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 .
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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) 1-4, 6, 8-10, 13, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamath et al. (US Publication No. 2017/0340253 A1).
Regarding claim 1, Kamath et al. discloses an analyte sensor system, comprising:
a first electrode (16) configured to generate a first analyte signal stream (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”);
a second electrode (18) configured to generate a non-enzyme signal stream indicating a level of a non-enzyme over time (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”; see also [0131] and [0138]-[0139]);
a sensor electronics module (see Figure 6) configured to:
determine a level of a first analyte based on the first analyte signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”); and
adjust the level of the first analyte based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode” and [0139] – “For example, if an interferant such as acetaminophen is ingested by a host implanted with a conventional implantable electrochemical glucose sensor (namely, one without means for eliminating acetaminophen), a transient non-glucose related increase in signal output would occur. However, by utilizing the electrode system of the preferred embodiments, both working electrodes respond with substantially equivalent increased current generation due to oxidation of the acetaminophen, which would be eliminated by subtraction of the auxiliary electrode signal from the glucose-measuring electrode signal”).
Regarding claim 2, Kamath et al. discloses the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to subtract, from the level of the first analyte, a value based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”).
Regarding claim 3, Kamath et al. discloses the first electrode and the second electrode are separate from each other (see Figure 1A).
Regarding claim 4, Kamath et al. discloses the first electrode comprises a first electrode at least partially covered by a membrane and the second electrode comprises a second electrode at least partially covered by the membrane (see [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments”).
Regarding claim 6, Kamath et al. discloses a third electrode (20) configured to generate a second analyte signal stream, wherein adjusting the level of the first analyte is further based on the second analyte signal stream (see [0118] – “The transport-measuring electrode can be configured to measure any of a number of substantially constant analytes or factors, such that a change measured by the transport-measuring electrode can be used to indicate a change in solute (for example, glucose) transport to the membrane system 22. Some examples of substantially constant analytes or factors that can be measured include, but are not limited to, oxygen, carboxylic acids (such as urea), amino acids, hydrogen, pH, chloride, baseline, or the like. Thus, the transport-measuring electrode provides an independent measure of changes in solute transport to the membrane, and thus sensitivity changes over time”).
Regarding claim 8, Kamath et al. discloses an analyte sensor system, comprising:
a first electrode (16) covered by a membrane, the first electrode configured to generate a first analyte signal stream (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor” and [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments”);
a second electrode (18) configured to generate a non-enzyme signal stream indicating a level of non-enzymes over time (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”; see also [0131] and [0138]-[0139]);
a sensor electronics module (see Figure 6), configured to:
determine a level of a first analyte based on the first analyte signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”); and
adjust the level of the first analyte based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode” and [0139] – “For example, if an interferant such as acetaminophen is ingested by a host implanted with a conventional implantable electrochemical glucose sensor (namely, one without means for eliminating acetaminophen), a transient non-glucose related increase in signal output would occur. However, by utilizing the electrode system of the preferred embodiments, both working electrodes respond with substantially equivalent increased current generation due to oxidation of the acetaminophen, which would be eliminated by subtraction of the auxiliary electrode signal from the glucose-measuring electrode signal”).
Regarding claim 9, Kamath et al. discloses the second electrode is covered by a second membrane (see [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments”).
Regarding claim 10, Kamath et al. discloses the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to subtract, from the level of the first analyte, a value based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”).
Regarding claim 13, Kamath et al. discloses a third electrode (20) covered by a second membrane configured to generate a second analyte signal stream indicating a level of a second analyte over time, wherein adjusting the level of the first analyte is further based on the second analyte signal stream (see [0096] – “In the illustrated embodiments of FIGS. 3A and 3B, the membrane system 22 is positioned at least over the glucose-measuring working electrode 16 and the optional auxiliary working electrode 18, however the membrane system may be positioned over the reference and/or counter electrodes 20,22 in some embodiments” and [0118] – “The transport-measuring electrode can be configured to measure any of a number of substantially constant analytes or factors, such that a change measured by the transport-measuring electrode can be used to indicate a change in solute (for example, glucose) transport to the membrane system 22. Some examples of substantially constant analytes or factors that can be measured include, but are not limited to, oxygen, carboxylic acids (such as urea), amino acids, hydrogen, pH, chloride, baseline, or the like. Thus, the transport-measuring electrode provides an independent measure of changes in solute transport to the membrane, and thus sensitivity changes over time”).
Regarding claim 15, Kamath et al. discloses a method comprising:
generating a first analyte signal stream using a first electrode (16) (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”);
generating a non-enzyme signal stream using a second electrode, wherein the non-enzyme signal stream indicates a level of non-enzymes over time (18) (see [0070] – “In some embodiments, the sensing region 14 includes a glucose-measuring working electrode 16, an optional auxiliary working electrode 18, a reference electrode 20, and a counter electrode 22. Generally, the sensing region 14 includes means to measure two different signals, 1) a first signal associated with glucose and non-glucose related electroactive compounds having a first oxidation potential, wherein the first signal is measured at the glucose-measuring working electrode disposed beneath an active enzymatic portion of a membrane system, and 2) a second signal associated with the baseline and/or sensitivity of the glucose sensor”; see also [0131] and [0138]-[0139]);
determining, using a sensor electronics module (see Figure 6), a level of a first analyte based on the first analyte signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”); and
adjusting, using the sensor electronics module, the level of the first analyte based on the non-enzyme signal stream (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode” and [0139] – “For example, if an interferant such as acetaminophen is ingested by a host implanted with a conventional implantable electrochemical glucose sensor (namely, one without means for eliminating acetaminophen), a transient non-glucose related increase in signal output would occur. However, by utilizing the electrode system of the preferred embodiments, both working electrodes respond with substantially equivalent increased current generation due to oxidation of the acetaminophen, which would be eliminated by subtraction of the auxiliary electrode signal from the glucose-measuring electrode signal”).
Regarding claim 16, Kamath et al. discloses adjusting the level of the first analyte comprises subtracting a value based on the non-enzyme signal stream from the level of the first analyte (see [0131] – “The auxiliary working electrode 18 provides a signal substantially comprising the baseline signal, b, which can be (for example, electronically or digitally) subtracted from the glucose signal obtained from the glucose-measuring working electrode to obtain the signal contribution due to glucose only according to the following equation: Signalglucose only=Signalglucose-measuring working electrode−Signalbaseline-measuring working electrode”).
Regarding claim 17, Kamath et al. discloses generating a second analyte signal stream using a third electrode (20), wherein the second analyte signal stream indicates a level of a second analyte over time, and wherein adjusting the level of the first analyte comprises subtracting a value based on the non-enzyme signal stream and a value based on the second analyte signal stream from the level of the first analyte (see [0118] – “The transport-measuring electrode can be configured to measure any of a number of substantially constant analytes or factors, such that a change measured by the transport-measuring electrode can be used to indicate a change in solute (for example, glucose) transport to the membrane system 22. Some examples of substantially constant analytes or factors that can be measured include, but are not limited to, oxygen, carboxylic acids (such as urea), amino acids, hydrogen, pH, chloride, baseline, or the like. Thus, the transport-measuring electrode provides an independent measure of changes in solute transport to the membrane, and thus sensitivity changes over time”).
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.
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.
Claim(s) 5, 11, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al., further in view of Bhavaraju et al. (US Publication No. 2019/0339222 A1).
Regarding claims 5 and 11, it is noted Kamath et al. does not specifically teach the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to adjust parameters of a model using the non-enzyme signal stream. However, Bhavaraju et al. teaches the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to adjust parameters of a model using the non-enzyme signal stream (see [0018] – “This direct-to-calibration solution type of system calibration can be performed over a broad range of analyte values, interferent materials, and other factors that affect sensor performance (e.g., low oxygen). This correlation of digital values to analyte concentration in a solution over a range can be used to build an accurate compensation model for in-vivo sensor performance”; see also [0277]). 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 system of Kamath et al., to include the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to adjust parameters of a model using the non-enzyme signal stream, as disclosed in Bhavaraju et al., so as to achieve a factory calibrated or automatically self-calibrating analyte sensor that does not require use of reference measurements for calibration (see Bhavaraju et al.: [0277]).
Regarding claim 18, it is noted Kamath et al. does not specifically teach adjusting the level of the first analyte comprises adjusting parameters of a sensor break-in model using the non-enzyme signal stream. However, Bhavaraju et al. teaches adjusting the level of the first analyte comprises adjusting parameters of a sensor break-in model using the non-enzyme signal stream (see [0037] – “Typical break-in curves can be obtained for sensors from this data as well as changes to the curves arising from changes induced by sterilization, temperature, humidity and/or storage time. These break-in curves may be used to compensate the sensor calibration model for deviations from the factory calibration”; see also [0306]). 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 method of Kamath et al., to include adjusting the level of the first analyte comprises adjusting parameters of a sensor break-in model using the non-enzyme signal stream, as disclosed in Bhavaraju et al., so as to compensate the sensor calibration model for deviations from the factory calibration (see Bhavaraju et al.: [0037]).
Claim(s) 7, 14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al., further in view of Gottlieb et al. (US Publication No. 2011/0319734 A1).
Regarding claims 7, 14, and 20, it is noted Kamath et al. does not specifically teach the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to determine a weighted sum of the first analyte signal stream, the non-enzyme signal stream, and the second analyte signal stream. However, Gottlieb et al. teaches the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to determine a weighted sum of the first analyte signal stream, the non-enzyme signal stream, and the second analyte signal stream (see [0051] – “Similarly, in some embodiments of the invention, at least one electrode array is constructed from materials designed to predominantly sense signals resulting from the presence of glucose; and at least one electrode array is constructed from materials designed to predominantly sense signals resulting from background noise and/or signals resulting from interfering compounds. Similarly, in some embodiments of the invention, multiple analytes are sensed. In some embodiments at least one electrode array is constructed from materials designed to predominantly sense signals resulting from the presence of a first analyte, for example glucose; and at least one electrode array is constructed from materials designed to predominantly sense signals resulting from a second analyte, for example lactate” and [0054] – “In certain embodiments the methods comprise assigning a weighted value to signal data obtained from each of the first, second, third and fourth electrode arrays; and using the weighted signal values to compute an analyte concentration by fusing the various weighted signal values”). 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 system and method of Kamath et al., to include the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to determine a weighted sum of the first analyte signal stream, the non-enzyme signal stream, and the second analyte signal stream, as disclosed in Gottlieb et al., so as to examine sensor interference and sensor drift as well as sensor initialization and/or start-up in vivo (e.g. the run-in time that it takes for a sensor to settle into its aqueous environment and start transmitting meaningful information after being implanted in vivo) (see Gottlieb et al.: [0105]).
Claim(s) 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath et al., further in view of Petisce (US Publication No. 2013/0197333 A1).
Regarding claims 12 and 19, it is noted Kamath et al. does not specifically teach the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to apply a correction factor based on the non-enzyme signal stream to the level of the first analyte. However, Petisce teaches the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to apply a correction factor based on the non-enzyme signal stream to the level of the first analyte (see [0004] – “Disclosed and described herein are analyte sensors and sensor assemblies comprising either at least one pH sensor or a hematocrit sensor positioned in proximity to electrodes and methods for providing a correction factor for adjusting a glucose concentration value based on a measured pH value and/or a measured hematocrit level”; see also [0089] and [0091]). 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 system and method of Kamath et al., to include the sensor electronics module being configured to adjust the level of the first analyte comprises the sensor electronics module being configured to apply a correction factor based on the non-enzyme signal stream to the level of the first analyte, as disclosed in Petisce, so as to compensate for the effect that pH and hematocrit have on the measurement of analyte when converting the raw signal to an analyte concentration value (see Petisce: [0089] and [0091]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hall et al. (US 2020/0196921 A1) describes a biosensor including multiple electrodes for performing electrochemical measurements that include a first measurement of the analyte concentration in the body fluid, a second measurement of a background interference present in the body fluid, and a third measurement of a pH level within the body fluid.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791