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 .
Status of Claims
Applicant's arguments, filed 05/28/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 05/28/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 60, 62, and 63.
Applicants have left claims 61 and 64 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 1-59.
Claims 60-64 are the current claims hereby under examination.
Claim Objections - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
Claim 63 is objected to because of the following informalities:
Regarding claim 63, lines 9-10 recite “the integrated sensing and data acquisition unit by a wire, which powers the integrated sensing and data acquisition unit”, however it appears it should read -- the integrated sensing and data acquisition circuit by a wire, which powers the integrated sensing and data acquisition circuit-- (emphasis added) to maintain consistent claim language.
Response to Arguments
Applicant’s arguments, see page 4 of Remarks, filed 05/28/2026, with respect to claim 63 have been fully considered and are persuasive. Applicants have amended the claim, rendering the objection moot. The objection of claim 63 has been withdrawn. However, there are new claim objections.
Claim Interpretation - 35 USC § 112(f) - Withdrawn
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Response to Arguments
Applicant’s arguments, see pages 4-5 of Remarks, filed 05/28/2026, with respect to the 112(f) interpretation of “a communication and power unit” and “an integrated communication and power unit” have been fully considered and are persuasive. Applicants have amended claims 60 and 63 to recite sufficient structure to perform the claimed function, rendering the 112(f) interpretation moot. The 112(f) interpretation of “a communication and power unit” and “an integrated communication and power unit” has been withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed 05/28/2026, with respect to claims 60-62 have been fully considered and are persuasive. Applicants have amended the claims, rendering the 112(b) rejections moot. The 112(b) rejections of claims 60-62 has been withdrawn.
Claim Rejections - 35 USC § 102 - Modified Necessitated by Applicant’s Amendments
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 60-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nazari et al. (US 20200178801 A1) (previously cited), hereinafter referred to as Nazari.
The claims are generally directed towards a monolithically integrated sensor chip configured for insertion into a patient comprising: at least two working electrodes for sensing two or more analytes and generating signals representative of analyte concentration, each working electrode paired with a different respective dedicated potentiostat of a plurality of potentiostats, each dedicated potentiostat of the plurality of potentiostats being configured to maintain a paired working electrode at a respective independent working potential, and a communication and power circuit, the communication and power circuit comprising a receiver subsystem, a transmitter subsystem, a rectifier and a voltage regulator, the communication and power circuit being connected to the plurality of potentiostats, which powers the plurality of potentiostats and transmits data representative of said analyte concentrations over a wired connection.
Regarding claim 60, Nazari discloses a monolithically integrated sensor chip configured for insertion into a patient (Abstract, Fig. 1, Fig. 2, Fig. 4A, para. [0008], para. [0011], para. [0014]) comprising:
at least two working electrodes for sensing two or more analytes and generating signals representative of analyte concentration (Fig. 2, element 160, para. [0034], “an integrated sensing element … consist of 3 electrodes … a working electrode …”, para. [0056], “integrated sensing element in response detects the analyte of interest based upon its surface chemistry …”, para. [0057], “sensor can include … one or more sensing elements”, para. [0059], “one or more sensors that can detect and measure the presence of one or more analyte of interest in tissue fluid …”, para. [0079], “one or more sensors … quantities and qualities of various parameters of interest can be determined as a function of these one or more data signals …”, para. [0112], “several working electrodes for sensing different analytes”, para. [0135], “sensing element can be functionalized to be sensitive and specific … enzyme that reacts with glucose … another working electrode without an enzyme coating can be used for background (e.g. oxygen) measurements …”), each working electrode paired with a different respective dedicated potentiostat of a plurality of potentiostats, each dedicated potentiostat of the plurality of potentiostats being configured to maintain a paired working electrode at a respective independent working potential (para. [0056], “sends DC power to the potentiostat which powers up the integrated sensing element …”, para. [0075], “potentiostat can be connected to the sensing element and control the sensing element electrode voltages …”, para. [0114], “in order to support multi-analyte sensing … each individual sensing element can be controlled by a dedicated potentiostat …”), and
a communication and power circuit, the communication and power circuit comprising a receiver subsystem, a transmitter subsystem, a rectifier and a voltage regulator, the communication and power circuit being connected to the plurality of potentiostats, which powers the plurality of potentiostats and transmits data representative of said analyte concentrations over a wired connection (Fig. 2, Fig. 4A, element 120, element 130, element 140, element 150, para. [0023], “schematic of the sensor … power management unit, a signal acquisition and processing unit, a signal receiver unit, a signal transmitter unit …”, para. [0056], “integrated sensing element … generates a current reading proportional to the concentration of analyte …”, para. [0060], “integrated system …”, para. [0065-0074], “rectifier … high voltage low dropout regulator …”, para. [0078], “output by the power management unit into the various circuits of the other functional modules …”, para. [0098], “supply provides power to the analog circuitry that includes potentiostats …” - the sensor 1 is an integrated system comprising of at least the receiver subsystem, the transmitter subsystem, the rectifier and the voltage regulator, and the integrated system comprising a power management unit that powers the potentiostats and detects the resulting signal of the analyte concentration. The integrated electronics platform 101 is all connected via wired connections).
Regarding claim 61, Nazari discloses the monolithically integrated sensor chip of claim 60, wherein the independent working potentials are different working potentials (para. [0080], “controls the operation of the integrated sensing element at a given potential different”, para. [0112], “independently controlling the potential different … in a multi-analyte sensor where there are several working electrodes for sensing different analytes”, para. [0131], “detection at different potentials”).
Regarding claim 62, Nazari discloses the monolithically integrated sensor chip of claim 60, wherein at least one dedicated potentiostat of the plurality of potentiostats is connected within half a millimeter to the entirety of at least one paired working electrode (para. [0059], para. [0118] - the dimensions of the sensor and the interconnected functional modules being as small as 30 microns x 50 microns x 200 microns allows for the at least one working electrode to be connected to the dedicated potentiostat within half a millimeter).
Response to Arguments
Applicant's arguments filed 05/28/2026 have been fully considered but they are not persuasive.
Applicants have argued on page 5 of Remarks, filed 05/28/2026, that “Amended claim 60 requires … each dedicated potentiostat concurrently maintain its paired working electrode at a respective independent working potential. Nazari does not disclose this arrangement”.
The Examiner respectfully disagrees. Applicants arguments are not commensurate in scope with the claimed invention. Amended claim 60 does not require the dedicated potentiostat to concurrently maintain the paired working electrode at a respective independent working potential.
Applicants have argued on page 5 of Remarks, filed 05/28/2026, that “Nazari is directed to a wireless platform … Nazari’s disclosed power management and communication structure is organized around that wireless link”.
The Examiner respectfully disagrees. Applicants arguments are not commensurate in scope with the claimed invention. The claims currently do not recite a power source or that a power source is integrated into the monolithically integrated sensor chip, and the claims currently do not limit what “transmits data” includes. Instead, as recited above, Nazari discloses a receiver subsystem, a transmitter subsystem, a rectifier and a voltage regulator are all integrated into a monolithically integrated sensor chip, and the claimed elements power the potentiostats and transmit data over a wired connection within the monolithically integrated sensor chip.
Claim Rejections - 35 USC § 103 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Nazari et al. (US 20200178801 A1) (previously cited), hereinafter referred to as Nazari, in view of Peter Seitz (US 20200182825 A1), hereinafter referred to as Seitz.
Regarding claim 63, Nazari discloses a monolithically integrated sensor chip configured for insertion into a patient (Abstract, Fig. 1, Fig. 2, Fig. 4A, para. [0008], para. [0011], para. [0014]) comprising:
an integrated sensing and data acquisition unit for sensing two or more analytes and generating signals representative of analyte concentration, said integrated sensing and data acquisition unit having at least two working electrodes (Fig. 2, element 160, para. [0034], “an integrated sensing element … consist of 3 electrodes … a working electrode …”, para. [0056], “integrated sensing element in response detects the analyte of interest based upon its surface chemistry …”, para. [0057], “sensor can include … one or more sensing elements”, para. [0059], “one or more sensors that can detect and measure the presence of one or more analyte of interest in tissue fluid …”, para. [0079], “one or more sensors … quantities and qualities of various parameters of interest can be determined as a function of these one or more data signals …”, para. [0112], “several working electrodes for sensing different analytes”, para. [0135], “sensing element can be functionalized to be sensitive and specific … enzyme that reacts with glucose … another working electrode without an enzyme coating can be used for background (e.g. oxygen) measurements …”), a first working electrode configured to work via a potentiostat (para. [0056], para. [0075], para. [0110], “electrochemical sensing elements using amperometric measurement at a given potential, a potentiostat can be designed and implemented to perform the function …”); and
an integrated communication and power circuit, the integrated communication and power circuit comprising a receiver subsystem, a transmitter subsystem, a rectifier and a voltage regulator, the integrated communication and power circuit being connected to the integrated sensing and data acquisition unit by a wire, which powers the integrated sensing and data acquisition unit and transmits data representative of said analyte concentrations over the wire (Fig. 2, Fig. 4A, element 120, element 130, element 140, element 150, para. [0023], “schematic of the sensor … power management unit, a signal acquisition and processing unit, a signal receiver unit, a signal transmitter unit …”, para. [0056], “integrated sensing element … generates a current reading proportional to the concentration of analyte …”, para. [0060], “integrated system …”, para. [0065-0074], “rectifier … high voltage low dropout regulator …”, para. [0078], “output by the power management unit into the various circuits of the other functional modules …”, para. [0098], “supply provides power to the analog circuitry that includes potentiostats …” - the sensor 1 is an integrated system comprising of at least the receiver subsystem, the transmitter subsystem, the rectifier and the voltage regulator, and the integrated system comprising a power management unit that powers the potentiostats and detects the resulting signal of the analyte concentration. The integrated electronics platform 101 is all connected via wired connections).
However, Nazari does not explicitly disclose a second working electrode configured to work via voltammetry concurrently with the first working electrode.
Seitz teaches an analogous monolithically integrated sensor chip configured for insertion into a patient comprising an integrated sensing and data acquisition unit for sensing two or more analytes (Abstract, para. [0033], para. [0036], para. [0087]). Seitz teaches the integrated sensing and data acquisition unit comprises a first working electrode configured to work via a potentiostat (para. [0077]). Seitz further teaches the integrated sensing and data acquisition unit comprises a second working electrode configured to work via voltametric concurrently with the first working electrode (para. [0003-0004], para. [0033], para. [0077], para. [0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the integrated sensing and data acquisition unit to additionally include a second working electrode configured to work via voltammetry concurrently with the first working electrode, as taught by Seitz. This is because Seitz teaches concurrent data collection utilizing both voltammetry and a potentiostat allow for multiple fluid properties to be obtained at the same time (para. [0003-0005], para. [0053]), allowing for the two concentrations to be compared.
Regarding claim 64, modified Nazari discloses the monolithically integrated sensor chip of claim 63, wherein the potentiostat is connected within half a millimeter to the entirety of the first working electrode (para. [0059], para. [0118] - the dimensions of the sensor and the interconnected functional modules being as small as 30 microns x 50 microns x 200 microns allows for the at least one working electrode to be connected to a respective potentiostat within half a millimeter).
Response to Arguments
Applicant’s arguments, see pages 5-7 of Remarks, filed 05/28/2026, with respect to the rejection(s) of claim(s) 63-64 under 35 USC 103 have been fully considered and are persuasive. Applicants have amended claim 63 to recite “a second working electrode configured to work via voltammetry concurrently with the first working electrode”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Peter Seitz (US 20200182825 A1), hereinafter referred to as Seitz.
Further, see the Response to Arguments section above in regards to “by a wire” in view Nazari.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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