DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 1/9/26 is acknowledged. The traversal is on the ground(s) that claim 15 has been amended to depend from the elected group. While the amendment makes the restriction functionally moot at this point in time, as previously noted for claims 13 and 14, should further amendments in the future result in any of these claims/groups being considered independent and distinct, they will be restricted out via election by original presentation.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites that the amount of hydrophilic substance in the glucose diffusion layer is 1.19 µg/cm2 or more and 1.19 g/cm2 or less. It is unclear whether applicant intended to recite the amount in terms of mass per area instead of mass per volume, which is the conventionally used measurement in describing the amount of a substance.
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, 2, 4, 5, 7, 9-11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Say et al. (US 2009/0069658).
As to claim 1, Say teaches an electrode (58) comprising: an enzyme electrode layer (64) comprising an electrode material (56) and a glucose oxidoreductase ([0141]); a permeation restricting layer (75) covering the enzyme electrode layer ([0164] – prevents penetration of large biomolecules into the electrodes); and a glucose diffusion layer (74; [0169] – mass transport limiting layer) comprising a hydrophilic substance ([0166] – interferent-eliminating layer incorporated into the mass transport limiting layer 74; c128 – interference domain comprises of at least one hydrophilic component) and disposed between the enzyme electrode layer and the permeation restricting layer (Fig. 9).
As to claim 2, Say teaches the enzyme electrode layer has a layer structure comprising a layer of a metal or carbon as the electrode material ([0115]) and a layer containing the glucose oxidoreductase disposed on the layer of a metal or carbon ([0141]).
As to claim 4, Say teaches the glucose oxidoreductase is glucose dehydrogenase ([0141]).
As to claim 5, Say teaches the hydrophilic substance is a hydrophilic polymer (c130).
As to claim 7, Say teaches the hydrophilic substance is crosslinked ([0165]).
As to claim 9, Say teaches the layer has a thickness of 10 nm or more and 10 mm or less ([0179] – As say teaches the width of the device is below 1 mm, the thickness of the layer must be less than that).
As to claim 10, Say teaches the glucose diffusion layer covers the entire surface of the enzyme electrode layer ([0164]).
As to claim 11, Say teaches the glucose diffusion layer is provided only on the enzyme electrode layer ([0169]).
As to claim 13, Say teaches a glucose sensor comprising the electrode according to claim 1 ([0001]).
As to claim 14, Say teaches a method of continuous glucose monitoring, comprising using the glucose sensor according to claim 13 ([0055]).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Say et al. (US 2009/0069658) in view of Staib et al. (US 2014/0018653).
As to claim 3, while Say does teach that the electrically conductive substance could comprise of a conductive polymer ([0088]), it does not teach that the layer contains a mixture of an electrically conductive substance as the electrode material and the glucose oxidoreductase. Staib teaches the use of a mixture of a conductive polymer paste that is cross-linked with an enzyme ([0114]). It would have been obvious to modify Say with Staib to utilize a mixture of the conductive substance and enzyme to ensure that the electrode layer is conductive for measurement purposes.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Say et al. (US 2009/0069658) in view of Yamamoto et al. (US 2001/0050227).
As to claim 6, Say does not specifically teach that the hydrophilic substance is one or more substances selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, or sodium alginate. However, Yamamoto teaches a biosensor coated with a hydrophilic polymer, said polymer being comprised of such materials as polyvinylpyrrolidone and polyvinyl alcohol ([0050]). Accordingly, it would have been obvious to modify Say with Yamamoto to utilize known materials for the hydrophilic substance as it would have been obvious to try.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Say et al. (US 2009/0069658).
As to claim 8, Say does not explicitly teach that the amount of the hydrophilic substance in the glucose diffusion layer is within the recited range. 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. 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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Say et al. (US 2009/0069658) in view of Gratzl et al. (US 2004/0180391).
As to claim 12, Say does not teach that the permeation restricting layer comprises one or more components selected from the group consisting of a cellulose polymer, polyurethane and polyvinyl pyridine. However, Gratzl teaches an in vivo biosensor (Abstract) in which a diffusion rate limiting membrane comprising polyurethane, is applied to regulate the diffusion of glucose and increase the linearity and dynamic range of the sensor ([0164], [0249]). As such, it would have been obvious to modify Say with Gratzl to utilize a polyurethane membrane to increase the accuracy of the device.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Say et al. (US 2009/0069658) in view of Sjolander (US 2008/0135408).
As to claim 15, while Say 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 and a glucose oxidoreductase ([0121], [0126]); and adding a glucose diffusion layer comprising a hydrophilic substance on the enzyme electrode layer; and a permeation restricting layer on the glucose diffusion layer (74 and 75) but fails to teach that the layers are laminated. However, 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.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791
1/12/26