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 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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1, 8, 18 and 19 recite methods of operating an implantable pulse generator implanted in a patient, and implantable pulse generators to:
determine an average daily voltage depletion of a battery in the implantable pulse generator per day at a set time of day or in response to the patient waking;
determine a current voltage of the battery in the implantable pulse generator;
determine a depletion voltage of the battery of the implantable pulse generator associated with the battery being depleted; and
transmit an alert in response to the current voltage being less than a sum of the average daily voltage depletion and the depletion voltage.
and
determine a current voltage of a battery in the implantable pulse generator at a set time of day or in response to the patient waking;
determine a current battery fill capacity percentage of the battery corresponding to the current voltage;
determine an average fill capacity percentage drop of the battery per day over a period of time;
determine a low battery voltage corresponding to the average fill capacity percentage drop; and
transmit an alert in response to the current voltage being less than the low battery voltage.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 and 8 are directed to methods, claim 18 and 19 are directed to devices specifically implantable pulse generators and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 8 and 18 and 19 recite:
determine an average daily voltage depletion of a battery in the implantable pulse generator per day at a set time of day or in response to the patient waking;
determine a current voltage of the battery in the implantable pulse generator;
determine a depletion voltage of the battery of the implantable pulse generator associated with the battery being depleted; and
transmit an alert in response to the current voltage being less than a sum of the average daily voltage depletion and the depletion voltage.
and
determine a current voltage of a battery in the implantable pulse generator at a set time of day or in response to the patient waking;
determine a current battery fill capacity percentage of the battery corresponding to the current voltage;
determine an average fill capacity percentage drop of the battery per day over a period of time;
determine a low battery voltage corresponding to the average fill capacity percentage drop; and
transmit an alert in response to the current voltage being less than the low battery voltage.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 8, and 15 recite an abstract idea of a mental process.
Claims 1, 8, 18 and 19 recite the abstract idea of a mental process. The limitations as drafted in the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic implantable pulse generator, a non-volatile memory, a communications device, a power supply and an inertial measurement unit, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example, a clinician/technician can obtain the current battery voltage or current power supply fill capacity from a daily printout and perform the claimed calculations to determine if the current voltage is less than a sum of the daily voltage depletion and the depletion voltage or of the current voltage is less than the low battery voltage to provide an alert.
Further, dependent Claims 2-7, 9-17 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 8, 18 and 19 recite the additional elements of an implantable pulse generator, a non-volatile memory, a communications device, a power supply and an inertial measurement unit and a processor. However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of an implantable pulse generator, a non-volatile memory, a communications device, a power supply and an inertial measurement unit and a processor as recited to perform the steps as claimed amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example: Pei et al (U.S. Patent Application Publication Number: US 2021/0001129 A1, hereinafter “Pei”), Tieu (U.S. Patent Application Publication Number: US 2013/0165819 A1, hereinafter “Tieu”), Gandhi et al (U.S. Patent Application Publication Number: US 2009/0182517 A1, hereinafter “Gandhi”) teach implantable pulse generator comprising a non-volatile memory device, communications device, power supply and inertial measurement unit and a processor) and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible. These additional elements are well‐understood, routine and conventional limitations that do not amount to significantly more.
Note: The claims do not recite any additional positively recited steps of providing and adjusting stimulation or recharging the battery or replacing the battery or device based on the determination of current battery voltage being lower than the average daily voltage depletion and the depletion voltage. the examiner suggests amending the claim to recite additional steps that may be used as a remedy based on the alert to overcome the rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8, 10, 11, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pei et al (U.S. Patent Application Publication Number: US 2021/0001129 A1, hereinafter “Pei”- APPLICANT CITED).
Regarding claims 1 and 18, Pei teaches a method of operating an implantable pulse generator (i.e. IMD e.g. Fig. 10, [0034], [0089]) and an implantable pulse generator (e.g. 1001 Fig.10) configured to be implanted in a patient, the implantable pulse generator comprising:
at least one processor (e.g. 1020 Fig.10);
a non-volatile memory device (e.g. 1060 Fig.10);
a communications device (e.g. 1064 Fig.10);
a power supply (e.g. 1072 Fig. 10); and
an inertial measurement unit (e.g.1070 Fig. 10 [0102]: activity, posture/position sensor), wherein the non-volatile memory device comprises instructions stored therein which, when executed by the at least one processor, cause the at least one processor to:
determine an average daily voltage depletion of a battery in the implantable pulse generator per day at a set time of day (e.g. [0050], [0051]: battery voltage measurements done periodically i.e. once per day) or in response to the patient waking;
determine a current voltage of the battery (i.e. current battery voltage e.g. 704 Fig. 7,[0080]: present battery voltage, [0051]: BV measurement at that point in time) in the implantable pulse generator;
determine a depletion voltage of the battery of the implantable pulse generator associated with the battery being depleted (e.g. [0081],[0082]: delta consumption is calculated and depletion voltage is calculated as remaining battery capacity RBC); and
transmit from the implantable pulse generator to an electronic device remote from the implantable pulse generator, an alert in response to the current voltage being less than a sum of the average daily voltage depletion and the depletion voltage ([0082]: alert is triggered to replace device or recharge battery).
Regarding claims 8 and 19, Pei teaches a method of operating an implantable pulse generator implanted in a patient (i.e. IMD e.g. Fig. 10, [0034], [0089]), and an implantable pulse generator (e.g. 1001 Fig.10) configured to be implanted in a patient, the implantable pulse generator comprising:
at least one processor (e.g. 1020 Fig.10);
a non-volatile memory device (e.g. 1060 Fig.10);
a communications device (e.g. 1064 Fig.10);
a power supply (e.g. 1072 Fig. 10); and
an inertial measurement unit (e.g.1070 Fig. 10 [0102]: activity, posture/position sensor), wherein the non-volatile memory device comprises instructions stored therein which, when executed by the at least one processor, cause the at least one processor to:
determine a current voltage of a battery in the implantable pulse generator at a set time of day (e.g. [0050], [0051]: battery voltage measurements done periodically i.e. once per day) or in response to the patient waking;
determine a current battery fill capacity percentage of the battery corresponding to the current voltage (i.e. current battery voltage e.g. 704 Fig. 7, [0080]: present battery voltage, [0051]: BV measurement at that point in time, Fig.1B: % depth of discharge, [0037]);
determine an average fill capacity percentage drop of the battery per day over a period of time (i.e. BV hist Fig.7, [0079-[0085]);
determine a low battery voltage corresponding to the average fill capacity percentage drop (e.g. Fig.1A, 708 Fig.7, BV current is compared to BV hist to determine if the RBC is within the specified margin to RRT show in Fig.1B); and
transmitting, from the implantable pulse generator to an electronic device remote from the implantable pulse generator, an alert in response to the current voltage being less than the low battery voltage ([0082]: alert is triggered to replace device or recharge battery).
Regarding claim 10, Pei teaches determining, by the at least one processor of the implantable pulse generator, the battery has non-linear discharge characteristics ( e.g. [0043] : non-linear behaviors associated with heavy usage Fig. 5) and wherein the determining the current battery fill capacity percentage corresponding to the current voltage comprises referencing a table comprising a plurality of voltages and a corresponding plurality of battery fill capacities ( e.g. [0050]: BV measurement and battery performance profile curve information, e.g., stored in a look-up- table (LUT)).
Regarding claim 11, Pei teaches determining the current battery fill capacity percentage corresponding to the current voltage further comprises performing linear interpolation between two adjacent battery fill capacities of the plurality of battery fill capacities in the table (e.g. Fig.1B).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Pei et al (U.S. Patent Application Publication Number: US 2021/0001129 A1, hereinafter “Pei”- APPLICANT CITED) in view of Tieu (U.S. Patent Application Publication Number: US 2013/0165819 A1, hereinafter “Tieu”).
Regarding claims 2 and 9, Pei teaches the claimed invention as discussed above and while they teach sensing the sleep-awake state of the patient, they do not specifically teach that determining that the patient has awoken comprises: determining, by an inertial measurement unit of the implantable pulse generator, that the implantable pulse generator is substantially vertical; and determining that the implantable pulse generator is substantially vertical for a threshold duration or at a time within a deviation of a mean or median wakeup time.
In a similar field of endeavor, Tieu teaches an implantable medical device ( e.g. 10 Fig.3) comprising a position sensor (e.g. 54 Fig. 3) and further teaches that the controller (i.e. processor) is configured to determine the posture state by determining that the implantable pulse generator is substantially vertical and determining that the implantable pulse generator is substantially vertical for a threshold duration (e.g. [0057]: a real-time current posture signal from the position sensor 54 may be collected (e.g., 1 minute, 20 minutes, 30 seconds). The current posture signal is compared to the calibration signals for the potential posture states and the actual posture state is determined to be upright or vertical). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Pei to include the posture state determination as taught by Tieu in order to provide the predictable results of providing a more accurate assessment of the patient state.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Pei et al (U.S. Patent Application Publication Number: US 2021/0001129 A1, hereinafter “Pei”- APPLICANT CITED) in view of Gandhi et al (U.S. Patent Application Publication Number: US 2009/0182517 A1, hereinafter “Gandhi”).
Regarding claims 3 and 13, Pei teaches the claimed invention as discussed above and they teach determining, by the at least one processor of the implantable pulse generator, the battery has linear discharge characteristics (e.g. Fig. 5 [0051]: plateau regions). but they do not specifically teach determining a standard deviation of the average daily voltage depletion over a period of time, wherein the transmitting the alert is in response to the current voltage being below a sum of the average daily voltage depletion and an integer multiple of the standard deviation.
In a similar field of endeavor, Gandhi teaches an implantable medical device comprising a processor that is configured to determine an abnormal battery depletion (e.g. abstract and determining a standard deviation of the average daily voltage depletion over a period of time, wherein the transmitting the alert is in response to the current voltage being below a sum of the average daily voltage depletion and an integer multiple of the standard deviation ( e.g. Fig. 9 ,[0058]: nominal minus one standard deviation for the minimum voltage 905, and nominal plus one standard deviation for the maximum voltage). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Pei to include the teachings of Gandhi in order to provide the predictable results of a more accurate assessment of the battery capacity.
Claim 12 are rejected under 35 U.S.C. 103 as being unpatentable over Pei et al (U.S. Patent Application Publication Number: US 2021/0001129 A1, hereinafter “Pei”- APPLICANT CITED) in view of Ho (U.S. Patent Application Publication Number: US 2011/0037475 A1, hereinafter “Ho”)
Regarding claim 12, Pei teaches a look up table g. [0050]: BV measurement and battery performance profile curve information, e.g., stored in a look-up- table (LUT)) as discussed above but do not specifically teach generating the table by discharging, with a fixed resistor or a fixed current sink, the battery of the implantable pulse generator; measuring a voltage of the battery at regular intervals during the discharging to generate the plurality of voltages; and determining the plurality of battery fill capacities corresponding to the plurality of voltages.
Ho teaches that it is well known to discharge a battery (e.g. 10 Fig.1) with a fixed resistor or a fixed current sink (e.g. 50,30 Fig.1) and measure a voltage of the battery at regular intervals during the discharging to generate the plurality of voltages and determine a plurality of battery fill capacities corresponding to the plurality of voltages (e.g. Fig. 2, [0014], [0015]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Pei to determine the table as taught by Ho in order to provide the predictable results of providing an accurate assessment of the battery status.
Claim 4 recites detecting a change in stimulation parameter of the implantable pulse generator and modifying the average daily voltage depletion based on the change. The prior art fails to teach the detecting a change in stimulation parameter of the implantable pulse generator and modification of the daily depletion based on the stimulation changes as claimed. Claim 14 recites detecting a change in a charge delivered by an electrode of the implantable pulse generator due to a change in at least one stimulation parameter of the implantable pulse generator. The prior art fails to teach the detection of a change in a charge delivered by an electrode of the implantable pulse generator due to a change in at least one stimulation parameter of the implantable pulse generator as claimed.
While no prior art rejection has been provided for claims 4-7 and 14-17, they cannot be indicated as allowable due to the rejection under 35 U.S.C. 101 discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792