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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/12/24, 06/20/24 and 05/09/24 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on June 18, 2026, amended claim 1 has been entered. Claim 6 has been cancelled. New claims 22-24 have been added.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered and were not persuasive
Applicant argues that neither Feldman, Ouyang and Liang teach mediators comprising an organo- metallic phenanthroline-dione; and/or Meldola blue. Examiner respectfully disagrees and notes that Liang teaches “In various embodiments, it may be beneficial to use an organic azine mediator such as, but not limited to toluidine blue, thionine, 1,10-phenanthroline-5,6-drone, meldola's blue, and methylene blue” [par. 37]. Therefore, this equates to mediators comprising an organo- metallic phenanthroline-dione; and/or Meldola blue, when taking into consideration broadest reasonable interpretation.
Applicant further argues that Feldman, Ouyang and Liang disclosures all fail to teach or suggest an enzyme layer comprising 3-hydroxybutyrate dehydrogenase enzyme, wherein the 3-hydroxybutyrate dehydrogenase enzyme is tethered to a polymer and the polymer is tethered to the electroactive material. Examiner disagrees and notes that Feldman teaches “the β-hydroxybutyrate dehydrogenase and the diaphorase may be covalently bonded to a polymer within the ketones-responsive active area of the analyte sensors” [par. 36]. Examiner additionally notes that in Feldman, the purpose of the enzyme being bonded to the polymer is for promoting retention. [par. 38], which Examiner interprets to imply the polymer is bound to the active area. Therefore, this equates to an enzyme layer comprising 3-hydroxybutyrate dehydrogenase enzyme, wherein the 3-hydroxybutyrate dehydrogenase enzyme is tethered to a polymer and the polymer is tethered to the electroactive material, when taking into consideration broadest reasonable interpretation.
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 1-9 and 21 are rejected under 35 U.S.C. 103 as being anticipated by Feldman (U.S. Patent Application Publication 2020/0237275 A1) and in further view of Ouyang (U.S. Patent Application Publication 2019/0024130 A1) and Liang (U.S. Patent Application Publication 2022/0304599 A1)
Feldman, Ouyang and Liang were applied in the previous office action
Regarding claim 1, Feldman teaches an amperometric analyte sensor system [fig. 3A, element 200; par. 44] comprising: a 3-hydroxybutyrate sensing electrode [fig. 3A, element 214; par. 12, 24] comprising: a layer of an electroactive material [fig. 3A, element 218b; par. 44, 45, 75, Examiner notes the active area comprises conductive material]; an enzyme layer comprising 3-hydroxybutyrate dehydrogenase enzyme in operable contact with the electroactive material [par. 32, 36]; a nicotinamide adenine dinucleotide in operable contact with the 3-hydroxybutyrate dehydrogenase enzyme [par. 36, 70]; a mediator in operable contact with the nicotinamide adenine dinucleotide [par. 36 “The NADH may then undergo reduction under diaphorase mediation, with the electrons transferred during this process providing the basis for ketone detection at the working electrode”, par. 70]; and a ketone modulating layer disposed over the enzyme layer [fig. 3A, element 220; par. 32, 45], wherein the ketone modulating layer comprises a composition that modulates the diffusion of ketones through the ketone modulating layer [par. 70]
However, Feldman does not teach wherein the mediator comprises: an organo-metallic phenanthroline-dione; and/or Meldola blue
Liang teaches wherein the mediator comprises: an organo-metallic phenanthroline-dione; and/or Meldola blue [par. 37]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Feldman to incorporate the mediator comprises: an organo-metallic phenanthroline-dione; and/or Meldola blue, as the selection or properties of the electrode reactive surface 114, and conditions of electropolymerization ultimately dictate conductance of the resulting mediator-enzyme-cofactor matrix, where the mediator can influence the performance of electron transfer or electron acceptance, as evidence by Liang [par. 37]
However, Feldman does not teach the 3-hydroxybutyrate modulating layer comprises a composition that modulates the diffusion of 3-hydroxybutyrate through the 3-hydroxybutyrate modulating layer
Ouyang teaches 3-hydroxybutyrate modulating layer comprises a composition that modulates the diffusion of 3-hydroxybutyrate through the 3-hydroxybutyrate modulating layer [par. 50]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Feldman to incorporate c3-hydroxybutyrate modulating layer comprises a composition that modulates the diffusion of 3-hydroxybutyrate through the 3-hydroxybutyrate modulating layer, to reduce the rate of mass transport of the analyte, as evidence by Ouyang [par. 50]
Regarding claim 2, Feldman further teaches the 3-hydroxybutyrate dehydrogenase enzyme, the mediator and/or the nicotinamide adenine dinucleotide is tethered/coupled to a polymer [par. 36].
Regarding claim 3, Feldman further teaches the polymer comprises a polyvinyl pyridine [par. 64, 65]
Regarding claim 4, Feldman further teaches the 3-hydroxybutyrate dehydrogenase enzyme, the mediator and/or the nicotinamide adenine dinucleotide is tethered/coupled to a polymer via crosslinking agent [par. 65, 67]
Regarding claim 5, Feldman further teaches the polymer is operably coupled to the 3-hydroxybutyrate sensing electrode [par. 65, 136]
Regarding claim 8, Feldman further teaches the amperometric analyte sensor system does not comprise a diaphorase [par. 38 “β-hydroxybutyrate dehydrogenase (HBDH) may again convert β-hydroxybutyrate and NAD into acetoacetate and NADH, respectively. Instead of electron transfer to the working electrode being completed by diaphorase (see FIG. 2A) and a transition metal electron transfer agent, the reduced form of NADH oxidase (NADHOx (Red)) undergoes a reaction to form the corresponding oxidized form (NADHOx (Ox))”]
Regarding claim 9, Feldman further teaches the amperometric analyte sensor system senses 3-hydroxybutyrate at an electrical potential of less than 0.7V, 0.6V, 0.5V, 0.4V, 0.3V, or 0.2V [par. 73].
Regarding claim 21, Feldman further teaches a glucose sensing electrode [fig. 3A, element 214; par. 44] comprising: a layer of an electroactive material [fig. 3A, element 218b; par. 44, 45, 75, Examiner notes the active area comprises conductive material]; an enzyme layer comprising glucose oxidase enzyme in operable contact with the electroactive material [par. 40]; and a glucose modulating layer disposed over the enzyme layer [fig. 3A, element 220; par. 27, 45], wherein: the glucose modulating layer comprises a composition that modulates the diffusion of glucose through the glucose modulating layer [par. 27]; and the amperometric analyte sensor system senses 3-hydroxybutyrate and glucose [par. 12, 24, 45]
Claims 22-24 are rejected under 35 U.S.C. 103 as being anticipated by Feldman and in further view of Ouyang
Regarding claim 22, Feldman teaches an amperometric analyte sensor system [fig. 3A, element 200; par. 44] comprising: a 3-hydroxybutyrate sensing electrode [fig. 3A, element 214; par. 12, 24] comprising: a layer of an electroactive material [fig. 3A, element 218b; par. 44, 45, 75, Examiner notes the active area comprises conductive material]; an enzyme layer comprising 3-hydroxybutyrate dehydrogenase enzyme [par. 32, 36], wherein the 3- hydroxybutyrate dehydrogenase enzyme is tethered to a polymer and the polymer is tethered to the electroactive material [par. 32, 36]; a nicotinamide adenine dinucleotide in operable contact with the 3-hydroxybutyrate dehydrogenase enzyme [par. 36, 70]; a mediator in operable contact with the nicotinamide adenine dinucleotide [par. 36 “The NADH may then undergo reduction under diaphorase mediation, with the electrons transferred during this process providing the basis for ketone detection at the working electrode”, par. 70]; and a ketone modulating layer disposed over the enzyme layer [fig. 3A, element 220; par. 32, 45], wherein the ketone modulating layer comprises a composition that modulates the diffusion of ketones through the ketone modulating layer [par. 70]
However, Feldman does not teach the 3-hydroxybutyrate modulating layer comprises a composition that modulates the diffusion of 3-hydroxybutyrate through the 3-hydroxybutyrate modulating layer
Ouyang teaches 3-hydroxybutyrate modulating layer comprises a composition that modulates the diffusion of 3-hydroxybutyrate through the 3-hydroxybutyrate modulating layer [par. 50]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Feldman to incorporate c3-hydroxybutyrate modulating layer comprises a composition that modulates the diffusion of 3-hydroxybutyrate through the 3-hydroxybutyrate modulating layer, to reduce the rate of mass transport of the analyte, as evidence by Ouyang [par. 50]
Regarding claim 23, Feldman further teaches the nicotinamide adenine dinucleotide is tethered to a polymer and the polymer is tethered to the electroactive material [par. 36 “the diaphorase may be covalently bonded to a polymer within the ketones-responsive active area”]
Regarding claim 24, Feldman further teaches the mediator is tethered to a polymer and the polymer is tethered to the electroactive material [par. 64 “Active areas suitable for detecting glucose and ketones may also comprise a polymer to which the electron transfer agents are covalently bound”]
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/
Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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