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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/28/25 is being considered by the examiner.
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:
control unit in claims 1-3, 5-10, and 13.
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.
For “a control unit” in claims 1-3, 5-10, and 13, the specification does not disclose a structure for the control unit. Therefore, it remains unclear how the limitation should be interpreted.
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.
Specification
The amendment filed 2/28/25 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The incorporation by reference of the international patent application PCT/EP2023/070337 and of the EP22195548.7 patent application are ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 7/21/2023, see MPEP 1893.03(b). Therefore the specification amendment of 2/28/2025 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action. Please see the below MPEP sections.
MPEP 608.01(p) I B:
As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and 211 et seq. where domestic benefit is claimed. See MPEP §§ 213 - 216 where foreign priority is claimed. See MPEP § 217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018).
MPEP 1893.03(b):
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
Similarly, PCT Article 11(3) provides that
...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.
Claim Objections
Claim 1 is objected to because of the following informalities: Applicant is encouraged to change the limitation of “and for implantation in or on the ventricles for performing a resynchronization therapy for synchronizing activity of the ventricles of the patient's heart” in lines 6-7 to recite -- and configured for implantation in or on the ventricles for performing a resynchronization therapy for synchronizing activity of the ventricles of the patient's heart-- for clarity purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Applicant is encouraged to change the limitation of “wherein at least one electrode lead of said arrangement of electrode leads comprises a first arrangement of electrode poles, arranged at a distal end of the at least one electrode lead, for sensing ventricular sense signals in one of the ventricles” in lines 8-10 to recite --wherein at least one electrode lead of said arrangement of electrode leads comprises a first arrangement of electrode poles, arranged at a distal end of the at least one electrode lead, configured for sensing ventricular sense signals in one of the ventricles-- for clarity purposes. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Applicant is encouraged to change the limitation of “and for inducing a stimulation in said one of the ventricles and a second arrangement of electrode poles, arranged at a location proximal to the distal end, for sensing atrial sense signals in an atrium of the patient's heart” in lines 10-13 to recite -- and configured for inducing a stimulation in said one of the ventricles and a second arrangement of electrode poles, arranged at a location proximal to the distal end, configured for sensing atrial sense signals in an atrium of the patient's heart-- for clarity purposes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 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 limitation “control unit” invokes 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. The specification does not disclose a structure for the control unit. Therefore, the claim is indefinite and is 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.
Claims 1, 7, 8, and 13 recite the limitation "the ventricles." There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the first instance of “the ventricles” in claims 1 and 13 to recite –ventricles--.
Claims 1 and 13 recite the limitation "the patient’s heart." There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the first instance of “the patient’s heart” to recite –a patient’s heart--.
Claim 8 recites the limitation "the other of the ventricles" in 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 8-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-13 are directed to statutory subject matter as the claims recite an implantable cardiac resynchronization therapy device and a method for operating an implantable cardiac resynchronization therapy device.
Step 2A, Prong One
Regarding claims 1 and 13, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Regarding claims 1 and 13, the limitations of “perform a sensing test to evaluate atrial sense signals sensed using said second arrangement of electrode poles based on at least one stability criterion and to perform, based on a result of said sensing test, an adaption routine to adapt at least one parameter for generating ventricular stimulation signals to be output using said arrangement of electrode leads; wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out data and evaluating atrial sense signals sensed using said second arrangement of electrode poles based on at least one stability criterion, based on the result of the sensing test, adapting at least one parameter, and the stability criterion includes either evaluating the print out to determine whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold or determining whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold.
Step 2A, Prong Two
For claims 1 and 13, the judicial exception is not integrated into a practical application. In particular, claims 1 and 13 recite “a generator; a control unit; and an arrangement of electrode leads, wherein at least one electrode lead of said arrangement of electrode leads comprises a first arrangement of electrode poles, arranged at a distal end of the at least one electrode lead, for sensing ventricular sense signals in one of the ventricles and for inducing a stimulation in said one of the ventricles and a second arrangement of electrode poles, arranged at a location proximal to the distal end, for sensing atrial sense signals in an atrium of the patient's heart.” The an arrangement of electrode leads, wherein at least one electrode lead of said arrangement of electrode leads comprises a first arrangement of electrode poles, arranged at a distal end of the at least one electrode lead, for sensing ventricular sense signals in one of the ventricles and for inducing a stimulation in said one of the ventricles and a second arrangement of electrode poles, arranged at a location proximal to the distal end, for sensing atrial sense signals in an atrium of the patient's heart amount to nothing more than pre-solution activity of data gathering. The generator and control unit are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional elements of an arrangement of electrode leads, wherein at least one electrode lead of said arrangement of electrode leads comprises a first arrangement of electrode poles, arranged at a distal end of the at least one electrode lead, for sensing ventricular sense signals in one of the ventricles and for inducing a stimulation in said one of the ventricles and a second arrangement of electrode poles, arranged at a location proximal to the distal end, for sensing atrial sense signals in an atrium of the patient's heart amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the an arrangement of electrode leads, wherein at least one electrode lead of said arrangement of electrode leads comprises a first arrangement of electrode poles, arranged at a distal end of the at least one electrode lead, for sensing ventricular sense signals in one of the ventricles and for inducing a stimulation in said one of the ventricles and a second arrangement of electrode poles, arranged at a location proximal to the distal end, for sensing atrial sense signals in an atrium of the patient's heart are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by WO 2021078853 (page 16, ¶1-an electrode lead configuration of another pacemaker, namely a triple chamber pacemaker 100 having a first electrode lead port 2, a second electrode lead port 20 and a third electrode lead port 200. The right ventricular electrode 6 is implanted in an apical region of the right ventricle 7 of the human heart 5. The right atrial electrode 3 is implanted in the atrium 4 of the human heart 5. such electrode configuration is particularly appropriate for conventional cardiac resynchronization therapy), US 20020082663 (¶23-conventional bradycardia pacing of an atrium and/or a ventricle may be considered as resynchronization therapy; ¶13-the pacemaker has atrial sensing and pacing channels comprising electrode 34a-b, leads 33a -b, sensing amplifiers 31a-b, pulse generators 32a-b, and atrial channel interfaces 30a-b which communicate bidirectionally with microprocessor 10. The device also has ventricular sensing and pacing channels for both ventricles comprising electrodes 24a-b, leads 23a-b, sensing amplifiers 21a-b, pulse generators 22a-b, and ventricular channel interfaces 20a-b), and US 20020120298 (¶13-centricular rate regularization therapy may, for example, be implemented in a device configured to deliver conventional bradycardia pacing therapy to the atria and/or ventricles; ¶32-the pacemaker has atrial sensing and pacing channels comprising electrode 34a-b, leads 33a-b, sensing amplifiers 31a-b, pulse generators 32a-b, and atrial channel interfaces 30a-b which communicate bidirectionally with microprocessor 10. The device also has ventricular sensing and pacing channels for both ventricles comprising electrodes 24a-b, leads 23a-b, sensing amplifiers 21 a-b, pulse generators 22a-b, and ventricular channel interfaces 20a-b). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-5 and 8-12, the limitations of claims 1 and 13 further define the limitations already indicated as being directed to the abstract idea.
Claims 2 and 3 are further directed to the abstract idea in claim 1.
Regarding claim 4, the limitations of “wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a sensed atrial interval is within a pre-defined first range, evaluating whether a change in a sensed atrial interval over a pre-defined number of cardiac cycles is within a predefined first limit, evaluating whether a peak amplitude of a sensed atrial peak is within a pre-defined second range, and evaluating whether a change of a peak amplitude of a sensed atrial peak over a pre-defined number of cardiac cycles is within a pre-defined second limit” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional receiving a print out of data and evaluating whether a sensed atrial interval is within a pre-defined first range, evaluating whether a change in a sensed atrial interval over a pre-defined number of cardiac cycles is within a predefined first limit, evaluating whether a peak amplitude of a sensed atrial peak is within a pre-defined second range, or evaluating whether a change of a peak amplitude of a sensed atrial peak over a pre-defined number of cardiac cycles is within a pre-defined second limit.
Regarding claim 5, the measuring step is further directed to pre-solution activity of data gathering. The adapting is further directed to the abstract idea as indicated in claim 1.
Regarding claim 6, this is a practical application, as ventricular stimulation signals are explicitly recited as being output based the paced atrial-ventricular delay.
Regarding claim 7, this is a practical application, as ventricular stimulation signals are explicitly recited as being output based on the measured intrinsic atrial-ventricular delay.
Regarding claim 8, the measuring steps are further directed to pre-solution activity of data gathering as indicated in claim 1.
Regarding claim 9, the limitation of “adapt said at least one parameter based on a comparison of the first atrial-ventricular delay and the second atrial-ventricular delay” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional changing a parameter value on paper based on a comparison of the first atrial-ventricular delay and the second atrial-ventricular delay.
Regarding claim 10, the limitation of “performing said sensing test cyclically employing a cycle length corresponding to a pre-defined number of cardiac cycles” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional performing the sensing test using pen and paper multiple times based on the number of cardiac cycles.
Regarding claim 11, wherein the implantable cardiac resynchronization therapy device is a CRT-D device amounts to pre-solution activity of data gathering. The CRT-D device is well-understood, routine, and conventional activity as evidenced by: US 20070088398 (¶32-conventional CRT-D or CRT-P systems), US 20060136004 (¶97-conventional CRT-D pacemaker/defibrillator), and US 20130046354 (¶51-this is also known in the art as cardio resynchronization therapy devices, otherwise known as CRT-D devices).
Regarding claim 12, wherein the implantable cardiac resynchronization therapy device is a CRT-P device amounts to pre-solution activity of data gathering. The CRT-P device is well-understood, routine, and conventional activity as evidenced by: US 20070088398 (¶4-an otherwise conventional pacemaker (CRT-P)), US 20160158545 (¶3-conventional pacemaker (CRT-P)), and US 20110224655 (¶3-CRT devices in pacemakers are known as CRT-P devices).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Taff (US 20180110980 filed on 10/5/17 as cited in the IDS) in view of Chebbo (NPL “Tachycardia detection in modern implantable cardioverter–defibrillators published in 2016 as cited in the IDS).
Regarding claim 1, Taff teaches an implantable cardiac resynchronization therapy device, comprising: a generator including a control unit configured to control operation of the implantable cardiac resynchronization therapy device (¶93-a right atrial stimulation pulse generator RA-STIM 50 , a right ventricular pulse generator RV-STIM 52 and a left ventricular pulse generator LV-STIM 54, control unit 62; Fig. 2; ¶3-a heart stimulator intended to administer cardiac resynchronization therapy (CRT)), and an arrangement of electrode leads configured for connection to the generator and for implantation in or on the ventricles for performing a resynchronization therapy for synchronizing activity of the ventricles of the patient's heart (¶93-during operation of the implantable medical device 100 , electrode leads 110 , 112 and 114 are connected to respective output/input terminals of the implantable medical device 100 as indicated in FIG. 2 and carry stimulating pulses to the tip electrodes 121 , 131 and one of 141 , 142 , 143 and 144 from a right atrial stimulation pulse generator RA-STIM 50 , a right ventricular pulse generator RV-STIM 52 and a left ventricular pulse generator LV-STIM 54; ¶3-a heart stimulator intended to administer cardiac resynchronization therapy (CRT)), wherein at least one electrode lead (¶87-lead 110) of said arrangement of electrode leads comprises a first arrangement of electrode poles (¶68-plurality of electrode poles of the multipolar left ventricular stimulation electrode lead automatically in a periodical manner; ¶109-a plurality of electrode poles 141, 142, 143 and 144 on the left ventricular electrode lead 114; ¶93), arranged at a distal end of the at least one electrode lead, for sensing ventricular sense signals in one of the ventricles and for inducing a stimulation in said one of the ventricles (¶68-plurality of electrode poles of the multipolar left ventricular stimulation electrode lead automatically in a periodical manner; ¶109-a plurality of electrode poles 141, 142, 143 and 144 on the left ventricular electrode lead 114; Fig. 1-shows poles 141, 142, 143, and 144 at the distal end of lead 114) and a second arrangement of electrode poles, arranged at a location proximal to the distal end, for sensing atrial sense signals in an atrium of the patient's heart (¶88-lead 112 is a right atrial electrode lead that has a pair of right atrial electrodes 131 and 132 that are in contact with the right atria of the heart; ¶89; ¶93-94; Fig. 1), wherein the control unit is configured to perform a sensing test to evaluate atrial sense signals sensed using said second arrangement of electrode poles based on at least one stability criterion (¶97-control unit CTRL 62 receives the output signals from the atrial sensing stage RA-SENS 56, an As-signal is generated, when the atrial sensing stage RA-SENS 56 detects a P-wave) and to perform, based on a result of said sensing test, an adaption routine to adapt at least one parameter for generating ventricular stimulation signals to be output using said arrangement of electrode leads (¶98-control unit 62 is preferably adapted to monitor right atrioventricular conduction behavior, in particular the time sequence of atrial events (As or Ap) and the next ventricular event in order to determine whether there is an intrinsic right-ventricular following an atrial event within a certain time; ¶99-control unit 62 receives a RVs-signal within a predetermined time period starting from an As-signal or an Ap event, control unit 62 switches in an operation mode corresponding to a lack of intrinsic atrioventricular (AV) conduction. As a consequence a right ventricular pacing pulse may be delivered and the pacing site for the left ventricle may be altered by selecting a different left ventricular electrode for delivery of the left ventricular pacing pulse than in the operation mode for intact intrinsic atrioventricular (AV) conduction; ¶100).
However, Taff does not explicitly teach wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold.
Chebbo relates generally to BIOTRONIK ICDs to utilize automatic sensitivity control to automatically adjust the atrial and ventricular sensing thresholds (page 171, left col., last ¶). Chebbo further teaches the invention using the following step:
wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold (Figs. 5-6; page 173, left col., ¶1-the atrial automatic sensitivity control works similar to the ventricular standard settings. Each P-wave is measured and used to define upper and lower atrial sensing thresholds. The upper threshold is set to 50% of the peak P-wave amplitude and is hold for 350 ms after atrial sensed and paced events. Then the atrial sensing threshold decreases to 25% and decays 12.5% every 156 ms until either the minimum atrial threshold is reached or until the next atrial event, sensed or paced, has occurred).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Taff to include wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold of Chebbo in order to adjust in cases of over- or undersensing (Chebbo, page 183, right col., Conclusion section).
Regarding claim 2, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein the control unit is configured to perform said adaption routine if and only if the sensing test is successful (Chebbo, page 172, Ventricular sensitivity section-the upper threshold after sensing is set to 50% of the peak R-wave amplitude. Following the upper threshold duration of 350 ms (after sensing), the device sets the lower threshold to 25% of the measured R-wave for 156 ms. The device will continue to decrement the actual sensing threshold by 12.5% every 156 ms until either the minimum threshold is reached or a new R-wave occurs; this means that until either the minimum threshold is reached or a new R-wave occurs, it is considered successful and adaption routine continues).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Taff to include wherein the control unit is configured to perform said adaption routine if and only if the sensing test is successful of Chebbo in order to adjust in cases of over- or undersensing (Chebbo, page 183, right col., Conclusion section).
Regarding claim 3, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein the control unit is configured to inhibit the performing of the adaption routine if the sensing test is not successful (Chebbo, page 172, Ventricular sensitivity section-the upper threshold after sensing is set to 50% of the peak R-wave amplitude. Following the upper threshold duration of 350 ms (after sensing), the device sets the lower threshold to 25% of the measured R-wave for 156 ms. The device will continue to decrement the actual sensing threshold by 12.5% every 156 ms until either the minimum threshold is reached or a new R-wave occurs; this means that once either the minimum threshold is reached or a new R-wave occurs, it is considered not successful and adaption routine is inhibited).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Taff to include wherein the control unit is configured to inhibit the performing of the adaption routine if the sensing test is not successful of Chebbo in order to adjust in cases of over- or undersensing (Chebbo, page 183, right col., Conclusion section).
Regarding claim 4, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a sensed atrial interval is within a pre-defined first range (Taff, ¶98-control unit 62 is preferably adapted to monitor right atrioventricular conduction behavior, in particular the time sequence of atrial events (As or Ap) and the next ventricular event in order to determine whether there is an intrinsic right-ventricular following an atrial event within a certain time), or evaluating whether a change in a sensed atrial interval over a pre-defined number of cardiac cycles is within a predefined first limit (Taff, ¶57-the control unit is adapted to determine the presence of an intrinsic right atrioventricular conduction if a number of recorded sensed right ventricular events exceeds a predetermined minimum, wherein each sensed right ventricular event within a specified count of cardiac cycles temporally correlates with a respective, preceding right atrial event (As; Ap)).
Regarding claim 5, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein the control unit is configured, within said adaption routine, to measure an intrinsic atrial-ventricular delay based on an atrial sense signal and a ventricular sense signal and to adapt at least one parameter based on a measured intrinsic atrial-ventricular delay (Taff, ¶98-control unit 62 is preferably adapted to monitor right atrioventricular conduction behavior, in particular the time sequence of atrial events (As or Ap) and the next ventricular event in order to determine whether there is an intrinsic right-ventricular following an atrial event within a certain time; ¶99-when control unit 62 receives a RVs-signal within a predetermined time period starting from an As-signal or an Ap event, control unit 62 switches in an operation mode for intact intrinsic atrioventricular (AV) conduction and delivery of a right ventricular pacing pulse is inhibited, a right ventricular pacing pulse may be delivered and the pacing site for the left ventricle may be altered by selecting a different left ventricular electrode for delivery of the left ventricular pacing pulse than in the operation mode for intact intrinsic atrioventricular (AV) conduction; ¶114-different left ventricular pacing sites are chosen depending on whether control unit 62 receives an RVs signal appropriately coordinated within a preceding Ax and thus detects an intrinsic atrioventricular conduction condition or not; ¶113).
Regarding claim 6, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 5, wherein the control unit is configured to set a paced atrial-ventricular delay based on said measured intrinsic atrial-ventricular delay and to generate ventricular stimulation signals to be output using said arrangement of electrode leads based on said paced atrial-ventricular delay (Taff, ¶33-the LV pacing vector can be chosen and updated according to said periodical assessments of the right-side atrioventricular state; ¶41-the implantable medical device may determine suitable left ventricular electrodes according to recently sensed events of the right atrioventricular conduction system and with respect to a detected right atrioventricular conduction state; ¶98-preferably adapted to monitor right atrioventricular conduction behavior, in particular the time sequence of atrial events (As or Ap) and the next ventricular event in order to determine whether there is an intrinsic right-ventricular following an atrial event within a certain time; ¶99-control unit 62 receives a RVs-signal within a predetermined time period starting from an As-signal or an Ap event, control unit 62 switches in an operation mode for intact intrinsic atrioventricular (AV) conduction; ¶102-the basic timing intervals used during operation of the implantable medical device 100 and AV delay values; ¶114-different left ventricular pacing sites are chosen depending on whether control unit 62 receives an RVs signal appropriately coordinated within a preceding Ax and thus detects an intrinsic atrioventricular conduction condition or not. Different pacing sited are established by choosing one (or a sub-set) of left ventricular electrodes 141 , 142 , 143 or 144 for delivery of left ventricular stimulation pulses; ¶113).
Regarding claim 7, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 6, wherein the control unit is configured to generate ventricular stimulation signals either for a bi-ventricular stimulation or for a stimulation in only one of the ventricles based on said measured intrinsic atrial-ventricular delay (Taff, ¶76-bi-ventricular implantable cardioverter/defibrillator (ICD); ¶114-different left ventricular pacing sites are chosen depending on whether control unit 62 receives an RVs signal appropriately coordinated within a preceding Ax and thus detects an intrinsic atrioventricular conduction condition or not. Different pacing sited are established by choosing one (or a sub-set) of left ventricular electrodes 141 , 142 , 143 or 144 for delivery of left ventricular stimulation pulses).
Regarding claim 8, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein the control unit is configured, within said adaption routine, to measure a first intrinsic atrial-ventricular delay based on an atrial sense signal (Taff, ¶102-the basic timing intervals used during operation of the implantable medical device 100 and AV delay values; ¶119-programmed AV delay facilitating the measurements for cases where right-side conduction prevailed; ¶97-control unit CTRL 62 receives the output signals from the atrial sensing stage RA-SENS 56 , from the right ventricular sensing stage RV-SENS 58 and from the left ventricular sensing stage LV-SENS 60) and a first ventricular sense signal sensed in one of the ventricles (Taff, ¶97-control unit CTRL 62 receives the output signals from the atrial sensing stage RA-SENS 56 , from the right ventricular sensing stage RV-SENS 58 and from the left ventricular sensing stage LV-SENS 60) and a second intrinsic atrial-ventricular delay based on an atrial sense signal and a second ventricular sense signal sensed in the other of the ventricles (Taff, ¶97-an As-signal is generated, when the atrial sensing stage RA-SENS 56 detects a P-wave and a RVs-signal is generated, when the right ventricular sensing stage RV-SENS 58 detects an R-wave; ¶102-the basic timing intervals used during operation of the implantable medical device 100 and AV delay values; ¶114-control unit 62 receives an RVs signal appropriately coordinated within a preceding Ax and thus detects an intrinsic atrioventricular conduction condition or not; ¶113).
Regarding claim 9, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 8, characterized in that the control unit is configured to adapt said at least one parameter based on a comparison of the first atrial-ventricular delay and the second atrial-ventricular delay (Taff, ¶24-the control unit is adapted to determine right atrioventricular conduction status and as such, may monitor sensed atrial (likely using a dedicated atrial lead) and/or ventricular activities to motivate and/or provide selection of one or more of the plurality of electrode poles found on the multipolar left ventricular stimulation lead in response to said conduction status; ¶26-the control unit is adapted to discriminate between at least two right-side atrioventricular conduction states, including a presence of intrinsic right-side atrioventricular conduction and/or an absence of right-side atrioventricular conduction (with possible further sub-classification and management on the basis of specific disturbed right-side atrioventricular conduction states); ¶114-different left ventricular pacing sites are chosen depending on whether control unit 62 receives an RVs signal appropriately coordinated within a preceding Ax and thus detects an intrinsic atrioventricular conduction condition or not).
Regarding claim 10, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein the control unit is configured to perform said sensing test cyclically employing a cycle length corresponding to a pre-defined number of cardiac cycles (Taff, ¶57).
Regarding claim 11, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein implantable cardiac resynchronization therapy device is a CRT-D device (Taff, ¶76-a three chamber bi-ventricular implantable cardioverter/defibrillator (ICD); ¶84; Fig. 1).
Regarding claim 12, the combination of Taff and Chebbo teaches the implantable cardiac resynchronization therapy device according to claim 1, wherein the implantable cardiac resynchronization therapy device is a CRT-P device (Taff, ¶84-the implantable medical device (also referred to as implantable cardiac device) is a three chamber biventricular pacemaker; Fig. 1).
Regarding claim 13, Taff teaches a method for operating an implantable cardiac resynchronization therapy device, comprising: providing a generator including a control unit configured to control operation of the implantable cardiac resynchronization therapy device (¶93-a right atrial stimulation pulse generator RA-STIM 50 , a right ventricular pulse generator RV-STIM 52 and a left ventricular pulse generator LV-STIM 54, control unit 62; Fig. 2; ¶3-a heart stimulator intended to administer cardiac resynchronization therapy (CRT)), and providing an arrangement of electrode leads configured for connection to the generator and for implantation in or on the ventricles for performing a re-synchronization therapy for synchronizing activity of the ventricles of the patient's heart (¶93-during operation of the implantable medical device 100 , electrode leads 110 , 112 and 114 are connected to respective output/input terminals of the implantable medical device 100 as indicated in FIG. 2 and carry stimulating pulses to the tip electrodes 121 , 131 and one of 141 , 142 , 143 and 144 from a right atrial stimulation pulse generator RA-STIM 50 , a right ventricular pulse generator RV-STIM 52 and a left ventricular pulse generator LV-STIM 54; ¶3-a heart stimulator intended to administer cardiac resynchronization therapy (CRT)) sensing ventricular sense signals in one of the ventricles and inducing a stimulation in said one of the ventricles using a first arrangement of electrode poles (¶87-lead 110; ¶68-plurality of electrode poles of the multipolar left ventricular stimulation electrode lead automatically in a periodical manner; ¶109-a plurality of electrode poles 141, 142, 143 and 144 on the left ventricular electrode lead 114; ¶93) arranged at a distal end of at least one electrode lead of said arrangement of electrode leads of the at least one electrode lead (¶68-plurality of electrode poles of the multipolar left ventricular stimulation electrode lead automatically in a periodical manner; ¶109-a plurality of electrode poles 141, 142, 143 and 144 on the left ventricular electrode lead 114; Fig. 1-shows poles 141, 142, 143, and 144 at the distal end of lead 114), sensing atrial sense signals in an atrium of the patient's heart (¶88-lead 112 is a right atrial electrode lead that has a pair of right atrial electrodes 131 and 132 that are in contact with the right atria of the heart; ¶89; ¶93-94; Fig. 1) using a second arrangement of electrode poles arranged at a location proximal to the distal end of said at least one electrode lead (¶88-lead 112 is a right atrial electrode lead that has a pair of right atrial electrodes 131 and 132 that are in contact with the right atria of the heart; ¶89; ¶93-94; Fig. 1), performing, using the control unit, a sensing test to evaluate atrial sense signals sensed using said second arrangement of electrode poles based on at least one stability criterion (¶97-control unit CTRL 62 receives the output signals from the atrial sensing stage RA-SENS 56, an As-signal is generated, when the atrial sensing stage RA-SENS 56 detects a P-wave), and performing, using the control unit and based on a result of said sensing test, an adaption routine to adapt at least one parameter for generating ventricular stimulation signals to be output using said arrangement of electrode leads (¶98-control unit 62 is preferably adapted to monitor right atrioventricular conduction behavior, in particular the time sequence of atrial events (As or Ap) and the next ventricular event in order to determine whether there is an intrinsic right-ventricular following an atrial event within a certain time; ¶99-control unit 62 receives a RVs-signal within a predetermined time period starting from an As-signal or an Ap event, control unit 62 switches in an operation mode corresponding to a lack of intrinsic atrioventricular (AV) conduction. As a consequence a right ventricular pacing pulse may be delivered and the pacing site for the left ventricle may be altered by selecting a different left ventricular electrode for delivery of the left ventricular pacing pulse than in the operation mode for intact intrinsic atrioventricular (AV) conduction; ¶100).
However, Taff does not explicitly teach wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold.
Chebbo teaches wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold (Figs. 5-6; page 173, left col., ¶1-the atrial automatic sensitivity control works similar to the ventricular standard settings. Each P-wave is measured and used to define upper and lower atrial sensing thresholds. The upper threshold is set to 50% of the peak P-wave amplitude and is hold for 350 ms after atrial sensed and paced events. Then the atrial sensing threshold decreases to 25% and decays 12.5% every 156 ms until either the minimum atrial threshold is reached or until the next atrial event, sensed or paced, has occurred).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Taff to include wherein said evaluation based on said at least one stability criterion includes at least one of: evaluating whether a peak amplitude of a sensed atrial peak is larger than a first pre-defined threshold, and evaluating whether a peak amplitude of a sensed atrial peak is smaller than a second pre-defined threshold of Chebbo in order to adjust in cases of over- or undersensing (Chebbo, page 183, right col., Conclusion section).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 12193801: to an implantable system for detecting electrical signals of a human heart or an animal heart, including a processor, a memory unit, a first detection unit for detecting an atrial activity, a second detection unit for detecting a right ventricular activity, and a third detection unit for detecting a left ventricular activity. The invention also relates to a method for controlling the operation of an implantable system for detecting electrical signals of a human heart or an animal heart and to a computer program product including computer-readable code, which prompts a processor to carry out steps when the code is being executed on the processor (col. 1 and lines 17-28).
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/LAURA HODGE/Examiner, Art Unit 3792
