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 final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/5/2026 has been entered.
Response to Amendment
This office action is in response to the communication filed 2/5/2026.
Amendments to claims 33, 35, 46, 51-53, filed 2/5/2026, are acknowledged and accepted.
Newly submitted claim 54-55, filed 2/5/2026, are acknowledged and accepted.
Cancellation of claims 1-32, filed 5/26/2022, remains in effect.
Response to Arguments
Applicant's arguments filed 2/5/2026 have been fully considered but they are not persuasive for at least the following reasons:
On pg. 10-11 of the Remarks, Applicant argues that Lin does not disclose a uniform power distribution without substantial amounts of primary spherical aberration, as newly amended into claim 33. Examiner disagrees – one can certainly identify such features in Lin’s contact lens; see the updated rejection below.
On pg. 11 of the Remarks, Applicant states that:
As the light blocking ring 1050 described in Lin is included in the contact lens 1000 to address problems with having defocus in the periphery whilst maintaining that defocus (e.g., see ¶ [0002] - [0003]), there is no motivation to apply the light blocking ring 1050 to a uniform power distribution optical zone.
This position is wholly unconvincing, however, as Applicant is merely imposing improper constraints on practitioners of the art without any reasonable justification. Applicant has no authority to speak on behalf of said practitioners, however, nor to dictate what motivations they are permitted to have – certainly not based on some arbitrary selection of paragraphs. One of ordinary skill is not confined to the narrow excerpts Applicant has decided to emphasize here. Rather, such a person possesses standard intelligence, creativity, and self-determination; they are more than capable of reading beyond some isolated passages, exercising independent critical thought, and making additional design considerations/modifications in pursuit of their own objectives.
It should also be noted that, in the argument quoted above, Lin is not nearly as limiting with respect to the light block ring as Applicant appears to suggest – Applicant, earlier on pg. 10 of their Remarks, even acknowledging that light blocking ring 1050 is only preferably found in the annular region. And as Examiner had noted in each office action prior to now, Lin plays rather loose with the boundaries of the light blocking region – establishing some broader range for its radial extent. Applicant is simply manufacturing constraints not present in the reference in order to assert their conclusory position that “there is no motivation…” which, again, lacks any proper justification and serves only argumentative convenience.
Examiner will lastly point out that ¶s 2-3 cited by Applicant do not even mention the light blocking ring. Applicant has either miscited or grossly mischaracterized Lin’s disclosure to suit their own arguments. There is simply no evidence supporting the notion that Lin’s light blocking ring 1050 is strictly intended to maintain defocus, and Applicant has yet to provide even a semblance of rationale as to why one of ordinary skill would believe this to be its only possible use or manner of implementation – which must, at the very least, be the case if Applicant even hopes to convincingly argue such hyperbolic absolutes as “there is no motivation…”.
On pg. 12 of the Remarks, Applicant then argues that:
“Lee is submitted to not be obviously transferrable to creating light blocking portions in an annular region ( or annular and peripheral region) of a contact lens as described in Lin. The mere fact that both lenses are in the field of myopia progression control is insufficient connection as the solutions are entirely different – one introduces defocus away from the central area (together with mitigating light blocking features) and the other introduces pin holes in the central area.”
However, Applicant is merely fixating on trivial differences between cited references – simple minutiae that Applicant overinterprets to restrict the inventive options available to a common practitioner. Such arguments serve little purpose other than to artificially reduce the level of ordinary skill in the art to some arbitrarily diminished standard for the sake of argumentative convenience. And without proper evidence to justify such restrictions, much of Applicant’s arguments remain merely conclusory in that they simply declare that such basic distinctions would somehow prevent a combination of references applied towards the rejection of claim 33. Applicant is thus again reminded that they have no authority to make such improper declarations – to unilaterally decide that some basic differences between the references present a gap in knowledge so great as to preclude combination – nor does Applicant have the authority to unjustifiably limit a person of ordinary skill simply to suit such improper arguments.
The fact remains that both references implement geometric light blocking/ shielding structures to control how light is transmitted through the lens and interacts with the eye to manage myopia. That one reference may place such features more centrally than the other hardly poses an insurmountable barrier preventing consideration of simple rearrangement or reshaping of such structures – at least not to one possessing ordinary intelligence and the basic capacity for critical thought. Moreover, Applicant’s mere opinion that there is “insufficient connection” based on alleged differences in the intended use of such structures is not particularly relevant here, as it adds nothing of substance with respect to what would specifically prevent one of ordinary skill from performing some straightforward combination/modification of the disclosed features.
Applicant’s remaining arguments on pgs. 11-12 of the Remarks, and regarding the open lines or striae, have been considered, but these are moot because the Applicant is arguing newly amended claims, filed 2/5/2026, not the Final Rejection, filed 11/13/2025. Newly amended claims are argued below.
Claim Objections
Claims 34 and 37-51, 53 are objected to because of the following informalities:
Applicant is reminded that “each element or step of the claim should be separated by a line indentation” – rather than bunched together as in several of the current claims, which obscures readability/comprehension. See 37 CFR 1.75(i). Claims 34, 37-40, 44, 47, 51, and 53, for example, all have separate limitations introduced by “wherein”, but each are presented in large continuous blocks, making some especially difficult to parse.
Claim 34 includes multiple coordinated limitations, separated by multiple coordinating conjunctions – rather than a single terminal conjunction per the formal standard. See lines 1-10: “wherein…; and wherein…; and wherein…; and wherein…; and wherein…; and wherein…; and wherein…”. See also the nested list spanning lines 5-8: “or hexagonal, or octagonal, or… , or… , or… ”
In claim 38, line 3, “between 420 to 760 nm” is grammatically improper and should read “between 420 and 760 nm” or “from 420 to 760 nm” or similar.
In claim 38, line 5, “linearly, or circularly, or…” has another improper conjunction “or” placed before “circularly”
In claim 38, lines 4-5, “at least in part” appears twice, with similar usage, but it is inconsistently punctuated. The first instance has no commas and the second instance improperly carries only a closing comma. The phrase is adverbial and should receive both opening+closing commas or none at all.
In claim 39, line 2, and claim 40, line 2, the comma following “physical” is improper punctuation and should be struck from the sentence.
In claim 39, line 6, claim 47, line 3, and claim 51, line 3, coordinating conjunctions (“and”) are missing before each claim’s final limitation (before “wherein”)
In claim 40, lines 6-7, “at least one of the image processing” is grammatically incomplete and is not clearly tied to the subsequent list; “image processing” should modify a noun such as “techniques” or “methods”, and it should also be preceded by the word “following”
Claim 40 also has poor list structure, with a missing semicolon (prior to the third “wherein”) and a misplaced “and” preceding the third “wherein” instead of the fourth. See lines 1-10: “wherein…; wherein… and wherein….; wherein…”
Claim 42 again improperly bunches together two separate limitations (“wherein the captured images… comprise… provides…”) without line indentation. On line 4, “provides” should read “provide” if attached to the plural noun “images”, and it should also be preceded by a conjunction (“and”) to coordinate with the previous limitation (“comprise…”)
In claim 45, line 5, the comma following “non-monotonic” is improper.
Appropriate correction is required. Claims not specifically addressed in the objections above inherit objections of the claim from which they depend.
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 33-55 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.
Regarding claims 33 and 52, in claim 33’s line 3 and claim 52’s line 4, the term “substantial amounts” is a relative term which renders the claim indefinite. The term “substantial amounts” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is thus unclear what qualifies as “substantial amounts of primary spherical aberration”, as recited in claim 33’s lines 3-4 and claim 52’ lines 4-5.
Further regarding claims 33 and 52, in claim 33’s lines 4-6 and claim 52’s lines 5-7, the phrase “(comprises…) plurality of low transmission nonrefractive features in the form of lines or striae, comprising a plurality of open lines or striae...” is ambiguous. It is not clear whether the limitation is simply redundant or whether it is establishing some self-similar structure. For examination purposes, the limitation shall be treated as simply redundant rather than communicating any fractalized structure.
Regarding claims 39-40, 44, 46, lines 5-6 of claim 39, line 12 of claim 40, lines 3-4 of claim 44, and line 3 of claim 46 each recite “a single vision lens [that is] devoid of the low transmission non-refractive features”. However, claim 33 already recited “a single vision lens… devoid of the plurality of low transmission non-refractive features”. The constant reintroduction of “a single vision lens…” causes ambiguity, as it is not clear if the phrase is being overloaded with multiple introductions such that each “single vision lens…” refers to distinct objects, or whether they represent a common object. If the latter, the problem is further exacerbated by the fact that Applicant does not refer to the singular concept in a consistent manner, which further indicates antecedence errors each time the phrasing is changed. For examination purposes, each “single vision lens…” shall be read to correspond to a common object regardless of phrasing.
Further regarding claim 40, lines 3-4 and 10-11 recite “[an/the] increase in spike trains depicting retinal ganglion cell activity”, which is grammatically ambiguous and imprecise – ultimately rendering the claim indefinite. It remains unclear whether the mere presence of spike trains adequately depicts the claimed retinal ganglion cell activity, or whether it is the “increase” specifically that is intended to correspond to the cell activity of interest. For examination purposes, the prior interpretation is adopted.
Further regarding claim 40, lines 6-7 recite “captured images serve as an input stream for a virtual retinal simulator comprising at least one of the image processing [techniques? methods? See Claim Objections above]” – which is grammatically ambiguous and imprecise – ultimately rendering the claim indefinite. It remains unclear whether the “comprising… image processing” applies to the input stream or to the retinal simulator. It is further unclear what it even means for either an input stream or retinal simulator to “compris[e]… image processing [techniques? methods?]”. For examination purposes, the limitation shall be interpreted to mean that images are processed according to the listed options during retinal simulation.
Regarding claims 41-42, line 3 recites “a retina of the model eye” after “the retina of the model eye” was already established in line 4 of claim 40. Claim 42 then goes on to recite “the retina of the model eye” again in line 5. It is therefore unclear each “retina of the model eye” correspond to different or common object(s)
Regarding claim 46, lines 2-5 reciting “ provides a wide-field optical performance relative to that obtained with a single vision lens devoid of the low transmission non-refractive features of a less than 5% variation in area under modulation transfer function (MTF) curves measured across 0 to 120 cycles/mm for a 5 mm pupil diameter” is unclearly worded/structured, with stacked modifiers that strain the grammar of the limitation and render the claim indefinite. For examination purposes, the limitation is interpreted to mean that the ophthalmic lens and the “single vision lens…” both act on an eye with a 5mm pupil, and that their wide-field optical performances are determined by extracting the areas below each lens’s MTF from the claimed frequency range. The limitation is also understood to require that these areas differ by less than 5% when the area of the “single vision lens…” provides the baseline for comparison.
Claims not specifically addressed in the rejections above inherit the indefiniteness of the claim from which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 33, 35-37, 52, and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al (US 20180373059 A1, hereinafter “Lin”) in view of Bowers and Dukes (US 20120019772 A1, hereinafter “Bowers”).
Regarding claims 33 and 52, Lin discloses (see FIG. 10, annotated below, and ¶s 122-125; see also FIGs. 1, 2(A-C), 3(A-C) and ¶s 43-44, 86-93 regarding other embodiments sharing much of the same structure) an ophthalmic lens (contact lens 1000) for an eye, the ophthalmic lens (contact lens 1000) comprising a front surface (“observe side”), a back surface (“reverse side”) , an optical centre (central point O), and an optical zone (central+annular region) about the optical centre (central point O), wherein:
the optical zone (central+annular region) has a uniform power distribution without substantial amounts of primary spherical aberration, comprises a base prescription for correcting myopia (see ¶s 138-139 and Table 3 – a power profile is provided having a base prescription of -3D for nearsightedness; the power remains constant across the center – arbitrarily small distances from which paraxial light will generally experience arbitrarily small amounts of primary spherical (Seidel) aberration of paraxial light, with wavefront error scaling as (pupil radius)4), and comprises at least one region with a plurality of low transmission non-refractive features (light blocking ring 1050);
the base prescription comprises a spherical correction, an astigmatic correction, or a spherical and an astigmatic correction (the base prescription of -3D is a (spherical) correcting power);
the plurality of low transmission non-refractive features (light blocking ring 1050) each absorb at least 80% of light incident on the low transmission non-refractive features (light blocking ring 1050) (see ¶ 215, indicating that black portions of light blocking ring 1050 may transmit <10% of visible light; note that black-colored objects are generally defined by their ability to absorb all visible wavelengths of light); and
a total light transmittance (central+annular region) through the optical zone is between 85 percent and 99 percent (≳80% encompasses this range, see rationale below) of a total light transmittance through the optical zone (central+annular region) of a single vision lens with the base prescription and devoid of the plurality of low transmission non-refractive features (light blocking ring 1050 – note:
per annotated FIG. 10 below, black portions occupy 50% of light blocking ring 1050,
per ¶ 124, light blocking ring 1050 has a minimum diameter of 6.79mm, while the maximum outer diameter is 9.1mm,
light blocking ring 1050 may thus occupy (a maximum of)
9.1
2
-
6.79
2
9.1
2
≅
44.3
%
of the optical zone,
per ¶ 215, the black portions may transmit <10% of visible light.
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647
1026
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[AltContent: textbox (FIG. 10 of Lin et al is annotated to highlight various features)]Lin’s light blocking ring 1050 may therefore reduce the transmittance of (visible) light in the optical zone by a total factor of
≲
50
%
×
44.3
%
×
(
100
-
10
)
%
≅
20
%
when applied to a similar single vision lens that is devoid of the light blocking ring – i.e., a total light transmittance of ≳80%, establishing a range which encompasses Applicant’s).
Lin does not disclose low transmission non-refractive features in the form of lines or striae, comprising a plurality of open lines or striae of width 300 microns or less
Lin and Bowers commonly relate to patterned contact lenses.
Bowers discloses (see FIG. 1, ¶s 13-16) low transmission non-refractive features in the form of lines or striae (¶ 16: “individual elements[…] are dots 12. However, elements[…] may be any of a wide variety of elements. Suitable elements include […] lines, […], striae”), comprising a plurality of open lines or striae of width 300 microns or less (¶ 16: “elements are[…] about 0.01 to about 0.3 mm”).
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Lin and Bowers, in order to achieve desired optical effects by influencing light rays entering the eye (e.g., managing photophobia, brightness; Lin ¶s 94-99) or to serve some simple cosmetic purposes such as enhancing/highlighting ocular features (e.g. the iris; Bowers ¶ 13).
Regarding claim 35, modified Lin discloses the ophthalmic lens of claim 33.
Bowers further discloses wherein each of the low transmission non-refractive features has a width between 5 μm to 250 μm (¶ 16: “elements are… about 0.01 to about 0.3 mm”), and is non-diffractive (naturally, as the cited length scales ≫ visible wavelengths).
Regarding claim 36, modified Lin discloses the ophthalmic lens of claim 33.
Lin further discloses wherein a total surface area of the plurality of low transmission non-refractive features (light blocking ring 1050) occupies between 2.5 percent and 15 percent of a total surface area of the optical zone (central+annular region) (per ¶ 124, light blocking ring 1050 has a minimum diameter of 6.79mm, while the maximum outer diameter is 9.1mm; thus, all 18 black portions shown in annotated FIG. 10 above occupies a (maximum) total surface area of approximately
1
2
*
π
*
9.1
m
m
2
2
-
6.79
m
m
2
2
≃
14.4
m
m
2
; this, in turn, corresponds to a maximum of
14.4
m
m
2
π
*
9.1
m
m
2
2
≃
22
%
of the optical zone, establishing a range which encompasses Applicant’s).
Regarding claim 37, modified Lin discloses the ophthalmic lens of claim 33.
Lin further discloses
wherein the plurality of low transmission non-refractive features (light blocking ring 1050) are applied at least in one of the locations: on the front surface (“observe side”), on the back surface (“reverse side”), or within a material of the ophthalmic lens (note that this list exhausts all possible locations where the non-refractive features can be applied; Lin’s contact lens 1000 must therefore satisfy this condition automatically); and
wherein the plurality of low transmission non-refractive features (light blocking ring 1050) are configured to be at least one of the following: opaque, translucent, reflective, spectrally sensitive, polarisation sensitive, or absorbent (black-colored objects are generally defined by their ability to absorb all visible wavelengths of light; black portions of light blocking ring 1050 are therefore opaque).
Regarding claim 54, modified Lin discloses the ophthalmic lens of claim 52.
Lin further discloses wherein the ophthalmic lens (contact lens 1000) is a contact lens.
Bowers further discloses wherein the low transmission non-refractive features are the plurality of open lines or striae of width 300 microns or less. (As established with respect to claim 52 above; see again FIG. 1 and ¶s 13-16).
Modified Lin, based on Lin’s embodiment cited above, does not disclose wherein the low transmission non-refractive features are within a central diameter of 5 mm of the optical zone.
Lin, in another embodiment, discloses wherein the low transmission non-refractive features (light blocking ring 450) are within a central diameter of 5 mm of the optical zone. (See ¶s 94-101 regarding contact lens 400 that is generic to the above-cited contact lens 1000. Its light blocking ring 450 has an inner diameter ranging from 3.5 mm ≤ DBi ≤ 11 mm, such that the features may occupy parts of the 5 mm central diameter of the contact lens/optical zone.)
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further combine design aspects of Lin’s different embodiments in order to meet practical/sizing demands (Lin ¶ 100) and to achieve more desirable transmission profile, image brightness, etc.
Regarding claim 55, modified Lin discloses the ophthalmic lens of claim 52.
Bowers further discloses wherein the low transmission non-refractive features are the plurality of open lines or striae of width 300 microns or less. (As established with respect to claim 52 above; see again FIG. 1 and ¶s 13-16).
Modified Lin, based on Lin’s embodiment cited above, does not disclose wherein the low transmission non-refractive features are within a central 30% area of the optical zone.
Lin, in another embodiment, discloses wherein the low transmission non-refractive features (light blocking ring 450) are within a central 30% area of the optical zone. (See ¶s 94-101 regarding contact lens 400. Its light blocking ring 450 has an inner diameter ranging from 3.5 mm ≤ DBo ≤ 11 mm and a contact lens diameter of 13 mm ≤ Do ≤ 15 mm. Thus, the features may occupy parts of the central 30% area of the contact lens/optical zone.)
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further combine design aspects of Lin’s different embodiments in order to meet practical/sizing demands (Lin ¶ 100) and to achieve more desirable transmission profile, image brightness, etc.
Claims 34 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bowers, as applied to claim 33 above, and in further view of Lee et al (KR 101504243 B1, hereinafter “Lee”).
Regarding claim 34, modified Lin discloses the ophthalmic lens of claim 33.
Lin further discloses:
wherein the plurality of low transmission non-refractive features (light blocking ring 1050) further comprise a plurality of borders forming a plurality of apertures (see annotated FIG. 10 above); and
wherein the plurality of apertures include at least 3 apertures (annotated FIG. 10 shows 18 apertures); and
wherein each aperture circumscribes a transparent region (unfilled portions of light blocking ring 1050); and
wherein a shape of each aperture is at least one of the following: circular, elliptical, oval, triangular, rectangular, square, pentagonal, or hexagonal, or octagonal, or any other regular polygon, or an irregular polygon, or a random shape (in annotated FIG. 10, apertures are carved from concentric rings and are shaped trapezoidally with a curved pair of edges); and
wherein a surface area of the circumscribed transparent region (unfilled portions of light blocking ring 1050) of at least one of the plurality of apertures is between 0.25 sq mm and 7.5 sq mm (light blocking ring 1050 has a minimum diameter of 6.79mm, while the maximum outer diameter is 9.1mm; thus, each of the 18 apertures shown in FIG. 10 circumscribes an unfilled portion/region whose area is approximately equal to
1
2
*
18
*
π
*
9.1
m
m
2
2
-
6.79
m
m
2
2
≃
0.8
m
m
2
, which falls within the desired range); and
wherein the plurality of apertures are configured in a circular, hexagonal, radial, spiral, regular, irregular, or random arrangement (the apertures are arranged circularly).
Modified Lin does not disclose:
wherein each aperture circumscribes a transparent region comprising the base prescription for the eye; and
wherein a width of the border of any of the plurality of apertures is between 5 μm to 250 μm such that the border remains non-diffractive.
Lin and Lee commonly relate to patterned contact lenses for myopia management.
Lee discloses a contact lens (see FIG. 5):
wherein each aperture (light shielding portion 20) circumscribes a transparent region (transparent portion 26) comprising the base prescription for the eye (see Tables 2-3 of original patent document and pg. 3 of the attached translation; “light-shielding portion 20 is printed on… base portion 10” in a “net(work) pattern”, forming “transparent portion 26” – i.e. the apertures overlie base portion 10, corresponding to a base-power/prescription contact lens, and circumscribe transparent regions); and
wherein a width of the border of any of the plurality of apertures (light shielding portion 20) is between 5 μm to 250 μm such that the border remains non-diffractive. (see pg. 3 of attached translation: “the thickness of the light shielding portion 20 is about 0.05mm to 0.2mm [50μm to 200 μm]”. This lies entirely within the claimed range. Related also is the fact that “the transparent portion 26… has an inner diameter of about 0.4 to 1.5mm”. Thus, Lee’s disclosed features all occur at length scales multiple orders of magnitude greater than the wavelengths of visible light, and any diffraction effects should be substantially negligible.)
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lin – both by adding apertures that cover the base prescription and by designing non-refractive features with ~μm-mm length scales, as taught by Lee – in order to facilitate the pinhole effect and associated visual correction effects (see pg. 3 of attached translation).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bowers, as applied to claim 37 above, and in further view of De Sio et al (AU 2014227461 A1, hereinafter “De Sio”).
Regarding claim 38, modified Lin discloses the ophthalmic lens of claim 37.
Lin further discloses wherein the low transmission non-refractive features (light blocking ring 1050) are configured such that the material characteristics are spectrally sensitive to certain visible wavelengths between 420 to 760 nm, inclusive (Lin discloses, in ¶ 220, blue blocker for contact lenses – which is known to filter out certain visible wavelengths between 400 and 500nm, and may therefore result in spectrally sensitivity)
Lin does not disclose wherein the plurality of low transmission non-refractive features are at least in part electronically tuneable, and are activated at least in part, when incident light on the ophthalmic lens is linearly, or circularly, or elliptically polarised.
Lin and De Sio commonly relate to dioptric ophthalmic lenses.
De Sio discloses (see FIGs. 2(A,B)) wherein the plurality of low transmission non-refractive features (variable optic insert 200) are at least in part electronically tuneable (see ¶s 82-84), and are activated at least in part, when incident light on the ophthalmic lens is linearly, or circularly, or elliptically polarised (see ¶ 84 regarding inclusion of liquid crystal materials in optic insert 200; see also ¶s 130-139 regarding azo dyes which provide photo-alignment for liquid crystal variable optic inserts via cis-trans photoisomerization (i.e. “activation”) when exposed to linearly polarized light).
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lin by incorporating electro- and photoactive aspects, as taught by De Sio, in order to provide more diagnostic and/or therapeutic functionality (De Sio ¶ 3).
Claims 39 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bowers and De Sio, as applied to claim 38 above, and in further view of Rosen et al (US 20150250585 A1, hereinafter “Rosen”).
Regarding claim 39, modified Lin discloses the ophthalmic lens of claim 38.
Modified Lin does not disclose:
wherein the ophthalmic lens is configured to provide, when tested on a schematic, bench-top, or a physical, model eye configured with a distance refractive error matching the base prescription, an on-axis, or an off-axis wide-field, optical performance, for at least one pupil between 3 mm and 6 mm inclusive, and at least one wavelength 420 nm to 760 nm inclusive, which is within 5% variation of that obtained with a single vison lens that is devoid of the low transmission non-refractive features;
wherein the optical performance is gauged as modulation transfer function as a function of spatial frequencies.
Lin and Rosen commonly relate to dioptric ophthalmic lenses and myopia management.
Rosen discloses an ophthalmic lens (toric intraocular lens IOL including an optic 500; see FIGs. 5A, 5D and ¶s 69-84. Note also that intraocular lenses also fall within the scope of ophthalmic lenses and are technically analogous to contact lenses, spectacle lenses, etc., as Rosen acknowledges in ¶s 9 and 35):
wherein the ophthalmic lens (IOL) is configured to provide (see ¶ 102; IOL’s optic 500 may have diffractive features, prismatic features, echelles, etc., and surface parameters selected for a desired optical performance), when tested on a schematic, bench-top, or a physical, model eye (i.e. using calculations/simulations, as disclosed in ¶ 95, corresponding to a virtual/schematic eye) configured with a distance refractive error matching the base prescription (see ¶ 94 regarding optical powers), an on-axis, or an off-axis wide-field, optical performance (modulus of optical transfer function MTF are simulated/calculated for various off-axis positions and quantify the optical performance; see ¶s 89-96 and annotated FIGs. 6(A-C) below), for at least one pupil between 3 mm and 6 mm inclusive (see ¶ 19: “the optic can be configured… for a 6mm pupil”), and at least one wavelength 420 nm to 760 nm inclusive (see ¶ 101; optic 500 operates at the visible range), which is within 5% variation (see annotated FIGs. 6(A-C) below) of that obtained with a single vison lens (standard toric IOL) that is devoid of the low transmission non-refractive features;
wherein the optical performance is gauged as modulation transfer function (MTF) as a function of spatial frequencies (see annotated FIG. 6(A-C) below).
[AltContent: textbox (FIGs. 6(A-C) of Rosen et al are overlayed and annotated to show how the modulus of the optical transfer function (MTF) profile can be modified by adjusting the intraocular lens (IOL) and the optic included with it. Strikingly, MTFs for sagittal rays (top three curves) can be tuned to produce variations ≲ 5% across wide spatial frequency ranges.)]
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It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify (or to confirm the desired) lens performance by simulating/adjusting MTFs, as taught by Rosen, in order to ensure improvement of overall vision for patients suffering from vision loss in portions of the retina (Rosen ¶ 10).
Regarding claim 53, modified Lin discloses the ophthalmic lens of claim 39.
Rosen further discloses wherein the ophthalmic lens (IOL) is configured to provide the off-axis wide-field optical performance and wherein the off-axis wide-field includes at least 5 degrees of a visual field of the model eye (see ¶ 80: “optic 500 can be configured to focus light incident at oblique angles between about 5 degrees and about 30 degrees with respect to the optical axis” – by symmetry, this corresponds to a maximum visual field of 60 degrees).
Claim 40-46 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bowers, De Sio, and Rosen, as applied to claim 39 above, and in further view of Schmeder and McPherson (US 20140233105 A1, hereinafter “Schmeder”) and Nirenberg (US 20130110236 A1).
Regarding claim 40, modified Lin discloses the ophthalmic lens of claim 39.
Modified Lin further discloses wherein the ophthalmic lens is configured to provide, when tested on the schematic, bench-top, or physical, model eye, a correction of the distance refractive error of the model eye (see, e.g., ¶s 43-45; Lin is directed to contact lenses for managing/correcting myopia – i.e. distance refractive error – in physical eyes, which may serve as model/demonstrative apparatuses, e.g., in a clinical or research environment).
Modified Lin does not disclose
wherein the ophthalmic lens is configured to provide an increase in spike trains depicting retinal ganglion cell activity;
wherein the retina of the model eye is configured to capture images of a visual scene projected through the model eye corrected with the ophthalmic lens and
wherein the captured images serve as an input stream for a virtual retinal simulator comprising at least one of the image processing:
(a) spatiotemporal filtering of the input stream of images resulting in a band-pass current,
(b) an instantaneous non-linear contrast gain control using variable feedback gate shunt conductance, and
(c) a discrete set of noisy integrate-and-fire cell models, resulting in spike trains depicting retinal ganglion cell activity;
wherein the ophthalmic lens provides the increase in spike trains depicting the retinal ganglion cell activity compared to that obtained with a single vison lens that is devoid of the low transmission non-refractive features.
Lin and Schmeder commonly relate to dioptric ophthalmic lenses.
Schmeder discloses:
wherein the ophthalmic lens is configured to provide an increase in retinal ganglion cell activity;
wherein the ophthalmic lens provides the increase in the retinal ganglion cell activity compared to that obtained with a single vison lens that is devoid of the low transmission non-refractive features.
(See ¶s 413-416; Schmeder discloses optical filters for ophthalmic lenses that are reported to increase ganglion cell stimulation/activation; it therefore provides an increase of retinal ganglion cell activity, relative to the activity provided by a lens that is devoid of the filter)
Lin and Nirenberg commonly relate to visual image processing.
Nirenberg discloses:
spike trains depicting retinal ganglion cell activity (see FIG. 13; ¶ 52);
wherein the retina of the model eye is configured to capture images of a visual scene projected through the model eye corrected with the ophthalmic lens (animal retina and retinal prostheses – with encoders modeling stimulus/response of retinal, e.g. ganglion, cells – are presented with “movies of natural scenes” and convert them into spike trains; see ¶s 13-24, 63-73, 281-282) and
wherein the captured images (movies of natural scenes) serve as an input stream (image stream) for a virtual retinal simulator (encoders) comprising at least one of the image processing:
(a) spatiotemporal filtering of the input stream (image stream) of images resulting in a band-pass current (firing rate
λ
m
),
(b) an instantaneous non-linear contrast gain control using variable feedback gate shunt conductance, and
(c) a discrete set of noisy integrate-and-fire cell models, resulting in spike trains depicting retinal ganglion cell activity;
(See ¶s 74-92, regarding the encoder’s image processing steps for converting images into spike train signals; a linear-nonlinear cascade method is disclosed which includes a spatiotemporal transformation/filter of preprocessed images to produce firing rate
λ
m
which may then be converted to spike trains. Note that the temporal function/component of the filter may be a sum of orthogonal basis functions, which are often implemented in constructing basic bandpass filters – e.g. Fourier sine/cosine series for a target passband).
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lin by incorporating optical coatings, as taught by Schmeder, in order to improve ganglion cell stimulation/activation and enjoy therapeutic benefit (see Schmeder ¶ 413).
It would have also been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to then apply Nirenberg’s retinal analysis and image processing techniques to the teachings of Lin, so that the effect Lin’s contact lens has on real biological systems may be more precisely measured/understood.
Regarding claim 41, modified Lin discloses the ophthalmic lens of claim 40.
Nirenberg further discloses wherein the captured images of the visual scene (movies of natural scenes) result in artificial edges, or spatial luminous contrast profiles, spread across a wide-field of a retina of the model eye (as disclosed in ¶ 74, each image at time t provides a luminance profile, I(j,t) or X(j,t), characterizing the brightness/luminance distribution across different positions j – i.e. a spatial luminous contrast profile. See also ¶ 79; disclosed is a (wide-)field of view that may cover up to 30°x30° for a particular ganglion cell that detects the image/profile X(j,t)).
Regarding claim 42, modified Lin discloses the ophthalmic lens of claim 41.
Nirenberg further discloses wherein the captured images of the visual scene (movies of natural scenes)
comprise captured images at various decentration positions to emulate one of the following: on-eye movement of the ophthalmic lens; eye movements of the wearer, or combination thereof (see FIG. 10 and ¶s 49, 269 – regarding optomotor experiments to analyze the drifting/movement of animal eyes as well as their ability to track moving stimulus/images, both with and without the encoder),
provides a temporal variation of the said artificial edges, or spatial luminous contrast profiles, spread across the wide-field of the retina of the model eye (as established in regards to claim 41 above, the spatial luminous contrast profiles X(j,t) are time-dependent (temporally varying) and may span a 30°x30° (wide-)field of view).
Regarding claim 43, modified Lin discloses the ophthalmic lens of claim 42.
Nirenberg further discloses wherein the retinal ganglion cell activity, gauged as mean retinal spike rate, or a non-stationarity in neural response, is observed in at least one of on-centre / off-surround retinal field and on-surround / off-centre retinal field. (While this list exhausts all possible combination of retinal fields, and must therefore be satisfied by Nirenberg’s experiments on retinal cell response, Nirenberg further discloses an explicit analysis of both on-center and off-center retinal fields – i.e. ON and OFF retinal cells. See FIG. 5 and ¶s 44, 241-244; both ON and OFF cells are tested with the encoder, in order to ensure that the neural response of the model cells produce the same response as the real animal cells. Note that the encoder here is presented with dynamic stimuli/images – i.e. the neural response is non-stationary).
Regarding claim 44, modified Lin discloses the ophthalmic lens of claim 43.
Schmeder further discloses wherein the retinal ganglion cell activity, or the non-stationarity in neural response, gauged as mean retinal spike rate integrated over a certain time frame, is at least 1.5 times of the retinal ganglion cell activity of a single vison lens that is devoid of the low transmission non-refractive features. (See ¶s 413-416; Schmeder discloses optical filters for ophthalmic lenses that are reported to increase ganglion cell stimulation/activation by as much as 50, 65, and 80 percent.)
Regarding claim 45, modified Lin discloses the ophthalmic lens of claim 44.
Nirenberg further discloses wherein the retinal ganglion cell activity, or the non-stationarity in neural response, gauged in terms of mean retinal spike rate as a function of time, follows one of the following: a non-linear, an aperiodic, a sinusoidal, a quasi- sinusoidal, a rectangular-wave, a quasi-rectangular-wave, a square-wave, a quasi-square-wave, or a non-monotonic, pattern depicting a temporal variation in the overall retinal ganglion cell activity (see ¶ 72; the ganglion cell spike trains may produce patterns including sinusoidal, square, triangular and sawtooth waveforms).
Regarding claim 46, modified Lin discloses the ophthalmic lens of claim 45.
Rosen further discloses wherein the ophthalmic lens provides visual performance that is similar to that obtained with a single vision lens devoid of the low transmission non-refractive features. (As established in regards to claim 39 above, Rosen discloses an ophthalmic system and methods in which optic 500’s surface characteristics are configured to produce optical/visual performance that is substantially similar – i.e. within 5% variation – to that of an analogous single vision lens.)
Rosen further discloses wherein the ophthalmic lens provides a wide-field optical performance relative to that obtained with a single vision lens devoid of the low transmission non-refractive features of a less than 5% variation in area under modulation transfer function (MTF) curves (as established in regards to claim 39 above, Rosen discloses an ophthalmic system and methods in which optic 500’s surface characteristics are configured to produce optical/visual performance that is substantially similar – i.e. within 5% variation – to that of an analogous single vision lens) measured across 0 to 100 cycles/mm (¶ 21: “can have MTF of at least 0.2 (e.g., at least …0.9…) for a spatial frequency of 100 cycles/mm”) for a 6 mm pupil diameter (¶ 19: “the optic can be configured… for a 6mm pupil”).
Modified Lin thus discloses the invention substantially as claimed, failing only to disclose measurements to 120 cycles/mm for a 5 mm pupil diameter. Examiner finds, however, there is no criticality associated with such experimental conditions which lie in proximity to those disclosed in the prior art.
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lin so that the imaging performance extends to the claimed conditions, in order to achieve more desirable image quality to suit a patient’s needs (Rosen ¶ 91) – since it has been held that, absent any showing of unexpected results or criticality, a prima facie case of obviousness exists where claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I).
Regarding claim 51, modified Lin discloses the ophthalmic lens of claim 41.
Nirenberg further discloses wherein the captured images of the visual scene of the visual scene (movies of natural scenes) comprise captured images at various decentration positions to emulate on-eye movement of the ophthalmic lens (see FIG. 10 and ¶s 49, 269 – regarding optomotor experiments to analyze the drifting/movement of animal eyes as well as their ability to track moving stimulus/images, both with and without the encoder), wherein the on-eye movement is within 1 mm of a well-centred on-eye lens position (see ¶ 49, 269 and FIG. 10; optomotor experiments were performed to analyze the drifting/movement of animal eyes as well as their ability to track moving stimulus/images, both with and without the encoder. Note that FIG. 10’s bottom right plot shows typical eye movement across all trials with the encoder, and a range of ~ 4° of displacement. Since humans have a typical eye radius of 11.5mm, any movement of a lens on the eye would fall within
(
11.5
m
m
*
sin
4
°
)
≃
0.8
m
m
of a central position) and in one of the following directions: horizontal, oblique, vertical or combinations thereof (any combination of horizontal, oblique, vertical directions would encompass all possible eye movements; one of these directions must have therefore been taken during Nirenberg’s optomotor experiments).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bowers, De Sio, Rosen, Schmeder, and Nirenberg, as applied to claim 46 above, and in further view of Phillips (US 7832859 B2).
Regarding claim 47, modified Lin discloses the ophthalmic lens of claim 46.
Lin further discloses wherein the ophthalmic lens provides at least one of slowing, retarding, or preventing myopia progression (see ¶ 2)
Modified Lin does not disclose that myopia progression is measured by change in axial length or distance refractive error of the eye over time; wherein the measurement of change over time is considered after at least 6, 12, or 24 months of lens wear.
Lin and Phillips commonly relate to dioptric ophthalmic lenses and the management of myopia.
Phillips discloses that myopia progression is measured by change in axial length (AXL or eye length) or distance refractive error (spherical error SER) of the eye over time; wherein the measurement of change over time is considered after at least 6, 12, or 24 months of lens wear (see Tables 2.(1,2), and corresponding FIGs. 2(a,b) – tracking AXL and SER as functions of wear time).
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to measure the myopia progression of a wearer of modified Lin’s contact lens, as taught by Phillips, in order to track visual changes in the wearer and/or to make appropriate ophthalmic adjustments as part of a treatment plan.
Claims 48-50 are rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Bowers, De Sio, Rosen, Schmeder, Nirenberg, and Phillips, as applied to claim 47 above, and in further view of Lee et al (KR 101504243 B1, hereinafter “Lee”).
Regarding claim 48, modified Lin discloses the ophthalmic lens of claim 47.
Modified Lin does not disclose wherein the low transmission non-refractive features were applied using pad-printing, laser etching, photo-etching, or laser printing.
Lin and Lee commonly relate to patterned contact lenses for myopia management.
Lee discloses wherein the low transmission non-refractive features (light shielding portion 20) were applied using pad-printing, laser etching, photo-etching, or laser printing (see pg. 3 of the attached translation; gravure printing is disclosed and is technically analogous to pad printing).
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Lin by employing a gravure/pad printing process, as taught by Lee, as an efficient and cost-effective way to produce intricate patterns of non-refractive lens features.
Regarding claim 49, modified Lin discloses the ophthalmic lens of claim 48.
Schmeder further discloses wherein the plurality of low transmission non-refractive features (variable optic insert 200) are activated and turn opaque, at least in part, when the incident light is coming from a LCD or a LED or an OLED monitor screen, TV screen, tablet screen, or mobile screen or a screen of similar electronic devices (As established previously in regards to claim 38, Schmeder discloses cis-trans photoisomerization/activation of azo dyes for variable optic insert 200. As is generally known, cis and trans azo dyes absorb – i.e. turn opaque to – visible and UV bands, and they are often used for their associated photochromic properties. Also disclosed, in ¶ 133, are LED light sources for the linearly polarized light which initiates the photoisomerization/activation).
Regarding claim 50, modified Lin discloses the ophthalmic lens of claim 49.
Rosen further discloses wherein the off-axis wide-field includes at least 15 degrees of a visual field of the model eye (see ¶ 80: “optic 500 can be configured to focus light incident at oblique angles between about 5 degrees and about 30 degrees with respect to the optical axis” – by symmetry, this corresponds to a maximum visual field of 60 degrees).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAI-GA D. HO whose telephone number is (571)270-1624. The examiner can normally be reached Monday through Friday, 10AM - 6PM E.T..
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/W.D.H./Examiner, Art Unit 2872
/STEPHONE B ALLEN/Supervisory Patent Examiner, Art Unit 2872
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