DETAILED CORRESPONDENCE
Summary
This Office Correspondence is based on the Amendment and Reply filed with the Office on 20 May 2026, regarding the Latour, et al. application.
Claims 22-44 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 22, 24-26, 30-34, and 39-41 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 US Patent Application Publication to Pei, et al. (US 2010/0270175 A1; hereinafter, “Pei”) and in view of a US Patent Application Publication to Liu, et al. (US 2012/0132525 A1; hereinafter, “Liu”).
Regarding claim 22, Feldman discloses an electrochemical analyte sensor (500, [0071]; which reads upon the claimed, “[a]n analyte sensor”). Feldman teaches a working electrode (501) and that the sensor may include more than one working electrode ([0071]; which reads on “at least a first working electrode and a second working electrode”). Feldman also teaches a sensing layer deposited upon the conductive material of a working electrode ([0078]; which reads on “a first active area disposed upon a surface of the first working electrode…”), the sensing layer comprising an electron transfer agents include but are not limited to a redox species, e.g., bound to a polymer which can in tum be disposed on or near the working electrode ([0083]) and an analyte-responsive enzyme ([0076]; which reads on “the first active area comprising a first polymer, a first redox mediator covalently bonded to the first polymers…”). As Feldman teaches there may be more than one working electrode ([0064]), it will be appreciated by one of ordinary skill in the art that the analyte monitoring system 100 may include more than one sensor 101 and/or more than one data processing unit 102, and/or more than one data processing terminal 105 ([0055]), wherein a second sensor would comprise the second working electrode and all the features a sensing layer ([0077]; rendering obvious “a second active area upon the surface of the second working electrode and responsive to a second analyte … the second active area comprising a second polymer, a second redox mediator different from the first redox mediator (to differentiate the signals) covalently bonded to the second polymer, and at least one enzyme responsive to the second analyte covalently bonded to the second polymer”). Additionally, Feldman teaches a mass transport limiting layer, e.g., an analyte flux modulating layer, may be included with the sensor to act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrodes ([0090]; which reads on “a mass transport limiting membrane permeable … that overcoats the first active area”). Feldman further teaches an insertion device can be used to subcutaneously insert the sensor into the patient ([0105]; which reads on “wherein the sensor is configured to be partially inserted into a user’s skin”).
Feldman teaches the analyte may be ketone bodies ([0051]). Feldman does not explicitly mention β-hydroxybutyrate as the first analyte, nor an enzyme system comprising multiple enzymes covalently bonded to the first polymer that are collectively responsive to β-hydroxybutyrate.
However, Pei discloses a biosensor for measuring an analyte (Abstract), wherein is taught a reagent that includes ferricyanide salt as mediator, β-hydroxybutyrate dehydrogenase as the first enzyme operative to catalyze the oxidation of β-hydroxybutyrate, NAD+ as a cofactor corresponding to the first enzyme, and diaphorase as the second enzyme operative to catalyze the oxidation of a reduction form of the cofactor (NADH) ([0014]).
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 substitute the β-hydroxybutyrate dehydrogenase/diaphorase enzyme system, which includes NAD as part of the reagent, to monitor β-hydroxybutyrate concentration, as taught by Pei, into the invention described by Feldman as monitoring β-hydroxybutyrate concentrations are important to determining health status in patients.
Feldman does not teach the structure of the first redox mediator in present claim 22.
However, Liu discloses transition metal complexes attached to polymeric
backbones can be used as redox mediators in enzyme based electrochemical sensors (Abstract), wherein one of the taught transition metal complex redox mediators, including the claimed structure (Formula X; [0070]; [0098]-[0099]).
At the time of the filing of the present application, it would have been obvious to one ordinary skill in the art it make the simple substitution of the transition metal complex redox mediator to arrive at the claimed invention with an predictable expectation of success.
As to the instant limitations, "wherein the low potential is above an oxidation-reduction potential of the first redox mediator and below about -80 mV relative to the Ag/AgCI reference electrode; wherein the oxidation-reduction potential of the first redox mediator ranges from about -200 m V to about -400 mV relative to the Ag/AgCI reference electrode", they are inherent chemical characteristics, which would be shared by identical chemical compositions.
Regarding claims 24 and 25, Feldman teaches in certain embodiments, a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole ([0091]).
Regarding claim 26, Liu teaches utilizing the cross-linker polyethylene glycol diglycidyl ether ([0033]), which is a homolog of polyethyleneglycol tetraglycidyl ether, rendering the latter obvious to one of ordinary skill in the art (MPEP 2144.09 II).
Regarding 30, Feldman teaches an analyte may be glucose ([0052]).
Regarding claim 31, Liu teaches the sensor 300 may be connected via a cord (not shown) to a portable, potentiostat-data logger device (not shown), which may be used to maintain working electrode 302 at a potential of +40 m V versus the g/AgCl reference electrode 304, while obtaining and storing instantaneous current values at 10-second intervals ([0179]).
Regarding claims 32 and 33, Feldman teaches in certain embodiments, a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole ([0091]).
Regarding claim 34, Liu teaches utilizing the cross-linker polyethylene glycol diglycidyl ether ([0033]), which is a homolog of polyethyleneglycol tetraglycidyl ether, rendering the latter obvious to one of ordinary skill in the art (MPEP 2144.09 II).
Regarding 39, Feldman teaches an analyte may be glucose ([0052]).
Regarding claims 40 and 41, all the shared limitations are taught by the combination of the teachings of Feldman, Pei, and Liu, as shown above in the rejection to instant claim 22.
Claims 23 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman, Pei and Liu as applied to claims 22 and 31 above, and further in view of a US Patent Application Publication to Nishizawa, et al. (US 2013/0130230 A1; hereinafter, “Nishizawa”).
Regarding claims 23 and 35, Feldman, Pei and Liu combine to render obvious all the limitations of claims 22 and 31, as outlined above. Additionally, the references teach the second analyte is glucose.
The references do not teach the at least one enzyme responsive to the second analyte comprises an enzyme system comprising multiple enzymes that are collectively responsive to the second analyte.
However, Nishizawa discloses a biosensor ([0006]), wherein is taught the enzyme for detection may be a combination of diaphorase and glucose dehydrogenase ([0055]).
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 dual enzyme system for glucose detection taught by Nishizawa in the invention disclosed by Feldman, McColl and Liu as it would be an example of selection of a known material based on its suitability for its intended use (MPEP 2144.07).
Claims 27-29, 36-38, and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman, Pei and Liu as applied to claims 22, 31, and 41 above, and further in view of US Patent Application Publication to Simpson, et al. (US 2007/0213611 A1; hereinafter, “Simpson”).
Regarding claims 27-29, 36-38 and 42-44, Feldman, Pei and Liu combined render obvious the limitations of claims 22, 31, and 41, as outlined above.
These references do not teach the mass transport limiting membrane is bilayer membrane.
However, Simpson disclose an electrode system, wherein is taught a membrane system that includes a plurality of layers ([0316]). The layers are deposited over the electroactive surfaces of the sensor ([0316]).
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 adapted the plurality-layered membrane system taught by Simpson in to the invention taught by the combined teaching of Feldman, McColl and Liu as the membrane system can provide a plurality of functions including diffusion resistance, limiting interfering species and hydrophilicity at the electrochemically reactive surface of the sensor interface (Simpson, [0326]).
Response to Arguments
Applicant's arguments filed 20 May 2026, regarding the obviousness double patenting rejection have been fully considered. The rejection is withdrawn.
Applicant’s arguments, filed 20 May 2026, with respect to the previous rejection of the pending claims under 35 USC 103, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the teachings found in the Pei prior art reference, as outlined above.
Interview with the Examiner
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
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