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 .
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.
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 – 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an
abstract idea without significantly more. Under the two-step 101 analysis, the claims fail to satisfy the
criteria for subject matter eligibility.
Step 1: Claims 1 – 24 are all within at least one of the four statutory categories.
Claims 1 – 10 are directed to a process
Claims 11 – 24 are directed to an apparatus.
Step 2A, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 - 10 recite the following limitations directed to an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
Claim 1 recites, A method comprising:
acquiring a set of measurements of impedance of an implantable medical lead ; Acquiring a set of measurements represents insignificant pre-solution activity, mere data gathering. Acquiring impedance measurements is known in the art (Thakur, et. al., US. PGPub. No 2017/0296810, hereinafter Thakur, paragraph [0078]) and is discussed in the application as the use of generic measurement circuitry that “may include capacitors, charge pumps, transistors, or the like for generating the signal, and sample and hold circuitry for measuring the resulting signal.”
determining a metric of variability of the set of impedance measurements Determining a metric of variability, such as the standard deviation of a data set, is a mathematical concept;
determining that the metric of variability satisfies a criterion Determining whether a metric of variability satisfies a criterion such as being above a threshold is a mental process that can be performed either entirely mentally or with the aid of pen and paper; and
generating a lead integrity alert in response to determining that the metric of variability satisfies the criterion. Generating an alert in response to the conclusion of a mental process is insignificant post-solution activity and well known. Thakur ([0006]) discusses generating an alert in response to a determination. .
Claim 2 further recites, The method of claim 1, wherein the set of measurements comprises impedances measured at a rate of N samples per second, wherein N is an integer greater than or equal to 1. While the limitations above further define the data gathering steps of claim 1, they are still directed toward data gathering.
Claim 3 further recites, The method of claim 2, wherein N equals 65. While the limitations above further define the data gathering steps of claims 1 and 2, they are still directed toward data gathering and do not add any additional elements.
Claim 4 further recites, The method of claim 1, wherein set of measurements comprises 500 measurements. While the limitations above further define the set of measurements, they still describe data gathering and do not add any additional elements.
Claim 5 further recites, The method of claim 1, wherein a resolution of the measurements is less than or equal to 0.1 ohms. While the limitations above further define the resolution of the measurements, the limitations are still directed to data gathering and do not add any additional elements.
Claim 6 further recites, The method of claim 1, wherein the metric of variability comprises a standard deviation of the set of measurements. While the limitations above further define the metric of variability to be standard deviation, they still define a mathematical concept and do not add any additional elements.
Claim 7 further recites, The method of claim 1, wherein determining that the metric of variability satisfies the criterion comprises determining that the metric of variability is greater than or equal to a threshold impedance value. While the limitations above further define the criterion of claim 1 to be a determination of whether the metric of variability is above or equal to a threshold, they still define a mental process and do not add any additional elements.
Claim 8 further recites, The method of claim 1, wherein acquiring the set of measurements of impedance of the implantable medical lead comprises acquiring a set of measurements of a path including at least one electrode of the implantable medical lead. The limitations above further define the machine from which data is being gathered but still describes a generic machine. Thakur, figure 1, shows implantable, intracardiac medical lead 115 with electrode 120.
Claim 9 further recites, The method of claim 8, wherein generating the lead integrity alert comprises indicating at least one of a fracture, partial fracture, or anticipated fracture of a conductor connector to the at least one electrode. Claim 9 is directed toward the generation of a lead integrity alert in response to the mental determination of a metric of variability satisfying a criterion. While further defining the lead integrity alert, claim 9 is still directed toward a process that can be performed entirely mentally or with the aid of pen and paper.
Claim 10 further recites, The method of claim 1, wherein the implantable medical lead comprises an intracardiac lead. The limitations above further define the machine from which data is being gathered but still describes a generic machine. Thakur, figure 1, shows implantable, intracardiac medical lead 115 with electrode 120.
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 11 – 24 are directed toward an apparatus that performs the method of claims 1 – 10, and many of the elements in claims 11 – 24 are substantially the same as in claims 1 – 10.
Claim 11 recites, A system comprising:
an implantable medical device configured to measure impedance of an implantable medical lead coupled to the implantable medical device an implantable medical device is shown in Thakur figure 2 coupled to leads/electrodes 250; and
processing circuitry configured to: perform the data gathering and abstract ideas discussed for claim 1. Thakur figure 2 additionally illustrates implant control circuit 236, as well as sensing circuits 232, defibrillation circuits 234, and a lead integrity component 230/130 which comprise microprocessors and general computing electronics configured to assess lead integrity as discussed in paragraphs [0067] and [0072]. In the specification of the present application, discussion of processing circuitry similarly pertains to general computing electronics “The term “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.” As such the additional elements discuss the use of a general machine towards the performance of mental processes, mathematical concepts, and data gathering, They are not directed towards a practical 1application of the mental processes, mathematical concepts, and data gathering.
Claims 12 – 16 do not recite any additional elements.
Claim 17 further recites, The system of claim 11, wherein, to determine that the metric of variability satisfies the criterion, the processing circuitry is configured to determine that the metric of variability is greater than or equal to a threshold impedance value. The above limitations further define the general computing electronics’ role in the performance of the mental processes discussed for claims 1 and 7. They are not directed toward a practical application of the mental processes.
Claim 18 further recites, The system of claim 11, wherein, to acquire the set of measurements of impedance of the implantable medical lead, the processing circuitry is configured to acquire a set of measurements of a path including at least one electrode of the implantable medical lead. The above limitations further define the general computing electronics’ role in the performance of data gathering discussed for claims 1 and 8. They are not directed toward a practical application of the data gathering.
Claim 19 further recites, The system of claim 18, wherein, to generate the lead integrity alert, the processing circuitry is configured to indicate at least one of a fracture, partial fracture, or anticipated fracture of a conductor connector to the at least one electrode. The above limitations further define the general computing electronics’ role in the performance of the mental processes discussed for claims 1 and 9. They are not directed toward a practical application of the mental processes.
Claim 20 does not introduce any additional elements.
Claim 21 further recites, The system of claim 11, wherein the processing circuitry comprises processing circuitry of the implantable medical device. The additional elements further define the processing circuitry of claim 11 used in the performance of abstract ideas and data gathering. They do not direct the elements of claim 11 toward a practical application.
Claim 22 further recites, The system of claim 11, further comprising a computing device configured to wirelessly communicate with the implantable medical device, wherein the processing circuitry comprises processing circuitry of the computing device. Thakur paragraphs [0071], [0072] and figure 2 additionally illustrates implant control circuit 236, sensing circuits 232, a lead integrity component 230/130 in an external computing device which comprise microprocessors and general computing electronics, as well as telemetry elements 238, 248, and 285. In the specification of the present application, communication between the external and implanted device is not performed with special or inventive circuitry, “External device 30 may communicate wirelessly with IMD 10 using communication circuitry 146, which may be configured for wireless communication with communication circuitry 118 of IMD 10.” As such the additional elements discuss the use of a general machine towards the performance of mental processes, mathematical concepts, and data gathering. They are not directed towards a practical application of the mental processes, mathematical concepts, and data gathering.
Claim 23 further recites, The system of claim 11, further comprising a computing device configured to wirelessly communicate with the implantable medical device, wherein the computing device is configured to present the lead integrity alert to a user. Thakur figure 2 additionally illustrates implant control circuit 236, as well as sensing circuits 232, defibrillation circuits 234, and a lead integrity component 230/130 in an external computing device with a user interface 254 and presentation device 258 which comprise microprocessors and general computing electronics configured to assess lead integrity as discussed in paragraphs [0067] and [0072]. In the specification of the present application, discussion of processing circuitry similarly pertains to general computing electronics, “Based on satisfaction of the criterion, processing circuitry 140 may provide an alert to a user, e.g., via UI 144.” Generating a lead integrity alert to user represents well known and insignificant extra-solution activity following the performance of the abstract ideas and data gathering discussed in claim 1. As such the additional elements discuss the use of a general machine towards the performance of mental processes, mathematical concepts, data gathering, and insignificant extra-solution activity, and are not incorporated into practical application.
Claim 24 further recites A non-transitory computer-readable storage medium comprising instructions that, when executing by processing circuitry, cause the processing circuitry to: perform the data gathering, mental process, and mathematical concepts discussed for claim 1. The additional elements are well known, in [0066] and [0067] Thakur discusses the use of computer-readable memory in the IMD, 105, and external device, 190, for the executing of functions by a processor. In the specification of the present application, it is stated that “Memory 108 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.” As such the additional elements of claim 24 are directed towards a general machine for the performance of data gathering, mental processes, and mathematical concepts, and are not incorporated into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements of claims 11, 17, 18, 19, 21, 22, 23, and 24 when considered individually and in combination are not enough to qualify as significantly more than the abstract idea discussed for claims 1 - 10. As discussed above the apparatus claim elements comprise generic processors, antennas, leads, electrodes, and memory electronics housed within implantable and external medical devices that share telemetry (Thakur figure 2, elements 232, 234, 236, 230, 238, 248, and 285, paragraphs [0066], [0067], [0071], [0072]). Additionally, there are process elements comprising instructions to apply apparatus elements toward: 1) the mere gathering of impedance data sets at various frequencies for set times and at a defined resolution 2) the mathematical determination of a metric of variability of the data set, including standard deviation 3) making a mental comparison of the metric of variability to a threshold and 4) making a mental determination to generate an alert or a specific type of alert pertaining to lead integrity. Finally displaying this alert on a user interface is insignificant extra-solution activity on well-understood, routine, and conventional electronics as seen in Thakur, figure 2, elements 254 and 258, [0072] and does not amount to significantly more.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 711, and 17 – 24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Thakur, et. al., (USPGPub. No. 2017/0296810, hereinafter Thakur).
In regard to claim 1, Thakur teaches A method comprising:
acquiring a set of measurements of impedance of an implantable medical lead; ([0060] In embodiments, for example, the therapy or sensing circuits 132, 134 may measure and determine a first set of information (e.g., impedance data), which may indicate that a lead is failing or has failed.)
determining a metric of variability of the set of impedance measurements; ([0073] Comparisons made between metrics of variability determined from a first and ongoing sets of measurements)
determining that the metric of variability satisfies a criterion ([0073] high variability, e.g. variability that satisfies a criterion, generates a first alert and triggers a second follow up study of impedance variability); and
generating a lead integrity alert in response to determining that the metric of variability satisfies the criterion (Figure 3 element 302 and 308, paragraph [0082] method 300 generates a first alert in response to variability, studies variability in depth, and confirms alert).
In regard to claim 7, Thakur [0077] teaches, The method of claim 1, wherein determining that the metric of variability satisfies the criterion comprises determining that the metric of variability is greater than or equal to a threshold impedance value. Thakur receives a first alert based on an impedance step change criteria (variability) during the same phase of the cardiac cycle [0060] and confirms the alert by comparing impedance variability through changes of posture [0077].
In regard to claim 8, Thakur teaches, The method of claim 1, wherein acquiring the set of measurements of impedance of the implantable medical lead comprises acquiring a set of measurements of a path including at least one electrode of the implantable medical lead. Impedance data [0060] is the implantable lead (110, 115, 125) impedance measurements, which include [0053] electrodes (114A, 114B, 116, 118, 120A, 120B).
In regard to claim 9, Thakur teaches, The method of claim 8, wherein generating the lead integrity alert comprises indicating at least one of a fracture, partial fracture, or anticipated fracture of a conductor connector ([0054]) to the at least one electrode (114A, 114B, 116, 118, 120A, 120B). In paragraph [0093], the analysis of variability may be used to differentiate between potential fracture, fracture, dislodgement, perforation, repositioning, etc.
In regard to claim 10, Thakur teaches, The method of claim 1, wherein the implantable medical lead comprises an intracardiac lead. Figure 1, leads 110, 115, 125, are intracardiac leads.
In regard to claim 11, Thakur teaches the claim elements substantially as discussed for claim 1. Thakur also teaches A system comprising:
an implantable medical device (105) configured to measure impedance ([0060] sensing circuits 132, 134) of an implantable medical lead (110, 115, & 125) coupled to the implantable medical device; and
processing circuitry ([0067], IMD and external device 105, 190 have processors) configured to:
acquire a set of measurements ([0060], 132, 134) of impedance of the implantable medical lead (110, 115, & 125) by the implantable medical device (105);
determine a metric of variability of the set of impedance measurements ([0073]);
determine that the metric of variability satisfies a criterion ([0073]); and
generate a lead integrity alert in response to determining that the metric of variability satisfies the criterion ([0082] Fig 3, element 302 and 308). See discussion for claim 1.)
In regard to claim 17, Thakur teaches, The system of claim 11, wherein, to determine that the metric of variability satisfies the criterion, the processing circuitry ([0067]) is configured to ([0060]) determine that the metric of variability is greater than or equal to a threshold impedance value. Thakur receives a first alert based on an impedance step change criteria (variability) during the same phase of the cardiac cycle [0060] and confirms the alert by comparing impedance variability through changes of posture [0077].
In regard to claim 18, Thakur teaches, The system of claim 11, wherein, to acquire the set of measurements of impedance ([0060]) of the implantable medical lead (110, 115, 125), the processing circuitry ([0067]) is configured to acquire a set of measurements of a path including at least one electrode (114A, 114B, [0053]) of the implantable medical lead. See discussion for claim 8.
In regard to claim 19, Thakur teaches, The system of claim 18, wherein, to generate the lead integrity alert, the processing circuitry is configured to indicate at least one of a fracture, partial fracture, or anticipated fracture of a conductor connector ([0054]) to the at least one electrode (114A, 114B, 116, 118, 120A, 120B). In paragraph [0093], the analysis of variability may be used to differentiate between potential fracture, fracture, dislodgement, perforation, repositioning, etc.
In regard to claim 20, Thakur teaches, The system of claim 11, wherein the implantable medical lead comprises an intracardiac lead. Figure 1, leads 110, 115, 125, are intracardiac leads.
In regard to claim 21, Thakur teaches, The system of claim 11, wherein the processing circuitry comprises processing circuitry of the implantable medical device ([0067], IMD and external device 105, 190 have processors).
In regard to claim 22, Thakur teaches, The system of claim 11, further comprising a computing device (190) configured to wirelessly communicate (185) with the implantable medical device (105, see Figure 1), wherein the processing circuitry comprises processing circuitry of the computing device ([0067], IMD and external device 105, 190 have processors).
In regard to claim 23, Thakur teaches, The system of claim 11, further comprising a computing device (190, 290) configured to wirelessly communicate (185, 285) with the implantable medical device (105, 205), wherein the computing device is configured to present the lead integrity alert to a user (254, 258, [0072] presentation device presents indication of lead failure to user).
In regard to claim 24, Thakur teaches, A non-transitory computer-readable storage medium comprising instructions that, when executing by processing circuitry, ([0068]) cause the processing circuitry ([0067], IMD and external device 105, 190 have processors) to:
acquire a set of measurements of impedance ([0060], 132, 134) of the implantable medical lead (110,115,125) by the implantable medical device (105);
determine a metric of variability of the set of impedance measurements ([0073]);
determine that the metric of variability satisfies a criterion ([0073]); and
generate a lead integrity alert in response to determining that the metric of variability satisfies the criterion ([0082] Fig 3, element 302 and 308). See discussion for claim 1).
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.
Claim 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur as applied to claims 1 and 11 above, and further in view of Ternes, et. al. (US. PGPub. No. 2017/0196458, hereinafter Ternes).
In regard to claim 2, Thakur teaches the method of claim 1 as discussed above. Thakur fails to teach, The method of claim 1, wherein the set of measurements comprises impedances measured at a rate of N samples per second, wherein N is an integer greater than or equal to 1. Ternes teaches a method for sampling data, storing data, and communicating telemetry to an external device from a typical implantable device that can sample as frequently as every 2.5ms (Ternes [0003]) in order to minimize impact on device longevity (Ternes [0005], [0006], and [0007]). At the time of filing of the invention, it would have been obvious for one of ordinary skill in the art to have modified the lead integrity method of Thakur with methods for high sampling rate in Ternes. In fact, Thakur explicitly does so by incorporating Ternes in its entirety by reference (Thakur [0073]). A predictable result of data being gathered at a frequency greater than 1Hz would ensue.
In regard to claim 12, Thakur teaches the system of claim 11 as discussed above. Thakur fails to teach, The system of claim 11, wherein the set of measurements comprises impedances measured at a rate of N samples per second, wherein N is an integer greater than or equal to 1. Ternes teaches a method for sampling data, storing data, and communicating telemetry to an external device from a typical implantable device that can sample as frequently as every 2.5ms (Ternes [0003]) in order to minimize impact on device longevity (Ternes [0005], [0006], and [0007]). At the time of filing of the invention, it would have been obvious for one of ordinary skill in the art to have modified the lead integrity method of Thakur with methods for high sampling rate in Ternes. In fact, Thakur explicitly does so by incorporating Ternes in its entirety by reference (Thakur [0073]). A predictable result of data being gathered at a frequency greater than 1Hz would ensue.
Claim 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur and Ternes as applied to claims 2, and 12 above, and further in view of Shannon (Procedings of the I.R.E., 1949, doi: 10.1109/JRPROC.1949.232969 hereinafter Shannon) and Haberl, et. al., (European Heart Journal, 1989, doi: 10.1093/oxfordjournals.eurheartj.a059488, hereinafter Haberl).
In regard to claim 3 and 13, Thakur and Ternes teach claims 2 and 12, substantially as discussed above, but do not teach, The method of claim 2, wherein N equals 65. The QRS complex width, representing the electrical activity of systolic contraction of the heart, is roughly 100ms wide (Haberl). By the Nyquist-Shannon sampling theorem systolic contraction of the heart should be sampled at least every 49ms or since N is defined as an integer in the claims, N > 20 (Shannon). For lead impedance variability, faster sampling will generally provide more data, but faster/more sampling and corresponding communication to an external device will also deplete battery life (Ternes [0054]). Therefore, it would have been obvious to optimize the sampling rate in order to provide a sufficient amount of data while balancing battery life. It has been held that "[W]here 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, 105 USPQ 233, 235 (CCPA 1955).
Claims 4, 5, 14, and 15 are rejected under 35 U.S.C. 103 as obvious over Thakur.
In regard to claims 4 and 14, Thakur teaches, the method of claim 1 and the system of claim 11, but fails to specifically teach that the data set comprises 500 measurements. However, Thakuyr does teach continually collecting high temporal resolution data. Therefore, it would be obvious to continually collect high temporal resolution data over the time period of an assessment of lead integrity and to collect a data set of any size sufficient to make a determination based on the data including collecting a data set comprising 500 measurements of impedance as claimed.
In regard to claims 5 and 15, Thakur teaches claims 1 and 11, substantially as discussed above but does not teach, a resolution of the measurements is less than or equal to 0.1 ohms. Thakur teaches high resolution measurements of impedance (Thakur [0073]). Although Thakur fails to teach a specific value for the resolution, it would have been obvious to optimize the resolution in order to detect failure as accurately and early as possible, and further obvious to try, selecting from a range of impedance resolution with the reasonable expectation of effectively detecting lead failure. It has been held that "[W]here 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, 105 USPQ 233, 235 (CCPA 1955).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur as applied to claims 1 and 11 above, and further in view of Ciarleglio (BJPsych Adv. 2021 March ; 27(2): 137–139. doi:10.1192/bja.2020.41. hereinafter Ciarleglio).
In regards to claims 6 and 16, Thakur teaches the method of claim 1 and the system of claim 11, but fails to teach that the metric of variability comprises a standard of deviation of the set of measurements. Ciarleglio teaches measurements of variability and precision in statistics and specifically teaches that standard deviation (s.d.) is a suitable measurement of variability in a data set. Therefore it would have been obvious to a person having ordinary skill in the art at the time of filing to use s.d. of the set of measurements as the measurement of variability as suggested by Ciarleglio in the method of Thakur. One of ordinary skill would have found it obvious to try – selecting from a limited number of identified measurements of variability as in Ciarleglio – to achieve the predictable result of accurately describing the variability in the set of measurements as desired by Thakur. See MPEP 2143(I)(e).
Conclusion
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/SAMUEL FRANK LITTICH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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