DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Oja, et al. application filed with the Office on 9 October 2024.
Claims 31-51 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application has an earliest effective filing date of 28 January 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 16 October 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
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.
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 31, 34-39, 41, 42, 44-49 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over a US Patent Application Publication to Feldman, et al. (US 2009/0294306 A1; hereinafter, “Feldman”) in view of a published International Patent Application to McColl, et al. (WO 2011030093 A1; hereinafter, “McColl”), a US Patent Application Publication to Simpson, et al. (US 2016/0328991 A1; hereinafter, “Simpson”) and a US Patent Application Publication to Liu, et al. (US 2012/0132525 A1; hereinafter, “Liu”).
Regarding claims 31 and 42, Feldman teaches an electrochemical analyte sensor (Paragraph 0047-0051, 0069, 0071-methods and devices for detecting at least one analyte; Fig. SA, sensor 500) for detecting glucose and ketones in vivo (Paragraph 0047-- Generally, embodiments of the present invention relate to methods and devices for detecting at least one analyte, such as glucose, in body fluid. Embodiments relate to the continuous and/or automatic in vivo monitoring of the level of one or more analytes ... ; Paragraph 0052--Analytes that may be monitored include ... glucose ... ketone bodies), the sensor comprising:
a first working electrode and a second working electrode (Paragraph 0071: insertion tip 530 comprises a working electrode 501, reference electrode 502, and a counter electrode 503 ... "a sensor may include more than one working electrode"; Fig. SA, working electrode 501);
a ketones-responsive active area for detecting ketones, the ketones-responsive active area disposed upon a surface of the first working electrode (Paragraph 0052--Analytes that may be monitored include ... ketone bodies), the ketones-responsive active area comprising a first polymer (Paragraph 0083-0085: electron transfer agents may include a redox species covalently bound in a polymeric composition ... one or more ligands covalently bound in a polymer ... ; Paragraph 0089, 0095-0096-in some embodiments, the sensing element is a redox active component that includes ... a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are cross linked together; paragraph 0090-0093-a mass-transport limiting membrane may be included in the sensor ... may include polymers and may be bio-compatible; paragraph 0096-0098-a sensing layer may contain a redox polymer ... substrate may be formed using polymeric materials ... ), and an enzyme system (Paragraph 0001-0002-biosensors, such as glucose biosensors utilize a reaction of an analyte with an enzyme, such as glucose with glucose oxidase; Paragraph 0042-enzymes present in the sensing layer; paragraph 0076, 0079, 0086-0087-analyte sensors may include an analyte responsive enzyme to provide a sensing component or a sensing layer; paragraph 0086-0087-may utilize enzymes such as nicotinamide adenine dinucleotide (NAD) or flavine adenine di nucleotide (FAD)) covalently bound to the first polymer (Paragraph 0089, 0095-0096-in some embodiments, the sensing element is a redox active component that includes ... a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are cross linked together),
a glucose-responsive active area for detecting glucose, the glucose-responsive active area disposed upon a surface of the second working electrode (Paragraph 0001-0002, 0051-0052: "Analytes that may be monitored include ... glucose"), the glucose-responsive active area comprising a second polymer (Paragraph 0083-0085: electron transfer agents may include a redox species covalently bound in a polymeric composition ... one or more ligands covalently bound in a polymer ... ; Paragraph 0089, 0095-0096-in some embodiments, the sensing element is a redox active component that includes ... a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are cross linked together; paragraph 0090-0093-a mass-transport limiting membrane may be included in the sensor ... may include polymers and may be bio-compatible; paragraph 0096-0098-a sensing layer may contain a redox polymer ... substrate may be formed using polymeric materials ... )) and a glucose-responsive enzyme (Paragraph 0001-0002-biosensors, such as glucose biosensors utilize a reaction of an analyte with an enzyme, such as glucose with glucose oxidase; Paragraph 0042-enzymes present in the sensing layer; paragraph 0076, 0079, 0086-0087-analyte sensors may include an analyte-responsive enzyme to provide a sensing component or a sensing layer), covalently bound to the second polymer (Paragraph 0089, 0095-0096-in some embodiments, the sensing element is a redox active component that includes ... a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are cross linked together),
a mass transport limiting membrane (Paragraph 0003-the working electrode is typically constructed of a sensing layer which is in direct contact with the conductive material of the electrode, and a diffusion-limiting membrane layer on top of the sensing layer; paragraph 0042, 0091-0094-a flux limiting membrane applied over the sensing layer of the working electrode that limits the flux of analytes to the enzymes present in the sensing layer), comprising:
a first barrier for limiting diffusion of ketones to the ketones-responsive active area disposed directly on the ketones-responsive active area (Paragraph 0003-the working electrode is typically constructed of a sensing layer which is in direct contact with the conductive material of the electrode, and a diffusion-limiting membrane layer on top of the sensing layer; Paragraph 0052--Analytes that may be monitored include ... ketone bodies; paragraph 0042, 0091-0094-a flux limiting membrane applied over the sensing layer of the working electrode that limits the flux of analytes to the enzymes present in the sensing layer);
a second barrier for limiting diffusion of glucose to the glucose-responsive active area disposed on the glucose-responsive active area (Paragraph 0042, 0094-in some embodiments, the electrode will further comprise a second flux limiting membrane ... sensing layer may be covered by one or more layers, e.g., a membrane that is selectively permeable to glucose)
wherein the sensor is configured to be partially inserted into a user's skin such that a distal portion of the sensor is in contact with an interstitial fluid to detect glucose and ketones in vivo (paragraph 0049--The sensor may be, for example, subcutaneously positionable in a patient for the continuous or periodic monitoring of a level of an analyte in a patient's interstitial fluid ... ; Paragraph 0071--insertion tip 530 positionable below the skin, e.g. penetrating through the skin and into, e.g., the subcutaneous space; Fig. SA, insertion tip 530).
However, Feldman does not specifically teach a ketones-responsive active area comprising at least two enzymes that facilitate detection of ketones.
McColl, in analogous art of a multianalyte measurement system (Abstract) wherein a system may be used for measuring both glucose and ketone concentrations (Paragraph 0034, 0045-may output at least two analyte concentrations, e.g., glucose and/or a ketone concentration) discloses wherein the system includes a ketones-responsive active area comprising an enzyme system of at least two enzymes that facilitate detection of ketones (Paragraph 0045-0046-may include at least one enzyme that selectively reacts with ketones ... the enzyme may include beta-hydroxybutyrate dehydrogenase ... the reagent layer used to measure ketones may include a second enzyme such as diaphorase ... ).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Feldman, which discusses using multiple working electrodes, one of which may be utilized to detect ketones, to utilize a particular combination of enzymes which are known in the art to predictably facilitate detection of ketones.
However, Feldman fails to specifically teach a sensor wherein the membrane comprises a second barrier for limiting diffusion of glucose disposed on the first membrane (which overcoats the ketones-responsive active).
Simpson, in the same field of endeavor of continuous analyte sensor devices which may include a first and second working electrode for the measurement of glucose and ketones, respectively, (Paragraph 0014, 0045, 0288, 0443-0444, 0524--Generally, implementations may include use of various sensors, including ketone sensors, glucose sensors, accelerometers, and sensors measuring glycerol, as well as combinations of these. Particular implementations of note may include a ketone sensor in isolation, a ketone and glucose sensor combination device, and a ketone, glucose and accelerometer sensor combination device ... Measurements of ketone bodies may be useful individually as well as in combination with glucose measurements to provide an indicator of diabetic control), discloses that a sensor device may include a first membrane permeable to ketones disposed directly upon the ketones responsive active area (Paragraph 0526--ln some embodiments, the sensor has a ketone-specific diffusion resistance layer. A ketone-specific resistance layer may also be constructed by appropriate modification of the diffusion resistance layer noted above ... Improved control of ketone permeability in these membranes may be enabled by control of hydrophilic channels within these membranes, as well as by control of the degree of membrane channel hydration and hydrogen bonding (PVP systems) ... NOTE: the diffusion resistance layer noted above relates to a glucose diffusion resistance layer); and
a second membrane permeable to glucose and ketones disposed upon the first membrane and upon the glucose-responsive active area (Paragraph 0513-- It is to be understood that sensing membranes modified for other sensors, for example, may include fewer or additional layers. For example, in some embodiments, the membrane system may comprise one electrode layer, one enzyme layer, and two bioprotective layers, but in other embodiments, the membrane system may comprise one electrode layer, two enzyme layers, and one bioprotective layer. In some embodiments, the bioprotective layer may be configured to function as the diffusion resistance domain and control the flux of the analyte (e.g., glucose) to the underlying membrane layers; paragraph 0515--It should be appreciated that the sensing membrane located over the working electrode does not have to have the same structure as the sensing membrane located over the reference electrode; for example, the enzyme domain deposited over the working electrode does not necessarily need to be deposited over the reference or counter electrodes). In particular, it may be seen that Simpson discloses a system that includes working electrodes for measuring ketones and glucose, a membrane structure which may be present on the working electrodes and which controls permeability of ketones and/or glucose, where the membrane structure may include multiple layers and where the membrane structure may be different or the same on different electrodes of the system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the membrane of the combination of Feldman to include the membrane features of Simpson because it allows for passage and restriction of specific analytes of interest, ketones and glucose, which together may allow for improved indications of diabetic control (Paragraph 0524 of Simpson).
Feldman additionally teaches a membrane comprises polyvinyl pyridine (Paragraph 0091) and generally teaches that a sensor may be coated in polyvinyl pyridine and/or polyvinylpyridine-co-styrene (Paragraph 0041, 0132).
However, the combination above fails to specifically teach a sensor wherein the first barrier comprises polyvinyl pyridine.
Liu teaches a membrane wherein the first membrane comprises polyvinylpyridine (Paragraph 0032, 0034, 0174, 0177: "attached to a poly(vinylpyridine)-based polymer" and Paragraph 0034, 0055: "comprise a poly(vinylpyridine-co-styrene) copolymer"). Liu further teaches that the membrane components may be selected according to various desirable properties such that it additionally may be seen to teach the membrane polymers are formulated to levelized sensitivity values detected for analytes of interest (Paragraph 0034--D may contribute to various desirable properties of the membrane including, but not limited to, hydrophobicity, hydrophilicity, solubility, biocompatibility, elasticity and strength. D may be selected to optimize or "fine-tune" a membrane made from the polymer in terms of its permeability to an analyte and its non-permeability to an undesirable, interfering component).
As Simpson teaches a membrane structure with multiple layers and provides motivation for deciding the composition of the layers of a membrane, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor of the combination of Feldman and McColl with Simpson, having a multi layered membrane, to additionally include the compositions of Liu, because it allows for specific analyte restriction and additional desired parameters of the membrane such that the modification would be a simple substitution known to those having ordinary skill in the art which would produce known results (i.e. the passage and restriction of specific analytes as desired).
Regarding claims 34-37 and 44-47, Feldman teaches an electron transfer agent (Paragraph 0083-0085: electron transfer agents may include a redox species covalently bound in a polymeric composition ... one or more ligands covalently bound in a polymer).
Regarding claims 38 and 48, Feldman teaches glucose oxidase (Paragraph 0089, 0095-0096-in some embodiments, the sensing element is a redox active component that includes ... a polymeric backbones and glucose oxidase enzyme molecules. These two constituents are cross linked together).
Regarding claims 39 and 49, McColl teaches β-hydroxybutyrate dehydrogenase and diaphorase (Paragraph 0045-0046-may include at least one enzyme that selectively reacts with ketones ... the enzyme may include beta-hydroxybutyrate dehydrogenase ... the reagent layer used to measure ketones may include a second enzyme such as diaphorase ... ).
Regarding claims 41 and 51, Feldman additionally teaches a membrane comprises polyvinyl pyridine (Paragraph 0091) and generally teaches that a sensor may be coated in polyvinyl pyridine and/or polyvinylpyridine-co-styrene (Paragraph 0041, 0132).
Claims 32, 33 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman in view of McColl, Simpson, and Liu as applied to claims 31 and 42 above, and further in view of a US Patent to Skotheim, et al. (US 5,264,092; hereinafter, “Skotheim”).
Regarding claims 32, 33, and 43, Feldman in view of McColl, Simpson and Liu teach the limitations of instant claims 31 and 42, as outlined above.
None of the cited references explicitly enzymes bonded to the first polymer.
However, Skotheim discloses electrochemical enzyme biosensors (Abstract), wherein is taught that it is advantageous to covalently immobilize the enzyme to the polymer backbone (Col. 5, lines 13-15).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the teaching of Skotheim to attach enzymes covalently to the polymer, as this achieves long-term stability (Skotheim, Col. 5, line 13).
Allowable Subject Matter
Claims 40 and 50 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 following is a statement of reasons for the indication of allowable subject matter: The cited references are the closest prior art to the instant claims. However, no cited reference anticipates or renders obvious the enzyme system comprising β-hydroxybutyrate dehydrogenase and nicotinamide adenine dinucleotide oxidase, as required by each of claims 40 and 50.
Interview with the Examiner
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
Prosecution Insights