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 .
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 recites “to acetaldehyde” in line e), but instead should be --to the acetaldehyde--. Claim 24 recites “the sensor” in line 1, but instead should be –the analyte sensor--. This change should be reflected in all “the sensor” recitations, e.g. last line in claim 24 (as seen in claims 41-42). Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
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 24-25, 28-31, and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Noritomi et al. (US 20160319232- cited by Applicant), hereinafter Noritomi, further in view of Papadimitrakopoulosimitrakopoulos et al. (US 20100116691), hereinafter Papadimitrakopoulosimitrakopoulos.
Regarding claim 24, Noritomi teaches an analyte sensor for detecting glucose and ethanol in vivo, the sensor comprising: a) a first working electrode (fig. 10D, electrode 10); b) a second working electrode (fig. 10D, a second working electrode 10/11. ¶[0047,0247]);
c) a glucose-responsive active area capable of generating a first signal at the first working electrode proportional to a glucose concentration, the glucose- responsive active area disposed upon a surface of the first working electrode, the glucose-responsive active area comprising a glucose-responsive enzyme (¶[0029-31,0034,0046], enzyme bodies 3 are placed in the vicinity of each electrode. ¶[0096-104,0275], enzyme body 3 can include more than one enzyme 5, including one responsive to glucose to measure glucose concentration and other );
d) an ethanol-responsive active area (¶[0270]) comprising: i) a first active area capable of reacting with acetaldehyde to generate a second signal at the second working electrode proportional to an ethanol concentration (¶[0087,0272], “Acetaldehyde . . . , can be sampled” and “when ethanol as the measurement target substance 6 is introduced to the mixture 102, acetaldehyde is generated due to oxidation of ethanol”), the first active area disposed directly upon the surface of the second working electrode (fig. 10D), the first active area comprising xanthine oxidase (¶[0104], enzyme list, the enzyme can comprises xanthine oxidase); and ii) a second active area capable of acetaldehyde upon exposure to ethanol, the second active area comprising glucose oxidase and catalase (¶[0096,0104,0272], enzyme area 3 can comprise a plurality of different enzymes, depending on the target analyte, including glucose oxidase and catalase).
Noritomi fails to teach a first membrane permeable to acetaldehyde disposed upon the first active area; and f) a second membrane permeable to glucose and ethanol disposed upon the glucose- responsive active area and the second active area, wherein the second active area is disposed directly upon the first membrane, and wherein the sensor is configured to be partially inserted into a user's skin.
Papadimitrakopoulos teaches an implantable biosensor comprising a working electrode 12 having a plurality of enzyme active regions separated by permeability adjusting spacers in a stacked configuration (abstract, fig. 1, and ¶[0054-55,0095], “first permeability-adjusting spacer 108, second permeability-adjusting spacer 110 and third permeability-adjusting spacer 112”). The spacers can be formed from a variety of polymers-.(¶[0062-70], the spacers equivalent to the instant membranes). Each of the spacers have an enzyme containing section 116-120 (fig. 1 and ¶[0051]). The spacers are disposed on a working electrode (¶0051]). That is, the configuration of the biosensor includes, a first active area 116 disposed between the electrode and the first permeability adjusting spacer 108, a second enzyme active area 118 disposed between 108 and the second permeability adjusting spacer 110, and a third enzyme active area 120, disposed between the second space 110 and the third permeability adjusting spacer 112 to facilitate measurement of target metabolites in a body while being impermeable to others (¶[0051,0061]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Noritomi, such that a first membrane permeable to acetaldehyde disposed upon the first active area, a second membrane permeable to glucose and ethanol disposed upon the glucose responsive active area and the second active area, wherein the second active area is disposed directly upon the first membrane, and wherein the sensor is configured to be partially inserted into a user's skin, as taught by Papadimitrakopoulos, to facilitate measurement of metabolites by modulating or excluding the permeation of a variety of species, e.g. wanted, unwanted (¶[0051,0095] of Papadimitrakopoulos).
Regarding claim 25, Papadimitrakopoulos teaches wherein the first membrane comprise a copolymer thereof, and the second membrane polymer is a copolymer thereof (¶[0063-64]).
Regarding claim 28, Noritoni teaches wherein the first active area further comprises a first polymer (¶[0096], enzyme body 3 (active area) comprises enzymes 5 which can be supported on polymeric material).
Regarding claim 29, Noritomi-Papadimitrakopoulos teach wherein the xanthine oxidase is covalently bound to the first polymer in the first active area (¶[0096,0139] of Noritomi teaches that the enzymes are supported by polymeric material bonded through covalent bonding, the enzyme being xanthine oxidase).
Regarding claim 30, Noritoni teaches wherein the second active area further comprises a second polymer (¶[0096], enzyme body 3 (active area) comprises enzymes 5 which can be supported on polymeric material. Fig. 10d, there are multiple active areas 3, each can comprise a different enzyme, and each can be supported).
Regarding claim 31, Noritomi-Papadimitrakopoulos teach wherein glucose oxidase is covalently bound to the second polymer in the second active area (¶[0096,0139] of Noritomi teaches that the enzymes are supported by polymeric material bonded through covalent bonding, the enzyme being glucose oxidase).
Regarding claim 42, Noritomi teaches a method of detecting glucose and ethanol in vivo, the method comprising: exposing the analyte sensor of claim 24 to a body fluid comprising at least one of glucose and ethanol (¶[0270,0275]); and applying a first potential to the first working electrode to generate the first signal of an oxidation-reduction potential of the glucose-responsive active area, the first signal a concentration of glucose in the fluid ¶[0041], “a current-potential curve obtained by cyclic voltammetry, a peak current value of oxidation or reduction of a product derived from an enzyme reaction may be obtained. The measurement target substance 6 may be measured based on the peak current value of oxidation or reduction of the electrode active material”); applying a second potential to the second working electrode to generate the second signal at the ethanol-responsive active area, the second signal being a concentration of ethanol in the fluid (¶[0270]); and correlating the first signal to the concentration of glucose in the fluid and the second signal to the concentration of ethanol in the fluid (¶[0270,0275]).
Naritomi fails to teach generating the first signal at or above an oxidation-reduction potential of the glucose-responsive active area, and that each generated signal is proportional to the concentration of the respective analyte.
Papadimitrakopoulos teaches applying a potential to the electrodes to generate a change in current, which is proportional to the amount of metabolite measured (¶[0052]). That is, the applied potential is at or above the oxidation-reduction potential because the potential drives the redox reaction that generates the measured current.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Naritomi-Papadimitrakopoulos, to generate the first signal at or above an oxidation-reduction potential of the glucose-responsive active area and each generated signal is proportional to the concentration of the respective analyte, as taught by Papadimitrakopoulos, to aid in determining the amount of a metabolite in the body of a living being or in a media sample (¶[0052] of Papadimitrakopoulos).
Regarding 43, Papadimitrakopoulos teaches wherein the body fluid is interstitial fluid (¶[0095]).
Claims 26-27 and 32-40 are rejected under 35 U.S.C. 103 as being unpatentable over Noritomi in view of Papadimitrakopoulos, as applied to claim 25, further in view of Liu et al. (US 2012132525- cited by Applicant), hereinafter Liu.
Regarding claims 26-27, Noritomi-Papadimitrakopoulos fail to teach wherein the first membrane comprises polyvinylpyridine and the second membrane comprises polyvinylpyridine-co-styrene.
Liu teaches that analyte restricting membranes for glucose can be “disposed over the sensing layer” and formed of “poly(vinylpyridine-co-styrene) copolymer of high molecular weight, that is cross-linked using a tri-functional, short-chain epoxide” (¶[0055]). Moreover, the membrane can also include poly(vinylpyridine) based polymer backbone (¶[0026,0032]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Noritomi-Papadimitrakopoulos, such that the first membrane comprises polyvinylpyridine and the second membrane comprises polyvinylpyridine-co-styrene, as taught by Liu, to facilitate measurement of metabolites by modulating or excluding the permeation of a variety of species, e.g. wanted, unwanted (¶[0051,0095] of Papadimitrakopoulos).
Regarding claim 32, Noritomi-Papadimitrakopoulos fail to teach wherein the first active area further comprises an electron transfer agent.
Liu teaches that the analyte sensing layer can comprise one or more electron transfer agents to help facilitate electron transfer between the enzyme and working electrode, thereby measuring the relevant analyte (¶[0058-63]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Noritomi-Papadimitrakopoulos-Liu, such that wherein the first active area further comprises an electron transfer agent, as taught by Liu, to facilitate measuring relevant compounds.
Regarding claim 33, Liu teaches that the electron transfer agent is covalently bound to an electrode via a polymer (¶[0058,0112], “ Electron transport involves an exchange of electrons between segments of the redox polymers (e.g., one or more transition metal complexes coupled to a polymeric backbone, as described above) in a crosslinked film disposed on an electrode” and “A transition metal complex can be bound to the polymer backbone though covalent, coordinative or ionic bonds”).
Regarding claim 34¸Liu teaches wherein the electron transfer agent comprises an osmium complex (¶[0151,0155], “synthesis of an osmium complex with three identical 2,2'-biimidazole bidentate ligands”).
Regarding claim 35, Noritomi teaches wherein the first active area further comprises catalase (¶[0096,0103-4], enzyme body 3 includes one or more enzymes 5, including catalase).
Regarding claim 36, Noritomi teaches wherein the glucose-responsive enzyme is glucose oxidase or glucose dehydrogenase (¶[0096,0103-4], enzyme body 3 includes one or more enzymes 5, including glucose oxidase and/or glucose dehydrogenase).
Regarding claim 37, Noritomi-Papadimitrakopoulos fail to teach wherein the glucose-responsive active area further comprises a third polymer.
Liu teaches sensing layer 312, comprises a polymer 316, glucose responsive enzyme 318, and a bi-functional cross-linker (¶[0170-71]). That is, the modified poly(vinylpyridine) backbone reads on the claimed third polymer in combination with the references above.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Noritomi-Papadimitrakopoulos-Liu, such that the glucose-responsive active area further comprises a polymer of Liu is incorporated, because poly(vinylpyridine) backbone is an effective mediator or facilitator of electron transport in the sensing layer (¶[0171] of Liu).
Regarding claim 38, Noritomi-Papadimitrakopoulos fail to teach wherein the glucose-responsive active area further comprises a second electron transfer agent.
Liu teaches that sensing layer 312 contains polymer mediator 316 and GOx, “where electrons from glucose are shuttled to a working electrode via one or more electron transfer agents.”
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Noritomi-Papadimitrakopoulos-Liu, such that the glucose-responsive active area further comprises a second electron transfer agent of Liu, to facilitate electron transport from glucose through the glucose responsive area to the working electrode (¶[0171-72] of Liu).
Regarding claim 39, Liu teaches wherein the second electron transfer agent is covalently bound to the third polymer (¶[0112], “Electron transport involves an exchange of electrons between segments of the redox polymers (e.g., one or more transition metal complexes coupled to a polymeric backbone, as described above) in a crosslinked film disposed on an electrode. A transition metal complex can be bound to the polymer backbone though covalent, coordinative or ionic bonds”).
Regarding claim 40, Liu teaches wherein the second electron transfer agent comprises an osmium complex (¶[0171-72], “modified poly(vinylpyridine) backbone, which is loaded with poly(bi-imidizyl) Os complexes that are securely anchored to the backbone via bidentate linkage” and “where electrons from glucose are shuttled to a working electrode via one or more electron transfer agents”).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Noritomi in view of Papadimitrakopoulos, as applied to claim 28, further in view of D’Allegro (Modern Medicine Soon your car will know when you are having a heart attack — and know how to react 2017).
Regarding claim 41, Noritomi teaches a control module in communication with the analyte, the control module including a computer system programmed to receive and process data provided by the analyte sensor (¶[0042]), but Noritomi-Papadimitrakopoulos fail to teach a control module in communication with an electrical system of a vehicle and wherein operation of the vehicle is controlled or disabled by the computer system when a real-time measured analyte level of the operator crosses a predetermined safe threshold.
D’Allegro teaches that heart rate and blood glucose levels can be monitored while behind the wheel of a to detect dangerous heart related issues (thereby recognizing a threshold to determine “dangerous” level) (¶[3-6], “heart rate and blood glucose levels can be effectively monitored, as they are associated with a relatively high number of vehicle crashes” and “Heart-related medical issues behind the wheel are extremely dangerous because the sufferer can lose consciousness”). The system further configured to pull of the road and call for assistance based on the information gathered (¶6], “People having heart attacks are not always aware of it, Badhwar said. A system that can detect dangerous heart rates, pull off the road and call for assistance would help”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Noritoni-Papadimitrakopoulos, such that the control module is in communication with an electrical system of a vehicle and wherein operation of the vehicle is controlled or disabled by the computer system when a real-time measured analyte level of the operator crosses a predetermined safe threshold, at taught by D’Allegro, because health parameters are associated with relatively high number of vehicle crashes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Heller teaches suitable electron transfer agents usable as redox mediators include osmium transition metal complexes with one or more ligands, each ligand having a nitrogen-containing heterocycle such as 2,2′-bipyridine, 1,10-phenanthroline, 1-methyl, 2-pyridyl biimidazole, or derivatives thereof. US 20170367584
Hoss teaches wherein the membrane structure further comprises a third membrane comprising a polymer and an analyte responsive enzyme. US 20150313520
Eshoo teaches Non-releasable electron transfer agents may include redox species that are coordinately bound to a polymer (e.g., coordination of an osmium or cobalt 2,2′-bipyridyl complex to poly(1-vinyl imidazole) or poly(4-vinyl pyridine)). US 20170258378
Buse teaches transition metal complexes of non-leachable redox polymers are typically covalently or coordinatively bound with the nitrogen-containing heterocycles (e.g., imidazole and/or pyridine rings) of the polymer. US 20090270764
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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