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 .
Response to Arguments
Applicant's arguments filed 8/3/2026 have been fully considered but they are not persuasive. Applicant argues that Yoon does not determine an MRI device when a rise of a magnetic field is measured. The examiner respectfully disagrees as Yoon, in Paragraph [0037] discloses the sensors are used to detect that a magnetic field of a particular intensity is present. This means the sensor is detecting the rise of the magnetic field and indicates that an MRI is present when the rise in magnetic field is of a particular intensity.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 3-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoon et al (US Publication 2017/0296835).
Referring to Claims 1 and 13, Yoon et al teaches an implantable medical device/method of operating an implantable medical device, comprising: a stimulation generator for providing stimulation functions (e.g. Figure 2, Elements 212, 216, and 218); a sensing device for sensing a measurement quantity indicative of a presence of an MRI device (e.g. Figure 2, Element 210), wherein a rise of magnetic fields as measured by the sensing device is indicative of a presence of an MRI device (e.g. Paragraph [0037]); a processing device for controlling operation of the implantable medical device and for identifying a presence of an MRI device based on measurement values obtained from the sensing device (e.g. Figure 2, Element 204 and Paragraphs [0038-0039] discloses the controller determines the pacing is needed during an MRI); program memory (e.g. Paragraph [0030] discloses computer readable instructions included on memory so the controller can execute various operations); an analysis module configured to store information concerning a multiplicity of events relating to operation of the implantable medical device (e.g. Figure 3, Element 302 and Figure 4, Elements 402, 406, 410, and 428), wherein the program memory is configured to store at least two program routines for operating the implantable medical device in case of a presence of an MRI device, wherein the processing device is configured, for controlling operation of the implantable medical device in the presence of an MRI device, to select from a predefined number of events of said multiplicity of events to perform a statistical analysis for selecting one of said at least two program routines to adapt a stimulation function of the stimulation generator (e.g. Figures 3 and 6 Figure 8 utilize algorithms 304,604 from predefined events 302, 602 and Paragraphs [0061] and [0078-0079] disclose the appropriate pacing mode during MRI (exposure) is chosen based on the stored events relating to operation of the IMD; pacing modes include OOO, AOO, VOO, and DOO).
Referring to Claim 3, Yoon et al teaches the implantable medical device of claim 1, wherein at least some events of said multiplicity of events relate to events of cardiac activity (e.g. Paragraphs [0038-0039] and Figure 3, Elements 302 or Figure 6, Element 602).
Referring to Claim 4, Yoon et al teaches the implantable medical device of claim 3, wherein events of cardiac activity are events of stimulated contractions or intrinsic contractions (e.g. Figure 3, Elements 302 or Figure 6, Element 602 and Paragraph [0079]).
Referring to Claim 5, Yoon et al teaches the implantable medical device of claim 1, wherein at least some events of said multiplicity of events relate to stimulation events (e.g. Figure 3, Elements 302 or Figure 6, Element 602 and Paragraph [0079]).
Referring to Claim 6, Yoon et al teaches the implantable medical device of claim 5, wherein stimulation events are events of a cardiac stimulation or a neuro-stimulation (e.g. Paragraphs [0038-0039]).
Referring to Claim 7, Yoon et al teaches the implantable medical device of claim 1, wherein at least some events of said multiplicity of events relate to a triggering of a therapeutic function (e.g. Figure 4, Element 406 and Paragraph [0046] discloses the pacing percentage information 406 is based on pacing activity).
Referring to Claim 8, Yoon et al teaches the implantable medical device of claim 1, wherein one of said at least two program routines represents an OFF mode in which a stimulation function is switched off (e.g. Figure 4, Element 414).
Referring to Claim 9, Yoon et al teaches the implantable medical device of claim 1, wherein one of said at least two program routines represents an asynchronous mode employing an asynchronous stimulation (e.g. Paragraph [0049] discloses asynchronous pacing mode).
Referring to Claim 10, Yoon et al teaches the implantable medical device of claim 1, wherein the processing device is configured to control the implantable medical device for cyclically conducting test operations for obtaining information concerning events relating to the operation of the implantable medical device (e.g. Figure 4, Element 406 and Paragraph [0046] discloses controller determines from pacing percentage information 406 stored by the IMD).
Referring to Claim 11, Yoon et al teaches the implantable medical device of claim 1, wherein the processing device is configured to adapt at least one parameter of any one of said at least two program routines based on a statistical analysis of information concerning said multiplicity of events (e.g. Paragraph [0050]).
Referring to Claim 12, Yoon et al teaches the implantable medical device of claim 1, wherein said a predefined number of events is programmable by a user (e.g. Figure 2, Element 204. The examiner notes the controller is programmed to perform the operations using a predetermined number of events as taught in Figure 8 and Paragraphs [0061] and [0078-0079]. The examiner notes the claim is not reciting an additional structure for programming the predefined number of events).
Referring to Claim 14, Yoon et al teaches an implantable medical device, comprising: a stimulation generator for providing stimulation functions (e.g. Figure 2, Elements 212, 216, and 218); a sensing device for sensing a measurement quantity indicative of a presence of an MRI device (e.g. Figure 2, Element 210), wherein a rise of magnetic fields as measured by the sensing device is indicative of a presence of an MRI device (e.g. Paragraph [0037]); a processing device for controlling operation of the implantable medical device and for identifying a presence of an MRI device based on measurement values obtained from the sensing device (e.g. Figure 2, Element 204 and Paragraphs [0038-0039] discloses the controller determines the pacing is needed during an MRI); a program memory (e.g. Paragraph [0030] discloses computer readable instructions included on memory so the controller can execute various operations); an analysis module configured to store information concerning a multiplicity of events relating to operation of the implantable medical device (e.g. Figure 3, Element 302 and Figure 4, Elements 402, 406, 410, and 428), wherein the program memory is configured to store at least two program routines for operating the implantable medical device in case of a presence of an MRI device, wherein the processing device controls operation of the implantable medical device in the presence of an MRI device by causing the implantable medical device to select from a predefined number of events of said multiplicity of events to perform a statistical analysis for adapting at least one parameter of the at least two program routines and for selecting one of said at least two program routine, the adapting and selecting being used to modify a stimulation function of the stimulation generator (e.g. Figures 3 and 6 Figure 8 utilize algorithms 304,604 from predefined events 302, 60, Figure 8 and Paragraphs [0050], [0061] and [0078-0079] disclose the appropriate pacing mode during MRI (exposure) is chosen based on the stored events relating to operation of the IMD; pacing modes include OOO, AOO, VOO, and DOO).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al (US Publication 2017/0296835) in view of Nappholz et al (US Patent 5,113,869).
Referring to Claim 2, Yoon et al teaches the implantable medical device of claim 1, except wherein the analysis module comprises a circular buffer for storing information concerning said predefined number of events. Nappholz et al teaches that it is known to using a circular buffer for storing events as set forth in Column 10 lines 27-34 to provide efficient usage of memory by replacing the oldest event with the newest event. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Yoon et al, with a circular buffer for storing events as taught by Nappholz et al, since such a modification would provide the predictable results of efficient usage of memory by replacing the oldest event with the newest event.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Doerr et al (US Publication 2023/0166114) discloses a processing device that identifies the presence of an MRI device due to a rise of the magnetic fields as measured by the sensing device.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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.
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/William J Levicky/Primary Examiner, Art Unit 3796
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