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 .
Priority
This application is a continuation of US Application no. 17/222,242, now US Patent no. 11,918,817, filed 5 April 2021, which claims the benefit of domestic priority from US Provisional Application nos. 63/033,737 and 63/005,628 respectively filed 2 June 2020 and 6 April 2020.
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.
Claim(s) 1, 3-6, 8-10, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stahmann et al. (US Publication no. 2018/0304085).
In regard to claims 1 and 21, (using claim 1 as template for rejection) Stahmann et al. disclose a method and system comprising an external device that is configured to communicate with an implantable medical device (IMD) implanted within a patient using conductive communication (para 6-10), wherein the external device includes or is communicatively coupled to at least three external electrodes that are in contact with the patient (para 6-7, the second medical device may be an external device that includes an antenna with three electrodes), the method and system comprising (referring to figure 13 ):
receiving, using each of at least first, second, and third subsets of the at least three external electrodes, conductive communication pulses transmitted by the IMD (figure 13, steps 1210-1240);
determining, for each subset of the external electrodes, of the first, second, and third subsets of the external electrodes, a respective metric indicative of power and/or quality of the conductive communication pulses received from the IMD using the subset of external electrodes (figure 13, steps 1280-1290);
identifying, based on results of the determining, a preferred one of the first, second, and third subsets of the at least three external electrodes (figure 13, step 1292); and
using the preferred one of the first, second, and third subsets of the at least three external electrodes to receive further conductive communication pulses transmitted by the IMD (para 1292; see paragraphs 110-111).
In regard to claim 3, in Stahmann et al., further comprises: storing within memory of the external device, data associated with the further conductive communication pulses received using the preferred one of the first, second, and third subsets of the at least three external electrodes (para 74, memory circuit and processing module 106 may store information).
In regard to claim 4, in Stahmann et al., the system and method is equipped for transmitting, to a patient care network, data associated with the further conductive communication pulses received using the preferred one of the first, second, and third subsets of the at least three external electrodes (para 112, a communication vector is tested during an interaction between a medical device and an external system that is configured to provide device or patient data to a clinician at a remote location).
In regard to claim 5, in Stahmann et al., the at least three external electrodes comprise first, second and third external electrodes; the first subset of the at least three external electrodes comprises the first and second external electrodes; the second subset of the at least three external electrodes comprises the first and third external electrodes; and the third subset of the at least three external electrodes comprises the second and third external electrodes (para 91, MD 320 may be the external device; para 92, MD 320 has a first electrode pair 325 between first electrode 322 and second electrode 324, a second electrode pair 327 between second electrode 324 and third electrode 326, and a third electrode pair 329 between first electrode 322 and third electrode 326 that can each be used, either individually or in combination, to sense, pace and/or communicate with another medical device).
In regard to claim 6, in Stahmann et al., the respective metric is indicative of power and comprises a measure of amplitude of the conductive communication pulses (para 93-95, 102, and 106, the signal strength is considered to be similar to a measure of the amplitude).
In regard to claim 8, in Stahmann et al., the respective metric at steps 1280/1290 is indicative of quality and comprises a measure of signal to noise ratio (para 111).
In regard to claim 9, in Stahmann et al., the external device is incapable of programming the IMD (para 91, MD 320 considered to comprise the external device may be an externally worn patch, which may or may be not a programmer).
In regard to claim 10, in Stahmann et al., the IMD comprises a leadless pacemaker (para 83, 90, 96).
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.
Claim(s) 2 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US Publication no. 2018/0304085) in view of Schilling et al. (US Publication no. 2018/0200525 – disclosed by Applicant).
In regard to claims 2 and 22, Stahmann et al. is considered to substantially disclose the invention as claimed, however does not teach receiving the conductive communication pulses transmitted by the IMD comprises receiving one or more advertisement sequences of pulses using each of at least the first, second, and third subsets of the at least three external electrodes. Schilling et al. teach that the IMD transmits one or more advertisement data packets and receives one or more advertisement data packets in an advertising mode (para 61). Modification of Stahmann et al. to use advertisement data packets received from the IMD is considered to have been obvious to one of ordinary skill in the art since it is a technique known for facilitating establishment of a communication session between implantable and external devices. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US Publication no. 2018/0304085) in view of Kane et al. (US Publication no. 2017/0173346).
In regard to claim 7, Stahmann et al. is considered to describe the invention substantially as claimed, except for the respective metric is indicative of quality and comprises a measure of how similar a morphology of one or more of the conductive communication pulses received from the IMD is/are to an expected morphology. Kane et al. is directed to conducted communication in an implantable medical device system. Kane et al. teach that a metric is indicative of quality includes a measure of how similar a morphology of one or more of the conductive communication pulses received from the IMD is/are to an expected morphology (para 103, morphology in phase helps identify signal vs noise). In view of this, it is considered to have been obvious to one of ordinary skill in the art at the time the invention was made to use the match in morphology as a signal quality indicator since Kane et al. teach that the morphology is useful to help identify a communication pulse signal from a noise signal.
Claim(s) 11, 13-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US Publication no. 2018/0304085) in view of Klimovitch et al. (US Publication no. 2016/02850483).
In regard to claim 11, (using claim 1 as template for rejection) Stahmann et al. disclose a method and system comprising an external device that is configured to communicate with an implantable medical device (IMD) implanted within a patient using conductive communication (para 6-10), wherein the external device includes or is communicatively coupled to at least three external electrodes that are in contact with the patient (para 6-7, the second medical device may be an external device that includes an antenna with three electrodes), the method and system comprising (referring to figure 13 ):
receiving, using each of at least first, second, and third subsets of the at least three external electrodes, conductive communication pulses transmitted by the IMD (figure 13, steps 1210-1240);
determining, for each subset of the external electrodes, of the first, second, and third subsets of the external electrodes, a respective metric indicative of power and/or quality of the conductive communication pulses received from the IMD using the subset of external electrodes (figure 13, steps 1280-1290);
identifying, based on results of the determining, a preferred one of the first, second, and third subsets of the at least three external electrodes (figure 13, step 1292); and
using the preferred one of the first, second, and third subsets of the at least three external electrodes to receive further conductive communication pulses transmitted by the IMD (para 1292; see paragraphs 110-111).
Stahmann et al. substantially describe the invention as claimed, however do not teach that the switches between the conductive communication receiver and at least three external electrodes that are configured to be placed in contact with the patient; and a controller configured to control the switches to cause each of first, second, and third subsets of the at least three external electrodes to be coupled to the conductive communication receiver, at different respective times, to thereby cause the conductive communication receiver to receive, using each of the first, second, and third subsets of the at least three external electrodes, conductive communication pulses transmitted by the IMD.
Klimovitch et al. discuses a system and method for communication between implantable and external devices. Klimovitch et al. teach use of an electrode configuration switch. The switch includes multiple switches for connecting the desired electrodes or sub-electrodes to the appropriate I/O circuits, thereby facilitating electrode programmability (para 97). The use of switches in this manner is considered a routine technique for selecting and connecting electrical pathways and electrode configuration. Modification of Stahmann et al. to incorporate a switching mechanism to select electrodes within a subset is considered to have been obvious to one of ordinary skill in the art since Klimovitch et al. teach that switches are well known for connecting the desired electrodes to the appropriate I/O circuits. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 13, in Stahmann et al., further comprises: storing within memory of the external device, data associated with the further conductive communication pulses received using the preferred one of the first, second, and third subsets of the at least three external electrodes (para 74, memory circuit and processing module 106 may store information).
In regard to claim 14, in Stahmann et al., the system and method is equipped for transmitting, to a patient care network, data associated with the further conductive communication pulses received using the preferred one of the first, second, and third subsets of the at least three external electrodes (para 112, a communication vector is tested during an interaction between a medical device and an external system that is configured to provide device or patient data to a clinician at a remote location).
In regard to claim 15, in Stahmann et al., the at least three external electrodes comprise first, second and third external electrodes; the first subset of the at least three external electrodes comprises the first and second external electrodes; the second subset of the at least three external electrodes comprises the first and third external electrodes; and the third subset of the at least three external electrodes comprises the second and third external electrodes (para 91, MD 320 may be the external device; para 92, MD 320 has a first electrode pair 325 between first electrode 322 and second electrode 324, a second electrode pair 327 between second electrode 324 and third electrode 326, and a third electrode pair 329 between first electrode 322 and third electrode 326 that can each be used, either individually or in combination, to sense, pace and/or communicate with another medical device).
In regard to claim 16, in Stahmann et al., the respective metric is indicative of power and comprises a measure of amplitude of the conductive communication pulses (para 93-95, 102, and 106, the signal strength is considered to be similar to a measure of the amplitude).
In regard to claim 18, in Stahmann et al., the respective metric at steps 1280/1290 is indicative of quality and comprises a measure of signal to noise ratio (para 111).
In regard to claim 19, in Stahmann et al., the external device is incapable of programming the IMD (para 91, MD 320 considered to comprise the external device may be an externally worn patch, which may or may be not a programmer).
In regard to claim 20, in Stahmann et al., the external device includes or is communicatively coupled to at least three external electrodes that are in contact with the patient (para 6-7, the second medical device may be an external device that includes an antenna with three electrodes).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US Publication no. 2018/0304085) in view of Klimovitch et al. (US Publication no. 2016/0250483), further in view of Schilling et al. (US Publication no. 2018/0200525 – disclosed by Applicant).
In regard to claim 12, Stahmann et al. is considered to substantially disclose the invention as claimed, however does not teach receiving the conductive communication pulses transmitted by the IMD comprises receiving one or more advertisement sequences of pulses using each of at least the first, second, and third subsets of the at least three external electrodes. Schilling et al. teach that the IMD transmits one or more advertisement data packets and receives one or more advertisement data packets in an advertising mode (para 61). Modification of Stahmann et al. to use advertisement data packets received from the IMD is considered to have been obvious to one of ordinary skill in the art since it is a technique known for facilitating establishment of a communication session between implantable and external devices. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US Publication no. 2018/0304085) in view of Klimovitch et al. (US Publication no. 2016/0250483), further in view of in view of Kane et al. (US Publication no. 2017/0173346).
In regard to claim 17, Stahmann et al. is considered to describe the invention substantially as claimed, except for the respective metric is indicative of quality and comprises a measure of how similar a morphology of one or more of the conductive communication pulses received from the IMD is/are to an expected morphology. Kane et al. is directed to conducted communication in an implantable medical device system. Kane et al. teach that a metric is indicative of quality includes a measure of how similar a morphology of one or more of the conductive communication pulses received from the IMD is/are to an expected morphology (para 103, morphology in phase helps identify signal vs noise). In view of this, it is considered to have been obvious to one of ordinary skill in the art at the time the invention was made to use the match in morphology as a signal quality indicator since Kane et al. teach that the morphology is useful to help identify a communication pulse signal from a noise signal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM 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, David E. Hamaoui can be reached at 571-270-5625. 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.
/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 4 June 2026
Prosecution Insights