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 .
Status of Claims
Claims 3, 5, 8-9, 12, and 14-16 are currently pending. Claims 14 and 16 are withdrawn. Claims 1-2, 4, 6-7, 10-11, and 13 are canceled. As per the amendments filed on 03/09/2026, claims 3, 5, 9, and 12 are amended. Claims 3, 5, 8-9, 12, and 15 are currently under examination.
Priority
The instant application (filed on 08/11/2022) is a national stage of PCT/EP2021/051974 (filed on 01/28/2021), filed under 35 USC 371. Acknowledgment is made of applicant's claim for foreign priority based on application EP20158713.6 filed on 02/21/2020. Amended claims 3, 5, 8-9, 12, and 15 are sufficiently supported in the foreign application to receive an effective filing date of 02/21/2020 for the instant application. Therefore, all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-8 (35 U.S.C. § 103 Claim Rejections), filed 03/09/2026, with respect to the rejections of claims 1-10, 12, and 15 under 35 U.S.C. § 103 have been fully considered. Note claims 1-2, 4, 6-7, and 10 are canceled and the corresponding rejections are moot. Regarding claim 3, Applicant argues:
As amended, claim 3 requires the processing device to increment a counter when a difference between two consecutive measurement values indicates an increase in the strength of the magnetic field, wherein the processing device concludes that an MRI device is present if the counter is incremented a predetermined number of times or is incremented beyond a threshold. (See Applicant's published application, [0033]).
The PTO admits that neither Lindevig nor Terry detects a change in magnetic field, but cites to Dianaty detection of a waveform slope to allege that it would have been obvious to a person of ordinary skill in the art (POSIT A) arrive at Applicant's claim 3. (See Office Action, Item 25, p. 15). For instance, Terry implements a count on a counter when a magnetic field has been detected. The PTO admits that this is not implementing a count when there is an increase in magnetic field, but rather only when a magnetic field has been detected. Dianaty detects a slope of the waveform ("magnetic field"), and the PTO alleges that a POSITA would have used the teachings of Dianaty and Terry to modify Lindevig to derive Applicant's claim 3.
However, amended claim 3 requires the processing device to increment a counter when a difference between two consecutive measurement values indicates an increase in the strength of the magnetic field. A difference between two consecutive measurement values (Applicant's claim) is not the same as the slope (Dianaty). Amended claim 3 also requires the processing device to conclude that an MRI device is present if the counter is incremented a predetermined number of times or is incremented beyond a threshold. Thus, when the difference of two consecutive measurement values indicates an increase in strength of magnetic field, the counter is incremented, and, if the counter is incremented a certain number of times or beyond the threshold, only then is it determined that the MRI device is present. This type of operation could not be done with the Terry-Dianaty combination. For instance, if the slope were used instead of a difference in consecutive measurement values and the rate of change is constant (i.e., the slope is constant), then there would not be more than one count as the count would only increment if there were increasing rates of change (i.e., the slope was not constant)- e.g., if there were 5 measurement values of 1, 2, 3, 4, and 5, Applicant's claims would increment the count 4 times, but the Terry-Dianaty would only increment the count once because the slope is the same each time.
Accordingly, independent claim 3 is allowable over the cited art, whether taken individually or in any combination, and Applicant respectfully requests withdrawal of the § 103 rejections. (pages 6-8, 03/09/2026 Remarks)
This argument is persuasive. The proposed combinations of prior art do not explicitly disclose a counter which increments a value as the magnetic field strength increases. Terry was relied upon to provide a counter which counted signal samples when a magnetic field was not detected and Dianaty was relied upon to characterize labeling magnetic signal polarity in a binary fashion. However, the combination of these two references did not explicitly teach a counting of polarity or slope as a measure of magnetic field strength. Therefore, the prior art rejection of claim 3 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made newly in view of Sison (US 2013/0268012 A1), see “Claim Rejections - 35 USC § 103” section.
Regarding dependent claims , Applicant argues:
Claims 5, 8-9, 12 and 15 depend cognately from independent claim 3, and add further structural features which further remove the presently claimed invention from the cited art. Given at least the distinctions identified above with respect to independent claim 3, dependent claims 5, 8-9, 12 and 15 are allowable over the cited art and a separate discussion of them will not be belabored for the sake of brevity. (page 8, 03/09/2026 Remarks)
This argument is persuasive due to the dependence of claims 5, 8-9, 12, and 15 on claim 3. The prior art rejections for claims 5, 8-9, 12, and 15 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made newly in view of Sison (US 2013/0268012 A1) and Motz (US 2012/0182658 A1), see “Claim Rejections - 35 USC § 103” section.
Summary: The prior art rejections for claims 3, 5, 8-9, 12, and 15 are withdrawn. New 35 USC § 103 rejections are added for claims 3, 5, 8-9, 12, and 15.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 3 and 15 are rejected under U.S.C 103 as being unpatentable over Lindevig (US 2018/0140856 A1) in view of Sison (US 2013/0268012 A1).
Regarding Claim 3, Lindevig discloses an implantable medical device ([0001]), comprising:
• a stimulation device configured to output electrical stimulation energy for performing therapeutic stimulation action to trigger and clock a therapeutic stimulation action ([0016] – the device can be a pacemaker or other type of cardiac stimulation device)
• a sensing device for sensing a magnetic field ([0005] – “a first magnetic field sensor communicatively coupled to the processor and configured to detect magnetic fields generated by a handheld magnet” and “at least one second magnetic field sensor communicatively coupled to the processor and configured to detect magnetic fields generated by a magnetic resonance imaging (MRI) scanner”); and
• a processing device configured to detect a presence of an MRI device based on a multiplicity of consecutive measurement values obtained from the sensing device ([0005] – “at least one second magnetic field sensor communicatively coupled to the processor and configured to detect magnetic fields generated by a magnetic resonance imaging (MRI) scanner”, [0004] – the outputs of the magnetic field sensors are sampled to detect the presence of the MRI);
wherein the sensing device is configured to conduct measurements at a specified sampling rate in between 1 Hz and 50 Hz, and to provide measurement values at the specified sampling rate ([0029] – “once the MRI mode is initiated, automatic MRI mode module 200 periodically (e.g., at a rate of 8 Hz) samples Hall sensors 206, 208, 210 to detect the MRI scanner”). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” The range is not explicitly identified in Lindevig, but the example of 8 Hz establishes that the ranges overlap. There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
However, Lindevig does not disclose a stimulation device to (1) sense electrical signals relating to cardiac activity, (2) wherein if it is concluded that an MRI device is present the processing device is configured to modify operation of the stimulation device by switching off the sensing function of the stimulation device so that the stimulation device provides a pacing action without a clocking by cardiac activity, (3) wherein the processing device is configured to increment a counter when a difference between two consecutive measurement values indicates an increase in the strength of the magnetic field, and (4) wherein the processing device is configured to conclude that an MRI device is present if the counter is incremented a predetermined number of times or is incremented beyond a threshold.
Sison, in the same of endeavor of altering medical device settings in the presence of a magnetic field ([0005-0006]), teaches a cardiac signal is sensed as part of determining the pacing program ([0026-0028]). Additionally, when in an “MRI safe mode,” the system can cease sensing cardiac signals to prevent aberrant stimulation due to magnetic field noise ([0067], [0070-0071], Claim 19 – “wherein the controller is configured to disable the sensing circuitry or ignore electrogram signals produced by the sensing circuitry, when the IMD is in the MRI safe mode”).
Sison also teaches the use of sensors to measure static and time-varying components of a magnetic field ([0055] – small static field; [0056] – large static field; [0043-0044] – acceleration sensor used as a proxy to measure time-varying magnetic fields, although a sensor to measure magnetic fields could be used in place to measure time varying fields). These signals would be used to characterize whether an MRI device is the source of the magnetic field which may interfere with pacemaker functionality ([0077-0078]). Sison further teaches time-domain analysis where features are counted in a sampled signal and the count reaching a particular threshold determines whether an MRI is present ([0080] – “In accordance with an embodiment, at step 304 the output signal(s) produced by the sensor 219 can be analyzed in the time domain by counting the number of zero crossing, peaks and/or other features of the signal(s) that occur within a time-window, and comparing the resulting count(s) to a corresponding threshold(s)”). The features of the sampled signal can be compared with templates of signals exposed to MRI ([0080] – “the morphology of the output signal(s) produced by the sensor 219 can be compared to one or more stored templates of time-varying gradient magnetic field sequences produced by MRI systems, and the results of the comparison(s) can be compared to a corresponding threshold”). These morphological features being analyzed and counted can include signal width or slope ([0081]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lindevig’s implantable device with an MRI detection mode by incorporating the “MRI safe mode” and time-domain morphologic feature counting to determine the presence of an MRI in Sison. This would have been obvious because both Lindevig and Sison discuss modifying pacing control in the presence of a magnetic field after an MRI field is identified and Sison provides a solution/improvement with a component to identify the time-varying attributes of the MRI signal in addition to the static field attributes to determine when to introduce an “MRI safe mode” (which prevents cardiac signals contaminated by magnetic fields from negatively affecting pacing). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Lindevig by incorporating the “MRI safe mode” and time-domain morphologic feature counting to determine the presence of an MRI in Sison.
Therefore, Claim 3 is obvious over Lindevig in view of Sison.
Regarding Claim 15, the implantable medical device according to Claim 3 is obvious over Lindevig in view of Sison, as indicated hereinabove. Lindevig further discloses sampling occurs at a specified frequency, where an example is provided at 8 Hz ([0029] – “once the MRI mode is initiated, automatic MRI mode module 200 periodically (e.g., at a rate of 8 Hz) samples Hall sensors 206, 208, 210 to detect the MRI scanner”). Lindevig does not explicitly teach a specified frequency of 4 Hz. Given the sampling frequency is explicitly given as 8 Hz in an example, there is no reason to suggest Lindevig is incapable of sampling at 4 Hz because the 8 Hz signal could merely be resampled from 8 Hz to 4 Hz by removing every other sample from the 8 Hz signal.
Therefore, Claim 15 is obvious over Lindevig in view of Sison.
Claim 5 is rejected under U.S.C 103 as being unpatentable over Lindevig (US 2018/0140856 A1) in view of Sison (US 2013/0268012 A1) and Motz (US 2012/0182658 A1).
Regarding Claim 5, the implantable medical device according to Claim 3 is obvious over Lindevig in view of Sison, as indicated hereinabove. Lindevig discloses a processor which indicates an increase in a magnetic field ([0004]). However, Lindevig does not disclose wherein the processing device is configured to decrement the counter value when a difference between two consecutive measurement values indicates a decrease of the strength of the magnetic field.
Motz, in the same field of endeavor of detecting and characterizing changes in a magnetic field (Abstract), teaches a magnetic field difference detection circuit used to characterize motion via receiving a magnetic field signal from a motion detector ([0018]). The detection circuit uses an Up/Down counter to track changes in a digital signal output where the counter increments or decrements based on increases or decreases in the magnetic field, respectively ([0044]). In this manner, the counter value is indicative of the changes in a comparator signal as caused by changes specific to the magnetic field being measured. Differences in the digital signal are used to determine shifts in operation mode of the device ([0001], [0021-0022]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Lindevig’s implantable device with an MRI detection mode by incorporating the Up/Down counter to detect changes in magnetic field in Motz. This would have been obvious because both Lindevig and Motz discuss detecting a magnetic field and Motz provides a solution/improvement with a circuit to detect changes in magnetic field as tracked with an Up/Down counter in order to characterize magnetic field polarity to better determine an operating mode of a device. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Lindevig by incorporating the Up/Down counter to detect changes in magnetic field in Motz.
Therefore, Claim 5 is obvious over Lindevig in view of Sison and Motz.
Claims 8-9 are rejected under U.S.C 103 as being unpatentable over Lindevig (US 2018/0140856 A1) in view of Sison (US 2013/0268012 A1) and Terry (US 2003/0144704 A1).
Regarding Claim 8, the implantable medical device according to Claim 3 is obvious over Lindevig in view of Sison, as indicated hereinabove. Lindevig discloses a processor which indicates an increase in a magnetic field ([0004]). However, Lindevig does not disclose the processing device is configured to reset the counter value to a start value if the counter value is not increased in a predefined period of time.
Terry, in the same field of endeavor of detecting magnetic fields associated with an MRI ([0009]), teaches a counter is reset when the value of N is exceeded, meaning there were insufficient samples indicating a magnetic field in the counter ([0048] – “The control unit 500 may, however, determine (at 645) that the counter 510 has substantially exceeded the predetermined value of N, indicating that no magnetic field has been detected (at 605) in approximately N magnet detection cycles. The control unit 500 may then, in one embodiment, clear (at 650) the counter 510, unset (at 655) the latch 520, turn off (at 660) power to the detection circuit 430(2), and return (at 635) control to the port 410, ending the magnet detection cycle”). This is applicable to the counting of slope values in Sison where positive slopes trend toward a magnetic field and would not increase if a magnetic field is not detected.
It would have been obvious to a person of ordinary skill in the art to alter Lindevig’s system by integrating the resetting sample counter of Terry into Lindevig’s magnetic field detector. This would have been obvious because both Lindevig and Terry discuss the detrimental effect of magnetic interference on vulnerable implantable devices and Terry provides a solution/improvement to conserve power by resetting the magnet detection mode and counter if a magnetic field is not detected for a specified count or time. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Lindevig by incorporating the resetting sample counter of Terry.
Therefore, Claim 8 is obvious over Lindevig in view of Sison and Terry.
Regarding Claim 9, the implantable medical device according to Claim 3 is obvious over Lindevig in view of Sison, as indicated hereinabove. Lindevig discloses a processor which indicates an increase in a magnetic field ([0004]). However, Lindevig does not disclose the processing device is configured to reset the counter value to a start value if the counter is decremented a predetermined number of times or is decremented beyond a threshold.
Terry, in the same field of endeavor of detecting magnetic fields associated with an MRI ([0009]), teaches a counter is reset when the value of N is exceeded, meaning there were a particular number of samples with no magnetic field detected ([0048]). This is applicable to the counting of slope values in Sison where positive slopes trend toward a magnetic field and negative slopes trend away from a magnetic field (i.e. signaling a magnetic field is actively disappearing).
It would have been obvious to a person of ordinary skill in the art to alter Lindevig’s system by integrating the resetting sample counter of Terry into Lindevig’s magnetic field detector. This would have been obvious because both Lindevig and Terry discuss the detrimental effect of magnetic interference on vulnerable implantable devices and Terry provides a solution/improvement to conserve power by resetting the magnet detection mode and counter if a magnetic field is not detected for a specified count or time. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Lindevig by incorporating the resetting sample counter of Terry to signal a diminishing magnetic field.
Therefore, Claim 9 is obvious over Lindevig in view of Sison and Terry.
Claim 12 is rejected under U.S.C 103 as being unpatentable over Lindevig (US 2018/0140856 A1) in view of Sison (US 2013/0268012 A1), Motz (US 2012/0182658 A1), and Terry (US 2003/0144704 A1).
Regarding Claim 12, the implantable medical device according to Claim 5 is obvious over Lindevig in view of Sison and Motz, as indicated hereinabove. Lindevig discloses the processing device is configured to:
• modify operation of the implantable medical device if it is concluded that an MRI device is present ([0004] – “The processor is configured to sample the first magnetic field sensor and the at least one second magnetic field sensor to detect the presence of the MRI scanner, and automatically initiate an MRI mode for the AIMD based on the detection”).
• terminate modification of operation of the implantable medical device when the termination timer reached a predefined time margin (different mechanisms based on times after a magnetic field has been removed are disclosed: [0028] – “Once the predetermined amount of time expires (i.e., after the patient has left the MRI scanner), AIMD 100 automatically returns to its default programming (e.g., a physician-recommended pacing therapy)”; [0029] – “instead of waiting for a predetermined amount of time to expire, once the MRI mode is initiated, automatic MRI mode module 200 periodically (e.g., at a rate of 8 Hz) samples Hall sensors 206, 208, 210 to detect the MRI scanner. Once automatic MRI mode module 200 no longer detects the MRI scanner for a predetermined time period, AIMD 100 returns to its default programming. This decreases the amount of time that AIMD 100 is in the MRI mode. The predetermined time period may be relatively short (e.g., five minutes) or relatively long (e.g., two to four hours)”).
Lindevig does not disclose the counter being reset in start a termination timer if the counter value is reset, and terminate modification of operation of the implantable medical device when the termination timer reaches a predefined time margin.
Terry, in the same field of endeavor of detecting magnetic fields associated with an MRI ([0009]), teaches a counter is reset when the value of N is exceeded, meaning there were a particular number of samples with no magnetic field detected ([0048] – “The control unit 500 may, however, determine (at 645) that the counter 510 has substantially exceeded the predetermined value of N, indicating that no magnetic field has been detected (at 605) in approximately N magnet detection cycles. The control unit 500 may then, in one embodiment, clear (at 650) the counter 510, unset (at 655) the latch 520, turn off (at 660) power to the detection circuit 430(2), and return (at 635) control to the port 410, ending the magnet detection cycle”).
It would have been obvious to a person of ordinary skill in the art to alter Lindevig’s system by integrating the resetting sample counter of Terry into Lindevig’s magnetic field detector. This would have been obvious because both Lindevig and Terry discuss the detrimental effect of magnetic interference on vulnerable implantable devices and Terry provides a solution/improvement to conserve power by resetting the magnet detection mode and counter if a magnetic field is not detected for a specified count or time. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Lindevig by incorporating the resetting sample counter of Terry as an initial indicator of magnetic field removal before the safety time period (after which settings return to normal) is applied in Lindevig.
Therefore, Claim 12 is obvious over Lindevig in view of Sison, Motz, and Terry.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 9:00 am to 5:00 pm.
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, Jennifer McDonald can be reached at 571-270-3061. 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.
/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights