Prosecution Insights
Last updated: October 02, 2026
Application No. 17/658,657

CONTACT LENS AND MANUFACTURING METHOD THEREOF

Non-Final OA §103§112
Filed
Apr 11, 2022
Priority
Apr 16, 2021 — provisional 63/175,567 +1 more
Examiner
KAHN, RACHEL
Art Unit
1766
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Pegavision Corporation
OA Round
3 (Non-Final)
28%
Grant Probability
At Risk
3-4
OA Rounds
0m
Est. Remaining
45%
With Interview

Examiner Intelligence

Grants only 28% of cases
28%
Career Allowance Rate
187 granted / 670 resolved
-37.1% vs TC avg
Strong +17% interview lift
Without
With
+17.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
42 currently pending
Career history
726
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
48.9%
+8.9% vs TC avg
§102
15.5%
-24.5% vs TC avg
§112
26.6%
-13.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 670 resolved cases

Office Action

§103 §112
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 . 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/22/2026 has been entered. Claims 1, 2 and 4-14 are pending as amended on 1/22/2026. Claims 8 and 9 stand withdrawn from consideration. Any rejections and/or objections made in the previous Office action and not repeated below are hereby withdrawn. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action. 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. Claim 11 is 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. Claim 11 further limits the “reactive vinylic monomer,” and recites “vinyl-functionalized acrylic acid” among a list of alternatives. The meaning of “vinyl-functionalized” is not clear. It is not a common term in the art, and the instant specification does not provide any example of a species which would be considered a “vinyl-functionalized acrylic acid,” nor any general guidance regarding what structure is implied by the term “vinyl-functionalized acrylic acid.” Therefore, the scope of the claim is unclear. Claim Rejections - 35 USC § 103 Claim(s) 1, 2, 4-7 and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu et al (US 2012/0026457) in view of Lai et al (US 2019/0009482) and Chen (US 4143949). As to claims 1, and 4-7, Qiu discloses a silicone hydrogel contact lens with a wettable and durable coating (surface) [0008]. The silicone hydrogel contact lens comprises amino or carboxyl groups on its surface, and is obtained by polymerizing a silicone hydrogel lens formulation comprising a reactive vinylic monomer [0009, 0052-53], with methacrylic acid named as an embodiment thereof [0054]. Qiu’s silicone hydrogel contact lens having carboxyl groups, obtained from a formulation comprising a reactive vinylic monomer (naming methacrylic acid, which is recited in instant claim 6), corresponds to the presently recited lens body comprising a reactive additive which has a reactive functional group (carboxyl group, meeting instant claim 5), wherein a surface of the lens body (prior to modification) has the reactive functional group. (Qiu discloses 0.1-10 wt% of the reactive vinylic monomer [0054], which is the same range recited in instant claim 7.) Qiu discloses [0009] providing the coating by heating the contact lens in the presence of hydrophilic polymeric material to covalently attach the hydrophilic material onto the surface of the contact lens. The hydrophilic polymeric material comprises: 20-95 wt% of first polymer chains derived from an epichlorohydrin-functionalized poly(amido)amine which has azetidinium groups (meeting instant claim 4), and 5-80 wt% of hydrophilic moieties or second polymer chains derived from a hydrophilicity enhancing agent that has an amino, carboxyl and/or thiol group as a reactive functional group. The hydrophilic moieties or second polymer chains of the hydrophilic polymeric material are covalently attached to the first polymer chains through covalent linkages between some (but not all [0080]) of the azetidinium groups of the first polymer chain and an amino/carboxyl/thiol group of the hydrophilicity enhancing agent. The hydrophilic material (which comprises the first polymer chains covalently linked to the hydrophilic moieties or second polymer chains) is then covalently attached to the surface of the contact lens via covalent linkages between a remaining unreacted azetidinium group of the hydrophilic material and a carboxyl group on the surface of the contact lens [0009, 0079-80]. In Qiu’s ultimately obtained coated contact lens, the first polymer chain is covalently linked to the surface of the silicone hydrogel lens via reaction of a remaining unreacted azetidinium group of the first polymer chain with a lens surface carboxyl group [0080], and therefore, the residues of Qiu’s first polymer chain attached to the lens body surface corresponds to a modification layer adhered on the surface of the lens body via covalently bonding a compound containing an azetidinium group to the reactive functional group of the lens body, as presently recited. Qiu’s hydrophilic moieties or second polymer chains are attached to residues of the first polymer chains via covalent bonding between an amino, carboxyl or thiol group of the hydrophilicity enhancing agent and an azetidinium group of the first polymer [0009], and therefore the residues of Qiu’s hydrophilic moieties or second polymer chains correspond to the presently recited “first hydrophilic layer” which is covalently bonded to the presently recited modification layer. As to the recitation that the lens body is sequentially covered by the modification layer and the first hydrophilic layer: Qiu teaches that adding hydrophilic polymer chains onto a polyamidoamine polymer chain forms a highly branched hydrophilic polymeric coating material with dangling polymer chains and/or chain segments. The coating is described as having a loose structure and dangling polymer chains, which is believed to impart a good surface hydrophilicity [0046]. As discussed above, Qiu discloses a contact lens wherein the lens body surface has amino or carboxyl reactive groups. Qiu’s hydrophilic polymeric coating material with dangling chains is formed by reaction of azetidinium groups on the polyamidoamine and hydrophilic polymer chains. Some of the azetidinium groups on the polyamidoamine remain unreacted and available for reaction with the lens body, thereby covalently attaching the coating material to the lens body. The hydrophilic polymer chains do not react directly with the lens body, rather, they are connected to the lens body via the polyamidoamine polymer chains. Given that the functional groups on the hydrophilic polymer chains do not react directly with the functional groups on the lens body, Qiu’s lens body must be adjacent to a layer of the polyamidoamine polymer, and the polyamidoamine polymer layer must be adjacent to the layer of dangling hydrophilic polymer chains (meeting the instant requirement that the lens body is “sequentially covered” by the modification layer and the first hydrophilic layer). As to the recitation that the contact lens has a contact angle hysteresis of less than or equal to 30 degrees: Qiu discloses that providing the hydrophilic coating onto a silicone hydrogel contact lens improves its hydrophilicity and lubricity [0002]. However, Qiu fails to teach a surface contact angle hysteresis of less than 30 degrees. Lai teaches that silicone hydrogel lenses have hydrophobic silicone components, and therefore they do not have good hydrophilicity [0007]. Lai teaches that surface wettability is generally associated with contact angle, and therefore contact angle is often used as a method of measuring wettability or hydrophilicity of contact lenses in the industry [0091]. Lai teaches a surface-modified contact lens having a surface contact angle hysteresis of less than 15 degrees, which has excellent lens lubricity in addition to excellent surface wettability [0035, 0096]. Lai teaches that the contact angle hysteresis is affected by the content of hydrophilic monomer in a reactive hydrophilic polymer [0170]. Like Qiu, Lai discloses a surface modified contact lens formed by covalently reacting hydrophilic layers on the surface of a lens body [0009, 20]. Lai teaches an embodiment for modifying a contact lens which is similar to Qiu’s modification, wherein a surface modified lens is formed by first reacting two different reactive hydrophilic polymers to form a “cross-linked hydrophilic polymer,” such that a first reactive functional group is in excess and remains available to react with functional groups on the surface of the lens in a subsequent step [0029, 89]. Lai teaches a hydrophilic polymer formed by copolymerization of a hydrophilic monomer (e.g., acrylamide) and a bifunctional monomer (e.g., (meth)acrylic acid) [0010] in a molar ratio of 25:1 to 2:1 [0011], which is substantially similar to a most preferred copolymer taught by Qiu in [0074]: poly(meth)acrylic acid-co-acrylamide with from 0.1-30 wt% (meth)acrylic acid). Considering Lai’s disclosure, the person having ordinary skill in the art would have been motivated to form a contact lens having a contact angle hysteresis of less than 15 degrees in order to achieve excellent lens lubricity in addition to excellent surface wettability. Considering the substantial similarities between the structures of the hydrophilic polymers taught in Qiu and Lai (particularly in the teachings of the monomers used to form hydrophilic polymers), one having ordinary skill in the art would have had a reasonable expectation of success in decreasing a contact angle hysteresis of Qiu’s lens to within the range taught by Lai. It would have been obvious to the person having ordinary skill in the art, therefore, to have formed a contact lens having improved hydrophilicity, as taught by Qiu, having any contact angle hysteresis within Lai’s disclosed range of less than 15 degrees (which falls within the presently recited range of less than or equal to 30 degrees). As to the recitation that the hydrophilic surface modification layer has a thickness of less than or equal to 100 nm: Qiu discloses that providing the hydrophilic coating onto a silicone hydrogel contact lens improves its hydrophilicity and lubricity [0002]. Lai teaches that the thickness of the surface modification layer can be controlled by using a cross-linked hydrophilic polymer in the surface modification [0089]. However, Qiu fails to teach a hydrophilic coating which has a thickness of less than or equal to 100 nm. Like Qiu (and Lai), Chen discloses a contact lens having a central core of a transparent hydrophobic oxygen permeable polymer material, with a coating of a hydrophilic polymeric material integrally bonded to the surface of the hydrophobic material (col 1, line 8-13). Chen discloses silicone polymers as the hydrophobic core material (col 3, lines 40-46), and monomers including (meth)acrylamide and meth(acrylic) acid as examples of monomers which are polymerizable to hydrophilic polymers (col 2, line 56 to col 3, line 26). Chen teaches that the hydrophilic polymer has significantly reduced oxygen permeability compared to the hydrophobic lens material, but that absence in reduction of oxygen permeability of the coated lens is achieved because the hydrophilic coating is ultrathin, desirably 100 to 200 Angstroms (col 2, lines 36-55; a range of 100-200 Angstroms corresponds to 10-20 nm). Considering Chen’s disclosure, when coating a hydrophobic silicone contact lens with a hydrophilic polymer, the person having ordinary skill in the art would have been motivated to select an appropriate thickness of the hydrophilic polymer layer in order to achieve a desired degree of hydrophilicity, while also preventing reduction in oxygen permeability. It would have been obvious to the person having ordinary skill in the art, therefore, to have formed a contact lens having improved hydrophilicity, as suggested by modified Qiu, by selecting any suitable thickness for the hydrophilic coating which achieves a desired balance between hydrophilicity and oxygen permeability of the contact lens, including a hydrophilic coating thickness within the presently claimed range of 100 nm or less (e.g., within Chen’s disclosed range of 10-20 nm). As to claim 2, modified Qiu suggests a contact lens according to claim 1, as set forth above. Qiu teaches that the hydrophilic polymer material which is provided to coat the contact lens comprises from 20-95 wt% of the polymer chains derived from an epichlorohydrin-functionalized poly(amido)amine and from 5-80 wt% of hydrophilic moieties or second polymer chains derived from at least one hydrophilicity enhancing agent [0009]. In embodiments as taught by Qiu wherein the content of polymer chains derived epichlorohydrin-functionalized poly(amido)amine is substantially higher than the content of moieties or polymer derived from hydrophilicity enhancing agent (e.g., 95 wt% polymer chains derived from an epichlorohydrin-functionalized poly(amido)amine and 5 wt% hydrophilic moieties or second polymer chains derived from at least one hydrophilicity enhancing agent), there must be hydrophilic moieties or second polymer chains derived from at least one hydrophilicity enhancing agent dispersed on at least a (“first”) portion of the lens body surface, and, because it is used in substantial excess, and there must at least be a (“third”) portion of the lens wherein the polymer chains derived from an epichlorohydrin-functionalized poly(amido)amine are “exposed.” However, Qiu fails to teach that there is a portion of the (carboxy functional) lens body that is exposed (corresponding to the presently recited “second” portion). Like Qiu, Lai discloses a surface modified contact lens formed by covalently reacting hydrophilic layers on the surface of a lens body [0020]. Liu teaches that in some embodiments, only a portion of the surface of the lens body reacts with a hydrophilic polymer to form a surface modification layer, and in some embodiments, two different reactive hydrophilic polymers react with different surfaces/portions of the lens body (such as a first reactive hydrophilic polymer with the concave surface and a second hydrophilic polymer with the convex surface) to form surface modification layers [0090]. Considering Lai’s disclosure, when providing a contact lens by modifying the surface of a lens body with a reactive hydrophilic polymer, it was known in the art to treat the concave and convex surfaces of a contact lens with different hydrophilic polymers. It would have been obvious to the person having ordinary skill in the art, therefore, to have provided a hydrophilic coating onto a silicone hydrogel contact lens to improves its hydrophilicity and lubricity, as suggested by modified Qiu, by providing Qiu’s coating on only the concave (or only the convex) surface of the lens (e.g., in order to provide a different treatment on the remaining untreated surface), thereby arriving at a lens having first, second and third portions as presently recited. As to claims 10-13, Qiu discloses several preferred types of hydrophilic polymers suitable as hydrophilicity enhancing agents, including a copolymer which is a polymerization product of a composition comprising (1) one or more reactive vinylic monomers and (2) at least one non-reactive hydrophilic vinylic monomers [0072], and names poly(meth)acrylic acid-co-acrylamide with from 0.1-30 wt% (meth)acrylic acid among the most preferred hydrophilicity-enhancing agents [0074]. (Poly(meth)acrylic acid-co-acrylamide with 0.1-30 wt% (meth)acrylic acid corresponds to a copolymer as recited in claims 10-13 wherein the reactive vinylic monomer comprises (meth)acrylic acid and the non-reactive vinylic monomer comprises acrylamide, and wherein acrylamide, the nonreactive vinylic monomer, is at least 70 wt% of the two monomers.) The person having ordinary skill in the art would have recognized that the properties of a polymer (including hydrophilicity) depend on polymer structure, and therefore would have been motivated to select any appropriate hydrophilicity enhancing agent disclosed by Qiu in order to provide a desired hydrophilicity/wettability to a silicone hydrogel lens. It would have been obvious to the person having ordinary skill in the art, therefore, to have formed a silicone hydrogel contact lens having a first covalently bonded layer of an azetidinium-containing epichlorohydrin-functionalized poly(amido)amine (via reaction of the azetidinium groups and the surface carboxyl groups), and a second covalently bonded hydrophilic layer of second polymer chains derived from a hydrophilicity enhancing agent, as taught by Qiu, by selecting any suitable hydrophilicity enhancing agent named by Qiu, including a copolymer which is a polymerization product of a composition comprising (1) one or more reactive vinylic monomers and (2) at least one non-reactive hydrophilic vinylic monomers (such as poly(meth)acrylic acid-co-acrylamide with from 0.1-30 wt% (meth)acrylic acid). Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Qiu et al (US 2012/0026457) in view of Lai et al (US 2019/0009482) and Chen (US 4143949), as set forth above, and further in view of Stachowski et al (US 2008/0002146). The rejection of the claims above under 35 USC 103 over Qiu in view of Lai and Chen is incorporated here by reference. As set forth above, modified Qiu suggests a coated contact lens wherein a silicone hydrogel contact lens having surface carboxyl groups is covalently bonded to a layer derived from an azetidinium-containing epichlorohydrin-functionalized poly(amido)amine (via reaction of the azetidinium groups and the lens surface carboxyl groups), and wherein a hydrophilic layer (hydrophilic moieties or second polymer chains derived from a hydrophilicity enhancing agent) is formed on the layer derived from the azetidinium-containing epichlorohydrin-functionalized poly(amido)amine by covalent attachment of an azetidinium group of the epichlorohydrin-functionalized poly(amido)amine to an amino, carboxyl and/or thiol group of the hydrophilicity enhancing agent (see Qiu, [0009]). Qiu discloses that providing the hydrophilic coating onto a silicone hydrogel contact lens improves its hydrophilicity and lubricity [0002]. However, Qiu fails to teach providing additional hydrophilic layers beyond the layer of azetidinium-containing epichlorohydrin-functionalized poly(amido)amine and the layer of hydrophilicity enhancing agent, and therefore, Qiu fails to teach a second hydrophilic layer covalently bonded to the first hydrophilic layer, as recited in claim 14. Stachowski discloses that in the field of contact lenses, various factors must be considered in order to yield a material that has appropriate characteristics, including oxygen permeability, wettability, strength and stability [0005]. Stachowski discloses that those in the art have long recognized the needed for rendering the surface of contact lenses hydrophilic or more hydrophilic in order to improve wettability with tear fluid (thereby improving comfort) [0007], and discloses forming a hydrophilic gradient surface that possesses an increased hydrophilicity from the bottom layer of the gradient (closest to the lens) to the top layer [0046], thus providing a device which can exhibit superior water wettability for a long wear period [0048]. The hydrophilic gradient is achieved by providing first, second and third layers having successively decreasing contact angles (see, e.g., claim 1). In examples, Stachowski teaches that the additional layers can likewise be added at any stage such that the hydrophilic gradient is formed and maintained [0099, 0102]. Stachowski discloses a method (which is substantially similar to the method of Qiu) of providing the hydrophilic gradient surface by immersing the contact lens in a solution of hydrophilic polymers having reactive functionalities which are complementary to reactive functionalities in the previously formed layer [0088]. [See also the discussion in [0084] for examples of complementarily reacted functional units; one having ordinary skill in the art would have understood Stachowski’s disclosure of attaching a layer by reacting complementary functionalities to mean that the layers are attached to one another by covalent bonds.] Considering Stachowski’s disclosure, when providing a hydrophilic coating on a silicone hydrogel lens, the person having ordinary skill in the art would have been motivated to add multiple hydrophilic layers having successively increased hydrophilicity (i.e., successively decreasing contact angles) in order to, e.g., improve water wettability for a long wear period. It would have been obvious to the person having ordinary skill in the art, therefore, to have formed a silicone hydrogel contact lens having a first covalently bonded layer of an azetidinium-containing epichlorohydrin-functionalized poly(amido)amine (via reaction of the azetidinium groups and the surface carboxyl groups), and a second covalently bonded hydrophilic layer of second polymer chains derived from a hydrophilicity enhancing agent, as suggested by modified Qiu, by subsequently providing an additional (covalently attached) layer having a higher degree of hydrophilicity than the second hydrophilic layer (as taught by Stachowski) in order to provide a contact lens having a hydrophilic gradient and the advantages associated therewith. Response to Arguments Applicant's arguments filed 1/22/2026 have been fully considered. Applicant argues (p 9) that, because Qiu discloses a process wherein a contact lens is modified with a polymeric material in “one step,” the contact lens of Qiu is coated by only a single layer, rather than two layers. However, as explained in the rejection of record, Qiu’s polymeric coating material is formed from two distinct components which are covalently bonded together, wherein one of the two components (the polyamidoamine) has functional groups which react with/bond to the lens, while the other of the two components (hydrophilicity enhancing agent which can be in the form of dangling polymer chains) has functional groups which react with/bond to the polyamidoamine. Qiu’s polyamidoamine component forms a layer between the lens and the hydrophilicity enhancing agent, because the azetidinium groups of the polyamidoamine react with the functional groups on both the lens and the hydrophilicity enhancing agent, while the reactive groups of the hydrophilicity enhancing agent and the lens do not react with each other. Therefore, Qiu’s lens is sequentially covered by a layer comprising the polyamidoamine bonded to the lens (corresponding to the instant modification layer) and then a layer comprising hydrophilicity enhancing agent bonded to polyamidoamine (corresponding to the instant first hydrophilic layer). Applicant has not provided any reasoning or explanation to support the conclusion that Qiu’s lens modification process results in a lens which “cannot include two layered structures,” and therefore, Applicant’s argument that Qiu fails to disclose the structure of the claimed hydrophilic surface modification layer is not persuasive. Applicant argues (pp 10-11) that because Chen (a secondary reference, relied on for teaching a hydrophilic coating thickness) does not disclose a compound containing an azetidinium group, the material of Chen’s hydrophilic polymer is totally different from the hydrophilic coating of Qiu, and therefore one would not adjust Qiu’s film thickness based on Chen. Applicant further cites differences in the ways Chen and Qiu form hydrophilic coatings (via plasma deposition and via heating in aqueous solution, respectively) as evidence that one would not combine the two references. See arguments p 12. However, Qiu and Chen are directed to solving the same problem (both teach that polysilicone soft lenses have excellent oxygen permeability, but that they are hydrophobic and therefore not wettable; see Chen col 1, lines 31-34; Qiu [0003]) by covalently bonding a wettable/hydrophilic coating on a silicone contact lens surface (see Chen col 2, lines 26-42; Qiu [0008-9]). Chen teaches that the hydrophilic polymer itself has significantly reduced oxygen permeability compared to the hydrophobic lens material (col 2, lines 42-45). Qiu and Chen name many of the same compounds as examples of monomers which can be polymerized to form a hydrophilic polymer coating (see Chen col 2, line 56 to col 3, line 26 and examples I-III; Qiu [0073-4]), including (meth)acrylamide, (meth)acrylic acid, hydroxyethyl(meth)acrylate and N-vinyl pyrrolidone (NVP). The properties (including oxygen permeability) of a polymer coating material depend on the chemical structure of the polymer material. Therefore, one having ordinary skill in the art would have had reasonable basis to conclude that Qiu’s hydrophilic coating material (formed from the same types of monomers taught by Chen) exhibits an oxygen permeability which (like the hydrophilic polymer taught by Chen) depends on the thickness of the hydrophilic coating. Qiu’s hydrophilic coated contact lens differs from Chen’s hydrophilic coated contact lens, because the hydrophilic polymer chains formed from hydrophilic monomers as named above in Chen’s coating are bonded directly to Chen’s hydrophobic lens surface, while the hydrophilic polymer chains of Qiu’s coating (see Qiu [0046]) are bonded to Qiu’s hydrophobic lens surface via polyamidoamine. However, given that the dangling hydrophilic polymer chains which form Qiu’s hydrophilicity-enhancing coating material are formed from the same types of monomers taught by Chen, one having ordinary skill in the art would have had reasonable basis to conclude that Qiu’s hydrophilic coating material, like Chen’s, has reduced oxygen permeability compared to the hydrophobic lens material, regardless of the presence of Qiu’s additional polyamidoamine component (via which the hydrophilic polymer chains in Qiu’s hydrophilic coating are attached to the hydrophobic lens surface). Chen’s disclosure establishes that the thickness of a hydrophilic coating on a hydrophobic lens was recognized in the art as being a variable which affects both the wettability and the oxygen permeability of a contact lens. Applicant has not provided any reasoning or evidence which establishes that Chen’s disclosure regarding hydrophilic coating thickness would not be considered applicable to Qiu due to the extra component (polyamidoamine) in Qiu’s hydrophilic coating. Therefore, the examiner maintains that one having ordinary skill in the art would have been motivated to apply Chen’s criteria for optimizing the thickness of a hydrophilic coating on a hydrophobic lens (i.e., to provide sufficient hydrophilic coating thickness in order to achieve desired wettability characteristics, while also minimizing the thickness of the hydrophilic coating in order to avoid reduction in oxygen permeability) to the selection of an appropriate thickness of Qiu’s hydrophilic coating on a hydrophobic lens. Applicant argues (p 11) that the thickness of a modification layer covering the surface of a lens is determined by its material, and that given their differences, one could not reasonably anticipate whether Qiu’s modification layer could achieve the thickness described by Chen. However, as set forth in the rejection of record, modified Qiu suggests a lens formed by reacting a hydrophobic lens body with hydrophilic polymeric material, wherein the hydrophilic polymeric material is formed by covalently attaching first polymer chains to second polymer chains. Lai similarly teaches a surface modified lens formed by reacting a “cross-linked hydrophilic polymer” with functional groups on the surface of the lens [0029, 89]. Lai teaches that the thickness of the surface modification layer can be controlled by using a cross-linked hydrophilic polymer in the surface modification [0089]. At least in view of Lai’s disclosure, one having ordinary skill in the art would have had a reasonable expectation of success in controlling the thickness of a hydrophilic surface modification layer formed by reacting a silicone lens body with a crosslinked (pre-formed) hydrophilic polymeric material, as suggested by modified Qiu. The examiner further notes that while the instant claims recite a thickness of less than or equal to 100 nm, minimal guidance is provided in the instant specification regarding process parameters/conditions which affect thickness, or which are critical for achieving a thickness within the recited range. Therefore, considering that adjusting the thickness of a hydrophilic surface modification layer when forming a contact lens must be considered by Applicant to be within the level of skill in the art, and further considering that one would have been motivated to obtain a thickness of Qiu’s modification layer within the claimed range, Applicant’s argument is unpersuasive. Applicant argues (p 13) that Chen does not provide examples having a thickness within the recited range. However, anticipatory examples are not requirements of either of 35 USC 102 or 103. The failure of a reference to provide an example of any particular feature described therein neither amounts to a failure of the broader disclosure in the reference to anticipate or suggest the presently claimed subject matter, nor amounts to a teaching away from the disclosure and teachings of the reference. Similarly, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments (see MPEP 2123). Applicant further argues (pp 13-14) that Chen’s exemplified contact lenses have a contact angle which is above the claimed range. This argument fails to establish non-obviousness for at least the reason that it does not consider that Lai was cited to meet the presently recited contact angle range. Applicant argues (p 14) that Qiu and Lai use different materials for modifying their contact lens surfaces, and therefore one could not anticipate whether Qiu’s modification layer could have a contact angle hysteresis as taught by Lai. However, as set forth in the rejection of record, Lai teaches that the contact angle hysteresis is affected by the content of hydrophilic monomer in a reactive hydrophilic polymer [0170]. Lai teaches a hydrophilic polymer formed by copolymerization of a hydrophilic monomer (e.g., acrylamide) and a bifunctional monomer (e.g., (meth)acrylic acid) [0010] in a molar ratio of 25:1 to 2:1 [0011]. Considering that Liu teaches a hydrophilic polymer which is substantially similar to a most preferred hydrophilic copolymer taught by Qiu in [0074] (poly(meth)acrylic acid-co-acrylamide with from 0.1-30 wt% (meth)acrylic acid), and given that contact angle depends on copolymer structure and content of hydrophilic monomer, one would have had a reasonable expectation that Liu’s contact angle could be successfully achieved using Qiu’s modification layer. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL KAHN whose telephone number is (571)270-7346. The examiner can normally be reached Monday to Friday, 8-5. 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, Randy Gulakowski can be reached at 571-272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RACHEL KAHN/Primary Examiner, Art Unit 1766
Read full office action

Prosecution Timeline

Apr 11, 2022
Application Filed
Jul 03, 2025
Non-Final Rejection mailed — §103, §112
Sep 24, 2025
Response Filed
Oct 24, 2025
Final Rejection mailed — §103, §112
Jan 22, 2026
Request for Continued Examination
Jan 27, 2026
Response after Non-Final Action
Sep 24, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
28%
Grant Probability
45%
With Interview (+17.4%)
3y 8m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 670 resolved cases by this examiner. Grant probability derived from career allowance rate.

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