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
Applicant's election with traverse of Group I in the reply filed on January 22, 2026 is acknowledged. The traversal is on the ground(s) that the searching of Groups I and II does not present a serious burden to the examiner. This is not found persuasive because a serious search burden may be prima facie shown by appropriate explanation of, inter alia, separate status in the art or different classification (see MPEP 803.II.). As described in the Election/Restriction requirement of October 21, 2025, the inventions of Groups I and II have acquired a separate status in the art in view of their different classifications.
The requirement is still deemed proper and is therefore made FINAL.
In the reply filed on January 22, 2026, Applicant has elected species for claims 1, 8, and 9, pursuant to the aforementioned 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.”
This Species election is incomplete because Applicant has not indicated a value for “n” within claim 8. Applicant has indicated a value of “x” within claim 8, however claim 8 does not reference a variable “x.”
Examiner has confirmed with Attorney Michael E. Carmen in an interview on March 2, 2026 that the indicated value for “x” (i.e., a value of 6) was intended for variable “n.” Therefore, the specie elected for claim 8 reflects one wherein “n” is 6. See Attached Interview Summary.
Double Patenting
Claims 1-5, 12-15, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-12, 16, and 18 of copending Application No. 18/422,186 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1-5 are directed towards the same subject matter as claims 6-10 of the copending application.
Claim 12-13 are directed towards the same subject matter as claim 12 of the copending application.
Claims 14-15 are directed towards the same subject matter as claim 11 of the copending application.
Claim 17 is directed towards the same subject matter as claim 16 of the copending application.
Claim 18 is directed towards the same subject matter as claim 18 of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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]):
PNG
media_image1.png
250
958
media_image1.png
Greyscale
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 claims 6-8, 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 6-8 because it is identical to the species elected for claim 8, as described above, 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, as described above, 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.
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.
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, Robert Jones can be reached at 571-270-7733. 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.
/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762