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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/3/26 has been entered.
Response to Amendment
Receipt is acknowledged of applicant's amendment filed on 2/3/26. Claims 4, 8-9 and 19 are cancelled. Claims 24-26 are new. Claims 1-3, 5-7, 10-18 and 20-26 are currently pending and an action on the merits is as follows.
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.
Claim(s) 1-3, 5, 10-14, 16, 20, 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. US 2010/0268043 in view of Cocco et al. “NADH oxidase from the extreme thermophile Thermus aquaticus YT-1” and Zweig US 2003/0068666.
Regarding claim 1, Yodfat discloses an analyte sensor for detecting ketones in vivo, the sensor comprising:
(i) at least a first working electrode ([FIG4a][¶52,79] cannula 6 is the tail and electrodes 100 and 900 are the sensors) comprising a conductive material ([¶92-93] the sensor are amperometric so the electrodes are conductive);
(ii) a ketones-responsive active area disposed upon a surface of the first working electrode, wherein the ketones-responsive active area comprises an enzyme system comprising a β-hydroxybutyrate dehydrogenase ([FIG4a][¶52,79] the enzymes used are β-hydroxybutyrate dehydrogenase and salicyclate hydroxylase which oxidizes NADH to NAD+).
wherein the ketones-responsive active area is responsive to ketones at a potential ([¶19] the voltage differential is measured of the working electrode and the reference).
wherein a distal portion of the sensor is configured to be inserted into a subject’s skin to detect ketones in vivo ([FIG3a,4a] [¶52,79]).
Yodfat does not specifically disclose using NADH oxidase or the potential range. Cocco teaches a similar analyte sensor that uses NADH oxidase ([pg. 267] an amperometric biosensor that uses NADH oxidase to produce hydrogen peroxide). Yodfat in view of Cocco teaches the ketones-responsive active area is responsive to ketones at a potential from about +0.2 V to about +0.5 V relative to an Ag/AgCl reference ([¶19] the voltage differential is measured of the working electrode and the reference. Yodfat and Cocco teach the claimed enzymes so the voltage response would be the same for the same ketones/analytes). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the NADH oxidase of Cocco with the device of Yodfat as it is the mere replacement of salicyclate hydroxylase with NADH oxidase to convert NADH to NAD+ while providing peroxide which is useful in biosensing assays ([pg. 267]).
Yodfat does not specifically disclose a mass transport limiting membrane permeable to ketones that overcoats at least a portion of the ketones-responsive active area or that the working electrode comprises a conductive material that oxidizes hydrogen peroxide. Zweig teaches a similar glucose and ketone sensor that has a limiting membrane ([¶79-81] filtering layers block large components that are not the analytes being sensed) and an electrodes that oxidizes hydrogen peroxide ([¶58] silver chloride). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the limiting layer of Zweig with the sensor of Yodfat in order to block interferents ([¶79]).
Regarding claim 2, Yodfat discloses the ketones-responsive active area does not include a redox mediator comprising a transition metal complex ([FIG4a][¶23,52,79] only β-hydroxybutyrate dehydrogenase is used).
Regarding claims 3, 14 and 23, Yodfat discloses the ketones-responsive active area does not include a superoxide dismutase ([FIG4a][¶23,52,79] only β-hydroxybutyrate dehydrogenase is used).
Regarding claims 5 and 16, Zweig teaches the ketones-responsive active area further comprises a stabilizer for stabilizing the enzyme system ([¶106] stabilizers are used).
Regarding claims 10 and 20, Yodfat discloses the sensor further comprising: (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 ketones, wherein the second active area comprises at least one enzyme responsive to the second analyte ([¶24,52,79] glucose sensor electrode 900).
Regarding claim 11, Zweig teaches further comprising a second mass transport limiting membrane overcoats the second active area ([¶79] the layer coats the electrodes).
Regarding claim 12, Yodfat discloses the second analyte is glucose ([¶24,52,79] glucose sensor electrode 900).
Regarding claim 13, Yodfat discloses a method for detecting ketones comprising:
(i) exposing the analyte sensor of claim 1 to a fluid comprising ketones
(ii) applying a potential to the first working electrode ([¶93] power is supplied for the reaction);
(iii) obtaining a first signal at or above an oxidation-reduction potential of the ketones- responsive active area, the first signal being proportional to a concentration of ketones in a fluid contacting the ketones-responsive active area ([¶52] the electrical signal is proportional the ketone concentration); and
(iv) correlating the first signal to the concentration of ketones in the fluid ([¶52]).
Regarding claim 21, Zweig teaches the second membrane also overcoats the mass transport limiting membrane overcoating the ketones-responsive active area ([¶79]).
Claim(s) 6, 7, 15, 17, 18 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. US 2010/0268043 in view of Cocco et al. and Zweig US 2003/0068666 further in view of Feldman et al. US 2010/0213082.
Regarding claims 6 and 17, Yodfat as modified by Zweig does not disclose the mass transport limiting membrane comprises a polyvinylpyridine, a polyvinylimidazole, a polyvinylpyridine copolymer, a polyacrylate, a polyurethane, a polyether urethane or a combination thereof. Feldman teaches a similar glucose sensor that uses polyvinylpyridine ([¶85,86] PVP acts as a mass limiting layer). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the PVP of Feldman with the sensor of Yodfat in order to fine tune the layer/barrier for the analyte or species of interest reducing interferents and noise ([¶86]).
Regarding claims 7 and 18, Feldman teaches the mass transport limiting membrane comprises a polyvinylpyridine ([¶85,86]).
Regarding claim 15 and 22, Yodfat does not disclose the working electrode comprises platinum. Feldman teaches a similar glucose sensor that uses platinum electrodes ([¶34,64]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the platinum electrode of Feldman with the sensor of Yodfat in order as it is now more than the substitution of one known element for another, platinum electrode replacing a carbon electrode, that would yield the predictable result of providing a conductive electrode ([¶64]).
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. in view of Cocco et al. and Zweig US further in view of Chen et al. US 2019/0320947.
Regarding claims 24- 26, Yodfat does not specifically disclose the mass transport limiting membrane that overcoats the ketones-responsive active area is a bilayer membrane, wherein a lower layer of the bilayer membrane comprises a polyvinylpyridine polymer and wherein an upper layer of the bilayer membrane comprises a polyvinylpyridine-co-styrene copolymer. Chen teaches a similar analyte sensor that has a bilayer membrane composed of both polyvinylpyridine and polyvinylpyridine-co-styrene ([¶34]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Yodfat with teachings of Chen in order to have sufficient response stability of the sensor ([¶71]).
Response to Arguments
Applicant's arguments filed 2/3/26 have been fully considered but they are not persuasive.
Regarding Applicant's arguments against the combination of Yodfat and Cocco, Examiner respectfully disagrees. Yodfat discloses a biosensor with an immobilized enzyme for sensing ketones. The signal is generated by the reaction of the enzyme coated electrode. The electrode is coated in HBDH which reacts to create NADH and acetoacetate and that is measured ([¶94]). Yodfat does not disclose the specific use of hydrogen peroxide in the reaction. Cocco teaches a biosensor applicable enzyme system that generates hydrogen peroxide for sensing. Yodfat already discloses the use of multiple enzymes bonded to the electrode sensing area and Cocco's use of NADH oxidase allows for the regeneration of the cofactor NAD+. The detection of hydrogen peroxide rather than just NADH allows the electrode to both sense the ketone and recycle the NADH into NAD+. Similarly the device could still function as Yodfat discloses as the oxidase is immobilized on the electrode just like the SHL. In regard to Cocco and Frew, they function the same as the electrode in the present device. Frew uses a different enzyme and Cocco specifically uses NADH oxidase to get the same reaction. The electrode produces the reaction through the bound enzyme.
Conclusion
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791