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 .
The amendment filed on October 27, 2025 has been received and considered. By this amendment, claims 1 and 3-15 are amended, claim 2 is cancelled, and claims 1 and 3-15 are now pending in the application.
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.
Claims 1 and 3-15 are 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 1 recites the limitation "is influenced directly or indirectly" in line 7. The metes and bounds of this limitation are unclear, as it is unknown what is meant by “influenced” in the context of the claim, and further what is meant by direct and indirect influence as claimed.
Claim 7 recites the limitation "a further communication device" in lines 3-4. It is unclear if this is the same or a different “further communication device” as recited in line 3 of the claim.
Claim 15 recites the limitation "is influenced directly or indirectly" in line 7. The metes and bounds of this limitation are unclear, as it is unknown what is meant by “influenced” in the context of the claim, and further what is meant by direct and indirect influence as claimed.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tieu (U.S. 2013/0165819, previously cited) in view of Hresko et al. (U.S. 2017/0095674). Regarding claim 1, Tieu discloses a medical device 10/910 for implantation in human or animal tissue, comprising: a unit 48/938/954/956/940/930/965/9106 adapted to perform at least one of the following functions: evaluation of signals and therapy delivery (see Figures 3 and 9 and “For example, based on calibrated X, Y, and Z axes, sensed by the position sensor 54, the controller 48 is able to determine the actual posture, such as vertical or horizontal, of the patient 41. The controller 48 may manually or automatically calibrate the IMD 10 to monitor for potential posture states including one or more of a supine state, prone state, right side position, or left side position.”, paragraph [0051], “The IMD 910 includes an atrial pulse generator 938 and a ventricular pulse generator 940 to generate pacing stimulation pulses for delivery by the right atrial lead, the right ventricular lead, and/or the coronary sinus lead via an electrode configuration switch 948.”, paragraph [0079], and “Atrial sensing circuit 954 and ventricular sensing circuit 956 may also be selectively coupled to the right atrial lead, coronary sinus lead, and the right ventricular lead, through the switch 948 for detecting the presence of cardiac activity in each of the four chambers of the heart.”, paragraph [0081]); an interface 46/50/964 to a network, wherein the interface is configured to communicate directly or indirectly with the network and the at least one function is influenced directly or indirectly via the network communication (see Figures 3 and 9, “The RF module 46 is loaded with a set of scan attributes from the memory 52 to be configured to establish an RF connection over one or more of primary and/or secondary frequency bands that are non-overlapping and distinct from one another.”, paragraph [0043], and “The pacing and other operating parameters of the IMD 910 may be non-invasively programmed into the memory 994 through a telemetry circuit 964 in telemetric communication with the external device 999, such as a programmer, trans-telephonic transceiver or a diagnostic system analyzer, or with a remote monitor.”, paragraph [0086]); and a predetection unit that activates a connection to the network only whenever a need for real-time assessment and/or influence has been detected (“Certain embodiments may provide an implantable medical device (IMD that includes an RF module configured to operate in first and second scan modes to establish an RF connection over a predetermined frequency band based on a scan attribute, memory configured to store predetermined first and second values for the scan attribute to define different first and second scan modes, respectively, a sensor configured to sense a posture state of a patient, and a controller configured to load the RF module with one of the predetermined first and second values for the scan attribute, based on the posture state determined, to cause the RF module to switch between the first and second scan modes.”, paragraph [0017], where the detected change in posture is considered the “immediate need for real-time assessment and/or influence has been detected” as claimed). However, Tieu fails to disclose that the predetection unit activates a connection to the network only when sufficient remaining power supply is ensured based on a remaining energy supply of the medical device. Hresko teaches a medical device 120 for sensing or therapy (“Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices”, paragraph [0066]) that includes network communication (“the network interface 306 can facilitate the communication of information between the controller 120 and one or more other devices or entities over a communications network. For example, the network interface 306 may be configured to communicate with a server (e.g., a remote server) where a caregiver can access information related to the patient”, paragraph [0098]). Further, Hresko teaches that in response to a low battery warning, wireless connectivity may be disabled in order to preserve remaining battery life (see paragraph [0181]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tieu such that the predetection unit activates a connection to the network only when sufficient remaining power supply is ensured based on a remaining energy supply of the medical device, as taught by Hresko, in order to preserve the remaining battery life of the medical device, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 3, Tieu discloses that the network has at least a bandwidth of greater than 100 Mbit/sec (“one scan mode may scan a first/high frequency range/band (e.g., 2.5 GHz band) at a first scan rate such as every minute, every 30 minutes, every hour, continuously and the like for connection requests.”, paragraph [0036], where the 2.5 GHz frequency band is known to have a bandwidth of greater than 100 Mbit/sec) and/or has at least a typical latency of less than 10 ms.
Regarding claim 4, Tieu discloses that the medical device is an active electronic implant for permanent or temporary implantation (see Abstract and reference to IMD throughout the disclosure, which stands for implantable medical device).
Regarding claim 5, Tieu discloses that the medical device is a battery-powered electronic device for permanent or temporary attachment to the body (see battery 55 in Figure 3 and battery 970 in Figure 9).
Regarding claim 6, Tieu discloses that the medical device is one of a cardiac pacemaker, a wireless pacemaker, an implantable defibrillator, a neurostimulator, a cardiac rhythm monitor, an implantable sensor for physiological parameters, an implantable communication system, an implant for monitoring medical prostheses, an implant for monitoring patient activity or compliance and an implant for monitoring the patient's medication intake (“The IMD may be one of various types of implantable devices, such as, for example, an implantable pacemaker, implantable cardioverter-defibrillator ("ICD"), neurostimulator, electrophysiology ("EP") mapping and radio frequency ("RF") ablation system, or the like.”, paragraph [0032])
Regarding claim 7, Tieu discloses that the interface is configured to facilitate communication between the medical device and a further communication device (see Figure 2 where IMD 10 can communicate with patient care system 42 either directly to using wands 45 and 47).
Regarding claim 8, Tieu discloses that the interface is directly connected or connectable to the network (see Figure 2 which shows IMD directly connected to PCS 42).
Regarding claim 9, Tieu discloses that the medical device comprises a detection unit for signaling interruptions of a connection to the network which activates a basic supply unit that provides a basic function of the medical device (“The frequency ranges/bands are defined to afford different performance characteristics. For example, one band may afford reliable, robust long range connections, while another band may utilize less power to maintain, but experience a shorter range or less reliable connection. The low frequency band (e.g. 400 MHz, 900 MHz, etc.) affords a longer range and more robust connection than the high frequency band (e.g., 1.25 GHz, 2.54 GHz, etc.). However, the high frequency band draws less power from the IMD when scanning for connection requests and during a communications session.”, paragraph [0040]).
Regarding claim 10, Tieu discloses that the medical device comprises a connection quality analysis unit configured to predict a probable interruption of a connection to the network and configured to activate the basic supply unit in advance (“The frequency ranges/bands are defined to afford different performance characteristics. For example, one band may afford reliable, robust long range connections, while another band may utilize less power to maintain, but experience a shorter range or less reliable connection. The low frequency band (e.g. 400 MHz, 900 MHz, etc.) affords a longer range and more robust connection than the high frequency band (e.g., 1.25 GHz, 2.54 GHz, etc.). However, the high frequency band draws less power from the IMD when scanning for connection requests and during a communications session.”, paragraph [0040]).
Regarding claim 11, Tieu discloses that the medical device is equipped with a modem for direct communication with a network (“The programmer 706 may wirelessly communicate with the IMD 100 and utilize protocols, such as Bluetooth, GSM, infrared wireless LANs, HIPERLAN, 3G, satellite, as well as circuit and packet data protocols, and the like. Alternatively, a hard-wired connection may be used to connect the programmer 706 to the IMD 100.”, paragraph [0070]). It is respectfully submitted that Bluetooth, GSM, 3G, and satellite are all comparable networks as claimed.
Regarding claim 12, Tieu discloses that the medical device comprises a power supply unit 55/970 (see Figures 3 and 9).
Regarding claim 13, Tieu discloses that the medical device comprises a power management unit that manages allowable power budgets or limits for operating network communications and enables operation only when the corresponding budget is still available or the limit is not exceeded (“first and second scan modes may designate different scan rates and scan powers to be used with the primary frequency band at different points in time or intervals. Different third and fourth scan modes may designate different scan rates and scan powers to be used with the secondary frequency band, at select points in time or select intervals.”, paragraph [0043]).
Regarding claim 14, Tieu discloses that the power management unit is adapted to recharge a rechargeable power source of the medical device to provide network communication and is adapted to control activation of network communication depending on a state of charge of the rechargeable power source (“the receive power level utilized by the IMD 10”, paragraph [0035] and “The second scan mode may scan a lower energy frequency range, but at an increased scan rate and increased receive power or gain.”, paragraph [0046]).
Regarding claim 15, Tieu discloses a computer-implemented method for operating a medical device, comprising the steps of: performing at least one of the following functions: evaluation of signals and therapy delivery by means of a unit (“For example, based on calibrated X, Y, and Z axes, sensed by the position sensor 54, the controller 48 is able to determine the actual posture, such as vertical or horizontal, of the patient 41. The controller 48 may manually or automatically calibrate the IMD 10 to monitor for potential posture states including one or more of a supine state, prone state, right side position, or left side position.”, paragraph [0051], “The IMD 910 includes an atrial pulse generator 938 and a ventricular pulse generator 940 to generate pacing stimulation pulses for delivery by the right atrial lead, the right ventricular lead, and/or the coronary sinus lead via an electrode configuration switch 948.”, paragraph [0079], and “Atrial sensing circuit 954 and ventricular sensing circuit 956 may also be selectively coupled to the right atrial lead, coronary sinus lead, and the right ventricular lead, through the switch 948 for detecting the presence of cardiac activity in each of the four chambers of the heart.”, paragraph [0081]); communicating directly or indirectly with the network, wherein the at least one function is influenced directly or indirectly via the network communication by means of an interface to a network (“The RF module 46 is loaded with a set of scan attributes from the memory 52 to be configured to establish an RF connection over one or more of primary and/or secondary frequency bands that are non-overlapping and distinct from one another.”, paragraph [0043], and “The pacing and other operating parameters of the IMD 910 may be non-invasively programmed into the memory 994 through a telemetry circuit 964 in telemetric communication with the external device 999, such as a programmer, trans-telephonic transceiver or a diagnostic system analyzer, or with a remote monitor.”, paragraph [0086]); and activating a connection to the network only whenever a need for real-time assessment and/or influence has been detected by means of a predetection unit (“Certain embodiments may provide an implantable medical device (IMD that includes an RF module configured to operate in first and second scan modes to establish an RF connection over a predetermined frequency band based on a scan attribute, memory configured to store predetermined first and second values for the scan attribute to define different first and second scan modes, respectively, a sensor configured to sense a posture state of a patient, and a controller configured to load the RF module with one of the predetermined first and second values for the scan attribute, based on the posture state determined, to cause the RF module to switch between the first and second scan modes.”, paragraph [0017], where the detected change in posture is considered the “immediate need for real-time assessment and/or influence has been detected” as claimed). However, Tieu fails to disclose activating a connection to the network only when sufficient remaining power supply is ensured based on a remaining energy supply of the medical device. Hresko teaches a medical device 120 for sensing or therapy (“Aspects of the present disclosure are directed to monitoring and/or therapeutic medical devices”, paragraph [0066]) that includes network communication (“the network interface 306 can facilitate the communication of information between the controller 120 and one or more other devices or entities over a communications network. For example, the network interface 306 may be configured to communicate with a server (e.g., a remote server) where a caregiver can access information related to the patient”, paragraph [0098]). Further, Hresko teaches that in response to a low battery warning, wireless connectivity may be disabled in order to preserve remaining battery life (see paragraph [0181]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tieu to include activating a connection to the network only when sufficient remaining power supply is ensured based on a remaining energy supply of the medical device, as taught by Hresko, in order to preserve the remaining battery life of the medical device, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant's arguments filed October 27, 2025 have been fully considered but they are not persuasive. Regarding the previous rejections under 35 USC 112(b), Applicant argues that the amendments to the claims overcome the previous rejections. However, as set forth above, the amendments fail to overcome all previous rejections and the rejections remain.
Applicant’s arguments with respect to claims 1 and 3-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796