DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 29, 2026, has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 7-19 are rejected under 35 U.S.C. 103 as being unpatentable over Maggio (US 2011/0237766 A1) in view of Nuñez (US 2019/0233593 A1).
Regarding claims 1-5, Maggio teaches silicone (meth)acrylamide monomers useful for contact lenses (Abstract), and a composition thereof ([0011]). Maggio teaches that the silicone (meth)Acrylamide monomer includes the following formula s5 ([0016]):
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Formula s5 of Maggio (US 20110237766 A1)
Formula s5 reads on the claimed “Formula I” because it is structurally identical to the elected compound of “Formula I,” as required by the Election/Restriction requirement discussed above.
Maggio further teaches the incorporation of copolymerization components having two or more reactive groups ([0055]), but differs from claim 1 because it is silent with regard to the incorporation of copolymerization components that are silicone-based.
In the same field of endeavor, Nuñez teaches a hydrogel useful in the formation of contact lenses ([0002]), teaches the formation of a polysiloxane polymer with two reactive functional groups ([0012], e.g. Ma2D37, see [0114]), and teaches the blending of monomers together within the inventive process, resulting in a contact lens product ([0087]-[0089]). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to substitute the bifunctional silicone-based polysiloxane polymer of Nuñez (e.g., Ma2D37) in place of the copolymerization component within the formulation of Maggio, as Nuñez teaches said materials as suitable for use within a monomeric mixture used to form a contact lens hydrogel.
In so doing, the composition of Maggio as modified by Nuñez meets the claimed limitation requiring “one or more silicone hydrogel-forming silicone comonomers.”
Regarding the limitation requiring that “the one or more silicone hydrogel-forming silicone comonomers comprise one or more non-bulky organosilicon-containing monomers,” Nuñez additionally teaches the incorporation of M1EDS6 ([0129]) in the formation of a contact lens, alongside the Ma2D37 bifunctional prepolymer ([0135]). Furthermore, as described above, Maggio is directed towards contact lens compositions ([0056]) and comprises an open formulation which explicitly includes additional monomers ([0045]) and which contemplates the specific mixture of inventive monomers with other co-monomers (e.g., [0042]). Finally, it is prima facie obvious to select a known ingredient based on its art recognized suitability for its intended use (see MPEP 2144.07). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to include the M1EDS6 monomer of Nuñez into the formulation of Maggio, as Nuñez recognizes it as a suitable comonomer alongside Ma2D37 in a contact lens formulation. M1EDS6 meets the claimed limitations because it is identical to the species elected for claim 8, which falls within the scope of the claimed formula within claim 8 – the instant Specification further utilizes M1EDS6 as an example thereof (c.f. instant Specification at [00124] and [00134], Table 1). Nuñez specifically shows that Ma2D37 contains two functional groups despite partial nonfunctional end-capping (c.f. [0116]). The product therefore meets the newly added limitation requiring first and second reactive functional end groups.
Regarding the limitation requiring that the silicone hydrogel-forming silicone comonomers comprise one or more polysiloxane prepolymers, Ma2D37 meets this limitation because it is identical to the species elected for claim 9, which falls within the scope of the claimed formula within claim 9, and which contains an amine-containing reactive functional end group (acrylamide). The instant specification further utilizes Ma2D37 as an example thereof (c.f. instant Specification at [00125] and [00134], Table 1).
Regarding the limitation requiring the claimed range of oxyen permeability, Maggio as modified by Nuñez is silent regarding the claimed characteristic. Nevertheless, Maggio as modified by Nuñez teaches a contact lens-forming silicone hydrogel composition which is structurally identical to the claimed composition, containing all of the same components in all of the claimed compositional amounts. . Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed characteristic will therefore necessarily be present in Maggio as modified by Nuñez, and as applied above.
Regarding claims 7 and 8, as described above, Nuñez additionally teaches the incorporation of M1EDS6 ([0129]) in the formation of a contact lens, alongside the Ma2D37 bifunctional prepolymer ([0135]). Furthermore, as described above, Maggio is directed towards contact lens compositions ([0056]) and comprises an open formulation which explicitly includes additional monomers ([0045]) and which contemplates the specific mixture of inventive monomers with other co-monomers (e.g., [0042]). Finally, it is prima facie obvious to select a known ingredient based on its art recognized suitability for its intended use (see MPEP 2144.07). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to include the M1EDS6 monomer of Nuñez into the formulation of Maggio, as Nuñez recognizes it as a suitable comonomer alongside Ma2D37 in a contact lens formulation. M1EDS6 meets the claimed limitations of claims 7 and 8 because it is identical to the species elected for claim 8, which falls within the scope of the claimed formula within claim 8 – the instant Specification further utilizes M1EDS6 as an example thereof (c.f. instant Specification at [00124] and [00134], Table 1).
Regarding claims 9-11, as described above, it would have been obvious to one having ordinary skill in the art at the time of filing to include Ma2D37 within the formulation of Maggio, as taught by Nuñez. Ma2D37 meets the claimed limitations of claims 9-11 because it is identical to the species elected for claim 9, which falls within the scope of the claimed formula within claim 9, and which contains an amine-containing reactive functional end group (acrylamide). The instant specification further utilizes Ma2D37 as an example thereof (c.f. instant Specification at [00125] and [00134], Table 1).
Regarding claim 12, Maggio teaches the incorporation of 30-98 wt% of silicone-containing components (including the silicone monomers reading on claimed component “(a)” and an additional hydrophilic polymer), and teaches the polymer may be included in amounts ranging from 1-30 wt% ([0050]). The inventive silicone-containing monomer may therefore comprise between about 0 and about 68 wt% of the formulation, which encompasses the claimed range of “about 5 wt% to about 40 wt%,” establishing a prima facie case of obviousness. Maggio further teaches that the total acrylamide monomer content ranges from 90-99 wt% ([0054]), and therefore the remaining comonomers ranges from about 22-99 wt% of the formulation, which overlaps the claimed range of “about 10 wt% to about 60 wt%,” establishing a prima facie case of obviousness. Moreover, Maggio teaches that the difunctional monomer may be included in amounts ranging from about 0.1 to about 10 wt% ([0055]), which overlaps the claimed range of “about 10 wt% to about 60 wt%,” establishing a prima facie case of obviousness.
Regarding claim 13, Maggio teaches the incorporation of 30-98 wt% of silicone-containing components (including the silicone monomers reading on claimed component “(a)” and an additional hydrophilic polymer), and teaches the polymer may be included in amounts ranging from 1-30 wt% ([0050]). The inventive silicone-containing monomer may therefore comprise between about 0 and about 68 wt% of the formulation, which encompasses the claimed range of “about 7 wt% to about 15 wt%,” establishing a prima facie case of obviousness. Maggio further teaches that the total acrylamide monomer content ranges from 90-99 wt% ([0054]), and therefore the remaining comonomers ranges from about 50-94 wt% of the formulation, which overlaps the claimed range of “about 15 wt% to about 50 wt%,” establishing a prima facie case of obviousness.
Regarding claim 14, Maggio specifically teaches the incorporation of a hydrophilic comonomer (0046).
Regarding claim 15, Maggio teaches that the hydrophilic comonomer may include inter alia 2-hydroxyethyl methacrylate ([0045]), which reads on “a hydroxyl-containing-(meth)acrylate” from the claimed list.
Regarding claim 16, Maggio teaches that the hydrophilic comonomer may comprise between 1-50 wt% of the composition ([0046]), which encompasses the claimed range of “about 20 wt% to 50 wt%,” establishing a prima facie case of obviousness.
Regarding claim 17, Maggio teaches the incorporation of, inter alia, UV absorbers ([0056]).
Regarding claims 18 and 19, Maggio as modified by Nuñez is silent regarding the claimed characteristics. Nevertheless, Maggio as modified by Nuñez teaches a contact lens-forming silicone hydrogel composition which is structurally identical to the claimed composition, containing all of the same components in all of the claimed compositional amounts. . Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed characteristics will therefore necessarily be present in Maggio as modified by Nuñez, and as applied above.
Response to Arguments
Applicant's arguments filed September 29, 2026 have been fully considered but they are not persuasive.
Applicant argues that Maggio and Nuñez fail to teach the newly added limitation of claim 1. However, as described above, the combined composition contains Ma2D37 which is specifically shown to include two reactive functional groups (c.f. Nuñez at [0116]).
Applicant argues that the prior art fails to contemplate the claimed oxygen permeability as a motivating factor to combine the prior art references. However, the motivation or reason to combine the prior art references need not be the same as that of the Applicant’s. The reason to or motivation to modify the reference may often suggest what is claimed, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by the Applicant. See MPEP 2144(IV).
Applicant points to comparative examples within the instant disclosure which allegedly fall within the teachings of the prior art, indicating that the mere incorporation of the first and second reactive functional group alone is insufficient to achieve the favorable result contemplated by the Applicant. However, while these comparative examples may fall within the teachings of Nuñez, the incorporation of compositions within the combined prior art which falls outside of the scope of the claimed composition does not rebut the additional existence of compositions within the combined prior art which falls inside the scope of the claimed composition.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA CALEB BLEDSOE whose telephone number is (703)756-5376. The examiner can normally be reached Monday-Friday 8:00 a.m. - 5:00 p.m. EST.
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/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
