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, 4-15, 24-25, and 28-31 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.
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: Independent claim 1 recites a method for a mental process, and is therefore directed to statutory categories of the invention.
STEP 2A, PRONG 1:
Claim 1 recites the following limitations:
Determining whether to deliver CCM pulse stimulation to the myocardial position via a ventricular electrode lead according to an R wave in the far-field electrocardiogram and an R wave in the in vivo near-field myocardial electrocardiogram.
The following limitation, under broadest reasonable interpretation, cover concepts that can practically be performed in the human mind (i.e. through the use of a pen and paper). For example, following the acquiring of a far-field and an in vivo near-field myocardial electrocardiogram (which corresponds to the myocardial position), the far-field and near-field R waves can be analyzed by a physician to determine whether to deliver CCM pulse stimulation to the patient.
STEP 2A, PRONG 2:
Claim 1 recite the following additional elements:
A control device/processor.
A ventricular electrode lead.
First pair of electrodes.
Second pair of electrodes.
Tip electrode.
The above-identified abstract idea in each of independent claim 1 is not integrated into a practical application under 2019 PEG because the additional elements either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of a control device/processor, a ventricular electrode lead (as recited in independent claim 1), and a first electrode pair, a second electrode pair, and a tip electrode as recited in dependent claims 4-15, 24-25, 28-31 are merely insignificant extra-solution activity and mere data gathering.
Furthermore, the additional elements of a control device/processor are generally recited are generically recited computer elements in independent Claim 1 (and it’s respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Moreover, the above identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer/control device or processor. For at least these reasons, the abstract idea identified above in independent Claim 1 (and it’s respective dependent claims) is not integrated into a practical application under 2019 PEG.
Additionally, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer/control device (or processor) as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer processor elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a control device/processor.
Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 and it’s respective dependent claims is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 and it’s respective dependent claims are each directed to an abstract idea under 2019 PEG.
STEP 2B:
None of the claims include additional elements that are sufficient to amount to significantly more than the judicial exception, since the control device comprises:
A control device/processor.
A ventricular electrode lead.
First pair of electrodes.
Second pair of electrodes.
Tip electrode.
The elements above are well understood and conventional, as shown by Gunderson et al. (US 2013/0060117 A1), which discloses a method for identifying oversensing in an IMD containing a control device/processor (see para [0041], para [0047]-[0052]) containing a ventricular electrode lead (see fig. 3 - 16), via a first pair of electrodes, a second pair of electrodes, and a tip electrode (see abstract, fig. 3– reference numbers 15-17 and 26, and para [0046] – “The EGM signals stored may be sensed from programmed near-field and/or far-field sensing electrode pairs. Typically, a near-field sensing electrode pair includes a tip electrode and a ring electrode located in the atrium or the ventricle, such as electrodes 17 and 21 or electrodes 26 and 24. A far-field sensing electrode pair may include any of the following exemplary combinations: any pair of defibrillation coil electrodes 8, 20 or 23; any of the defibrillation coil electrodes 8, 20 or 23 with housing 11; a tip electrode 17 or 26 with housing 11; a tip electrode 17 or 26 with a defibrillation coil electrode 20 or 23; or an atrial tip electrode 17 with ventricular ring electrode 24 ”). Rousso et al. (US 2009/0099618 A1) teaches devices, systems, and methods for controlling the delivery of electrotherapeutic signals to the heart using a control device/processor (see para [0202]), containing a ventricular electrode lead (see fig. 3 – 42 and para [0137]-[0138]), first electrodes, and seconds electrodes, where both the first and second electrodes contain tip electrodes (see fig. 3 – 42A-42B, 44A-44B, para [0130]-[0131], and para [0245]-[0246]).
Furthermore, per applicant’s specification in para [0262], the processor is construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018).
For at least the above reasons, the method of Claim 1 is directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR).
In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself.
Thus, claim 1 merely apply an abstract idea to a computer/processor and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
DEPENDENT CLAIMS:
Claims 4-15, 24-25, and 28-31 merely further limit the abstract idea and mental process, therefore failing to amount to “significantly more” than the abstract idea either alone or in combination.
In order to overcome the above 101 rejection, Applicant should make amendments similar to claim limitations with regard to the CCM delivery step stated in claims 16-23.
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.
Claims 1, 26, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable under US 2009/0099618 A1 to Rousse et al. (hereinafter “Rousse”) in view of US 2013/0060117 A1 to Gunderson et al. (hereinafter “Gunderson”).
Regarding claim 1, Rousso teaches:
A control device/processor, being configured to execute a pulse stimulation control method (to deliver pacing/CCM treatment - see abstract, para [0002], para [0022], para [0076], para [0202], para [0331]),
the pulse stimulation control method comprising the following steps:
acquiring a far-field/global electrocardiogram and an in vivo near-field/local myocardial electrocardiogram corresponding to a myocardial position (see abstract, fig. 3, para [0007], and [0018], and para [0146]),
determining whether to deliver CCM pulse stimulation to the myocardial position via a ventricular electrode lead according to ECG signal(s) of the far-field/global electrocardiogram ,and an R-R interval of the local myocardial electrocardiogram (see fig. 3 – 42 and 44, para [0017]-[0018], para [0022], [0043]-[0044], para [0047], para [0076]-[0077], para [0122], para [0152]-[0155]), but does not explicitly disclose wherein the control device method comprises acquiring a far-field electrocardiogram and an in vivo near-field myocardial electrocardiogram corresponding to a myocardial position, and
determining whether to deliver pulse stimulation to the myocardial position via a ventricular electrode lead according to an R wave in the far-field electrocardiogram and an R wave in the in vivo near-field myocardial electrocardiogram.
However, Gunderson teaches a method for identifying oversensing for an implantable cardioverter defibrillators (ICDs—see abstract, fig. 5, para [0007]-[0008], para [0012], and para [0054]). The method comprises the following steps of acquiring a far-field electrocardiogram and an in vivo near-field myocardial electrocardiogram corresponding to a myocardial position (see abstract, fig. 3 – 16, 24 and 28, and para [0037]), and determining whether to deliver pulse stimulation to the myocardial position via a ventricular electrode lead according to an R wave in the far-field electrocardiogram and an R wave in the in vivo near-field myocardial electrocardiogram (see fig. 5 and fig. 11, para [0004], para [0007]-[0009], para [0013]-[0014], para [0017]-[0018], para [0033], para [0054]-[0055], para [0078], para [0081]-[0084], and para [0122]-[0124]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rousso with the teachings of Gunderson to arrive at the claimed invention. Such combination would improve the system by providing one device configured to provide CCM and pacing capabilities for prompt sensing and accurate treatment of cardiac abnormalities in the patient ultimately, providing proper therapeutic treatment to the patient.
Regarding claim 26, Rousso as modified teaches:
The control device according to claim 1, wherein the step of delivering the CCM pulse stimulation to the myocardial position specifically comprises:
delivering the CCM pulse stimulation to the myocardial position if a current heart rate parameter is detected to be within a preset range;
and/or,
the CCM pulse stimulation is delivered during at least one of the following ventricular electrical activities:
a sinus beat, a ventricular beat originating from atrial conduction, a ventricular beat originating from a ventricle, and a ventricular beat originating from ventricular pacing (see Rousso – figs. 7-8 and para [0154]-[0159]).
Regarding claim 29, Rousso as modified teaches:
A medical instrument/device, comprising the control device/processor according to claim 1 (see para [0002] and para [0022]), the ventricular electrode lead (see para [0007] and para [0017]), a first pair of electrodes and a second pair of electrodes (see fig. 3 – 42, 42A-42B, 44, , and 44A-44B),
the first pair of electrodes being used for sensing (see para [0013], para [0017]-[0018], para [0022], and para [0130]-[0134]), the second pair of electrodes being used for sensing and stimulation (see abstract, para [0130]-[0132] – the electrode pairs (42A-42B and 44A-44B on the leads 42 and 44 can be used for either sensing and/or stimulation or a combination thereof)),
the second pair of electrodes comprising a tip electrode (see fig. 3 – 44A and para [0131]), the tip electrode being configured on the ventricular electrode lead and arranged at a myocardial position of a ventricle (see fig. 3 – 44 and 44A);
the control device is configured to acquire the far-field/global electrocardiogram based on the first pair of electrodes, and to acquire the in vivo near-field/local myocardial electrocardiogram based on the second pair of electrodes (See Gunderson - abstract, fig. 3, and para [0046]).
Regarding claim 30, Rousso as modified teaches:
The medical instrument according to claim 29, wherein the second pair of electrodes are both configured on the ventricular electrode lead (See Rousso – fig. 3 – 44, 44A-44B, para [0130]-[0132] and para [0138]), and the medical instrument/device is used for providing a cardiac pacing function and/or a defibrillation therapy function via the ventricular electrode lead (see Rousso’s abstract – emphasis on the following two sentences: “The devices, systems and methods process the sensed signals and are capable of delivering electroptherapeutic signals to the heart in the presence of a supra-ventricular arrhythmia such as atrial fibrillation and atrial flutter, while inhibiting the delivering electroptherapeutic signals in the presence of PVCs and/or extopic beats, and/or ventricular arrhythmia. The electrotherapeutic signals may include, among others, pacing signals and cardiac contractility modulating signals.”, para [0002], and Gunderson – fig. 3, para [0022], and para [0037]).
Regarding claim 31, Rousso as modified teaches:
The medical instrument/device according to claim 29, wherein the first pair of electrodes are both configured on the ventricular electrode lead (See Rousso – 42, 42A-42B, para [0131]-[0132], and para [0138] – first sentence) or configured as additional electrodes disposed within a blood vessel, within a cardiac chamber, on an epicardium, within a thoracic cavity other than heart, or subcutaneously,
and
the far-field/global electrocardiogram is an in vivo far-field myocardial electrocardiogram (See Gunderson – para [0046]: “A far-field sensing electrode pair may include any of the following exemplary combinations: any pair of defibrillation coil electrodes 8, 20 or 23; any of the defibrillation coil electrodes 8, 20 or 23 with housing 11; a tip electrode 17 or 26 with housing 11; a tip electrode 17 or 26 with a defibrillation coil electrode 20 or 23; or an atrial tip electrode 17 with ventricular ring electrode 24. ”);
or, the first pair of electrodes are configured as surface electrodes for application on the skin, and the far-field electrocardiogram is a surface electrocardiogram.
Examiner’s Note
The claims above contain subject matter that would be allowable if the 101 rejections of claims 1, 4-15, 24-25, and 28-31 above are overcome. The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art references of record considered are US 2013/0060117 A1 to Gunderson et al., US 2009/0099618 A1 to Rousso et al., US 2022/0088402 A1 to Prutchi et al., US 8,265,738 B1 to Min et al., US 2004/0220631 A1 to Burnes et al., and US 10,881,862 B2 to Ghosh.
Regarding claim 4 and it’s dependent claims 5-25 and 28, the above prior art alone or in combination, fails to explicitly teach all the following limitation:
determining whether to deliver the CCM pulse stimulation to the myocardial position according to the pulse delivery start time and the deliverable pulse time window.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2010/0121395 A1 to Gill et al. teaches a pacemaker or implantable cardioverter-defibrillator based, at least in part, on far-field atrial events sensed using ventricular pacing leads.
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/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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