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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/28/2026 has been entered.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant’s arguments, filed 01/28/2026, with respect to the claims 1-24 under 35 USC § 101 have been fully considered and are persuasive. The 35 USC § 101 rejections of claims 1-24 are withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive. Applicant argues that the Armstrong (US 20070100407 A1 – hereinafter Armstrong) references, fails to teach the limitations of “…calculating a first impedance value of a lead…calculating a second impedance value of the electrical stimulation device...” as claimed in claims 1, 7, 13 and 17. Examiner respectfully disagrees; under the broadest reasonable interpretation of the claims, claims 1, 7, 13 and 17, which requires calculating a first impedance value of a lead, Examiner relies on the Armstrong figure 2, 1st impedance 240, which details in paragraph 0039 – “The first impedance may be indicative of the lead impedance of the lead that couples the first electrode 220 to the IMD 200”. Although the passage states that the impedance 240 is of the first electrode 220 and IMD 200, the passage states that the impedance 240 would also indicate the impedance of the lead which connects the first electrode 220 to the IMD 200, and therefore impedance of the lead is calculated as required by the claims. As per the calculation of the second impedance value of the electrical stimulation device, Examiner relies on Armstrong’s figure 2, 2nd impedance 260 and paragraph 0039 – “The IMD 200 may also measure a second impedance 260, which is the impedance of the second electrode 230 in relation to a reference electrode, e.g., the case 121 of the IMD 200”), where the bidirectionality of the 2nd impedance 260 includes the impedance of the IMD 200. Therefore, under the broadest reasonable interpretation of the claims, the second impedance 260 including the IMD 200 would sufficiently obtain the second impedance of the IMD and would satisfy the limitations as required by the claims.
PNG
media_image1.png
258
262
media_image1.png
Greyscale
PNG
media_image2.png
372
464
media_image2.png
Greyscale
In response to applicant's argument that additional reference Parker (US 20110009927 A1 – hereinafter Parker) does not teach the technical features of claims 1, 7, 13 and 17, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Armstrong teaches an electrical stimulation device performing the required calculation of lead impedance and IMD device impedance, as stated in the rejection below. Parker is relied upon in the same field of endeavor to teach another electrical stimulation device and the known functions/steps of measuring a total impedance value, obtaining a tissue impedance value by subtracting the first impedance value and the second impedance value from the total impedance value, and an electrical stimulation signal according to the tissue impedance value, in which one of ordinary skill in the art would reasonably combine/modify one reference which teaches calculation of first lead and second IMD impedance (Armstrong), with another reference teaching total impedance value measurement and respective subtraction from the total impedance value while generating and delivering stimulation (Parker as stated in the rejection below) to predictably result in delivering appropriate electrical therapy signals to a patient based on impedance (Parker abstract) and address patient pain (Parker paragraph 0004). Furthermore, the step of “…obtaining a tissue impedance value by…” is considered an intended result that should result from meeting all the claimed steps, which the combination meets by subtracting the first impedance value and the second impedance value from the total impedance value, as stated in the rejection below. Furthermore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Parker teaches the claimed limitation in the amendment, “…and by the electrical stimulation device, transmitting the electrical stimulation signal to a target region for performing an electrical stimulation treatment…”, as stated in the rejection below.
Newly cited reference Guillory (US 20160121115 A1 – hereinafter Guillory) is relied upon to teach the amendment, “…wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment”, as stated in the rejection below.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CN202111633749.6, filed on December 29, 2021.
Information Disclosure Statement
The information disclosure statement(s) filed July 13, 2023 has/have been considered by the Examiner.
Claim Interpretation
The term(s) “for” and “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Furthermore, the employment of the claimed steps must inherently produce the same intended results else the claims are incomplete for failing to recite a critical aspect of the invention.
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(s) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong (US 20070100407 A1 – hereinafter Armstrong) in view of Parker (US 20110009927 A1 – hereinafter Parker) and Guillory (US 20160121115 A1 – hereinafter Guillory) [NEW].
Re. claim 1, Armstrong, as best understood, teaches an electrical stimulation method comprising by an impedance compensation device (figure 3, impedance unit 350; paragraph 0049 – “The impedance unit 350 is capable of calculating the impedance…”, which Examiner interprets to align with Applicant’s impedance compensation device 600 in figure 6 comprising measurement circuit 610, which measures impedance), calculating a first impedance value of a lead (figure 2, 1st impedance 240; paragraph 0039 – “The first impedance may be indicative of the lead impedance of the lead that couples the first electrode 220 to the IMD 200”);
PNG
media_image3.png
372
464
media_image3.png
Greyscale
by the impedance compensation device (figure 3, impedance unit 350), calculating a second impedance value of the electrical stimulation device (figure 2, 2nd impedance 260, where the bidirectionality of the 2nd impedance 260 includes the impedance of the IMD 200; paragraph 0039 – “The IMD 200 may also measure a second impedance 260, which is the impedance of the second electrode 230 in relation to a reference electrode, e.g., the case 121 of the IMD 200.”).
PNG
media_image1.png
258
262
media_image1.png
Greyscale
Armstrong does not explicitly teach providing the high-frequency environment, and by the electrical stimulation device, measuring a total impedance value by the electrical stimulation device, obtaining a tissue impedance value by subtracting the first impedance value and the second impedance value from the total impedance value; by the electrical stimulation device, generating an electrical stimulation signal according to the tissue impedance value; and by the electrical stimulation device, transmitting the electrical stimulation signal to a target region for performing an electrical stimulation treatment.
Parker teaches a similar stimulation system based on impedance (Parker abstract – “System and methods for adjusting electrical therapy based on impedance changes are disclosed herein”), comprising a stimulation system 100 with a detector 119 (Parker figure 4A), and teaches its system providing a high-frequency environment (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
PNG
media_image4.png
264
536
media_image4.png
Greyscale
Parker further teaches by the electrical stimulation device, measuring a total impedance value by the electrical stimulation device (Parker paragraph 0044 – “In any of the foregoing embodiments, the detector 119 will typically detect the impedance of a circuit that includes at least two contacts, e.g., C1 and C2… In any of these cases, however, the impedance of the tested circuit will include the impedances of all the contacts in the circuit…For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
obtaining a tissue impedance value by subtracting the first impedance value and the second impedance value from the total impedance value (Parker paragraph 0044 – “For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
by the electrical stimulation device, generating an electrical stimulation signal according to the tissue impedance value (Parker paragraph 0024 – “Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”),
PNG
media_image5.png
312
324
media_image5.png
Greyscale
and by the electrical stimulation device, transmitting the electrical stimulation signal to a target region for performing an electrical stimulation treatment -(figure 2, step 227 which adjust stimulation delivered based on the impedance changes; paragraph 0024 – “The process 220 includes applying electrical therapy to a patient via an implanted or partially implanted system (process portion 225)…Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”).
Armstrong and Parker all teach within the field of impedance measuring systems, specifically with stimulation devices. Therefore, 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 invention of Armstrong, specifically the stimulation device, to incorporate the stimulation device functions of providing a high-frequency environment, obtaining total impedance value, subtracting impedance values from a total impedance value, and generating a stimulation signal according to the tissue impedance, as taught by Parker, since such modification would predictably result in delivering appropriate electrical therapy signals to a patient based on impedance (Parker abstract) and address patient pain (Parker paragraph 0004).
The combined invention of Armstrong and Parker (hereinafter the combined invention) does not explicitly teach wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment.
Guillory teaches an implantable electrical stimulation system (abstract – “Disclosed herein are various embodiments of electrical stimulation systems configured to stimulate tissue in a subject”) which measures impedance (paragraph 0036 – “The stimulator may also include programmable ranges that are sufficiently small (e.g., below 1 μA peak-to-peak) to synthesize low-level sine waves and other signals for measurement of electrode impedance”).
Guillory further teaches wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment (Guillory teaches the system which sets safety limits on stimulation voltages to stop stimulation, paragraph 0039 – “The resting and stimulated voltages for the electrodes can also be used to detect problems and faults with the electrodes and output circuitry of the stimulator. Stimulation response waveforms can be tested against known templates for stimulation impedance and voltage features. The system 100 may include methods for setting safety limits for these features and other basic features such as peak response voltage or total estimated charge per cycle. These limits may be used to prematurely stop or limit stimulation cycles or force the module into a fail-safe condition”).
Therefore, 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 combined invention, specifically the electrical stimulation delivering, to incorporate the target energy value safety limits as taught by Guillory since such modification would predictably result in preventing tissue damage to a patient when delivering stimulation pulses.
Re. claim 2, the newly combined invention of Armstrong, Parker and Guillory (hereinafter the combined invention) further teaches wherein the high-frequency environment is simulated with an electrical stimulation frequency used by the electrical stimulation device (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 3, the combined invention further teaches wherein a pulse frequency range of the high-frequency environment is between 1 KHz and 1000 KHz (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 4, the combined invention further teaches wherein the impedance compensation device is an external device or is arranged within the electrical stimulation device (Armstrong figure 3, impedance unit 350 within implantable medical device 200; paragraph 0049 – “The impedance unit 350 is capable of calculating the impedance…”).
PNG
media_image6.png
322
422
media_image6.png
Greyscale
Re. claim 5, the combined invention further teaches wherein the lead is implanted into a tissue of a human body (Armstrong paragraph 0036 – “Embodiments of the present invention provide for assessing a lead and/or an electrode condition associated with an implantable medical device system, which includes an implantable medical device, a plurality of leads and a plurality of electrodes. Various electrodes and corresponding leads may be implanted into a portion of a patient's body, such as a portion of a vagus nerve”, shown in figure 1D with lead 122 attached to vagus nerve 127).
PNG
media_image7.png
262
242
media_image7.png
Greyscale
Re. claim 6, the combined invention further teaches wherein the lead and the electrical stimulation device are implanted into a tissue of a human body (Armstrong figure 1B shows the lead 122 implanted in the vagus nerve 127, and signal generator case 121 implanted inside a chest cavity/pocket 145 in the body).
PNG
media_image8.png
414
390
media_image8.png
Greyscale
Re. claim 7, Armstrong, as best understood, teaches an electrical stimulation system (paragraph 0013 – “The IMD includes a stimulation unit to providing a first test signal to a first electrode coupled to the IMD through a first lead and to provide a second test signal to a second electrode coupled to the IMD through a second lead”), the system including:
a lead (figure 2 shows leads connecting first electrode 220, second electrode 230 to the IMD 200);
an electrical stimulation device (figure 2, implantable medical device [IMD] 200; paragraph 0038 – “The implantable medical device 200 (IMD) is capable of delivering a stimulation signal to a portion of the patient's body…”);
PNG
media_image9.png
372
464
media_image9.png
Greyscale
And an impedance compensation device (figure 3, impedance unit 350; paragraph 0049 – “The impedance unit 350 is capable of calculating the impedance…”, which Examiner interprets to align with Applicant’s impedance compensation device 600 in figure 6 comprising measurement circuit 610, which measures impedance), calculating a first impedance value of a lead (figure 2, 1st impedance 240; paragraph 0039 – “The first impedance may be indicative of the lead impedance of the lead that couples the first electrode 220 to the IMD 200”);
PNG
media_image3.png
372
464
media_image3.png
Greyscale
And impedance compensation device (figure 3, impedance unit 350), calculating a second impedance value of the electrical stimulation device (figure 2, 2nd impedance 260, where the bidirectionality of the 2nd impedance 260 includes the IMD; paragraph 0039 – “The IMD 200 may also measure a second impedance 260, which is the impedance of the second electrode 230 in relation to a reference electrode, e.g., the case 121 of the IMD 200”);
PNG
media_image1.png
258
262
media_image1.png
Greyscale
Armstrong does not explicitly teach providing the high-frequency environment, and wherein the electrical stimulation device measures a total impedance value, the electrical stimulation device obtains a tissue impedance value by subtracting the first impedance value and the second impedance value from the total impedance value, and the electrical stimulation device generates an electrical stimulation signal according to the tissue impedance value; and the electrical stimulation device transmits the electrical stimulation signal to a target region for performing an electrical stimulation treatment.
Parker teaches a similar stimulation system based on impedance (Parker abstract – “System and methods for adjusting electrical therapy based on impedance changes are disclosed herein”), comprising a stimulation system 100 with a detector 119 (Parker figure 4A) and teaches its system providing a high-frequency environment (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
PNG
media_image4.png
264
536
media_image4.png
Greyscale
Parker further teaches wherein the electrical stimulation device measures a total impedance value (Parker paragraph 0044 – “In any of the foregoing embodiments, the detector 119 will typically detect the impedance of a circuit that includes at least two contacts, e.g., C1 and C2… In any of these cases, however, the impedance of the tested circuit will include the impedances of all the contacts in the circuit…For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
the electrical stimulation device obtains a tissue impedance value by subtracting the first impedance value and the second impedance value from the total impedance value (Parker paragraph 0044 – “For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
the electrical stimulation device generates an electrical stimulation signal according to the tissue impedance value (Parker paragraph 0024 – “Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”).
PNG
media_image5.png
312
324
media_image5.png
Greyscale
and the electrical stimulation device transmits the electrical stimulation signal to a target region for performing an electrical stimulation treatment (Parker figure 2, step 227 which adjust stimulation delivered based on the impedance changes; paragraph 0024 – “The process 220 includes applying electrical therapy to a patient via an implanted or partially implanted system (process portion 225)…Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”);
Armstrong and Parker all teach within the field of impedance measuring systems, specifically with stimulation devices. Therefore, 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 invention of Armstrong, specifically the stimulation device, to incorporate the stimulation device functions of providing a high-frequency environment, obtaining total impedance value, subtracting impedance values from a total impedance value, and generating a stimulation signal according to the tissue impedance, as taught by Parker, since such modification would predictably result in delivering appropriate electrical therapy signals to a patient based on impedance (Parker abstract) and address patient pain (Parker paragraph 0004).
The combined invention of Armstrong and Parker (hereinafter the combined invention) does not explicitly teach wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment.
Guillory teaches an implantable electrical stimulation system (abstract – “Disclosed herein are various embodiments of electrical stimulation systems configured to stimulate tissue in a subject”) which measures impedance (paragraph 0036 – “The stimulator may also include programmable ranges that are sufficiently small (e.g., below 1 μA peak-to-peak) to synthesize low-level sine waves and other signals for measurement of electrode impedance”).
Guillory further teaches wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment (Guillory teaches the system which sets safety limits on stimulation voltages to stop stimulation, paragraph 0039 – “The resting and stimulated voltages for the electrodes can also be used to detect problems and faults with the electrodes and output circuitry of the stimulator. Stimulation response waveforms can be tested against known templates for stimulation impedance and voltage features. The system 100 may include methods for setting safety limits for these features and other basic features such as peak response voltage or total estimated charge per cycle. These limits may be used to prematurely stop or limit stimulation cycles or force the module into a fail-safe condition”).
Therefore, 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 combined invention, specifically the electrical stimulation delivering, to incorporate the target energy value safety limits as taught by Guillory since such modification would predictably result in preventing tissue damage to a patient when delivering stimulation pulses.
Re. claim 8, the combined invention further teaches wherein the impedance compensation device simulates the high-frequency environment with an electrical stimulation frequency used by the electrical stimulation device (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 9, the combined invention further teaches wherein a pulse frequency range of the high-frequency environment is between 1 KHz and 1000 KHz (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 10, the combined invention further teaches wherein the impedance compensation device is an external device or is arranged within the electrical stimulation device (Armstrong figure 3, impedance unit 350).
PNG
media_image6.png
322
422
media_image6.png
Greyscale
Re. claim 11, the combined invention further teaches wherein the lead is implanted into a tissue of a human body (Armstrong paragraph 0036 – “Embodiments of the present invention provide for assessing a lead and/or an electrode condition associated with an implantable medical device system, which includes an implantable medical device, a plurality of leads and a plurality of electrodes. Various electrodes and corresponding leads may be implanted into a portion of a patient's body, such as a portion of a vagus nerve”, shown in figure 1D with lead 122 attached to vagus nerve 127).
PNG
media_image7.png
262
242
media_image7.png
Greyscale
Re. claim 12, the combined invention further teaches wherein the lead and the electrical stimulation device are implanted into a tissue of a human body (Armstrong figure 1B shows the leads implanted in the vagus nerve, and signal generator case 121 implanted inside a chest cavity/pocket 145 in the body).
PNG
media_image8.png
414
390
media_image8.png
Greyscale
Re. claim 13, Armstrong, as best understood, teaches an electrical stimulation method comprising by an impedance compensation device (figure 3, impedance unit 350; paragraph 0049 – “The impedance unit 350 is capable of calculating the impedance…”, which Examiner interprets to align with Applicant’s impedance compensation device 600 in figure 6 comprising measurement circuit 610, which measures impedance),
calculating an impedance value of the electrical stimulation device (figure 2, 2nd impedance 260; paragraph 0039 – “The IMD 200 may also measure a second impedance 260, which is the impedance of the second electrode 230 in relation to a reference electrode, e.g., the case 121 of the IMD 200.”);
PNG
media_image1.png
258
262
media_image1.png
Greyscale
Armstrong does not explicitly teach providing the high-frequency environment, by the electrical stimulation device, measuring a total impedance value by the electrical stimulation device, obtaining a tissue impedance value by subtracting the impedance value from the total impedance value; by the electrical stimulation device, generating an electrical stimulation signal according to the tissue impedance value; and by the electrical stimulation device, transmitting the electrical stimulation signal to a target region for performing an electrical stimulation treatment.
Parker teaches a similar stimulation system based on impedance (Parker abstract – “System and methods for adjusting electrical therapy based on impedance changes are disclosed herein”), comprising a stimulation system 100 with a detector 119 (Parker figure 4A), and teaches its system providing a high-frequency environment (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
PNG
media_image4.png
264
536
media_image4.png
Greyscale
Parker further teaches by the electrical stimulation device, measuring a total impedance value by the electrical stimulation device (Parker paragraph 0044 – “In any of the foregoing embodiments, the detector 119 will typically detect the impedance of a circuit that includes at least two contacts, e.g., C1 and C2… In any of these cases, however, the impedance of the tested circuit will include the impedances of all the contacts in the circuit…For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
obtaining a tissue impedance value by subtracting the impedance value from the total impedance value (Parker paragraph 0044 – “For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
by the electrical stimulation device, generating an electrical stimulation signal according to the tissue impedance value (Parker paragraph 0024 – “Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”).
PNG
media_image5.png
312
324
media_image5.png
Greyscale
And by the electrical stimulation device, transmitting the electrical stimulation signal to a target region for performing an electrical stimulation treatment (Parker figure 2, step 227 which adjust stimulation delivered based on the impedance changes; paragraph 0024 – “The process 220 includes applying electrical therapy to a patient via an implanted or partially implanted system (process portion 225)…Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”).
Armstrong and Parker all teach within the field of impedance measuring systems, specifically with stimulation devices. Therefore, 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 invention of Armstrong, specifically the stimulation device, to incorporate the stimulation device functions of providing a high-frequency environment, obtaining total impedance value, subtracting impedance values from a total impedance value, and generating a stimulation signal according to the tissue impedance, as taught by Parker, since such modification would predictably result in delivering appropriate electrical therapy signals to a patient based on impedance (Parker abstract) and address patient pain (Parker paragraph 0004).
The combined invention of Armstrong and Parker (hereinafter the combined invention) does not explicitly teach wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment.
Guillory teaches an implantable electrical stimulation system (abstract – “Disclosed herein are various embodiments of electrical stimulation systems configured to stimulate tissue in a subject”) which measures impedance (paragraph 0036 – “The stimulator may also include programmable ranges that are sufficiently small (e.g., below 1 μA peak-to-peak) to synthesize low-level sine waves and other signals for measurement of electrode impedance”).
Guillory further teaches wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment (Guillory teaches the system which sets safety limits on stimulation voltages to stop stimulation, paragraph 0039 – “The resting and stimulated voltages for the electrodes can also be used to detect problems and faults with the electrodes and output circuitry of the stimulator. Stimulation response waveforms can be tested against known templates for stimulation impedance and voltage features. The system 100 may include methods for setting safety limits for these features and other basic features such as peak response voltage or total estimated charge per cycle. These limits may be used to prematurely stop or limit stimulation cycles or force the module into a fail-safe condition”).
Therefore, 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 combined invention, specifically the electrical stimulation delivering, to incorporate the target energy value safety limits as taught by Guillory since such modification would predictably result in preventing tissue damage to a patient when delivering stimulation pulses.
Re. claim 14, the combined invention further teaches wherein the high-frequency environment is simulated with an electrical stimulation frequency used by the electrical stimulation device (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 15, the combined invention further teaches wherein a pulse frequency range of the high-frequency environment is between 1 KHz and 1000 KHz (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 16, the combined invention further teaches wherein the impedance compensation device is an external device or is arranged within the electrical stimulation device (Armstrong figure 3, impedance unit 350).
PNG
media_image6.png
322
422
media_image6.png
Greyscale
Re. claim 17, Armstrong, as best understood, teaches an electrical stimulation system (paragraph 0013 – “The IMD includes a stimulation unit to providing a first test signal to a first electrode coupled to the IMD through a first lead and to provide a second test signal to a second electrode coupled to the IMD through a second lead”), the system including:
an electrical stimulation device (figure 2, implantable medical device [IMD] 200; paragraph 0038 – “The implantable medical device 200 (IMD) is capable of delivering a stimulation signal to a portion of the patient's body…”);
PNG
media_image9.png
372
464
media_image9.png
Greyscale
and an impedance compensation device (Armstrong figure 3, impedance unit 350; paragraph 0049 – “The impedance unit 350 is capable of calculating the impedance…”, which Examiner interprets to align with Applicant’s impedance compensation device 600 in figure 6 comprising measurement circuit 610, which measures impedance) calculating an impedance value of the electrical stimulation device (figure 2, 2nd impedance 260, where the bidirectionality of the 2nd impedance 260 includes the IMD; paragraph 0039 – “The IMD 200 may also measure a second impedance 260, which is the impedance of the second electrode 230 in relation to a reference electrode, e.g., the case 121 of the IMD 200).
PNG
media_image1.png
258
262
media_image1.png
Greyscale
Armstrong does not explicitly teach providing the high-frequency environment, and wherein the electrical stimulation device measures a total impedance value, the electrical stimulation device obtains a tissue impedance value by subtracting the impedance value from the total impedance value, the electrical stimulation device generates an electrical stimulation signal according to the tissue impedance value; and the electrical stimulation device transmits the electrical stimulation signal to a target region for performing an electrical stimulation treatment.
Parker teaches a similar stimulation system based on impedance (Parker abstract – “System and methods for adjusting electrical therapy based on impedance changes are disclosed herein”), comprising a stimulation system 100 with a detector 119 (Parker figure 4A), and teaches its system providing a high-frequency environment (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
PNG
media_image4.png
264
536
media_image4.png
Greyscale
Parker further teaches wherein the electrical stimulation device measures a total impedance value (Parker paragraph 0044 – “In any of the foregoing embodiments, the detector 119 will typically detect the impedance of a circuit that includes at least two contacts, e.g., C1 and C2… In any of these cases, however, the impedance of the tested circuit will include the impedances of all the contacts in the circuit…For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
the electrical stimulation device obtains a tissue impedance value by subtracting the impedance value from the total impedance value (Parker paragraph 0044 – “For example, in one case, a nominal impedance can be assigned to other contacts included in the circuit (e.g., if multiple contacts are coupled in parallel in the circuit), and then subtracted from a total impedance to obtain the impedance for a given contact”),
the electrical stimulation device generates an electrical stimulation signal according to the tissue impedance value (Parker paragraph 0024 – “Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”).
PNG
media_image5.png
312
324
media_image5.png
Greyscale
and the electrical stimulation device transmits the electrical stimulation signal to a target region for performing an electrical stimulation treatment (Parker figure 2, step 227 which adjust stimulation delivered based on the impedance changes; paragraph 0024 – “The process 220 includes applying electrical therapy to a patient via an implanted or partially implanted system (process portion 225)…Based on the detected impedance change, the process 220 can still further include automatically adjusting signal delivery parameters in accordance with which the therapy is provided, without human intervention (process portion 227)”).
Armstrong and Parker all teach within the field of impedance measuring systems, specifically with stimulation devices. Therefore, 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 invention of Armstrong, specifically the stimulation device, to incorporate the stimulation device functions of providing a high-frequency environment, obtaining total impedance value, subtracting impedance values from a total impedance value, and generating a stimulation signal according to the tissue impedance, as taught by Parker, since such modification would predictably result in delivering appropriate electrical therapy signals to a patient based on impedance (Parker abstract) and address patient pain (Parker paragraph 0004).
The combined invention of Armstrong and Parker (hereinafter the combined invention) does not explicitly teach wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment.
Guillory teaches an implantable electrical stimulation system (abstract – “Disclosed herein are various embodiments of electrical stimulation systems configured to stimulate tissue in a subject”) which measures impedance (paragraph 0036 – “The stimulator may also include programmable ranges that are sufficiently small (e.g., below 1 μA peak-to-peak) to synthesize low-level sine waves and other signals for measurement of electrode impedance”).
Guillory further teaches wherein the electrical stimulation device performs an electrical stimulation to the target region according to a target energy value until the corresponding target energy value is sent to the target region, then stops the electrical stimulation to finish the electrical stimulation treatment (Guillory teaches the system which sets safety limits on stimulation voltages to stop stimulation, paragraph 0039 – “The resting and stimulated voltages for the electrodes can also be used to detect problems and faults with the electrodes and output circuitry of the stimulator. Stimulation response waveforms can be tested against known templates for stimulation impedance and voltage features. The system 100 may include methods for setting safety limits for these features and other basic features such as peak response voltage or total estimated charge per cycle. These limits may be used to prematurely stop or limit stimulation cycles or force the module into a fail-safe condition”).
Therefore, 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 combined invention, specifically the electrical stimulation delivering, to incorporate the target energy value safety limits as taught by Guillory since such modification would predictably result in preventing tissue damage to a patient when delivering stimulation pulses.
Re. claim 18, the combined invention further teaches wherein the impedance compensation device simulates the high-frequency environment with an electrical stimulation frequency used by the electrical stimulation device (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 19, the combined invention further teaches wherein a pulse frequency range of the high-frequency environment is between 1 KHz and 1000 KHz (Parker paragraph 0047 – “In any of the foregoing embodiments, the therapy signal can be applied at frequencies ranging from about 1.5 kHz to about 100 kHz…”).
Re. claim 20, the combined invention further teaches wherein the impedance compensation device is an external device or is arranged within the electrical stimulation device (Armstrong figure 3, impedance unit 350).
PNG
media_image6.png
322
422
media_image6.png
Greyscale
Re. claim 21, the combined invention further teaches the method further comprising: storing the first impedance value and the second impedance value for calculating the tissue impedance value (Armstrong paragraph 0055 – “…previously calculated indications of the expected values of the first and second impedances may be stored in the IMD 200”).
Re. claim 22, the combined invention further teaches wherein the first impedance value and the second impedance value are stored in the electrical stimulation device for calculating a compensation for the tissue impedance value (Armstrong paragraph 0055 – “…previously calculated indications of the expected values of the first and second impedances may be stored in the IMD 200”).
Re. claim 23, the combined invention further teaches the method further comprising: storing the impedance value for calculating the tissue impedance value (Armstrong paragraph 0055 – “…previously calculated indications of the expected values of the first and second impedances may be stored in the IMD 200”).
Re. claim 24, the combined invention further teaches wherein the impedance value is stored in the electrical stimulation device for calculating the tissue impedance value (Armstrong paragraph 0055 – “…previously calculated indications of the expected values of the first and second impedances may be stored in the IMD 200”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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, CARL LAYNO can be reached at 571-272-4949. 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.
/ANH-KHOA N DINH/Examiner, Art Unit 3796