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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 16116346 and 18460271, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The independent claims of the instant application recite limitations related to the use of both an analyte sensor and an EGM to determine a relationship between the two for analyte concentration determination. This is not present in the parent Applications, and therefore the priority date for all claims is set at 04/03/2024.
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.
Claim(s) 1, 2, 5, 6, 7, 8, 11, 12, 15, 16, 17, 18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Obrien et al. (US 2022/0248965 A1), hereinafter Obrien.
Regarding Claim 1 and 11, Obrien teaches: A system and method comprising:
an electrochemical sensor comprising one or more work electrodes configured to produce one or more signals indicative of a concentration of one or more analytes in a patient (paragraph 0030);
an implantable medical device (IMD) configured to sense a cardiac electrogram (EGM) of the patient ()paragraph 0016; 0021); and
processing circuitry in communication with the electrochemical sensor and the IMD (abstract), wherein the processing circuitry is configured to:
determine one or more patient-specific relationships between the one or more signals indicative of the concentration of the one or more analytes over a first period of time and the cardiac EGM for the patient collected over the first period of time (figure 2); and
based on the patient-specific relationships, determine an estimated concentration of the one or more analytes based on the EGM for the patient collected over a second period of time (figure 2; abstract).
Regarding Claim 2 and 12, Obrien teaches: The system of claim 1 and method of claim 11, further comprising a biocompatible medical device comprising the electrochemical sensor and configured for insertion through skin and into interstitial fluid of the patient (paragraph 0055-0057; 0060-0061).
Regarding Claim 5 and 15, Obrien teaches: The system of claim 1 and method of claim 11, wherein the cardiac EGM comprises an electrocardiogram (ECG) (paragraph 0006), and wherein the processing circuitry is configured to determine the one or more patient-specific relationships between the one or more signals and characteristics of the ECG (paragraph 0021).
Regarding Claim 6 and 16, Obrien teaches: The system of claim 5 and method of claim 15, wherein the characteristics comprise one or more of: an RT interval, a QT interval, T-wave amplitude, T-wave inversion, U-wave visibility, ST segment depression, R-wave amplitude, or QRS width (paragraph 0021).
Regarding Claim 7 and 17, Obrien teaches: The system of claim 1 and method of claim 11, wherein to determine the one or more patient-specific relationships between the one or more signals and the cardiac EGM, the processing circuitry is configured to:
train a machine learning model to determine the estimated concentration of the one or more analytes as output based on an input cardiac EGM segment using a set of training data that includes the one or more signals indicative of the concentration of the one or more analytes and the cardiac EGM, wherein each segment of the one or more signals includes a label indicating a corresponding segment of the cardiac EGM (figure 2; paragraph 0020-0021; 0031).
Regarding Claim 8 and 18, Obrien teaches: The system of claim 1 and method of claim 11, wherein each work electrode of the one or more work electrodes comprises a respective membrane disposed on a respective reagent substrate, and wherein the respective membrane is selectively permeable to the respective analyte (paragraph 0055; 0058).
Regarding Claim 20, Obrien teaches: A non-transitory computer-readable storage medium (paragraph 0025), comprising instructions that, when executed by processing circuitry, cause the processing circuitry to:
determine one or more patient-specific relationships between the one or more signals indicative of the concentration of the one or more analytes over a first period of time and the cardiac EGM for a patient collected over the first period of time; and
based on the patient-specific relationships, determine an estimated concentration of the one or more analytes based on the EGM for the patient collected over a second period of time (figure 8 and figure 2).
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.
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.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Obrien in view of Hahn et al. (US 2020/0069226 A1), hereinafter Hahn.
Regarding Claim 3 and 13, Obrien teaches: The system of claim 1 and method of claim 11, but does not explicitly mention
wherein the electrochemical sensor comprises:
a common counter electrode;
a common reference electrode; and
a work electrode platform comprising the one or more work electrodes, wherein the one or more work electrodes comprise:
a first work electrode comprising a first reagent substrate configured to react with potassium to produce a signal indicative of a concentration of potassium; and
a second work electrode comprising a second reagent substrate configured to react with glucose to produce a signal indicative of a concentration of glucose,
wherein the first work electrode and the second work electrode are electrically coupled to the common counter electrode and common reference electrode, and wherein the processing circuitry is further configured to:
receive from the electrochemical sensor a signal from each of the first work electrode and the second work electrode;
identify one or more of a signal corresponding to the first work electrode and a signal corresponding to the second work electrode; and
determine, based on the identified signal, one or more of the concentration of potassium and the concentration of glucose associated with the first work electrode or the second work electrode, respectively.
Hahn teaches wherein the electrochemical sensor comprises:
a common counter electrode;
a common reference electrode; and
a work electrode platform comprising the one or more work electrodes, wherein the one or more work electrodes comprise:
a first work electrode comprising a first reagent substrate configured to react with potassium to produce a signal indicative of a concentration of potassium; and
a second work electrode comprising a second reagent substrate configured to react with glucose to produce a signal indicative of a concentration of glucose,
wherein the first work electrode and the second work electrode are electrically coupled to the common counter electrode and common reference electrode, and wherein the processing circuitry is further configured to:
receive from the electrochemical sensor a signal from each of the first work electrode and the second work electrode;
identify one or more of a signal corresponding to the first work electrode and a signal corresponding to the second work electrode; and
determine, based on the identified signal, one or more of the concentration of potassium and the concentration of glucose associated with the first work electrode or the second work electrode, respectively (abstract; paragraph 0029; 0044-0049; paragraph 0132-0135; claim 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention to include wherein the electrochemical sensor comprises:
a common counter electrode;
a common reference electrode; and
a work electrode platform comprising the one or more work electrodes, wherein the one or more work electrodes comprise:
a first work electrode comprising a first reagent substrate configured to react with potassium to produce a signal indicative of a concentration of potassium; and
a second work electrode comprising a second reagent substrate configured to react with glucose to produce a signal indicative of a concentration of glucose,
wherein the first work electrode and the second work electrode are electrically coupled to the common counter electrode and common reference electrode, and wherein the processing circuitry is further configured to:
receive from the electrochemical sensor a signal from each of the first work electrode and the second work electrode;
identify one or more of a signal corresponding to the first work electrode and a signal corresponding to the second work electrode; and
determine, based on the identified signal, one or more of the concentration of potassium and the concentration of glucose associated with the first work electrode or the second work electrode, respectively as the substitution of one analyte sensor for another would have yielded predictable results to one of ordinary skill.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Obrien.
Regarding Claim 9, Obrien teaches: The system of claim 1, but does not mention wherein the first period of time comprises a week. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the invention wherein the first period of time comprises a week it would have been the result of routine optimization in view of MPEP section 2144.05 where it is noted that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: with respect to claims 4, 10, 14 and 19 Examiner notes that no prior art of record teaches a sensor that can determine when a replicable part has been replaced and further determining if the replaceable part needs calibration and then recalibrating the sensor. Further, none of the prior art considered teaches determining HRV based on the patient specific relation and the signals from the electrochemical sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Friedman et al. - US 20180350468 A1 (estimating glucose/analyte levels from ECG using machine learning).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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