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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/04/2025 has been entered.
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 1-9 and 19-20 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 is rejected because it is unclear what system component delivers therapy as now claimed. Claim 1 is also rejected because it is unclear if the therapy is the treatment previously set forth. Claim 1 is also rejected because it is unclear how therapy can be delivered in the second mode which only appears to detect a time varying magnetic resonance generated gradient field and discriminate the time varying magnetic resonance generated gradient field from biological signals. Claim 19 appears to have the same issues. Claim 1 is rejected because it is unclear how the processor “manages operation” in the second mode. Claim 19 is rejected because “the first coil” (line 15) lacks proper antecedent basis.
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, 6-8 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0053652 to Dianaty et al. “Dianaty” in view of U.S. Publication No. 2012/0277606 to Ellingson et al. “Ellingson”.
As for Claims 1 and 19, Dianaty discloses an implantable medical device (IMD) system and method including a field detection module to detect exposure of a coil to an external magnetic field and to switch operation to an MR safe mode to prevent the IMD from malfunctioning (Abstract; Paragraph [0023]). Dianaty discloses wherein the system includes a “multi-function” coil configured to perform two or more functions for the IMD. For example, the coil may be a telemetry coil that is used to wirelessly communicate data with an external device and to determine when the IMD is exposed to an external magnetic field (Paragraphs [0029]-[0033]). Such disclosures are considered to read on the claimed limitations of a first coil configured to operate in a first mode (e.g. wirelessly communicating mode) and a second mode (e.g. detect time varying MR field along first axis) in its broadest reasonable interpretation. The IMD continues to detect time varying MR generated gradient fields in order to determine if the IMD should switch back to a different mode (Paragraph [0076]). In addition, in the second mode, Dianaty explains the IMD may change one or more algorithms processes, methods, analyses and the like that are used to sense and monitor the cardiac signals (Paragraph [0074]). For example, the IMD may switch to a VOO mode which stops sensing cardiac signals and paces the heart at a predetermined pace, an AOO mode which stops sensing cardiac signals and paces both of the atria of the heart at a predetermined rate, a DOO mode which stops sensing and monitoring and paces both an atrium and a ventricle of the heart at a fixed, predetermined rate or the IMD may continue to sense and monitor cardiac signals in the safe mode using one or more algorithms that differ from the algorithms used in the normal mode (Paragraphs [0074]-[0075]). Thus, Dianaty’s system is able to discriminate between a signal generated by the time varying MR generated gradient field and biological signals and deliver treatment (e.g. pacing) based on the monitored cardiac signals when the IMD continues to sense and monitor the cardiac signals in its broadest reasonable interpretation.
Nonetheless, Ellingson teaches from within a similar field of endeavor with respect to IMDs in a noisy environment (e.g. near MRI) where a control module of the IMD is configured to adjust a threshold of the cardiac sensing module in response to a noisy environment (Abstract). Ellingson makes it clear the adjusted threshold allows the device to distinguish between intrinsic cardiac signals and noise-induced signals to provide improved sensing and pacing (Paragraph [0006]).
Accordingly, one skilled in the art would have been motivated to have modified the adjusted algorithms used in the MRI safe mode described by Dianaty with Ellingson’s adjusted thresholds in order to distinguish between intrinsic cardiac signals and noise-induced signals to provide improved sensing and pacing. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claims 2, Examiner notes that in the modified device, the dual mode coils detect cardiac activity signals when not detecting the varying MR generated gradient field in its broadest reasonable interpretation.
As for Claim 6, Dianaty discloses wherein the telemetry circuit included in the IMD can be used to transmit and/or receive from the external device (Paragraph [0030]). Such an arrangement is considered to read on a transceiver in its broadest reasonable interpretation.
Regarding Claims 7-8, Dianaty discloses wherein the coil may be a conductive coil that is included in a transformer circuit that increases an electric potential supplied by a power source (Paragraphs [0028], [0031] and [0082]).
Regarding Claim 20, Dianaty discloses wherein the system can automatically detect when the IMD is within a magnetic field and switch operation of the IMD responsive to the detection (Paragraph [0083]).
Claim(s) 3-5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dianaty and Ellingson as applied to claim 1 above, and further in view of U.S. Publication No. 2016/0144167 to Bakker et al. “Bakker”.
As for Claim 3, Dianaty and Ellingson disclose an IMD with various modes as described above. Dianaty further discloses wherein the IMD includes additional coils (e.g. second coil, third coil) configured to provide cardiac sensing and stimulation (Paragraphs [0024]-[0025]; 120, 126, 128 in Fig. 1 and corresponding descriptions) and explains the field detection module may apply signals to any coil in the IMD (Paragraph [0082]). Examiner notes that each coil (e.g. second coil or third coil) is able to detect the varying MR generated gradient field along its axis (e.g. second axis, third axis) in its broadest reasonable interpretation.
However, while Dianaty discloses detecting the varying MR generated gradient field with multiple coils, it is not clear if three coils are used to detect the field as claimed.
Bakker teaches from within a similar field of endeavor with respect to IMDs within an MRI environment (Abstract; Paragraphs [0001] and [0006]) where a magnetic field detector utilizes multiple coils (e.g. orthogonal coils) to detect a magnetic field (Paragraph [0076]).
Examiner notes that one skilled in the art would have been motivated to have modified the IMD described by Dianaty and Ellingson to use multiple coils (e.g. first, second and third coils) to detect the varying MR generated gradient field with multiple in order to enhance the MR field detection and improve patient safety.
As for Claim 4, Examiner notes that in the modified device, the dual mode coils detect cardiac activity signals when not detecting the varying MR generated gradient field in its broadest reasonable interpretation.
Regarding Claim 5, Dianaty discloses wherein the system can automatically detect when the IMD is within a magnetic field and switch operation of the IMD responsive to the detection (Paragraph [0083]).
As for Claim 9, Dianaty discloses wherein a coil can be all of a telemetry coil, a transformer coil and an auxiliary coil (Paragraph [0028]). Furthermore, as explained above, other coils within the system may be given multi-function roles (Paragraph [0082]). Accordingly, one skilled in the art would have been motivated to have duplicated the multi-function coils described by Dianaty in order to efficiently use coils within the system as desired. Such a modification merely involves a duplication of parts.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 and 19-20 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797