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 10, filed 07/29/2025, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 10-13, filed 07/29/2025, with respect to the rejection(s) of the claims under 35 U.S.C. 102 and 103 have been fully considered. Applicant argues on page 12 that “Stahmann does not disclose that its LCP (when interpreted as the first implantable stimulation device according to the PTO’s interpretation) is only allowed to deliver ATP therapy when the analysis of the ECG carried out by the LCP reveals an absence of a shock therapy. Likewise, Stahmann does not disclose that its MD is only allowed to deliver a second ATP therapy or shock therapy only when the analysis of the ECG carried out by the MD reveals an absence of a first ATP therapy.” Examiner disagrees because only one of these limitations are required and Stahmann teaches Fig. 7(710) shows no shock therapy during which ATP therapy 720 is applied.
Applicant further argues on pages 12-13 that “CRMS of the type required by Applicant’s claims benefits from the combined use of a first implantable stimulation device and a second implantable stimulation device providing combined therapy and which is synchronized without using any separate communication channel. Stahmann does not contemplate any of its features being able to achieve this, as there is nothing in Stahmann related to addressing this technical aspect.” Examiner disagrees because the communication relationship between the devices are not claimed. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made obvious in view of Stahmann et al. (US 20160008615)(IDS)(Hereinafter Stahmann).
Claim Objections
Claim 1 is objected to because of the following informalities: the phrases “first/second processor adapted to” and “first/second detection unit adapted to” should be amended to recite “first/second processor configured to” and “first/second detection unit configured to”.
Examiner notes that "configured to" is indicative of a state of the device that is capable of performing the steps, whereas "adapted to" contains a stronger implication that the device was actively changed from one configuration to another configuration. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “allow delivery of the second signal” in line 18 is missing an “and” at the beginning of the limitation and should recite “and allow delivery of the second signal”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claims 1 and 9 fail to sufficiently describe criterions A’-E’ for one skilled in the art to understand what each criteria/threshold/range of the criterions represents. The mere statement and recitation of the criterion A’, B’, C’, D’, and E’ in claims 1-15 and in the instant specification fail to define each criterion individually. The mere statement and recitation of the of different criterions in the claim and criterions A’ and B’ may be revealed if “a pre-defined heart rate or QRS duration is exceeded by the detected cardiac rhythm of the patient is within the time period A or the time period B… For example, the pre-defined heart rate up to which an ATP- therapy is delivered may be 120 to 180 bpm (beats per minute), in particular160 bpm. This criterion may be part of the tachycardia criterion A’” (Page 7 of the instant specification) and criterions C’ and D’ may be revealed if “a pre-defined heart rate or QRS duration is exceeded by the detected cardiac rhythm of the patient is within the time period C or the time period D. A pre-defined heart rate is, for example, a heart rate120 to 220 bpm” (Page 10 of the instant specification), and “Pre-defined tachycardia criteria E' may be (alone or in combination) a heart rate from 120 to 220 bpm, pathologic QRS waveform, pathologic ECG signal pattern (e.g., over 10 to 20 sec), sudden rate increase, rate stability/instability” provides insufficient disclosure of the details of how the criterions are different than one another, other than the mere nominal differenced used in the claim. Furthermore, the threshold value of each criterion is not defined, leaving one of ordinary skilled in the art speculating on a threshold value used to define a criterion based on a large threshold of heart rate BPM. Moreover, Applicant fails to define what the criteria (A’-E’) is for QRS duration (of A’-D’) pathologic QRS waveform (E’), pathologic ECG signal pattern (e.g., over 10 to 20 sec) (E’), sudden rate increase (E’), and rate stability/instability (E’) may be, and what the threshold requirements for these parameters are. Therefore, claims 1-15 do not provide sufficient detail for Applicant to fulfill the written description requirement.
Applicant’s recitation of the limitations “wherein the pre-defined tachycardia criterion C' is different from the pre-defined tachycardia criterion A' and the pre-defined tachycardia criterion D' is different from the pre-defined tachycardia criterion B’” (claims 5 and 13) lacks written description support. The mere statement and recitation of the of different criterions in the claim and criterions A’ and B’ may be revealed if “a pre-defined heart rate or QRS duration is exceeded by the detected cardiac rhythm of the patient is within the time period A or the time period B… For example, the pre-defined heart rate up to which an ATP- therapy is delivered may be 120 to 180 bpm (beats per minute), in particular160 bpm. This criterion may be part of the tachycardia criterion A’” (Page 7 of the instant specification) and criterions C’ and D’ may be revealed if “a pre-defined heart rate or QRS duration is exceeded by the detected cardiac rhythm of the patient is within the time period C or the time period D. A pre-defined heart rate is, for example, a heart rate120 to 220 bpm” (Page 10 of the instant specification) provides insufficient disclosure of the details of how the criterions are different than one another. Specifically, the instant specification fails to distinguish between how the criterions are different, other than a numerical difference. Furthermore, the numerical difference in which the criterions represent are overlapping, which raises the issues on how the criterions can be different than one another if the criterions can be the same exact numerical value as the other. Ultimately, the specification is written generically such that it only defines the invention in functional language specifying a desired result but does not sufficiently identify how the function is performed or the result is achieved (see MPEP §2161.01).
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 1-15 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.
Regarding claim 1, it is unclear if the “shock therapy” of lines 14 and 20 are the same or different than the “shock therapy” of line 11. Both phrases are modified by the article “a” thus implying two separate and distinct shock therapies.
Regarding claim 1, it is unclear if the “determination” steps used of line 21 is the same or different than the “determination” of line 17. Both phrases are modified by the article “the” thus implying a single determination, however, claim 1 determines the absence of shock and ATP therapy based on criterion A’ and B’, respectively.
Regarding claim 2, it is unclear if the “determination” steps used of line 6 is the same or different than the “determination” of claim 1 lines 17 and 21. All three phrases are modified by the article “the” thus implying a single determination, however, claim 1 determines the absence of shock and ATP therapy based on criterion A’ and B’, respectively.
Regarding claim 7, it is unclear if the “determination” steps used of line 8 and 13 is the same or different than the “determination” of claim 1 lines 17 and 21. All fur phrases are modified by the article “the” thus implying a single determination, however, claim 1 determines the absence of shock and ATP therapy based on criterion A’ and B’, respectively.
Regarding claim 9, it is unclear if the “shock therapy” of lines 14 and 20 are the same or different than the “shock therapy” of line 11. Both phrases are modified by the article “a” thus implying two separate and distinct shock therapies.
Regarding claim 9, it is unclear if the “determination” steps used of line 21 is the same or different than the “determination” of line 17. Both phrases are modified by the article “the” thus implying a single determination, however, claim 1 determines the absence of shock and ATP therapy based on criterion A’ and B’, respectively.
Regarding claim 10, it is unclear if the “determination” steps used of line 6 is the same or different than the “determination” of claim 1 lines 17 and 21. All three phrases are modified by the article “the” thus implying a single determination, however, claim 1 determines the absence of shock and ATP therapy based on criterion A’ and B’, respectively.
Regarding claim 15, it is unclear if the “determination” steps used of line 8 and 13 is the same or different than the “determination” of claim 1 lines 17 and 21. All fur phrases are modified by the article “the” thus implying a single determination, however, claim 1 determines the absence of shock and ATP therapy based on criterion A’ and B’, respectively.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US 20160008615)(IDS)(Hereinafter Stahmann).
Regarding claims 1 and 9, Stahmann teaches A cardiac rhythm management system/method ([0075] “FIGS. 3 and 4 show illustrative medical device systems”), comprising:
at least one first implantable stimulation device and at least one second implantable stimulation device ([0075] “FIG. 3, an LCP 302 is shown fixed to the interior of the left ventricle of the heart 310, and a pulse generator 306 is shown coupled to a lead 312 having one or more electrodes 308a-308c.”),
wherein the at least one first implantable stimulation device comprises a first detection unit adapted to detect a first cardiac rhythm and a first processor adapted to analyze the detected first cardiac rhythm for a pre-defined preceding time period A and to deliver first signals for a first antitachycardia pacing therapy (Fig. 1 (110) [0062] “electrical sensing module 106 may be connected to electrodes 114/114′, and electrical sensing module 106 may be configured to receive cardiac electrical signals conducted through electrodes 114/114′.” [0060] “Pulse generator 104 may then use the energy of the one or more capacitors to deliver the generated electrical stimulation signals via electrodes 114 and/or 114′.” [0089] “FIGS. 6 and 7 illustrate timelines 614 and 714, which include an onset of a tachyarrhythmia at times 612 and 712, along with various functions performed by Device 1 and Device 2.”),
wherein the at least one second implantable stimulation device comprises a second detection unit adapted to detect a second cardiac rhythm and a second processor adapted to analyze the detected second cardiac rhythm for a pre-defined preceding time period B and to deliver second signals for shock therapy or a second antitachycardia pacing therapy (Fig. 2 (210) [0075] “In FIG. 3, an LCP 302 is shown fixed to the interior of the left ventricle of the heart 310, and a pulse generator 306 is shown coupled to a lead 312 having one or more electrodes 308a-308c. In some cases, the pulse generator 306 may be part of a subcutaneous implantable cardioverter-defibrillator (S-ICD),” [0069] “In some cases, electrodes 214 may conduct intrinsically generated electrical signals to leads 212, e.g. signals representative of intrinsic cardiac electrical activity.” [0115] “In this case, device 2 may also detect the occurrence of the tachyarrhythmia at time 1212, either on its own or with the aid of device 1 and/or another device. After determining the occurrence of a tachyarrhythmia at time 1212, device 2 may begin a defibrillation shock therapy program.”), and
wherein the first processor is adapted determine a pre-defined tachycardia criterion A' has occurred in an absence of a shock therapy, and allow delivery of the first signals for antitachycardia pacing therapy based on the determination (Fig. 7(706) shows no shock therapy. [0090] “device 1 may determine a heart rate parameter based on the sensed electrical signals. Device 1 may identify R-waves or QRS complexes, or other features to determine heart contractions. Device 1 may count these identified features for a period of time to determine how many of the features occur within the period of time, ultimately resulting in a heart rate in beats per minute. Device 1 may compare the heart rate to a heart rate threshold [criterion A’].” The implementation of comparing the heart rate to a heart rate threshold can be done to any of Figs. 6-12 because the determination of tachyarrhythmia can be done the same way across them all.), and/or (Examiner notes that the top or the bottom limitation can be selected, and thereby, the other limitation is not required. Examiner selected the top limitation.)
wherein the second processor is adapted determine a pre-defined tachycardia criterion B' has occurred in an absence of the first antitachycardia pacing therapy, to allow delivery of the second signals for shock therapy or a second antitachycardia therapy based on the determination ([0094] “a device 2 may determine the occurrence of the tachyarrhythmia. Regardless of how a device 2 determines the occurrence of the tachyarrhythmia (e.g. either based on sensed cardiac electrical signals [criterion B’, which is the same of criterion A’] and/or based on a received determination of an arrhythmia from another device), device 2 may begin a defibrillation shock therapy program.”).
Although Chien does not explicitly teach a predefined period of time for determining tachyarrhythmia for the second device/processor, for a person of ordinary skill in the art, making such modifications would have required nothing more than a predictable application of a known technique to a known device ready for improvement. See KSR, 550 U.S. at 416-417. A skilled artisan would have understood how to modify Stahmann to have predefined period of time for determining tachyarrhythmia (as shown in Fig. 12(1206) for the first device/processor), especially when Stahmann defines a period of time for determining a tachyarrhythmia between the time of the occurrence of the tachyarrhythmia 1212 and the beginning of defibrillation shock therapy program including the start of the charging of a capacitor (signaling the end of tachyarrhythmia detection) for the second device/processor ([0115]) to distinguish periods of time between detection and therapy. The use of l a predefined period of time for determining tachyarrhythmia for the second device/processor would not have been “uniquely challenging or difficult for one of ordinary skill in the art” or “represented an unobvious step over the prior art” to modify Stahmann as discussed above. Leapfrog Enters., Inc. v. Fisher- Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418-19).
Regarding claim 8, Stahmann teaches wherein the at least one first implantable stimulation device is an implantable leadless pacemaker (ILP), and the at least one second implantable stimulation device is a subcutaneous implantable cardioverter defibrillator or a second ILP ([0075] “the pulse generator 306 may be part of a subcutaneous implantable cardioverter-defibrillator (S-ICD), and the one or more electrodes 308a-308c may be positioned subcutaneously adjacent the heart. In some cases, the LCP 302 may communicate with the subcutaneous implantable cardioverter-defibrillator (S-ICD).”).
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US 20160008615)(IDS)(Hereinafter Stahmann) in view of Doerr (US 9393436)(Hereinafter Doerr).
Regarding claims 2 and 10, claim 1 and 9 is obvious over Stahmann. Stahmann does not teach first processor is adapted to determine the pre-defined tachycardia criterion A' has occurred during a shock therapy, and to prevent delivery of the first signals for the first antitachycardia pacing therapy for a time period C based on the determination. Doerr, in the same field of endeavor, teaches (Abstract), and further teaches wherein the first processor is adapted to determine the pre-defined tachycardia criterion A' has occurred during a shock therapy, and to prevent delivery of the first signals for the first antitachycardia pacing therapy for a time period C based on the determination (Col. 8 lines 29-41 “the control unit 4 may emit the antitachycardiac defibrillation shock after the end of charging additionally dependent on the current cardiac frequency then exceeding a tachycardia redetection limit. If in this case the evaluation of the intracardial electrocardiogram recorded after the end of charging of the high voltage capacitor by detection unit 2 indicates that the cardiac frequency lies above the tachycardia redetection limit, according to one or more embodiments, detection unit 2 may generate a tachycardia redetection signal which causes control unit 4 to actuate antitachycardiac defibrillation shock synchronization unit 3, such that detection unit 2 emits an antitachycardiac defibrillation shock that may be synchronized.” Examiner notes that ATP therapy and shock of Figs. 2-5 never overlap, which means that when the shock occurs during criterion A’, ATP therapy does not occur. ) to terminate a ventricular tachycardia (Col. 8 lines 42-45). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Stahmann, with the first processor is adapted to determine the pre-defined tachycardia criterion A' has occurred during a shock therapy, and to prevent delivery of the first signals for the first antitachycardia pacing therapy for a time period C based on the determination of Doerr, because such a modification would allow to terminate a ventricular tachycardia.
Claim(s) 3-4 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US 20160008615)(IDS)(Hereinafter Stahmann) in view of Doerr (US 9393436)(Hereinafter Doerr) and Stahmann et al. (US 20150196758)(Hereinafter Stahmann2).
Regarding claims 3 and 11, claim 1 and 9 is obvious over Stahmann. Stahmann does not teach wherein the second processor is adapted to determine the pre-defined tachycardia criterion B' has occurred during the first antitachycardia pacing therapy, and to prevent delivery of the second signals for the shock therapy or the second antitachycardia pacing therapy for a time period D. Stahmann2, in the same field of endeavor, teaches an LCP and SICD used for determining tachyarrhythmia (Abstract and [0038]-[0039]), and further teaches wherein the second processor is adapted to determine the pre-defined tachycardia criterion B' has occurred during the first antitachycardia pacing therapy, and to prevent delivery of the second signals for the shock therapy or the second antitachycardia pacing therapy for a time period D ([0108] “one or more devices of the system may determine whether the tachycardia rate is above threshold…Once the tachyarrhythmia is determined to be susceptible to the ATP therapy, one or more devices may cause the first leadless cardiac pacemaker to deliver ATP therapy to the heart, and in some cases, may cause an implantable cardioverter defibrillator to suspend delivering defibrillation shock therapy at least during delivery of ATP therapy, as shown at 1708.”) to provide appropriate therapy during a tachyarrhythmia ([0108]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Stahmann, with the second processor is adapted to determine the pre-defined tachycardia criterion B' has occurred during the first antitachycardia pacing therapy, and to prevent delivery of the second signals for the shock therapy or the second antitachycardia pacing therapy for a time period D of Stahmann2, because such a modification would allow to provide appropriate therapy during a tachyarrhythmia.
Regarding claims 4 and 12, Stahmann teaches wherein the first processor is adapted to re-analyze the first cardiac rhythm according to the pre-defined tachycardia criterion A' during the time period C and/or the second processor is adapted to re-analyze the second cardiac rhythm according to the pre-defined tachycardia criterion B' during the time period D ([0108] “device 2 may be configured to wait a predetermined period after determining an occurrence of a tachyarrhythmia and then determine whether the tachyarrhythmia is still occurring.”).
Claim(s) 5-6 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US 20160008615)(IDS)(Hereinafter Stahmann) in view of Doerr (US 9393436)(Hereinafter Doerr), Stahmann et al. (US 20150196758)(Hereinafter Stahmann2) and Huelskamp et al. (US 20160228701)(Hereinafter Huelskamp).
Regarding claims 5 and 13, claim 1 and 9 is obvious over Stahmann. Stahmann does not teach the second processor is adapted to re-analyze the second cardiac rhythm according to a pre-defined tachycardia criterion D' during the time period D… the pre-defined tachycardia criterion D' is different from the pre-defined tachycardia criterion B’. Huelskamp, in the same field of endeavor, teaches the application of ATP therapy from multiple LCP devices (Abstract and Fig. 3), and further teaches wherein the first processor is adapted to re-analyze the first cardiac rhythm according to a pre-defined tachycardia criterion C' during the time period C and/or the second processor is adapted to re-analyze the second cardiac rhythm according to a pre-defined tachycardia criterion D' during the time period D, wherein the pre-defined tachycardia criterion C' is different from the pre-defined tachycardia criterion A' and the pre-defined tachycardia criterion D' is different from the pre-defined tachycardia criterion B’ ([0106] “If LCP 402 determines that the heart rate is less than the arrhythmia threshold, LCP 402 may exit out of the flow diagram without performing ATP therapy, as shown at 706.” [0104] “LCP 402 may determine a heart rate and compare the determined heart rate to the arrhythmia threshold. If LCP 402 determines that the heart rate is equal to or greater than the arrhythmia threshold, LCP 402 may be allowed to proceed to increase the ATP therapy burst counter. After increasing the ATP therapy burst counter, LCP 402 may compare the ATP therapy burst counter to the ATP therapy burst count threshold. If LCP 402 determines that the ATP therapy burst counter is less than the ATP therapy burst count threshold, LCP 402 may be allowed to proceed with delivering ATP therapy.” Examiner notes that time duration D is when the therapy or shock is not applied. In the instant case, LCP can be exited following the determination of heart rate below a criterion, and re-enter the cycle when the ATP monitoring enabled. Examiner defines the reentering the cycle and monitoring of heart rate threshold and ATP burst counter as time duration D.) to safely apply therapy to a user ([0104]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Stahmann, with the second processor is adapted to re-analyze the second cardiac rhythm according to a pre-defined tachycardia criterion D' during the time period D… the pre-defined tachycardia criterion D' is different from the pre-defined tachycardia criterion B’ of Huelskamp, because such a modification would allow to safely apply therapy to a user.
Regarding claims 6 and 14, Stahmann teaches wherein the first and/or second processor are/is adapted to terminate the time period C and/or the time period D upon receipt of a termination signal ([0103] “If the tachyarrhythmia is not still occurring, device 2 may abort the defibrillation shock therapy program and safely discharge the capacitor.”).
Claim(s) 7 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al. (US 20160008615)(IDS)(Hereinafter Stahmann) in view of Greenhut et al. (US 8744572)(Hereinafter Greenhut).
Regarding claims 7 and 15, claim 1 and 9 is obvious over Stahmann. Stahmann does not teach a shock unit adapted to deliver at least one shock comprising a loading time period prior the at least one shock, wherein the system is adapted to determine that the first cardiac rhythm and/or the second cardiac rhythm during a time period E corresponds to a pre-defined tachycardia criterion E', and to cause the shock unit to deliver the at least one shock based on the determination, and wherein the system is adapted to determine that the first cardiac rhythm and/or the second cardiac rhythm during the time period E does not correspond to the pre-defined tachycardia criterion E', and to prevent delivery of the at least one shock based on the determination. Greenhut, in the same field of endeavor, teaches an LPD and S-ICD for analyzing cardiac rhythm and delivering ATP and shock therapy (Abstract) teaches further comprising:
a shock unit adapted to deliver at least one shock comprising a loading time period prior the at least one shock ([0112] “If processor 70 determines that a shock is needed to treat a detected arrhythmia ("YES" branch of block 142), processor 70 may begin charging shock module 75 of SICD 30 (144)[charging the device requires a loading time]… If SICD 30 is charged ("YES" branch of block 146), processor 70 may command signal generator 76 [shock unit] to deliver an anti-tachyarrhythmia shock to patient 14 (148).”);
wherein the system is adapted to determine that the first cardiac rhythm and/or the second cardiac rhythm during a time period E corresponds to a pre-defined tachycardia criterion E', and to cause the shock unit to deliver the at least one shock based on the determination (Col. 29 lines 47-65 “If processor 70 determines that a shock is needed to treat a detected arrhythmia ("YES" branch of block 142) [criterion E’], processor 70 may begin charging shock module 75 of SICD 30 (144)… If SICD 30 is charged ("YES" branch of block 146), processor 70 may command signal generator 76 to deliver an anti-tachyarrhythmia shock to patient 14 (148).”);
wherein the system is adapted to determine that the first cardiac rhythm and/or the second cardiac rhythm during the time period E does not correspond to the pre-defined tachycardia criterion E', and to prevent delivery of the at least one shock based on the determination (Col. 29 lines 47-53 “processor 70 of SICD 30 monitors a sensed ECG for a shockable rhythm (140). For example, processor 70 may detect tachyarrhythmias as a shockable rhythm eligible for anti-tachycardia therapy. If processor 70 determines that no shock is needed ("NO" branch of block 142), processor 70 may continue to monitor the ECG for tachyarrhythmias (140).”) to treat a detected arrhythmia (Col. 29 lines 47-65). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Stahmann, with the shock unit adapted to deliver at least one shock comprising a loading time period prior the at least one shock, wherein the system is adapted to determine that the first cardiac rhythm and/or the second cardiac rhythm during a time period E corresponds to a pre-defined tachycardia criterion E', and to cause the shock unit to deliver the at least one shock based on the determination, and wherein the system is adapted to determine that the first cardiac rhythm and/or the second cardiac rhythm during the time period E does not correspond to the pre-defined tachycardia criterion E', and to prevent delivery of the at least one shock based on the determination of Greenhut, because such a modification would allow to treat a detected arrhythmia.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796