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 arguments, see page 7, filed 06/10/2026, with respect to claim objections have been fully considered and are persuasive. The claim objections have been obviated by amendments to claim 7. The claim objections have been withdrawn.
Applicant’s arguments, see page 7, filed 06/10/2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered. Most of the previously-held 35 U.S.C. 112(b) rejections have been obviated by Applicant’s amendments to the claims. However, there are still some outstanding 35 U.S.C. 112(b) rejections outstanding. Please see 35 U.S.C. 112(b) rejections hereinbelow.
Applicant’s arguments, see pages 7-8, filed 06/10/2026, with respect to 35 U.S.C. 101 rejections have been fully considered but they are not persuasive. The Applicant argues that the technical effect of the added limitation to the independent claims is that monitoring of the operation of the implantable pacemaker device for conducting a threshold test measurement may be reliably established even if the implantable pacemaker device is implanted deep in the patient. The Applicant argues that when an implantable pacemaker device is implanted deep in the patent, establishing direct data communication between the implantable pacemaker device and an external device is difficult. The Applicant argues that with the claimed invention, however, monitoring of the implantable pacemaker device when conducting a threshold test measurement is carried out by the implantable medical device based on the sensing of electrocardiogram signals, and thus no data transmission from the implantable pacemaker device to an external device is required to communicate information relating to a measured threshold for producing stimulation signals. The Applicant further argues that with the claimed invention, deep implantation state of the implantable pacemaker device has no negative impact on data communication. The Applicant argues that this is clearly a technological improvement to the operation of an implantable medical device - e.g., it allows for easy and reliable monitoring of a stimulation threshold concerning a device which may be implanted deep in a patient. The Applicant concludes by arguing that even when the claims are misconstrued as being directed to an abstract idea, they distinctly integrate any alleged abstract idea into a practical application.
This is not found persuasive. The 35 U.S.C. 101 rejections are maintained even when accounting for the Applicant’s claim amendments. Firstly, the Examiner maintains that the independent claims 1 and 15 are directed to an abstract idea and that the claims have not been misconstrued. As explained below, the “identifying” and “monitoring” steps are considered mental process steps when given their broadest reasonable interpretation (please see rejections hereinbelow). The Applicant appears to be directing their argument to Step 2A Prong 2 and Step 2B of the 35 U.S.C. 101 Subject Matter Eligibility Test, where Step 2A Prong 2 asks the question of whether the claim recites additional elements that integrate the judicial exception into a practical application and Step 2B asks the question of whether the claim recites additional elements that amount to significantly more than the judicial exception. It is maintained that the claims do not include any limitations that are indicative of integration into a practical application (see Step 2A Prong 2 Analysis below) or any additional elements that amount to significantly more than the abstract idea (see Step 2B Analysis below). For instance, the sensing arrangement for sensing electrocardiogram signals is considered insignificant pre-solution activity that simply amounts to mere data gathering. The communication circuitry and processing circuitry is also recited at a high level of generality in the Applicant’s specification and amounts to insignificant extra-solution activity in that it amounts to generic computer implementation of the abstract idea. It is also noted that storing and receiving information using the processing circuitry is considered insignificant extra-solution activity. It is also noted that none of these additional elements amount to anything more than what is well-understood, routine, and conventional. For instance, Hastings, et al. (U.S. PGPub No. 2006/0085039) shows that a sensing arrangement for sensing electrocardiogram signals is conventional (Par. [0053]). The Applicant’s alleged technological improvement therefore does not amount to and is not reflected in the claims to be considered as integrating a practical application or to amount to significantly more than the judicial exception. Therefore, the 35 U.S.C. 101 rejections are maintained. Please see 35 U.S.C. 101 rejections hereinbelow.
Applicant’s arguments, see pages 9-10, filed 06/10/2026, with respect to 35 U.S.C. 102 rejections have been fully considered but they are not persuasive. The Applicant points to cited Par. [0100] of Carney and argues that Carney monitors control signals being transmitted. The Applicant argues that Carney does not monitor whether stimulation functions of the implantable medical device are in accordance with a programmed stimulation function based on an identification of a stimulation event, as is required by amended claims 1 and 15.
This is not found persuasive. The Examiner maintains that Carney continues to teach the added limitation to independent claims 1 and 15 (from previous claim 8) and therefore maintains the 35 U.S.C. 102 rejections. Carney is not found to only teach monitoring control signals being transmitted, as argued by the Applicant. Instead, Carney also teaches that the ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30) (Par. [0100]). Carney further teaches that based on the sensed signals anticipated from, or resulting from, PD 16, ICD may take appropriate corrective action (Par. [0100]). Carney teaches that the ICD system 30 may determine that the PD 16 has not delivered a predetermined number of therapies (e.g., one, two, three, or more) expected by ICD system 30 based on the transmitted control signals (Par. [0100]). Therefore, Carney does teach sensing signals using sensing circuitry 78 (electrodes 28, 32a, and 32b shown in Fig. 1) that indicate that therapy was delivered by the PD 16 and therefore Carney does teach monitoring whether stimulation functions of the implantable medical device are in accordance with a programmed stimulation function based on an identification of a stimulation event, as required by amended claims 1 and 15. Therefore, the 35 U.S.C. 102 rejections are maintained for independent claims 1 and 15, as well as the dependent claims. Please see 35 U.S.C. 102 rejections hereinbelow.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations are:
“the processing circuitry is configured to identify, based on the sensed electrocardiogram signals, a stimulation event caused by an implantable pacemaker device” in claim 1 (lines 6-7) and claim 15 (lines 5-8).
“the processing circuitry configured to statistically analyze a multiplicity of stimulation events caused by the implantable pacemaker device” in claim 7 (lines 2-4).
“the processing circuitry is configured to identify, based on the sensed electrocardiogram signals, a requirement for a stimulation event” in claim 9 (lines 3-4).
“the processing circuitry is configured to … monitor, based on the sensed electrocardiogram signals, whether the implantable pacemaker device causes a stimulation event in relation to an identification of a requirement for a stimulation event” in claim 9 (lines 2-6).
“the processing circuitry is configured to identify an anti-tachycardia stimulation event caused by the implantable pacemaker device” in claim 10 (lines 2-3).
“the processing circuitry is configured to identify a requirement for an anti-bradycardia stimulation” in claim 11 (lines 2-3).
“the processing circuitry is configured to … monitor whether the implantable pacemaker device causes an anti-bradycardia stimulation event in relation to an identification of a requirement for an anti-bradycardia stimulation” in claim 11 (lines 2-5).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181(II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations of the specification (References are made to “Clean Specification” filed 05/28/2024):
Figs. 1-2; Page 13, line 31 – Page 14, line 13
Figs. 1-2; Page 13, line 31 – Page 14, line 13; Page 15, lines 9-13
Figs. 1-2; Page 15, line 15 – Page 16, line 10
Figs. 1-2; Page 15, lines 15-23
Figs. 1-2; Page 15, lines 25 – Page 16, line3
Figs. 1-2; Page 16, lines 5-10
Figs. 1-2; Page 16, lines 5-10
If applicant does not intend to have these limitations 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 § 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 1-7 and 9-15 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 1 recites the limitation “stimulation event” in line 15, whereas a stimulation event was already introduced in claim 1 (line 8). It is unclear whether the Applicant intended to claim the same or a different stimulation event. Consider changing to “the stimulation event”.
Claim 9 recites the limitation “a stimulation event” in lines 4-5, whereas a stimulation event was already introduced in a claim that claim 9 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different stimulation event. Consider changing to “the stimulation event”.
Claim 9 recites the limitation “an identification of a requirement” in line 6, whereas identify … a requirement was already introduced in claim 9 (lines 2-3). It is unclear whether the Applicant intended to claim the same or a different identification of a requirement. Consider changing to “the identification of the requirement”.
Claim 15 recites the limitation “stimulation event” in line 15, whereas a stimulation event was already introduced in claim 15 (line 7). It is unclear whether the Applicant intended to claim the same or a different stimulation event. Consider changing to “the stimulation event”.
*All other claims are rejected due to their dependency on a rejected claim.
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 1-7 and 9-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of identifying a stimulation event from an electrocardiogram signal and transmitting to an external device) without significantly more.
Step 1
Independent claims 1 and 15 are directed to an apparatus and a method, and thus meet the requirements for step 1.
Step 2A, Prong 1
Regarding claims 1 and 15, the following steps recite an abstract idea:
“identify[ing], based on the sensed electrocardiogram signals, a stimulation event caused by an implantable pacemaker device” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human (e.g., doctor, cardiologist) could evaluate an ECG signal and could mentally make a judgement of when a stimulation event occurred that was caused by an implantable pacemaker device.
“monitor[ing] whether stimulation functions of the implantable medical device are in accordance with said programmed stimulation function based on said identification of a stimulation event” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could monitor/compare (i.e., evaluate/make judgements) the stimulation functions of the implantable medical device with the programmed stimulation function (i.e., comparing stored vs. actual stimulation values).
Step 2A, Prong 2
Regarding claims 1 and 15, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
a sensing arrangement for sensing electrocardiogram signals – insignificant pre-solution activity, i.e. mere data gathering
a communication circuitry for data communication with a device external to the patient – The “communication circuitry” is defined functionally and with a high level of generality, as it is explained that communication circuitry is configured, for example, to establish a communication according to the MICS protocol, the ISM protocol, the BLE protocol, the Zigbee protocol, or according to another communication scheme (Page 13, lines 14-17). This limitation describes transmitting data with an external device (i.e., computer). The communication of information among computers is considered an ordinary functionality of a computer. “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) … does not integrate a judicial exception into a practical application” (MPEP 2106.05(f)(2)). Hence, this limitation amounts to generic computers executing insignificant extra-solution activity.
a processing circuitry … configured to … cause a transmission of information concerning said identification of a stimulation event to the device external to the patient – This limitation describes transmitting data with an external device (i.e., computer). The communication of information among computers is considered an ordinary functionality of a computer. “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) … does not integrate a judicial exception into a practical application” (MPEP 2106.05(f)(2)). This limitation could also be interpreted as insignificant post-solution activity that does not meaningfully limit the claim if the external device is a display device. Hence, this limitation amounts to generic processing circuitry executing insignificant extra-solution activity.
the processing circuitry is configured to store programming information indicative of a programmed stimulation function of the implantable pacemaker device – This limitation involves using processing circuitry to store programming information (e.g., on a memory), which is insignificant extra-solution activity in that it amounts to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)]. It is also noted that storing and receiving information is considered insignificant extra-solution activity [MPEP 2106.05(d)(II)(iv.)].
Therefore, the claims are directed to an abstract idea without a practical application.
Step 2B
The additional elements of claims 1 and 15, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the “sensing arrangement”, “communication circuitry”, and “processing circuitry”, along with their associated functions and components, are recited with a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)].
a sensing arrangement for sensing electrocardiogram signals -– Hastings, et al. (U.S. PGPub No. 2006/0085039), Par. [0053]: “Alternatively, a conventional single or dual lead pacemaker may sense the local cardiac electrocardiogram (ECG)”.
a communication circuitry for data communication with a device external to the patient – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network”).
a processing circuitry … configured to … cause a transmission of information concerning said identification of a stimulation event to the device external to the patient – MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network”).
the processing circuitry is configured to store programming information indicative of a programmed stimulation function of the implantable pacemaker device – MPEP 2106.05(d)(II)(“iv. Storing and retrieving information in memory”)
Hence, the claims are directed to an abstract idea without a practical application and without significantly more.
Dependent claims
Regarding dependent claims 2-3 and 13-14, the limitations only further define the apparatus to which the claim is directed to.
Regarding dependent claims 4-7 and 12, the limitations only further define insignificant extra-solution activity of generic computer implementation of the abstract idea.
Regarding dependent claims 9-11, the limitations only further define the abstract idea.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 9-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Carney, et al. (U.S. PGPub No. 2018/0289973).
Regarding claim 1, Carney teaches (Fig. 1, # 9 – Implantable Cardioverter defibrillator (ICD), i.e. implantable medical device) an implantable medical device for providing a diagnostic and/or therapeutic cardiac function within a patient (Par. [0032]; Par. [0034-0035] – ICD may include sensing electrodes (i.e., diagnostic function). Cardiac resynchronization therapy (CRT) is one type of therapy delivered by an IMD or group of IMDs such as ICD 9), comprising:
(Fig. 1, # 25A, 32a/b – sensing electrodes) a sensing arrangement for sensing electrocardiogram signals (Par. [0034] – Defibrillation lead 25A may also include one or more sensing electrodes, such as sensing electrodes 32a and 32b, located along the distal portion of defibrillation lead 25A);
(Fig. 1, # 21 – external device; Fig. 4, # 80) a communication circuitry for data communication with a device external to the patient (Par. [0054] – External device 21 may be configured to communicate with ICD system 30A; Par. [0056] – external device may communicate with ICD system via wireless communication using techniques known in the art; Par. [0089] – Communication circuitry 80 includes any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as PD 16 and/or device 21 (Fig. 1)); and
(Fig. 1, # 16 – pacing device, 21; Fig. 4, # 78 – sensing circuitry, 70 – processing circuitry) a processing circuitry for processing the sensed electrocardiogram signals, wherein the processing circuitry is configured to identify, based on the sensed electrocardiogram signals, a stimulation event caused by an implantable pacemaker device (Par. [0010] – PD (Pacing Device), i.e. pacemaker device; Par. [0071]; Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30). Based on the sensed signals anticipated from, or resulting from PD 16, ICD may take appropriate corrective action.) and (Fig. 6, # 21 – external device) to cause a transmission of information concerning said identification of the stimulation event to the device external to the patient (Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0106] – The programming mode may be scheduled at request of the external device 21; Par. [0140] – external device may be a dedicated hardware device with dedicated software for the programming and/or interrogation of one or more devices within cardiac system 8, including either PD 16 or IMD 30; Par. [0145]); wherein (Fig. 4, # 72) the processing circuitry is configured to store programming information indicative of a programmed stimulation function of the implantable pacemaker device (Par. [0071] – Memory 72 includes computer-readable instructions that, when executed by processing circuitry 70, cause ICD system 30 and processing circuitry 70 to perform various functions attributed to ICD system 30 and processing circuitry 70 herein (e.g., communication with PD 16); Par. [0080] – processing circuitry 70 may determine the time for therapy delivery by another device, such as a pacing signal by PD 16, and generate a control signal for transmission to the PD 16 during a transmission window that indicates when the PD 16 is to deliver the pacing signal), wherein the processing circuitry is configured to monitor whether stimulation functions of the implantable medical device are in accordance with said programmed stimulation function based on said identification of a stimulation event (Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30)).
Therefore, claim 1 is unpatentable over Carney, et al.
Regarding claim 2, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 1, # 9 – ICD, 25A – cardiac defibrillation lead, 28 – defibrillation electrode) the implantable medical device is an implantable non-transvenous defibrillator device configured to emit a shock pulse for achieving a defibrillation (Par. [0032] – extracardiovascular ICD system 30A includes ICD 9 coupled to a cardiac defibrillation lead 25A, which extends subcutaneously above the ribcage from ICD 9 (i.e., representative of “non-transvenous”); Par. [0033-0034] – defibrillation electrode 28 (i.e., deliver shock for achieving a defibrillation)).
Therefore, claim 2 is unpatentable over Carney, et al.
Regarding claim 3, Carney teaches the implantable medical device according to claim 2, wherein (Fig. 1, # 9, 25A – cardiac defibrillation lead, 28 – defibrillation electrode) the implantable non-transvenous defibrillator device comprises a lead to be implanted extracardially and a shock electrode arranged on the lead (Par. [0032] – extracardiovascular ICD system 30A includes ICD 9 coupled to a cardiac defibrillation lead 25A, which extends subcutaneously above the ribcage from ICD 9 (i.e., representative of “non-transvenous”); Par. [0033-0034] – defibrillation electrode 28 (i.e., deliver shock for achieving a defibrillation)).
Therefore, claim 3 is unpatentable over Carney, et al.
Regarding claim 4, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 4, # 70 – processing circuitry, 72 – memory) the processing circuitry is configured to store a portion of the sensed electrocardiogram signals dependent on said identification of the stimulation event (Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0071]; Par. [0090]; Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30). Based on the sensed signals anticipated from, or resulting from PD 16, ICD may take appropriate corrective action.) and (Fig. 6, # 21 – external device) to transmit the stored portion of the sensed electrocardiogram signals to the device external to the patient (Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0106] – The programming mode may be scheduled at request of the external device 21; Par. [0140] – external device may be a dedicated hardware device with dedicated software for the programming and/or interrogation of one or more devices within cardiac system 8, including either PD 16 or IMD 30; Par. [0145]).
Therefore, claim 4 is unpatentable over Carney, et al.
Regarding claim 5, Carney teaches the implantable medical device according to claim 4, wherein (Fig. 4, # 72) the processing circuitry comprises a circular buffer for circularly storing the sensed electrocardiogram signals (Par. [0081] – a portion of memory 72 may be configured as a plurality of recirculating buffers, capable of holding series of measured intervals).
Therefore, claim 5 is unpatentable over Carney, et al.
Regarding claim 6, Carney teaches the implantable medical device according to claim 4 wherein (Fig. 4) said portion comprises a signal portion prior to the stimulation event, a signal portion containing the stimulation event and/or a signal portion after the stimulation event (Par. [0100] – ICD system 30 may monitor the operation of PD 16 as a check to ensure that PD 16 is receiving transmitted control signals. For example, ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30 (i.e., a signal portion containing the stimulation event)).
Therefore, claim 6 is unpatentable over Carney, et al.
Regarding claim 7, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 1, # 16 – pacing device, 21; Fig. 4, # 78 – sensing circuitry, 70 – processing circuitry) the processing circuitry is configured to statistically analyze a multiplicity of stimulation events caused by the implantable pacemaker device (Par. [0081] – … which may be analyzed by processing circuitry 70 in response to the occurrence of pace or sense interrupt; Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30). Based on the sensed signals anticipated from, or resulting from PD 16, ICD may take appropriate corrective action. ICD system 30 may determine that PD 16 has not delivered a predetermined number of therapies (e.g., one, two, three, or more) expected by ICD system 30) and (Fig. 6, # 21 – external device) to communicate statistical information concerning said multiplicity of stimulation events to the device external to the patient (Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0106] – The programming mode may be scheduled at request of the external device 21; Par. [0140] – external device may be a dedicated hardware device with dedicated software for the programming and/or interrogation of one or more devices within cardiac system 8, including either PD 16 or IMD 30; Par. [0145]).
Therefore, claim 7 is unpatentable over Carney, et al.
Regarding claim 9, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 4, # 70 and 78) the processing circuitry is configured to identify, based on the sensed electrocardiogram signals, a requirement for the stimulation event (Par. [0047]; Par. [0071]; Par. [0078] – Sensing may be done to identify events within a cardiac cycle (e.g., p-waves, QRS complexes, t-waves, etc.), determine heart rates or heart rate variability, or to detect arrhythmias (e.g., tachyarrhythmia) or other electrical signals; Par. [0084]) and to monitor, based on the sensed electrocardiogram signals, whether the implantable pacemaker device causes a stimulation event in relation to an identification of the requirement for the stimulation event (Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16).
Therefore, claim 9 is unpatentable over Carney, et al.
Regarding claim 10, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 1, # 16 and 21; Fig. 4, # 70 and 78) the processing circuitry is configured to identify an anti-tachycardia stimulation event caused by the implantable pacemaker device and to cause a transmission of information concerning said anti-tachycardia stimulation event to the device external to the patient (Par. [0038] – PD 16 may be configured to deliver a pacing pulse to the left ventricle according to the commands provided by ICD 9; Par. [0078] – sensing circuitry detects arrhythmias; Par. [0051]; Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0055]; Par. [0078] – sensing circuitry detects arrhythmias; Par. [0100] – ICD system 30 may monitor the operation of PD 16 as a check to ensure that PD 16 is receiving transmitted control signals. For example, ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30).; Par. [0106]).
Therefore, claim 10 is unpatentable over Carney, et al.
Regarding claim 11, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 1, # 16 and 21; Fig. 4, # 70 and 78) the processing circuitry is configured to identify a requirement for an anti-bradycardia stimulation and to monitor whether the implantable pacemaker device causes an anti-bradycardia stimulation event in relation to the identification of the requirement for an anti-bradycardia stimulation (Par. [0050] – PD 16 may be configured to deliver pacing therapy such as bradycardia pacing therapy to the heart; Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data;; Par. [0055]; Par. [0078] – sensing circuitry detects arrhythmias; Par. [0100] – ICD system 30 may monitor the operation of PD 16 as a check to ensure that PD 16 is receiving transmitted control signals. For example, ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30).; Par. [0106]).
Therefore, claim 11 is unpatentable over Carney, et al.
Regarding claim 12, Carney teaches the implantable medical device according to claim 1, wherein (Fig. 1, # 21; Fig. 6, # 21) the processing circuitry is configured to trigger a data communication message to the device external to the patient based on said identification of the stimulation event, or to include said information concerning said identification of the stimulation event in a data message scheduled according to a pre-defined regular communication scheme (Par. [0054-0055] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0089]; Par. [0106]; Par. [0140-0141]; Par. [0145]).
Therefore, claim 12 is unpatentable over Carney, et al.
Regarding claim 13, Carney teaches (Fig. 1, # 8A – medical device system, 9 - ICD, 16 – Pacing Device, 30A – ICD system) an implantable therapy system (Par. [0032]), comprising: (Fig. 1, # 16 – pacing device, i.e. pacemaker device) an implantable pacemaker device for emitting a cardiac stimulation signal for achieving an intra-cardiac pacing (Par. [0032]; Par. [0036] – One or more PDs 16 may provide pacing pulses to heart 26 based on the electrical signals sensed within heart 26 and/or in response to control signals transmitted to PDs 16 from ICD 9); and an implantable medical device according to claim 1 (please see rejection hereinabove to claim 1).
Therefore, claim 13 is unpatentable over Carney, et al.
Regarding claim 14, Carney teaches the implantable therapy system according to claim 13, wherein (Fig. 1, # 16) the implantable pacemaker device is a leadless pacemaker device (Par. [0003]; Par. [0070] – the techniques described herein are generally described with regard to a leadless pacing device or intracardiac pacing device such as PD 16).
Therefore, claim 14 is unpatentable over Carney, et al.
Regarding claim 15, Carney teaches (Fig. 1, # 9 – Implantable Cardioverter defibrillator (ICD), i.e. implantable medical device) a method for operating an implantable medical device for providing a diagnostic and/or therapeutic cardiac function within a patient (Par. [0005-0006]; Par. [0032]; Par. [0034-0035] – ICD may include sensing electrodes (i.e., diagnostic function). Cardiac resynchronization therapy (CRT) is one type of therapy delivered by an IMD or group of IMDs such as ICD 9), comprising:
(Fig. 1, # 25A, 32a/b – sensing electrodes) sensing, using a sensing arrangement of the implantable medical device, electrocardiogram signals (Par. [0034] – Defibrillation lead 25A may also include one or more sensing electrodes, such as sensing electrodes 32a and 32b, located along the distal portion of defibrillation lead 25A);
(Fig. 1, # 16 – pacing device, 21; Fig. 4, # 78 – sensing circuitry, 70 – processing circuitry) processing, using a processing circuitry of the implantable medical device, the sensed electrocardiogram signals, wherein the processing includes: identifying, based on the sensed electrocardiogram signals, a stimulation event caused by an implantable pacemaker device (Par. [0010] – PD (Pacing Device), i.e. pacemaker device; Par. [0071]; Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30). Based on the sensed signals anticipated from, or resulting from PD 16, ICD may take appropriate corrective action.) and (Fig. 6, # 21 – external device) causing a transmission, using a communication circuitry of the implantable medical device, of information concerning the identification of the stimulation event to a device external to the patient (Par. [0054] – the user may interact with device 21 to send an interrogation request and retrieve therapy delivery data; Par. [0106] – The programming mode may be scheduled at request of the external device 21; Par. [0140] – external device may be a dedicated hardware device with dedicated software for the programming and/or interrogation of one or more devices within cardiac system 8, including either PD 16 or IMD 30; Par. [0145]);
(Fig. 4, # 72) storing, via the processing circuitry, programming information indicative of a programmed stimulation function of the implantable pacemaker device (Par. [0071] – Memory 72 includes computer-readable instructions that, when executed by processing circuitry 70, cause ICD system 30 and processing circuitry 70 to perform various functions attributed to ICD system 30 and processing circuitry 70 herein (e.g., communication with PD 16); Par. [0080] – processing circuitry 70 may determine the time for therapy delivery by another device, such as a pacing signal by PD 16, and generate a control signal for transmission to the PD 16 during a transmission window that indicates when the PD 16 is to deliver the pacing signal);
monitoring, via the processing circuitry, whether stimulation functions of the implantable medical device are in accordance with said programmed stimulation function based on said identification of a stimulation event (Par. [0100] – ICD system 30 may control sensing circuitry 78 to sense for signals indicating that therapy was delivered by PD 16 (e.g., sense for a paced signal or any other therapy commanded by ICD system 30))
Therefore, claim 15 is unpatentable over Carney, et al.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
Prosecution Insights