DETAILED ACTION
Claim Objections
Claim 84 is objected to because of the following informalities: “pyrroloquinoline quinone (PQQ)” is recited twice. Appropriate correction is required.
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.
Claims 79 are 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.
As to claim 79, the claim recites a “membrane system comprising, independently” of two domains and at least one regenerative cofactor. It is unclear what “independently” means in this context, whether it means the first domain, the second domain, and the at least one regenerative cofactor do not interact, share any common space, etc or whether it is the membrane system as a whole that is independent of the analyte sensor. Further clarification and/or amendment is required.
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) 79 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Liu et al. (US 2022/0186278).
As to claim 79, Liu teaches a continuous analyte sensor device ([0093]) comprising: an analyte sensor (Fig. 20 - 300) operably coupled to a signal transducer (304), the analyte sensor comprising at least one membrane system adjacent the signal transducer(340), the at least one membrane system comprising, independently: a first domain ([0271] – 340a) comprising at least one first transducing element ([0271] – e.g. NADH oxidase), a second domain (340b) adjacent the first domain ([0271]), the second domain being the same or different as the first domain ([0271]); and at least one regenerative cofactor ([0288]).
As to claim 80, Liu teaches the analyte sensor is a multi-analyte sensor ([0059]).
As to claim 81, Liu teaches the multi-analyte sensor is a glucose and a ketone analyte sensor, or a glucose and creatinine analyte sensor, or a ketone and potassium ion analyte sensor ([0059], [0077]).
As to claim 82, Liu teaches the signal transducer comprises at least one electrode ([0271] – working electrode 304).
As to claim 83, Liu teaches the first domain comprises at least one first transducing element and the second domain comprises at least one second transducing element, the second transducing element being different from the first transducing element ([0271] – using different enzyme systems, [0309]).
As to claim 84, Liu teaches the at least one regenerative cofactor is one or more of NAD, NADH, NAD(P)H, NAD(P)+, ATP, flavin adenine dinucleotide (FAD), magnesium (Mg++), pyrroloquinoline quinone (PQQ), and functionalized derivatives thereof ([0288]).
As to claim 85, Liu teaches at least one mediator present in the first domain, the second domain, or in both the first and second domains ([0311]).
As to claim 86, Liu teaches the mediator is one or more of 2, 2'-bipryidine, poly-1,10-phenanthroline-5,6-dione, polyvinylferrocene, hexacyanoferrate, phthalocyanine or organometallic compounds thereof, organometallic compounds of osmium or ruthenium, and functionalized derivatives thereof, and complexes of one or more transition metals with one or more polymers or ligands and salts thereof ([0311]).
As to claim 87, Liu teaches the first domain comprises the at least one mediator ([0311]) and the at least one first transducing element (0271]), and the second domain comprises the at least one regenerative cofactor ([0288]), or wherein the first domain comprises the at least one regenerative cofactor and the at least one first transducing element and the second domain comprises the at least one mediator ([0271] – various configurations for the membranes can be used, [0354]).
As to claim 88, Liu teaches the at least one first transducing element and the at least one second transducing element are independently a dehydrogenase enzyme, a reductase enzyme, a kinase enzyme, a peroxidase enzyme, an esterase enzyme, an (amido)hydrolase enzyme, an oxidase enzyme, or combinations thereof ([0008], [0287], [0303]).
As to claim 89, Liu teaches the at least one first transducing element and the at least one second transducing element are independently beta-hydroxybutyrate dehydrogenase, alcohol dehydrogenase, lipase, amidohydrolase, glycerol kinase, creatinine kinase, creatine amidohydrolase, alcohol oxidase, cholesterol oxidase, galactose oxidase, choline oxidase, glutamate oxidase, glycerol-3-phosphate oxidase, bilirubin oxidase, urease, pyruvate oxidase, xanthine oxidase, glucose oxidase, lactate oxidase, sarcosine oxidase, malate dehydrogenase, formaldehyde dehydrogenase, glutathione reductase, glutathione peroxidase, 3-hdyroxy steroid dehydrogenases, NADH oxidase, or combinations thereof ([0300], [0301])
As to claim 90, Liu teaches the at least one first transducing element is beta-hydroxybutyrate dehydrogenase, and the at least one second transducing element is NADH oxidase ([0341]).
As to claim 91, Liu teaches the at least one electrode comprises platinum or palladium ([0278]); an interference domain deposited on the at least one electrode; the first domain is adjacent the interference domain ([0345-0348]), the first domain comprising beta- hydroxybutyrate dehydrogenase, NADH oxidase, and the regenerative cofactor ([0351]); and the second domain adjacent the first domain, the second domain comprising poly vinylpyridine polymer or copolymer ([0352]); wherein the continuous analyte sensor device is configured to provide a continuous analyte signal without a transition metal-containing mediator ([0308] – use of an enzymatic system including β-hydroxybutyrate dehydrogenase and NADH oxidase does not include an electron transfer agent e.g., a redox mediator, e.g., an osmium redox mediator).
As to claim 92, Liu teaches the at least one regenerative cofactor is NAD ([0351]).
As to claim 93, Liu teaches the interference domain is configured to block diffusion of at least one of acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine, dopamine, ephedrine, ibuprofen, L-dopa, methyldopa, salicylate, tetracycline, tolazamide, tolbutamide, triglycerides, and uric acid from the electrode surface ([0345]).
As to claim 94, Liu teaches the interference domain comprises polyurethanes, polyurethane-zwitterion polymers, polymers having pendant ionic groups, NAFIONTM,chitosan, cellulose, alternating layers of polyallylamine and polyacrylate acid or combinations or blends thereof ([0346]).
As to claim 95, Liu teaches the first domain or the second domain comprises an amphiphilic polymer or copolymer ([0327] – contains both hydrophilic and hydrophobic regions, which is amphiphilic)
As to claim 96, Liu teaches the first domain or the second domain comprises a heterocyclic polymer or copolymer, or an at least partially quarternized heterocyclic polymer or copolymer ([0324]).
As to claim 97, Liu teaches a transmitter configured to wireless transmit data to a paired display device or therapeutic delivery device ([0089], [0100], [0103]).
As to claim 98, Liu teaches the continuous analyte sensor device is sterilized ([0146]).
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 4/7/26
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