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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, 5, 7-11, 14, 15 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
The claims are drawn to a medical device (Claims 1-10) and a method of use (Claims 11-20)
Step 2A, Prong 1
Claims 1 and 11 recite the steps of determining a feature of a cardiac signal; determining a sending control parameter base don the determined feature; and detecting a cardiac event signal from the cardiac signal according to the control parameter. These steps, given their broadest reasonable interpretation, involve looking at a cardiac signal; visually (or with the aid of pen and paper) identifying a feature from the signal; mentally determining a sensing control parameter (such as defining a window of a length of time in which to analyze a signal); and then visually inspecting again (or with the aid of pen and paper) the cardiac signal within the defined window. These steps are mental process abstract ideas.
Step 2A, Prong 2
The claims do not include any additional elements that amount to integration of the abstract idea into a practical application. Claim 1 includes the additional element of a sensor; a control circuit; and a processor. The sensor simply gathers data for the analysis and thus amounts to the insignificant, extra-solution activity of data gathering. The control circuit and processor are generically claimed that they amount to generic computer-implementation of the abstract idea. Claim 11 likewise includes the sensing and the processor. Insignificant extra-solution activity and generic computer implementation of the abstract idea do not amount to integration of the abstract idea into a practical application.
Step 2B
The claims do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself. Claim 1 includes the additional element of a sensor; a control circuit; and a processor. The sensor simply gathers data for the analysis and thus amounts to the insignificant, extra-solution activity of data gathering. The control circuit and processor are generically claimed that they amount to generic computer-implementation of the abstract idea. Claim 11 likewise includes the sensing and the processor. Insignificant extra-solution activity and generic computer implementation of the abstract idea do not, alone or in combination, amount to significantly more than the abstract idea itself.
Claims 4, 5, 7, 8, 14, 15, 17 and 18 only further define the abstract idea.
Claims 9, 10, 19 and 20 only further define the data gathering functions.
Claims 2, 3, 6, 12, 13 and 16 are not rejected under 35 USC 101 as they include a practical application, namely the application of therapy pulses in response to the abstract idea determinations.
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, 2, 4, 5, 11, 12, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sullivan et al. (2018/0093102).
Regarding Claims 1, 4, 11 and 14, Sullivan discloses a medical device (a wearable cardioverter defibrillator) having a sensor for sensing cardiac signal and a control circuit configured to determine a feature of the cardiac signal during a plurality of cardiac cycles. The control circuit initially examines the cardiac signal to determine if the features gathered over a plurality of cycles (and not during any blanking periods) indicates a possible shockable rhythm. If a possible shockable rhythm is detected, the system wakes up the main processor (par. [0157]) and, when woken up, changes the sensing parameters to, for example, analyze more sensing channels (the number of channels analyzed being a sensing control parameter, see par. [0094]). A second level analysis 542 is then performed on the cardiac signal to determine if a shockable rhythm is present (a cardiac event signal), see par. [0074-0077].
In regard to Claims 2 and 12, Sullivan discloses that an electrical charge can be delivered in response to the detection of a cardiac event signal and that this pulse is not only limited to a defibrillation pulse but can also be a pacing pulse (par. [0053]).
Regarding Claims 5 and 15, Sullivan discloses this process of having a first check; waking up the processor in response to the first check and analyzing the signal with a second level analysis is iterative (Fig. 5, 12; par. [0092]) and that sensing control parameters such as number of channels analyzed, various trigger conditions and thresholds, etc. can be updated over time (par. [0083-0089]) can be updated over time.
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 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (2018/0093102) in view of Shuros et al. (2010/0249860). Sullivan discloses all of the claim invention except for generating a pacing pulse at an AV interval from detected cardiac activity. However, in the same field of endeavor of external cardiac management devices, Shuros discloses monitoring a user’s intrinsic AV delay from cardiac signals and adjusting pacing at an AV interval in response to the detection (par. [0048-0049]) for the purpose of promoting a cardioprotection effect that would minimize risk of damaging the heart such as during reperfusion (par. [0006]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Sullivan reference to include adjusting a pacing pulse based on an AV interval sensed from a patient, as taught and suggested by Shuros, for the purpose of promoting a cardioprotection effect that would minimize risk of damaging the heart such as during reperfusion.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sullivan et al. (2018/0093102). Sullivan discloses that a preset time can be used t wake-up the processor, the preset time being on the order of a few seconds to 30 min (par. [0086]). Sullivan does not mention timing based off of cardiac cycles. However, typical cardiac cycle length in a normal heart ranges between 50-80 beats per minute, meaning the ranges provided by Sullivan would encapsulate multiple pluralities of heart cycles (defined by a beat). Therefore, while not necessarily timing the wake-up trigger to a specific number of heart cycles, the time ranges disclosed by Sullivan would encapsulate a number of heart cycles and thus would trigger after a plurality of heart cycles have occurred. It would have been obvious to one having ordinary skill in the art at the time the invention was made to trigger the wake-up of the processor after a set number of cycles, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Ultimately, Sullivan teaches cycling the processor on and off after certain amounts of time in order to reduce power consumption and determining the optimum number of cardiac cycles (which would coincide with an optimal amount of time) would only involve routine optimization and experimentation.
Claims 1, 6, 7, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (2010/0069985) in view of Sullivan et al. (2018/0093102) .
Regarding Claims 1, 6, 7, 16 and 17, Stahmann discloses a medical device (cardiac rhythm management system, see Abstract) that analyzes electrical activity of the heart to determine when to deliver and/or withhold therapy with a pulse generator (par. [0304-0305]). Stahmann further discloses that an accelerometer can be used to detect an activity level that can then be used to adjust a pacing rate to meet a metabolic demand of a user (par. [0318]). Stahmann is silent regarding waking up a processor for analyzing cardiac signals and/or activity signals. However, in the same field of endeavor of cardiac therapy devices. Sullivan discloses that a first analysis level can be used to effectively pre-screen sensed data to identify potential treatable rhythms and then awaking up a processor to perform a more computationally intense second analysis on the diagnostic data to confirm a treatable rhythm (par. [0073-0076]) for the purpose of reducing power consumption and thus reducing size and weight of the device due to less circuitry needed to implement (see Abstract; par. [0009]). While Sullivan is more focused on a wearable device, the Examiner notes the common problem of power supply size; power efficiency; computational time, etc. are relevant to both implanted and external devices. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Stahmann reference to include first and second level data analysis that wakes up a processor when a more intense level of analysis is needed, as taught and suggested by Sullivan, for the purpose of reducing power consumption and thus reducing size and weight of the device due to less circuitry needed to implement.
The Examiner notes the combination of Stahmann and Sullivan would produce an iterative process that would collect data; analyze it at a first level to identify potential cardiac issues; and then wake-up a a processor to perform a more intensive analysis of the data to verify the identified issue. Therefore, if an issue is not identified, then the processor would not wake-up and a further analysis would not occur.
Claims 9, 10, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann (2010/0069985) in view of Sullivan et al. (2018/0093102), further in view of Perschbacher et al. (2019/0232065). Stahmann and Sullivan disclose all of the claimed invention except for the use of a multi-axis accelerometer. Perschbacher shows that single and multi-axis accelerometers are equivalent structures known in the art. Therefore, because single and multi-axis accelerometers were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to use and/or substitute a multi-axis accelerometer in lieu of a single axis accelerometer.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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