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 .
Claim Objections
Claims 9 and 10 are objected to because they depend from themselves.
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 1-2, 4-7, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kudo, U.S. Patent Application Publication No. 2015/0361114.
Kudo teaches the preparation of monomers adhering to the structure set forth in the abstract and their subsequent polymerization. A first synthetic approach for their formation is summarized in [0045-0049]. Relevant to the present discussion, it is indicated that a polymerization initiator may be added to the monomer-forming system in amounts corresponding to preferably 10 to 100 ppm. In an exemplification of the method outlined in Example 1, 0.02 grams total of a mixture of BHT and 4-methoxyphenol are added to 272.6 total grams of the precursors from which the monomer that constitutes Kudo’s contribution to the prior art. Their reaction does not involve the concomitant production of a by-product and, thus, the weight of the monomer product, or the weight of the monomer product and unreacted starting materials where conversion is less than 100%, will be the same. That is, the amount of inhibitors (0.02 g) relative to the amount of monomer would be the same as its contribution to the starting mixture:
0.02 g/272.6 g =0.0000734
One gram of the cross-linking monomer (10) prepared in Example 1, containing 0.0000734 grams of the inhibitor mixture, is subsequently combined with 60 parts of TRIS and 30 parts of N,N-dimethylacrylamide. Hence, the amount of said inhibitor mixture as a fraction of the total weight of the monomer composition would be:
.0000734/91 = 8.06 x 10-7 (100) = 8.06 x 10-5 %
The claims stipulate no more than 50 ppm, which equates to 0.005 wt.% of the total, and, insofar as 8.06 x 10-5 % < 0.005 wt.%, there will be less than 50 ppm of total residual inhibitor in the polymer derived from the aforementioned monomer mixture.
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.
Claims 1-2, 4-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al., JP 2004-115790.
This reference teaches a monomer mixture (a) and (a’) where the two monomers are constitutional isomers. See paragraph [0005-0006] of the original and the associated description of variables in [0007] of the translation. To the monomer mixture is added 5 to 400 ppm of an inhibitor conforming with formula (b), again with the aromatic substituent groups being defined in [0007], of which at least one is a hydroxyl group. Specific permutations of (a) and (a’) are disclosed in [0027] as (c) and (c’). Favored permutations of the phenol inhibitor (b) are delineated in [0019]. Paragraph [0021] makes clear that an upper limit on the amount of a polymerization inhibitor is set so that the desired polymerization behavior is not deleteriously affected. Ostensibly, one predictable way in which the polymerization reaction might be impacted by too much inhibitor is to preclude, or substantially slow, the polymerization. An amount of the inhibitor of 5 to 400 ppm is reiterated with 20-300 ppm being preferred, both ranges of which overlap with that in claim 1. In a 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, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
This reference is alluded to early in Applicants’ Specification and it is not entirely clear what in the claim language constitutes a differentiating feature insofar as monomer (c’) is distinct from (c) and there is no requirement that the claimed monomer (b) be differentiated from claimed monomer (a) by, for instance, being devoid of silicon-centered functional group. Moreover, while it is appreciated that the reference curiously only expressly teaches (co)polymers derived from a mixture of (c) and (c’), it is observed that the monomers are to be employed in the production of contact lenses and IOLs and the Examiner takes notice of the fact that almost the entirety of the literature directed to contact lenses comprising acrylic polymers with structural contributions from silicon/siloxane-containing monomers disclose the copolymerization of similar monomers with other monomers. Together, these monomers furnish copolymers with a balance of the properties sought in a contact lens or IOL. Generally speaking, siloxane-containing monomers are involved in the copolymerization because the siloxane groups impart much needed gas permeability. Of course, where the siloxane-containing monomer is copolymerized with other monomers, this would result in a further diluting of the inhibitor concentration in the polymer.
As for claim 2, the monomers (b) and (c) will be considered by one of ordinary skill to be first generation carbosiloxane dendrimers.
Regarding claim 6, BHT is another name for 2,6-di-t-butyl-4-methylphenol.
Claim 7 merely recites an intended use of the claimed copolymer and, therefore, is regarded as being of the same scope as claim 1. The same is true of claim 12 because it is merely directed to a so-called cosmetic “material”, as opposed to a cosmetic composition that contains additional components beyond the copolymer, and the prior art copolymer is certainly capable of being used in this capacity.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Fujisawa et al., JP 2004-115790 in view of Tsukazaki, JP 2019137807.
Paragraph [0021] contemplates the removal of the inhibitor from the monomer prior to polymerization and [0023] mentions techniques such as purification via silica gel column “or the like”. Tsukazaki establishes that “the like” will be understood by one of ordinary skill to include activated carbon in addition to silica. See the attached keyword-in-context-view of theJP ‘807 disclosure.
As for claim 9, Fujisawa does not expressly state that the silica gel column would be in-line in a continuous process but the act of making a bulk process continuous, where feasible, is an obvious feature of a method. In re Dilnot, 319 F.2d 188, 138 USPQ 248 (CCPA 1963) (Claim directed to a method of producing a cementitious structure wherein a stable air foam is introduced into a slurry of cementitious material differed from the prior art only in requiring the addition of the foam to be continuous. The court held the claimed continuous operation would have been obvious in light of the batch process of the prior art.).
Regarding claim 10, a column is just another name for a filter. The efficiency of any filter/column would never be so high as to enable all inhibitor to be removed with one pass of the inhibitor-containing solution through it and, therefore, recirculating the solution back through the filter/column a multitude of times would be obvious. An in-line diagnostic technique that measures phenol concentration could be used to determine when the inhibitor has been removed to a suitably low level.
Allowable Subject Matter
Claims 3 and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The Examiner did not encounter any disclosures directed to monomers adhering to formula 1, or polymers obtained therefrom, for which it was clear that the inhibitor concentration limitation had been met nor did the prior art appear to teach a comparably-constituted composition wherein the inhibitor had been introduced only after a preliminary purification step involving passing the monomer(s) over a bed of alumina or activated carbon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC S ZIMMER whose telephone number is (571)272-1096. The examiner can normally be reached M-F 8:30-5:00.
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MARC S. ZIMMER
Primary Examiner
Art Unit 1765
January 10, 2026
/MARC S ZIMMER/Primary Patent Examiner, Art Unit 1765