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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-10 in the reply filed on September 24, 2025 is acknowledged. Currently claims 1-20 are pending in this application, with claims 11-20 withdrawn from consideration.
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 3 and 6-8 is 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 3 recites the limitation “wherein the COI further represents R-R interval.” Claim 2, upon which claim 3 depends, recites the limitation “wherein the COI represents amplitude.” It is unclear how the COI can represent both “an amplitude” and “R-R interval”, which is a time variable. Further clarification and/or correction is required.
Claim 6 recites “wherein the criteria include amplitude criteria and RR interval criteria.” It is unclear how a single “characteristic of interest” can have both amplitude and interval criteria.”
Similar issues exist with claim 7, “wherein the criteria include an amplitude criteria and an RR interval criteria).
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.
Claims 1-5 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gill (US 2019/0336083).
Regarding claim 1, Gill discloses the claimed implantable medical device comprising:
electrodes configured to obtaining cardiac activity (CA) signals for a cardiac beat (e.g. electrodes 146, 126 as shown in Figure 1);
sensing circuitry configured to compare the CA signals to a sensitivity level to detect a sensed event (e.g. sensing circuitry as disclosed in [0071]);
memory to store specific executable instructions; and one or more processors configured to execute the specific executable instructions for:
changing the sensitivity level, utilized by the sensing circuitry, over the cardiac beat based on an adaptive sensitivity profile, the adaptive sensitivity profile having a maximum sensitivity limit (MSL) (e.g. adjustment of adaptive sensing level 918 of Figure 9A using the method of Figure 9B);
determining whether a characteristic of interest (COI) from a candidate event satisfies criteria relative to the COI for a collection of prior sensed events (e.g. detection of R-wave at 922 and also described in Figure 9B, [0173]; [0195]);
declaring the candidate event to be a valid sensed event or a false sensed event based on the determine operation (e.g. confirm/deny brady/asystole at step 930 of Figure 9A, further disclosed in Figure 9C, specification the determination of beat segment of interest results of under sensing at 966 of Figure 9C; [0210] – [0215]); and
adjusting the maximum sensitivity limit based on when the COI from the candidate event satisfies the criteria to provide adaptive sensing of CA signals (e.g. adjusting the max sensitivity 946 as disclosed in Figure 9D wherein the analysis at 939 determines that a threshold adjustment should occur; [0236]).
Regarding claim 2, Gill additionally discloses wherein the COI represents amplitude, the sensed event represents an R-wave (e.g. COI can include R-wave which necessarily involves peak amplitude; [0059]) and the criteria includes an amplitude criteria for when the amplitude of a candidate R-wave is greater than or equal to a predetermined percentage of a mathematical combination of the amplitudes for a collection of prior R- waves (e.g. detection of R-wave as disclosed at 922 of Figure 9A).
Regarding claim 3, as best the claim can be understood, Gill additionally wherein the COI further represents R-R interval (e.g. additional instantaneous and moving average R-R intervals at 988 of Figure 9E), and the criteria further includes an RR interval criteria for when an R-R interval of the candidate R-wave is less than or equal to a predetermined percentage of a mathematical combination of RR intervals for the collection of prior R-waves, the one or more processors further configured to apply the RR interval criteria only when the amplitude criteria is not satisfied (e.g. searching possible under detection with an abrupt change from the moving average at 990).
Regarding claim 4, Gill additionally discloses wherein the COI represents R-R interval, the sensed event represents an R-wave (e.g. additional instantaneous and moving average R-R intervals at 988 of Figure 9E) and the criteria includes an RR interval criteria for when an R-R interval of a candidate R-wave is less than or equal to a predetermined percentage of a mathematical combination of RR intervals for a collection of prior R-waves (e.g. searching possible under detection with an abrupt change from the moving average at 990).
Regarding claim 5, Gill additionally discloses wherein, when the criteria is satisfied, the one or more processors further configured to adjust the maximum sensitivity limit by returning the maximum sensitivity limit to a baseline value and to save the candidate event as a valid sensed event (e.g. updating of sensitivity profile parameters as disclosed in 947 of Figure 9D).
Regarding claim 9, Gill additionally discloses wherein, the one or more processors are further configured to repeat the comparing, determining, declaring and adjusting operations, in real-time, for multiple cardiac cycles and to detect an arrhythmia based on the valid sensed events detected for the multiple cardiac cycles (e.g. repeating as mentioned in the Abstract and step 924 of Figure 9A).
Regarding claim 10, Gill additionally discloses wherein, the sensitivity level represents an instantaneous sensitivity level that the sensing circuitry compares to the CA signals, the instantaneous sensitivity level continuously varying over time and over a course of the cardiac beat (e.g. constant recalculation of sensitivity level as disclosed in steps 922, 926 and 928 of Figure 9A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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