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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 10/18/2024 has been considered by the Examiner.
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 11 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 11 contains the trademark/trade name ‘Bluetooth’. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a wireless data communication link and, accordingly, the identification/description is indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9-10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ellingson et al (US 20110160791 A1), hereinafter referred to as Ellingson ‘791.
Regarding claim 1, Ellingson ‘791 teaches a computer-implemented method for controlling a medical device implanted in a patient in presence of an external device in the patient's environment (see [0006]; method for the operation of an IMD due to exposure to a disruptive energy field), the method comprising:
receiving a detection signal indicating the presence of the external device in the patient's environment (see Fig. 5, [0101]; exposure characteristic determination module 81 may input signals from one or more of disruptive field detector 68, antenna 78, lead 34 or lead 36 and analyze the signals to detect a condition indicative of the presence of MRI scanner 16),
wherein the detection signal comprises a unique identifier for the external device (see [0096-0097], [0103]; processor 60 may determine a type of MRI scanner);
selecting an operating mode for the medical device by comparing the identifier to a list of known identifiers (see Fig. 5, [0103]; processor 60 may determine a type of MRI scanner and select an exposure operating mode that is specifically tailored for the particular type of MRI scanner),
wherein each known identifier is associated with a predefined operating mode for the medical device (see [0103]; operating mode specifically tailored for the particular type of MRI scanner); and
applying the selected operating mode to the medical device, thereby adjusting the medical device so that undesirable electromagnetic interaction between the medical device and the external device is reduced (see [0027]; to reduce the undesirable effects of disruptive energy field 11, IMD 14 is capable of operating in accordance with settings that are less susceptible to undesirable operation during exposure to disruptive energy field 11),
wherein the list comprises known identifiers for at least one of the following device types:
an industrial machine, an industrial tool, an industrial robot, a vehicle, a security gate, a further medical device (see [0097]; determining the type of MRI scanner such as a 1.5T scanner or a 3.0 scanner, [0024]; IMD 14 may operate in accordance with the disclosed techniques when the disruptive energy field 11 is generated by an MRI scanner, CT scanner, X-ray machine, electrocautery device, diathermy device, ablation device, radiation therapy device, electrical therapy device, magnetic therapy device, RFID security gate, or any other environment with devices that radiate energy to produce magnetic, electromagnetic, electric fields or other disruptive energy fields.).
Regarding claim 2, Ellingson ‘791 teaches the method of claim 1, wherein each predefined operating mode may be defined by a set of specific operating parameters (see [0057]; processor 60 may select one of a plurality of exposure operating modes that corresponds to the type of MRI scanner, wherein the selected exposure operating mode may include at least one operating parameter that is specifically tailored for exposure to a particular type of MRI scanner),
wherein different predefined operating modes in the list may differ from each other in at least one of these parameters (see [0057-0058]; for example, processor 60 may implement a filter to attenuate signals at a first frequency when operating in the exposure operating mode corresponding to a 1.5T MRI scanner and implement a filter to attenuate signals at a second frequency when operating in the exposure operating mode corresponding to a 3.0T MRI scanner.).
Regarding claim 3, Ellingson ‘791 teaches the method of claim 1 wherein, by applying the selected operating mode, at least one diagnostic and/or therapeutic function of the medical device is modified or deactivated (see [0054]; when operating in exposure operating mode, control processor 60 is configured to operate with different functionality compared to normal operating mode, for example in exposure operating mode processor 60 may be configured to operate with reduced functionality and may not provide sensing, not delivery therapy, deliver only a subset of possible therapies, not log collected data, or the like; processor 60 may use a different sensor or algorithm to detect cardiac activity such as pressure sensor measurements rather than electrical activity).
Regarding claim 4, Ellingson ‘791 teaches the method of claim 1 wherein the medical device is configured to sense biosignals from the patient along different sensing vectors; wherein applying the selected operating mode causes the medical device to switch between the sensing vectors (see [0054]; in exposure operating mode processor 60 may use a different sensor or algorithm to detect cardiac activity such as pressure sensor measurements rather than electrical activity).
Regarding claim 5, Ellingson ‘791 teaches the method of claim 1 wherein, by applying the selected operating mode, at least one hardware component of the medical device, in particular at least one sensor of the medical device, is deactivated (see [0054]; in exposure operating mode processor 60 may be configured to operate with reduced functionality and may not provide sensing).
Regarding claim 6, Ellingson ‘791 teaches the method of claim 1 wherein the medical device comprises an interference detector (62) configured to detect interference in an output signal provided by at least one sensor of the medical device (see [0055]; processor 60 may configure IMD 32 to operating in exposure operating mode after determining that sensing performance or sending thresholds are being changed/compromised dur to disruptive energy field 11);
wherein, by applying the selected operating mode, the interference detector is modified or deactivated (see [0054]; in exposure operating mode, processor 60 may not provide sensing).
Regarding claim 7, Ellingson ‘791 teaches the method of claim 1 wherein applying the selected operating mode prevents the medical device from switching into a power saving mode (see [0059-0060]; upon no longer being exposed to disruptive energy field 11, control processor may be configured to operate IMD in the normal operating mode, which corresponds to an operating mode than a physician or user feels provides a most efficacious or optimal therapy for the patient).
Regarding claim 9, Ellingson ‘791 teaches the method of claim 1 wherein the selected operating mode is applied only as long as the detection signal is received (see [0059]; processor 60 may automatically disable the exposure operating mode in response to disruptive field detector 68 no longer detecting disruptive energy field 11 of MRI scanner 16).
Regarding claims 10 and 11, Ellingson ‘791 teaches the method of claim 1 wherein the detection signal is received via a wireless data communication link for data communication, in particular unidirectional data communication, between the medical device and the external device (see [0052]; magnetic field detector 68 may include an antenna to receive RF energy; a signal may be induced on antenna 78 by the pulsed RF fields generated by MRI scanner 16).
As noted above, claim 11 is rejected under 35 USC 112 as it contains a trademark/trade name ‘Bluetooth’. Within the context of the claim, Examiner is regarding ‘Bluetooth’ as a means for wireless data communication and examining the limitation in accordance.
Regarding claim 12, Ellingson ‘791 teaches a control unit comprising a processor (60) configured to carry out the method of claim 1 (Figs. 3-4).
Regarding claim 13, Ellingson ‘791 teaches an implantable medical device (32) comprising the control unit (60) of claim 12 (Fig. 3).
Regarding claim 14, Ellingson ‘791 teaches the implantable medical device of claim 13, wherein the implantable medical device is at least one of an implantable pulse generator (IPG), an implantable cardioverter defibrillator (ICD), a cardiac resynchronization therapy (CRT) pacemaker, a neurostimulator, an electrocardiogram (ECG) recorder, a pressure sensor, a biochemical sensor, a drug pump or a hearing aid (see [0030]; IMD 32 is an implantable cardiac device that senses electrical activity of a heart and/or provides electrical stimulation therapy, sometimes referred to as cardiac rhythm management therapy, which may include pacing, cardioversion, defibrillation, and/or cardiac resynchronization therapy).
Regarding claim 15, Ellingson ‘791 teaches a computer program comprising instructions which, when the program is executed by a processor (60), cause the processor to carry out the method of claim 1 (see [0079]; memory 72 may include computer-readable instructions that may be executed by control processor 60).
Claims 1-5, 8-10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ellingson et al (US 20110077706 A1), hereinafter referred to as Ellingson ‘706
Regarding claim 1, Ellingson ‘706 teaches a computer-implemented method for controlling a medical device implanted in a patient in presence of an external device in the patient's environment (see [0006]; method for the operation of an IMD in a disruptive energy field), the method comprising:
receiving a detection signal indicating the presence of the external device in the patient's environment (see Fig. 5, [0101]; processor 60 determines whether IMD 32 is exposed to disruptive energy field 11 by receiving one or more signals from disruptive field detector 68),
wherein the detection signal comprises a unique identifier for the external device (see [0081]; processor 60 may automatically determine the parameters of the exposure operating mode in response to detecting a static magnetic field having an amplitude corresponding to MRI scanner 16);
selecting an operating mode for the medical device by comparing the identifier to a list of known identifiers (see Fig. 5, [0102]; in response to receiving a signal from disruptive energy field detector 68, processor 60 retrieves the automatically determine parameters of the exposure operating mode from memory 72),
wherein each known identifier is associated with a predefined operating mode for the medical device (see [0028]; IMD having normal operating mode and exposure operating mode); and
applying the selected operating mode to the medical device, thereby adjusting the medical device so that undesirable electromagnetic interaction between the medical device and the external device is reduced (see [0028]; to reduce the undesirable effects of disruptive energy field 11, IMD 14 is capable of operating in an exposure mode that is less susceptible to undesirable operation during exposure to disruptive energy field 11),
wherein the list comprises known identifiers for at least one of the following device types:
an industrial machine, an industrial tool, an industrial robot, a vehicle, a security gate, a further medical device (see [0081]; processor 60 may automatically determine the parameters of the exposure operating mode in response to detecting a static magnetic field having an amplitude corresponding to MRI scanner 16, [0025]; IMD 14 may operate in accordance with the disclosed techniques when the disruptive energy field 11 is generated by an MRI scanner, CT scanner, X-ray machine, electrocautery device, diathermy device, ablation device, radiation therapy device, electrical therapy device, magnetic therapy device, RFID security gate, or any other environment with devices that radiate energy to produce magnetic, electromagnetic, electric fields or other disruptive energy fields).
Regarding claim 2, Ellingson ‘706 teaches the method of claim 1, wherein each predefined operating mode may be defined by a set of specific operating parameters (see [0078]; in exposure operating mode, processor 60 may be configured to operate with reduced functionality and may not provide sensing, not delivery therapy, deliver only a subset of possible therapies, not log collected data, or the like),
wherein different predefined operating modes in the list may differ from each other in at least one of these parameters (see [0078]; when operating in exposure operating mode, control processor 60 is configured to operate with different functionality compared to normal operating mode).
Regarding claim 3, Ellingson ‘706 teaches the method of claim 1 wherein, by applying the selected operating mode, at least one diagnostic and/or therapeutic function of the medical device is modified or deactivated (see [0078]; when operating in exposure operating mode, control processor 60 is configured to operate with different functionality compared to normal operating mode, for example in exposure operating mode processor 60 may be configured to operate with reduced functionality and may not provide sensing, not delivery therapy, deliver only a subset of possible therapies, not log collected data, or the like; processor 60 may use a different sensor or algorithm to detect cardiac activity such as pressure sensor measurements rather than electrical activity).
Regarding claim 4, Ellingson ‘706 teaches the method of claim 1 wherein the medical device is configured to sense biosignals from the patient along different sensing vectors; wherein applying the selected operating mode causes the medical device to switch between the sensing vectors (see [0078]; in exposure operating mode processor 60 may use a different sensor or algorithm to detect cardiac activity such as pressure sensor measurements rather than electrical activity).
Regarding claim 5, Ellingson ‘706 teaches the method of claim 1 wherein, by applying the selected operating mode, at least one hardware component of the medical device, in particular at least one sensor of the medical device, is deactivated (see [0078]; in exposure operating mode processor 60 may be configured to operate with reduced functionality and may not provide sensing).
Regarding claim 8, Ellingson ‘706 teaches the method of claim 1 wherein the medical device comprises a recording function configured to record an output signal provided by at least one sensor of the medical device (see [0029]; in normal operating mode, the IMD may sense physiological events, deliver a number of different therapies, and log collected data),
wherein applying the selected operating mode causes the recording function to stop recording the output signal (see [0030]; in exposure operating mode, the IMD may not log collected data).
Regarding claim 9, Ellingson ‘706 teaches the method of claim 1 wherein the selected operating mode is applied only as long as the detection signal is received (see [0025], [0030]; it is desirable that IMD 14 be reconfigured from the exposure operating mode to the normal operating mode as soon as safely possible after exiting environment 10, wherein environment 10 includes an energy source that generates disruptive field 11).
Regarding claim 10, Ellingson ‘706 teaches the method of claim 1 wherein the detection signal is received via a wireless data communication link for data communication, in particular unidirectional data communication, between the medical device and the external device (see [0093]; disruptive field detector 68 may include a magnetic field detector such as a hall sensor or reed switch).
Regarding claim 12, Ellingson ‘706 teaches a control unit comprising a processor (60) configured to carry out the method of claim 1 (Fig. 4).
Regarding claim 13, Ellingson ‘706 teaches an implantable medical device (32) comprising the control unit (60) of claim 12 (Fig. 4).
Regarding claim 14, Ellingson ‘706 teaches the implantable medical device of claim 13, wherein the implantable medical device is at least one of an implantable pulse generator (IPG), an implantable cardioverter defibrillator (ICD), a cardiac resynchronization therapy (CRT) pacemaker, a neurostimulator, an electrocardiogram (ECG) recorder, a pressure sensor, a biochemical sensor, a drug pump or a hearing aid (see [0047]; IMD 32 is an implantable cardiac device that senses electrical activity of a heart and/or provides electrical stimulation therapy, sometimes referred to as cardiac rhythm management therapy, which may include pacing, cardioversion, defibrillation, and/or cardiac resynchronization therapy).
Regarding claim 15, Ellingson ‘706 teaches a computer program comprising instructions which, when the program is executed by a processor (60), cause the processor to carry out the method of claim 1 (see [0059]; memory 72 may include computer-readable instructions that may be executed by control processor 60).
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.
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ellingson et al (US 20110160791 A1), hereinafter referred to as Ellingson ‘791, in view of Ellingson (US 20110093040 A1), hereinafter referred to as Ellingson ‘040.
Regarding claim 11, Ellingson ‘791 teaches the method of claim 1, wherein the detection signal is received via a wireless data communication link (see Ellingson ‘791 [0052]; magnetic field detector 68 may include an antenna to receive RF energy; a signal may be induced on antenna 78 by the pulsed RF fields generated by MRI scanner 16).
As noted above, claim 11 is rejected under 35 USC 112 as it contains a trademark/trade name ‘Bluetooth’. Within the context of the claim, Examiner is regarding ‘Bluetooth’ as a means for wireless data communication and examining the limitation in accordance.
Ellingson ‘040 teaches an IMD configured to adjust its operating mode and/or sensing configuration of a sensing module in response to the presence of an interfering signal from an external source, wherein the external device may wirelessly communicate with the IMD to cause the IMD to transition to an MRI-compatible operating mode (Ellingson ‘040 [0043-0045]), wherein the wireless communication may be via Bluetooth (Ellingson ‘040 [0092]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Ellingson ‘791’s magnetic/disruptive field detector with Ellingson ‘040’s system of receiving a wireless signal via Bluetooth from the external device which instructs the IMD to transition to an exposure operating mode. One of ordinary skill in the art would have been motivated to make this modification in order to efficiently transition the IMD into an environment compatible operating mode by directly receiving instructions from the external device. It can be appreciated that the use of Bluetooth is a known means for wireless communication and the substitution of Bluetooth for another method of wireless communication would merely be a substitution of equivalents known for the same purpose. See MPEP 2144.06.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Ellingson (US 20120108908 A1) which teaches enhanced sensing by an implantable medical device in the presence of an interfering signal from an external source.
Doerr et al (US 20150352354 A1) which teaches a detector for electromagnetic fields.
Doerr (US 20160151623 A1) which teaches an active implantable device and MRI sensor suitable for use in an MRI scanner.
Newman (US 20130289638 A1) which teaches a magnetic field detector for implantable medical devices.
Schmidt et al (US 20130116750 A1) which teaches a method for safeguarding implanted medical devices in a diagnostic device emitting electromagnetic radiation.
Jenison (US 20110196449 A1) which teaches enablement and/or disablement of an exposure mode of an implantable medical device.
Buchheit (US 8761717 B1) which teaches a safety feature to disable an electronic device when a wireless implantable medical device is proximate.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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