DETAILED ACTION
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7, 10-14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Wang et al. (US 2008/0026473).
As to claim 1, Wang teaches an electrode ([0010]) comprising: an enzyme electrode layer ([0058]) comprising an electrode material (104) and a glucose oxidoreductase (glucose oxidase); a permeation restricting layer (112) covering the enzyme electrode layer (Fig. 2); and a glucose diffusion layer (116) consisting of a hydrophilic substance or cross-linked product thereof ([0104] – crosslinked protein comprising human/bovine serum albumin, which is hydrophilic) and disposed between the enzyme electrode layer and the permeation restricting layer (Fig. 2).
As to claim 2, Wang teaches the enzyme electrode layer has a layer structure comprising a layer of a metal or carbon as the electrode material ([0055]), and a layer containing the glucose oxidoreductase disposed on the layer of a metal or carbon (Fig. 2 - 110).
As to claim 3, Wang teaches the enzyme electrode layer is a layer containing a mixture of an electrically conductive substance as the electrode material and the glucose oxidoreductase ([0100]).
As to claim 4, Wang teaches glucose oxidoreductase is glucose dehydrogenase ([0049]).
As to claim 5, Wang teaches the hydrophilic substance is a hydrophilic polymer ([0104] – crosslinked).
As to claim 7, Wang teaches the hydrophilic substance is cross-linked ([0104]).
As to claim 10, Wang teaches the glucose diffusion layer covers the entire surface of the enzyme electrode layer (Fig. 2).
As to claim 11, Wang teaches the glucose diffusion layer is provided only on the enzyme electrode layer (Fig. 2).
As to claim 12, the permeation restricting layer comprises one or more components selected from the group consisting of a cellulose polymer, polyurethane and polyvinyl pyridine ([0120], [0151]).
As to claim 13, Wang teaches a glucose sensor comprising the electrode according to claim 1 ([0003]).
As to claim 14, Wang teaches a method of continuous glucose monitoring using the glucose sensor according to claim 13 ([0035]).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2008/00264573) in view of Brister et al. (US 2009/0124879).
As to claim 6, Wang fails to teach that the hydrophilic substance is one or more substances selected from the group consisting of polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol and sodium alginate. However, Wang notes that the protein layer is something that “serves as a crosslinkable matrix” ([0115]) and its presence results in a greater diffusion path for molecules and enhancing sensor sensitivity ([0104]). Brister teaches a polyurethane membrane to control the diffusion of glucose and notes that it is possible to use non-polyurethane type materials including protein based materials. Accordingly, it would have been obvious to modify Wang with Brister to utilize polyurethane as it would have been obvious to try.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2008/00264573).
As to claim 8, Wang does not teach the specific amounts of the hydrophilic substance or its specific thickness. It does teach the thickness of the enzyme layer to be in the micron range ([0128]). However, it is noted that a range of 1.19 µg/cm2 or more and 1.19 g/cm2 or less is an enormous range, with 1 gram being equivalent to a million micrograms. The same is true between 10 nm and 10 mm, with a micron being fully within that range. Moreover, the specifications fail to state a criticality to the specific range (and in fact, teaches ranges overlapping the recited one or within it to be alternatives). Accordingly, one of ordinary skill in the art would have arrived at the recited range as a matter of routine optimization within prior art conditions.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2008/00264573) in view of Sjolander (US 2008/0135408).
As to claim 15, Wang teaches a method of producing the electrode of claim 1, the method comprising the steps of: forming an enzyme electrode layer comprising an electrode material ([0145-0146]) and a glucose oxidoreductase ([0157]); forming a glucose diffusion layer consisting of a hydrophilic substance or cross-linked product thereof on the enzyme electrode layer ([0104]; Fig. 2); and forming a permeation restricting layer on the glucose diffusion layer ([0108]). While Wang does not explicitly teach the forming via laminating, it teaches that various methods can be used to create the layers, including deposition methods or spin coating ([0140], [0143])). Sjolander teaches an electrode assembly in which multiple layers are formed on top of each other by laminating the layers ([0150]). Accordingly, it would have been obvious to modify the above combination with Sjolander to utilize a technique known to result in discrete layers.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 7/29/26
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