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 .
Notice of Amendment
In response to the amendment filed on 9/11/2025, amended claims 5 and 9 are acknowledged. Claims 1-20 remain pending.
Information Disclosure Statement
The IDS filed 4/20/2024 has been considered but the reference number listed for the Stahmann U.S. Patent Application Publication is incorrect and therefore has been lined through. The correct Publication Number appears to be 20070088220 A1.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Specifically, claim 1 recites an abstract idea of “determine an implantable pressure sensor parameter in real time based on the characteristics of interest related to a patient; provide a drift threshold related to the implantable pressure sensor parameter; determine whether the drift threshold has been exceeded based on the implantable pressure sensor parameter”. Similarly, claim 10 recites an abstract idea of “determining, with a controller, an implantable pressure sensor parameter in real time based on the characteristics of interest related to the patient; obtaining a drift threshold related to the implantable pressure sensor parameter; determining, with the controller, whether the drift threshold has been exceeded based on the implantable pressure sensor parameter; and recalibrating, with the controller, the implantable pressure sensor”. Lastly, claim 16 recites an abstract idea of “determine an implantable pressure sensor parameter in real time based on the characteristics of interest related to the patient; provide a drift threshold related to the implantable pressure sensor parameter; determine whether the drift threshold has been exceeded based on the implantable pressure sensor parameter; and calibrate the implantable pressure sensor based on the alert”. Under the broadest reasonable interpretation, there is nothing in the claims that foreclose them from being performed by a human, mentally or with pen and paper. The “determin(ing) an implantable pressure sensor parameter”, “provide”/”obtaining”, “determin(ing) whether the drift threshold has been exceeded”, and “recalibrating”/”calibrate” steps all represent steps that amount to an observation, evaluation, or judgement that is a mental process performed on a generic computer based on the data received from the implantable pressure sensor (step 2A: Prong One).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The claimed “one or more processors”, “memory”, “controller”, and “computer program product” are merely generic computer components performing generic computer functions which are well-understood, routine, and conventional in the art; as such, they do not meaningfully limit the claim to be more than just the abstract idea.
The steps of “receive, from an implantable pressure sensor, characteristics of interest related to a patient”, “obtaining, from the implantable pressure sensor, characteristics of interest related to a patient”, and “obtain characteristics of interest related to a patient from an implantable pressure sensor” are merely insignificant extra-solution activity, such as mere data gathering, recited at a high level of generality and/or in a well-understood, routine, and conventional way, of the information needed to carry out the claimed algorithm.
The claimed “implantable pressure sensor” is well-understood, routine, and conventional in the art, as evidenced by Applicant’s description of the sensor in [0039] of the specification. It represents a component that would routinely be used in applying the abstract idea. As such, they do not meaningfully limit the claim, taken as a whole, to a particular application of the abstract idea.
The steps of “communicate an alert in response to determining the drift threshold has been exceeded” is merely insignificant extra-solution activity, such as outputting the result of the claimed algorithm, recited at a high level of generality and/or in a well-understood, routine, and conventional way (step 2A: Prong Two).
Moreover, the judicial exception is not integrated into a practical application because the claim does not recite any limitations, either individually, or in combination, that amount to an improvement in the functioning of a computer, or an improvement to other technology or technical field, apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement the judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (step 2B).
Regarding dependent claims 2-9, 11-15, and 17-20, the limitations of these dependent claim(s) merely add details to the algorithm which forms the abstract idea, but does not contain any further “additional elements”. Thus, the dependent claim(s) are not significantly more than the extended abstract idea.
Claim 12 does include the additional element of “conducting an invasive right heart catheterization (RHC) in response to receiving the alert to verify the drift threshold has been exceeded”, but this limitation is well-understood, routine, and conventional in the art, as evidenced by Applicant’s description of it in [0003] of the specification, and further evidenced by Singh et al. (US 2025/0176838 A1 – see [0007]) and Minor (US 2023/0165475 A1 – see [0009]-[0010]). It represents a component that would routinely be used in applying the abstract idea. As such, they do not meaningfully limit the claim, taken as a whole, to a particular application of the abstract idea.
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) 1 and 4-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent No. 11,330,981 B2), further in view of Mann et al. (US Patent No. 8,068,907 B2).
Regarding claim 1, Anderson et al. discloses a controller for calibrating an implantable pressure sensor, comprising:
one or more processors (124, 152) (see Figure 1 and col. 5, lines 52-58 – “The implantable device 102 is also shown as including a communication module 114, a serial interface 116, random access memory (RAM) 122, one or more timers 126, a microcontroller unit (MCU) 124, sensor measurement circuitry 128, and a temperature sensor 132, each of which is shown as being connected to a bus 110. The serial interface 116 is connected between non-volatile memory (NVM) 120 and the bus 110” and col. 6, lines 39-41 – “While not specifically shown, the external device 152 can also include a microcontroller unit (MCU), which can be part of or separate from the driver 156”); and
a memory coupled to the one or more processors, wherein the memory stores program instructions (see Figure 1 and col. 6, lines 15-22 – “In accordance with certain embodiments, the MCU 124 executes program code that is stored in memory 118 (e.g., the NVM 120 and/or RAM 122) of the implantable device 102 to thereby control operations of the implantable device 102. Such program code can be provided to the implantable device 102 and/or updated by the non-implantable device 152 or some other external device. The memory can also store diagnostic data, sensor measurements, etc.”), wherein the program instructions are executable by the one or more processors to:
receive, from an implantable pressure sensor, characteristics of interest related to a patient (see col. 3, lines 20-24 – “In accordance with certain embodiments, the implantable device is configured to be implanted in a pulmonary artery, and the sensor measurements obtained using the sensor of the implantable device are indicative of pulmonary artery pressure (PAP)”);
determine an implantable pressure sensor parameter in real time based on the characteristics of interest related to a patient (see col. 3, lines 20-24 – “In accordance with certain embodiments, the implantable device is configured to be implanted in a pulmonary artery, and the sensor measurements obtained using the sensor of the implantable device are indicative of pulmonary artery pressure (PAP)” and col. 12, lines 52-65 – “As noted above, the capacitive pressure sensor Cpr is configured such that its capacitance should change with changes in the pressure (e.g., PAP) being measured. By contrast, the reference capacitor Cref is configured such that its capacitance is not affected by (i.e., is independent of) changes in the pressure (e.g., PAP) being measured, and such that any changes in measurements of the capacitance of the reference capacitor Cref are indicative of drift of the active circuitry (e.g., the ADC 312) of the sensor measurement circuitry 128. Drift is a phenomenon where operation of the ADC 312 (and/or other active circuitry) changes not because of a change to the input to the ADC, but rather due to changes to circuit elements resulting from aging and/or changes in temperature”).
Anderson et al. teaches calibrating the pressure sensor measurements by applying a drift error correction factor or by compensating for non-linearity and/or offset (see col. 13, lines 10-61) but does not specifically teach providing a drift threshold related to the implantable pressure sensor parameter, determining whether the drift threshold has been exceeded based on the implantable pressure sensor parameter, and communicating an alert in response to determining the drift threshold has been exceeded. However, Mann et al. teaches providing a drift threshold related to the implantable pressure sensor parameter (see col. 4, lines 4-8 – “determining an error value based upon the difference between the measured actual pressure and the calculated pressure value; and calibrating the pressure monitoring system when the error value exceeds a predetermined threshold” and col. 9, lines 40-46 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is monitored as described above to derive an offset correction, but the offset correction is not always automatically applied. Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold”), determining whether the drift threshold has been exceeded based on the implantable pressure sensor parameter (see col. 4, lines 4-8 – “determining an error value based upon the difference between the measured actual pressure and the calculated pressure value; and calibrating the pressure monitoring system when the error value exceeds a predetermined threshold” and col. 9, lines 40-46 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is monitored as described above to derive an offset correction, but the offset correction is not always automatically applied. Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold”), and communicating an alert in response to determining the drift threshold has been exceeded (see col. 4, lines 14-16 – “In another embodiment, the method further comprising generating an alert when the error value exceeds the predetermined threshold” and col. 9, lines 43-46 – “Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold” and lines 58-62 – “In another embodiment, the alert includes an instruction to the patient to go to the physician's office to perform a calibration so that the physician can evaluate whether the discordance between LAP and f-LAP is physiological or sensor drift”).
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 controller of Anderson et al. to include providing a drift threshold related to the implantable pressure sensor parameter, determining whether the drift threshold has been exceeded based on the implantable pressure sensor parameter, and communicating an alert in response to determining the drift threshold has been exceeded, as disclosed in Mann et al., so as to distinguish between a change in physiological condition and a change in sensor calibration (see Mann et al.: col. 9, lines 37-40).
Regarding claim 4, Anderson et al. teaches to determine the implantable pressure sensor parameter comprises using a first numerical method in real time using the characteristics of interest received from the implantable pressure sensor (see col. 12, lines 52-65 – “As noted above, the capacitive pressure sensor Cpr is configured such that its capacitance should change with changes in the pressure (e.g., PAP) being measured. By contrast, the reference capacitor Cref is configured such that its capacitance is not affected by (i.e., is independent of) changes in the pressure (e.g., PAP) being measured, and such that any changes in measurements of the capacitance of the reference capacitor Cref are indicative of drift of the active circuitry (e.g., the ADC 312) of the sensor measurement circuitry 128. Drift is a phenomenon where operation of the ADC 312 (and/or other active circuitry) changes not because of a change to the input to the ADC, but rather due to changes to circuit elements resulting from aging and/or changes in temperature” and col. 13, lines 25-28 – “For example, a ratio between an initial reference capacitor measurement and a present reference capacitor measurement can be applied to a present pressure sensor capacitor measurement as a scaling factor to compensate the drift error”). Mann et al. further teaches to determine the implantable pressure sensor parameter comprises using a first numerical method in real time using the characteristics of interest received from the implantable pressure sensor (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 5, Anderson et al. teaches the one or more processors are located remotely with respect to the implantable pressure sensor (see col. 6, lines 39-41 – “While not specifically shown, the external device 152 can also include a microcontroller unit (MCU), which can be part of or separate from the driver 156”). Mann et al. also teaches the one or more processors are located remotely with respect to the implantable pressure sensor (see col. 6, lines 59-65 – “In one embodiment, a system for remote non-invasive calibration of implantable medical devices analyzes uploaded pressure waveforms to determine sensor calibration. In another embodiment, a system remotely monitors implantable medical devices by analyzing uploaded pressure waveforms to detect either a change in a physiological condition or a miscalibration of a sensor”).
Regarding claim 6, Mann et al. teaches to determine whether the drift threshold has been exceeded comprises utilizing a second numerical method using the parameter determined using the first numerical method (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 7, Mann et al. teaches the second numerical method includes utilizing a Hoeffding's Bound method (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 8, Mann et al. teaches the one or more processors are further configured to dynamically update the drift threshold in real time based on the characteristics of interest received from the implantable pressure sensor (see col. 3, lines 24-27 – “Alternatively, the indicator data obtained in the second time period may be used to calibrate a pressure sensing device, wherein said calibration can occur automatically or via patient instructions” and col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 9, Mann et al. teaches the drift threshold is manually input to the controller (see col. 3, lines 24-27 – “Alternatively, the indicator data obtained in the second time period may be used to calibrate a pressure sensing device, wherein said calibration can occur automatically or via patient instructions”).
Regarding claim 10, Anderson et al. discloses a method for calibrating an implantable pressure sensor comprising:
obtaining, from the implantable pressure sensor, characteristics of interest related to a patient (see col. 3, lines 20-24 – “In accordance with certain embodiments, the implantable device is configured to be implanted in a pulmonary artery, and the sensor measurements obtained using the sensor of the implantable device are indicative of pulmonary artery pressure (PAP)”);
determining, with a controller, an implantable pressure sensor parameter in real time based on the characteristics of interest related to the patient (see col. 3, lines 20-24 – “In accordance with certain embodiments, the implantable device is configured to be implanted in a pulmonary artery, and the sensor measurements obtained using the sensor of the implantable device are indicative of pulmonary artery pressure (PAP)” and col. 12, lines 52-65 – “As noted above, the capacitive pressure sensor Cpr is configured such that its capacitance should change with changes in the pressure (e.g., PAP) being measured. By contrast, the reference capacitor Cref is configured such that its capacitance is not affected by (i.e., is independent of) changes in the pressure (e.g., PAP) being measured, and such that any changes in measurements of the capacitance of the reference capacitor Cref are indicative of drift of the active circuitry (e.g., the ADC 312) of the sensor measurement circuitry 128. Drift is a phenomenon where operation of the ADC 312 (and/or other active circuitry) changes not because of a change to the input to the ADC, but rather due to changes to circuit elements resulting from aging and/or changes in temperature”); and
recalibrating, with the controller, the implantable pressure sensor (see col. 13, lines 25-28 – “ For example, a ratio between an initial reference capacitor measurement and a present reference capacitor measurement can be applied to a present pressure sensor capacitor measurement as a scaling factor to compensate the drift error” and lines 47-61 – “The non-linearity calibration data can be determined prior to implant of the implantable device 102, e.g., during or after manufacture thereof, and the offset calibration data can be determined, e.g., after implant of the implantable device 102 into a patient. For a more specific example, after the implantable device 102 is implanted in a patient's pulmonary artery, a PAP measurement can be obtained using the implantable device and calibrated to compensate for a non-linearity of the sensor. This calibrated measurement can be compared to a PAP measurement obtained using the standard pulmonary artery catheterization (PAC) method in order to determine an offset, and calibration offset data can be transmitted to the implantable device and stored in its NVM 120 to provide for later access to such calibration data. Other variations are also possible”).
Anderson et al. teaches calibrating the pressure sensor measurements by applying a drift error correction factor or by compensating for non-linearity and/or offset (see col. 13, lines 10-61) but does not specifically teach obtaining a drift threshold related to the implantable pressure sensor parameter, and determining, with the controller, whether the drift threshold has been exceeded based on the implantable pressure sensor parameter. However, Mann et al. teaches obtaining a drift threshold related to the implantable pressure sensor parameter, and determining, with the controller, whether the drift threshold has been exceeded based on the implantable pressure sensor parameter (see col. 4, lines 4-8 – “determining an error value based upon the difference between the measured actual pressure and the calculated pressure value; and calibrating the pressure monitoring system when the error value exceeds a predetermined threshold” and col. 9, lines 40-46 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is monitored as described above to derive an offset correction, but the offset correction is not always automatically applied. Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold”).
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 Anderson et al. to include obtaining a drift threshold related to the implantable pressure sensor parameter, and determining, with the controller, whether the drift threshold has been exceeded based on the implantable pressure sensor parameter, as disclosed in Mann et al., so as to distinguish between a change in physiological condition and a change in sensor calibration (see Mann et al.: col. 9, lines 37-40).
Regarding claim 11, Mann et al. teaches communicating, with the controller, an alert in response to determining the drift threshold has been exceeded (see col. 4, lines 14-16 – “In another embodiment, the method further comprising generating an alert when the error value exceeds the predetermined threshold” and col. 9, lines 43-46 – “Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold” and lines 58-62 – “In another embodiment, the alert includes an instruction to the patient to go to the physician's office to perform a calibration so that the physician can evaluate whether the discordance between LAP and f-LAP is physiological or sensor drift”).
Regarding claim 12, Anderson et al. in view of Mann et al. teaches conducting an invasive right heart catheterization (RHC) in response to receiving the alert to verify the drift threshold has been exceeded (see Anderson et al.: col. 13, lines 55-61 and Mann et al.: col. 4, lines 14-16, and col. 9, lines 43-62); and
recalibrating the implantable pressure sensor in response to verifying the drift threshold has been exceeded by the RHC (see Anderson et al.: col. 13, lines 25-28 and 47-61 and Mann et al.: col. 9, lines 16-28 and 58-62).
Regarding claim 13, Mann et al. teaches obtaining the drift threshold comprises dynamically updating the drift threshold in real time based on the characteristics of interest related to the patient see col. 3, lines 24-27 – “Alternatively, the indicator data obtained in the second time period may be used to calibrate a pressure sensing device, wherein said calibration can occur automatically or via patient instructions” and col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 14, Anderson et al. teaches determining the implantable pressure sensor parameter comprises using a first numerical method in real time using the characteristics of interest obtained by the implantable pressure sensor (see col. 12, lines 52-65 – “As noted above, the capacitive pressure sensor Cpr is configured such that its capacitance should change with changes in the pressure (e.g., PAP) being measured. By contrast, the reference capacitor Cref is configured such that its capacitance is not affected by (i.e., is independent of) changes in the pressure (e.g., PAP) being measured, and such that any changes in measurements of the capacitance of the reference capacitor Cref are indicative of drift of the active circuitry (e.g., the ADC 312) of the sensor measurement circuitry 128. Drift is a phenomenon where operation of the ADC 312 (and/or other active circuitry) changes not because of a change to the input to the ADC, but rather due to changes to circuit elements resulting from aging and/or changes in temperature” and col. 13, lines 25-28 – “For example, a ratio between an initial reference capacitor measurement and a present reference capacitor measurement can be applied to a present pressure sensor capacitor measurement as a scaling factor to compensate the drift error”). Mann et al. further teaches determining the implantable pressure sensor parameter comprises using a first numerical method in real time using the characteristics of interest obtained by the implantable pressure sensor (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 15, Mann et al. teaches to determining whether the drift threshold has been exceeded comprises utilizing a second numerical method using the parameter determined using the first numerical method (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 16, Anderson et al. discloses a computer program product comprising a non-transitory computer readable storage medium comprising computer executable code (see Figure 1 and col. 6, lines 15-22 – “In accordance with certain embodiments, the MCU 124 executes program code that is stored in memory 118 (e.g., the NVM 120 and/or RAM 122) of the implantable device 102 to thereby control operations of the implantable device 102. Such program code can be provided to the implantable device 102 and/or updated by the non-implantable device 152 or some other external device. The memory can also store diagnostic data, sensor measurements, etc.”) to:
obtain characteristics of interest related to a patient from an implantable pressure sensor (see col. 3, lines 20-24 – “In accordance with certain embodiments, the implantable device is configured to be implanted in a pulmonary artery, and the sensor measurements obtained using the sensor of the implantable device are indicative of pulmonary artery pressure (PAP)”);
determine an implantable pressure sensor parameter in real time based on the characteristics of interest related to the patient (see col. 3, lines 20-24 – “In accordance with certain embodiments, the implantable device is configured to be implanted in a pulmonary artery, and the sensor measurements obtained using the sensor of the implantable device are indicative of pulmonary artery pressure (PAP)” and col. 12, lines 52-65 – “As noted above, the capacitive pressure sensor Cpr is configured such that its capacitance should change with changes in the pressure (e.g., PAP) being measured. By contrast, the reference capacitor Cref is configured such that its capacitance is not affected by (i.e., is independent of) changes in the pressure (e.g., PAP) being measured, and such that any changes in measurements of the capacitance of the reference capacitor Cref are indicative of drift of the active circuitry (e.g., the ADC 312) of the sensor measurement circuitry 128. Drift is a phenomenon where operation of the ADC 312 (and/or other active circuitry) changes not because of a change to the input to the ADC, but rather due to changes to circuit elements resulting from aging and/or changes in temperature”);
Anderson et al. teaches calibrating the pressure sensor measurements by applying a drift error correction factor or by compensating for non-linearity and/or offset (see col. 13, lines 10-61) but does not specifically teach providing a drift threshold related to the implantable pressure sensor parameter, determining whether the drift threshold has been exceeded based on the implantable pressure sensor parameter, communicating an alert in response to determining the drift threshold has been exceeded, or calibrating the implantable pressure sensor based on the alert. However, Mann et al. teaches providing a drift threshold related to the implantable pressure sensor parameter (see col. 4, lines 4-8 – “determining an error value based upon the difference between the measured actual pressure and the calculated pressure value; and calibrating the pressure monitoring system when the error value exceeds a predetermined threshold” and col. 9, lines 40-46 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is monitored as described above to derive an offset correction, but the offset correction is not always automatically applied. Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold”), determining whether the drift threshold has been exceeded based on the implantable pressure sensor parameter (see col. 4, lines 4-8 – “determining an error value based upon the difference between the measured actual pressure and the calculated pressure value; and calibrating the pressure monitoring system when the error value exceeds a predetermined threshold” and col. 9, lines 40-46 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is monitored as described above to derive an offset correction, but the offset correction is not always automatically applied. Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold”), communicating an alert in response to determining the drift threshold has been exceeded (see col. 4, lines 14-16 – “In another embodiment, the method further comprising generating an alert when the error value exceeds the predetermined threshold” and col. 9, lines 43-46 – “Instead, a calibration alert is generated whenever the correction derived from the LAP versus f-LAP difference exceeds a predetermined threshold” and lines 58-62 – “In another embodiment, the alert includes an instruction to the patient to go to the physician's office to perform a calibration so that the physician can evaluate whether the discordance between LAP and f-LAP is physiological or sensor drift”), and calibrating the implantable pressure sensor based on the alert (see col. 9, lines 58-62 – “In another embodiment, the alert includes an instruction to the patient to go to the physician's office to perform a calibration so that the physician can evaluate whether the discordance between LAP and f-LAP is physiological or sensor drift”).
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 controller of Anderson et al. to include providing a drift threshold related to the implantable pressure sensor parameter, determining whether the drift threshold has been exceeded based on the implantable pressure sensor parameter, communicating an alert in response to determining the drift threshold has been exceeded, and calibrating the implantable pressure sensor based on the alert, as disclosed in Mann et al., so as to distinguish between a change in physiological condition and a change in sensor calibration (see Mann et al.: col. 9, lines 37-40).
Regarding claim 17, Anderson et al. teaches to determine the implantable pressure sensor parameter comprises using a first numerical method in real time using the characteristics of interest received from the implantable pressure sensor (see col. 12, lines 52-65 – “As noted above, the capacitive pressure sensor Cpr is configured such that its capacitance should change with changes in the pressure (e.g., PAP) being measured. By contrast, the reference capacitor Cref is configured such that its capacitance is not affected by (i.e., is independent of) changes in the pressure (e.g., PAP) being measured, and such that any changes in measurements of the capacitance of the reference capacitor Cref are indicative of drift of the active circuitry (e.g., the ADC 312) of the sensor measurement circuitry 128. Drift is a phenomenon where operation of the ADC 312 (and/or other active circuitry) changes not because of a change to the input to the ADC, but rather due to changes to circuit elements resulting from aging and/or changes in temperature” and col. 13, lines 25-28 – “For example, a ratio between an initial reference capacitor measurement and a present reference capacitor measurement can be applied to a present pressure sensor capacitor measurement as a scaling factor to compensate the drift error”). Mann et al. further teaches to determine the implantable pressure sensor parameter comprises using a first numerical method in real time using the characteristics of interest received from the implantable pressure sensor (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 5, Anderson et al. teaches the one or more processors are located remotely with respect to the implantable pressure sensor (see col. 6, lines 39-41 – “While not specifically shown, the external device 152 can also include a microcontroller unit (MCU), which can be part of or separate from the driver 156”). Mann et al. also teaches the one or more processors are located remotely with respect to the implantable pressure sensor (see col. 6, lines 59-65 – “In one embodiment, a system for remote non-invasive calibration of implantable medical devices analyzes uploaded pressure waveforms to determine sensor calibration. In another embodiment, a system remotely monitors implantable medical devices by analyzing uploaded pressure waveforms to detect either a change in a physiological condition or a miscalibration of a sensor”).
Regarding claim 18, Mann et al. teaches to determine whether the drift threshold has been exceeded comprises utilizing a second numerical method using the parameter determined using the first numerical method (see col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 19, Mann et al. teaches to provide the drift threshold, the drift threshold is dynamically calculated in real time (see col. 3, lines 24-27 – “Alternatively, the indicator data obtained in the second time period may be used to calibrate a pressure sensing device, wherein said calibration can occur automatically or via patient instructions” and col. 9, lines 16-28 – “In one embodiment of the present invention, the difference between LAP and an f-LAP is used to perform sensor calibration. In one such embodiment, the difference is averaged over a number of measurements or over an interval of time to derive an offset correction. In one embodiment the interval of time is one week, and an offset correction is applied to the sensor LAP readings each week. In another embodiment, the interval is one month, or some other interval that may be chosen by the patient's physician. In another embodiment, the interval is one week, and a new calibration is applied each day based on the most recent seven-day average difference. Any interval may be selected, such as minutes, hours, days, weeks, months, and/or years, or a combination thereof”).
Regarding claim 20, Mann et al. teaches to provide the drift threshold, the drift threshold is received from manually input (see col. 3, lines 24-27 – “Alternatively, the indicator data obtained in the second time period may be used to calibrate a pressure sensing device, wherein said calibration can occur automatically or via patient instructions”).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. and Mann et al., further in view of White et al. (US Publication No. 2014/0155769 A1 A1).
Regarding claims 2-3, it is noted Anderson et al. teaches the sensor measurements are indicative of pulmonary artery pressure, but does not specifically teach a systolic pulmonary artery pressure (sPAP) and a diastolic pulmonary artery pressure (dPAP), or a distance between a dPAP and a SPAP (mPAP). However, White et al. teaches the characteristics of interest include a systolic pulmonary artery pressure (sPAP) and a diastolic pulmonary artery pressure (dPAP) and the implantable pressure sensor parameter is a distance between a dPAP and a sPAP (mPAP) (see [0054] – “PAP values are optionally determined by analysis of the pressure waveform to determine the average maximum waveform values for systolic PAP, average minimum waveform values for diastolic PAP, and average of all waveform values for mean PAP” and [0091] – “With increased mean, systolic, or diastolic average pulmonary arterial pressures, the pulmonary arterial wall strain modulus increases, and compliance decreases in a predictable manner, due to the mechanical properties of the pulmonary vessels. (Pasierski TJ, CHEST 1993). Based on this relationship, changes in mean, systolic, or diastolic average pulmonary pressures from baseline to a follow-up measurement can be used to infer proportional changes in characteristic impedance from baseline 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 controller of Anderson et al. and Mann et al. to include the characteristics of interest include a systolic pulmonary artery pressure (sPAP) and a diastolic pulmonary artery pressure (dPAP) and the implantable pressure sensor parameter is a distance between a dPAP and a sPAP (mPAP), as disclosed in White et al., so as to determine changes in the pulmonary arterial wall strain modulus and compliance due to the mechanical properties of the pulmonary vessels in order to infer proportional changes in characteristic impedance from baseline values (see White et al.: [0091]).
Conclusion
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791