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 .
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.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fishler et al. (US 2020/0054880, hereinafter “Fishler”) in view of Yoon et al. (US 2022/0072316, hereinafter “Yoon”).
In regards to claims 1 and 7, Fishler discloses a system and method comprising a first intracardiac device for implantation within the heart of a patient and at least one second implantable device (Fig. 1A, elements 102 and 104),
wherein the first intracardiac device (104) comprises
a first processing unit for controlling a first signal generator unit (par. 0033; “The controller 112 can include, e.g., a microprocessor (or equivalent control circuitry)”),
a first data memory comprising pre-defined first signal parameters for a first treatment signal (par. 0033; “RAM and/or ROM memory”; par. 0059) and
a first measurement unit for determining at least one first bodily value and at least one second bodily value (Fig. 1B, elements 154, 158, 132),
and the second device (102), for example an intracardiac device, comprises
a second processing unit for controlling a second signal generator unit (par. 0033; “The controller 112 can include, e.g., a microprocessor (or equivalent control circuitry)”) and
a second data memory comprising pre-defined second signal parameters for a second treatment signal (par. 0033; “RAM and/or ROM memory”; par. 0059) and
a second measurement unit for determining at least one third bodily value (Fig. 1B, elements 154, 158, 132),
wherein the first signal generator unit is adapted to deliver a first electric and/or electromagnetic treatment signal to the patient's heart with at least one first signal parameter and an information carrying parameter (par. 0039),
wherein the at least one first signal parameter of the first treatment signal is derived from the first data memory based on the at least one determined first bodily value (par. 0059; delay based on cardiac sensing stored in memory),
wherein the information carrying parameter is determined by the first processing unit based on the determined second bodily value (par. 0039; transmitting motion or temperature data to the other device),
wherein the second signal generator is adapted to deliver a second electric and/or electromagnetic treatment signal, for example to the patient's heart (pars. 0047-0049, 0055),
wherein at least one second signal parameter of the second treatment signal is derived from second data memory based on the at least one determined third bodily value and is further based on the determined information carrying parameter of the first electric and/or electromagnetic treatment signal recently provided by the first intracardiac device (pars. 0059, 0069, 0079; programmed base rate adjusted by activity via communication of the motion/temperature data).
Although Fischler discloses that the signal parameter may be derived by “a controller can additionally, or alternatively, including one or more comparators and/or logic gates that are collectively configured to compare one or more outputs to one or more respective thresholds and trigger responses in the manners summarized with reference to the high-level flow diagram of FIG. 3,” but does not expressly disclose wherein the second processing unit selects the derived at least one second signal parameter from a data matrix containing pre-defined signal parameters associated with possible measurable third bodily values.
However, Yoon in the same field of endeavor of multi-device pacing (Fig. 1) teaches selecting at least one second signal parameter (the sensor indicated pacing rate) from a data matrix containing pre-defined signal parameters associated with possible measurable third bodily values (par. 0414, a look up table to adjust the sensor indicated pacing rate based on measured activity count change and temperature change) to provide the predictable results of more accurate rate responsive pacing adjustments according to changes in activity and temperature (par. 0343).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Fischler by selecting at least one second signal parameter from a data matrix containing pre-defined signal parameters associated with possible measurable third bodily values to provide the predictable results of more accurate rate responsive pacing adjustments according to changes in activity and temperature.
In regards to claims 2 and 8, the first treatment signal is an electric ventricular pacing signal (Fig. 1A, element 104), wherein the at least one first signal parameter of the first intracardiac device is a start time position of the ventricular pacing signal (par. 0059) and/or its amplitude and/or a ventricular pacing rate and/or wherein the second treatment signal is an electric atrial pacing signal (Fig. 1A, element 102), wherein the second signal parameter of the second device is at least one of an atrial pacing rate, an amplitude of the pacing signal and a start time position of the atrial pacing signal (par. 0059).
In regards to claims 3 and 9, the information carrying parameter is a time period by which a pre-defined first electric and/or electromagnetic treatment signal section is shortened or prolonged, e.g. an AV delay value is shortened or prolonged, and/or a rate of a pre-defined first electric and/or electromagnetic treatment signal (par. 0075, 0079).
In regards to claims 4 and 10, the first bodily value comprises the intrinsic atrial activity and/or the intrinsic ventricular activity (Fig. 1A, element 104; pars. 0047, 0059) and/or the third bodily value comprises the intrinsic ventricular activity and/or the intrinsic atrial activity (Fig. 1A, element 102; pars. 0047, 0059).
In regards to claims 5 and 11, the second bodily value is a signal determined by an accelerometer sensor and/or impedance sensor of the first measurement unit (par. 0042).
In regards to claims 6 and 12, the second device only allows change of the second electric and/or electromagnetic treatment signal previously applied to the patient's heart if the second measurement unit has received confirmation of the recently determined information carrying parameter (par. 0083; “In an alternative embodiment, the base pacing rate is only increased following both the initial detection of the onset of patient activity using the temperature sensor, and the confirmation of the onset of patient activity as determined using the motion sensor”).
Response to Arguments
Applicant’s arguments with respect to claims 1-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejections under section 112 have been overcome by amendment. Please also see the new grounds of rejection, necessitated by amendment, in view of Yoon above.
Conclusion
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 MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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