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 .
Response to Arguments
Applicant’s cancellation of claim 82 has overcome the 35 USC 112(b) rejection.
Applicant's amendment and arguments filed 1/29/2026 regarding the 35 USC 101 rejection have been fully considered but they are not persuasive.
Regarding the 35 USC 101 rejection, Applicant argues, “Applicant submits that claim 56 is not merely directed to an abstract idea, but to specific, technical improvements in the functionality of a medical device. Claim 56 is also integrated into a practical application. Reconsideration and withdrawal of the rejection is respectfully requested.”
However, Applicant has not pointed out or discussed any particular improvements to the functionality of a medical device as argued and Applicant has not pointed to any specific limitation or combination of limitations that show integration of the abstract idea into a practical application. The amended limitations only further define the abstract idea (a clinician could mentally (or with the aid of pen and paper) average a few data points and make decisions based on that average. These concepts are also mathematical concept abstract ideas. Furthermore, the amendment does not have any additional elements that amount to a practical application of the abstract idea. The claim ends with “wherein the control signal triggers the blood pump”. Applicant has not specified any particular action that this “triggering” produces. This is a generic recitation that are mere instructions to apply the abstract idea in a generic way. See MPEP §2106.04(d)(2)(a), “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.” The “triggering” claim limitation is analogous to the generic “administering a suitable medication to a patient” in the example. The 35 USC 101 rejection of the claims is maintained.
Applicant’s amendment has added features to Claim 56 that has overcome the 35 USC 102 rejection with respect to Inamori et al. (2008/0249456). However, the amended limitations were previously addressed with the secondary art of Maier et al. (2020/0360583), e.g. the spatial evaluation by averaging measurements from multiple leads; and Harris (U.S. Patent 3,590,811), e.g. temporal evaluation of averaging R peaks at different timepoints. The rejection has been reformatted to address the amended limitations of Claim 56.
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.
Claim 94 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 94 states “wherein evaluating the data points comprises both spatially evaluating the data points and temporally evaluating the data points”. Claim 56, from which Claim 94 depends, states “to determine at least one amplitude change within the cardiac cycle from the evaluated data points” and “to output a control signal for the extracorporeal circulatory support at a predefined time point after the at least one amplitude change.” It is unclear how the separately evaluated data points (using the claimed spatial and temporal evaluations) are combined to produce an amplitude change measure (or if they are even combined) and then unclear after which evaluations results the control signal is triggered off of (or if it is triggered after each separate evaluation) or if the evaluations are somehow combined to produce a single change metric that is then used to time the control pulse. The metes and bounds of the claim are unclear.
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 56, 57, 78-81, 83-86 and 88-94 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 product (i.e. a system)
Step 2A, Prong 1
The claims recite the steps of “spatially evaluating the data points, wherein the ECG signal comprises at least a first measurement signal from a first ECG lead and a second measurement signal from a second ECG lead that are spatially separated from one another, and wherein the at least one amplitude change is determined based on addition or averaging of the first measurement signal and the second measurement signal”; “temporally evaluating the data points, wherein the at least one amplitude change is determined based on an addition or averaging of data points for at least one time point corresponding in time in at least two cardiac cycles”; and “determine at least one amplitude change within the cardiac cycle from the evaluated data points.” These steps, given the broadest reasonable interpretation are steps that are performable in the human mind. A clinician could take data points form multiple leads; average them ; and determine an averaged amplitude change over the average values. Likewise, a clinician could average data points over multiple cycles to determine the amplitude change over time. These concept are also mathematical concept abstract idea in that data averaging is a mathematical process. Therefore, the claims recite a mental process abstract idea and mathematical concept abstract idea.
Step 2A, Prong 2
The claims do not include any additional elements that amount to integration of the abstract idea into a practical application. The claims recite the additional elements of a blood pump; an interface for receiving an ECG signal; a control unit; receiving a measurement of the ECG signal; outputting a control signal; and triggering a pump with the control signal. The blood pump recitation only generally links the use of the judicial exception to a particular technological environment or field of use; the interface for receiving an ECG signal and the actual step of receiving a measurement of an ECG is insignificant, extra-solution activity (mere data gathering). The control unit is generically recited such that it amounts to a generic computer component (e.g. a processor) for implementing the abstract idea on a computer. The generation of a control signal is insignificant, extra-solution activity (data output/reporting). Lastly, the “trigger” limitation is a generic recitation that are mere instructions to apply the abstract idea in a generic way. See MPEP §2106.04(d)(2)(a). Generically linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity and generic computer implementation 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. The claims recite the additional elements of a blood pump; an interface for receiving an ECG signal; a control unit; receiving a measurement of the ECG signal; and outputting a control signal. The blood pump recitation only generally links the use of the judicial exception to a particular technological environment or field of use; the interface for receiving an ECG signal and the actual step of receiving a measurement of an ECG is insignificant, extra-solution activity (mere data gathering). The control unit is generically recited such that it amounts to a generic computer component (e.g. a processor) for implementing the abstract idea on a computer. The generation of a control signal is insignificant, extra-solution activity (data output/reporting). Lastly, the “trigger” limitation is a generic recitation that are mere instructions to apply the abstract idea in a generic way. See MPEP §2106.04(d)(2)(a). Generically link the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity and generic computer implementation do not, alone or in combination, amount to significantly more than the abstract idea itself.
Claims 57 and 83 only further include the data gathering device (insignificant extra-solution activity).
Claims 78-81 and 84-94 only further define the abstract idea.
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 56, 57, 83, 85 and 86 are rejected under 35 U.S.C. 103 as being unpatentable over Inamori et al. (2008/0249456) in view of Maier et al. (2020/0360583).
Regarding Claims 56 and 57, Inamori discloses an extracorporeal circulatory support system comprising a blood pump 3 connectable to venous and arterial patient accesses (elements 2 and 8, respectively; see par. [0053]; Fig. 1, 3). Inamori further discloses an ECG interface/device 13 for receiving an ECG signal from the patient; and a control unit 11 (Fig. 1, 3). The control unit 11 is configured to receive an ECG signal of the patient over time; evaluate the ECG to detect a change in amplitude, namely an R-wave, and then output a control signal that is delayed with respect to the amplitude change (i.e. the R-wave) to control a setting of the blood pump, namely to open a valve 7 of the pumping system (par. [0075]). Inamori is silent regarding either spatially evaluating the ECG signal by averaging signals form two spatially separated leads or temporally evaluating the data points by averaging a time point in two separate cardiac cycles.
However, in a similar field of endeavor of ECG monitoring and analysis, Maier discloses that the processing and control on a single lead set can be extrapolated onto multiple leads, depending on how many leads are available. In the multi-lead embodiment, the signals across the leads can be averaged in order to help correct for potential errors or distortions on any one lead at a given time (par. [0104-0105]). 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 Inamori reference to include averaging data over multiple leads, as taught and suggested by Maier, for the purpose of correcting for potential errors or distortions on any one lead at a given time.
Regarding Claim 83, the Examiner notes the designation of leads as transthoracic, transesophageal, etc. are intended use recitations. Inamori has two disclosed ECG electrodes and the Examiner notes these electrodes are certainly capably of being placed the thorax of a patient. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to Claims 85 and 86, Inamori discloses the device detects ECG signals in real-time and continuously while the patient is connected to the extracorporeal blood pump thus making the system capable of detecting R-waves (amplitude changes) continuously (par. [0022]).
Claims 78-81 are rejected under 35 U.S.C. 103 as being unpatentable over Inamori et al. (2008/0249456) in view of Maier et al. (2020/0360583), further in view of Xu (2021/0290095).
Regarding Claim 78-81, Inamori and Maier disclose the concept of controlling a pump based on R-waves in an ECG signal (see claim 56 rejection) but is silent regarding the particular process used to detect an R-wave from the ECG. However, concerned with a common problem of identifying R-wave peaks in an ECG, Xu discloses sampling numerous data points of an ECG signal over a sensing window (e.g. a time interval) and to track amplitude changes over that window such that an R-wave is identified when a sampling point is greater than a first threshold and when that sampling point is a maximum value over a period of time ([par. [0046-0049]). This provides the benefit of improving R-wave detection accuracy (par. [0062]). 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 Inamori and Maier combination to include R-wave, as taught and suggested by Xu, for the purpose of improving R-wave detection accuracy.
Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Inamori et al. (2008/0249456) in view of Maier et al. (2020/0360583), further in view of Flanagan et al. (3,430,624). Inamori and Maier disclose the concept of controlling a pump based on R-waves in an ECG signal (see rejection of Claim 56) but is silent regarding using R-R intervals to control pump timing. However, in the same field of endeavor of pump control, Flanagan discloses identifying R-wave peaks (amplitudes) in two cycles; identifying an R-R interval and timing pump control based on the length of the R-R-interval (col. 3, lines 5-26) for the purpose of optimizing pump timing with the systolic and diastolic phases of the heart (col. 2, lines 55-67). 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 Inamori reference to include obtaining an R-R time interval, as taught and suggested by Flanagan, for the purpose of optimizing pump timing with the systolic and diastolic phases of the heart.
Claims 56, 57 and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Inamori et al. (2008/0249456) in view of Harris (U.S. Patent 3,590,811).
Regarding Claims 56 and 57, Inamori discloses an extracorporeal circulatory support system comprising a blood pump 3 connectable to venous and arterial patient accesses (elements 2 and 8, respectively; see par. [0053]; Fig. 1, 3). Inamori further discloses an ECG interface/device 13 for receiving an ECG signal from the patient; and a control unit 11 (Fig. 1, 3). The control unit 11 is configured to receive an ECG signal of the patient over time; evaluate the ECG to detect a change in amplitude, namely an R-wave, and then output a control signal that is delayed with respect to the amplitude change (i.e. the R-wave) to control a setting of the blood pump, namely to open a valve 7 of the pumping system (par. [0075]). Inamori is silent regarding either spatially evaluating the ECG signal by averaging signals form two spatially separated leads or temporally evaluating the data points by averaging a time point in two separate cardiac cycles. However, concerned with a common problem of identifying R-wave peaks in an ECG, Harris discloses averaging data points over time, such as 10 seconds (a number of cycles) to define an adaptive R-wave peak detection threshold (see Claim 1; col. 2, lines 20-25) in order to account for fluctuations in overall signal quality (col. 1, lines 38-65). 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 Inamori reference to include averaging multiple data points over time, as taught and suggested by Harris, for the purpose of accounting for fluctuations in overall signal quality.
Regarding Claim 88, the Inamori and Harris combination discloses averaging over a window of 10 seconds in one example. Given an average heart rate for an adult is between 60 and 100 bpm, a 10 second window would have at least 10 cardiac cycles. Alternatively, since Harris does not disclose the exact number of cardiac cycles and only discusses a window length, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to average over 10-40 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.
Claims 92 and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Inamori et al. (2008/0249456) in view of Maier et al. (2020/0360583), further in view of Hao et al. (2019/0139275).
Regarding Claims 92 and 93, Inamori and Maier disclose the concept of controlling a pump based on R-waves in an ECG signal (see rejection of Claim 56) but is silent regarding the particular process used to detect an R-wave from the ECG. However, concerned with a common problem of identifying R-wave peaks in an ECG, Hao discloses exponentiating data points, such as with an exponent of “4”, (par. [0164]) in an R-wave detection process for the purpose of increasing accuracy in R-wave detection capabilities (par. [0172-0174]). 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 Inamori and Maier combination to include exponentiating the ECG data, as taught and suggested by Harris, for the purpose of increasing accuracy in R-wave detection capabilities.
Claim 56, 57 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Inamori et al. (2008/0249456) in view of Maier et al. (2020/0360583).
Regarding Claims 56 and 57, Inamori discloses an extracorporeal circulatory support system comprising a blood pump 3 connectable to venous and arterial patient accesses (elements 2 and 8, respectively; see par. [0053]; Fig. 1, 3). Inamori further discloses an ECG interface/device 13 for receiving an ECG signal from the patient; and a control unit 11 (Fig. 1, 3). The control unit 11 is configured to receive an ECG signal of the patient over time; evaluate the ECG to detect a change in amplitude, namely an R-wave, and then output a control signal that is delayed with respect to the amplitude change (i.e. the R-wave) to control a setting of the blood pump, namely to open a valve 7 of the pumping system (par. [0075]). Inamori is silent regarding both spatially evaluating the ECG signal by averaging signals form two spatially separated leads and temporally evaluating the data points by averaging a time point in two separate cardiac cycles.
However, in a similar field of endeavor of ECG monitoring and analysis, Maier discloses that the processing and control on a single lead set can be extrapolated onto multiple leads, depending on how many leads are available. In the multi-lead embodiment, the signals across the leads can be averaged in order to help correct for potential errors or distortions on any one lead at a given time (par. [0104-0105]). 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 Inamori reference to include averaging data over multiple leads, as taught and suggested by Maier, for the purpose of correcting for potential errors or distortions on any one lead at a given time.
Inamori and Maier fail to disclose temporally evaluating the data points by averaging a time point in two separate cardiac cycles. However, concerned with a common problem of identifying R-wave peaks in an ECG, Harris discloses averaging data points over time, such as 10 seconds (a number of cycles) to define an adaptive R-wave peak detection threshold (see Claim 1; col. 2, lines 20-25) in order to account for fluctuations in overall signal quality (col. 1, lines 38-65). 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 Inamori and Maier combination to include averaging multiple data points over time, as taught and suggested by Harris, for the purpose of accounting for fluctuations in overall signal quality.
Conclusion
The Examiner notes there are not any prior art rejections on claims 89, 90 and 91. However, those claims are currently rejected under 35 USC 101 and therefore are not in condition for allowance.
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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