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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “signal acquisition module” in claims 1, 12 and 15 and “communications module” in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-17 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1, 12 and 19 recite an external monitoring apparatus and methods of monitoring pacing of a patient's heart by use of an apparatus adapted to monitor a temporary cardiac pacing device. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to an apparatus and 12 and 19 are directed to methods, and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 12 and 19 recite the steps comprising:
“ii. receive instantaneous values of quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses
iii. compare the instantaneous values against the values in the data store to establish differences therebetween;
iv. analyze any difference(s) at step iii above in terms of its/their quality, size and timing and, in the event a noise signal occurs or a noise signal occurs and no cardiac signal or evoked signal is received, to follow at least one of:
an oversensing algorithm when a noise signal is received to determine whether or not there has been any oversensing and an undersensing algorithm to determine whether or not there has been any undersensing; and
v. raise an alarm if it determines that there has been any oversensing and/or any undersensing”.
The steps: “i. establish a base level operation of the heart and pacing device and to store the associated quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses in the data store; and ii. receive instantaneous values of quality, size and/or timing values of the cardiac and evoked signals and the pacing impulses” are considered as the pre-solution activity of collecting data from the temporary pacing device.
Steps iii-v are the abstract idea that can be performed by a clinician by reviewing the collected data that has been acquired and received.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 12, and 19 recite an abstract idea of a mental process.
The limitations as drafted in the claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic cardiac pacing device, a memory and a processor, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example a clinician can compare the instantaneous values against previous data values on a strip chart or manually to establish differences therebetween, analyze any differences by viewing the data in terms of its/their quality, size and timing and, in the event a noise signal occurs or a noise signal occurs and no cardiac signal or evoked signal is received by comparing it to thresholds, determine there is an oversensing any undersensing by comparing to established thresholds; and raise an alarm by flagging the data .
Further, dependent Claims 2-11 and 13-17 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 12 and 19 recite the additional elements of a “processor”, “memory”, “signal acquisition module” and the “cardiac pacing device” (which is not positively claimed as part of the claimed external monitoring apparatus). However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, “processor”, “memory”, “signal acquisition module” and the “cardiac pacing device” (which is not positively claimed as part of the claimed external monitoring apparatus) are being interpreted as generic components to perform the steps of data collection and analysis and amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”) and Bulkes et al (U.S. Patent Application Publication Number: US 2008/0039904 A1 hereinafter “Bulkes”) are teachings of an external monitoring device for a cardiac pacing device.
and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
It is suggested that the claims be amended to include limitations from claim 18 that recite that the processor is configured to further alter the parameters of the external monitoring system or of the temporary cardiac pacing device in response to the processor raising the alarm in order to overcome the rejection under 35 U.S.C. 101.
Claims 10 and 15 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter. claim 10 and 15 are directed to the apparatus and recite
10. The apparatus according to claim 1, further comprising electrical connections with the heart and with the pacing device, wherein in which the electrical connections to the heart are placed so as to provide pacing signals to one of or to both of the atrial and ventricular chambers.
15. The external monitoring apparatus according to claim 1 wherein the temporary cardiac pacing device from which the signal acquisition module acquires pacing signals is located externally to a patient's body.
Applicant recites part of a human, i.e. "… the electrical connections to the heart are placed …” (Claim 1, lines 8-9) "… is located externally to a patient's body.”(Claim 25 & 29, lines 4-5). Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be placed/located" when referring to the location of the elements in relation to heart or body.
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.
Claims 1, 2, 7, 8, 10, 12-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”).
Regarding claims 1, 12 and 19, Hecker teaches an external monitoring apparatus (e.g. 506, 508 Fig.5) and a method to monitor a temporary cardiac pacing device (i.e. IMD e.g. 502 Fig.5, Col. 7 lines 29-40 Note: the claim does not positively recite the IMD as part of the claimed invention and also does not provide any limitations of the IMD that qualify it as “temporary”), the external monitoring apparatus comprising:
a signal acquisition module adapted to acquire cardiac signals indicative of cardiac operation, pacing impulses emitted by the pacing device, evoked signals emitted from a patient's heart in response to the pacing impulses, and any noise signals (e.g. Col. 2 lines 9-16, 25-32, 102, 103 Fig.1, 302 Fig.2)); and
a processor adapted to receive from the signal acquisition module and to analyze the cardiac and evoked signals, the pacing impulses and the any noise signals; and a data store (e.g. Col. 6 lines 63- col.7 line 8, Col. 7 lines 29-40: Hecker teaches that the data collected by the pacemaker IMD 502 is transmitted to the external device 504 which then analyzes the collected cardiac and evoked signals, pacing impulses and noise signals to determine if there is any oversensing or undersensing).
Hecker further teaches that the processor is configured to analyses the collected data by determining a baseline and comparing the instantaneous values against the values in the data store to establish differences therebetween and analyze any differences above in terms of its/their quality, size and timing ( e.g. col. 2 lines 64-col. 3 lines 7: a baseline of heart activity may be determined utilizing the data and may be compared to current heart activity, such that a problem may be automatically identified based on the comparison) and
to follow at least one or an oversensing or undersensing algorithm to determine whether or not there has been any oversensing and or there has been any undersensing (e.g. Abstract, Figs.2,3 Fig.4A) and raise an alarm if it determines that there has been any oversensing and/or any undersensing (e.g. 307 Fig.3 , Col. 5 lines 3-14): user may or may not choose to confirm the changes that may be instituted and therefore the user is provided with a notification about the oversensing or undersensing).
Regarding claim 2, Hecker teaches that the undersensing algorithm comprises determining that there has been the undersensing if the processor receives a pacing signal within an undersensing time window after it receives the cardiac signal. (e.g. Fig. 4A, col. 5 line 19-46).
Regarding claim 7, Hecker teaches a visual and or audible alarm to alert an operator/medic/nurse that the functioning of the patient's heart and/or the pacing device is incorrect (e.g. Col. 8 lines 1-7, Col. 8 lines 19-37, claim 6).
Regarding claim 8, Hecker teaches a communications module adapted to communicate to/from a user interface which is remote from the apparatus (e.g. Fig. 5 Col. 6 lines 63- Col. 7 line 40).
Regarding claim 10, Hecker teaches electrical connections with the heart and with the pacing device, wherein in which the electrical connections to the heart are placed so as to provide pacing signals to one of or to both of the atrial and ventricular chambers (e.g. col. 2 lines 15-16. col. 3 lines 10-18).
Regarding claim 13, Hecker teaches that the oversensing algorithm comprises determining that there has been oversensing if: the processor detects a noise signal; and the processor either receives no cardiac signal within an oversensing time window following a pacing signal, or receives a plurality of cardiac signals at a rate below a pacing base rate (e.g. Fig.2, Col. 4 lines 6-13, Fig. 4A,B).
Regarding claim 14, Hecker teaches that the processor is adapted to follow both the oversensing algorithm and the undersensing algorithm (e.g. Abstract, Fig.4A).
Regarding claim 16, Hecker teaches that the external monitoring apparatus (e.g. 504 Fig.5) is a separate device to the temporary cardiac pacing device (e.g. 205 Fig.5).
Regarding claim 17, Hecker teaches monitoring the external monitoring apparatus during an initial, set up stage to ensure that the base levels established by the processor are correct and do not correspond to any inappropriate functioning of the patient's heart or the temporary cardiac pacing device. e.g. Col. 2 line 67- col. 3 line 9: a baseline of heart activity may be determined, user-configured to cover a certain timeframe … if it is found that non-physiological activity is identified (which did not exist with respect to the baseline), such may be an indication that a sensing problem exists).
Regarding claim 18, Hecker teaches further altering parameters of the external monitoring apparatus or of the temporary cardiac pacing device in response to the processor raising the alarm (e.g. e.g. 304, 307 Fig.3, Col. 5 lines 3-14).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”) in view of Ferek-Petric (U.S. Patent Number: US 5076272 hereinafter “Ferek-Petric”).
Regarding claim 3, Hecker teaches the claimed invention as discussed above except for the processor being adapted to follow a loss of capture algorithm to establish whether there has been a loss of capture and to raise an alarm if there is determined to have been a loss of capture, wherein following the loss-of-capture algorithm comprises determining that there has been a loss of capture if the processor receives no cardiac signal within an evoked response time window after receiving a pacing impulse.
In a similar field of endeavor, Ferek- Petric teaches an implantable cardiac pacemaker comprising a processor that is adapted to follow a loss of capture algorithm to establish whether there has been a loss of capture and to raise an alarm if there is determined to have been a loss of capture, wherein following the loss-of-capture algorithm comprises determining that there has been a loss of capture if the processor receives no cardiac signal within an evoked response time window after receiving a pacing impulse. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Hecker to include the loss of capture algorithm to determine if the processor receives no cardiac signal within an evoked response time window after receiving a pacing impulse as taught Ferek-Petric in order to provide the predictable results of improving monitoring of the implantable pacing device.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”) in view of Bulkes et al (U.S. Patent Application Publication Number: US 2008/0039904 A1, hereinafter “Bulkes”).
Regarding claim 4, Hecker teaches the claimed invention as discussed above except for the processor being adapted to follow an arrhythmia algorithm to sense arrhythmia by detecting a sudden change in cardiac rhythm, and to raise an alarm when the arrhythmia is sensed.
In a similar field of endeavor, Bulkes teaches a system (e.g. Fig. 3, 6 [0268], [0270])) that comprises an external monitoring device (i.e. data processing device 230 Fig. 6) that provides an alarm ( e.g. [0305]-[0309]) when a sudden change in cardiac rhythm is detected (e.g. [0308], [0309]: if the data indicates either a serious condition of the patient, for example, absence of heartbeat for a pre-specified amount of time). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Hecker to that the processor is adapted to sense arrhythmia by detecting a sudden change in cardiac rhythm, and to raise an alarm when the arrhythmia is sensed in order to provide the predictable results of providing a more efficient monitoring device for alerting the patient and clinician.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”) in view of Helfenbein et al (U.S. Patent Application Publication Number: US 2011/0092838 hereinafter “Helfenbein”).
Regarding claim 5, Hecker teaches the claimed invention as discussed above except for the processor being adapted to respond to an operator input request to carry out QT analysis or rhythm analysis and to follow respective algorithms to perform a requested analysis.
In a similar field of endeavor, Helfenbein teaches ECG monitoring system (e.g. [0029]) that continuously monitors a patient's ECG waveform and periodically identifies the patient's QT interval as well as perform rhythm analysis (e.g. [0028]: beat classifications are used to determine the heart rhythm) based on the user selected settings and provides alarms (e.g. abstract, [0039]- [0041]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Hecker to respond to an operator input request to carry out QT analysis or rhythm analysis and to follow respective algorithms to perform a requested analysis as taught by Helfenbein in order to provide the predictable results of improving the monitoring of the patient.
Regarding claim 6, Hecker in view of Helfenbein teaches the claimed invention as discussed above and Hecker further teaches that the data store is adapted to contain causal data and values relating to the causes of cardiac arrythmia and related pacing device settings appropriate for each cause, the processor being adapted when requested to perform the rhythm analysis to compare instantaneous values with those in the data store, identify the cause which best matches the causal data and values in the data store and to display related pacing device settings (e.g. col. 7 lines 56-67: display to a user through a graphical interface (such as on the display of external device 504) the current non-ideal programmed settings and the suggested ideal settings while graphically depicting both parameter sets as an overlay on either the stored or frozen real-time electrogram where a sensing anomaly has occurred).
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”) in view of Adams et al (U.S. Patent Number: US 5304209 hereinafter “Adams”).
Regarding claim 9, Hecker teaches the claimed invention as discussed above except for the apparatus being configured to be connected to the patient's heart and the temporary cardiac pacing device by electrical connections such that the patient's heart, the apparatus and the pacing device are connected in an inline arrangement by the electrical connections.
In a similar field of endeavor, Adams teaches an external monitoring apparatus that is configured to be connected to the patient's heart and the temporary cardiac pacing device (e.g. 14 Fig.1, 2) by electrical connections such that the patient's heart, the apparatus and the pacing device are connected in an inline arrangement by the electrical connections. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Hecker to to be a temporary pacing device with inline connections as taught by Adams in order to provide the predictable results of having a more easily replaceable device for the evaluation period.
Regarding claim 15, Hecker teaches the claimed invention as discussed above except for the temporary cardiac pacing device from which the signal acquisition module acquires pacing signals being located externally to a patient's body.
In a similar field of endeavor, Adams teaches a system 10 including a temporary external pacemaker 14 and a lead 16 secured to the temporary pacemaker and which is introduced transcutaneously into the patient's heart 42 (e.g. Fig.2, col. 5 lines 33-59). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Hecker to so that the temporary cardiac pacing device from which the signal acquisition module acquires pacing signals is located externally to a patient's body in order to provide the predictable results of having a more easily replaceable device for the evaluation period.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hecker et al (U.S. Patent Number: US 9610020B1 hereinafter “Hecker”) in view of Schrock et al (U.S. Patent Application Publication Number: US 2016/0339248 A1 hereinafter “Schrock”).
Regarding claim 11, Hecker teaches the claimed invention as discussed above except for the processor being adapted to integrate and utilize data from additional biomedical sensors. In a similar field of endeavor, Adams teaches a system for providing multi-site cardiac pacing and which utilizes data from additional physiological sensors for analysis by the processor (e.g. [0057]: Physiological sensors 70 may include pressure sensors, accelerometers, flow sensors, blood chemistry sensors, activity sensors, heart sound sensors, or other physiological sensors for use with implantable devices). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the processor in the teachings of Hecker to include data from one or additional more physiological sensors as taught by Schrock in order to provide the predictable results of improved detection and analysis of physiological events and conditions.
Conclusion
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792