DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,072,914 in view of Belacazar (US 2006/0064149). Claims 21-43 are directed to obvious variations of an implantable or subcutaneous implantable cardioverter-defibrillator and leadless pacing device as claimed in claims 1-20 of U.S. Patent No. 9,072,914 except for the feature of transmitting the communication message during a refractory period to the leadless pacing device to deliver anti-tachycardia pacing therapy to the heart.
One of ordinary skill would have found it obvious to provide this refractory period and transmit the communication message during this time since Belacazar suggest it is conventional in the art to do this with pacing devices. See para. [0012].
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 limitation(s) is/are: “sensing circuitry” in claims 21, 29, 31, 40, and 43; “processing circuitry” in claims 21, 23, 24, 28, 29, 30, 31, 32, 34, 41, 43, 44, and 46; “shock module” in claims 23 and 34; “sensing module” in claims 30 and 41.
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.
The terms will be interpreted as follows:
1) “sensing circuitry” will be interpreted as generic sensing components, such as electrodes.
2) “processing circuitry” will be interpreted as a generic computer processor structure.
3) “shock module” will be interpreted as a capacitor holding electric charge.
4) “sensing module” will be interpreted as generic sensing components, such as electrodes.
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 30 and 41 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 30, which is dependent from claim 21, recites, “a sensing module.” It is not clear if the sensing module is the same structure or different structure than the “sensing circuitry” recited in claim 21. Both “sensing module” and “sensing circuitry” are invoke 112(f) interpretations, and the specification does not provide clarity as to what the difference is between the recited terms. Claim 41, which is dependent from claim 32, is rejected for the same reason.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(c) he has abandoned the invention.
(d) the invention was first patented or caused to be patented, or was the subject of an inventor’s certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor’s certificate filed more than twelve months before the filing of the application in the United States.
Claim(s) 21, 22, 26-28, 30, 32, 37-39, 41, and 42 are rejected under pre-AIA 35 U.S.C. 102(a)/(b) as being anticipated by Jacobson (US 20070088394 A1).
Regarding claim 21, Jacobson teaches a system comprising: a subcutaneous implantable cardioverter-defibrillator (SICD) (Fig. 1A; implantable cardioverter-defibrillator (ICD) 106.) configured to be implanted within a patient (para. [0046]: "implantable cardioverter-defibrillator (ICD) 106"), wherein the SICD comprises: sensing circuitry (para. [0049]: " The housing 110 also contains circuits 132 for sensing cardiac activity from the electrodes 108"; para. [0108]: " The implanted cardioverter-defibrillator (ICD) 106 can comprise a case and be fitted with a pair of electrodes mounted on or near the case.") configured to sense electrical signals associated with a heart of the patient (para. [0108]: "The ICD 106 can be configured to receive and transmit conducted communication using a pulse modulated or frequency modulated carrier signal whereby the ICD 106 can detect communication pulses from co-implanted leadless cardiac pacemakers 102 and transmit programming information to the co-implanted leadless cardiac pacemakers 102. In some embodiments, an implanted cardioverter-defibrillator (ICD) 106 configured to receive conducted communication using two implantable electrodes."; para. [0046]: "One or more of the leadless cardiac pacemakers 102 can comprise at least two leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and uni-directionally or bi-directionally communicating with the co-implanted ICD 106."; The electrodes 108 are also used in 106 to sense electrical signals for the defibrillator as well as 102 for the pacing); and processing circuitry (Fig. 1B; processor or controller 112) configured to: detect, based on at least a portion of the electrical signals, a treatable rhythm (para. [0092]: "The illustrative schemes for transmitting data enable assignment of designated codes to events detected or caused by a leadless cardiac pacemaker, such as sensing a heartbeat or delivering a pacing pulse at the location of the pacemaker that senses the event…Each other leadless cardiac pacemaker can react appropriately to the conveyed information in a predetermined manner encoded in the internal processor 112, as a function of the type and location of the event coded in the received pulse. The ICD 106 can also use the information for arrhythmia detection."; The processor uses amplified signals sensed from 108 (see Fig. 1B)); control the SICD to transmit, a communication message to a leadless pacing device (LPD) (para. [0092]: " By delivery of a coded pacing pulse with a code assigned according to the pacemaker location, a leadless cardiac pacemaker can transmit a message to any and all other leadless cardiac pacemakers 102 and the ICD 106 implanted in the same patient"), the communication message requesting that the LPD deliver anti-tachyarrhythmia pacing (ATP) therapy to the heart. (para. [0065]: "In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
Regarding claim 22, the claim does not require any additional structure other than the structure previously recited in claim 21. The limitations of claim 22 only further define the operations of the SICD, and does not further recite structural limitations regarding the SICD. Therefore, since Jacobson recites the structural limitations of claim 21 (see rejection above), then, absent evidence the contrary, the SICD (106) of Jacobson would be able to operate without receiving communications from the LPD. Therefore, the structures of Jacobson read on the limitations of claim 22. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Regarding claim 26, Jacobson teaches the system of claim 21 (see above), wherein the treatable rhythm comprises a tachyarrhythmia. (para. [0065]: "In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
Regarding claim 27, Jacobson teaches the system of claim 21 (see above), wherein the communication message comprises a plurality of electrical signals (para. [0046]: "One or more of the leadless cardiac pacemakers 102 can comprise at least two leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and uni-directionally or bi-directionally communicating with the co-implanted ICD 106."), and wherein the system further comprises a signal generator (pulse generator 116) configured to deliver the plurality of electrical signals of the communication message via implanted electrodes (para. [0049]: "The housing 110 also contains circuits 132 for sensing cardiac activity from the electrodes 108, circuits 134 for receiving information from at least one other device via the electrodes 108, and a pulse generator 116 for generating pacing pulses for delivery via the electrodes 108 and also for transmitting information to at least one other device via the electrodes 108.").
Regarding claim 28, Jacobson teaches the system of claim 21 (see above), wherein the processing circuitry is configured to control the SICD to transmit a plurality of communication messages requesting respective ATP therapy events before delivering a shock to the patient, wherein the plurality of communication messages comprises the communication message. (para. [0092]: " By delivery of a coded pacing pulse with a code assigned according to the pacemaker location, a leadless cardiac pacemaker can transmit a message to any and all other leadless cardiac pacemakers 102 and the ICD 106 implanted in the same patient, where the code signifies the origin of the event. Each other leadless cardiac pacemaker can react appropriately to the conveyed information in a predetermined manner encoded in the internal processor 112, as a function of the type and location of the event coded in the received pulse."; para. [0093]: "Referring again to FIG. 1B, the circuit 132 for receiving communication via electrodes 108 receives the triggering information as described and can also optionally receive other communication information, either from the other implanted pulse generator 106 or from a programmer outside the body.").
Regarding claim 30, Jacobson teaches the system of claim 21 (see above), further comprising the LPD, wherein the LPD comprises LPD processing circuity (Fig. 1B; processor or controller 112), a sensing module (Fig. 1B; electrodes 108 in conjunction with the sense amplifier 132), and a signal generator (Fig. 1B; pulse generator 116), wherein the sensing module is configured to receive the communication message via electrodes of the LPD (para. [0050]: "The one or more leadless electrodes 108 can be configured to communicate bidirectionally among the multiple leadless cardiac pacemakers and/or the implanted ICD to coordinate pacing pulse delivery using messages that identify an event at an individual pacemaker originating the message and a pacemaker receiving the message react as directed by the message depending on the origin of the message."), and wherein the LPD processing circuitry (Fig. 1B; processor or controller 112) is configured to: control the sensing module to receive, via the electrodes of the LPD, the communication message from the SICD (para. [0050]: " The one or more leadless electrodes 108 can be configured to communicate bidirectionally among the multiple leadless cardiac pacemakers and/or the implanted ICD to coordinate pacing pulse delivery using messages that identify an event at an individual pacemaker originating the message and a pacemaker receiving the message react as directed by the message depending on the origin of the message."); and control the signal generator (Fig. 1B; controller 112 in communication with pulse generator 116) to deliver the ATP therapy to the heart (para. [0065]: " In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
Regarding claim 32, Jacobson teaches a method comprising: sensing, by sensing circuitry (para. [0049]: "The housing 110 also contains circuits 132 for sensing cardiac activity from the electrodes 108"; para. [0108]: "The implanted cardioverter-defibrillator (ICD) 106 can comprise a case and be fitted with a pair of electrodes mounted on or near the case.") of a subcutaneous implantable cardioverter-defibrillator (SICD)(Fig. 1A; implantable cardioverter-defibrillator (ICD) 106.) configured to be implanted within a patient (para. [0046]: "implantable cardioverter-defibrillator (ICD) 106"), electrical signals associated with a heart of the patient (para. [0108]: "The ICD 106 can be configured to receive and transmit conducted communication using a pulse modulated or frequency modulated carrier signal whereby the ICD 106 can detect communication pulses from co-implanted leadless cardiac pacemakers 102 and transmit programming information to the co-implanted leadless cardiac pacemakers 102. In some embodiments, an implanted cardioverter-defibrillator (ICD) 106 configured to receive conducted communication using two implantable electrodes."; para. [0046]: "One or more of the leadless cardiac pacemakers 102 can comprise at least two leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and uni-directionally or bi-directionally communicating with the co-implanted ICD 106."; The electrodes 108 are also used in 106 to sense electrical signals for the defibrillator as well as 102 for the pacing); detecting, by processing circuitry and based on at least a portion of the electrical signals, a treatable rhythm (para. [0092]: "The illustrative schemes for transmitting data enable assignment of designated codes to events detected or caused by a leadless cardiac pacemaker, such as sensing a heartbeat or delivering a pacing pulse at the location of the pacemaker that senses the event…Each other leadless cardiac pacemaker can react appropriately to the conveyed information in a predetermined manner encoded in the internal processor 112, as a function of the type and location of the event coded in the received pulse. The ICD 106 can also use the information for arrhythmia detection."; The processor uses amplified signals sensed from 108 (see Fig. 1B); and controlling, by the processing circuitry, the SICD to transmit, a communication message to a leadless pacing device (LPD) (para. [0092]: " By delivery of a coded pacing pulse with a code assigned according to the pacemaker location, a leadless cardiac pacemaker can transmit a message to any and all other leadless cardiac pacemakers 102 and the ICD 106 implanted in the same patient"), the communication message requesting that the LPD deliver anti-tachyarrhythmia pacing (ATP) therapy to the heart (para. [0065]: "In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
Regarding claim 37, Jacobson teaches The method of claim 32 (see above), wherein the treatable rhythm comprises a tachyarrhythmia (para. [0065]: "In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
Regarding claim 38, Jacobson teaches the method of claim 32 (see above), wherein controlling the SICD to transmit (para. [0038]: " The housing can also contain circuits for sensing cardiac activity from the electrodes, receiving information from at least one other device via the electrodes, generating pacing pulses for delivery via the electrodes, transmitting information to at least one other device via the electrodes"), the communication message comprises a plurality of electrical signals (para. [0046]: "One or more of the leadless cardiac pacemakers 102 can comprise at least two leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and uni-directionally or bi-directionally communicating with the co-implanted ICD 106."), and wherein the system further comprises a signal generator (pulse generator 116) configured to deliver the plurality of electrical signals of the communication message via implanted electrodes (para. [0049]: "The housing 110 also contains circuits 132 for sensing cardiac activity from the electrodes 108, circuits 134 for receiving information from at least one other device via the electrodes 108, and a pulse generator 116 for generating pacing pulses for delivery via the electrodes 108 and also for transmitting information to at least one other device via the electrodes 108.").
Regarding claim 39, Jacobson teaches the method of claim 32 (see above), further comprising controlling the SICD to transmit a plurality of communication messages requesting respective ATP therapy events before delivering a shock to the patient, wherein the plurality of communication messages comprises the communication message. (para. [0092]: " By delivery of a coded pacing pulse with a code assigned according to the pacemaker location, a leadless cardiac pacemaker can transmit a message to any and all other leadless cardiac pacemakers 102 and the ICD 106 implanted in the same patient, where the code signifies the origin of the event. Each other leadless cardiac pacemaker can react appropriately to the conveyed information in a predetermined manner encoded in the internal processor 112, as a function of the type and location of the event coded in the received pulse."; para. [0093]: "Referring again to FIG. 1B, the circuit 132 for receiving communication via electrodes 108 receives the triggering information as described and can also optionally receive other communication information, either from the other implanted pulse generator 106 or from a programmer outside the body.").
Regarding claim 41, Jacobson teaches the method of claim 32 (see above), further comprising: controlling, by LPD processing circuitry (Fig. 1B; processor or controller 112) of the LPD (Fig. 1B; 102), a sensing module of the LPD (Fig. 1B; electrodes 108 in conjunction with the sense amplifier 132) to receive the communication message from the SICD; and controlling, by the LPD processing circuitry (Fig. 1B; controller 112 in communication with pulse generator 116), a signal generator (Fig. 1B; controller 112 in communication with pulse generator 116) of the LPD to deliver the ATP therapy to the heart. (para. [0065]: " In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
Regarding claim 42, Jacobson teaches the method of claim 32 (see above), further comprising controlling a signal generator (para. [0084]: " As controlled by processor 112, pulse generator 116 selectively generates or does not generate…") of the SICD to transmit the communication message to the LPD (para. [0047]: " The leadless cardiac pacemakers 102 can communicate with one another and/or communicate with a non-implanted programmer and/or the implanted ICD 106 via the same electrodes 108 that are also used to deliver pacing pulses.") as one or more electrical pulses of a plurality of electrical pulses delivered via at least one of the plurality of electrodes of a lead coupled to the SICD. (Fig. 1B; electrodes 108; para. [0047]: "The leadless cardiac pacemakers 102 can communicate with one another and/or communicate with a non-implanted programmer and/or the implanted ICD 106 via the same electrodes 108 that are also used to deliver pacing pulses.").
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1, “Jacobson A”) in view of Jacobson (US 20070088396 A1, “Jacobson B”).
Regarding claim 22, while still maintaining the previous assertation that Jacobson recites the structural limitations necessary for claim 22 (as detailed in the 102 rejection of claim 22), Jacobson B also recites the limitations of claim 22. Jacobson B, in the same field of endeavor of defibrillators and pacemakers, discloses a pacemaker and defibrillator system where the implantable devices are in communication. Jacobson B recites, wherein the SICD is configured to operate without receiving communications from the LPD (para. [0040]: "The processor 112 communicates with a device external to the pacemaker, for example typically an external programmer or another implanted device 106, by conducted communication signals transmitted via the electrodes 108. Communication is typically bidirectional although some implementations may include only one-way communication, either to or from the pacemaker 102. The processor 112 controls electrical pulse delivery based on one or more programmable parameters and can be programmed by conducted communication signals transmitted over the electrodes 108.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jacobson A to include defibrillator operations with one way communication between the defibrillator and pacemaker. One of ordinary skill would recognize that the device of Jacobson B would improve the efficiency of power consumption by optimizing the power consumed by communication circuitry (see Jacobson B, para. [0020]). Therefore, it would be desirable to include efficient communication and power consumption to improve the device of Jacobson A.
Regarding claim 33, Jacobson A discloses the method of claim 32 (see 102 rejection above). However, Jacobson A does not explicitly disclose that the method includes a SICD is configured to operate without receiving communications from the LPD. The Examiner notes that claim 33 is directed towards a method, not an apparatus. Therefore, the argument regarding the structural limitations disclosed by Jacobson A, as asserted in the 102 rejection of claim 22 directed to a system, do not apply to the methods of claim 33.
Jacobson B, in the same field of endeavor of defibrillators and pacemakers, discloses a pacemaker and defibrillator system where the implantable devices are in communication. Jacobson B discloses wherein the SICD is configured to operate without receiving communications from the LPD (para. [0040]: "The processor 112 communicates with a device external to the pacemaker, for example typically an external programmer or another implanted device 106, by conducted communication signals transmitted via the electrodes 108. Communication is typically bidirectional although some implementations may include only one-way communication, either to or from the pacemaker 102. The processor 112 controls electrical pulse delivery based on one or more programmable parameters and can be programmed by conducted communication signals transmitted over the electrodes 108.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Jacobson A to include defibrillator operations with one way communication between the defibrillator and pacemaker. One of ordinary skill would recognize that the device and method of Jacobson B would improve the efficiency of power consumption by optimizing the power consumed by communication circuitry (see Jacobson B, para. [0020]). Therefore, it would be desirable to include efficient communication and power consumption to improve the method of Jacobson A.
Claims 23 and 34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1) in view of Perschbacher et al. (US 20050222629 A1, "Perschbacher").
Regarding claims 23 and 34, Jacobson teaches the system of claim 21 (see above) and the method of claim 32 (see 102 rejection above). However, Jacobson does not expressly teach wherein the SICD comprises a shock module, and wherein the processing circuitry is configured to begin charging the shock module control the SICD to transmit the communication message during the charging of the shock module.
Perschbache, in the same field of endeavor of pacemakers and defibrillators, discloses a system and method for delivering pacing and defibrillating shocks. Perschbache discloses wherein the SICD comprises a shock module (para. [0043]: "…the ICD charges a defibrillation capacitor at 560, and delivers a shock at 570 after the charging is completed."), and wherein the processing circuitry (para. [0007]: "The charging controller detects the presence of the ATP activation signal.") is configured to begin charging the shock module (para. [0043]: "…the ICD charges a defibrillation capacitor at 560, and delivers a shock at 570 after the charging is completed.") and control the SICD to transmit the communication message during the charging of the shock module (para. [0020]: " In response to a VT episode detected while the ATP-BC mode is active, the ICD delivers the ATP and verifies the effect of ATP in terminating the VT. Only if the VT sustains after an ATP delivery, the ICD charges its one or more defibrillation capacitors."; The messages signal the effectiveness of the ATP while charging the shock to be delivered if deemed ineffective).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Jacobson A to include the charging shock module that charges and to deliver shock, as disclosed by Perschbache. One of ordinary skill would recognize that the device and method of Perschbache, by having both defibrillator shocks and anti-tachyarrhythmia therapy capabilities, would be able to effectively treat arrythmia with optimal power consumption and minimal patient discomfort. Therefore, it would have been obvious to improve the device and method of Jacobson A with the features of Perschbache.
Claims 24, 25, 35, and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1) in view of Zhou (US 20080269819 A).
Regarding claims 24 and 35, Jacobson teaches the system of claim 21 (see 102 rejection above) and the method of claim 32 (see 102 rejection above). However, Jacobson does not expressly disclose wherein the communication message is a first communication, and wherein the processing circuitry is configured to: determine, based on the electrical signals, and responsive to determining that the ATP therapy is not effective, controlling the SICD to transmit a second communication message to the LPD that requests the LPD to deliver subsequent ATP therapy with a change to one or more parameters that defines the subsequent ATP therapy.
Zhou, in the same field of endeavor of defibrillators and pacemakers, discloses a device and method for discriminating between types of tachycardia. Zhou discloses wherein the communication message is a first communication message (para. [0002]: " The ICD is typically programmed to deliver a therapy in response to a tachycardia detection."; The detection of an arrhythmia is considered a message to begin therapy.), and wherein the processing circuitry (para. [0016]: "IMD 10 generally includes timing and control circuitry 52 and an operating system that may employ microprocessor 54 or a digital state machine for timing sensing and therapy delivery functions and controlling other device functions in accordance with a programmed operating mode.") is configured to: determine, based on the electrical signals (para. [0002] "in response to tachycardia detection…"), and responsive to determining that the ATP therapy is not effective (para. [0041]: " Neural stimulation parameters are adjusted at block 330 until effective stimulation is achieved as evidenced by a change from baseline at block 325."; this implies that the therapy was not effective before), controlling the SICD to transmit a second communication message to the LPD that requests the LPD to deliver subsequent ATP therapy with a change to one or more parameters that defines the subsequent ATP therapy (para. [0040]: "At block 320, neural stimulation is initiated. At block 325, the IMD monitors for a change in the baseline parameter measurement indicating the neural stimulation is effective in exciting the neural tissue. One or more criteria may be defined for establishing effective neural stimulation based, for example, on a decrease in heart rate, increase in PR interval, and/or decrease in ventricular pressure. A threshold may be defined as a function of the baseline measurement(s) for detecting effective neural stimulation. If no change in the baseline measurement is detected, the neural stimulation parameters are adjusted at block 330. The stimulation pulse amplitude, pulse width, pulse number, and/or pulse frequency may be adjusted. When other electrodes are positioned for stimulating neural tissue, a different electrode may be selected at block 330."; para. [0041]: " Neural stimulation parameters are adjusted at block 330 until effective stimulation is achieved as evidenced by a change from baseline at block 325."; Additionally, the stimulation refers to ATP; para. [0002]: "Tachycardia and fibrillation, referred to collectively as "tachycardia" herein, are detected when a required number of intervals are less than a predefined tachycardia detection interval. The ICD is typically programmed to deliver a therapy in response to a tachycardia detection, which may be anti-tachycardia pacing (ATP)").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Jacobson to include the method of adjusting therapy, as disclosed by Zhou. One of ordinary skill would recognize that the device and method of Zhou would improve the device of Jacobson by ensuring an effective level of stimulation is achieved to treat tachycardia. Therefore, it would have been obvious to combine the device and method of Zhou with the device and method of Jacobson.
Regarding claims 25 and 36, Jacobson, in combination with Zhou, discloses the system of claim 24 (see above), and the method of claim 35 (see above). Zhou further discloses wherein the one or more parameters comprises a duration of the subsequent ATP therapy. (para. [0040]: "The stimulation pulse amplitude, pulse width, pulse number, and/or pulse frequency may be adjusted.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Jacobson to include the method of adjusting therapy, as disclosed by Zhou. One of ordinary skill would recognize that the device and method of Zhou would improve the device of Jacobson by ensuring an effective level of stimulation is achieved to treat tachycardia. Therefore, it would have been obvious to combine the device and method of Zhou with the device and method of Jacobson.
Claims 29 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1) in view of Hess (US 20060224193 A1).
Regarding claim 29 and claim 40, Jacobson discloses the system of claim 21 (see above) and the method of claim 32 (see 102 rejection above). However, Jacobson does not expressly disclose wherein the processing circuitry is configured to control the SICD to start a blanking period that controls the sensing circuitry from sensing the electrical signals during delivery of the ATP therapy by the LPD.
Hess, in the same field of endeavor of cardiac pacing, discloses a method for operating a cardiac rhythm management device. Hess discloses wherein a processing circuitry is configured to control the SICD to start a blanking period that controls the sensing circuitry from sensing the electrical signals during delivery of the ATP therapy by the LPD. (para. [0018]: "Blanking periods are used to prevent saturation of the sense amplifier or to prevent oversensing. The sensing electrode can be blanked for a specified blanking interval by disabling the sense amplifier when a pace is delivered.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device and method of Jacobson to include the method and processor for controlling a blanking period for the sensors during delivery, as disclosed by Hess. One of ordinary skill would recognize that by including a blanking period, the device and method of Hess would improve the accuracy and detection of arrythmias by preventing false readings during the stimulation period. Therefore, it would have been obvious to include the blanking period, as disclosed by Hess, in the device and method of Jacobson.
Claims 31 and 43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1) in view of Xiao et al. (US 20120232606 A1, "Xiao").
Regarding claim 31, Jacobson teaches the system of claim 21 (see 102 rejection above). Further, Jacobson teaches wherein the processing circuitry (Fig. 1B; processor or controller 112) is configured to control the signal generator (para. [0084]: " As controlled by processor 112, pulse generator 116 selectively generates or does not generate…") to transmit the communication message to the LPD (para. [0047]: " The leadless cardiac pacemakers 102 can communicate with one another and/or communicate with a non-implanted programmer and/or the implanted ICD 106 via the same electrodes 108 that are also used to deliver pacing pulses.") as one or more electrical pulses of the plurality of electrical pulses delivered via at least one of the plurality of electrodes (Fig. 1B; electrodes 108; para. [0047]: "The leadless cardiac pacemakers 102 can communicate with one another and/or communicate with a non-implanted programmer and/or the implanted ICD 106 via the same electrodes 108 that are also used to deliver pacing pulses."). However, Jacobson does not teach a lead configured to be coupled to the SICD and including a plurality of electrodes.
Xiao, in the same field of endeavor of implantable medical devices for cardiac stimulation, discloses an apparatus and method for sensing and treating arrythmia. Xiao discloses a lead (Fig. 2; leads 16, 32, and 52) configured to be coupled to the SICD (para. [0027]: "Each lead (and in turn individual electrodes associated with each lead) coupled to the ICD.") and including a plurality of electrodes (para. [0030]: "ICD 14 is configured to deliver pacing pulses to the atrial electrodes associated with lead 16"); and delivering a plurality of electrical pulses via at least one electrode of the plurality of electrodes (para. [0027]: "FIG. 2 is a functional block diagram of the ICD 14 shown in FIG. 1, according to one embodiment. Circuitry 24, located within ICD 14 of FIG. 1, includes pacing circuitry 25, defibrillation circuitry 26, sensing circuitry 27, control processor 28, memory 29, and communication system 30. Leads 16, 32 and 52 are connected to pacing circuitry 25, defibrillation circuitry 26 and sensing circuitry 27. Each lead (and in turn individual electrodes associated with each lead) coupled to the ICD may be used in multiple capacities to sense cardiac depolarizations (e.g. P-waves and R-waves), deliver pacing pulses, and deliver CV/DF shocks.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jacobson to include the lead with a plurality of electrodes as disclosed by Xiao. One of ordinary skill would recognize that by including a lead with electrodes, one would be able to effectively distinguish between arrythmia types and treat arrythmias with reduced unnecessary shocks (see Xiao para. [0004]). Therefore, it would have been an obvious improvement to include the lead and electrodes in the device of Jacobson.
Regarding claim 43, Jacobson discloses an implantable cardioverter-defibrillator (Fig. 1A; implantable cardioverter-defibrillator (ICD) 106.)(ICD), wherein the ICD comprises: sensing circuitry (para. [0049]: " The housing 110 also contains circuits 132 for sensing cardiac activity from the electrodes 108"; para. [0108]: " The implanted cardioverter-defibrillator (ICD) 106 can comprise a case and be fitted with a pair of electrodes mounted on or near the case.") configured to sense electrical signals associated with a heart of the patient (para. [0108]: "The ICD 106 can be configured to receive and transmit conducted communication using a pulse modulated or frequency modulated carrier signal whereby the ICD 106 can detect communication pulses from co-implanted leadless cardiac pacemakers 102 and transmit programming information to the co-implanted leadless cardiac pacemakers 102. In some embodiments, an implanted cardioverter-defibrillator (ICD) 106 configured to receive conducted communication using two implantable electrodes."; para. [0046]: "One or more of the leadless cardiac pacemakers 102 can comprise at least two leadless electrodes 108 configured for delivering cardiac pacing pulses, sensing evoked and/or natural cardiac electrical signals, and uni-directionally or bi-directionally communicating with the co-implanted ICD 106."; The electrodes 108 are also used in 106 to sense electrical signals for the defibrillator as well as 102 for the pacing) via at least one of the plurality of electrodes (Fig. 1B; electrodes 108); and a signal generator (Fig. 1B; pulse generator 116) configured to deliver electrical pulses via at least one of the plurality of electrodes (Fig. 1B; electrodes 108; para. [0047]: "The leadless cardiac pacemakers 102 can communicate with one another and/or communicate with a non-implanted programmer and/or the implanted ICD 106 via the same electrodes 108 that are also used to deliver pacing pulses."); and processing circuitry configured to: detect, based on at least a portion of the sensed electrical signals, a treatable rhythm (para. [0092]: "The illustrative schemes for transmitting data enable assignment of designated codes to events detected or caused by a leadless cardiac pacemaker, such as sensing a heartbeat or delivering a pacing pulse at the location of the pacemaker that senses the event…Each other leadless cardiac pacemaker can react appropriately to the conveyed information in a predetermined manner encoded in the internal processor 112, as a function of the type and location of the event coded in the received pulse. The ICD 106 can also use the information for arrhythmia detection."; The processor uses amplified signals sensed from 108 (see Fig. 1B); control the signal generator to transmit, a communication message as one or more electrical pulses to a leadless pacing device (LPD) (para. [0092]: " By delivery of a coded pacing pulse with a code assigned according to the pacemaker location, a leadless cardiac pacemaker can transmit a message to any and all other leadless cardiac pacemakers 102 and the ICD 106 implanted in the same patient"), via at least one of the plurality of electrodes (Fig. 1B; electrodes 108), the communication message requesting that the LPD deliver anti-tachyarrhythmia pacing (ATP) therapy to the heart. (para. [0065]: "In some embodiments, individual pacemakers 102 of the one or more leadless cardiac pacemakers can be configured to receive conducted communication from a co-implanted cardioverter-defibrillator (ICD) 106 that configures the pacemakers 102 to deliver overdrive anti-tachycardia pacing in response to a detected tachyarrhythmia.").
However, Jacobson does not disclose a lead. Xiao discloses a lead (Fig. 1; 16, 32, or 52) including a plurality of electrodes (para. [0019]: “Each lead has at least one electrical conductor and pace/sense electrode”) and configured to be implanted within a patient (implantable cardioverter defibrillators are implanted within a patient) (ICDs); an implantable cardioverter-defibrillator (ICD) configured to be coupled to the lead (para. [0019]: “Three transvenous leads 16, 32 and 52 connect the ICD 14 with the RA, the RV and the LA and LV, respectively.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jacobson to include the lead with a plurality of electrodes as disclosed by Xiao. One of ordinary skill would recognize that by including a lead with electrodes, one would be able to effectively distinguish between arrythmia types and treat arrythmias with reduced unnecessary shocks (see Xiao para. [0004]). Therefore, it would have been an obvious improvement to include the lead and electrodes in the device of Jacobson.
Claims 44 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1, “Jacobson A”) in view of Jacobson (US 20120109236 A1, “Jacobson C”).
Regarding claim 44, Jacobson A teaches the system of claim 21 (see 102 rejection above). However, Jacobson A does not expressly disclose wherein the processing circuitry is configured to control the SICD to transmit the communication message to the LPD during a refractory period of a cardiac cycle.
Jacobson C, in the same field of endeavor as Jacobson A of arrythmia treatment, discloses a pacemaker device. Jacobson discloses wherein the processing circuitry is configured to control the SICD to transmit the communication message to the LPD during a refractory period of a cardiac cycle (para. [0159]: "In some embodiments, the pacemaker 102 can transmit communication pulses to the external device 106 during the pacemaker's absolute refractory period. Doing so advantageously ensures that the transmission does not interfere with heartbeat sensing and that the induction of arrhythmias is prevented. Signals can be transmitted only during the absolute refractory period, as the refractory period is sufficiently long to permit full transmission of such signals in place of those encoded in a pacing pulse or in a refractory pulse triggered by sensing. Alternatively, signals can be transmitted during the absolute refractory period in addition to being encoded in a pacing pulse or in a refractory period triggered by sensing, which advantageously increases the data rate of the signal.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jacobson to include the communication transmission during the refractory period, as disclosed by Jacobson C. One of ordinary skill would recognize that the refractory period would reduce signal interference and improve accuracy. This would improve the device of Jacobson A, and therefore, it would have been obvious to combine signal transmission during a refractory period, as disclosed by Jacobson C, in the device of Jacobson A.
Regarding claim 45, Jacobson C teaches the method of claim 32 (see 102 rejection above). However, Jacobson A does not expressly disclose wherein controlling the SICD to transmit the communication message to the LPD comprises controlling the SICD to transmit the communication message to the LPD during a refractory period of a cardiac cycle.
Jacobson C, in the same field of endeavor as Jacobson A of arrythmia treatment, discloses a pacemaker device. Jacobson discloses wherein controlling the SICD to transmit the communication message to the LPD comprises controlling the SICD to transmit the communication message to the LPD during a refractory period of a cardiac cycle. (para. [0159]: "In some embodiments, the pacemaker 102 can transmit communication pulses to the external device 106 during the pacemaker's absolute refractory period. Doing so advantageously ensures that the transmission does not interfere with heartbeat sensing and that the induction of arrhythmias is prevented. Signals can be transmitted only during the absolute refractory period, as the refractory period is sufficiently long to permit full transmission of such signals in place of those encoded in a pacing pulse or in a refractory pulse triggered by sensing. Alternatively, signals can be transmitted during the absolute refractory period in addition to being encoded in a pacing pulse or in a refractory period triggered by sensing, which advantageously increases the data rate of the signal.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jacobson to include the communication transmission during the refractory period, as disclosed by Jacobson C. One of ordinary skill would recognize that the refractory period would reduce signal interference and improve accuracy. This would improve the method of Jacobson A, and therefore, it would have been obvious to combine signal transmission during a refractory period, as disclosed by Jacobson C, in the device of Jacobson A.
Claim 46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jacobson (US 20070088394 A1, “Jacobson A”), Xiao et al. (US 20120232606 A1, "Xiao"), and Jacobson (US 20120109236 A1, “Jacobson C”).
Regarding claim 46, Jacobson A, in combination with Xiao, discloses the system of claim 43 (see 103 rejection above). However, neither reference discloses wherein the processing circuitry is configured to control the signal generator to transmit the communication message to the LPD during a refractory period of a cardiac cycle.
Jacobson C discloses wherein the processing circuitry is configured to control the SICD to transmit the communication message to the LPD during a refractory period of a cardiac cycle (para. [0159]: "In some embodiments, the pacemaker 102 can transmit communication pulses to the external device 106 during the pacemaker's absolute refractory period. Doing so advantageously ensures that the transmission does not interfere with heartbeat sensing and that the induction of arrhythmias is prevented. Signals can be transmitted only during the absolute refractory period, as the refractory period is sufficiently long to permit full transmission of such signals in place of those encoded in a pacing pulse or in a refractory pulse triggered by sensing. Alternatively, signals can be transmitted during the absolute refractory period in addition to being encoded in a pacing pulse or in a refractory period triggered by sensing, which advantageously increases the data rate of the signal.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Jacobson, in combination with Xiao, to include the communication transmission during the refractory period, as disclosed by Jacobson C. One of ordinary skill would recognize that the refractory period would reduce signal interference and improve accuracy. This would improve the device of Jacobson A, and therefore, it would have been obvious to combine signal transmission during a refractory period, as disclosed by Jacobson C, in the device of Jacobson A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F).
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. Additionally, SPE Carl Layno may be reached at (571) 272-4949.
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.
/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights