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 Objections
Claims 1 and 7 are objected to because of the following informalities: in line 21 of claim 1, and line 31 of claim 7, “derived from second data memory” should read --derived from the second data memory”. Appropriate correction is required.
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 1-12 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.
In regards to claim 1, in lines 9 and 20, “for example” is vague. It is unclear whether the claim requires the second device to be an intracardiac device.
In regards to claims 2 and 8, the phrase “second signal parameter of the second device is an atrial pacing rate, an amplitude of the pacing signal and a start time position of the atrial pacing signal” is vague. Claim 1 (from which it depends) requires “at least one second signal parameter,” so it is unclear whether claim 2 requires all of these parameters or at least one of the parameters. Due to the language in claim 1 and claim 2’s recitation of “parameter” in the singular, the examiner is considering the claim to require at least one of these parameters for prior art purposes, but clarification is respectfully requested.
In regards to claims 3 and 9, the term “e.g.” is vague. It is unclear whether “an AV delay value is shortened or prolonged” is required by the claim or not.
In regards to claims 6 and 12, the limitation “if the second measurement unit has received confirmation” is vague. Since the first unit has not been recited as sending any sort of second confirmation signal, it is unclear whether the scope of this claim requires a second confirmation to be sent by the first unit, whether the “confirmation” can be performed by the second unit alone, or the claim requires some other scope.
In regards to claim 7, in lines 8 and 29, “for example” is vague. It is unclear whether the claim requires the second device to be an intracardiac device.
The remaining claims are rejected by virtue of their dependency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Fishler et al. (US 2020/0054880, hereinafter “Fishler”).
In regards to claims 1 and 7 (as best understood), 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).
In regards to claims 2 and 8 (as best understood), 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 (as best understood), 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 (as best understood), 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”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Min (US 2020/0368538) is another example of leadless pacing devices that communicate with each other.
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.
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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