DETAILED ACTION
Claim Objections
Claim 79 is objected to because of the following informalities: “the least one” in line 3 should be “the at least one”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 99 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 99 recites “wherein the at least one membrane system comprises two or more membrane systems, each independently comprising the first domain, the second domain, and the at least one regenerative cofactor”
The original disclosure fails to provide support for such a feature. In particular, the specifications does not describe an embodiment in which each of the two or more membrane systems independently contains a regenerative cofactor. Applicant is requested to identify, by paragraph number, the portion of the application as filed that provides written description support for this limitation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 79-82, 84, 85, 87, and 95-98 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rao et al. (US 2023/0123613).
As to claim 79, Rao teaches a continuous analyte sensor device ([0025]) comprising: an analyte sensor operably coupled to a signal transducer ([0031]), the analyte sensor comprising at least one membrane system adjacent the signal transducer (Fig. 1B), the least one membrane system comprising: a first domain comprising at least one first transducing element (Fig. 1B – enzyme layer); a second domain adjacent the first domain, the second domain being the same or different as the first domain(Fig. 1B – NAD layer); and at least one regenerative cofactor ([0037] – NAD regeneration strategy).
As to claim 80, Rao teaches the analyte sensor is a multi-analyte sensor ([0047] – systems designed to monitor both 3-hydroxybutyrate and glucose).
As to claim 81, Rao teaches the multi-analyte analyte sensor is a glucose and ketone analyte sensor, or a glucose and creatinine analyte sensor, or a ketone and potassium ion analyte sensor ([0047] – 3-hydroxybutyrate being a ketone).
As to claim 82, Rao teaches the signal transducer comprises at least one electrode ([0039] – working electrode).
As to claim 84, Rao teaches the at least one regenerative cofactor is one or more of NAD, NADH, NAD(P)H, NAD(P)+, ATP, flavin adenine dinucleotide (FAD), magnesium (Mg++), pyrroloquinoline quinone (PQQ), pyrroloquinoline quinone (PQQ), and functionalized derivatives thereof ([0008]).
As to claim 85, Rao teaches at least one mediator present in the first domain, the second domain, or in both the first and second domains ([0031] – a mediator in operable contact with the NAD).
As to claim 87, Rao teaches the first domain comprises the at least one mediator and the at least one first transducing element, and the second domain comprises the at least one regenerative cofactor, or wherein the first domain comprises the at least one regenerative cofactor and the at least one first transducing element and the second domain comprises the at least one mediator (Fig. 1B – enzyme layer coated by an NAD-containing layer; [0009] – the mediator and/or the NAD can be entrapped within a polymer disposed over the electroactive material).
As to claim 95, Rao teaches the first domain or the second domain comprises an amphiphilic polymer or copolymer ([0053] – Wang teaches a polyurethane/polyurea polymer which is blended with a branched acrylate polymer which is amphiphilic).
As to claim 96, Rao teaches the first domain or the second domain comprises a heterocyclic polymer or copolymer, or an at least partially quarternized heterocyclic polymer or copolymer ([0045] – enzyme layer comprising PVA-SBQ; [0078] – PVA can be acetalized with N-methyl-4-(p-formyl styryl) Pyridinium methosulfate (SbQ) – the N-methyl pyridinium moiety being a quarternized nitrogen heterocycle)
As to claim 97, Rao teaches a transmitter ([0093] – transmitter 100) configured to wireless transmit data to a paired display device or therapeutic delivery device (214).
As to claim 98, Rao teaches the continuous analyte sensor device is sterilized ([0063] – sealed sterile dry package).
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) 83, 86, 88, and 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 2023/0123613) in view of Cardosi et al. (US 2018/0128766).
As to claim 83, Rao teaches first domain comprises at least one first transducing element (Fig. 1B – enzyme layer) and the second domain comprises (Fig. 1B – NAD-containing layer), but fails to expressly teach the second domain comprises at least one second transducing element, the second transducing element being different from the first transducing element. Cardosi teaches an enzymatic electrochemical analyte sensor (Abstract) in which the sensing chemistry is disposed in two adjacent layers (Fig. 4; [0074] – layer 410 adjacent the working electrode and layer 420 comprising NAD(P)+). Cardosi notes that by disposing sensing chemistry in layers upon the working electrode, the device can be made more efficient ([0040]). Accordingly, it would have been obvious to modify Rao with Cardosi to optimize the performance of the device.
As to claim 86, Cardosi teaches the mediator is one or more of 2, 2'-bipryidine, poly-1,10-phenanthroline-5,6-dione, polyvinylferrocene, hexacyanoferrate, phthalocyanine or organometallic compounds thereof, organometallic compounds of osmium or ruthenium, and functionalized derivatives thereof, and complexes of one or more transition metals with one or more polymers or ligands and salts thereof ([0043]). It would have been obvious to modify Rao with Cardosi to utilize a known mediator as taught by Cardosi to reduce the potential of interference from an electroactive species such as uric acid.
As to claim 88, the above combination teaches the at least one first transducing element and the at least one second transducing element are independently a dehydrogenase enzyme, a reductase enzyme, a kinase enzyme, a peroxidase enzyme, an esterase enzyme, an (amido)hydrolase enzyme, an oxidase enzyme, or combinations thereof (Rao – hydroxybutyrate dehydrogenase ([0008]), diaphorase ([0017]); Cardosi – an NAD(P)+ dependent dehydrogenase and diaphorase ([0073])).
As to claim 99, Rao teaches a multimodal sensor system comprising both a 3-hydroxybutyrate and a glucose sensing electrode, each with its own enzyme and analyte modulating layer ([0013],[0039]). It does not expressly teach that each of the two membrane systems independently comprises at least one regenerative cofactor. Cardosi teaches that each analyte-sensitive layer independently contains the cofactor NAD+ together with the analyte-specific dehydrogenase (Fig. 6-8 – B-hydrobutyrate dehydrogenase, NAD-GDH, glycerol dehydrogenase). It would have been obvious to modify Rao with Cardosi further such that each of the two membrane systems independently comprises a first and second domain, and a regenerative cofactor to allow for optimization for a specific analyte for each transducer.
Claim(s) 89 and 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 2023/0123613) in view of Cardosi et al. (US 2018/0128766), and further in view of Liu et al. (US 2022/0186278).
As to claims 89 and 90, the above combination results in a teaching where the first domain comprises a dehydrogenase (Rao - [0079] - 3-hydroxybutyrate dehydrogenase) and the adjacent second domain comprises a second, different NADH-oxidizing enzyme (Cardosi – [0017] - diaphorase). The combination fails to expressly teach that the second transducing element in NADH oxidase.
Liu teaches a continuous ketone sensor employing an enzyme system comprising B-hydroxybutyrate dehydrogenase and NADH oxidase, in which the NAD+ serves as the cofactor and the NADH oxidase reoxidizes the NADH generated by the dehydrogenase ([0268], [0271], [0288-0292]). It would have been obvious to modify the above combination with Liu to substitute NADH oxidase for the diaphorase of Cardosi as they perform the same function within the context of the electrochemical sensor, and would thus constitute an obvious substitution that would yield similar results.
Claim(s) 91-94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 2023/0123613) in view of Liu (US 2022/0186278).
As to claim 91, Rao teaches the at least one electrode comprises platinum or palladium ([0051]); an interference domain deposited on the at least one electrode ([0076] – interference rejection constituent); the first domain is adjacent the interference domain, the first domain comprising the dehydrogenase and the regenerative cofactor(Fig. 1A, [0013] – layer comprising 3-hydroxybutyrate dehydrogenase enzyme, NAD, and other components, [0045]). Rao fails to expressly teach that the first domain further comprises NADH oxidase, that the second domain comprises a poly vinylpyridine polymer or copolymer, or that the device is configured to provide a continuous analyte signal without a transition metal-containing mediator.
Liu teaches a continuous ketone sensor in which a ketone-responsive layer comprising B-hydroxybutyrate dehydrogenase, NADH oxidase, and NAD is disposed on a working electrode ([0007]; [0351]), is overcoated by a mass transport limiting membrane comprising a polyvinylpyridine polymer or copolymer ([0008]; [0352]), and in which the ketone-responsive active area does not include an electron-transfer agent ([0012]). It would have been obvious to modify Rao with Liu as it would avoid the problem that Rao states with mediators, as the mediators conventionally used are “highly toxic compounds … and can therefore migrate in aqueous environments”, which can pose a “significant use when considering their use in continuous in vivo measurement” ([0028]), and make the device safter for the user.
As to claim 92, the Rao teaches the at least one regenerative cofactor is NAD ([0008]).
As to claim 93, Rao teaches the interference domain is configured to block diffusion of at least one of acetaminophen, ascorbic acid, bilirubin, cholesterol, creatinine, dopamine, ephedrine, ibuprofen, L-dopa, methyldopa, salicylate, tetracycline, tolazamide, tolbutamide, triglycerides, and uric acid from the electrode surface ([0076]).
As to claim 94, Rao teaches the interference domain comprises polyurethanes, polyurethane-zwitterion polymers, polymers having pendant ionic groups, NAFIONTM,chitosan, cellulose, alternating layers of polyallylamine and polyacrylate acid or combinations or blends thereof ([0076]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant has argued that the cited portions of Liu fail to teach a second domain adjacent the first domain. While the primary embodiment that was recited does dispose the membrane portions on opposite faces of a substrate, the examiner notes that applicant’s own specification defines a membrane system as a permeable or semi-permeable membrane that can be comprised of two or more domains, layers, or layers within a domain ([0171] of the printed publication) and further states that the membrane system comprises an enzyme, which enables an analyte reaction to occur. Applicant then goes on to define a domain as “a region of membrane that can be a layer, a uniform or non-uniform gradient … or a portion of a membrane that is capable of sensing one … or more analytes” ([0155]). Liu’s ketones-responsive active area and the overlying mass transport limiting membrane constitutes a “membrane system” as defined by applicant’s own specification, with Liu’s active area being a “domain” or a “region of a membrane system that can be a layer … or a portion of a membrane that is capable of sensing one … or more analytes” and the mass transport limiting membrane being a second such domain, deposited directly upon and therefore adjacent the first. Moreover, Liu discloses a structure that recites the claims in a secondary embodiment: a ketones-responsive active area comprising B-hydroxybutylate dehydrogenase, NADH oxidase and NAD+ deposited on a platinum working electrode, overcoated by a polyvinylpyridine mass transport limiting membrane (Abstract) and is also the same structure that was cited for claim 91 in the previous rejection. Nonetheless, in the interest of compact prosecution, a new reference was found which is more closely related to the disclosed invention and was applied.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/15/26
Prosecution Insights