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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-14 are objected to because of the following informalities:
In re claim 1, the limitation: “Implantable medical device”, on line 1, should read “An implantable medical device”.
In re claim 1, the limitation: “wherein in that the memory unit comprises”, beginning on line 4, should read “wherein the memory unit comprises”.
Claims 2-13 recite the preamble “Implantable medical device according to claim” and should all read “The implantable medical device according to claim”.
In re claim 14, the limitation: “Method for optimizing”, on line 1, should read “A method for optimizing”.
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 6 and 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 re claim 6, the following limitation, “ii) a therapeutic mode, in which the computer-readable program causes the processor to emit at least one stimulation pulse and optionally to differentiate between a ventricular tachycardia that requires therapy and a tachycardia having a different origin and not requiring therapy” is unclear because of the use of the word “optionally”. Specifically, it is unclear if the limitation following the word “optionally” is required or not. It implies that while in the second operational mode, therapy will be applied even in instances when the tachycardia origin is differentiated and determined not to need therapy. For purposes of examination, the limitation will be interpreted as best understood in light of the specification wherein when the tachycardia type is differentiated and determined not to require therapy, therapy will not be applied.
In re claim 12, the following limitation is unclear, “to perform step d) only if a predeterminable morphologic criterion is fulfilled” is unclear. It suggests that step d) cannot be performed unless the predeterminable morphologic criterion is fulfilled. However, in claim 1, from which claim 12 depends, step d) is performed if the determined percentage exceeds a predeterminable threshold. This limitation suggests that step d) can only be performed when meeting the predeterminable morphologic criterion, regardless of the predeterminable threshold in claim 1. For purposes of examination, the limitation will be interpreted as the predeterminable morphologic criterion must be fulfilled in order to perform step d), and if the determined percentage exceeds a predeterminable threshold.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-14 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Step 1: Claim 1 is drawn to a product.
Step 2A – Prong 1:
Claim 1 is drawn to an abstract idea, that under its broadest reasonable interpretation, covers mental processes and mathematical concepts but for the recitation of insignificant extra-solution activity and generic computer components to collecting and processing data. In particular, claim 1 recites the following limitations:
a computer-readable program that causes the processor to perform the following steps when executed on the processor:
repeatedly detecting, with the detection unit, a cardiac electric signal (mental process);
b) determining a duration of a cardiac interval from the detected cardiac electric signal and calculating a theoretic cardiac rate for each interval from the determined duration (mental process);
c) determining a percentage of cardiac intervals lying within a first band having a predeterminable first width around a border between a first cardiac rate zone in which the implantable medical device is operated in a first operational mode and a second cardiac rate zone in which the implantable medical device is operated in a second operational mode (mental process); and
d) if the determined percentage exceeds a predeterminable threshold,
i) outputting a notification signal being indicative for a recommended adjustment of the border between the first cardiac rate zone and the second cardiac rate zone (mental process) or
ii) automatically adjusting the border between the first cardiac rate zone and the second cardiac rate zone (mental process).
These limitations of claim 1 are drawn to an abstract idea because they are processes that, under their broadest reasonable interpretation, are steps merely comprised of mental processes.
Step 2A – Prong Two:
Claim 1 recites the following emphasized (indicated in bold) additional elements that are beyond the judicial exception:
Implantable medical device for stimulating a human or animal heart,
comprising a processor (generic computer element),
a memory unit (generic computer element),
a stimulation unit (generic computer element) configured to stimulate a human or animal heart,
a detection unit (generic computer element) configured to detect an electric signal of the same heart,
wherein in that the memory unit comprises
a computer-readable program (generic computer element) that causes the processor to perform the following steps when executed on the processor:
The additional elements do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. The stimulation unit configured to stimulate a human or animal heart does not positively recite providing treatment (see 2106.04(d)(2)). The detection unit configured to detect an electric signal of the heart amounts to no more than pre-solution activity of data gathering to receive the physiological data. The processor, memory unit, and computer-readable program are computer elements that carry out abstract steps described in claim 1 (see 2106.05(g) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Further, the judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field. The alleged improvement made by the claimed invention as argued by the application above sets forth the improvement in a conclusory manner and the claim does not include the components or steps of the invention that the improvement described.
Step 2B:
Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The processor, memory unit, and computer-readable program are computer elements that carry out abstract steps described in claim 1. The stimulation unit does not positively recite providing treatment. The detection unit amounts to no more than pre-solution activity of data gathering to receive the physiological data. Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well understood, routine, conventional activity.
Regarding the limitation “the stimulation unit configured to stimulate a human or animal heart does not positively recite providing treatment”, see Moffitt et al. (US 9339643) which discloses electrical stimulation of body tissues including pacemakers and implantable cardiac defibrillators (Col. 1, ln. 16-27) comprising a stimulating unit (Col. 4, ln. 3-9) configured to stimulate the human or animal heart (Col. 1, ln. 16-31). Thus, the limitations directed to the stimulation units are well-understood, routine, and conventional, as evidenced by the reference above.
Regarding the limitation “a detection unit configured to detect an electric signal of the same heart”, see Legay et al. (US 5702424) which discloses an implantable system for stimulating a human or animal heart (abstract) comprising a detection circuit (abstract: “conventional detection circuit”) configured to stimulate the human or animal heart [0010]. Thus, the limitations directed to the detection unit are well-understood, routine, and conventional, as evidenced by the reference above.
Moreover, implementing an abstract idea on a generic computer, does not add significantly more. Reconsidering the claim limitations individually and as a combination, the claims fail to meet the requirements for eligibility under 35 U.S.C. 101. All uses of the recited abstract idea require the pre-solution data gathering.
Claims 2-13 recite the same abstract idea as parent claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea. While Claim 6 discloses an option for applying a stimulation pulse, it does not overcome the 35 U.S.C. 101 rejection in all cases as there is a path wherein no therapy is applied.
Claim Rejections - 35 USC § 103
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.
Claims 1-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kroll (US 6445949) in view of Ungstrup (US 20160173999)
In re claim 1, Kroll discloses an implantable (abstract) medical device (Fig. 1: 20) for stimulating a human or animal heart (stimulates 28; abstract),
comprising a processor (22; Col. 4, ln. 29-37),
a memory unit (44; Col. 4, ln. 32-37),
a stimulation unit configured to stimulate a human or animal heart (26; Col. 3, ln. 32-35),
a detection unit configured to detect an electric signal of the same heart (42; Col. 3, ln. 51-54),
wherein in that the memory unit comprises
a computer-readable program that causes the processor to perform the following steps when executed on the processor (Col. 3, ln. 32-37):
a) repeatedly (Fig. 2: arrows pointing from 216 and 208 to 202; Col. 2, ln. 17-18; Col. 7, ln. 45-46) detecting, with the detection unit, a cardiac electric signal (Fig. 2: 202; Fig. 5: 300; Col. 3, ln. 51-64);
b) determining a duration of a cardiac interval from the detected cardiac electric signal (Col. 5, ln. 10-21) and calculating a theoretic cardiac rate for each interval from the determined duration (Col. 5, ln. 21-24);
c) determining if the cardiac intervals lie above or below a border (Fig. 2: 206; Fig. 5: “DETERMINE CARDIAC CONDITION?” splits to 304, 308, 5B and 5C) between
a first cardiac rate zone (Fig. 5: “VT1I<VRI<BRI”) in which the implantable medical device is operated in a first operational mode (304; Col. 7, ln. 1-2) and
a second cardiac rate zone (Fig. 5: “VT2I<VRI<VT2I”; note: this should read “VT2I<VRI<VT1I”) in which the implantable medical device is operated in a second operational mode (308 and proceeding steps; Col. 7, ln. 9-67 – Col. 8, ln. 1-21); and
d) if a distribution of cardiac intervals exceed a predeterminable threshold (214; 308, 318, and 322; Col. 7, ln. 48-67 – Col. 8, ln. 1-21),
i) outputting a notification signal being indicative for a recommended adjustment of the border between the first cardiac rate zone and the second cardiac rate zone or (optional)
ii) automatically adjusting the border between the first cardiac rate zone and the second cardiac rate zone (214; 320, and 324; Col. 7, ln. 48-67 – Col. 8, ln. 1-21).
Kroll lacks:
determining a percentage of cardiac intervals lying within a first band having a predeterminable first width around a border between a first cardiac rate zone in which the implantable medical device is operated in a first operational mode and a second cardiac rate zone in which the implantable medical device is operated in a second operational mode; and
if the determined percentage exceeds a predeterminable threshold
i) outputting a notification signal being indicative for a recommended adjustment of the border between the first cardiac rate zone and the second cardiac rate zone or
ii) automatically adjusting the border between the first cardiac rate zone and the second cardiac rate zone.
Ungstrup discloses a hearing aid (medical device) that, similar to the implantable medical device disclosed by Kroll, classifies received signals into intervals (i.e. zones) below or above an adjustable threshold (i.e. border) which determine which operation mode is selected (abstract). Ungstrup further discloses determining if a standard deviation of the signals is below a predetermined value (i.e. predeterminable threshold) [0074-0075] and determining if the threshold (i.e. border) is within a standard deviation of the mean [0076-0077]. Then, if the threshold (i.e. border) is within a standard deviation that is within a predetermined value, adjusting the threshold (Fig. 7: 69; [0077]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable medical device as disclosed by Kroll by providing determining if a standard deviation of signals is below a predetermined value and adjusting the threshold if it is within a standard deviation of the mean because it would significantly reduce the risk of the medical device switching to an incorrect program due to a misinterpretation of signals, which could prevent the user from receiving required treatment (Ungstrup [0069]). Such a combination would yield determining a percentage of cardiac intervals lying within a first band having a predeterminable first width around a border and automatically adjusting the border if the determined percentage exceeds a predeterminable threshold.
In re claim 2, the proposed combination lacks:
wherein the predeterminable first width lies in a range of from 4 % to 15 % of a cardiac rate of the border.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the predeterminable first width lies in a range of from 4 % to 15 % of a cardiac rate of the border, 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.
In re claim 3, the proposed combination lacks:
wherein the predeterminable threshold lies in a range of from 10 % to 75%.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the predeterminable threshold lies in a range of from 10 % to 75%, 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.
In re claim 4, Kroll discloses an implantable medical device according to claim 1, characterized in that the automatic adjusting of the border is limited to a predeterminable optimizing rate per optimization iteration (Col. 9, ln. 11-17).
In re claim 5, Kroll discloses wherein the predeterminable optimizing rate is 5% of the border (Col. 9, ln. 11-17).
The proposed system lacks:
wherein the predeterminable optimizing rate lies in a range of from 1 % to 6 % of a cardiac rate of the border
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the predeterminable optimizing rate lies in a range of from 1 % to 6 % of a cardiac rate of the border, 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.
In re claim 6, Kroll discloses wherein
the first operational mode is a standard mode, in which the computer-readable program causes the processor not to perform further analyses of the cardiac electric signal exceeding steps b) and c) (Fig. 2: “NO” output of 208, 304), and
in that the second operational mode is
i) a monitoring mode, in which the computer-readable program causes the processor to differentiate between a ventricular tachycardia that requires therapy and a tachycardia having a different origin and not requiring therapy (308; Col. 7, ln. 12-16), or
ii) a therapeutic mode, in which the computer-readable program causes the processor
to emit at least one stimulation pulse (312; Col. 7, ln. 40-44) and optionally
to differentiate between a ventricular tachycardia that requires therapy and a tachycardia having a different origin and not requiring therapy (308; Col. 7, ln. 12-16).
In re claim 14, see above 35 U.S.C. 103, In re claim 1.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kroll (US 6445949) in view of Ungstrup (US 20160173999) in view of Cao (US 20180028086).
In re claim 7, the proposed system lacks:
wherein the computer-readable program causes the processor to perform step d) upon detection of a termination of a tachycardic episode.
Cao discloses an implantable medical device (Fig. 1: 10; abstract) that, like the medical devices disclosed by Kroll and Ungstrup, automatically adjust a threshold (i.e. border) (Fig. 10(b): switches between 602 and 604; [0137]). Further, the threshold is automatically adjusted after the termination of an atrial fibrillation event (i.e. tachycardic episode) [0134, 0056].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable medical device of the proposed combination by providing wherein a threshold is adjusted after a termination of a tachycardic episode as taught by Cao because it allows the threshold to reset after it has adjusted to ensure that the entire episode is correctly classified as being a tachycardic episode, lowering the threshold at an appropriate time (Cao: [0132]). This proposed combination would yield wherein the computer-readable program causes the processor to perform step d) upon detection of a termination of a tachycardic episode.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kroll (US 6445949) in view of Ungstrup (US 20160173999) in view of Budgifvars (US 6029088).
In re claim 8, the proposed system lacks:
wherein the computer-readable program causes the processor to perform step d) in regular intervals.
Budgifvars discloses an evoked response detector for a heart stimulator (abstract) that, like the medical devices disclosed by Kroll and Ungstrup, automatically adjusts a threshold (i.e. border). Further, the threshold is automatically adjusted at regular time intervals (Col. 3, ln. 18-21).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable medical device of the proposed combination by providing wherein a threshold is adjusted at regular time intervals as taught by Budgifvars as it would allow the unit to have a routine check of the threshold which would be beneficial in cases when the threshold was mistakenly adjusted or not adjusted (Budgifvars: Col. 1, ln. 38-41; Col. 3, ln. 25-29).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kroll (US 6445949) in view of Ungstrup (US 20160173999) in view of Perschbacher (EP 3592220).
In re claim 9, the proposed system lacks:
wherein the computer-readable program causes the processor to perform an additional step for checking a stability of the theoretic cardiac rate,
wherein the theoretic cardiac rate is classified as stable if at least 90 % of the analyzed intervals have a duration lying within a second band having a predeterminable second width around an average duration of a predeterminable number of preceding intervals.
Perschbacher discloses an implantable medical device, that similar to the medical device disclosed by Kroll, is for stimulating a heart [0002]. Perschbacher further discloses a step for checking the stability of a heart rate [0017] wherein the rate is considered stable based on either a histogram or Lorenz plot of representative ventricular heart rates (i.e. cardiac rates) does not exceed a stability threshold [0050, 0051]. The Lorenz plot stability measure may include a maximal length and width of the LP shape (i.e. a second band having a predeterminable second width) and a density measure of the LP scatterplots [0050].
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable medical device of the proposed combination by providing an additional step for checking stability and having a threshold for a stability measure of a histogram or Lorenz plot with a maximal length and width and a density measure as disclosed by Perschbacher because it would prevent the implantable medical device from detecting a false cardiac event in the event that the heart rate is not stable (Perschbacher [0051]).
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the theoretic cardiac rate is classified as stable if at least 90 % of the analyzed intervals have a duration lying within a second band having a predeterminable second width around an average duration of a predeterminable number of preceding intervals, 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. This proposed combination would yield wherein the computer-readable program causes the processor to perform an additional step for checking a stability of the theoretic cardiac rate, wherein the theoretic cardiac rate is classified as stable if at least 90 % of the analyzed intervals have a duration lying within a second band having a predeterminable second width around an average duration of a predeterminable number of preceding intervals.
In re claim 10, the proposed combination lacks:
wherein the predeterminable second width lies in a range of from 2 % to 60 % of the average duration of the predeterminable number of preceding intervals.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the predeterminable second width lies in a range of from 2 % to 60 % of the average duration of the predeterminable number of preceding intervals, 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.
In re claim 11, the proposed combination lacks:
wherein the predeterminable number of preceding intervals lies in a range of from 2 to 20.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the predeterminable number of preceding intervals lies in a range of from 2 to 20, 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.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kroll (US 6445949) in view of Ungstrup (US 20160173999) in view of Zhang (US 20140323894).
In re claim 12, the proposed combination lacks:
wherein the computer-readable program causes the processor
to additionally perform a morphologic analysis of the cardiac electric signal over time and
to perform step d) only if a predeterminable morphologic criterion is fulfilled.
Zhang discloses a medical device for stimulating the heart (abstract), that similar to the medical devices disclosed by Kroll and Ungstrup, automatically adjusts a cut-off value (i.e. border) [0028, 0059]. A morphologic analysis of ECG signals, which is indicative of sinus rhythm [0055, 0059], is performed on a cardiac signal over time and if the analysis does not meet a detection criterion (Fig. 5: 310 and 312; [0049-0055]: “population-based thresholds”), a heart rate is determined and the heart rate cut-off is adjusted (Fig. 5: 313; [0056-0059]).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the implantable medical device of the proposed combination by providing a step for performing a morphologic analysis of a beat feature over n cycles and only adjusting a cut-off if a concerning rhythm criterion is not detected as disclosed by Zhang because it provides an important safety precaution in the case of lethal tachycardia and immediately provides therapy without additional checks (Zhang [0054]) and adjusts the heart rate cut-off upon confirmation of sinus rhythm to better establish boundaries when the heart rate conditions are desired for learning and correlating patient-specific features (Zhang [0056-0059]).
In re claim 13, regarding the limitation “wherein the predeterminable morphologic criterion is indicative for a sinusoidal rhythm of the cardiac electric signal” see above 35 U.S.C. 103, In re claim 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bailin (US 7120491) discloses an implantable medical device wherein the heart rate data is used to determine the tachycardic state of the patient dependent on thresholds that are automatically adjusted and wherein morphologic analysis is used to determine whether to adjust the thresholds when in one tachycardic state.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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