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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 9, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/14/23 and 04/12/22 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on April 9, 2026, amended claims 1, 4, 22 and 23 have been entered.
Response to Arguments
Applicant’s amendments with respect to the claim objections were fully considered and were persuasive. Therefore these, objections have been withdrawn
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Pei and Wang references), and updated obviousness rationale.
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 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 1, 3, 4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Oja (U.S. Patent Application Document 2019/0004005A1) and in further view of Pei (U.S. Patent Application Document 2021/0219876A1), Ouyang (U.S. Patent Application Document 2019/0024130A1), and Wang (U.S. Patent Application Document 2019/0125223A1)
Oja and Ouyang were applied in the previous office action
Regarding claim 1, Oja teaches an analyte sensor for detecting glutamate in vivo [par. 14, 63, 135], the sensor comprising:(i) at least a first working electrode [par. 7]; (ii) a glutamate-responsive active area disposed upon a surface of the first working electrode [par. 14, 112, 114], wherein the glutamate-responsive active area comprises glutamate dehydrogenase [par. 7, 16]; and (iii) a mass transport limiting membrane permeable to glutamate that overcoats at least the glutamate-responsive active area [par. 21, 28, 93], wherein a distal portion of the sensor is configured to be inserted into a subject's skin to detect glutamate in vivo [par. 14, 135]
However, Oja does not teach the glutamate-responsive active area comprises an NAD(P)-dependent glutamate dehydrogenase and a stabilizing agent.
Pei teaches the glutamate-responsive active area comprises an NAD(P)-dependent glutamate dehydrogenase [par. 16, 25, 60] and a stabilizing agent [par. 45].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, to incorporate the glutamate-responsive active area comprises an NAD(P)-dependent glutamate dehydrogenase and a stabilizing agent, so the oxidized form of the redox mediator can be used for an increase in stability, shelf life and producing a more sensitive response, as evidence by Pei [par. 8].
However, Oja does not teach the active area further comprises an NAD(P)-dependent diaphorase.
Ouyang teaches the active area further comprises an NAD(P)-dependent diaphorase [par. 4, 23]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, to incorporate the active area further comprises an NAD(P)-dependent diaphorase, as it facilitates a reduction in the occurrence of delamination of the enzyme compositions from an electrode, as evidence by Ouyang [par. 37].
However, Oja does not teach the sensor has a linear signal sensitivity to glutamate from 0 uM to 100 uM
Wang teaches the sensor has a linear signal sensitivity to glutamate from 0 uM to 100 uM [par. 84]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, to incorporate the sensor has a linear signal sensitivity to glutamate from 0 uM to 100 uM, for providing high-fidelity glutamate measurements as evidence by Wang [par. 84].
Regarding claim 3, Oja further teaches the glutamate-responsive active further comprises an electron transfer agent [par. 84]
Regarding claim 4, Ouyang further teaches one or more of the enzymes in the enzyme system comprising glutamate dehydrogenase and diaphorase are covalently bonded to a polymer in the glutamate-responsive active area [par. 4]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, to incorporate one or more of the enzymes in the enzyme system comprising glutamate dehydrogenase and diaphorase are covalently bonded to a polymer in the glutamate-responsive active area, for mobilizing the dehydrogenase and diaphorase on the surface of the electrode, as evidence by Ouyang [par. 4].
Regarding claims 7 and 8, Oja further teaches the mass transport limiting membrane comprises a polyvinylpyridine-based polymer [par. 93]
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Oja, Pei, Ouyang and Wang and in further view of Deng (U.S. Patent Application Document 2016/0355862 A1).
Deng was applied in the previous office action
Regarding claim 6, Oja, Pei, Ouyang and Wang teach an analyte sensor for detecting glutamate in vivo
However, Oja, Pei, Ouyang and Wang do not teach the stabilizing agent comprises an albumin
Deng teaches wherein the stabilizing agent comprises an albumin [par. 99]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, Pei, Ouyang and Wang, to incorporate wherein the stabilizing agent comprises an albumin, for stabilizing the enzyme, the oxidized redox mediator and prevent denaturation of the protein, as evidence by Deng [par. 99].
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Oja, Pei, Ouyang and Wang and in further view of Petisee (U.S. Patent Application Document 2013/0199944A1).
Petisee was applied in the previous office action
Regarding claim 9, Oja, Pei, Ouyang and Wang teach an analyte sensor, as disclosed above.
However, Oja, Pei, Ouyang and Wang do not teach (iv) a second working electrode; and(v) a second active area disposed upon a surface of the second working electrode and responsive to a second analyte differing from glutamate, wherein the second active area comprises at least one enzyme responsive to the second analyte
Petisee teaches (iv) a second working electrode [par. 99]; and (v) a second active area disposed upon a surface of the second working electrode and responsive to a second analyte differing from glutamate [par. 99; Examiner notes in order for the first analyte to be measured on the first working electrode, the electrode comprises an active area. Therefore, the second working electrode measuring the second analyte would comprise an active area], wherein the second active area comprises at least one enzyme responsive to the second analyte [par. 106]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, Pei, Ouyang and Wang, to incorporate (iv) a second working electrode; and (v) a second active area disposed upon a surface of the second working electrode and responsive to a second analyte differing from glutamate, wherein the second active area comprises at least one enzyme responsive to the second analyte, for providing a means for measuring a second analyte, as evidence by Petisee [par. 99].
Regarding claim 10, Petisee further teaches a second portion of the mass transport limiting membrane overcoats the second active area, a second mass transport limiting membrane overcoating the second active area [par. 93 “The membrane layers covering the pH sensor may also be different from the membrane layers covering the working electrode”, 103, 107, 134; Examiner notes that the membrane system is deposited over the working electrode and the substrate may comprise a second working electrode]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, Pei, Ouyang and Wang, to incorporate a second portion of the mass transport limiting membrane overcoats the second active area, a second mass transport limiting membrane overcoats the second active area or a second mass transport limiting membrane overcoats the second active area and the glutamate- responsive active area, for dictating the extent and the affect of the local environment of the electrode surface, as evidence by Petisee [par. 93].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Oja, Pei, Ouyang, Wang and Petisee and in further view of Boock (U.S. Patent Application Document 2012/0035445A1).
Boock was applied in the previous office action
Regarding claim 21, Oja, Pei, Ouyang, Wang and Petisee teach an analyte sensor, as disclosed above.
However, Oja, Pei, Ouyang, Wang and Petisee do not teach the second mass transport limiting membrane also overcoats the glutamate-responsive active area.
Boock teaches the second mass transport limiting membrane also overcoats the glutamate-responsive active area [par. 69 Examiner notes the first mass transport limiting membrane is the diffusion resistance layer and the second mass transport limiting layer is the interference layer; par. 47, Examiner notes the sensor may comprise an additional working electrode for measuring an additional analyte, which would comprise the same elements as the first working electrode]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Oja, Pei, Ouyang, Wang and Petisee, to incorporate teach the second mass transport limiting membrane also overcoats the glutamate-responsive active area, for preventing interferents from penetrating, as evidence by Boock [par. 110].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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