DETAILED ACTION
Status of the Claims
1. Claims 1-23 and 25-27 are pending.
Status of the Rejections
2. Rejection of claims 1-6, 9 and 12 on the ground of nonstatutory double patenting as being unpatentable over claims 25 and 46 of co-pending Application No. 17/818,143 (hereinafter ‘143) in view of Feldman et al. (US 2014/0054171) is maintained.
Rejection of claims 1-12-20, 22, 23, 26 and 27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4, 9, 10 and 15 of co-pending Application No. 19/320,168 (hereinafter ‘168) in view of Feldman et al. (US 2014/0054171) is being modified in view of applicant’s amendments.
Claim 15 is allowable over cited prior arts, Feldman et al. and Wilsey et al.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-6, 9 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25 and 46 of co-pending Application No. 17/818,143 (hereinafter ‘143) in view of Feldman et al. (US 2014/0054171).
Claim 1, ‘143 teach an electrochemical analyte sensor for detecting ketone in vivo, the electrochemical analyte sensor comprising:
a first portion configured to be positioned above a user’s skin;
a second portion configured to be transcutaneously positioned in the user’s skin and in contact with the user’s biological fluid (reads on interstitial fluid) to monitor the level of ketone in vivo, the second portion comprises:
a working electrode having an enzyme composition disposed thereon (an electrode and an enzyme composition disposed thereon);
the enzyme composition comprises:
a) nicotinamide adenine dinucleotide (phosphate) (NAD(P)+) or derivative thereof (NAD(P)+ or derivative thereof);
b) D-3-hydroxybutyrate dehydrogenase;
c) diaphorase;
d) an electron transfer agent; and
e) a polymer,
wherein the NAD(P)+ or derivative thereof is not covalently bonded to the polymer (see claim 25).
‘143 teach a membrane disposed on the enzyme composition (see claim 25 iii)) but do not explicitly teach the membrane is a mass transport limiting membrane which limits flux of D-3- hydroxybutyrate to the working electrode, sensor electronics and a receiver.
However, Feldman et al. teach an in-vivo electrochemical analyte sensor comprised a working electrode, counter electrode/reference electrode are
disposed at least portion of the substrate (see Fig 1 and [0013]). A mass transport limiting layer is disposed to act as diffusion limiting barrier to reduce the rate of mass transport of analyte (ketone i.e. hydroxybutyrate) into the region of working electrode so that sensor is linearly responsive over a large range of analyte (hydroxybutyrate) concentrations and easily calibrated [0012][0086]. The sensors are generally configured with sensor electronics and communicate data with a receiver [0141][0142].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Feldman et al. teaching to dispose mass transport limiting layer onto the enzyme composition of ‘143 to obtain linear sensor response over range of analyte concentration and calibrate sensor easily. Furthermore, it would have been obvious to connect the sensor to electronics and receiver to communicate detected analyte data to health care provider.
Claim 2. Feldman et al. teach the sensor electronics are coupled to the sensor (electronics connected to sensor; [0141]).
Claim 3. Feldman et al. teach the sensor electronics comprise memory for storing sensor data relating to a level of D-3-hydroxybutyrate from signals generated by the sensor (electronics for storing data corresponding to the detected analyte level of user; [0142]).
Claims 4-6. Feldman et al. teach the sensor electronics are communicatively coupled to the receiver (electronics communicate with receiver by Bluetooth RF; [0143]).
Claim 9. Feldman et al. teach the receiver is configured to display the level of D- 3-hydroxybutyrate (server device has display to show detected analyte level; [0143][0142]).
Claim 12, Feldman teach the mass transport limiting membrane comprising polyvinylpyridine [0089].
This is a provisional nonstatutory double patenting rejection.
Claims 1-23, 25, 26 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4, 9, 10 and 15 of co-pending Application No. 19/320,168 (hereinafter ‘168) in view of Feldman et al. (US 2014/0054171).
Claims 1 and 10, ‘168 teach a sensor for detecting D-3 hydroxybutyrate in vivo, the sensor comprising:
a second portion configured to be transcutaneously positioned in the user’s skin to monitor the level of D-3 hydroxybutyrate in vivo, the sensor comprising:
a working electrode is configured to generate a signal associated with the level of D-3-hydroxybutyrate;
an enzyme composition disposed on surface of working electrode, the enzyme composition comprises:
a) nicotinamide adenine dinucleotide (phosphate) (NAD(P)+) or derivative thereof (NAD(P)+ or derivative thereof);
b) D-3-hydroxybutyrate dehydrogenase;
c) diaphorase;
d) an electron transfer agent; and
e) a polymer,
wherein the NAD(P)+ or derivative thereof is not covalently bonded to the polymer; and
a mass transport limiting membrane disposed over the enzyme composition which limits flux of D-3- hydroxybutyrate to the working electrode (see claims 1 and 6).
‘168 do not explicitly teach sensor system comprised of sensor electronics and a receiver.
However, Feldman et al. teach an in-vivo electrochemical analyte sensor comprised a working electrode, counter electrode/reference electrode are
disposed at least portion of the substrate (see Fig 1 and [0013]) wherein sensors are generally configured with sensor electronics and communicate data with a receiver [0141][0142].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Feldman et al. teaching to connect the sensor to electronics and receiver to communicate detected analyte data to health care provider.
Claim 2. Feldman et al. teach the sensor electronics are coupled to the sensor (electronics connected to sensor; [0141]).
Claim 3. Feldman et al. teach the sensor electronics comprise memory for storing sensor data relating to a level of D-3-hydroxybutyrate from signals generated by the sensor (electronics for storing data corresponding to the detected analyte level of user; [0142]).
Claims 4-6 and 8. Feldman et al. teach the sensor electronics are communicatively coupled to the receiver (electronics communicate with receiver by Bluetooth RF protocol; [0143]).
Claim 7. Feldman et al. teach the sensor electronics communicate sensor data with the receiver automatically and periodically (sensor monitors the level of analyte in user for continuous/automatic or periodic monitoring; [0070], thus sensor electronics which sends data to receiver [0141] is configured to send data continuously and periodically).
Claim 9. Feldman et al. teach the receiver is configured to display the level of D- 3-hydroxybutyrate (server device has display to show detected analyte level; [0143][0142]).
Claim 11. ‘168 teach the signal decays no more than 8% when exposed to D-3 hydroxybutyrate concentration for 45 hours (see claim 15).
Claim 12, ‘168 teach the mass transport limiting membrane comprising polyvinylpyridine (claim 9).
Claim 13. ‘168 teach the mass transport limiting membrane comprises poly(4-vinylpyridine-co-styrene) (see claim 10).
Claim 14, ‘168 teach a sensor for detecting D-3 hydroxybutyrate in vivo, the sensor comprising:
a second portion configured to be transcutaneously positioned in the user’s skin to monitor the level of D-3 hydroxybutyrate in vivo, the sensor comprising:
a working electrode is configured to generate a signal associated with the level of D-3-hydroxybutyrate;
an enzyme composition disposed on surface of working electrode, the enzyme composition comprises:
a) nicotinamide adenine dinucleotide (phosphate) (NAD(P)+) or derivative thereof (NAD(P)+ or derivative thereof);
b) D-3-hydroxybutyrate dehydrogenase;
c) diaphorase;
d) an electron transfer agent and a polymer (the electron transfer agent is covalently bound to polymer; reads on polymeric redox mediator),
a mass transport limiting membrane disposed over the enzyme composition which limits flux of D-3- hydroxybutyrate to the working electrode; and
wherein the signal increases linearly as function of D-3-hydroxybutyrate concentration over a range from 0mM-10 mM (see claims 1 and 4).
‘168 do not explicitly teach sensor system comprised of sensor electronics and a receiver.
However, Feldman et al. teach an in-vivo electrochemical analyte sensor comprised a working electrode, counter electrode/reference electrode are
disposed at least portion of the substrate (see Fig 1 and [0013]) wherein sensors are generally configured with sensor electronics and communicate data with a receiver [0141][0142].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Feldman et al. teaching to connect the sensor to electronics and receiver to communicate detected analyte data to health care provider.
Claim 15. ‘168 teach NADP+ is not covalently bonded to the polymer which is covalently bonded to electron transfer agent (see claims 1 and 4), thus it is apparent NADP+ is not covalently bonded to polymeric redox mediator.
Claim 16. Feldman et al. teach the sensor electronics are coupled to the sensor (electronics connected to sensor; [0141]).
Claim 17. Feldman et al. teach the sensor electronics comprise memory for storing sensor data relating to a level of D-3-hydroxybutyrate from signals generated by the sensor (electronics for storing data corresponding to the detected analyte level of user; [0142]).
Claims 18-20 and 22. Feldman et al. teach the sensor electronics are communicatively coupled to the receiver (electronics communicate with receiver by Bluetooth RF protocol; [0143]).
Claim 21. Feldman et al. teach the sensor electronics communicate sensor data with the receiver automatically and periodically (sensor monitors the level of analyte in user for continuous/automatic or periodic monitoring; [0070], thus sensor electronics which sends data to receiver [0141] is configured to send data continuously and periodically).
Claim 23. Feldman et al. teach the receiver is configured to display the level of D- 3-hydroxybutyrate (server device has display to show detected analyte level; [0143][0142]).
Claim 25. ‘168 teach the signal decays no more than 8% when exposed to D-3 hydroxybutyrate concentration for 45 hours (see claim 15).
Claim 26, ‘168 teach the mass transport limiting membrane comprising polyvinylpyridine (claim 9).
Claim 27. ‘168 teach the mass transport limiting membrane comprises poly(4-vinylpyridine-co-styrene) (see claim 10).
This is a provisional nonstatutory double patenting rejection.
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.
Claim(s) 14, 16-23, 25 and 26 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. (US 2014/0054171) in view of Wilsely et al. (US 6,541,216).
Claim 14. Feldman et al. teach analyte sensor system (analyte sensor connected to amperometer; [0141] comprising:
transcutaneously analyte sensor for detecting D-3-hydroxybutyrate in vivo (second portion comprising insertion tip 530 configured to be positioned below the skin, to monitor ketone in vivo in the presence of hydroxybutyrate; [0065] and Fig 5, thus ketone being detected is hydroxybutryate), the sensor comprising:
(i) a working electrode configured to generate a signal associated with level of D-3- hydroxybutyrate (working electrode senses analyte i.e. hydroxybutyrate; [0054][0065])
enzyme layer disposed on the working electrode (sensing layer comprising enzyme disposed on the working electrode; [0054], the enzyme layer comprising:
b) D-3- hydroxybutyrate dehydrogenase suitable for monitoring the concentration of lactate (beta hydroxybutyrate dehydrogenase [0065][0131]), an NAD+ dependent dehydrogenase);
d) polymeric redox mediator (redox mediator bound to polymer; [0063]); and
ii) a mass transport limiting membrane disposed over enzyme composition to limit flux of D-3-hydroxbutyrate to the working electrode; [0086]); and
sensor electronics; and a receiver [0141][0142].
Feldman et al. teach sensing layer comprised of beta hydroxybutyrate dehydrogenase to detect ketone/hydroxybutyrate (3-HBA) [0065], enzymatic reaction to detect hydroxybutyrate with hydroxybutyrate dehydrogenase inherently involves nicotinamide adenine dinucleotide (phosphate) (NAD(P)+) as evidenced by Wilsey et al. (Fig 3 and [0077]).
Feldman et al. do not explicitly teach the enzyme composition is comprised of diaphorase.
However, Wilsey et al. teach amperometric biosensor for detecting ketone/3HBA comprised of a reagent composition comprised of 3-hydroxybutyrate dehydrogenase to react with 3-HBA and diaphorase (NADH oxidoreductase) for oxidizing NADH to NAD+ (see col. 3, ll. 34-52 and equations 1 and 2).
Since Feldman et al. and Wilsey are to same field of endeavor i.e. detecting 3-D-HBA with enzymatic electrode, therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention in view of Wilsey et al. teaching to use diaphorase as the second catalyst in the Feldman et al. sensing layer because it was known enzyme/catalyst to be used to react with resulting product from catalyzed reaction of 3HBA and moreover to recycle reduced NADH to its oxidized form to be reused for accurate determination of analyte concentration.
Combined teachings of Feldman et al. and Wilsey teach enzyme composition comprised of NADP, D-3-hydroxbutyrate dehydrogenase, diaphorase and polymeric redox mediator, thus enzyme composition is same as applicant’s claimed/disclosed invention and therefore the sensor would inherently have signal increase linearly as function of D-3-hydroxybutyrate concentration over a range from 0mM to 10mM.
Claim 16. Feldman et al. teach the sensor electronics are coupled to the sensor (electronics connected to sensor; [0141]).
Claim 17. Feldman et al. teach the sensor electronics comprise memory for storing sensor data relating to a level of D-3-hydroxybutyrate from signals generated by the sensor (electronics for storing data corresponding to the detected analyte level of user; [0142]).
Claims 18-20. Feldman et al. teach the sensor electronics are communicatively coupled to the receiver (electronics communicate with receiver by Bluetooth RF; [0143]).
Claim 23. Feldman et al. teach the receiver is configured to display the level of D- 3-hydroxybutyrate (server device has display to show detected analyte level; [0143][0142]).
Claim 21. Feldman et al. teach the sensor electronics communicate sensor data with the receiver automatically and periodically (sensor monitors the level of analyte in user for continuous/automatic or periodic monitoring; [0070], thus sensor electronics which sends data to receiver [0141] is configured to send data continuously and periodically).
Claim 22. Feldman et al. teach the sensor electronics communicate sensor data with the receiver non-automatically using RFID protocol (data is communicated using Bluetooth RF protocol [0143]).
Claim 25 recites property of sensor wherein the signal decays no more than 8% in 45 hours. The limitation does not further impart any structural limitation to the claimed analyte sensor. When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary (see MPEP § 2112.01, I.).
Claim 26, Feldman et al. teach the mass transport limiting membrane comprising polyvinylpyridine [0088].
Response to Arguments
Applicant's arguments filed 3/16/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 7-8 of remarks that cited prior art, Wilsey is unrelated to in vivo sensing chemistry, wherein the reagent formulation is comprised of ferricyanide and is not a polymeric redox mediator and therefore one of skilled artisan would not have considered Wilsey relevant to Feldman’s sensor and therefore would not infer Feldman’s sensor linearity in view of Wilsey’s teaching.
In response, in making the rejection, examiner used Wilsey reference to use diaphorase as the second catalyst in the Feldman et al. sensing layer because it was known enzyme/catalyst to be used to react with resulting product from catalyzed reaction of 3HBA and moreover to recycle reduced NADH to its oxidized form to be reused for accurate determination of analyte concentration. Examiner did not suggest in making any changes to Feldman’s polymeric mediator or test chamber dimensions, therefore use of diaphorase as second catalyst in Feldman et al. to recycle NADH would have been obvious and would not change the operation of Feldman’s in vivo sensor. Furthermore, incorporation of diaphorase in the enzymatic composition of Feldman et al. would yield same enzyme as of applicant’s claimed/disclosed enzyme compsition and therefore the sensor would inherently have signal increase linearly as function of D-3-hydroxybutyrate concentration over a range from 0mM to 10mM.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/GURPREET KAUR/
Primary Examiner
Art Unit 1759
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