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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the remote monitoring system (claim 1), tachyarrhythmia detection unit, anti-tachycardia pacing timing unit (claim 2), fault detection device (claim 3), battery (claim 3), first control unit (claim 4), receiving unit (claim 8), information unit (claim 8), second control unit (claim 9), and boundary zone for tachycardia detection (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Regarding this objection; in figure 1 figure numbers 16, 18, 20, 22, 24, 26 and 36 all share one arrow pointing to what appears to be a leadless pacemaker. Therefore the leadless pacemaker is shown in the drawings but the remainer of the elements claimed are not shown in the drawing. Further, figure numbers 10, 30, 12, 28, 32 and 34 all point to the implantable defibrillator, therefore the implantable defibrillator is shown but the remaining elements housed in the defibrillator are not shown. Figure 1 further includes reference numbers 14 and 15 which are to a message and remote monitoring system and they both point to a signal emitted from the defibrillator. The signal may be sent to an external device but no external device is shown.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "16, 18, 20, 22, 24, 26 and 36", reference characters “10, 30, 12, 28, 32, 34” and reference characters “14, 15” point to the same element in the drawing. Stated another way reference characters "16, 18, 20, 22, 24, 26 and 36" all correspond to the implanted pacemaker, ", reference characters “10, 30, 12, 28, 32, 34” all correspond to the implanted defibrillator and reference characters “14, 15” point to a signal. The IPD and the ICD are all clearly shown and the signal is shown the other elements are not shown. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claim 14 recites “Computer program with program code to perform the method of claim 13”. In the broadest reasonable interpretation a computer program can be transitory or non-transitory in nature. The claim language needs to be amended to recite that this is a non-transitory computer program in order to comply with the 101 statute.
Claim 15 recites “Computer-readable data carrier”. In the broadest reasonable interpretation a computer-readable data carrier can be transitory or non-transitory in nature. The claim language needs to be amended to recite that this is a non-transitory computer program in order to comply with the 101 statute.
Claim Interpretation
It is noted that the claims use the language and/or, claim limitation written in this manner only require one of the claimed limitations.
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 limitation(s) is/are:
“tachyarrhythmia detection unit”, “anti-tachycardia pacing timing unit” in claim 2
“fault detection device” in claim 3
“receiving unit” and “information unit” in claim 8
Regarding the 3-pong analysis
The nonce term are considered to be “detection unit”, “pacing timing unit”, “detection device”, “receiving unit”, and “information unit”. Each of these terms are modified by the language “configured to” followed by function.
tachyarrhythmia detection unit configured to detect a tachycardia
anti-tachycardia pacing timing unit configured to deliver an anti-tachycardia pacing sequence
fault detection device configured to detect the unavailability of anti-tachycardia pacing
receiving unit configured to receive at least one information unit
Each nonce term underlined above is considered to be a generic placeholder, which has no specific structural meaning. Each term is then modified by functional language with the linking phrase “configured to”. None of the terms are modified by structure, material or acts to perform the claimed function. It is unclear what the structure of the detection unit, pacing timing unit and/or receiving unit is or could be, the functional language provides no insight as to what the actual structure is in these claims.
It is further noted that the first and second control units (claim 4 and claim 9) are considered to be controllers and are understood by one of ordinary skill in the art.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 2-3 and 7-9, 10 and 12 are 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 7 recites “wherein the implantable pacing device is configured to signal the unavailability of anti-tachycardia pacing to the implantable cardiodefibrillator by an absence of expected anti-tachycardia pacing, in particular if anti-tachycardia pacing is not provided for a predetermined period of time in case of a detected tachycardia”. This language is unclear, it is unclear if the pacing device is sending a message to the cardio defibrillator or if is the cardio defibrillator itself is determining/sensing if ATP therapy has ceased or was not applied.
Claim 8 recites “wherein the implantable cardioverter defibrillator comprises at least one receiving unit configured to receive at least one information unit, in particular indicating the unavailability of the anti-tachycardia pacing and/or anti-bradycardia pacing, from the implantable pacing device”. It is unclear what applicant intends an “information unit” to be. The use of the language “unit” indicates structure but this structure is not known nor is the language understood. A receiving unit is considered to be telemetry and equivalents and the information unit is considered to be a signal.
Claim 10 recites “wherein the implantable cardio defibrillator is configured to detect the at least one information unit if one or more expected anti-tachycardia pacing attempts are not sensed by the implantable cardio defibrillator.” It is not clear what an “information unit” is or could be. This could be a signal or it could be some other signal. Furthermore, claim 10 seems to recites that the defibrillator senses ATP attempts made (lines 3-4 of claim 10), however nowhere in claim 1 from which claim 10 depends, is there any indication of the defibrillator sensing if and when the pacemaker is delivering ATP therapy, therefore it is unclear when and if the defibrillator is sensing when the attempts to utilize ATP are being made. It is further unclear how the defibrillator would be configured to “expect anti-tachycardia pacing attempts”. This language is therefore indefinite.
Claim 12 recites “at least one zone boundary”, the zone boundary is found in figure 1 and indicates the defibrillator. It is not clear what a zone boundary is or could be. The specification provides no indication as to what applicant intends the zone boundary to be.
Regarding claims 2-3 and 8: the claim limitations “tachyarrhythmia detection unit”, “anti-tachycardia pacing timing unit” in claim 2, “fault detection device” in claim 3 and “receiving unit” and “information unit” in claim 8 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
With respect to the tachyarrhythmia detection unit and the anti-tachycardia pacing timing unit there are two passages within applicants specification which mention these two units/components.
page 7 in the final paragraph it is stated “According to an aspect of the invention, the implantable pacing device is configured to stimulate at least one ventricle of a human or animal heart, wherein the implantable pacing device comprises a configurable tachyarrhythmia detection unit configured to detect a tachycardia and further comprises an anti-tachycardia pacing timing unit configured to deliver an anti-tachycardia pacing sequence in response to tachycardia detection.”
page 11 in the final paragraph it is stated “The implantable pacing device IPD is configured to stimulate at least one ventricle of a human or animal heart H. Moreover, the implantable pacing device IPD comprises a configurable tachyarrhythmia detection unit 16 configured to detect a tachycardia and further comprises an anti-tachycardia pacing timing unit 18 configured to deliver an anti-tachycardia pacing ATP sequence in response to tachycardia detection.”
Neither of these passages/paragraphs in the specification proved what the actual configuration of these two units could be. There is no structure recited which results in a lack of sufficient structure recited to perform the stated function.
With respect to the “fault detection device” the claim language is repeated in the specification however the specification does not include any structure which is capable of the function.
With respect to the “receiving unit” and “information unit” the same language is found in the specification without reciting any specific structure which results in a lack of sufficient structure to perform the stated function.
Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6, 8-9 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hareland et al. US 2017/0312514.
Regarding claim 1: Hareland discloses an implantable system including a leadless pacemaker 16 (“IPD” or “Intracardiac Pacing Device”, figures 1, 2A, 2B, 2C, 3 and 4) and a non-transvenous implantable cardioverter/defibrillator 30 (“extracardiovascular ICD system”, figures 2, 2A, 2B, 2C and 5); the leadless pacemaker 16 detects tachycardia (paragraph 0077) and delivers anti-tachycardia pacing to treat the tachycardia (paragraphs 0025, 0038, 0041 and 0047). The pacemaker 16 signals the defibrillator 30 to alter operation upon an ATP disable alert (figure 12), in this situation the pacemaker sends signal 950 (figure 12) to the defibrillator that ATP (antitachycardia therapy) is disabled and the defibrillator alters operation, a message is also sent to the external controller 908 (figure 12, also see paragraph 0166-67). The leadless pacemaker 16 (figure 4) includes a communication circuit 94 (figure 4) and the defibrillator 31 (figure 5) includes communication circuitry 80 (figure 5). Signals are communication in a bidirectional manner (paragraphs 0110-
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[AltContent: textbox (Figure 1: Figure 12 of Hareland)]0111) and the signals include the disable ATP signal sent from the pacemaker to the defibrillator (figure 12). The pacemaker 16 includes a processor 90 (figure 4) and the defibrillator 31 includes a processor 70 (figure 5), as is shown in figure 12 a disable alert 940 is send from the pacemaker to the defibrillator and the defibrillator alters operation which is considered to be adjusting therapy. The cardioverter defibrillator includes both a sensing circuit 78 and a communication circuit 80 (figure 5) both of which are configured to sense and/or receive signals, this is true during ATP sensed or not sensed at the defibrillator.
Regarding claim 2: Hareland discloses that the pacemaker is configured to stimulate the ventricles (paragraph 0038), the tachyarrhythmia detection unit is considered to be the sensing circuit 98 (figure 4) and the anti-tachycardia pacing timing unit is considered to be the signal generator 96 (figure 4). The sensing circuit 98 (paragraph 0077) is considered to be configurable (“Processing circuitry 90 may control the functionality of sensing circuitry 98 by providing signals via a data/address bus”, paragraph 0077). The signal generator 96 (figure 4) delivers ATP therapy and post-shocking pacing (paragraph 0080).
Regarding claim 6: Hareland discloses the use of RF communication/telemetry (paragraph 0111) between the two implants.
Regarding claim 8: Hareland discloses the defibrillator 30 (figures , 2A, 2B and 5) has a receiving unit 80/78 (“communication circuitry” and/or “sensing circuitry”, figure 5) which receives signals (considered to be an information unit) which indicate unavailability of ATP (“Similarly, communications circuitry 80 within ICD system 30 may detect a disable alert or information about a disable alert sent by IPD 16 (940 and 950).” paragraph 0167 also relevant paragraphs 0110, 0111, 0166).
Regarding claim 9: Hareland discloses the defibrillator 30 (figures , 2A, 2B and 5) has a second control unit 70 (“processing circuitry”, figure 5) which adjusts therapeutic behavior of the defibrillator upon receipt of the information unit ( “Responsive to receiving the disable alert or information about the disable alert, ICD system 30 may alter its operation. See FIG. 12.”, paragraph 0167).
Regarding claim 13: Hareland discloses software to perform the methods in the form of non-transitory computer readable medium which includes instructions to implement the methods (paragraph 0174) which includes ATP as well as the delivery of cardioversion/shocks (paragraph 0003) which includes providing an implantable system 8 (figure 7) both the defibrillator/ICD 30 (“extracardiovascular ICD system”, figures 2, 2A, 2B, 2C and 5) and leadless pacemaker/IPD 16 are implanted as shown in figures 1, 2A and 2B) for providing shock therapy and ATP (the IPD provides ATP and ICD provides defibrillation); the leadless pacemaker/IPD 16 detects tachycardia via the sensing circuit 98 (figure 4, paragraph 0077) and provides ATP via the signal generator 96 (figure 4, paragraph 0080); the leadless pacemaker/IPD 16 signals the defibrillator that ATP is unavailable 940 (figure 12 “send disable alert” this alert is sent from the pacemaker to the defibrillator); once the defibrillator receives the signal the shock therapy parameters can be adjusted (“alter operation upon ATP disable”).
Regarding claim 14: Hareland discloses non-transitory computer readable medium which includes instructions to perform “any of the function and techniques described”, paragraph 0171) this is program code to perform methods clearly this occurs once executed.
Regarding claim 15: Hareland discloses the non-transitory computer readable medium which includes instructions to perform “any of the function and techniques described”, paragraph 0171) this is considered to be a data carrier which contains code and is clearly occurs once executed.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hareland et al. US 2017/0312514 in view of Demmer et al. US 2020/0254262.
Regarding claim 3 as understood: Hareland discloses the claimed invention however Hareland does not disclose a fault detection device which alerts the defibrillator of battery exhaustion or a fault condition of the pacemaker. Demmer however teaches of a heart rate monitor (HRM) which can be an implantable ICD which works with a leadless pacemaker 14 (figure 1), if the leadless pacemaker has a battery threshold level which indicates that the battery life is ending, then the ICD will receive this information about the battery and supply back-up pacing while the pacemaker is unavailable (paragraph 0109). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Hareland to include determining a battery life of an implanted pacemaker and use this information to allow a secondary device to supply pacing, as taught by Demmer, in order to provide continuous pacing.
Regarding claim 4: Hareland discloses the leadless pacemaker 16 (figure 4) which includes a first control unit 96 (“signal generator”, figure 4) which will disable ATP 938 (figure 12 “Disable Delivery of ATP”) and signal both an external unit 21 (paragraph 0163, the left side of figure 12) as well as the defibrillator (paragraph 0163, the right side of figure 12); this is the pacemaker signaling the defibrillator that ATP is disabled. However Hareland does not disclose that the signal to disable is due to battery exhaustion. Demmer however teaches of a heart rate monitor (HRM) which can be an implantable ICD which works with a leadless pacemaker 14 (figure 1), if the leadless pacemaker has a battery threshold level which indicates that the battery life is ending, then the ICD will receive this information about the battery and supply back-up pacing while the pacemaker is unavailable (paragraph 0109). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Hareland to include determining a battery life of an implanted pacemaker and use this information to allow a secondary device to supply pacing, as taught by Demmer, in order to provide continuous pacing.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hareland et al. US 2017/0312514 in view of Greenhut et al. US 8,744,572.
Regarding claim 7: Hareland discloses the implantable pacemaker 16 (figures 1, 2A, 2B and 4) which signals to the defibrillator 30 (figures 1, 2A, 2B and 5) that ATP therapy is not available 938 (figure 12). However Hareland does not disclose that the defibrillator determines an absence of ATP which is used as the disabled ATP message. Greenhut however teaches of a similar device which includes pacemaker 16 (figure 1) and defibrillator 30 (figure 1), the defibrillator monitors signals to determine if ATP therapy has been delivered by the pacemaker (column 27, lines 60-67 “SICD 30 may monitor LPD 16 actions to infer reasons for certain actions and non-actions.”). In certain instances the LPD 16 may not deliver therapy because the LPD 16 has not itself sensed tachycardia (column 28, lines 8-9), therefore the LPD is signaling an unavailability to deliver anti-tachycardia pacing. The defibrillator may also receive signals that the pacemaker is not delivering ATP based on battery charge, electrode contact and functioning electronics (column 32, lines 19-30). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Hareland to include that the defibrillator monitors to determine if ATP therapy has been delivered by the pacemaker and determine that ATP has been disabled based on the lack of delivery of ATP, as taught by Greenhut, in order to determine a reason why the ATP has not been delivered to the patient.
Regarding claim 10: Harland discloses the claimed invention however Harland does not disclose that the defibrillator detects a signal / information unit if ATP is expected yet not sensed by the defibrillator. Greenhut however teaches of a similar device which includes pacemaker 16 (figure 1) and defibrillator 30 (figure 1), the defibrillator monitors signals to determine if ATP therapy has been delivered by the pacemaker (column 27, lines 60-67 “SICD 30 may monitor LPD 16 actions to infer reasons for certain actions and non-actions.”). In certain instances the LPD 16 may not deliver therapy because the LPD 16 has not itself sensed tachycardia (column 28, lines 8-9), therefore the LPD is signaling an unavailability to deliver anti-tachycardia pacing. The defibrillator may also receive signals that the pacemaker is not delivering ATP based on battery charge, electrode contact and functioning electronics (column 32, lines 19-30). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Hareland to include that the defibrillator detects a signal / information unit if ATP is expected yet not sensed by the defibrillator, as taught by Greenhut in order to determine a reason why the ATP has not been delivered to the patient.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hareland et al. US 2017/0312514 in view of Stahmann et al. US 2015/0630041.
Regarding claim 11: Hareland discloses the claimed invention however Hareland does not disclose shortening a defibrillation delay and ATP is not available. Stahmann however teaches of a leadless cardiac pacemaker which triggers defibrillation (paragraph 0009), once the trigger message is received the shock is delivered (paragraph 0015). This indicates that there is no delay between the message being sent and the shock being delivered resulting in zero delay. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Hareland to include a trigger with no/zero delay to deliver defibrillation when ATP is not working, as taught by Stahmann, in order to appropriately treat the cardiac tissue.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hareland et al. US 2017/0312514 in view of Starkweather US 5,836,971.
Regarding claim 12 as understood: Hareland discloses the claimed invention however Harland does not disclose zone boundaries. Starkweather however teaches of and ICD which includes control circuitry to adjust rate zone boundaries for arrhythmia detection (abstract). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Hareland to include rate zone boundaries, as taught by Starkweather, in order to include higher rate zones for arrhythmia detection.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: claim 5 in combination with claim 1 requires that the pacemaker monitors battery depletion and withholds ATP in a first stage of battery depletion and allows for anti-bradycardia pacing and in a second stage of battery depletion the device withholds both ATP and anti-bradycardia, these limitations in combination with the limitations of claim 1 appear to be unique in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796