DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 01/12/2026 (“Amendment”). Claims 41-57 are currently under consideration. The Office acknowledges the addition of new claim 57.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim 41-44 and 55 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Patent 6,236,873 (“Holmstrom”) in view of US Patent Application Publication 2011/0089957 (“Sheppard”).
Regarding claim 41, Holmstrom teaches [an electrochemical] monitoring device, comprising: a[n analyte] sensor (Title, Abstract, oxygen in blood) having a plurality of sensor electrodes including a working electrode and a reference electrode (Fig. 5, WE and RE), the [analyte] sensor having at least a portion configured to be in contact with fluid in a body of a user (Abstract, in contact with blood), wherein the plurality of sensor electrodes are configured to generate at least one signal corresponding to a[n analyte] level in the fluid (Abstract, oxygen concentration); and sensor electronics connected to the [analyte] sensor (components connected to the electrodes as shown in Fig. 5), the sensor electronics comprising: a unity gain amplifier (Fig. 5, voltage follower E1 – col. 5, lines 64-66, col. 8, lines 22-25) having an output coupled to the working electrode (via switch S5, as shown in Fig. 5), a first input coupled to the working electrode (Fig. 5), and a second input coupled to a reference electrode (Fig. 5), … .
Holmstrom does not appear to explicitly teach the device being a glucose monitoring device, having a glucose sensor to detect a glucose level in body fluid, or wherein the amplifier is configured to generate a fixed offset voltage as a bias for the [analyte] sensor (although R1 in Fig. 5 may accomplish this purpose).
Sheppard teaches a potentiostat circuit (Title) usable for detecting glucose levels in body fluid (¶¶s 0035, 0036, 0039, etc., detecting glucose via glucose oxidase). Sheppard also teaches that the non-inverting input of its amplifier 406 is provided at a working electrode set point voltage, which is relative to a reference electrode set point. The output of the amplifier 406 may have a DC offset (i.e., a fixed offset) equal to the working electrode set point (bias) voltage (¶ 0045).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the circuit of Holmstrom for measuring glucose as an analyte (instead of oxygen), as in Sheppard, since glucose/diabetes management is important to the health of many people (Sheppard: ¶¶s 0003, 0004). It would have been obvious to generate a fixed offset with the amplifier E1 of Holmstrom, as in Sheppard, as a known means of determining information regarding the sensor current detected by the working electrode (Sheppard: ¶ 0045).
Regarding claim 42, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard further teaches wherein the fixed offset voltage is generated across the reference electrode and the working electrode (Sheppard: ¶ 0045).
Regarding claim 43, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard further teaches a reference generator configured to generate a first voltage for the unity gain amplifier (Holmstrom: Fig. 5, the components leading to the non-inverting input of E1, including e.g. the output of the reference electrode; Sheppard: the circuitry creating the set points).
Regarding claim 44, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard further teaches wherein the plurality of sensor electrodes further comprises a counter electrode (Holmstrom: Fig. 5, CE).
Regarding claim 55, Holmstrom teaches an analyte monitoring device, comprising: an analyte sensor (Title, Abstract, oxygen in blood) having a plurality of sensor electrodes including a working electrode and a reference electrode (Fig. 5, WE and RE), the analyte sensor having at least a portion configured to be in contact with fluid in a body of a user (Abstract, in contact with blood), wherein the plurality of sensor electrodes are configured to generate at least one signal corresponding to an analyte level in the fluid (Abstract, oxygen concentration); and sensor electronics connected to the analyte sensor (components connected to the electrodes as shown in Fig. 5), the sensor electronics comprising: a unity gain amplifier (Fig. 5, voltage follower E1 – col. 5, lines 64-66, col. 8, lines 22-25) having an output coupled to the working electrode (via switch S5, as shown in Fig. 5), a first input coupled to the working electrode (Fig. 5), and a second input coupled to a reference electrode (Fig. 5), … .
Holmstrom does not appear to explicitly teach wherein the amplifier is configured to generate a fixed offset voltage as a bias for the analyte sensor (although R1 in Fig. 5 may accomplish this purpose).
Sheppard teaches a potentiostat circuit (Title) usable for detecting glucose levels in body fluid (¶¶s 0035, 0036, 0039, etc., detecting glucose via glucose oxidase). Sheppard also teaches that the non-inverting input of its amplifier 406 is provided at a working electrode set point voltage, which is relative to a reference electrode set point. The output of the amplifier 406 may have a DC offset (i.e., a fixed offset) equal to the working electrode set point (bias) voltage (¶ 0045).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to generate a fixed offset with the amplifier E1 of Holmstrom, as in Sheppard, as a known means of determining information regarding the sensor current detected by the working electrode (Sheppard: ¶ 0045).
Claims 45 and 46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holmstrom-Sheppard in view of US Patent Application Publication 2009/0120810 (“Phan”).
Regarding claim 45, Holmstrom-Sheppard teaches all the features with respect to claim 44, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach wherein the sensor electronics further comprise a capacitor and a resistor connected between the counter electrode and a reference potential node (Holmstrom: Fig. 5, CE).
Phan teaches arranging a capacitor and resistor between a counter electrode and a reference potential node (Fig. 9B, showing capacitors and resistors of filter 28 arranged along the CE_REF path, which has a counter electrode 18 at one end (Fig. 9A) and a reference potential node at another end (Fig. 9A, non-inverting input of U2, or any of the ground points shown in Fig. 9B along CE_REF, etc.)).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate a filter into the combination as in Fig. 9B of Phan, thereby arranging a capacitor and resistor as claimed, for the purpose of filtering out high-frequency noise (Phan: ¶ 0090). Alternatively, it would have been obvious to incorporate the potentiostat 22 elements shown in Fig. 9A of Phan into the combination, thereby arranging a capacitor and resistor as claimed, for the purpose of implementing a counter electrode in a way that reduces noise and increases circuit stability, and for division of return current (Phan: ¶ 0083).
Regarding claim 46, Holmstrom-Sheppard teaches all the features with respect to claim 44, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach an analog-to-digital converter configured to receive a voltage signal from the counter electrode.
Phan teaches receiving a counter electrode voltage signal at an ADC (Fig. 9D, at ADC 32).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate an ADC into the combination as in Phan, for the purpose of digitizing signals to enable processing with a processor (Phan: ¶¶s 0044, 0112, etc.).
Claim 47 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holmstrom-Sheppard in view of US Patent Application Publication 2007/0102304 (“Tam”) and US Patent Application Publication 2014/0235452 (“Rothberg”).
Regarding claim 47, Holmstrom-Sheppard teaches all the features with respect to claim 44, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach a preamplifier coupled with the counter electrode and configured to buffer a voltage signal from the counter electrode; and an analog-to-digital converter coupled with the preamplifier and configured to receive a buffered voltage signal from the preamplifier.
Tam teaches connecting electrodes, including a counter electrode, to a potentiostat circuit comprising a preamplifier and an analog to digital converter (Fig. 7B, sensors 110 connected to pre-amplification circuitry 140 and then to an analogue-to-digital converter 180 – also see ¶¶s 0027, 0063, 0083, etc., the counter electrode that is provided with each potentiostat circuit and/or each sensor chip).
Rothberg teaches that a preamplifier buffers a signal and can provide a selectable gain of 1, 2, 5, 10, etc. (¶ 0424).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate a preamplifier and analog to digital converter into the combination as in Tam, for the purpose of digitizing signals to enable processing with a processor, and as the implementation of a known potentiostat circuit design to enable electrochemical sensing (Tam: ¶¶s 0008, 0063). Rothberg evidences that a preamplifier buffers a signal, but it also would have been obvious to buffer with selectable gain, as in Rothberg, for the purpose of increasing circuit options (Rothberg: ¶ 0424).
Claims 48-50 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holmstrom-Sheppard-Tam-Rothberg in view of US Patent Application Publication 2002/0016568 (“Lebel”).
Regarding claim 48, Holmstrom-Sheppard-Tam-Rothberg teaches all the features with respect to claim 47, as outlined above. Holmstrom-Sheppard-Tam-Rothberg does not appear to explicitly teach a battery configured to produce a battery voltage, and a charge pump coupled with the battery and configured to produce a charge pump voltage greater than a battery voltage.
Lebel teaches using a charge pump and a battery to power different elements of a medical device (Fig. 3, batteries in both the external subsystem and the implantable unit, ¶¶s 0060, 0249, etc., battery voltage at e.g. 2.3 volts; ¶¶s 0247, 0247, 0293, etc., charge pump at e.g. 16 volts and nominal power at 3 volts).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use a charge pump and a battery for powering the device of the combination, as in Lebel, for the purpose of providing different amounts of power to different components as necessary (Lebel: ¶ 0247, powering a pump as compared to less power hungry components like RAM and processors).
Regarding claims 49 and 50, Holmstrom-Sheppard-Tam-Rothberg-Lebel teaches all the features with respect to claim 48, as outlined above. Holmstrom-Sheppard-Tam-Rothberg-Lebel further teaches wherein the preamplifier and the analog-to-digital converter are both powered by the battery voltage and not the charge-pump voltage, wherein the unity gain amplifier is powered by the charge-pump voltage and not the battery voltage (as above, Lebel teaches that different elements have different voltage requirements. It would have been obvious to use a battery to power most components, and a charge pump to power the unity gain amplifier, as a mere matter of design choice, and for the purpose of providing enough power to more power-hungry components).
Claims 51-53 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holmstrom-Sheppard in view of US Patent Application Publication 2006/0247508 (“Fennell”).
Regarding claims 51 and 52, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach a guard trace amplifier connected to a guard trace, wherein the guard trace is for one electrode of the plurality of sensor electrodes, wherein the guard trace amplifier has an input impedance of 100 Giga Ohms.
Fennell teaches using a guard electrode and guard traces (¶ 0054) to detect a leakage signal (¶ 0055) and protect the working electrode from current leakage (¶ 0032). The configuration enables 10,000 MOhms of leakage resistance (¶ 0045). The guard trace is connected to a guard trace amplifier (Fig. 4A, ¶¶s 0031, 0032, etc.).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate a guard trace amplifier and guard trace into the combination as in Fennell, for the purpose of protecting the working electrode from leakage current (Fennell: ¶¶s 0004, 0032). Further, the input impedance of a guard trace amplifier is a known results-effective variable because it can be changed as desired to guard different amounts of current in different applications. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the guard trace amplifier have an input impedance of 100 Giga Ohms, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 53, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach wherein the fixed offset voltage is a poise voltage associated with the glucose sensor (because the term “poise” is not used).
Fennell teaches a poise voltage of e.g. 40 mV between working and reference voltage sources (¶ 0034).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the fixed offset of Sheppard a poise voltage (including 40 mV as described in Fennell and Applicant’s own disclosure), as the implementation of a known glucose sensor analog front end (Fennell: Abstract, ¶ 0034, etc.), for the purpose of protecting the working electrode from leakage current (Fennell: ¶¶s 0004, 0032).
Claim 54 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holmstrom-Sheppard in view of US Patent Application Publication 2006/0224141 (“Rush”).
Regarding claim 54, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach an on body housing comprising an interior that holds a portion of the glucose sensor and the sensor electronics, and an adhesive layer configured to adhere to a skin surface of the user (although Sheppard does teach using a monitor or device that incorporates an array of biosensors including packaging for housing electronics, etc. (¶ 0026), the monitors/devices interfaced with the skin (¶ 0004)).
Rush teaches adhering a glucose monitoring device to the skin (Fig. 1, transmitter 150 and sensor 160 adhered to the skin via an adhesive layer 180 - ¶¶s 0026 and 0027).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the electronics of the combination into a skin-adherable housing as in Rush, for the purpose of firmly retaining the device on the patient (Rush: ¶ 0026).
Claim 56 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Holmstrom-Sheppard in view of US Patent 4,496,454 (“Berger”).
Regarding claim 56, Holmstrom-Sheppard teaches all the features with respect to claim 41, as outlined above. Holmstrom-Sheppard does not appear to explicitly teach wherein the sensor electronics comprise a signal path from the reference electrode to the working electrode, and wherein the unity gain amplifier is the only amplifier on the signal path.
Berger teaches the configuration of an electrochemical cell as including a signal path between the working and reference electrodes (Figs. 1 and 2). The potentiostat (of e.g. Fig. 1) forms a unit gain buffer amplifier between the electrodes (col. 12, lines 43-56).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to simplify the potentiostat of the combination, as in Berger, by e.g. not using the extra amplifier E2, as the simple substitution of one potentiostat configuration for another with predictable results (typical potentiostat function), and for the purpose of needing to optimize fewer components (Berger: col. 12, lines 43-56).
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 41-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,980,669 (“the reference patent”) in view of Holmstrom, Sheppard, Phan, Tam, Rothberg, Lebel, Fennell, Rush, and/or Berger. Claims 1-16 of the reference patent teach all features of claims 41-57 (e.g. respective amplifiers and guard traces for the reference and counter electrodes) except for those made up by Holmstrom, Sheppard, Phan, Tam, Rothberg, Lebel, Fennell, Rush, and/or Berger as outlined above.
Allowable Subject Matter
Claim 57 is allowable over the prior art, but is objected to as being dependent upon a rejected base claim. Therefore, it will be allowed if related double patenting rejections are overcome, and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to teach or fairly suggest the glucose monitoring device having guard traces and guard trace amplifiers for the reference and counter electrodes, but not the working electrode, in combination with all other recited limitations.
Response to Arguments
Applicant’s arguments filed 01/12/2026 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 103, they are not persuasive. Because Applicant has repeated a large part of the arguments presented in their 06/23/2025 Remarks, the Office’s response on 10/16/2025 is also repeated below.
First, it should be noted that a unity gain amplifier generates a fixed offset voltage due to inherent input offset voltage. Thus, Holmstrom itself meets the claim limitations. But to make things more clear, Sheppard was used to more explicitly teach generation of an offset voltage. It is maintained that using a set point voltage as in Sheppard would not change the principle of operation of Holmstrom, and would not make it unsatisfactory for its intended purpose. The offset/bias would affect the circuit and the electrode’s output as a whole, and thus would not affect relative observations within the circuit. E.sub.0 could still be reapplied. I.e., using it as a correction is compatible with using an offset voltage for a particular component. Even if E.sub.0 were different because the circuit conditions were different, that different value could still be stored and then reapplied. But, it appears that E.sub.0 does not change even with a bias (because it does not have to directly affect the capacitor). Further, the claims do not require any particular order for the bias to be generated. I.e., there is no requirement for the value to be stored, and then the bias to be applied, and then E.sub.0 to be reapplied.
The arguments around E.sub.0 also do not imply a change in principal of operation, or that the combination would make Holmstrom unsatisfactory for its intended purpose.
In any case, the rejection does not even mention E.sub.0, and Applicant is arguing something that is not mentioned or implied by the claims. All that is claimed is generation of a fixed offset voltage, and Applicant has not addressed that even the amplifier of Holmstrom inherently generates this.
The Office disagrees that Berger does not teach that for which it is cited. See Figs. 1 and 2, as well as col. 12, lines 43-56 (which refer to Fig. 7).
All claims remain rejected in light of the prior art.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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