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 .
Election/Restrictions
As described in the previous Office Action, in the reply filed on January 22, 2026, Applicant elected species for claims 1, 8, and 9, pursuant to the previous Election/Restriction requirement. The Applicant has elected the following:
“For the monofunctional silicone monomer of claim 1, Applicant elects methyl for substituents R1-R6, butyl for substituent R7, and the numeric variable 3 for each of x and y for prosecution on the merits. For the non-bulky organosilicon monomer of claim 8, Applicant elects methyl for substituents R1-R9, hydrogen for substituents R10 and R", propyl for V, methacrylate for L and the numeric variable 6 for x and 2 for y for prosecution on the merits. For the silicon comonomer of claim 9, Applicant elects methyl for substituents R17-R22, propyl for L, methacrylamide for V and the numeric variable 37 for x for prosecution on the merits. All of the claims of Invention I are believed to read on the elected species.”
Examiner has further confirmed with Attorney Michael E. Carmen, as described in the previous Office Action, that the specie elected for claim 8 reflects one wherein “n” is 6.
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 1-19 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).
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, see Applicant’s Remarks, filed June 9, 2026, with respect to Double Patenting have been fully considered and are persuasive. The Double Patenting rejection of claims 1-5, 12-15, and 17-18 has been withdrawn.
Applicant's remaining arguments have been fully considered but they are not persuasive.
Applicant states that Maggio and Nunez fail to disclose the claimed composition; however, as described above and previously, every feature of both the previous and current claim sets are present therein.
Applicant asserts that one having ordinary skill in the art would not be led to combine the references for the purpose of achieving a product with the claimed oxygen permeability characteristic; 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 indicates examples of the instant disclosure which fall within the scope of the prior art which does not possess the claimed oxygen permeability characteristic; however, the presence of compositions within the prior art which fall outside the claimed composition does not rebut the fact that compositions within the prior art which fall within the claimed composition are additionally present. The Examiner has explained that, prima facie, the claimed oxygen permeability characteristic will be present in those compositions within the prior art which meet all of the claimed compositional limitations will possess the claimed oxygen permeability. Arguments directed towards the compositions within the prior art which do not meet the claimed compositional limitations, therefore, do not rebut said prima facie determination; compositions falling outside of the claimed composition are not the ones being assessed to inherently possess the claimed characteristic.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762
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