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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/22/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that independent claim 1 recites “a non-rechargeable battery that is one of population of non-rechargeable batteries” and that the “population of non-rechargeable batteries” is to provide characteristics of the non-rechargeable battery, and therefore the citation to Gielen does not appear to be relevant. It appears the applicant is affording this recitation a narrower interpretation than that afforded by the examiner. Examiner is affording the claim language, “a non-rechargeable battery that is one of a population of non-rechargeable batteries”, it’s broadest reasonable interpretation as indicating there is a population/plurality of batteries present in the IMD and the “non-rechargeable battery” recited is one of this population/plurality. The interpretation afforded by the examiner appears to be supported by the applicant’s disclosure as recited in Specification ¶0093: “power source 224 may include any one or more of a plurality of different battery types”. Therefore, the examiner believes the obviousness modification in view of Gielen, as disclosed in the Final Rejection mailed 09/22/2025, is relevant.
Moreover, as disclosed in the Final Rejection mailed 09/22/2025, Gielen is relied upon to teach the claim element of using a population of batteries for the IMD, instead of a single battery, as taught by Armstrong. A person having ordinary skill in the art would be motivated to make this change to the system for a benefit of an increased battery capacity by using a population of batteries connected in parallel.
Applicant further argues that the rejection of claim 1 does not show how the voltage value of VKnee is equivalent to the “battery threshold voltage derived from a shared voltage magnitude, each of the non-rechargeable batteries in the population having a characteristic to converge at the shared voltage magnitude… and each having a same estimated percent depth of discharge (%DoD) at the charge voltage magnitude”. Examiner respectfully disagrees. As disclosed in the rejection of claim 1, as presented in the Final Rejection mailed 09/22/2025, and in view of the interpretation of the claim provided above, the examiner explains that it would be an obvious modification of Armstrong, in view of Gielen. When using a population of batteries connected in parallel, it would be obvious to determine a VKnee for a population of cells as the same for a VKnee for a single cell, by ensuring the cells which make up the population are the same, i.e. having the same chemistry/starting voltage/capacity, since it is understood that the voltage measured across the cells would be unchanged from a voltage measured on a single cell; voltages do not add when connected in parallel. This would allow for improved accuracy in the system measurement by ensuring the batteries in the population converge at the same shared voltage magnitude associated with the same %DoD, at the same time.
Applicant replied to the Examiner’s response, regarding limitations from the specification are not read into the claims, stating that the information from the specification was included to assist with understanding of the independent claim and not to rely on limitations from the specification. Examiner respectfully disagrees. It appears that the applicant is reading limitations from the specification into the claims by interpreting independent claim 1 where the batteries in the population of non-rechargeable batteries have different starting voltages and discharge curves, as shown in applicant’s Fig.2B. This interpretation is narrower than that afforded by the examiner since the claim as written does not preclude a broad reasonable interpretation that the population of batteries have the same starting voltage and discharge curve. With this interpretation batteries of the same chemistry would be understood to converge at a shared voltage magnitude and have the same %DoD at the shared voltage magnitude.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., each of the non-rechargeable batteries in the population having a different voltage discharge curve and different total capacity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
Claim(s) 1, 13, & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong et al. (USPGPN 2007/0179548 A1 – published 2007), in view of Gielen (USPGPN 2003/0204219 A1 – published 2003).
Regarding Claims 1 & 13, Armstrong (Figs. 2-4 & 7) teaches a system comprising:
at least one electrode configured to deliver electrical stimulation to a patient (125); and
an implantable medical device (IMD), the IMD comprising:
processing circuitry (220) operatively coupled to a memory (280);
a non-rechargeable battery (210: ¶0039: battery unit 210 may be non-rechargeable); and
a sensor, operatively coupled to the processing circuitry, the sensor configured to measure a battery voltage of the non-rechargeable battery (¶0043: voltage determination unit measures voltage of the battery, indicating presence of a sensor),
wherein the memory is configured to store (¶0039: memory stores program codes and data) a battery voltage threshold (Vknee-) derived from a voltage magnitude (Vknee corresponds to a voltage value) prior to the end of service life (VEOS), and having an estimated percent depth of discharge (%DoD) at the voltage magnitude (¶0084: percentage of battery capacity typically remaining at the knee; battery capacity, or state of charge, is the opposite of depth of discharge and therefore a percent of battery capacity remaining would also indicate the percent of capacity used, or depth of discharge); and
wherein the processing circuitry is configured to:
calculate an amount of time remaining before the end of service life of the non- rechargeable battery (430), wherein the calculation is based on:
receiving an indication from the sensor that the measured battery voltage satisfies the battery voltage threshold (760), and
a usage rate of electrical energy output by the battery (770 & 775: current usage); and
output an elective replacement indicator (ERI) based on the calculation (790).
Armstrong fails to explicitly teach a population of non-rechargeable batteries, the battery voltage threshold derived voltage magnitude is a voltage magnitude where each of the non-rechargeable batteries in the population have a characteristic to converge at the shared voltage magnitude prior to end of service life and each having a same estimated %DoD at the shared voltage magnitude.
However, Gielen teaches an IMD which uses a population of batteries (¶0077: electrical power supply 308 can include one or more electrochemical cells).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong to include a population of batteries. Doing so would provide a higher capacity via a parallel connection.
Armstrong, in view of Gielen, discloses the claimed invention except for the battery voltage threshold is not explicitly disclosed as derived from a shared voltage magnitude. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to determine the battery voltage threshold from a shared voltage magnitude, a magnitude equal to the voltage value of Vknee for each of the number of battery cells, by providing the same battery, i.e. same chemistry/starting voltage/capacity, for each of the batteries in the population. Doing so would provide improved accuracy for the system since each battery in the population would have the same shared voltage magnitude and %DoD at the same time, and allow for a voltage measurement of the entire population to determine if the shared magnitude is reached rather than a measurement per battery (a Vknee of 2.6V for a battery cell would be equivalent to a Vknee of 2.6V for two battery cells in parallel).
Examiner’s note: The claim as written does not preclude a broad reasonable interpretation that the population of batteries have the same starting voltage. With this interpretation batteries of the same chemistry would be understood to converge at a shared voltage magnitude and have the same %DoD at the shared voltage magnitude.
Regarding Claim 20, Armstrong (Figs.2-4 & 7) teaches a method for operating a battery powered medical device, the method comprising:
receiving, from a sensor operatively coupled to a non-rechargeable battery, a battery voltage of the non-rechargeable battery (¶0043: voltage determination unit measures voltage of the battery, indicating presence of a sensor);
comparing, by processing circuitry, the received battery voltage to a battery voltage threshold stored at a memory operatively coupled to the processing circuitry (¶0039: memory stores program codes and data; Vknee- threshold),
wherein the battery voltage threshold is derived from a voltage magnitude (Vknee corresponds to a voltage value),
the non-rechargeable battery having an estimated percent depth of discharge (%DoD) at the voltage magnitude (¶0084: percentage of battery capacity typically remaining at the knee; battery capacity, or state of charge, is the opposite of depth of discharge and therefore a percent of battery capacity remaining would also indicate the percent of capacity used, or depth of discharge);
in response to determining that the received battery voltage satisfies the battery voltage threshold (760), calculating, by the processing circuitry, an amount of time remaining before the end of service life of the non-rechargeable battery (430), wherein the calculation is based on the estimated percent depth of discharge (%DoD) at the voltage magnitude (¶0085, Eq.9: %knee) and a usage rate of electrical energy output by the non-rechargeable battery (770 & 775: current usage).
Armstrong fails to explicitly teach a population of non-rechargeable batteries, the battery voltage threshold derived voltage magnitude is a voltage magnitude where each of the non-rechargeable batteries in the population have a characteristic to converge at the shared voltage magnitude prior to end of service life and each having a same estimated %DoD at the shared voltage magnitude.
However, Gielen teaches an IMD which uses a population of batteries (¶0077: electrical power supply 308 can include one or more electrochemical cells).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong to include a population of batteries. Doing so would provide a higher capacity via a parallel connection.
Armstrong, in view of Gielen, discloses the claimed invention except for the battery voltage threshold is not explicitly disclosed as derived from a shared voltage magnitude. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to determine the battery voltage threshold from a shared voltage magnitude, a magnitude equal to the voltage value of Vknee for each of the number of battery cells, by providing the same battery, i.e. same chemistry/starting voltage/capacity, for each of the batteries in the population. Doing so would provide improved accuracy for the system since each battery in the population would have the same shared voltage magnitude and %DoD at the same time, and allow for a voltage measurement of the entire population to determine if the shared magnitude is reached rather than a measurement per battery (a Vknee of 2.6V for a battery cell would be equivalent to a Vknee of 2.6V for two battery cells in parallel).
Claim(s) 2, 4-7, 11, 12, 14, 16-19, 22, & 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong, in view of Gielen, as applied in the rejections of claims 1 & 13 above, and further in view of Kelly et al. (US Patent 6,820,019 B1 – published 2004).
Regarding Claims 2 & 14, Armstrong further teaches wherein the processing circuitry is configured to determine the usage rate based on the %DoD used per unit time (¶0055: usage rate is a rate at which electrical charge is depleted from a battery).
Armstrong fails to explicitly teach wherein the processing circuitry calculates the usage rate by dividing the used %DoD of the non-rechargeable battery by a length of time since beginning of life.
However, Kelly teaches that a usage rate can also be determined based on dividing the used %DoD of the non-rechargeable battery by a length of time since beginning of life (Col.7, lines 8-10: usage rate is determined by dividing the used capacity by the length of time the device has been in operation).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong, in view of Gielen, with Kelly to include a usage rate based on the %DoD of the non-rechargeable battery divided by the length of time since beginning of life. Doing so would allow for an average usage rate for calculating the remaining time of service for the battery based on an average usage pattern since beginning of life rather than estimated consumption rates.
Regarding Claim 4 & 16, Armstrong fails to explicitly teach wherein the usage rate is a first usage rate, and
wherein to calculate the amount of time remaining, the processing circuitry is configured to calculate the amount of time remaining based on an estimation that the first usage rate from beginning of life (BOL) to a percent depth of discharge (%DoD) at which the sensor indicates that the battery voltage satisfies the battery voltage threshold, will be substantially the same as a second usage rate from when the battery voltage satisfies the battery voltage threshold to the end of service life.
However, Kelly teaches the usage rate determined based on the beginning of life to a %DoD is used to further determine the time until the end of service life (Col.7, lines 8-14: The usage rate is determined from the time the device has been working and a percent depth of discharge. This same usage rate is used to determine an estimated remaining time until the battery is expended).
Armstrong, in view of Gielen and Kelly, does not specifically identify these as two different usage rates, one associated with the timeframe before calculation and one associated with the timeframe after calculation, however, the system taught by Armstrong, in view of Kelly, is functionally equivalent. Armstrong, in view of Kelly, uses a usage rate to determine an estimated remaining time until the battery is expended (second usage rate), which is the same (substantially similar) as the usage rate from the beginning of life to the calculation time (first usage rate).
Regarding Claims 5 & 17, Armstrong further teaches wherein the processing circuitry is configured to output the elective replacement indication at a predetermined calculated time remaining before the end of service life, (¶0087: ERI is typically 1 week to 1 year, typically 6 months, earlier than the end of service), wherein the predetermined calculated time remaining is based on: %DoD; and the second usage rate (as disclosed in the rejection of claim 4 above).
Regarding Claim 6, Armstrong further teaches the calculation of the amount of time remaining before the end of service life is based on the time from the beginning of operation of the device to a calculation time and the percent depth of discharge at the calculation time, (as disclosed in the rejection of claim 4 above).
Armstrong, in view of Gielen and Kelly, fails to explicitly teach wherein the calculation is according to: X * (1-Y)/Y, wherein: X is the amount of time from beginning of life (BOL) to a time the processing circuitry received the indication from the sensor that the measured battery voltage equals the shared voltage magnitude, and Y is a percent depth of discharge at which the measured battery voltage equals the shared voltage magnitude.
However, Armstrong, in view of Gielen and Kelly, teaches an equation equivalent to the equation claimed. Armstrong, in view of Gielen and Kelly, teaches that the remaining time is calculated using the remaining depth of discharge divided by a usage rate. The usage rate is determined using by dividing the depth of discharge at the time of calculation, by the time from the beginning of operation of the device to the time of calculation. Substituting the usage rate for the formula allows us to view the remaining time calculation as a time from the beginning of operation of the device to the time of calculation, multiplied by a remaining depth of discharge (inherently 1 - the current percent depth of discharge), then divided by the current percent depth of discharge.
Regarding Claim 7, Armstrong further teaches wherein the processing circuitry is configured to output the elective replacement indication at a time in which the processing circuitry received the indication from the sensor that the measured battery voltage satisfies the battery voltage threshold (Fig.7, indicator 790 is generated after voltage is below voltage at transition point).
Regarding Claims 11 & 18, Armstrong further teaches wherein the processing circuitry is configured to output an indication of end of service life based on a calculated duration after the processing circuitry outputs the indication of the elective replacement indicator (¶0036: EOS signal provides indication the operation of the implantable device is at or near termination while ERI is a recommended replacement point, indicating EOS would be after ERI).
Regarding Claims 12 & 19, Armstrong further teaches wherein the processing circuitry is configured to output an indication of end of service life based on the measured battery voltage satisfying an end of service life threshold stored in a look-up table at the memory and after the processing circuitry outputs the indication of the elective replacement indicator (Fig.3, VEOS is less than Vknee).
Regarding Claim 22, Armstrong further teaches wherein the shared voltage magnitude is less than a voltage magnitude associated with a beginning of life of the battery and greater than a voltage magnitude associated with end of service life (Fig.3, Vknee is prior to VEOS and after beginning of life of the battery).
Regarding Claim 23, this claim appears to be a substantial repetition of claim 22, except the battery voltage threshold is “based on” a shared voltage magnitude associated with end of service life, instead of “derived from”. “Based on” is a broader limitation than “derived from”, and would therefore be rejected for the same reasons as claim 22.
Claim(s) 3, 15, & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong, in view of Gielen, as applied in the rejections of claims 1 & 13 above, and further in view of Davis et al. (USPGPN 2011/0106213 A1 – 2011).
Regarding Claims 3 & 15, Armstrong, further teaches wherein the sensor comprises an electrical voltage sensor (¶0043: voltage determination unit).
Armstrong fails to explicitly teach the device further comprising an electrical current sensor configured to measure battery electrical current magnitude, wherein the processing circuitry is configured to determine the usage rate based on the measured battery electrical current magnitude, and wherein the processing circuitry is configured to determine the amount of time remaining before the end of service life of the non-rechargeable battery based on: the measured battery electrical current magnitude; and the %DoD.
However, Davis teaches a system which uses a current sensor (Fig.3, 55) which measures a current magnitude and where the measured current magnitude is used with the amount of remaining power to determine a time remaining until end of service (¶0124: The coulomb counter may measure the amount of current output relative to the amount of charge remaining to determine the amount of time until recharge).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong, in view of Kelly, with Davis to include a current sensor and use the current measurement to determine a time remaining before the end of service life. Doing so may allow for an indication that an adjustment could be made to reduce the energy consumption of the device, as evidenced by Davis.
Regarding Claim 21, Armstrong fails to explicitly teach wherein the IMD comprises a pudendal neuromodulation device.
However, Davis teaches that IMDs may be used to stimulate pelvic nerves or muscles (¶0043: other systems may be configured to stimulate pelvic nerves; Examiner equates pelvic nerves to pudendal nerves).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong, in view of Gielen, with Davis to include a pudendal neuromodulation device. Doing so would allow for stimulation of a pudendal nerve to provide pelvic floor stimulation, as taught by Davis (¶0048).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong, in view of Gielen, as applied in the rejection of claim 1 above, and further in view of Schmidt et al. (USPGPN 2008/0177345 A1 – published July 24, 2008).
Regarding Claim 8, Armstrong fails to explicitly teach wherein the battery voltage threshold is based on a guard band associated with the shared voltage magnitude.
However, Schmidt teaches that it is common for measurements to be given a guard band when compared to a predetermined value (¶0018: it is determined if a difference between a determined voltage and a measured voltage is less than .0001 volt).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong, in view of Gielen, with Schmidt to include a guard band associated with the shared voltage magnitude to base the battery voltage threshold. Doing so allows for a small level of compensation relating to the comparison to a threshold, in an event of an inaccurate measurement.
Claim(s) 9 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong, in view of Gielen, as applied in the rejection of claim 1 above, and further in view of Younker et al. (USPGPN 2019/0209847 A1 – published July 11, 2019).
Regarding Claim 9, Armstrong fails to explicitly teach wherein the non-rechargeable battery comprises SVO battery chemistry (or battery type).
However, Younker teaches an IMD which uses SVO battery chemistry (¶0061: power source may comprise SVO battery).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by Armstrong, in view of Gielen, with Younker to use SVO batteries for the non-rechargeable battery. Doing so would provide a relatively long, flat plateau of the battery voltage near the end of service, as taught by Younker.
Regarding Claim 10, Armstrong further teaches wherein the shared voltage magnitude is approximately the same magnitude for each non-rechargeable battery in the population of non-rechargeable batteries (as disclosed in the rejection of claim 1 above) with manufacturing variability (BRI of manufacturing variability may be related to physical variability and not electrical).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P ONDRASIK whose telephone number is (703)756-1963. The examiner can normally be reached Monday - Friday 7:30 a.m. - 5 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julian Huffman can be reached at (571) 272-2147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN P ONDRASIK/Examiner, Art Unit 2859
/JULIAN D HUFFMAN/Supervisory Patent Examiner, Art Unit 2859