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 .
DETAILED ACTION
Claims 14-20 withdrawn
Claims 1-13 pending
Election/Restrictions
Applicant’s election without traverse of claims 1-13 in the reply filed on 02/24/2026 is acknowledged.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US Pat. 6,565,776 B1) in view of Lamrani (PG Pub 2019/0282094 A1) and in further view of Liu (PG Pub 2019/0039293 A1).
Consider Claim 1, Li teaches the process of making a mold for forming contact lens (abstract). Li teaches the step of using a prepared clear-resin mold assembly (5) (Col. 5, lines 52-55, figure 1). Li teaches the step of casting a hydrogel materials (soft mold) (Col. 5, lines 15-18) within the mold assembly cavities (Col. 5, lines 52-55, and figure 1), where the clear-resin is coated with protection coating (11) to prevent any interaction between the clear-resin and the hydrogel (Col. 6, lines 22-27), including small molecules leaching out (from the mold and the resin surface) to inhibit the crosslinking of hydrogel contact lens (addressed as hydrogel negative mold).
Li does not teach the casting of the PDMS (silicone rubber elastomer) over the hydrogel contact lens (hydrogel negative mold).
However, Lamrani is in the prior art of forming contact lens (abstract), teaches the use of hydrogel contact lens that is dropped/casted with PDMS at room temperature [0138], as master mold.
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li with Lamrani to cast/coat the hydrogel contact lens (hydrogel negative mold) with PDMS material, to enhance the wetting properties [0138].
The combined Li (with Lamrani) does not teach the process of preparing the resin mold.
However, Liu is in the process 3D printing builds using resin powder (abstract) such as mold master [0001], where the resin powder is formed into liquid and then printed and cured (abstract, [0001]).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li (with Lamrani) with Liu to 3D print the clear resin assumably molds, to provide with an extremely low shrinkage [0007].
Consider Claim 2, the combined Li (with Lamrani and Liu) teaches the silicone rubber elastomer is PDMS (Lamrani, [0138]).
Consider Claim 10, the combined Li (with Lamrani and Liu) teaches the 1:1 replication process of the master molding (Li, Figure 1). Where it would be obvious for skilled person that the replication process would generate 1:1, with reasonable expectation of success.
Consider Claims 12-13, the combined Li (with Lamrani and Liu) teaches the forming of hydrogel contact lens is biocompatible and coated to prevent any leaching any toxins (Li, Col. 6, lines 20-27).
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US Pat. 6,565,776 B1) in view of Lamrani (PG Pub 2019/0282094 A1) and in further view of Liu (PG Pub 2019/0039293 A1), and in further view of Lee (US Pat. 6,790,840 B1).
Consider Claims 3-5, the combined Li (with Lamrani and Liu) teaches the crosslinking of the hydrogel (Li, Col. 6, lines 1-8).
The combined Li (with Lamrani and Liu) does not teach the crosslinking density.
However, Lee is in the prior art of cross linking hydrogel (abstract), teaches the resulting of high crosslinking density with less than 16x105 mol/cm3 (Col. 5, lines 33-38). In the case where the claimed ranges, “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (MPEP 2144.05).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li (with Lamrani and Liu) with Lee to provide the hydrogel with properties that overcome the mechanical stiffness for biomedical application (Col. 2, lines 26-30).
Claim(s) 6 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US Pat. 6,565,776 B1) in view of Lamrani (PG Pub 2019/0282094 A1) and in further view of Liu (PG Pub 2019/0039293 A1), and in further view of Phelan (PG Pub 2008/0143003 A1).
Consider Claim 6, the combined Li (with Lamrani and Liu) teaches the crosslinking of the hydrogel (Li, Col. 6, lines 1-8).
The combined Li (with Lamrani and Liu) does not teach the crosslinking toughness of the hydrogel.
However, Phelan is in the prior art of forming hydrogel contact lens (abstract), teaches the toughness (for example #43) with 603 KJ/m3 (table 16).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li (with Lamrani and Liu) with Phelan to have high toughness, to provide with an increasing tensile strength and toughness of resultant lenses; and increasing durability and Dk [0126].
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US Pat. 6,565,776 B1) in view of Lamrani (PG Pub 2019/0282094 A1) and in further view of Liu (PG Pub 2019/0039293 A1), and in further view of Majmudar (PG Pub 2010/0055153 A1).
Consider Claims 7-8, the combined Li (with Lamrani and Liu) teaches the use of a hydrogel materials (soft mold) (Li, Col. 5, lines 15-18).
The combined Li (with Lamrani and Liu) does not teach the use of Agar.
However, Majmudar is in the prior art of using hydrogel for contact lens [0002], teaches the process of adding to the hydrogel about of 1.5% w/v agar/polysaccharide [0025].
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li (with Lamrani and Liu) to add Agar to the hydrogel to add agar/polysaccharide, to provide with superior mechanical strength [0017].
Claim(s) 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US Pat. 6,565,776 B1) in view of Lamrani (PG Pub 2019/0282094 A1) and in further view of Liu (PG Pub 2019/0039293 A1), and in further view of Nabatian (PG Pub 2016/0324985 A1).
Consider Claims 7 and 9, the combined Li (with Lamrani and Liu) teaches the use of a hydrogel materials (soft mold) (Li, Col. 5, lines 15-18).
The combined Li (with Lamrani and Liu) does not teach the use of alginate.
However, Nabatian is in the prior art of using hydrogel for contact lens [0005], teaches the process of adding to the hydrogel about of 1-6% w/v alginate [0008].
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li (with Lamrani with Liu) with Nabatian to added alginate to the hydrogel, to provide with a medical benefit to patient [0006].
Claim(s) 11 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US Pat. 6,565,776 B1) in view of Lamrani (PG Pub 2019/0282094 A1) and in further view of Liu (PG Pub 2019/0039293 A1), and in further view of Turner (US Pat. 6,478,423 B1).
Consider Claim 11, the combined Li (with Lamrani and Liu) teaches the use of a hydrogel materials (soft mold) (Li, Col. 5, lines 15-18).
The combined Li (with Lamrani and Liu) does not teach size of the surface feature.
However, Turner is in the prior art of forming a contact lens (abstract), teaches the coating of contact lens (Col. 8, lines 40-42) with no surface defect/feature of more than 4 micron (Col 8, lines 64-65), leading to surface defect/features of less than 4 micron (on the order of 10 micron). In the case where the claimed ranges, “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). (MPEP 2144.05).
A person having ordinary skill in the art before the effective date of the claimed invention would combine Li (with Lamrani and Liu) with Turner to coat the hydrogel contact lens, to provide with surface defect of less than 4 micron, as low surface roughness.
Conclusion
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/Mohammad Mayy/
Art Unit 1718
/GORDON BALDWIN/Supervisory Patent Examiner, Art Unit 1718