DETAILED CORRESPONDENCE
Summary
This Office Correspondence is based on the Response filed with the Office on 26 January 2026, regarding the LaTour, et al. application.
Claims 1-36 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 .
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 1, 3, 5, 6, 8, 16, 18, 20, 21, 29, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over a US Patent Application Publication to Feldman, et al. (US 2007/0193019 A1; hereinafter, “Feldman”) in view of any of US Patent Application Publication to Taub (US 2008/0319294 A1; hereinafter, “Taub”), US Patent Application Publication to Russell, et al. (US 2004/0138543 A1; hereinafter, “Russell”), and US Patent to Guo, et al. (US 5,695,947; hereinafter, “Guo”).
Regarding claim 1, Feldman discloses a sensor utilizing a non-leachable or diffusible redox mediator (Abstract; which reads upon the instantly claimed, “[a]n analyte sensor”). Feldman teaches the sensor also includes a nonleachable redox mediator on the working electrode of at least one of the electrode pairs ([0011]; which reads on “a sensor tail comprising at least a first working electrode”). Feldman teaches the redox mediator can be immobilized by covalent attachment of the redox mediator to a polymer on the working electrode ([0153]; reading on “wherein the first active area comprises a first polymer, a first redox mediator covalently bounded to the first polymer”). Feldman also teaches a suitable second electron transfer agent is an enzyme which catalyzes a reaction of the analyte ([0166]; reading on “at least one enzyme responsive to the first analyte”). The Feldman reference teaches a redox mediator including osmium or ruthenium transitional metal complexes with one or more ligands, each ligand having one or more nitrogen-containing heterocycles ([0122]), wherein the structure of the ligands may be derivatives for pyridine including 2,6-bis(2-imidazolyl)pyridine ([0137]), which is the ligand of instant claim 1. Feldman additionally teaches the transition metal complexes may have vinyl functional groups through which the complexes can be co-polymerized ([0155]), wherein is taught such vinyl functional groups can be pendent from a pyridine ring (R13), as shown in structure XIV ([0140]; reading on “wherein the linking group covalently bonds the first redox mediator to the first polymer”).
Feldman does not explicitly teach a mass transport limiting membrane comprising any of the claimed polymers.
However, Taub discloses analyte monitoring devices and systems that include an analyte sensor ([0018]), wherein is taught a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole, and embodiments also include membranes that are made of a polyurethane, or polyether urethane, or chemically related material, or membranes that are made of silicone, and the like.
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to incorporate the mass transport limiting layer of Taub into the sensor disclosed by Feldman because the mass transport limiting layer act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrode (Taub, [0059]).
Regarding claim 3, Feldman teaches glucose determination (Abstract).
Regarding claim 5, Feldman does not explicitly teach a mass transport limiting membrane comprising any of the claimed polymers.
However, Taub discloses analyte monitoring devices and systems that include an analyte sensor ([0018]), wherein is taught a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole, and embodiments also include membranes that are made of a polyurethane, or polyether urethane, or chemically related material, or membranes that are made of silicone, and the like.
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to incorporate the mass transport limiting layer of Taub into the sensor disclosed by Feldman because the mass transport limiting layer act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrode (Taub, [0059]).
Regarding claim 6, Feldman does not explicitly teach the first active area comprises a cofactor.
However, Russell discloses a method of measuring an analyte concentration in body fluid (Abstract), wherein is taught an analyte sensing element including enzyme and enzyme cofactor are mixed into the layer that includes a conductive, redox mediating polymer ([0012]).
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to have incorporated the enzyme cofactor analyte sensing layer into the invention of Feldman as the cofactor allow the enzymatic reaction for sensing to occur.
Feldman does not explicitly teach the claimed first active area comprises a stabilizing agent.
However, Guo discloses a sensor of amperometric assay (Abstract), wherein is taught a reagent strip is a porous or fibrous carrier, typically a paper, impregnated with a mixture containing the second redox mediator, enzymes, at least one surfactant and at least one stabilizer comprising an aqueous thickening agent (Abstract).
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to have incorporated the stabilizer into the invention of Feldman as it allows thickening or gelling to retain the enzyme in place on the sensor (Col. 6, line 15-18).
Regarding claim 8, Feldman teaches osmium ([0122]).
Regarding claims 16, the combination of Feldman and Taub teaches the shared limitations with instant claim 1, as outlined above. Feldman additionally teaches sensor is operated at an applied potential of no more than about +100 mV, +50 mV, +25 mV, 0 mV, -25 mV, -50 mV, -100 m V, or -150 m V between the working electrode and the counter or counter/reference electrode ([0109]). Feldman also teaches reactions are transduced to an electrical signal that can be correlated to an amount or concentration of analyte (Abstract).
Regarding claim 18, Feldman teaches glucose determination (Abstract).
Regarding claim 20, Feldman does not explicitly teach a mass transport limiting membrane comprising any of the claimed polymers.
However, Taub discloses analyte monitoring devices and systems that include an analyte sensor ([0018]), wherein is taught a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole, and embodiments also include membranes that are made of a polyurethane, or polyether urethane, or chemically related material, or membranes that are made of silicone, and the like.
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to incorporate the mass transport limiting layer of Taub into the sensor disclosed by Feldman because the mass transport limiting layer act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrode (Taub, [0059]).
Regarding claim 21, Feldman does not explicitly teach the first active area comprises a cofactor.
However, Russell discloses a method of measuring an analyte concentration in body fluid (Abstract), wherein is taught an analyte sensing element including enzyme and enzyme cofactor are mixed into the layer that includes a conductive, redox mediating polymer ([0012]).
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to have incorporated the enzyme cofactor analyte sensing layer into the invention of Feldman as the cofactor allow the enzymatic reaction for sensing to occur.
Feldman does not explicitly teach the claimed first active area comprises a stabilizing agent.
However, Guo discloses a sensor of amperometric assay (Abstract), wherein is taught a reagent strip is a porous or fibrous carrier, typically a paper, impregnated with a mixture containing the second redox mediator, enzymes, at least one surfactant and at least one stabilizer comprising an aqueous thickening agent (Abstract).
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to have incorporated the stabilizer into the invention of Feldman as it allows thickening or gelling to retain the enzyme in place on the sensor (Col. 6, line 15-18).
Regarding claim 35, Feldman does not explicitly teach a mass transport limiting membrane comprising any of the claimed polymers.
However, Taub discloses analyte monitoring devices and systems that include an analyte sensor ([0018]), wherein is taught a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole, and embodiments also include membranes that are made of a polyurethane, or polyether urethane, or chemically related material, or membranes that are made of silicone, and the like.
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to incorporate the mass transport limiting layer of Taub into the sensor disclosed by Feldman because the mass transport limiting layer act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrode (Taub, [0059]).
Regarding claim 36, Feldman does not explicitly teach a mass transport limiting membrane comprising any of the claimed polymers.
However, Taub discloses analyte monitoring devices and systems that include an analyte sensor ([0018]), wherein is taught a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole, and embodiments also include membranes that are made of a polyurethane, or polyether urethane, or chemically related material, or membranes that are made of silicone, and the like.
At the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to incorporate the mass transport limiting layer of Taub into the sensor disclosed by Feldman because the mass transport limiting layer act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrode (Taub, [0059]).
Allowable Subject Matter
Claims 2, 4, 7, 9-15, 17, 19, and 22-34 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 Feldman reference is considered the closest prior art reference to the indicated claims. However, Feldman does not anticipate nor render obvious the limitations of the instant indicated claims.
Response to Arguments
Applicant's arguments filed 26 January 2026, have been fully considered but they are not persuasive. While the Applicant has correctly pointed out the difference between the Feldman structures IV & V with the claimed chemical structure, Feldman is shown to teach an osmium complex with ligands that may be 2,6-bis(2-imidazolyl)pyridine, which is the claimed ligand of claims 1 and 16. Therefore, the prior art renders obvious the limitations of the indicated claims.
Interview with the Examiner
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https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
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https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached on M - F, 9 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795