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 national stage entry under 35 USC 371 of PCT/EP2022/065445 filed 8 June 2022, which claims the benefit of foreign priority from European Patent Application no. 21184266.1 filed 7 July 2021.
Election/Restrictions
Applicant’s election without traverse of Species I pertaining to claims 2 and 9 in the reply filed on 18 June 2026 is acknowledged.
Claims 3 and 4 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply.
Claims 1, 2, and 5-14 are pending for examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 13 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a “computer program product” which is held to be non-statutory subject matter. It is recommended that the claim instead recite a “non-tangible computer readable medium”.
In regard to claim 14, the recited “computer readable data carrier” is considered directed to a non-statutory category relating to a signal per se. It is unclear what constitutes the recited “data carrier”, including whether the term is directed to a non-transitory computer readable medium, a transitory propagating signal (i.e., a carrier wave) carrying the computer program product, or both.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 recites a “computer readable data carrier storing a computer program product.” It is unclear what constitutes the recited “data carrier”, including whether the term is directed to a non-transitory computer readable medium, a transitory propagating signal (i.e., a carrier wave) carrying the computer program product, or both. Accordingly, the metes and bounds of the claimed “computer readable data carrier” are unclear.
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) 1, 2, 4-6, and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke et al. (US Patent no. 5,683,432) in view of Thompson (US Publication no. 2002/0045920).
In regard to claim 1, Goedeke et al. disclose a communication system for wireless data transmission between an implantable medical device 10 and an external device 20 (col 11 lines 38-41, figure 1) comprising a communication unit 22 (figure 1) and a processor (not shown, but described at col 15 lines 22-32), said system comprising said IMD 10 and said external device 20,
wherein the IMD 10 is configured to monitor a bodily parameter of a patient and/or is configured to deliver a therapy signal to the patient (col 11 lines 8-28, the device is a pacemaker with pacing/sensing functions),
wherein the IMD 10 comprises a transceiver module 34 (comprising receiver 102 and transmitter 104, col 16 lines 32-34) configured to exchange the data with the communication unit 22 of the external device 20 in an uplink direction from the transceiver module 34 to the communication unit and in a downlink direction from the communication unit 22 to the transceiver module 34 (col 11 lines 38-45, uplink and downlink directionality defined at col 2 lines 42-49),
wherein the processor 32 and transceiver module 34 of the IMD 10 is configured to determine the signal strength of at least one data packet received by the communication unit 22 and sent by the transceiver module 34 of the implanted IMD 10 with a predetermined initial data rate and to determine the noise level of the communication unit 22 (col 16 lines 32-63, a signal strength circuit 108 measures signal plus noise using the noise strength detection circuit 110; see col 22 lines 12-23 which discusses that the initial communication between the devices may take place using a telemetry transmission protocol determined to be acceptable for transmission of control signals between the devices, as verified by return transmissions, and that this initial communication will establish the type of telemetry transmission to follow. The initial communication used in this manner is considered to be suggestive of the predetermined initial data rate).
It is acknowledged that the signal strength is determined by the IMD side of the system in Goedeke et al., and not the external programmer side. Additionally, Goedeke et al. fail to teach that the processor is further configured to determine a highest possible uplink data rate value for data transmission in the uplink direction and a highest possible downlink data rate value for data transmission in the downlink direction based on the immediately previously determined signal strength of the at least one data packet received by the communication unit from the transceiver module and the current noise level of the communication unit.
Thompson describes a similar system and technique. Thompson establishes that measurements from an IMD transmission can be processed by a programming unit 20 (para 68, which teaches that the programming unit can evaluate transmission channel quality by measuring the signal-to-noise ratio (SNR) on each channel). Additionally, Thompson is found to disclose that once the channel quality is determined (as in para 68), a processor is configured to determine a highest possible uplink value (para 75, the programmer can then make an evaluation and select a channel for further communication transmissions that takes into consideration the best channel from the standpoint of the reception of the uplink transmission to the programmer; the “best” channel is considered suggestive of the highest uplink value) and a highest possible downlink data rate value for data transmission in the downlink direction (para 75, the programmer can then make an evaluation and select a channel for further communication transmissions that takes into consideration the best channel from the standpoint of both the reception of the downlink transmission to the IMD, the “best” channel is considered suggestive of the highest downline value). This technique is considered complementary to the signal strength determination technique of Goedeke et al. by providing additional information about the quality of the signal received to determine the best achievable communication channel to provide more reliable communications in Geodeke et al.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the signal strength determination of Goedeke et al. with the channel evaluation technique of Thompson that selects the best or highest channel based on the SNR in order to enable the external programmer of Goedeke et al. to determine the best achievable uplink and downlink quality and optimize reliable communication.
In regard to claim 2, Goedeke et al. teach that the highest possible uplink data rate values for data transmission in the uplink direction and in the downlink direction consider a bit error rate (BER) between 10-¹ and 10-6, preferably a BER of 10⁻², 10⁻³ or 10⁻⁵ (col 14 line 36 – col 15 line 11).
In regard to claim 5, Goedeke et al. further teaches that the external programmer 20 is configured to transmit a determined data rate to the IMD wherein the IMD sets the data rate according to the determined data rate (col 21 line 15 – col 22 line 11, Goedeke et al. teaches that the external programmer transmits instructions to the IMD to change the data transmission rate based upon the communication performance determination, such that when the external programmer determines that an error rate is greater than an acceptable error rate, the external programmer instructs the IMD to decrease transmission speed and likewise if the error rate of the received transmission is below the acceptable error rate, the programmer may instruct the implanted device to decrease the power level of its transmission). Goedeke et al. therefore teaches communicating a determined rate adjustment from the external device to the IMD for setting the IMD transmission rate. Thompson further teaches that the programmer makes an evaluation for further communication transmissions taking into consideration both reception of downlink transmission to the IMD and reception of the uplink transmission to the programmer (para 75). It would have been obvious to one of ordinary skill in the art to modify the system of Goedeke et al. to configure the external device to transmit at the highest possible data rate and highest possible downlink data rate to the IMD and to configure the IMD to set its uplink data rate and downlink data rate according to received values, thereby permitting subsequent bidirectional communications to occur at the determined optimized rates.
In regard to claim 6, Goedeke et al. further teaches that the external device sets a data rate of its communication unit according to determined communication conditions (col 21 line 15 – col 22 line 11, Goedeke et al. teaches that the external programmer transmits instructions to the IMD to change the data transmission rate based upon the communication performance determination, such that when the external programmer determines that an error rate is greater than an acceptable error rate, the external programmer instructs the IMD to decrease transmission speed and likewise if the error rate of the received transmission is below the acceptable error rate, the programmer may instruct the implanted device to decrease the power level of its transmission). Thompson further teaches that the external programmer evaluates communication conditions for further transmission based on the quality of both the downlink transmission to the IMD and the uplink transmission to the programemr (para 75). In the modified system of Goedeke et al. in which the processor of the external device determines the best/highest possible uplink data rate value and the best/highest possible downlink rate value, it would have been obvious to one of ordinary skill in the art to configure the external device to set the uplink and downlink data rates to the best/highest data rates in order to provide the most reliable communication between devices.
In regard to claim 8, Goedeke et al. disclose a communication method for a wireless data transmission between an implantable medical device 10 (IMD) and an external device 20 (col 11 lines 38-41, figure 1) comprising a communication unit 22 and a processor (not shown, but described at col 15 lines 22-32) wherein the IMD 10 monitors a bodily parameter of a patient and/or delivers a therapy signal to the patient after implantation within the patient's body (col 11 lines 8-28, the device is a pacemaker with pacing/sensing functions), wherein the IMD 10 comprises a transceiver module 34 (comprising receiver 102 and transmitter 104, col 16 lines 32-34) exchanging the data with the communication unit 22 of the external device 20 in an uplink direction from the transceiver module 34 to the communication unit 22 and in a downlink direction from the communication unit 22 to the transceiver module 34 (col 11 lines 38-45, uplink and downlink directionality defined at col 2 lines 42-49), with the following steps: the processor 32 of the external device 34 determines the signal strength of at least one data packet received by the communication unit 22, which was sent by the transceiver module 34 of the implanted IMD 10 with a pre-determined initial data rate, the processor of the external device determines the noise level of the communication unit (col 16 lines 32-63, a signal strength circuit 108 measures signal plus noise using the noise strength detection circuit 110; see col 22 lines 12-23 which discusses that the initial communication between the devices may take place using a telemetry transmission protocol determined to be acceptable for transmission of control signals between the devices, as verified by return transmissions, and that this initial communication will establish the type of telemetry transmission to follow. The initial communication used in this manner is considered to be suggestive of the predetermined initial data rate) Geodeke et al. does not teach that the processor determines a highest possible uplink data rate value for data transmission in the uplink direction and a highest possible downlink data rate value for data transmission in the downlink direction based on the immediately previously determined signal strength of the at least one data packet received by the communication unit from the transceiver module and the current noise level of the communication unit. It is also acknowledged that the signal strength is determined by the IMD side of the system in Goedeke et al., and not the external programmer side. Thompson describes a similar system and technique. Thompson establishes that measurements from an IMD transmission can be processed by a programming unit 20 (para 68, which teaches that the programming unit can evaluate transmission channel quality by measuring the signal-to-noise ratio (SNR) on each channel). Additionally, Thompson is found to disclose that once the channel quality is determined (as in para 68), a processor is configured to determine a highest possible uplink value (para 75, the programmer can then make an evaluation and select a channel for further communication transmissions that takes into consideration the best channel from the standpoint of the reception of the uplink transmission to the programmer; the “best” channel is considered suggestive of the highest uplink value) and a highest possible downlink data rate value for data transmission in the downlink direction (para 75, the programmer can then make an evaluation and select a channel for further communication transmissions that takes into consideration the best channel from the standpoint of both the reception of the downlink transmission to the IMD, the “best” channel is considered suggestive of the highest downline value). This technique is considered complementary to the signal strength determination technique of Goedeke et al. by providing additional information about the quality of the signal received to determine the best achievable communication channel to provide more reliable communications in Geodeke et al. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the signal strength determination of Goedeke et al. with the channel evaluation technique of Thompson that selects the best or highest channel based on the SNR in order to enable the external programmer of Goedeke et al. to determine the best achievable uplink and downlink quality and optimize reliable communication.
In regard to claim 9, Goedeke et al. teach that the highest possible uplink data rate values for data transmission in the uplink direction and in the downlink direction consider a bit error rate (BER) between 10-¹ and 10-6, preferably a BER of 10⁻², 10⁻³ or 10⁻⁵ (col 14 line 36 – col 15 line 11).
In regard to claim 10, Goedeke et al. further teaches that the external programmer 20 is configured to transmit a determined data rate to the IMD wherein the IMD sets the data rate according to the determined data rate (col 21 line 15 – col 22 line 11, Goedeke et al. teaches that the external programmer transmits instructions to the IMD to change the data transmission rate based upon the communication performance determination, such that when the external programmer determines that an error rate is greater than an acceptable error rate, the external programmer instructs the IMD to decrease transmission speed and likewise if the error rate of the received transmission is below the acceptable error rate, the programmer may instruct the implanted device to decrease the power level of its transmission). Goedeke et al. therefore teaches communicating a determined rate adjustment from the external device to the IMD for setting the IMD transmission rate. Thompson further teaches that the programmer makes an evaluation for further communication transmissions taking into consideration both reception of downlink transmission to the IMD and reception of the uplink transmission to the programmer (para 75). It would have been obvious to one of ordinary skill in the art to modify the system of Goedeke et al. to configure the external device to transmit at the highest possible data rate and highest possible downlink data rate to the IMD and to configure the IMD to set its uplink data rate and downlink data rate according to received values, thereby permitting subsequent bidirectional communications to occur at the determined optimized rates.
In regard to claim 11, Goedeke et al. further teaches that the external device sets a data rate of its communication unit according to determined communication conditions (col 21 line 15 – col 22 line 11, Goedeke et al. teaches that the external programmer transmits instructions to the IMD to change the data transmission rate based upon the communication performance determination, such that when the external programmer determines that an error rate is greater than an acceptable error rate, the external programmer instructs the IMD to decrease transmission speed and likewise if the error rate of the received transmission is below the acceptable error rate, the programmer may instruct the implanted device to decrease the power level of its transmission). Thompson further teaches that the external programmer evaluates communication conditions for further transmission based on the quality of both the downlink transmission to the IMD and the uplink transmission to the programmer (para 75). In the modified system of Goedeke et al. in which the processor of the external device determines the best/highest possible uplink data rate value and the best/highest possible downlink rate value, it would have been obvious to one of ordinary skill in the art to configure the external device to set the uplink and downlink data rates to the best/highest data rates in order to provide the most reliable communication between devices.
Claim(s) 7 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke et al. (US Patent no. 5,683,432) in view of Thompson (US Publication no. 2002/0045920), further in view of Ericksen et al. (US Patent no. 6,128,528) and Miller et al. (US Publication no 2004/0203474).
In regard to claims 7 and 12, Goedeke et al. in view of Thompson teaches monitoring the quality of a bidirectional communication link including the received signal strength and noise. Thompson further teaches that the processor may continue to monitor the noise level of the selected communication channel and take corrective action when the noise exceeds a predetermined threshold. Neither reference teaches that the processor of the external device determines a signal loss in the data transmission in the uplink and downlink direction. observes the noise level of the communication unit over a pre-determined time period in order to identify subsections of the time period in which regularly the noise level is higher than in other subsections. Ericksen et al. teaches that it is known in the art for IMD telemetry protocols to minimize the corruption of data transmitted from the IMD to the external programmer due to such noise and signal loss. In addition, error detection schemes are disclosed that are used in order to ensure that any such corruption of the data that occurs during or because of a faulty uplink telemetry transmission is not mistaken as accurate data stored in the IMD (col 4 lines 51-59). It would have been obvious to modify the invention suggested by Goedeke et al. and Thompson according to Ericksen et al. to determine signal loss in the uplink and downlink data transmissions in order to identify degradation or failure of respective transmissions and permit appropriate correcting action to maintain reliable bidirectional communication.
Neither Goedeke et al., Thompson, nor Ericksen et al. teach observing the noise level of the communication unit over a pre-determined time period in order to identify subsections of the time period in which regularly the noise level is higher than in other subsections. Miller et al. teach detecting periodic or quasi-periodic interference in a wireless communication system and determining a start time, duration of, and period of occurrence of interference or noise in the signal so that subsequent communications may be scheduled to avoid recurring interference intervals (para 25, 43, 51 and 53). It would have been obvious to one of ordinary skill to modify the invention describes by Goedeke et al., Thompson, and Ericksen et al. to further observe the noise/interference conditions over time and identify recurring time intervals having increased noise or interference, in order to permit subsequent communications to avoid those regularly occurring periods of degraded communication conditions.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goedeke et al. (US Patent no. 5,683,432) in view of Thompson (US Publication no. 2002/0045920), further in view of Willerton et al. (US Publication no. 2010/0121413).
In regard to claim 13, Goedeke et al. in view of Thompson suggest the invention as claimed including a processor to perform the steps of the method according to any of the claim 8. However, neither reference teaches a computer program product or computer readable medium for storing instructions on the external device. Willerton et al. is directed to a similar technique for determining a link quality of a communication link between an external and implantable medical device. The method is performed by a processor of an external device, wherein the processor executes instructions stored on a computer program product located on the external device (para 20-21 and 44). It would have been obvious to one of ordinary skill in the art to associate a computer readable medium with the external programmer in the invention suggested by Goedeke et al. in view of Thompson in order to permit the external programmer to retrieve and execute instructions necessary to performing the communication function of the external device.
In regard to claim 14, Goedeke et al. in view of Thompson suggest the invention as claimed including a processor to perform the steps of the method according to any of the claim 8. However, neither reference teaches a computer readable data carrier storing a computer program product. Willerton et al. is directed to a similar technique for determining a link quality of a communication link between an external and implantable medical device. The method is performed by a processor of an external device, wherein the processor executes instructions stored on a computer program product located on the external device, wherein the instructions may be realized as a computer program (para 20-21 and 44). It would have been obvious to one of ordinary skill in the art to associate a computer readable data carrier with the external programmer in the invention suggested by Goedeke et al. in view of Thompson in order to permit the encode operating instructions necessary to performing the communication function of the external device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following reference pertain in general to adjustment of transmission rates between implanted medical devices and external programmers:
Schwartz et al. (US Patent no. 7,580,755) performs real time adjustment of the data transfer rate between an implanted medical device and external programmer;
Tzannes et al. (US Publication no. 2008/0049601) maximizes the communication data rate between a transmitter and receiver;
Vallapureddy et al. (US Publication no. 2006/0161223) describes selecting optimal communication channels based on noise between an implanted medical device and external device;
Amundson et al. (US Publication no. 2003/0009204 – disclosed by Applicant) selects between a low data rate and a higher data rate based on distances between implanted and external devices.
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.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 3 September 2026
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