DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1 to 13, drawn to an embedded contact lens, classified in G02C7/04
II. Claims 14 and 15, drawn to a method of making an embedded lens, classified in B29D11/00038
The inventions are independent or distinct, each from the other because:
Inventions of group II and I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product as claimed can be made by another and materially different process such as 3D printing and curing the insert-forming composition to form a cured insert.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Groups I-II, listed above, are drawn to two inventions, wherein the inventions have acquired a separate status in the art in view of their different classification. The inventions have acquired a separate status in the art due to their recognized divergent subject matter, which require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
During a telephone conversation with Jian Zhou on 8/18/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office Action. Claims 14-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Status
Claims 1-15 are pending. Claims 1-13 are under examination on the merits. Claims 14-15 are withdrawn to a non-elected invention from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/05/2024 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 received on 02/27/2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities:
Page 4, [0023], “SiHy maerial” should read “SiHy material”.
Page 5, [0028], line 3, “An insert can be any object have any geometrical shape…” should read “An insert can be any object having any geometrical shape…”.
Page 5, [0031], line 2, “a imaginary reference line” should read “an imaginary reference line”.
Page 11, [0049], line 1, “insert embedded in an manner” should read “insert embedded in a manner”.
Page 12, [0054], line 11, “an hydroxyl group” should read “a hydroxyl group”
Appropriate correction is required.
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 5-13 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 pre-AIA the applicant regards as the invention.
Claim 5 recites “wherein the crosslinked polymeric material of the insert has a first refractive index of at least about 1.47 (preferably at least about 1.49, more preferably at least about 1.51, even more preferably at least about 1.53)”, wherein the inclusion of a term within parentheses renders the claim indefinite because it is unclear whether the included term is part of the claimed invention.
Also, regarding claim 5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 6-13 being depended on claim 5 are rejected as well.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Borja et al. (US Pub. No. 2021/0191153 A1, hereinafter “Borja”) in view of Riall et al. (US Pub. No. 2014/0268015 A1, hereinafter “Riall”) as further evidenced by Samuel et al. (US Pub. No. 2020/0324314 A1, hereinafter “Samuel”).
Regarding claim 1: The disclosure of Borja teaches an embedded contact lens (Abstract), comprising:
a lens body that has an anterior surface and an opposite posterior surface (page 3, [0035] and Figure 1, “contact lens 10”),
that is composed of a bulk hydrogel material (page 4, [0039], lines 6-7, “the first lens portion may comprise a hydrogel or a silicon hydrogel first lens material (M1)” ),
and an insert embedded in the bulk hydrogel material (page 3, [0035] and Figure 1, “an inner diffractive optical element 20 embedded within an outer lens substrate 40”),
wherein the insert is made of a crosslinked polymeric material different from the bulk hydrogel material (page 4, [0039], lines 8-9, “the second lens portion may comprise a silicon elastomer second lens material (M2)”; silicon elastomer is a crosslinked polymeric material.),
wherein the insert is circular (page 3, [0035] and Figure 1, “the central optical zone 22 is generally circular” and “the peripheral optical zone 24 has a generally annular profile”) and has a convex surface, an opposite concave surface, (obvious from Figures 1 to 4) and a peripheral edge (it is obvious that the insert must have a peripheral edge).
Borja teaches an opaque or intensity apodizing iris pattern printed outside the central optical zone for diameters greater than 5 mm (preferably greater than 6 mm) to reduce stray light and halo effects due to the diffractive optical element when subtended by large pupils and off-axis rays (page 9, [0092]). Borja does not express teach the contact lens comprises an annular mask on the anterior surface or the posterior surface, wherein both the annular mask and the insert are concentric with a central axis of the lens body, wherein the annular mask is an opaque colored area that covers or overlaps the peripheral edge of the insert so as to minimize or eliminate optical disturbances induced by the peripheral edge of the insert. However, in a similar field of endeavor, Riall teaches a hydrogel contact lens comprising an insert contained within the contact lens in a biocompatible fashion where a patterning either occurs on surfaces of the insert or at or near the surface of the contact lens (page 1, right column, [0005], lines 3-5; page 6, [0073], lines 2-3). The color pattern is a camouflage pattern that obstructs the observance of components within the insert (page 1, [0007], lines 5-8), or comprises a colorant that is opaque to visible light (page 1, [0008], lines 6-9). The pattern is ring-shaped or annular (Figure 5, Figure 6). It is obvious that both the annular pattern and the insert are concentric with a central axis of the lens body (Figures 4 to 6). The patterned region may cover or obscure underlying components (page 5, [0071], lines 6-8; Figure 5; page 6, [0076], lines 3-4; Figure 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Borja to incorporate the teachings of Riall to provide an annular mask (pattern) on the surface of the contact lens, wherein both the annular mask and the insert are concentric with a central axis of the lens body, wherein the annular mask is an opaque colored area. Such an annular mask (pattern) would cover or obscure the underlying components (i.e., the peripheral edge of the insert), as recognized by Rially (page 5, [0071], lines 6-8; Figure 5; page 6, [0076], lines 3-4; Figure 6). Such an opaque annular mask (pattern) would perform the identical function specified in the claim “so as to minimize or eliminate optical disturbances induced by the peripheral edge of the insert”.
Borja does not expressly teach that the bulk hydrogel material has a water content of from about 10% to about 70% by weight when being fully hydrated. However, this water content range is typical of contact lenses and would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. As further evidenced, Samuel disclosed a preformed SiHy contact lens can have an equilibrium water content of from about 10% to about 70%, preferably from about 35% to about 70%, more preferably from about 40% to about 65%; even more preferably from about 40% to about 60%, most preferably from about 40% to about 55% by weight. (page 14, [0151]).
Borja does not expressly teach that the lens body has a diameter of from about 12.5 mm to about 15.5 mm. However, the diameter range is typical of contact lenses and would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention).
Regarding claim 2: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches the bulk hydrogel material is a silicone hydrogel or non-silicone hydrogel (page 4, [0039], lines 6-7) but does not expressly teach the bulk hydrogel material is a non-silicone hydrogel material which comprises at least 50% by mole of repeating units of at least one hydroxyl-containing vinylic monomer. However, in a similar field of endeavor, Samuel teaches a method of coating hydrogel contact lenses, wherein the contact lens is a non-silicon hydrogel contact lens essentially made of a non-silicone hydrogel material which comprises at least 50% by mole of at least one hydroxyl-containing vinylic monomer (page 24, 11th paragraph). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Borja to incorporate the teachings of Samuel to provide a non-silicone hydrogel material which comprises at least 50% by mole of repeating units of at least one hydroxyl-containing vinylic monomer as the bulk hydrogel material and would have been motivated to do so with reasonable expectation of success in obtaining an contact lens, as recognized in Samuel.
Regarding claim 3: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches that the bulk substrate material properties alone or in combination with a coating layer, provide a wettable smooth continuous optical surface in contact with the ocular surfaces, as well as the oxygen (Dk) and ion permeability required for proper comfort and fit of the contact lens system (page 1, [0008]). Borja does not expressly teach that the bulk hydrogel material is a silicone hydrogel material and when being fully hydrated has: an oxygen permeability of at least about 50 barrers, an elastic modulus of from about 0.2 MPa to about 2.0 MPa, an oxygen transmissibility of at least 60 barrers/mm, and an averaged water contact angle of less than 90 degrees. However, these properties are typical of contact lenses and would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. As further evidenced, Samuel teaches a SiHy contact lens has an oxygen permeability of at least about 50, preferably at least about 60, more preferably at least about 70, even more preferably at least about 90 barrers, most preferably at least about 110 Barrers (page 14, [0151]). Also, Samuel teaches the SiHy contact lens can have a bulk elastic modulus of from about 0.3 MPa to about 1.8 MPa, preferably from 0.4 MPa to about 1.5 MPa, more preferably from about 0.5 MPa to about 1.2 MPa (page 13, [0153]).
The oxygen transmissibility of at least 60 barrers/mm as recited in claim is not expressly taught in Samuel, however, the value would be obvious to a person of ordinary skill in the art given the oxygen permeability range taught in Samuel matches that claimed range and the thickness of the claimed contact lens would be in common range as that in Samuel.
Hydrogel is a hydrophilic material. The surface of a hydrophilic material typically shows a water contact angle of less than 90 degrees. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to recognize that the bulk silicone hydrogel material has an averaged water contact angle of less than 90 degrees.
Regarding claim 4: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches that a contact lens utilizes the refractive index difference (ΔRI) between the bulk substrate and embedded diffractive element to achieve multifocality for the treatment and correction of presbyopia, myopia, or other conditions affecting the vision of a treated human or animal subject (page 1, [0007]). Borja teaches that the lens substrate or other first portion or first layer of the lens may be formed of a first material (M1) having a first refractive index (n1, about 1.40 -1.42), and the diffractive element or other second portion or second layer of the lens may be formed of a second material (M2) having a second refractive index (n2, about 1.50 -1.55) differing from the first refractive index resulting in a ΔRI (ΔRI=n2-n1) of for example at least about 0.08-0.15, for example about 0.10. (page 4, [0038], lines 3-9; [0039], lines 1-12). The first material (lens substrate) taught by Borja reads on the bulk hydrogel material which has the lower refractive index in the instant claim, while the second material (diffractive element) reads on the crosslinked polymeric material which has the higher refractive index. Thus, Borja teaches the limitation in claim 4 “the crosslinked polymeric material has a first refractive index and the bulk hydrogel material has a second refractive index different from the first refractive index, wherein the first refractive index is at least 0.05 (preferably at least 0.07, more preferably at least 0.09, even more preferably at least 0.10) higher than the second refractive index”.
Regarding claim 5: The disclosure of Borja in view of Rially and Samule is adequately set forth in paragraph above and is incorporated herein by reference. As outlined in claim 4, Borja teaches that a second material (M2) having a second refractive index (n2, about 1.50 -1.55) (page 4, [0038], lines 3-9; [0039], lines 1-12). It reads on the crosslinked polymeric material of the insert has a first refractive index of at least about 1.47 (preferably at least about 1.49, more preferably at least about 1.51, even more preferably at least about 1.53)
Regarding claim 6: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches that the insert is a diffractive optical element (page 1, [0006]).
Regarding claim 7: The disclosure of Borja in view of Rially is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches that the diffractive optical element is approximately 3 to 6 mm in diameter (page 3, [0035], lines 27-28). Also, Rially teaches that a multi-piece insert with a diameter of between about 6 mm to 10 mm (page 4, [0054], line 5).
Regarding claims 8-9: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Raily teaches that the patterning either occurs on surfaces of the insert or at or near the surface of the ophthalmic device itself (page 1, right column, [0005], lines 3-5; page 6, [0073], lines 2-3). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the annular mask on either the anterior or the posterior surface of the lens body.
Regarding claim 10: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Rially teaches the annular pattern has an inner radius and an outer radius (obvious for the annular patterns in Figures 5 and 6) and the patterned region may cover or obscure underlying components, for example, completely covering the Insert 512 from the dense limbic ring 520 (corresponding to the outer radius) to the other side 530 (corresponding to the inner radius) (page 5, [0071], lines 6-8; Figure 5; page 6, [0076], lines 3-4; Figure 6). Rially does not expressly teach the inner radius and the outer radius compared with peripheral edge of the insert. However, a person having ordinary skill in the art would recognize that the inner radius and the outer radius are routine parameters to control the efficiency of covering or obscuring underlying components. Given the prior art’s effectiveness, it would be obvious to select the inner radius and the outer radius compared with peripheral edge of the insert, such as those cited in claim 10, to achieve the desired results without undue experimentation. Therefore, the claimed radius range is obvious over the prior art.
Regarding claim 11: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. As discussed in claim 10, the selection of an inner radius and an outer radius and the difference between the outer radius and an inner radius would be obvious over the prior art to a person having ordinary skill in the art before the effective filing date of the claimed invention. Also, Rially teaches that the annular mask has a substantially even outer radial edge and a substantially even or an uneven inner radial edge (Figure 6).
Regarding claim 12: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches the insert is embedded such that the convex surface of the insert is merged with the anterior surface of the lens body (Figures 4C and 4D).
Regarding claim 13: The disclosure of Borja in view of Rially and Samuel is adequately set forth in paragraph above and is incorporated herein by reference. Borja teaches the insert is embedded such that the concave surface of the insert is merged with the posterior surface of the lens body (Figures 4A and 4B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to the applicant’s disclosure.
Chen (CN109608576 A) teaches functional corneal contact lens which comprises a light-blocking layer and a lens main body; the light-blocking layer is in an annular shape, the light-blocking layer comprises at least one of a front light-blocking layer and a back light-blocking layer, the front light-blocking layer is attached to the front surface of the lens main body, and the back light-blocking layer is attached to the back surface of the lens main body.
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/HAOPENG WANG/Examiner, Art Unit 1763 /JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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