cross section of the treatment zone to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens.
However, Legerton teaches in the same field of invention of Systems and Methods For Regulation of Emerging of Myopia (see Figs. 1-5, Title, Abstract, paragraphs [01, 06-09, 18-39,44-50, 59-73] including e.g. contact lens for corneal reshaping as multi-focal lenses for regulation of emerging of myopia comprising a central reading zone, an annular zone and a peripheral zone) and further teaches that the surface shape of the annular treatment zone comprises the portion of a generally toroidal shape that is projecting outwardly from a front surface of the ophthalmic lens (i.e. as contact multi-focal lens includes toroidal surface, toroid of clearance in annular zone 320 surface and is projecting outwardly from the front surface of the contact lens, see Figs. 1-3B, paragraphs [18-39,44-50], as the toroid surface allows for the commencement of an increase in corneal thickness just medial to annular zone 320 and facilitates a transfer of epithelial cells and intracellular and intrastromal fluids into annular zone 320 as a response to the compression force of the lens on the eye during closed eye wearing and due to lid force pushing on aligned central zone 310 and on peripheral zone 330).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and adapt annular treatment zone of Brennan with generally toroidal shaped surface projecting outwardly from front surface of the ophthalmic lens according to teachings of Legerton in order to provide toroidal surface that allows for the commencement of an increase in corneal thickness just medial to annular zone and facilitates a transfer of epithelial cells and intracellular and intrastromal fluids into annular zone as a response to the compression force of the lens on the eye during closed eye wearing and due to lid force pushing on aligned central zone 310 and on peripheral zone 330 (see Legerton, paragraphs [44-50]).
Further, Lau teaches in same field of invention of contact lens comprising non-coaxial lenslets zones for preventing and/or slowing myopia progression (see Figs. 1-12, Title, Abstract, paragraphs [02-06, 15-21, 37, 41-46, 50-52], including similar configuration with central base sphere lens 401,501 surrounded by non-coaxial lenslets 403,503 in ring like fashion having common optical axis 406, 506, see e.g. Figs. 4-6, 9, 10) and further teaches the at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees (non-coaxial lenslets zone 403, 503 which are sloped and have different slopes, and since central ray zero tilt angle of zone 403 makes angle of 20 degrees at intersection with central axis 406 and retinal plane 402, as central ray tilt angle of 503 zone makes angle of 23 degrees at intersection with central axis 506 and before/in front of the retinal plane 502, thus comparative angle of +3 degrees, as clearly depicted in Figs. 4,5, paragraphs [41-42]) configured to direct an innermost ray relative to a cross section of the treatment zone (i.e. inner most rays 403, 503, 603 from inner most lenslets, as depicted in Figs. 4-6, paragraphs [41-43]) to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens (i.e. as rays from inner most lenslets have focal points in front of the retina and cross the common optical axis 406/506/606 before or at the retina, as depicted in Figs. 4-6, paragraphs [41-43], in order to deliver positive foci of light in front of the retina providing myopic defocus to inhibit myopia progression without impacting visual acuity and contrast sensitivity, and also allow for fine tuning and manipulation of the distribution of rays coming from such lenslets zones to strike retina, e.g. for correcting local astigmatism, see paragraphs [37, 46, 15-16]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the design and teachings of Lau of using different slopes of patterns of lenticles of non-coaxial lenslets to the treatment zones producing different slopes in treatment zones to deliver positive foci of light in front of the retina providing myopic defocus to further inhibit myopia progression without impacting visual acuity and contrast sensitivity, and further to allow for fine tuning and manipulation of the distribution of rays coming from such lenslets zones to strike retina, e.g. for correcting local astigmatism, see paragraphs [37, 46, 15-16]).
Regarding claim 15, the Brennan-Legerton-Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the tilt angle (i.e. as different slopes angles of treatment zones as due to modification with Lau) is configured to direct the innermost ray to cross the principal axis at a point between the retinal plane and a point on the principal axis that represents a coincident point focus of the treatment zone (i.e. as rays from inner most lenslets applied to treatment zones and having focal points in front of the retina crossing the common optical axis 406/506/606 before or at the retina, as depicted in Lau in Figs. 4-6, paragraphs [41-43]).
Regarding claim 16, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the portion of the generally toroidal shape may be derived from a torus (e.g., a spheroidal torus) (i.e. as toric lens(es) with concentric circular treatment zones i.e. such toroidal can be derived from torus, see paragraphs [45-46, 48-51, 54-55], and with combination with Legerton), after making a slice in the shape of the surface of a right circular cone through the surface of the spheroidal torus wherein the principal axis of the cone is coincident with the axis of rotation about which the torus is generated (i.e. as toric lens(es) with concentric circular treatment zones i.e. such toroidal shapes can be derived from torus e.g. spheroidal torus with the principal axis of the cone is coincident with the axis of rotation about which the torus as the toric shape including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55], and with combination with Legerton; note that further limitations of claim 16 are directed to method steps of making the device,. The method limitations are not germane to patentability pursuant to MPEP §2112.02, since it has been held that “'[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.' In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).”; in addition the above limitation appear to recite mathematical formulation by which torus shape can be derived, and therefore are treated as optional, since such mathematical derivations are statement or facts that either are correct and true or are not).
Regarding claim 17, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that further comprising a transition zone (i.e. as e.g. zone between points A-B, or zone between center and further enhanced treatment zone (i.e. at least one enhanced treatment zone in which power is added within the center zone), as depicted in e.g. Figs. 6a-c, 8a-c, 9, paragraphs [45-46, 49-51]) disposed between then center zone and the at least one treatment zone (i.e. between center zone up to point A, and treatment zone B-C, or further enhanced treatment zone, as depicted in e.g. Figs. 6a-c, 8a-c, 9, paragraphs [45-46, 49-51]) such that the at least one treatment zone, the transition zone, and the center zone form a continuous surface (i.e. as center A/906, and treatment zones treatment zones A-B, B-C or enhanced treatment zones are arranged as continuous surface i.e. no surface gaps, as depicted in e.g. Figs. 6a-9, paragraphs [44, 46, 49-51]).
Regarding claim 18, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the at least one treatment zone (A-B, B-B, enhancement treatment zones, have dioptric add power greater than +5.00 D, see paragraphs [26-27, 45-46, 49]) comprises an ADD power relative to the myopia correction power of greater than +5.00 D (i.e. as A-B, B-B, enhancement treatment zones, have dioptric add power greater than +5.00 D, see paragraphs [26-27, 45-46, 49], see Figs. 6a-c, 8a-c).
Regarding claim 19, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the at least one treatment zone comprises an optical power from about -10.00 D to about +15.00 D (i.e. as A-B, B-B, enhancement treatment zones, have dioptric add power in the above range, see paragraphs [26-27, 45-46, 49], see Figs. 6a-c, 8a-c).
Regarding claim 20, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the tilt angle (i.e. as different slopes of treatment zone(s)) is dependent upon the optical power of the treatment zone (i.e. due to different slopes of lenticles as applied to treatment zones which have given optical power(s) but are configured so that rays from inner most lenslets have focal points in front of the retina and cross the common optical axis 406/506/606 before or at the retina, see Lau Figs. 4-6, paragraphs [41-43, 46, 50-52, 55], in order to deliver positive foci of light in front of the retina).
Regarding claim 21, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that a diameter of the center zone is about 2 mm to about 7 mm (i.e. as diameter or center zone A/906 is in the claimed range, see paragraphs [45, 50]).
Regarding claim 22, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the at least one treatment zone (i.e. A-C, B-C, enhanced treatment zones, zones 908) has an outer margin at about 4.5 mm from a center of the lens (i.e. as depicted for e.g. zones B-C, further enhanced treatment zone, or outer boundary of 908 zone, as depicted in Figs. 6a-c, 8a-c, point C at 4.5 mm from lens center, described in paragraphs [46, 49, 50]).
Regarding claim 23, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that a halo effect is minimized (i.e. as the lenses are designed to minimize halo effect, Abstract, paragraphs [22, 24-26,28, 42, 44, 47-48, 52]).
Regarding claim 24, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the ophthalmic lens comprises a contact lens (i.e. as ophthalmic lenses include contact lenses designed to slow, retard, or prevent myopia progression, Abstract, paragraphs [02,07, 25-30, 42-46, 49-52, 55]).
Regarding claim 25, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the ophthalmic lens comprises a spectacle lens (i.e. as ophthalmic lenses include spectacle lenses designed to slow, retard, or prevent myopia progression, Abstract, paragraphs [04, 55]).
Regarding claim 26, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that the ophthalmic lens comprises an intraocular lens, a corneal inlay, or a corneal onlay (i.e. as ophthalmic lenses include and may be utilized as intraocular lenses, corneal inlays and onlays to slow, retard, or prevent myopia progression, Abstract, paragraphs [55]).
Regarding claim 27, the Brennan-Legerton -Lau combination teaches the invention as set forth above, and Brennan further teaches (see Figs. 1-9) that further comprising one or more stabilization mechanisms (i.e. as the ophthalmic lens outer zone 904 may include one or more stabilization mechanisms to reduce lens rotation when on eye, see paragraph [50]).
In regard to independent claim 28, Brennan teaches (see Figs. 1-9) an ophthalmic lens for at least one of slowing, retarding or preventing myopia progression (i.e. ophthalmic lenses, including contact lenses designed to slow, retard, or prevent myopia progression, see Title, Abstract, paragraphs [02,07, 25-30, 42-46, 49-52, 55]), the ophthalmic lens comprising:
a center zone with a negative power for myopic vision correction (i.e. center zone with negative focal power to correct existing myopic distance vision condition, to point A, see Figs 6a-c, 8a-c and 906 center zone in Fig. 9, see paragraphs [45-46, 49-50]), the center zone having a principal axis orthogonal to a surface thereof and passing through a center of the ophthalmic lens (i.e. as central axis, e.g. axis of rotation of circular center zone A/906, as depicted in e.g. 9 applied to radial profiles in e.g. Figs. 6a-c, 8a-c, paragraphs [45-46, 49-51]); and
at least one treatment zone surrounding the center zone (i.e. at least one treatment zone(s) that surround the center zone A/906, as zones from A-B and B-C, enhanced treatment zones, i.e. peripheral zones 908, see Figs. 6-9, paragraphs [45-46, 49-50]), the at least one treatment zone (A-B, B-C, 908) having a power profile comprising a positive power relative to the center zone ( as treatment zone A-B, B-C, 908 carries a large amount of high add or high plus power relative to the power in the center zone A/906, as depicted in Figs. 6a-c, 8a-c, see paragraphs [45-46, 49-50, 52]), the at least one treatment zone having a surface shape comprising a portion of a generally toroidal shape (i.e. lenses are toric including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55]),
wherein the at least one treatment zone is arranged as to form a continuous surface with the center zone (i.e. as center and treatment zones arranged as continuous surface, as depicted in e.g. Figs. 6a-9, paragraphs [44, 46, 49-51]),
wherein the at least one treatment zone exhibits a focal ring with a locus of each of infinite focal points on the ring being displaced non-coaxially from the principal axis (i.e. as treatment zones A-B, B-C, enhanced treatment zones, and/or 908 zones, as depicted in Figs. 6a-c, 8a-c, 9 are concentric circular (or elliptical) zones with the center zone A, 906, sharing central common axis (of rotation), e.g. paragraphs [44-46, 49-51] and exhibit ring-like structure, paragraphs [21-23], not on central common axis as ring-like structure is formed, as this feature of enhanced treatment zones 908 is seen as inherent teaching and implicit feature of the enhanced treatment zone e.g. zones in A-B B- C, regions 908, due to their optical structural features of the ophthalmic lens device since at least one treatment zone i.e. A-B, B-C, enhanced treatment zones 908, as due its’ structure forms such continuous focal ring in front of the retina because since it’s ring-like defocus blur is on the retina, due to light propagation and light rays diverging and defocusing past the focal points, with the locus of each infinite focal point on the ring, i.e. as a ring-like structure, see paragraphs [21-23], that is displaced i.e. non- coaxial from the geometric axis of the center zone, i.e. not on central common axis as ring-like structure is formed, because Brennan clearly discloses that high +D powers of annular and continuous treatments zones beyond e.g. 2.25 mm radial location from center of lens, where light rays passing through these high plus or high add power zones do form sharp foci in front of the retina, and that due to the continued propagation to the retina, rays form a ring-like focal shape then diverge and exhibit a ring-like defocus blur on the retina, which is presented in paragraphs [21-23]; further the slopes of the lens power profiles in treatment zones, in e.g. Figs. 6a-c contribute to ring-like foci (see paragraphs [21-23, 45-46, 49, 51-52]; 112 section above), that is displaced i.e. non-coaxial from the geometric axis of the center zone; thus, such features are disclosed, and it is apparent that as sharp foci are formed in front of the retina, and that due to the continued propagation to the retina, these rays are diverging as defocused ring-like blur on the retina, its’ sharp foci form the ring-like shape right before the retina, and hence the above features must be present for the ophthalmic lens device to function as intended. This feature is further also evidenced by Lau who discloses that non-coaxial large +D concentric circular lenslets that are not on the central axis, see Figs. 4-8 and 9-10, and are this analogous to concentric circular treatment zones of Brennan that are outside the center treatment zone, showing that in cross section two displaced focal points shown, as each lenslet forming focuses at each single focal points e.g. 408, 410 in front of the retina 402, and where e.g. 408, 410 that do not coincide with the original common optical axis 406 and are therefore non-coaxial, as depicted in Fig. 4, and analogously in Figs. 5-8, see paragraphs [41-46, 50-52]; Moreover regarding the above features of the enhanced annular treatment zone(s), it is noted that because the structure of the claimed system, as identified above is the same as that claimed, it must inherently perform the same function of forming the ring-like focus before the retina, as the ring-like defocus blur is formed on the retina. 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) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). MPEP §2114),
wherein the at least one treatment zone has an annular configuration sharing a common geometric axis with the center zone (i.e. as treatment zones A-B, B-C, enhanced treatment zones, and/or 908 zones, as depicted in Figs. 6a-c, 8a-c, 9 are concentric circular (or elliptical) zones with the center zone A, 906, as depicted in Figs. 6a-c, 8a-c, 9 sharing central common axis (of rotation), paragraphs [44-46, 49-51]).
But Brennan is silent that the at least one treatment zone (A-B, B-B, enhanced treatment zone(s), 906) with the surface shape comprising a portion of generally toroidal shape ( as noted above, since lenses are toric including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55]) is also projecting outwardly from a front surface of the ophthalmic lens, and
that at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees configured to direct an innermost ray relative to a cross section of the treatment zone to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens.
However, Legerton teaches in the same field of invention of Systems and Methods For Regulation of Emerging of Myopia (see Figs. 1-5, Title, Abstract, paragraphs [01, 06-09, 18-39,44-50, 59-73] including e.g. contact lens for corneal reshaping as multi-focal lenses for regulation of emerging of myopia comprising a central reading zone, an annular zone and a peripheral zone) and further teaches that the surface shape of the annular treatment zone comprises the portion of a generally toroidal shape that is projecting outwardly from a front surface of the ophthalmic lens (i.e. as contact multi-focal lens includes toroidal surface, toroid of clearance in annular zone 320 surface and is projecting outwardly from the front surface of the contact lens, see Figs. 1-3B, paragraphs [18-39,44-50], as the toroid surface allows for the commencement of an increase in corneal thickness just medial to annular zone 320 and facilitates a transfer of epithelial cells and intracellular and intrastromal fluids into annular zone 320 as a response to the compression force of the lens on the eye during closed eye wearing and due to lid force pushing on aligned central zone 310 and on peripheral zone 330).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and adapt annular treatment zone of Brennan with generally toroidal shaped surface projecting outwardly from front surface of the ophthalmic lens according to teachings of Legerton in order to provide toroidal surface that allows for the commencement of an increase in corneal thickness just medial to annular zone and facilitates a transfer of epithelial cells and intracellular and intrastromal fluids into annular zone as a response to the compression force of the lens on the eye during closed eye wearing and due to lid force pushing on aligned central zone 310 and on peripheral zone 330 (see Legerton, paragraphs [44-50]).
Further, Lau teaches in same field of invention of contact lens comprising non-coaxial lenslets zones for preventing and/or slowing myopia progression (see Figs. 1-12, Title, Abstract, paragraphs [02-06, 15-21, 37, 41-46, 50-52], including similar configuration with central base sphere lens 401,501 surrounded by non-coaxial lenslets 403,503 in ring like fashion having common optical axis 406, 506, see e.g. Figs. 4-6, 9, 10) and further teaches the at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees (non-coaxial lenslets zone 403, 503 which are sloped and have different slopes, and since central ray zero tilt angle of zone 403 makes angle of 20 degrees at intersection with central axis 406 and retinal plane 402, as central ray tilt angle of 503 zone makes angle of 23 degrees at intersection with central axis 506 and before/in front of the retinal plane 502, thus comparative angle of +3 degrees, as clearly depicted in Figs. 4,5, paragraphs [41-42]) configured to direct an innermost ray relative to a cross section of the treatment zone (i.e. inner most rays 403, 503, 603 from inner most lenslets, as depicted in Figs. 4-6, paragraphs [41-43]) to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens (i.e. as rays from inner most lenslets have focal points in front of the retina and cross the common optical axis 406/506/606 before or at the retina, as depicted in Figs. 4-6, paragraphs [41-43], in order to deliver positive foci of light in front of the retina providing myopic defocus to inhibit myopia progression without impacting visual acuity and contrast sensitivity, and also allow for fine tuning and manipulation of the distribution of rays coming from such lenslets zones to strike retina, e.g. for correcting local astigmatism, see paragraphs [37, 46, 15-16]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the design and teachings of Lau of using different slopes of patterns of lenticles of non-coaxial lenslets to the treatment zones producing different slopes in treatment zones to deliver positive foci of light in front of the retina providing myopic defocus to further inhibit myopia progression without impacting visual acuity and contrast sensitivity, and further to allow for fine tuning and manipulation of the distribution of rays coming from such lenslets zones to strike retina, e.g. for correcting local astigmatism, see paragraphs [37, 46, 15-16]).
In addition as a result of the combination of Brennan with Legerton and Lau, the combination also teaches and renders obvious that the at least one treatment exhibits a focal ring with a locus of each of infinite focal points on the ring being displaced non-coaxially from the principal axis (i.e. as treatment zones A-B, B-C, enhanced treatment zones, and/or 908 zones, as depicted in Figs. 6a-c, 8a-c, 9 are concentric circular (or elliptical) zones with the center zone A, 906, sharing central common axis (of rotation), e.g. paragraphs [44-46, 49-51] and exhibit ring-like structure, and with modification of the treatment zone due to Lau, exhibiting that in cross section two displaced focal points shown, as each lenslet forming focuses at each single focal points e.g. 408, 410 in front of the retina 402, and where e.g. 408, 410 that do not coincide with the original common optical axis 406 and are therefore non-coaxial, as depicted in Fig. 4, and analogously in Figs. 5-8, see paragraphs [41-46, 50-52]).
In regard to independent claim 29, Brennan teaches (see Figs. 1-9) an ophthalmic lens for at least one of slowing, retarding or preventing myopia progression (i.e. ophthalmic lenses, including contact lenses designed to slow, retard, or prevent myopia progression, see Title, Abstract, paragraphs [02,07, 25-30, 42-46, 49-52, 55]), the ophthalmic lens comprising:
a center zone with a negative power for myopic vision correction (i.e. center zone with negative focal power to correct existing myopic distance vision condition, to point A, see Figs 6a-c, 8a-c and 906 center zone in Fig. 9, see paragraphs [45-46, 49-50]), the center zone having a principal axis orthogonal to a surface thereof and passing through a center of the ophthalmic lens (i.e. as central axis, e.g. axis of rotation of circular center zone A/906, as depicted in e.g. 9 applied to radial profiles in e.g. Figs. 6a-c, 8a-c, paragraphs [45-46, 49-51]); and
at least one treatment zone surrounding the center zone (i.e. at least one treatment zone(s) that surround the center zone A/906, as zones from A-B and B-C, enhanced treatment zones, i.e. peripheral zones 908, see Figs. 6-9, paragraphs [45-46, 49-50]), the at least one treatment zone (A-B, B-C, 908) having a power profile comprising a positive power relative to the center zone ( as treatment zone A-B, B-C, 908 carries a large amount of high add or high plus power relative to the power in the center zone A/906, as depicted in Figs. 6a-c, 8a-c, see paragraphs [45-46, 49-50, 52]), the at least one treatment zone having a surface shape comprising a portion of a generally toroidal shape (i.e. lenses are toric including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55]),
wherein the at least one treatment zone is arranged as to form a continuous surface with the center zone (i.e. as center and treatment zones arranged as continuous surface, as depicted in e.g. Figs. 6a-9, paragraphs [44, 46, 49-51]),
wherein the at least one treatment exhibits a focal ring with a locus of each of infinite focal points on the ring being displaced non-coaxially from the principal axis (i.e. as treatment zones A-B, B-C, enhanced treatment zones, and/or 908 zones, as depicted in Figs. 6a-c, 8a-c, 9 are concentric circular (or elliptical) zones with the center zone A, 906, sharing central common axis (of rotation), e.g. paragraphs [44-46, 49-51] and exhibit ring-like structure, paragraphs [21-23], not on central common axis as ring-like structure is formed, as this feature of enhanced treatment zones 908 is seen as inherent teaching and implicit feature of the enhanced treatment zone e.g. zones in A-B B- C, regions 908, due to their optical structural features of the ophthalmic lens device since at least one treatment zone i.e. A-B, B-C, enhanced treatment zones 908, as due its’ structure forms such continuous focal ring in front of the retina because since it’s ring-like defocus blur is on the retina, due to light propagation and light rays diverging and defocusing past the focal points, with the locus of each infinite focal point on the ring, i.e. as a ring-like structure, see paragraphs [21-23], that is displaced i.e. non- coaxial from the geometric axis of the center zone, i.e. not on central common axis as ring-like structure is formed, because Brennan clearly discloses that high +D powers of annular and continuous treatments zones beyond e.g. 2.25 mm radial location from center of lens, where light rays passing through these high plus or high add power zones do form sharp foci in front of the retina, and that due to the continued propagation to the retina, rays form a ring-like focal shape then diverge and exhibit a ring-like defocus blur on the retina, which is presented in paragraphs [21-23]; further the slopes of the lens power profiles in treatment zones, in e.g. Figs. 6a-c contribute to ring-like foci (see paragraphs [21-23, 45-46, 49, 51-52]; 112 section above), that is displaced i.e. non-coaxial from the geometric axis of the center zone; thus, such features are disclosed, and it is apparent that as sharp foci are formed in front of the retina, and that due to the continued propagation to the retina, these rays are diverging as defocused ring-like blur on the retina, its’ sharp foci form the ring-like shape right before the retina, and hence the above features must be present for the ophthalmic lens device to function as intended. This feature is further also evidenced by Lau who discloses that non-coaxial large +D concentric circular lenslets that are not on the central axis, see Figs. 4-8 and 9-10, and are this analogous to concentric circular treatment zones of Brennan that are outside the center treatment zone, showing that in cross section two displaced focal points shown, as each lenslet forming focuses at each single focal points e.g. 408, 410 in front of the retina 402, and where e.g. 408, 410 that do not coincide with the original common optical axis 406 and are therefore non-coaxial, as depicted in Fig. 4, and analogously in Figs. 5-8, see paragraphs [41-46, 50-52]; Moreover regarding the above features of the enhanced annular treatment zone(s), it is noted that because the structure of the claimed system, as identified above is the same as that claimed, it must inherently perform the same function of forming the ring-like focus before the retina, as the ring-like defocus blur is formed on the retina. 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) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). MPEP §2114).
But Brennan is silent that the at least one treatment zone (A-B, B-B, enhanced treatment zone(s), 906) with the surface shape comprising a portion of generally toroidal shape ( as noted above, since lenses are toric including concentric circular treatment zones, see paragraphs [45-46, 48-51, 54-55]) is also projecting outwardly from a front surface of the ophthalmic lens, and
that at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees configured to direct an innermost ray relative to a cross section of the treatment zone to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens.
However, Legerton teaches in the same field of invention of Systems and Methods For Regulation of Emerging of Myopia (see Figs. 1-5, Title, Abstract, paragraphs [01, 06-09, 18-39,44-50, 59-73] including e.g. contact lens for corneal reshaping as multi-focal lenses for regulation of emerging of myopia comprising a central reading zone, an annular zone and a peripheral zone) and further teaches that the surface shape of the annular treatment zone comprises the portion of a generally toroidal shape that is projecting outwardly from a front surface of the ophthalmic lens (i.e. as contact multi-focal lens includes toroidal surface, toroid of clearance in annular zone 320 surface and is projecting outwardly from the front surface of the contact lens, see Figs. 1-3B, paragraphs [18-39,44-50], as the toroid surface allows for the commencement of an increase in corneal thickness just medial to annular zone 320 and facilitates a transfer of epithelial cells and intracellular and intrastromal fluids into annular zone 320 as a response to the compression force of the lens on the eye during closed eye wearing and due to lid force pushing on aligned central zone 310 and on peripheral zone 330).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and adapt annular treatment zone of Brennan with generally toroidal shaped surface projecting outwardly from front surface of the ophthalmic lens according to teachings of Legerton in order to provide toroidal surface that allows for the commencement of an increase in corneal thickness just medial to annular zone and facilitates a transfer of epithelial cells and intracellular and intrastromal fluids into annular zone as a response to the compression force of the lens on the eye during closed eye wearing and due to lid force pushing on aligned central zone 310 and on peripheral zone 330 (see Legerton, paragraphs [44-50]).
Further, Lau teaches in same field of invention of contact lens comprising non-coaxial lenslets zones for preventing and/or slowing myopia progression (see Figs. 1-12, Title, Abstract, paragraphs [02-06, 15-21, 37, 41-46, 50-52], including similar configuration with central base sphere lens 401,501 surrounded by non-coaxial lenslets 403,503 in ring like fashion having common optical axis 406, 506, see e.g. Figs. 4-6, 9, 10) and further teaches the at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees (non-coaxial lenslets zone 403, 503 which are sloped and have different slopes, and since central ray zero tilt angle of zone 403 makes angle of 20 degrees at intersection with central axis 406 and retinal plane 402, as central ray tilt angle of 503 zone makes angle of 23 degrees at intersection with central axis 506 and before/in front of the retinal plane 502, thus comparative angle of +3 degrees, as clearly depicted in Figs. 4,5, paragraphs [41-42]) configured to direct an innermost ray relative to a cross section of the treatment zone (i.e. inner most rays 403, 503, 603 from inner most lenslets, as depicted in Figs. 4-6, paragraphs [41-43]) to cross the principal axis at a point that is at or anterior to a retinal plane of a wearer of the ophthalmic lens (i.e. as rays from inner most lenslets have focal points in front of the retina and cross the common optical axis 406/506/606 before or at the retina, as depicted in Figs. 4-6, paragraphs [41-43], in order to deliver positive foci of light in front of the retina providing myopic defocus to inhibit myopia progression without impacting visual acuity and contrast sensitivity, and also allow for fine tuning and manipulation of the distribution of rays coming from such lenslets zones to strike retina, e.g. for correcting local astigmatism, see paragraphs [37, 46, 15-16]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the design and teachings of Lau of using different slopes of patterns of lenticles of non-coaxial lenslets to the continuous treatment zones of Brennan producing different slopes in treatment zones to deliver positive foci of light in front of the retina providing myopic defocus to further inhibit myopia progression without impacting visual acuity and contrast sensitivity, and further to allow for fine tuning and manipulation of the distribution of rays coming from such lenslets zones to strike retina, e.g. for correcting local astigmatism, see paragraphs [37, 46, 15-16]).
In addition as a result of the combination of Brennan with Legerton and Lau, the combination also teaches and renders obvious that the at least one treatment exhibits a focal ring with a locus of each of infinite focal points on the ring being displaced non-coaxially from the principal axis (i.e. as treatment zones A-B, B-C, enhanced treatment zones, and/or 908 zones, as depicted in Figs. 6a-c, 8a-c, 9 are concentric circular (or elliptical) zones with the center zone A, 906, sharing central common axis (of rotation), e.g. paragraphs [44-46, 49-51] and exhibit ring-like structure, and with modification of the treatment zone due to Lau, exhibiting that in cross section two displaced focal points shown, as each lenslet forming focuses at each single focal points e.g. 408, 410 in front of the retina 402, and where e.g. 408, 410 that do not coincide with the original common optical axis 406 and are therefore non-coaxial, as depicted in Fig. 4, and analogously in Figs. 5-8, see paragraphs [41-46, 50-52]).
Response to Arguments
Applicant’s arguments filed in the Remarks dated 09/23/2025 with respect to claim(s) 14 have been considered but are not persuasive.
Applicant argues on page 6-7 of the Remarks that the combination of cited prior art of Brennan, Legerton and Lau does not disclose the new amended limitation where (1) “the at least one treatment zone has a tilt angle between +0.035 and +0.3215 degrees” because the prior art teaches the non-coaxial lenslets 403,503 which are slopped and have different slopes, but does not disclose the specific tilt angle that is claimed. The Examiner respectfully disagrees. Initially, as noted the above limitation introduces a new indefiniteness issue as detailed above. Further, with respect to the above issue, as noted in the rejection above, the cite prior art of Brennan teaches most of the limitations of claim 14 and in combination with cited prior art of Legerton and Lau teaches and renders obvious all limitations of claim 14, as Brennan teaches (see Figs. 1-9) an ophthalmic lens for at least one of slowing, retarding or preventing myopia progression (i.e. ophthalmic lenses, including contact lenses designed to slow, retard, or prevent myopia progression, see Title, Abstract, paragraphs [02,07, 25-30, 42-46, 49-52, 55]), the ophthalmic lens comprising:
a center zone with a negative power for myopic vision correction (i.e. center zone with negative focal power to correct existing myopic distance vision condition, to point A, see Figs 6a-c, 8a-c and 906 center zone in Fig. 9, see paragraphs [45-46, 49-50]), the center zone having a principal axis orthogonal to a surface thereof and passing through a center of the ophthalmic lens (i.e. as central axis, e.g. axis of rotation of circular center zone A/906, as depicted in e.g. 9 applied to radial profiles in e.g. Figs. 6a-c, 8a-c, paragraphs [45-46, 49-51]); and
at least one treatment zone surrounding the center zone (i.e. at least one treatment zone(s) that surround the center zone A/906, as zones from A-B and B-C, enhanced treatment zones, i.e. peripheral zones 908, see Figs. 6-9, paragraphs [45-46, 49-50]), the at least one treatment zone (A-B, B-C, 908) having a power profile comprising a positive power relative to the center zone ( as treatment zone A-B, B-C, 908 carries a large amount of high add or high plus power relative to the power in the center zone A/906, as depicted in Figs. 6a-c, 8a-c, see paragraphs [45-46, 49-50, 52]), the at least one treatment zone having a surface shape comprising a portion of a generally toroidal shape (i.e. lenses are toric includi