DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the LATOUR, et al. application filed with the Office on 12 June 2024.
Claims 22-44 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment filed on 23 August 2024, is acknowledged and has been entered.
Priority
The instant application is a continuation of US Patent Application 17/132,360, filed on 23 December 2020, which claim priority to a US Provisional Patent Application, 62/952,558, filed on 23 December 2019. Thus, 23 December 2019, is the effective filing date of the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 23 August 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Double Patenting
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 22, 24-28, 31-34, 36, 37, and 40-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, and 12 of U.S. Patent No. 12, 044,648 B2 (hereinafter, “LaTour”) in view of a US Patent Application Publication to Pei, et al (US 2010/0270175 A1; hereinafter, “Pei”), a US Patent Application Publication to Yodfat, et al. (US 2010/0268043 A1; hereinafter, “Yodfat”), and a US Patent Application Publication to Simpson, et al. (US 2007/0213611 A1; hereinafter, “Simpson”).
Regarding claim 22, patented claim 1 of LaTour teaches all the limitations except claim 1 does not teach “an enzyme system comprising multiple enzymes covalently bonded to the first polymer that are collectively responsive to β-hydroxybutyrate” and “wherein the sensor is configured to be partially inserted into a user’s skin”.
However, Pei discloses a biosensor, wherein is taught a system of β-hydroxybutyrate dehydrogenase and diaphorase for the determination of β-hydroxybutyrate concentration levels ([0014]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to utilize enzyme system comprising multiple enzymes responsive to β-hydroxybutyrate, as it would allow recycling of NAD+/NADH for efficient electron transport.
Yodfat discloses a device for monitoring bodily analytes, wherein is taught the subcutaneous insertion of the element to monitor ketone levels ([0022]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to adapt a subcutaneous sensor as this would allow for continuous ketone monitoring and dispensing insulin ([0022]).
Regarding claim 24, the patent claim 3 teaches all the limitations.
Regarding claim 25, the patent claim 4 teaches all the limitations.
Regarding claim 26, the patent claim 5 teaches all the limitations.
Regarding claims 27 and 28, the patented claims do not teach the limitations.
However, Simpson discloses a continuous analyte sensor, wherein is taught a membrane system deposited over the electroactive surfaces of a sensor wherein the membrane system includes a plurality of layers ([0316]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to adapted the multiple layer membrane system of Simpson to the device claimed by LaTour as a variety of characteristics can be introduced via the multiple layer membrane system.
Regarding claim 31, patented claim 6 teaches all the limitations recited.
Regarding claim 32, patented claim 7 teaches all the limitations.
Regarding claim 33, patented claim 8 teaches all the limitations.
Regarding claim 34, patented claim 9 teaches all the limitations.
Regarding claim 36 and 37, the patented claims do not teach the limitations.
However, Simpson discloses a continuous analyte sensor, wherein is taught a membrane system deposited over the electroactive surfaces of a sensor wherein the membrane system includes a plurality of layers ([0316]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to adapted the multiple layer membrane system of Simpson to the device claimed by LaTour as a variety of characteristics can be introduced via the multiple layer membrane system.
Regarding claim 40, patented claim 12 teach all the limitations except “wherein the at least one enzyme comprises an enzyme system comprising multiple enzymes that are collectively responsive to β-hydroxybutyrate” and “wherein the sensor is configured to partially inserted into a user’s skin”.
However, Pei discloses a biosensor, wherein is taught a system of β-hydroxybutyrate dehydrogenase and diaphorase for the determination of β-hydroxybutyrate concentration levels ([0014]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to utilize enzyme system comprising multiple enzymes responsive to β-hydroxybutyrate, as it would allow recycling of NAD+/NADH for efficient electron transport.
Yodfat discloses a device for monitoring bodily analytes, wherein is taught the subcutaneous insertion of the element to monitor ketone levels ([0022]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to adapt a subcutaneous sensor as this would allow for continuous ketone monitoring and dispensing insulin ([0022]).
Regarding claims 42 and 43, the patented claims do not teach the limitations.
However, Simpson discloses a continuous analyte sensor, wherein is taught a membrane system deposited over the electroactive surfaces of a sensor wherein the membrane system includes a plurality of layers ([0316]).
At the time of the filing of the instant application, one of ordinary skill would have found it obvious to adapted the multiple layer membrane system of Simpson to the device claimed by LaTour as a variety of characteristics can be introduced via the multiple layer membrane system.
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.
Claims 22, 24-26, 30-34, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over a US Patent Application Publication to Feldman, et al. (US 2009/0294306 A1; hereinafter, “Feldman”) in view of a published International Patent Application to McColl, et al. (WO 2011/030093 A1; hereinafter, “McColl”) and in view of a US Patent Application Publication to Liu, et al. (US 2012/0132525 A1; hereinafter, “Liu”).
Regarding claim 22, Feldman discloses an electrochemical analyte sensor (500, [0071]; which reads upon the claimed, “[a]n analyte sensor”). Feldman teaches a working electrode (501) and that the sensor may include more than one working electrode ([0071]; which reads on “at least a first working electrode and a second working electrode”). Feldman also teaches a sensing layer deposited upon the conductive material of a working electrode ([0078]; which reads on “a first active area disposed upon a surface of the first working electrode…”), the sensing layer comprising an electron transfer agents include but are not limited to a redox species, e.g., bound to a polymer which can in tum be disposed on or near the working electrode ([0083]) and an analyte-responsive enzyme ([0076]; which reads on “the first active area comprising a first polymer, a first redox mediator covalently bonded to the first polymers…”). As Feldman teaches there may be more than one working electrode ([0064]), it will be appreciated by one of ordinary skill in the art that the analyte monitoring system 100 may include more than one sensor 101 and/or more than one data processing unit 102, and/or more than one data processing terminal 105 ([0055]), wherein a second sensor would comprise the second working electrode and all the features a sensing layer ([0077]; rendering obvious “a second active area upon the surface of the second working electrode and responsive to a second analyte … the second active area comprising a second polymer, a second redox mediator different from the first redox mediator (to differentiate the signals) covalently bonded to the second polymer, and at least one enzyme responsive to the second analyte covalently bonded to the second polymer”). Additionally, Feldman teaches a mass transport limiting layer, e.g., an analyte flux modulating layer, may be included with the sensor to act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte into the region around the working electrodes ([0090]; which reads on “a mass transport limiting membrane permeable … that overcoats the first active area”). Feldman further teaches an insertion device can be used to subcutaneously insert the sensor into the patient ([0105]; which reads on “wherein the sensor is configured to be partially inserted into a user’s skin”).
Feldman teaches the analyte may be ketone bodies ([0051]). Feldman does not explicitly mention β-hydroxybutyrate as the first analyte, nor an enzyme system comprising multiple enzymes covalently bonded to the first polymer that are collectively responsive to β-hydroxybutyrate.
However, McColl discloses an analyte measurement system ([0008]), wherein is taught determining the ketone concentration of β-hydroxybutyrate using β-hydroxybutyrate dehydrogenase and a second enzyme such as diaphorase ([0046]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have substitute the β-hydroxybutyrate dehydrogenase/diaphorase enzyme system to monitor β-hydroxybutyrate concentration, as taught by McColl, into the invention described by Feldman as monitoring β-hydroxybutyrate concentrations are important to determining health status in patients.
Feldman does not teach the structure of the first redox mediator in present claim 22.
However, Liu discloses transition metal complexes attached to polymeric
backbones can be used as redox mediators in enzyme based electrochemical sensors (Abstract), wherein one of the taught transition metal complex redox mediators, including the claimed structure (Formula X; [0070]; [0098]-[0099]).
At the time of the filing of the present application, it would have been obvious to one ordinary skill in the art it make the simple substitution of the transition metal complex redox mediator to arrive at the claimed invention with an predictable expectation of success.
As to the instant limitations, "wherein the low potential is above an oxidation-reduction potential of the first redox mediator and below about -80 mV relative to the Ag/AgCI reference electrode; wherein the oxidation-reduction potential of the first redox mediator ranges from about -200 m V to about -400 mV relative to the Ag/AgCI reference electrode", they are inherent chemical characteristics, which would be shared by identical chemical compositions.
Regarding claims 24 and 25, Feldman teaches in certain embodiments, a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole ([0091]).
Regarding claim 26, Liu teaches utilizing the cross-linker polyethylene glycol diglycidyl ether ([0033]), which is a homolog of polyethyleneglycol tetraglycidyl ether, rendering the latter obvious to one of ordinary skill in the art (MPEP 2144.09 II).
Regarding 30, Feldman teaches an analyte may be glucose ([0052]).
Regarding claim 31, Liu teaches the sensor 300 may be connected via a cord (not shown) to a portable, potentiostat-data logger device (not shown), which may be used to maintain working electrode 302 at a potential of +40 m V versus the g/AgCl reference electrode 304, while obtaining and storing instantaneous current values at 10-second intervals ([0179]).
Regarding claims 32 and 33, Feldman teaches in certain embodiments, a mass transport limiting layer is a membrane composed of crosslinked polymers containing heterocyclic nitrogen groups, such as polymers of polyvinylpyridine and polyvinylimidazole ([0091]).
Regarding claim 34, Liu teaches utilizing the cross-linker polyethylene glycol diglycidyl ether ([0033]), which is a homolog of polyethyleneglycol tetraglycidyl ether, rendering the latter obvious to one of ordinary skill in the art (MPEP 2144.09 II).
Regarding 39, Feldman teaches an analyte may be glucose ([0052]).
Regarding claims 40 and 41, all the shared limitations are taught by the combination of the teachings of Feldman, McColl, and Liu, as shown above in the rejection to instant claim 22.
Claims 23 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman, McColl and Liu as applied to claims 22 and 31 above, and further in view of a US Patent Application Publication to Nishizawa, et al. (US 2013/0130230 A1; hereinafter, “Nishizawa”).
Regarding claims 23 and 35, Feldman, McColl and Liu combine to render obvious all the limitations of claims 22 and 31, as outlined above. Additionally, the references teach the second analyte is glucose.
The references do not teach the at least one enzyme responsive to the second analyte comprises an enzyme system comprising multiple enzymes that are collectively responsive to the second analyte.
However, Nishizawa discloses a biosensor ([0006]), wherein is taught the enzyme for detection may be a combination of diaphorase and glucose dehydrogenase ([0055]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have utilized the dual enzyme system for glucose detection taught by Nishizawa in the invention disclosed by Feldman, McColl and Liu as it would be an example of selection of a known material based on its suitability for its intended use (MPEP 2144.07).
Claims 27-29, 36-38, and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman, McColl and Liu as applied to claims 22, 31, and 41 above, and further in view of US Patent Application Publication to Simpson, et al. (US 2007/0213611 A1; hereinafter, “Simpson”).
Regarding claims 27-29, 36-38 and 42-44, Feldman, McColl and Liu combined render obvious the limitations of claims 22, 31, and 41, as outlined above.
These references do not teach the mass transport limiting membrane is bilayer membrane.
However, Simpson disclose an electrode system, wherein is taught a membrane system that includes a plurality of layers ([0316]). The layers are deposited over the electroactive surfaces of the sensor ([0316]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have adapted the plurality-layered membrane system taught by Simpson in to the invention taught by the combined teaching of Feldman, McColl and Liu as the membrane system can provide a plurality of functions including diffusion resistance, limiting interfering species and hydrophilicity at the electrochemically reactive surface of the sensor interface (Simpson, [0326]).
Interview with the Examiner
If at any point during the prosecution it is believe an interview with the Examiner would further the prosecution of an application, please consider this option.
The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
The AIR form can be filled out online, and is automatically forwarded to the Examiner, who will call to confirm a requested time and date, or set up a mutually convenient time for the interview. The form can be found at:
https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795