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 .
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.
Priority
This application is a 371 of PCT/JP2020/032014 08/25/2020.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 05/04/23 and 08/09/24 have been considered. Please refer to Applicant's copy of the 1449 submitted herewith.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11, 13, 16-17, 19, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGee (US 5336797; IDS filed on 05/04/23).
Regarding claims 1-3, 10-11, 22, McGee discloses an ocular lens such as contact lens (column 3, lines 15-24) comprising a polymer obtained by polymerizing a polymerizable monomer such as siloxane monomer having a siloxane bond, wherein the siloxane monomer has single polymerizable group and 2-25 siloxane, and a siloxane-fee crosslinkable monomer free of any siloxane bond, wherein the siloxane-free crosslinkable monomer includes an alkylene glycol chain-containing crosslinkable monomer having: a chain moiety containing 6 or more alkylene glycol repeating units; and polymerizable groups arranged at both terminals of the chain moiety such as polyethyleneglycol dimethacrylate (average chain molecular weight of 1K; column 3, lines 25-43, column 5, lines 59-62, column 10, lines 22-25, claims 1, 5, 11-12), meeting the requirements of claims 1-3, 10-11, 22.
Regarding claim 4, 16-17, 19, McGee discloses additional siloxane monomer (column 7, lines 13-40) and/or the hydrophilic polymeric monomers such as N-vinyl lactams (e.g. N-vinyl pyrrolidone (NVP)) (column 6, lines 6, 1-13).
Regarding claims 5-7, McGee discloses 70.5 mol% siloxane monomer (Mn =2500 and polydispersity 2.3; example 2, table 1, column 9, lines 25-27), 15.1 mol% dimethylacrylamide, and 14.4 mol% PPGDMA (4K) (table 1, example 2), result in 6 wt% of PPGDMA (4K), fall into claim 5 range of 2 wt% or more or 0.9 wt% or more, claim 6 range of 2 wt% or more, or claim 7 range of from 3 to 25 wt%.
Regarding claim 8, McGee discloses PEGDMA (1K) (column 10, lines 23-25, table 1, example 1). Formula used for HLB = 20 x Mh/M (Griffin’s equation used for the non-ionic surfactant). Mh = molecular weight of hydrophilic portion (PEG chain). M = total molecular weight. In PEGDMA (1K), MDMA =172 and Mh = 828.
HLB = 20 x 828/1000 = 16.56, fall into claimed range of from 5 to 20.
Regarding claim 9, McGee discloses the amount of siloxane monomer is from about 20 to 70 wt% (column 7, lines 54-55), fall into claimed range of from 10 to 70 wt%.
Regarding claim 13, McGee discloses the siloxane monomer has Mw = 3,109 (column 9, lines 65-68), fall into claimed weight average molecular weight of 10,000 or less.
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.
Claims 15, 18 are rejected under 35 U.S.C. 103 as being unpatentable over McGee as applied to claims 1, 16, above.
MaGee includes the features of claims 1, 16, above.
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Regarding claim 15, McGee discloses siloxane monomer represented by formula
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wherein m is integers from 2 to 25, chain transfer agent is thioglycolic acid, and B is polymerizable group such as glycidyl(meth)acrylate (column 2, lines 35-, column 5, lines -13), results in the molecular weight overlapping the claimed requirements of 1,000 or less, wherein the copolymerizable siloxane monomer
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represented by formula
(column 7, lines 30-38), read on claimed molecular weight of more than 1,000, wherein the siloxane monomer is present in an amount of about 1 to about 90 wt%, and copolymerizable siloxane monomer is present in an amount of up to 80 wt% (column 7, lines 51-58), overlapping range of claims ratio of siloxane monomer B to total of the siloxane monomers is 20 wt% or less.
A prima facie case of obviousness exists for the composition, wherein McGee discloses siloxane monomer represented by formula above, and siloxane monomer is present in an amount of about 1 to about 90 wt%, and copolymerizable siloxane monomer is present in an amount of up to 80 wt%, overlapping the requirement of claim 15. See In re Wertheim regarding prima facie cases with overlapping ranges (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) See MPEP § 2144.05).
Regarding claim 18, McGee discloses the copolymerizable siloxane monomer in an amount of up to about 60 wt% (column 7, lines 13-58), overlapping claimed range of from 20 to 70 wt%.
A prima facie case of obviousness exists for the composition, wherein McGee discloses the copolymerizable siloxane monomer in an amount of up to about 60 wt%, overlapping the requirement of claim 18. See In re Wertheim regarding prima facie cases with overlapping ranges (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) See MPEP § 2144.05).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over McGee as applied to claim 1, above and further in view of Satake (US 2016/ 0289368).
MaGee includes the features of claim 1, above.
Regarding claims 20-21, MaGee does not disclose claimed stress relaxation rate and Young’s modulus.
However, Satake discloses an ocular lens such as contact lens (column 3, lines 15-24) comprising a polymer obtained by polymerizing a polymerizable monomer such as siloxane monomer having a siloxane bond, hydrophilic monomer, and crosslinking agent (para [0010], [0031], [0053],) wherein the composition has stress relaxation rate of from 10-20% (para [0025]) fall into claimed range of from 10 to 40 wt% and Young’s modulus of from 0.3 to 1 MPa (para [0025]), fall into claimed range of 0.3 to 2.3 MPa for providing excellent wearing comfort required for its use as the contact lens, and has sufficiently high flexibility and an adequate degree of deformation recovery property required for its use as the intraocular lens (para [0024]). MaGee and Sakate are pertinent to the ocular lens such as contact lens comprising a polymer obtained by polymerizing a polymerizable monomer such as siloxane monomer having a siloxane bond, hydrophilic monomer, and crosslinking agent.
It would have been obvious to one with ordinary skill, in the art at the time of invention, to modify MaGee composition to obtain stress relaxation rate of from 10-20% and Young’s modulus of from 0.3 to 1 MPa, as taught by Satake. The rationale to do so would have been motivation provided by of Satake that to do so would provide excellent wearing comfort required for its use as the contact lens, and has sufficiently high flexibility and an adequate degree of deformation recovery property required for its use as the intraocular lens.
Conclusion
References Robertson (US 5770669), Ueyama (US 2009/0234089), and Ford (US 2007/0138692) were cumulative in nature to the above rejection and thus not set forth.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KUMAR R BHUSHAN whose telephone number is (313)446-4807. The examiner can normally be reached 9.00 AM to 5.50 PM (EST).
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/KUMAR R BHUSHAN/Primary Examiner, Art Unit 1766