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.
Election/Restrictions
Applicant's election with traverse of Invention I (Claims 1-9 and 21) in the reply filed on 02/09/26 is acknowledged. The traversal is on the ground(s) that Applicant notes the subject matter of each of the claim Groups is linked by a common inventive concept, and there is no serious burden on the Examiner to examine the different claim Groups. This is not found persuasive because the process of Invention II can be used to practice another and materially different apparatus than Invention I that comprises an electrical conduit. Additionally, the apparatus of Invention I can be used to practice another and materially different process than Invention III, that comprises external skin sensing. Invention II (Claims 10-19) and Invention III (Claim 20) have been withdrawn
The requirement is still deemed proper and is therefore made FINAL.
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 1-6, 8, 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)
Feldman was applied in the Applicant’s IDS filed on 08/12/24
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 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 6, Feldman further teaches the mediator comprises: an organo-metallic phenanthroline-dione, and/or Meldola blue [par. 39]
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]
Claim 7 is rejected under 35 U.S.C. 103 as being anticipated by Feldman and Ouyang and in further view of Liang (U.S. Patent Application Publication 2022/0304599 A1)
Regarding claim 7, Feldman and Ouyang teach an amperometric analyte sensor system, as disclosed above.
However, Feldman and Ouyang do not teach the mediator: is embedded within a screen printed carbon electrode; and/or is coupled to the electrode via an electropolymerization process
Liang teaches the mediator: is embedded within a screen printed carbon electrode; and/or is coupled to the electrode via an electropolymerization process
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Feldman and Ouyang, to incorporate the mediator: is embedded within a screen printed carbon electrode; and/or is coupled to the electrode via an electropolymerization process, to dictate conductance of the resulting mediator-enzyme-cofactor matrix, as evidence by Liang [par. 37]
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