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 .
Election/Restrictions
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Groups II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 18th, 2026.
Applicant's election with traverse of Group I (Claims 1-10) in the reply filed on May 18th, 2026 is acknowledged. The traversal regarding Groups I and II is on the ground(s) that the apparatus and system claim groups overlap in structure, operation, and/or calibration purpose, and are not mutually exclusive. This is not found persuasive because although Groups I and II have similar limitations, the claim limitations are indeed different. Even if an independent claim of a group recites similar limitations to the dependent claims of another group, the features that are included in the independent claims are still distinct, which can lead to the inventions to be either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j).
Furthermore, the traversal regarding Group III is on the ground(s) that the method claims do not recite a materially different process. This is not found persuasive because although Groups I, II, and III have similar limitations, Groups III and I are related as process and apparatus for its practice and Groups III and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another materially different process such as a method for diabetes monitoring and management.
Applicant may amend the withdrawn claims concurrently during prosecution and would likely be able to rejoin them if any found allowable subject matter is inputted into those claims. The requirement is still deemed proper and is therefore made FINAL.
Claim Objection
Claim 4 is objected to because of the following informality:
Claim 4 recites “is inserted” in line 1, but should read “is configured to be inserted”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites “an analyte sensor” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “analyte sensor” from Claim 3, or a separate element.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1, 3, 5, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al (EP 1739415 A2; cited by Applicant).
Regarding Claim 1, Xu discloses an apparatus configured to calibrate multiple analyte monitoring devices (An electrochemical sensor system and membrane and method thereof for increased accuracy and effective life of electrochemical and enzyme sensors; Abstract; [0038-0066]; Figure 2), the apparatus comprising:
a voltage source (the electrical interface 38 between the sensors in the plastic card 50 and the microprocessor 40 through the analog board 45. The analog board 45 houses analog-to-digital and digital-to-analog converters. The signal from the electrode interface 38 passes through the analog-to-digital converter, converted into digital form for the processor 40 to store and display. Conversely, the digital signals from the processor 40, for example, the polarization voltage for oxygen sensor, go through the digital-to-analog converter, converted into an analog form and fed to the sensors for control, through the electrode interface 38; [0048]);
a plurality of electrodes (electrode interface 38, electrode interface 156) configured to receive an input voltage from the voltage source, each of the plurality of electrodes being connected to a different analyte monitoring device of the multiple analyte monitoring devices ([0048]; Figures 1-2 and 5); and
a single ground electrode configured to complete a circuit for each of the multiple analyte monitoring devices during calibration of the multiple analyte monitoring devices (The ground 105 illustrated in FIG. 2, is a silver wire inserted through the substrate 50. A ground serves as a common electric reference point for all electrodes. The ground may also serve as a counter electrode for the amperometric sensor system; [0078]).
Regarding Claim 3, Xu discloses wherein each of the plurality of electrodes is connected to an analyte sensor of a respective one of the multiple analyte monitoring devices via a contact that conducts the input voltage from the voltage source to an analyte-sensing element of the analyte sensor (Referring to FIG. 1, sensors are available as a bank of electrodes 10 fabricated in a plastic card 50 and housed in the disposable cartridge 37 that interfaces with a thermal block assembly 39 of a suitably adapted blood chemistry analysis machine…The sensors connect to the electrode interface 38 which select one of the plurality of electrical signals generated by the sensors and passes the electrical signal to the microprocessor 40 in the machine through an analog-to-digital converter into the analog board 45 where it is converted from analog to digital form, suitable for storage and display…the microprocessor 40 is suitably programmed to perform measurement, calculation, storage, and control functions such as differences in electrical potential across one or more electrodes; [0048-0049]; Figures 1-2).
Regarding Claim 5, Xu discloses wherein at least one of the plurality of electrodes is connected to an analyte sensor that is used to generate at least one calibration parameter for calibrating one or more different analyte sensors (When the calibrating solutions from, for example, containers 14, 16 and 23 are pumped into the electrode assembly 10, the electrodes forming part of the assembly make measurements of the parameters of the sample and the microprocessor 40 stores there electrical values. Based upon measurements made during the passage of the calibration solutions through the electrode assembly 10, and the known values of the measured parameters contained within the calibrating solution from containers 14,16, and 23, the microprocessor 40 effectively creates a calibration curve for each of the measured parameters so that when a blood sample is passed through the electrode assembly 10 the measurements made by the electrodes can be used to derive accurate measurements of the parameters of interest. These parameters are stored and displayed by the microprocessor 40. The microprocessor 40 is suitably programmed to perform measurement, calculation, storage, and control functions such as differences in electrical potential across one or more electrodes; [0049]).
Regarding Claim 9, Xu discloses wherein the input voltage from the voltage source causes each of the multiple analyte monitoring devices to generate an electrical current when an analyte-sensing element contacts a fluid that contains an analyte, wherein the electrical current indicates a concentration of the analyte within the fluid ([0076]).
Regarding Claim 10, Xu discloses wherein the analyte-sensing element includes an enzyme that generates an electrochemical reaction when contacting the analyte, wherein the electrical current is generated from the electrochemical reaction ([0074-0077]; [0095-0110]; Figure 3A).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 2 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al in view of NPL Lee et al (Lee, J. H., Lim, T. S., Seo, Y., Bishop, P. L., & Papautsky, I. (2007). Needle-type dissolved oxygen microelectrode array sensors for in situ measurements. Sensors and Actuators B: Chemical, 128(1), 179-185.; cited by Applicant).
Regarding Claim 2, Xu fails to specifically teach wherein the single ground electrode is not physically connected to the multiple analyte monitoring devices.
In a similar technical field, NPL Lee teaches needle-type dissolved oxygen microelectrode array sensors for in situ measurements (Abstract), wherein the single ground electrode is not physically connected to the multiple analyte monitoring devices (DO microelectrode sensors were polarized and calibrated with a commercial Ag/AgCl reference electrode (MI-401, Microelectrodes Inc.); 2.3 Characterization; Page 181; Figure 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the configuration teachings of NPL Lee into the invention of Xu in order to prevent ground loops, reduce noise, and maintain measurement accuracy.
Regarding Claim 6, Xu fails to specifically teach a plurality of current meters, wherein each of the plurality of current meters monitors a current of the circuit for a corresponding one of the multiple analyte monitoring devices during calibration of the multiple analyte monitoring devices.
In a similar technical field, NPL Lee teaches needle-type dissolved oxygen microelectrode array sensors for in situ measurements (Abstract), comprising a current meter, wherein the current meter monitors a current of the circuit for a corresponding one of the multiple analyte monitoring devices during calibration of the multiple analyte monitoring devices (Picoammeter was used to measure current; Page 182; An Ag/AgCl reference milli-electrode connected to the ground of a picoammeter (Diamond General Development Corp., Product No.1231) was situated in the biofilm chamber, and the MEA was connected to the current input as a working electrode. By observing through an optical microscope set over the biofilm sample, the position of the electrodes was precisely controlled to perform all measurements at the same point. DO measurements were performed vertically at every 100 m step down into the mineral salt solution and at 50 m intervals in the biofilm using the micromanipulator; 3.3 Application to biofilm evaluation; Page 184).
Furthermore, although NPL Lee only teaches a singular picoammeter, it has been held that "mere duplication of parts has no patentable significance unless a new and unexpected result is produced." MPEP 2144.04 VI. B.; In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). All of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the picoammeter teachings of NPL Lee into the invention of Xu, as a picoammeter is a highly sensitive instrument capable of measuring extremely small electric currents.
Regarding Claim 7, Xu fails to specifically teach wherein the apparatus is configured such that inserting the single ground electrode into a reference bath causes an analyte-sensing element for each of the multiple analyte monitoring devices to be inserted into the reference bath during calibration of the multiple analyte monitoring devices.
In a similar technical field, NPL Lee teaches needle-type dissolved oxygen microelectrode array sensors for in situ measurements (Abstract), wherein the apparatus is configured such that inserting the single ground electrode into a reference bath (Following polarization, a test solution was prepared in both saline and mineral salt solutions; 2.3 Characterization; Page 181) causes an analyte-sensing element for each of the multiple analyte monitoring devices to be inserted into the reference bath during calibration of the multiple analyte monitoring devices (Fig. 4. Schematic diagram of the calibration cell. DO microelectrodes were characterized using the calibration cell with a commercial Ag/AgCl reference electrode. Picoammeter was used to measure current; Page 182).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the solution teachings of NPL Lee into the invention of Xu for the uses of microelectrode characterization and biofilm testing (NPL Lee 2.3 Characterization; Page 181).
Regarding Claim 8, Xu fails to specifically teach wherein the reference bath includes a known concentration of an analyte to be measured by the multiple analyte monitoring devices.
In a similar technical field, NPL Lee teaches needle-type dissolved oxygen microelectrode array sensors for in situ measurements (Abstract), wherein the reference bath includes a known concentration of an analyte to be measured by the multiple analyte monitoring devices (Following polarization, a test solution was prepared in both saline and mineral salt solutions by aeration with pure nitro gen gas (0% O2 saturation, 0mg/L), a gas containing 10% O2 and 90% N2 (10% O2, 4.1mg/L), and air (21% O2, 8.7mg/L); 2.3 Characterization; Page 181).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the solution teachings of NPL Lee into the invention of Xu for the uses of microelectrode characterization and biofilm testing (NPL Lee 2.3 Characterization; Page 181).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Xu et al in view of Wu (U.S. Publication No. 2021/0068725).
Regarding Claim 4, Xu fails to specifically teach wherein the analyte-sensing element is inserted subcutaneously into a user when the respective one of the multiple analyte monitoring devices is worn by the user.
In a similar technical field, Wu teaches methods and apparatus for information gathering, error detection and analyte concentration determination during continuous analyte sensing (Abstract), wherein the analyte-sensing element is inserted subcutaneously into a user when the respective one of the multiple analyte monitoring devices is worn by the user (a continuous analyte monitoring (CAM) device may include a wearable portion having a biosensor configured to be subcutaneously inserted into a subject. The biosensor may include a counter electrode, a reference electrode and a working electrode having a chemical composition configured to oxidize a point-of-interest analyte and to produce analyte (e.g., glucose) signals from interstitial fluid; [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the subcutaneous insertion teachings of Wu into the invention of Xu in order to enable oxidization of a point-of-interest analyte and production of analyte (e.g., glucose) signals from interstitial fluid while the device is worn by the user (Wu [0104]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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