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 .
Response to Amendment
This office action is in response to the communication filed 3/10/2026.
Withdrawal of claims 6-8 and 14-17, filed 3/10/2026, is acknowledged and accepted.
Election/Restrictions
Applicant’s election without traverse of species A, corresponding to claims 3-5 and 9-13 in the reply filed on 3/10/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement submitted on 8/6/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 220 (¶ 42, line 5), 321 (¶ 45, line 12). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because
the first sentence is not a complete sentence
the “application” of design parameters, for example widths, as recited in lines 3-5, is not particularly meaningful. See also Claim Rejections - 35 USC § 112 below
“at least one design parameter selected from width, […] and combinations thereof the peripheral edge of the insert” as recited in lines 3-5 is ungrammatical. See also Claim Objections (9A) below
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The disclosure is further objected to because the specification is replete with informalities and terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some informalities and unclear, inexact, or verbose terms used in the specification are listed as follows:
In ¶ 9, lines 9-11, “at least one design parameter selected from width, […] and combinations thereof the peripheral edge of the insert” is apparently improper/ ungrammatical. See also Claim Objections (9A) below
In ¶ 21, “Figure 8B is a cross-sectional view of the contact lens of Figure 6A” is almost certainly wrong. “6A” should likely read “8A”
In ¶ 28, line 1, “A siloxane, which often also described as a silicone” is apparently missing a verb; “which” may be replaced with “which is”
In ¶ 32, line 3, “any object have any geometrical shape” is ungrammatical should read “any object having any geometrical shape”
In ¶ 44, lines 18-19 appears to be abruptly begin describing Figure 2 features without any warning, despite having just spent the entire paragraph describing Figure 3 (and despite Figure 2 having already been described in the previous paragraph 43)
In ¶ 45, lines 10-16, the W2 feature of Figure 3 appears to be cited despite the paragraph being apparently intended to address Figure 4.
Examiner notes that this list is not exhaustive, and reiterates that the specification should
be revised carefully in order to comply with 35 U.S.C. 112(a). Applicant’s specification should be provided in clear and proper idiomatic English and contain no new matter.
Claim Objections
Claims 1-5, 9-13, 18-20 are objected to because they are generally replete with grammatical and idiomatic errors, listed as follows:
In claim 1, lines 13-14; claim 18, lines 10-12, “at least one design parameter selected from width, […] and combinations thereof the peripheral edge of the insert” appears to be assigning possession of the “width, […]” to “the peripheral edge of the insert”, but in an apparently improper/ungrammatical manner. Possible correction may involve referencing the peripheral edge earlier and with a clear preposition – perhaps after “design parameter [of the peripheral edge of the insert]”
In claim 3, line 3 reciting “a tapered inner first segment an outer second segment” should read “a tapered inner first segment and an outer second segment”
In claim 3, line 6; claim 4, line 4, “arcute” appears to be a misspelling of “arcuate”
In claim 3, line 6, “in in” appears to be an improper duplication
In claim 3, lines 7-8; claim 4, line 2; claim 5, lines 2-3; claim 13, line 2; “between […] to […]” is ungrammatical and should read “between […] and […]”
In claim 9, lines 3-4, “the insert portion surrounds immediately […]” is awkward/ unclear, but may be corrected to read “the insert portion immediately surrounds […]”
In claim 18, line 9, a comma is improperly duplicated
In claim 20, line 2, “outer peripheral edge” is missing an article (“an”)
The word “claim” is sporadically capitalized throughout the claims – see line 1 of claims 2-5 and 19-20. Applicant is free to adopt their own capitalization style, but capitalization should be consistent across the claim set.
The claims appear to recite various synonymous alternatives, such as
“flat or linear” (claim 3, line 4)
“arcute [sic] or curved” (claim 3, line 6)
“normal or perpendicular” (claim 5, line 3)
Such wording is generally unnecessary and redundant, manufacturing verbosity and possibly some ambiguity as to whether the listed terms are intended to communicate structural alternatives or simple synonyms
Claims not specifically addressed in the objections above inherit the objections of the claim from which they depend. Appropriate correction is required.
The claims are further objected to because they recite a plurality of elements or steps which have not been separated by line indentations. Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
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 1-5, 9-13, and 18-20 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 1 and 18, lines 12-14 of claim 1 and lines 10-11 of claim 18 each recite
“selective application of at least one design parameter selected from width, angle, shape configuration, and combinations thereof”.
However, it is not particularly clear or meaningful what it means to “appl[y]” a width, for example. For examination purposes, these limitations will be interpreted simply to mean that the listed design parameters are chosen to provide claim 1’s “improved lens performance” or to “optimiz[e] performance” as in claim 20.
Further regarding claim 1, lines 9-10 recite
“wherein said at least one peripheral edge of the insert is configured to provide improved lens performance”,
which is a vague descriptor that lacks clear or definite meaning, given that no baseline has been established with respect to which the lens performance is “improved”. Besides the lack of clarity, the phrase is also redundantly and improperly repeated verbatim in next two lines 11-12, overloading the “improved lens performance” with multiple introductions and generating further confusion and antecedence issues – i.e. regarding whether each “improved lens performance” refers to a common object or distinct ones. For examination purposes, the “improved lens performance” is understood to encompass any arbitrary performance level that supports basic/practical use of the contact lens. Moreover, each instance of “improved lens performance” is understood to refer to a common object.
Regarding claims 3 and 4, claim 3, lines 5 and 7-8; claim 4, line 4 each recite “the tapered outer second segment” which lacks a proper antecedent basis. For examination purposes, this limitation shall be read as “the outer second segment” as introduced in line 3 of claim 3.
Further regarding claim 4, lines 3-4 recites “and/or wherein the tapered outer second segment is arcute [sic]”, despite claim 3 already reciting “the tapered outer second segment is arcute or curved in in [sic]”. It is therefore unclear why the claim is re-proposing this limitation as an option. For examination purposes, claim 4’s recitation shall simply be interpreted as an improper and misplaced redundancy.
Further regarding claim 18, lines 3 and 7 each recite “a carrier portion”, overloading the phrase with multiple introductions and causing ambiguity as to whether each “carrier portion” refers to a common object or distinct ones. For examination purposes, each “carrier portion” shall be understood to refer to a common object.
Regarding claim 19, line 1 recites “the insert-carrier interface shape configuration” which lacks a proper antecedent basis. For examination purposes, this limitation shall be read as “the shape configuration” as introduced in line 11 of claim 18.
Regarding claim 20, line 3 recites “the optimized lens performance” which lacks a proper antecedent basis. For examination purposes, this limitation shall be read as “the performance” as introduced in line 1 of claim 18
Further regarding claim 20, lines 4-5 recite “delamination of the insert portion from the bulk hydrogel material”. This is simply unclear because the insert portion was earlier defined to include the hydrogel material in line 9 of claim 18. For examination purposes, the limitation will be read as “delamination of the insert from the bulk hydrogel material”.
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 1-5, 11-13, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Borja et al (WO 2021124218 A1, hereinafter “Borja”) in view of Dahi et al (US 20040212779 A1, hereinafter “Dahi”).
Regarding claims 1 and 18, Borja discloses (see FIGs. 4(A-D), ¶s 46-47, with FIG. 4A annotated below) a bi-layer contact lens (410a) comprising (see also ¶s 35-45 detailing base/alternative embodiments which share much of the same features)
an anterior surface,
an opposite posterior surface,
a bulk hydrogel material (lens substrate 440a),
an insert (diffractive structure 420a) embedded in the bulk hydrogel material (lens substrate 440a),
an insert portion, and
a carrier portion,
wherein the insert (diffractive structure 420a) is made of a crosslinked polymeric material different from the bulk hydrogel material (lens substrate 440a) and has a convex surface, an opposite concave surface, and at least one peripheral edge,
(Regarding items C and G’s hydrogel and crosslinked polymeric materials, see ¶s 38-40:
“lens substrate 40, 140 or other first portion or first layer of the lens may be formed of a first material (M1) […] diffractive element 20, 120 or other second portion or second layer of the lens may be formed of a second material (M2)”
“first lens portion may comprise a hydrogel or a silicon hydrogel first lens material (M1) […] second lens portion may comprise a silicon elastomer [= crosslinked polymer] second lens material (M2)”)
wherein the insert portion is surrounded immediately by the carrier portion made of the bulk hydrogel material (lens substrate 440a),
wherein the insert portion comprises the insert (diffractive structure 420a) and a layer of the bulk hydrogel material (lens substrate 440a) in direct contact with the insert (diffractive structure 420a) via one of the convex and concave surfaces, and
wherein said at least one peripheral edge of the insert is configured to provide improved lens performance,
wherein said at least one peripheral edge of the insert (diffractive structure 420a) is configured to provide improved lens performance by selective application of at least one design parameter selected from width, angle, shape configuration, and combinations thereof the peripheral edge of the insert (diffractive structure 420a).
[AltContent: textbox (FIG. 4A of Borja is annotated to highlight various features)]
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(Regarding items J-K above note FIG. 4a’s mechanical bonding region 432a at the peripheral edge. See also ¶ 48 describing an analogous mechanical bonding feature 650e “to allow excellent optical performance” in another lens 610a embodiment. Note, the efficacy of any “mechanical” bonding structure is naturally affected by its physical form, and that of the peripheral edge will generally encompass all of the physical attributes recited as design parameters.)
Borja does not explicitly disclose wherein the bi-layer contact lens has a diameter of about 12.5 mm to about 15.5 mm,
Borja and Dahi commonly relate to hybrid contact lenses.
Dahi discloses wherein the bi-layer contact lens has a diameter of about 12.5 mm to about 15.5 mm. (¶ 64: “overall diameter […] between about 10.0 mm. to about 18.0 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 teachings of Borja and Dahi, in order to provide hybrid contact lenses that are appropriately dimensioned for human use, that have smooth transitions and adequate bonding strength between soft/hard portions, and that support increased durability and/or comfort (Dahi ¶s 3-12, 58, 84).
Regarding claims 2 and 19, modified Borja discloses the bi-layer contact lens of Claim 1 and the method of Claim 18.
Borja further discloses wherein the shape configuration of said at least one peripheral edge of the insert (diffractive structure 420a) is selected from a straight angled shape configuration or a rounded shape configuration. (FIG. 4A shows the peripheral edges terminating in a rounded manner.)
Regarding claim 3, modified Borja discloses the bi-layer contact lens of Claim 2.
Borja further discloses the tapered outer second segment is arcute or curved in in cross-sectional profile (FIG. 4A shows the peripheral edges terminating in a curved manner.)
Dahi further discloses (see FIGs. 6-6A and ¶ 83-90)
wherein said at least one peripheral edge (“interface” or “junction”; junction 75 in FIG. 6A) of the insert (“hard section” or “hard portion”) comprises a segmented edge geometry (geometries 55 in FIG. 6) which comprises a tapered inner first segment an outer second segment,
wherein the tapered inner first segment is flat or linear in cross-sectional profile (i.e., frustoconical in three-dimensional configuration) whereas the tapered outer second segment is arcute or curved in in cross-sectional profile,
(Regarding items A and B above, note –
¶ 83: “a variety of coupling configurations are contemplated that securely couple the [i.e. peripheral edge of] hard and soft sections of a hybrid contact lens”
FIG. 6 shows some interface/junction geometries, including multi-segmented cuts – for example, the rightmost geometry 55 in FIG. 6
¶ 86: “Surface geometries 55 may include ledges [which, by definition, are flat], protuberances, […], serrations, gradations, or any other shape that is not substantially straight, or planar [i.e. curved]”
As Borja already provides peripheral edges that terminate in a curved outer segment, Dahi thus renders it trivial to simply shape the edges into multiple segments – i.e. with an additional flat inner segment– to produce a configuration providing durability/comfort (¶ 84).)
Modified Borja does not explicitly disclose wherein the tapered inner first segment spans a radial distance of between about 0.1 to about 100µm, wherein the tapered outer second segment spans a radial distance of between about 25 to about 500µm. However, Examiner does find that the prior art provides sufficient indirect evidence to infer a length scale for the peripheral edge segments on the order of 100 μm (see NOTE below) – thus providing radial distances which are, at the very least, close to the claimed ranges without explicitly overlapping them. Moreover, Examiner notes that Applicant has established no criticality for these ranges.
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(NOTE: we consider the length scales associated with Dahi’s geometries/interfaces/junctions. To provide a simple estimate of such length scales, refer to the exemplary contact lens 332 detailed in FIGs. 41-42 and ¶s 160-165, having a V-shaped junction/geometry.
In this example, substantially rigid portion 300 corresponds to the insert, while junctions 334 correspond to the peripheral edges, and we find junction 334 occupies roughly 1/15 the diameter of rigid portion 300 in FIG. 41 annotated above. Considering also that, per ¶ 64,
“The substantially rigid center section may have [...] a diameter that may range between about 4.0 mm. to about 12.0 mm”. This implies the junction/geometry/interface or peripheral edge may span lengths of ~ [0.27,0.8] mm. Dividing the peripheral edge further into multiple (adjacent) segments, say two or three, each segment is inferred to have a length
∼
O
[100 μm].)
It would have therefore been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to form peripheral edge segments with radial distances that lie within the claimed ranges, in order to provide adequate bonding strength between soft/hard portions, increased durability, and/or comfort (Dahi ¶ 84) – 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 4, modified Borja discloses the bi-layer contact lens of Claim 3.
Dahi further discloses wherein the tapered inner first segment extends at an angle of between about 90º to about 170º with respect to a cylindrical axis parallel to the lens central axis of the bi-layer contact lens, and/or wherein the tapered outer second segment is arcute and has a radius of curvature of from about 25 to about 500µm. (See, e.g., upper surface of FIG. 6A’s junction 75, or upper surface of FIG. 41-42’s junction 334 (corresponding to FIG. 42’s first segment 338); each surface/segment is moderately oblique with respect to the vertical upwards direction corresponding to the central axis. )
Regarding claim 5, modified Borja discloses the bi-layer contact lens of Claim 3.
Dahi further discloses wherein said at least one peripheral edge (interface/junction) of the insert (hard/rigid section/portion) spans a radial distance of between about 0.25 mm to about 0.5 mm, measured in a transverse direction normal or perpendicular to the central axis of the bi-layer contact lens. (See NOTE accompanying claim 3 above, where a length or radial distance spanning ~ [0.27,0.8] mm was inferred for the peripheral edge.)
Regarding claim 11, modified Borja discloses the bi-layer contact lens of claim 4.
Borja further discloses wherein the insert (diffractive structure 420a) has a circular shape and comprises one sole peripheral edge (see annotated FIG. 4A above; see also base/ alternative embodiments of FIGs. 1-2 and ¶s 35-36, detailing contact lenses 10 and 110 having circular diffractive optical elements 20 and 120, respectively).
Regarding claims 12 and 20, modified Borja discloses the bi-layer contact lens of claim 4 and the method of Claim 19.
Borja further discloses wherein the improved lens performance provided relates to at least one of resisting lens deformation, resisting delamination of the insert from the bulk hydrogel material, controlling optical distortion, and/or improving wearer comfort. (See again ¶ 48 describing an analogous mechanical bonding feature 650e “preventing delamination of the multiple layers” in another lens 610a embodiment.)
Regarding claim 13, modified Borja discloses the bi-layer contact lens of claim 4.
Dahi further discloses
wherein the insert (hard/rigid section/portion) has an outer diameter of between 7 mm to 13 mm and comprises a diffractive lens element (¶ 64: “The substantially rigid center section may have [...] a diameter that may range range between about 4.0 mm to about 12.0 mm”),
wherein the crosslinked polymeric material of the insert (hard/rigid section/portion) has an oxygen permeability of at least 40 barrers (¶ 63: “The center is a substantially rigid gas permeable-type with a gas permeability DK value greater than 30, preferably about 150”)
Borja further discloses
wherein the crosslinked polymeric material of the insert (diffractive structure 420a) has a first refractive index (n2) of at least 1.47,
wherein the bulk hydrogel material (lens substrate 440a) has a second refractive index (n1),
wherein a differential (ΔRI = n2 – n1) between the first refractive index (n2) and the second refractive index (n1) is at least about 0.05.
(See again ¶s 38-39:
“first lens portion [...] having a first refractive index (n1) of about 1.40 - 1.42”
“second lens portion [...] having second refractive index (n2) of about 1.50 - 1.55”)
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Borja in view of Dahi, as applied to claim 4 above, and in further view of Bowers (US 20170276959 A1).
Regarding claim 9, modified Borja discloses the bi-layer contact lens of claim 4.
Borja further discloses wherein the insert (diffractive structure 420a) has a circular shape and said at least one peripheral edge comprises an outer peripheral edge (see annotated FIG. 4A above; see also base/alternative embodiments of FIGs. 1-2 and ¶s 35-36, detailing contact lenses 10 and 110 having circular diffractive optical elements 20 and 120, respectively).
Modified Borja does not disclose an annular ring shape and said at least one peripheral edge comprises an inner peripheral edge and an outer peripheral edge, wherein the insert portion surrounds immediately a circular central lens portion.
Borja and Bowers commonly relate to hybrid contact lenses.
Bowers discloses (see FIG. 2, ¶ 70) a central portion 204 with an annular ring shape and said at least one peripheral edge comprises an inner peripheral edge and an outer peripheral edge (i.e. inner and outer edges of central portion 204), wherein the insert portion (central portion 204) surrounds immediately a circular central lens portion (center region 202).
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 teachings of Borja and Bowers, in order to provide a clear central lens portion and maintain visual acuity (Bower ¶s 70, 85)
Regarding claim 10, modified Borja discloses the bi-layer contact lens of claim 9.
Dahi further discloses wherein the outer peripheral edge (interface/junction) of the insert (hard/rigid section/portion) has a diameter of from about 7 mm to about 13 mm (¶ 64: “The substantially rigid center section may have [...] a diameter that may range range between about 4.0 mm to about 12.0 mm”).
Bowers further discloses the inner peripheral edge of the insert (i.e. the inner edge of central portion 204 – which bounds central region 202) has a diameter of from about 2 mm to about 5 mm (¶ 70: “a center region 202 that is sized to substantially correspond to the size and location of an individual pupil”; Examiner notes that human pupils generally vary in diameter, from ~2-4 mm in the good lighting to ~4-8mm in the dark).
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephone Allen can be reached at (571) 272-2434. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.D.H./Examiner, Art Unit 2872
/STEPHONE B ALLEN/Supervisory Patent Examiner, Art Unit 2872
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