DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "30" and "360" have both been used to designate a housing. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "24" and "358" have both been used to designate a proximal housing-based electrode. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: 30 and 24. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 5-7, 10-15, and 18-20 are objected to because of the following informalities:
In claim 1, line 2, “the right ventricle” should read “a right ventricle”
In claim 1, line 2, “the patient’s heart” should read “a patient’s heart”
In claim 1, line 4, “the ventricular septal wall” should read “a ventricular septal wall”
In claim 1, line 6, “the left ventricle” should read “a left ventricle”
In claim 1, line 8, “the right atrium” should read “a right atrium”
In claim 5, line 2, “the mid-septal potion” should read “a mid-septal portion”
In claim 5, lines 2-3, “the right bundle branch” should read “a right bundle branch”
In claim 5, line 4, “the left bundle branch” should read “a left bundle branch”
In claim 6, line 2, “the base” should read “a base”
In claim 6, line 2, “the right bundle branch” should read “a right bundle branch”
In claim 6, lines 3-4, “the left bundle branch” should read “a left bundle branch”
In claim 7, line 4, “the blood volume” should read “a blood volume”
In claim 10, line 2, “the endocardium” should read “an endocardium”
In claim 11, line 2, “the endocardium” should read “an endocardium”
In claim 12, line 2, “the endocardium” should read “an endocardium”
In claim 13, line 2, “the endocardium” should read “an endocardium”
In claim 14, line 2, “initiate the delivery cardiac therapy to” should read “initiate the delivery of cardiac therapy”
In claim 15, line 5, “the ventricular septal wall” should read “a ventricular septal wall”
In claim 15, line 6, “the left ventricle” should read “a left ventricle”
In claim 15, line 7, “the lead” should read “a lead”
In claim 15, line 8, “the right atrium” should read “a right atrium”
In claim 18, line 2, “the mid-septal portion” should read “a mid-septal portion”
In claim 18, lines 2-3, “the right bundle branch” should read “a right bundle branch”
In claim 18, line 4, “the left bundle branch” should read “a left bundle branch”
In claim 19, line 2, “the base” should read “a base”
In claim 19, line 2, “the right bundle branch” should read “a right bundle branch”
In claim 19, lines 3-4, “the left bundle branch” should read “a left bundle branch”
In claim 20, line 2, “the right ventricle” should read “a right ventricle”
In claim 20, line 5, “the ventricular septal wall” should read “a ventricular septal wall”
In claim 20, lines 6-7, “the left ventricle” should read “a left ventricle”
In claim 20, line 12, “the right atrium” should read “a right atrium”
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 6, 14, and 20 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 6 recites the limitation "the right ventricular electrode" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the atrial electrode" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the ventricular…electrode" in line 13. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear which ventricular electrode the Applicant is referring to in said claim limitation, as both “a left ventricular electrode” and “a right ventricular electrode” are recited previously.
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 1-3, 5-6, 10-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Demmer et al. (U.S. PGPub No. 2016/0310726) in view of Prinzen et al. (U.S. PGPub No. 2004/0230283).
Regarding claim 1, Demmer teaches a system (Fig. 10, Paragraph 0100, lines 1-2,
300) comprising: an intracardiac housing (Fig. 10, Paragraph 0102, line 1, 360)
implantable in the right ventricle of the patient's heart (Fig. 11A, Paragraph 0105, lines 7-8); a plurality of electrodes (340/342/344) comprising: a ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344) implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart (Fig. 11A, Paragraph 0102, lines 3-4 and Paragraph 0105, lines 7-8); and a right atrial electrode (Fig. 10, Paragraph 0104, lines 2-3, 340/342) implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart (Fig. 11A, Paragraph 0105, lines 3-7); a therapy delivery circuit (Paragraph 0102, lines 5-6, “pulse generator”); a sensing circuit (Paragraph 0102, line 6, “sensing module”) operably coupled to the plurality of electrodes to sense electrical activity of the patient's heart (Paragraph 0104, lines 4-8); and a controller (Fig. 10, Paragraph 0102, lines 6-7, 362) contained in the intracardiac housing (Fig. 10, Paragraph 0102, lines 6-8).
The present embodiment disclosed in Figure 10 of Demmer does not explicitly teach: a therapy delivery circuit that is operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient’s heart; a controller comprising processing circuitry operably coupled to the therapy delivery circuit and the sensing circuit; and that the controller is configured to monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode; and deliver cardiac therapy based on the monitored electrical activity.
In an alternative embodiment, however, Demmer teaches a system (Fig. 6, Paragraph 0075, lines 1-2, 10) that comprises an RV capsule (Fig. 6, Paragraph 0079, line 1, 14) with an intracardiac housing (Fig. 2, Paragraph 0040, lines 2-3, 60) implanted in the right ventricle of a patient’s heart (Fig. 1, Paragraph 0029, lines 3-5). Demmer teaches that the RV capsule (14) includes a therapy delivery circuit (Fig. 6, Paragraph 0079, line 1, 202), a sensing circuit (Fig. 6, Paragraph 0079, lines 1-2, 204), and a controller (Fig. 6, Paragraph 0079, line 2, 206). Demmer teaches that the system (10) includes a ventricular electrode (Fig. 6, Paragraph 0079, line 5, 44/46) and an atrial electrode (Fig. 6, Paragraph 0076, lines 2-3, 40/42).
Demmer teaches that the therapy delivery circuit (202) is operably coupled to the plurality of electrodes (Fig. 6) to deliver cardiac therapy to the patient’s heart (Paragraph 0079, lines 3-5). Demmer teaches that the sensing circuit (204) is operably coupled to the plurality of electrodes (Fig. 6) to sense electrical activity of the patient’s heart (Paragraph 0080, lines 1-3). Demmer teaches that the controller (206) comprises processing circuitry (Paragraph 0075, lines 5-14) and is operably coupled to the therapy delivery circuit and the sensing circuit (Fig. 6, Paragraph 0081, lines 4-8 and Paragraph 0080, lines 3-4). Furthermore, Demmer teaches that the controller (206) is configured to monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode (Paragraph 0081, lines 1-7); and deliver cardiac therapy based on the monitored electrical activity (Paragraph 0081, lines 7-8).
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 disclosed in Figure 10 of Demmer with the invention disclosed in Figure 6 of Demmer to include that a therapy delivery circuit is operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient’s heart, a controller comprising processing circuitry is operably coupled to the therapy delivery circuit and the sensing circuit; and that the controller is configured to monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode and deliver cardiac therapy based on the monitored electrical activity. Doing so would ensure that the control module may receive sensing data and analyze said data to detect cardiac events and control the therapy delivery circuit to deliver appropriate therapy (Paragraph 0081, lines 1-8), as recognized by Demmer.
Demmer also does not teach that the ventricular electrode is implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart. Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable in the ventricular septal wall of a patient’s heart (Fig. 3, Paragraph 0016, line 4 and Paragraph 0017, lines 10-11, 7/27). Prinzen teaches that the ventricular electrode (140) delivers cardiac therapy or senses electrical activity of the left ventricle of the patient’s heart (Paragraph 0015, lines 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the ventricular electrode is implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 2, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 1. Demmer does not teach that the delivering cardiac therapy comprises delivering cardiac resynchronization therapy. Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140), and that delivers cardiac resynchronization therapy by pacing both the left and right ventricles (Paragraph 0016, lines 1-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the delivering cardiac therapy comprises delivering cardiac resynchronization therapy. Doing so would allow for bi-ventricular pacing to manage a patient’s cardiac rhythm (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 3, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 1, wherein the plurality of electrodes (340/342/344) includes a ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344) that is implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart (Fig. 11A, Paragraph 0102, lines 3-4 and Paragraph 0105, lines 7-8). Demmer does not teach that the plurality of electrodes further comprises a right ventricular electrode implantable in the right ventricle of the patient’s heart to deliver cardiac therapy to or sense electrical activity of the right ventricle.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a right ventricular electrode (Fig. 3, Paragraph 0015, line 7, 160) that is implantable in the right ventricle of a patient’s heart (Fig. 3, Paragraph 0016, lines 3-4 and Paragraph 0017, lines 13-14, 7/37). Prinzen teaches that the right ventricular electrode (160) delivers cardiac therapy or senses electrical activity of the right ventricle of the patient’s heart (Paragraph 0015, lines 13-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the plurality of electrodes further comprises a right ventricular electrode implantable in the right ventricle of the patient’s heart to deliver cardiac therapy to or sense electrical activity of the right ventricle. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 5, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 3 that includes the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the right ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the left bundle branch.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a right ventricular electrode (Fig. 3, Paragraph 0015, line 7, 160) that is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7) proximate to the right bundle branch (Fig. 3, Paragraph 0016, lines 3-4, 37). Prinzen also teaches that the pacing lead (100) includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable through the ventricular septal wall of the patient’s heart (7) proximate to the left bundle branch (Fig. 3, Paragraph 0016, line 4, 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the right ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the left bundle branch. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
The limitations “the right ventricular electrode is implantable at the mid-septal portion of the patient’s heart” and “the ventricular electrode is implantable at the mid-septal portion of the patient’s heart” is directed towards the intended use of the system and is not given patentable weight. Therefore, the prior art is not required to explicitly disclose the particular functions, but merely have the capability to be implanted at the mid-septal portion of the patient’s heart, thereby providing different anatomical locations of implantation to best suit the needs of each individual patient. Prinzen teaches that the pacing lead (100) is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7). Therefore, it would be well understood by a person of ordinary skill in the art that the pacing lead (100) disclosed in Prinzen would be capable of being implanted at the mid-septal portion of the patient’s heart.
Regarding claim 6, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 1 that includes the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the right ventricular electrode is implantable at the base of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the base of the patient's heart proximate to the left bundle branch.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a right ventricular electrode (Fig. 3, Paragraph 0015, line 7, 160) that is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7) proximate to the right bundle branch (Fig. 3, Paragraph 0016, lines 3-4, 37). Prinzen also teaches that the pacing lead (100) includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable through the ventricular septal wall of the patient’s heart (7) proximate to the left bundle branch (Fig. 3, Paragraph 0016, line 4, 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the right ventricular electrode is implantable at the base of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the base of the patient's heart proximate to the left bundle branch. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
The limitations “the right ventricular electrode is implantable at the base of the patient’s heart” and “the ventricular electrode is implantable at the base of the patient’s heart” is directed towards the intended use of the system and is not given patentable weight. Therefore, the prior art is not required to explicitly disclose the particular functions, but merely have the capability to be implanted at the base of the patient’s heart, thereby providing different anatomical locations of implantation to best suit the needs of each individual patient. Prinzen teaches that the pacing lead (100) is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7). Therefore, it would be well understood by a person of ordinary skill in the art that the pacing lead (100) disclosed in Prinzen would be capable of being implanted at the base of the patient’s heart.
Regarding claim 10, Demmer in view of Prinzen discloses the claimed invention
of claim 1. Demmer further discloses the system (Fig. 10, Paragraph 0100, lines 1-2, 300) according to claim 1, wherein the right atrial electrode (Fig. 10, Paragraph 0104, lines 2-3, 340/342) is implantable in the endocardium of the right atrium of the patient's heart (Fig. 11A, Paragraph 0104, lines 12-14 and Paragraph 0107, lines 14-16).
Regarding claim 11, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-2, 300) according to claim 1 that includes the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the ventricular electrode is implantable in the endocardium of the left ventricle of the patient’s heart.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable (Fig. 3, Paragraph 0017, lines 8-9) in the endocardium of the left ventricle (Fig. 3, Paragraph 0017, lines 10-11, 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the ventricular electrode is implantable in the endocardium of the left ventricle of the patient’s heart. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 12, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-2, 300) according to claim 1 that includes the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the ventricular electrode is implantable through the ventricular septal wall in the right ventricle into the endocardium of the left ventricle.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable (Fig. 3, Paragraph 0017, lines 8-9) through the ventricular septal wall (Fig. 3, Paragraph 0017, line 13, 7) in the right ventricle (Fig. 3, Paragraph 0015, line 4, 4) into the endocardium of the left ventricle (Fig. 3, Paragraph 0017, lines 10-11, 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the ventricular electrode is implantable through the ventricular septal wall in the right ventricle into the endocardium of the left ventricle. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 13, Demmer in view of Prinzen discloses the claimed invention of claim 1. Demmer further discloses the system (Fig. 10, Paragraph 0100, lines 1-2, 300) according to claim 1, further comprising a fixation assembly (Fig. 10, Paragraph 0100, line 4, 332) operably coupled to (Fig. 10-11) the intracardiac housing (Fig. 10, Paragraph 0102, line 1, 360) couplable to the endocardium of the right ventricle (Fig. 11A, Paragraph 0103, lines 1-12, Paragraph 0104, lines 14-15, and Paragraph 0105, lines 7-8).
Regarding claim 14, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-2, 300) according to claim 1 that includes the controller (Fig. 10, Paragraph 0102, lines 6-7, 362). The present embodiment of Demmer does not teach that the controller is wirelessly operably coupled to the atrial electrode to initiate the delivery cardiac therapy to or sense electrical activity of the right atrium of the patient’s heart.
In an alternative embodiment, however, Demmer teaches a system (Fig. 8, Paragraph 0089, line 2, 10) that comprises an RA capsule (Fig. 8, Paragraph 0089, line 3, 12) and an RV capsule (Fig. 8, Paragraph 0089, line 10, 14). Demmer teaches that the RA capsule (12) includes a telemetry module (Fig. 8, Paragraph 0089, line 3, 108), and that the RV capsule (14) includes a telemetry module (Fig. 8, Paragraph 0087, line 5, 208). Demmer teaches that the RV capsule controller (Fig. 8, Paragraph 0081, line 4, 206) is wirelessly operably coupled, via the two telemetry modules (Paragraph 0039, lines 14-16), to an atrial electrode (Fig. 8, Paragraph 0081, line 3, 40/42) to initiate the delivery cardiac therapy to or sense electrical activity of the patient’s heart (Paragraph 0081, lines 4-8).
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 embodiment disclosed in Figure 10 of Demmer with the embodiment disclosed in Figure 8 of Demmer to include that the controller is wirelessly operably coupled to the atrial electrode to initiate the delivery cardiac therapy to or sense electrical activity of the right atrium of the patient’s heart. Doing so would allow wireless communication between the capsules to transmit operating control parameters to coordinate dual chamber or multi-site pacing (Paragraph 0098, lines 1-8), as recognized by Demmer.
Regarding claim 15, Demmer teaches a system (Fig. 10, Paragraph 0100, lines 1-
2, 300) comprising: an intracardiac housing (Fig. 10, Paragraph 0102, line 1, 360) implantable in the right ventricle of the patient's heart (Fig. 11A, Paragraph 0105, lines 7-8); a plurality of electrodes (340/342/344) comprising: a ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344) coupled to the intracardiac housing (Fig. 10) and
implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle
of the patient's heart (Fig. 11A, Paragraph 0102, lines 3-4 and Paragraph 0105, lines 7-8); and a right atrial electrode (Fig. 10, Paragraph 0104, lines 2-3, 340/342) coupled to the lead (Fig. 10, Paragraph 0104, lines 1-7, 315/316) and implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart (Fig. 11A, Paragraph 0105, lines 3-7); and a first controller (Fig. 10, Paragraph 0102, lines 6-7, 362) contained in the intracardiac housing (Fig. 10, Paragraph 0102, lines 6-8).
The present embodiment disclosed in Figure 10 of Demmer does not explicitly teach: a first controller comprising processing circuitry, wherein the first controller is operably coupled to the ventricular electrode; and a second controller comprising processing circuitry and operably coupled to the right atrial electrode, wherein the first and second controllers are configured to wirelessly communicate with each other to: monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode; and deliver cardiac therapy using one or both of the right atrial electrode and the ventricular electrode based on the monitored electrical activity.
In an alternative embodiment, however, Demmer teaches a system (Fig. 8, Paragraph 0089, line 2, 10) that comprises an RA capsule (Fig. 8, Paragraph 0089, line 3, 12) and an RV capsule (Fig. 8, Paragraph 0089, line 10, 14). Demmer teaches that the RA capsule (12) contains a controller (Fig. 8, Paragraph 0081, line 4, 106), and that the RV capsule (14) contains a controller (Fig. 8, Paragraph 0081, line 4, 206). Demmer teaches that the first controller (206) is operably coupled to (Fig. 8) a ventricular electrode (Fig. 8, Paragraph 0081, line 3, 44/46). Demmer teaches that the second controller (106) is operably coupled to (Fig. 8) a right atrial electrode (Fig. 8, Paragraph 0081, line 3, 40/42).
Demmer teaches that the RA capsule (12) includes a telemetry module (Fig. 8, Paragraph 0089, line 3, 108), and that the RV capsule (14) includes a telemetry module (Fig. 8, Paragraph 0087, line 5, 208). Demmer teaches that the first controller (206) is wirelessly operably coupled, via the two telemetry modules (Paragraph 0039, lines 14-16), to the second controller (106).
Demmer teaches that the first and second controllers (206/106) both comprise processing circuitry (Paragraph 0075, lines 5-14) and are configured to monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode (Paragraph 0081, lines 1-7); and deliver cardiac therapy using one or both of the right atrial electrode and the ventricular electrode based on the monitored electrical activity (Paragraph 0081, lines 1-8).
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 disclosed in Figure 10 of Demmer with the invention disclosed in Figure 8 of Demmer to include: a first controller comprising processing circuitry, wherein the first controller is operably coupled to the ventricular electrode; and a second controller comprising processing circuitry and operably coupled to the right atrial electrode, wherein the first and second controllers are configured to wirelessly communicate with each other to: monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode; and deliver cardiac therapy using one or both of the right atrial electrode and the ventricular electrode based on the monitored electrical activity.
Doing so would ensure that the controllers may receive sensing data and analyze said data to detect cardiac events and control the therapy delivery circuit to deliver appropriate therapy (Paragraph 0081, lines 1-8), as recognized by Demmer. Doing so would also allow wireless communication between the capsules to transmit operating control parameters to coordinate dual chamber or multi-site pacing (Paragraph 0098, lines 1-8), as recognized by Demmer.
Demmer also does not teach that the ventricular electrode is implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart. Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable in the ventricular septal wall of a patient’s heart (Fig. 3, Paragraph 0016, line 4 and Paragraph 0017, lines 10-11, 7/27). Prinzen teaches that the ventricular electrode (140) delivers cardiac therapy or senses electrical activity of the left ventricle of the patient’s heart (Paragraph 0015, lines 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the ventricular electrode is implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 16, Demmer teaches the system (Fig. 10, Paragraph 0100, lines
1-2, 300) according to claim 15 that comprises a ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344) coupled to (Fig. 10) the intracardiac housing (Fig. 10, Paragraph 0102, line 1, 360) and implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart (Fig. 11A, Paragraph 0102, lines 3-4 and Paragraph 0105, lines 7-8). Demmer does not teach that the system further comprises a right ventricular electrode implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient’s heart.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a right ventricular electrode (Fig. 3, Paragraph 0015, line 7, 160) that is implantable in the right ventricle of a patient’s heart (Fig. 3, Paragraph 0016, lines 3-4 and Paragraph 0017, lines 13-14, 7/37). Prinzen teaches that the right ventricular electrode (160) delivers cardiac therapy or senses electrical activity of the right ventricle of the patient’s heart (Paragraph 0015, lines 13-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the system further comprises a right ventricular electrode implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient’s heart. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
Regarding claim 18, Demmer teaches the system (Fig. 10, Paragraph 0100, lines
1-2, 300) according to claim 16 that includes the ventricular electrode (Fig. 10, Paragraph
0102, lines 2-3, 344). Demmer does not teach that the right ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the left bundle branch.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a right ventricular electrode (Fig. 3, Paragraph 0015, line 7, 160) that is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7) proximate to the right bundle branch (Fig. 3, Paragraph 0016, lines 3-4, 37). Prinzen also teaches that the pacing lead (100) includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable through the ventricular septal wall of the patient’s heart (7) proximate to the left bundle branch (Fig. 3, Paragraph 0016, line 4, 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the right ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the mid-septal portion of the patient's heart proximate to the left bundle branch. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
The limitations “the right ventricular electrode is implantable at the mid-septal portion of the patient’s heart” and “the ventricular electrode is implantable at the mid-septal portion of the patient’s heart” is directed towards the intended use of the system and is not given patentable weight. Therefore, the prior art is not required to explicitly disclose the particular functions, but merely have the capability to be implanted at the mid-septal portion of the patient’s heart, thereby providing different anatomical locations of implantation to best suit the needs of each individual patient. Prinzen teaches that the pacing lead (100) is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7). Therefore, it would be well understood by a person of ordinary skill in the art that the pacing lead (100) disclosed in Prinzen would be capable of being implanted at the mid-septal portion of the patient’s heart.
Regarding claim 19, Demmer teaches the system (Fig. 10, Paragraph 0100, lines
1-2, 300) according to claim 16 that includes the ventricular electrode (Fig. 10, Paragraph
0102, lines 2-3, 344). Demmer does not teach that the right ventricular electrode is implantable at the base of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the base of the patient's heart proximate to the left bundle branch.
Prinzen, however, teaches a pacing lead (Fig. 3, Paragraph 0015, line 2, 100) that includes a right ventricular electrode (Fig. 3, Paragraph 0015, line 7, 160) that is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7) proximate to the right bundle branch (Fig. 3, Paragraph 0016, lines 3-4, 37). Prinzen also teaches that the pacing lead (100) includes a ventricular electrode (Fig. 3, Paragraph 0015, line 6, 140) that is implantable through the ventricular septal wall of the patient’s heart (7) proximate to the left bundle branch (Fig. 3, Paragraph 0016, line 4, 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Prinzen to include that the right ventricular electrode is implantable at the base of the patient's heart proximate to the right bundle branch and the ventricular electrode is implantable at the base of the patient's heart proximate to the left bundle branch. Doing so would allow for bi-ventricular pacing (Paragraph 0016, lines 1-20), as recognized by Prinzen.
The limitations “the right ventricular electrode is implantable at the base of the patient’s heart” and “the ventricular electrode is implantable at the base of the patient’s heart” is directed towards the intended use of the system and is not given patentable weight. Therefore, the prior art is not required to explicitly disclose the particular functions, but merely have the capability to be implanted at the base of the patient’s heart, thereby providing different anatomical locations of implantation to best suit the needs of each individual patient. Prinzen teaches that the pacing lead (100) is implantable through the ventricular septal wall of the patient’s heart (Fig. 3, Paragraph 0017, lines 13-14, 7). Therefore, it would be well understood by a person of ordinary skill in the art that the pacing lead (100) disclosed in Prinzen would be capable of being implanted at the base of the patient’s heart.
Claims 4, 7-9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Demmer (previously cited) in view of Prinzen (previously cited) as applied to claims 1, 3, and 16 above, and further in view of Bornzin et al. (U.S. PGPub No. 2013/0123872).
Regarding claim 4, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 3 that comprises the intracardiac housing (Fig. 10, Paragraph
0102, line 1, 360) and the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the system further comprises a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing and comprising the right ventricular electrode and the ventricular electrode distal to the right ventricular electrode.
Bornzin, however, teaches a leadless implantable medical device (Fig. 4A, Paragraph 0067, line 2, 400) that includes an intracardiac housing (Fig. 4A, Paragraph 0067, line 3, 402) that is implantable in a right ventricle of the patient’s heart (Fig. 3C). Bornzin teaches that the system further comprises a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409) that is coupled to and extending from the intracardiac housing (Fig. 4A, Paragraph 0068, lines 1-4). Bornzin teaches that the tissue-penetrating electrode assembly (409) comprises a right ventricular electrode (Fig. 4A, Paragraph 0070, lines 4-5, 416) and a ventricular electrode (Fig. 4A, Paragraph 0070, lines 5-7, 418) distal to the right ventricular electrode (Fig. 4A).
Figure 3C of Bornzin depicts a variety of locations in the heart where the implantable medical device (400) can be implanted. Configuration 356 depicts the IMD (400) being implanted in the right ventricle, and through the ventricular septal wall (Fig. 3C, Paragraph 0066, lines 10-11).
Bornzin teaches that a proximal segment (Fig. 4A, Paragraph 0068, lines 4-5, 426) of the tissue-penetrating electrode assembly (409), which includes the right ventricular electrode (416), can be located in a local sensing site (Fig. 4A, Paragraph 0068, line 6, 436) that includes any and all tissue within the conduction network of the local chamber (Fig. 4A, Paragraph 0068, lines 9-12, 401, e.g. the right ventricle from configuration 356).
Bornzin also teaches that a distal segment (Fig. 4A, Paragraph 0069, lines 1-2, 428) of the tissue-penetrating electrode assembly (409), which includes the ventricular electrode (418), can be located in a distal sensing site (Fig. 4A, Paragraph 0069, line 3, 438) that includes any and all tissue within the conduction network of the adjacent chamber (Fig. 4A, Paragraph 0069, lines 6-8, 407, e.g. the left ventricle from configuration 356).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Bornzin to include that the system further comprises a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing and comprising the right ventricular electrode and the ventricular electrode distal to the right ventricular electrode. Doing so would ensure that the ventricular electrode and right ventricular electrode are able to be properly secured in the desired cardiac tissue (Paragraph 0068, lines 4-12 and Paragraph 0069, lines 1-8), as recognized by Bornzin.
Regarding claim 7, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 1 that comprises the intracardiac housing (Fig. 10, Paragraph
0102, line 1, 360) and the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the system further comprises a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing and comprising the ventricular electrode, wherein the tissue-penetrating electrode assembly does not deliver the ventricular electrode into the blood volume of the left ventricle.
Bornzin, however, teaches a leadless implantable medical device (Fig. 4A, Paragraph 0067, line 2, 400) that includes an intracardiac housing (Fig. 4A, Paragraph 0067, line 3, 402) that is implantable in a right ventricle of the patient’s heart (Fig. 3C). Bornzin teaches that the system further comprises a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409) that is coupled to and extending from the intracardiac housing (Fig. 4A, Paragraph 0068, lines 1-4). Bornzin teaches that the tissue-penetrating electrode assembly (409) comprises a ventricular electrode (Fig. 4A, Paragraph 0070, lines 5-7, 418). Furthermore, Bornzin teaches that the tissue-penetrating electrode assembly (409) does not deliver the ventricular electrode (418) into the blood volume of the left ventricle (Fig. 4A, Paragraph 0069, lines 5-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Bornzin to include that the system further comprises a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing and comprising the ventricular electrode, wherein the tissue-penetrating electrode assembly does not deliver the ventricular electrode into the blood volume of the left ventricle. Doing so would ensure that the ventricular electrode is able to be properly secured in the desired cardiac tissue (Paragraph 0069, lines 1-8), as recognized by Bornzin.
Regarding claim 8, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 1 that includes the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the system further comprises a tissue-penetrating electrode assembly comprising a helix electrode assembly comprising the ventricular electrode.
Bornzin, however, teaches a leadless implantable medical device (Fig. 4A, Paragraph 0067, line 2, 400) that includes a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409). Bornzin teaches that the tissue-penetrating electrode assembly (409) comprises a helix electrode assembly (Fig. 4A) comprising a ventricular electrode (Fig. 4A, Paragraph 0070, lines 5-7, 418).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Bornzin to include that the system further comprises a tissue-penetrating electrode assembly comprising a helix electrode assembly comprising the ventricular electrode. Doing so would ensure that the ventricular electrode is able to be properly secured in the desired cardiac tissue (Paragraph 0069, lines 1-8), as recognized by Bornzin.
Regarding claim 9, Demmer teaches the system (Fig. 10, Paragraph 0100, lines 1-
2, 300) according to claim 1 that includes the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the system further comprises a tissue-penetrating electrode assembly comprising a dart electrode assembly comprising the ventricular electrode.
Bornzin, however, teaches a leadless implantable medical device (Fig. 5, Paragraph 0087, line 2, 500) that includes a tissue-penetrating electrode assembly (Fig. 5, Paragraph 0088, line 5, 511). Bornzin teaches that the tissue-penetrating electrode assembly (511) comprises a dart electrode assembly (Fig. 5) comprising a ventricular electrode (Fig. 5, Paragraph 0090, lines 2-4, 518).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Bornzin to include that the system further comprises a tissue-penetrating electrode assembly comprising a dart electrode assembly comprising the ventricular electrode. Doing so would ensure that the ventricular electrode is able to be properly secured in the desired cardiac tissue (Paragraph 0089, lines 1-11), as recognized by Bornzin.
Regarding claim 17, Demmer teaches the system (Fig. 10, Paragraph 0100, lines
1-2, 300) according to claim 16 that comprises the intracardiac housing (Fig. 10, Paragraph 0102, line 1, 360) and the ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344). Demmer does not teach that the system further comprises a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing and comprising the right ventricular electrode and the ventricular electrode distal to the right ventricular electrode.
Bornzin, however, teaches a leadless implantable medical device (Fig. 4A, Paragraph 0067, line 2, 400) that includes an intracardiac housing (Fig. 4A, Paragraph 0067, line 3, 402) that is implantable in a right ventricle of the patient’s heart (Fig. 3C). Bornzin teaches that the system further comprises a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409) that is coupled to and extending from the intracardiac housing (Fig. 4A, Paragraph 0068, lines 1-4). Bornzin teaches that the tissue-penetrating electrode assembly (409) comprises a right ventricular electrode (Fig. 4A, Paragraph 0070, lines 4-5, 416) and a ventricular electrode (Fig. 4A, Paragraph 0070, lines 5-7, 418) distal to the right ventricular electrode (Fig. 4A).
Figure 3C of Bornzin depicts a variety of locations in the heart where the implantable medical device (400) can be implanted. Configuration 356 depicts the IMD (400) being implanted in the right ventricle, and through the ventricular septal wall (Fig. 3C, Paragraph 0066, lines 10-11).
Bornzin teaches that a proximal segment (Fig. 4A, Paragraph 0068, lines 4-5, 426) of the tissue-penetrating electrode assembly (409), which includes the right ventricular electrode (416), can be located in a local sensing site (Fig. 4A, Paragraph 0068, line 6, 436) that includes any and all tissue within the conduction network of the local chamber (Fig. 4A, Paragraph 0068, lines 9-12, 401, e.g. the right ventricle from configuration 356).
Bornzin also teaches that a distal segment (Fig. 4A, Paragraph 0069, lines 1-2, 428) of the tissue-penetrating electrode assembly (409), which includes the ventricular electrode (418), can be located in a distal sensing site (Fig. 4A, Paragraph 0069, line 3, 438) that includes any and all tissue within the conduction network of the adjacent chamber (Fig. 4A, Paragraph 0069, lines 6-8, 407, e.g. the left ventricle from configuration 356).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Bornzin to include that the system further comprises a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing and comprising the right ventricular electrode and the ventricular electrode distal to the right ventricular electrode. Doing so would ensure that the ventricular electrode and right ventricular electrode are able to be properly secured in the desired cardiac tissue (Paragraph 0068, lines 4-12 and Paragraph 0069, lines 1-8), as recognized by Bornzin.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Demmer et al. (U.S. PGPub No. 2016/0310726) in view of Bornzin et al. (U.S. PGPub No. 2013/0123872).
Regarding claim 20, Demmer teaches a system (Fig. 10, Paragraph 0100, lines 1-
2, 300) comprising: an intracardiac housing (Fig. 10, Paragraph 0102, line 1, 360) implantable in the right ventricle of the patient's heart (Fig. 11A, Paragraph 0105, lines 7-8); a plurality of electrodes (340/342/344) comprising: a ventricular electrode (Fig. 10, Paragraph 0102, lines 2-3, 344) implantable to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart (Fig. 11A, Paragraph 0102, lines 3-4 and Paragraph 0105, lines 7-8); and a right atrial electrode (Fig. 10, Paragraph 0104, lines 2-3, 340/342) implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart (Fig. 11A, Paragraph 0105, lines 3-7); a therapy delivery circuit (Paragraph 0102, lines 5-6, “pulse generator”); a sensing circuit (Paragraph 0102, line 6, “sensing module”) operably coupled to the plurality of electrodes to sense electrical activity of the patient's heart (Paragraph 0104, lines 4-8); and a controller (Fig. 10, Paragraph 0102, lines 6-7, 362).
Demmer does not teach that the system comprises a tissue-penetrating electrode assembly coupled to the intracardiac housing comprising: a left ventricular electrode implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart; and a right ventricular electrode implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart.
Bornzin, however, teaches a leadless implantable medical device (Fig. 4A, Paragraph 0067, line 2, 400) that includes an intracardiac housing (Fig. 4A, Paragraph 0067, line 3, 402) that is implantable in a right ventricle of the patient’s heart (Fig. 3C). Bornzin teaches that the system further comprises a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409) that is coupled to the intracardiac housing (Fig. 4A, Paragraph 0068, lines 1-4). Bornzin teaches that the tissue-penetrating electrode assembly (409) comprises a left ventricular electrode (Fig. 4A, Paragraph 0070, lines 5-7, 418) and a right ventricular electrode (Fig. 4A, Paragraph 0070, lines 4-5, 416).
Figure 3C of Bornzin depicts a variety of locations in the heart where the implantable medical device (400) can be implanted. Configuration 356 depicts the IMD (400) being implanted in the right ventricle, and through the ventricular septal wall (Fig. 3C, Paragraph 0066, lines 10-11).
Bornzin teaches that a proximal segment (Fig. 4A, Paragraph 0068, lines 4-5, 426) of the tissue-penetrating electrode assembly (409), which includes the right ventricular electrode (416), can be located in a local sensing site (Fig. 4A, Paragraph 0068, line 6, 436) that includes any and all tissue within the conduction network of the local chamber (Fig. 4A, Paragraph 0068, lines 9-12, 401, e.g. the right ventricle from configuration 356).
Bornzin also teaches that a distal segment (Fig. 4A, Paragraph 0069, lines 1-2, 428) of the tissue-penetrating electrode assembly (409), which includes the ventricular electrode (418), can be located in a distal sensing site (Fig. 4A, Paragraph 0069, line 3, 438) that includes any and all tissue within the conduction network of the adjacent chamber (Fig. 4A, Paragraph 0069, lines 6-8, 407, e.g. the left ventricle from configuration 356).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer to incorporate the teachings of Bornzin to include that the system further comprises a tissue-penetrating electrode assembly coupled to the intracardiac housing comprising: a left ventricular electrode implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart; and a right ventricular electrode implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart. Doing so would ensure that the ventricular electrode and right ventricular electrode are able to be properly secured in the desired cardiac tissue (Paragraph 0068, lines 4-12 and Paragraph 0069, lines 1-8), as recognized by Bornzin.
The present embodiment disclosed in Figure 10 of Demmer does not explicitly teach: a therapy delivery circuit is operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient’s heart; a controller comprising processing circuitry operably coupled to the therapy delivery circuit and the sensing circuit; and that the controller is configured to monitor electrical activity using one or more of the right atrial electrode, the right ventricular electrode, and the ventricular electrode; and deliver cardiac therapy using one or more of the right atrial electrode, the right ventricular electrode, and the ventricular electrode based on the monitored electrical activity.
In an alternative embodiment, however, Demmer teaches a system (Fig. 6, Paragraph 0075, lines 1-2, 10) that comprises an RV capsule (Fig. 6, Paragraph 0079, line 1, 14) with an intracardiac housing (Fig. 2, Paragraph 0040, lines 2-3, 60) implanted in the right ventricle of a patient’s heart (Fig. 1, Paragraph 0029, lines 3-5). Demmer teaches that the RV capsule (14) includes a therapy delivery circuit (Fig. 6, Paragraph 0079, line 1, 202), a sensing circuit (Fig. 6, Paragraph 0079, lines 1-2, 204), and a controller (Fig. 6, Paragraph 0079, line 2, 206). Demmer teaches that the system (10) includes a ventricular electrode (Fig. 6, Paragraph 0079, line 5, 44/46) and an atrial electrode (Fig. 6, Paragraph 0076, lines 2-3, 40/42).
Demmer teaches that the therapy delivery circuit (202) is operably coupled to the plurality of electrodes (Fig. 6) to deliver cardiac therapy to the patient’s heart (Paragraph 0079, lines 3-5). Demmer teaches that the sensing circuit (204) is operably coupled to the plurality of electrodes (Fig. 6) to sense electrical activity of the patient’s heart (Paragraph 0080, lines 1-3). Demmer teaches that the controller (206) comprises processing circuitry (Paragraph 0075, lines 5-14) and is operably coupled to the therapy delivery circuit and the sensing circuit (Fig. 6, Paragraph 0081, lines 4-8 and Paragraph 0080, lines 3-4). Furthermore, Demmer teaches that the controller (206) is configured to monitor electrical activity using one or more of the right atrial electrodes and the ventricular electrodes (Paragraph 0081, lines 1-7); and deliver cardiac therapy using one or more of the right atrial electrodes and the ventricular electrodes based on the monitored electrical activity (Paragraph 0081, lines 1-8).
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 disclosed in Figure 10 of Demmer with the invention disclosed in Figure 6 of Demmer to include that a therapy delivery circuit is operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient’s heart, a controller comprising processing circuitry is operably coupled to the therapy delivery circuit and the sensing circuit, and that the controller is configured to: monitor electrical activity using one or more of the right atrial electrode, the right ventricular electrode, and the ventricular electrode; and deliver cardiac therapy using one or more of the right atrial electrode, the right ventricular electrode, and the ventricular electrode based on the monitored electrical activity. Doing so would ensure that the control module may receive sensing data and analyze said data to detect cardiac events and control the therapy delivery circuit to deliver appropriate therapy (Paragraph 0081, lines 1-8), as recognized by Demmer.
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 1-3 and 6-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-11, and 13 of U.S. Patent No. 12,350,500. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of Patent ’500 anticipates the majority of the limitations of claim 1 in the Instant Application. See the table below:
Instant Application ’774 Claim 1:
Reference Patent ’500 Claim 1:
A system comprising:
A leadless implantable medical device for a patient’s heart comprising:
an intracardiac housing implantable in the right ventricle of the patient’s heart;
an intracardiac housing implantable in the right ventricle of the patient’s heart;
a leadlet coupled to the intracardiac housing extendable through the tricuspid valve of the patient’s heart into the right atrium of the patient’s heart;
a plurality of electrodes comprising:
a plurality of electrodes coupled to one or both of the intracardiac housing and the leadlet, the plurality of electrodes comprising:
a ventricular electrode implantable in the ventricular septal wall of the patient’s heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient’s heart; and
a ventricular electrode implantable in the ventricular septal wall of the patient’s heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient’s heart; and
a right atrial electrode implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient’s heart;
a right atrial electrode coupled to the leadlet and implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient’s heart;
a therapy delivery circuit operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient’s heart; and
a therapy delivery circuit operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient’s heart;
a sensing circuit operably coupled to the plurality of electrodes to sense electrical activity of the patient’s heart; and
a sensing circuit operably coupled to the plurality of electrodes to sense electrical activity of the patient’s heart; and
a controller contained in the intracardiac housing and comprising processing circuitry operably coupled to the therapy delivery circuit and the sensing circuit, the controller configured to:
a controller comprising processing circuitry operably coupled to the therapy delivery circuit and the sensing circuit, the controller configured to:
monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode; and
monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode; and
deliver cardiac therapy based on the monitored electrical activity.
deliver cardiac therapy based on the monitored electrical activity.
Claim 2 of the present application is anticipated by claim 2 of U.S. Patent No. 12,350,500 (reference patent).
Claim 3 of the present application is anticipated by claim 3 of U.S. Patent No. 12,350,500 (reference patent).
Claim 6 of the present application is anticipated by claim 5 of U.S. Patent No. 12,350,500 (reference patent).
Claim 7 of the present application is anticipated by claim 6 of U.S. Patent No. 12,350,500 (reference patent).
Claim 8 of the present application is anticipated by claim 7 of U.S. Patent No. 12,350,500 (reference patent).
Claim 9 of the present application is anticipated by claim 8 of U.S. Patent No. 12,350,500 (reference patent).
Claim 10 of the present application is anticipated by claim 9 of U.S. Patent No. 12,350,500 (reference patent).
Claim 11 of the present application is anticipated by claim 10 of U.S. Patent No. 12,350,500 (reference patent).
Claim 12 of the present application is anticipated by claim 11 of U.S. Patent No. 12,350,500 (reference patent).
Claim 13 of the present application is anticipated by claim 13 of U.S. Patent No. 12,350,500 (reference patent).
Claims 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12,350,500 in view of Bornzin et al. (U.S. PGPub No. 2013/0123872).
Regarding claim 4 of the present case, Patent ’500 recites the system (Claim 4, line 1) according to claim 3, further comprising a tissue-penetrating electrode assembly (Claim 4, line 2) comprising the right ventricular electrode (Claim 4, lines 2-3) and the ventricular electrode distal to the right ventricular electrode (Claim 4, lines 3-4).
The limitation “a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing” does not map to claim 4 of Patent ’500. Bornzin, however, teaches a leadless implantable medical device that includes a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409) coupled to and extending from an intracardiac housing (Fig. 4A, Paragraph 0068, lines 1-4).
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 device recited in Patent ’500 to include a tissue-penetrating assembly coupled to and extending from an intracardiac housing, as taught by Bornzin, to ensure that the ventricular electrode and right ventricular electrode are able to be properly secured in the desired cardiac tissue (Paragraph 0068, lines 4-12 and Paragraph 0069, lines 1-8), as recognized by Bornzin.
Regarding claim 5 of the present case, Patent ’500 recites the system (Claim 5, line 1) according to claim 3, wherein the right ventricular electrode (Claim 5, lines 1-2) is implantable at the patient’s heart proximate to the right bundle branch (Claim 5, lines 2-3) and the ventricular electrode (Claim 5, line 4) is implantable at the patient’s heart proximate to the left bundle branch (Claim 5, lines 4-5).
The limitations “the right ventricular electrode is implantable at the mid-septal portion of the patient’s heart” and “the ventricular electrode is implantable at the mid-septal portion of the patient’s heart” do not map to claim 5 of Patent ’500. Rather, claim 5 of Patent ’500 recites that the right ventricular electrode and ventricular electrode are implantable at the base of the patient’s heart. Bornzin, however, teaches a leadless implantable medical device that can be implanted near the middle of the septal wall of a patient’s heart (Fig. 3C, Paragraph 0066, lines 10-11, 356).
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 device recited in Patent ’500 to include that the right ventricular electrode and ventricular electrode are implantable at the base of the patient’s heart. Doing so would ensure that the IMD can provide right ventricle and left ventricle sensing and pacing from the right ventricle (Paragraph 0066, lines 10-11), as recognized by Bornzin.
Claims 15-16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of U.S. Patent No. 12,350,500 in view of Demmer et al. (U.S. PGPub No. 2016/0310726). Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of Patent ’500 anticipates the majority of the limitations of claim 1 in the Instant Application. See below:
Regarding claim 15 of the present case, Patent ’500 recites a system (Claim 1,
line 1) comprising: an intracardiac housing implantable in a right ventricle of a patient's heart (Claim 1, lines 3-4); a plurality of electrodes (Claim 1, line 8) comprising: a ventricular electrode coupled to the intracardiac housing and implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart (Claim 1, lines 11-14); and a right atrial electrode coupled to the lead and implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart (Claim 1, lines 15-18); a controller comprising processing circuitry (Claim 1, line 25), the controller configured to: monitor electrical activity using one or both of the right atrial electrode and the ventricular electrode (Claim 1, lines 28-29); and deliver cardiac therapy using one or both of the right atrial electrode and the ventricular electrode based on the monitored electrical activity (Claim 1, lines 30-31).
The limitations “a first controller comprising processing circuitry and contained in the intracardiac housing, wherein the first controller is operably coupled to the ventricular electrode” and “a second controller comprising processing circuitry and operably coupled to the right atrial electrode, wherein the first and second controller are configured to wirelessly communicate with each other” do not map to claim 1 of Patent ’500. Demmer teaches a system (Fig. 8, Paragraph 0089, line 2, 10) that comprises an RA capsule (12) and an RV capsule (14). Demmer teaches that the RA capsule contains a controller (Fig. 8, Paragraph 0081, line 4, 106), and that the RV capsule contains a controller (Fig. 8, Paragraph 0081, line 4, 206). Demmer teaches that the first controller (206) is operably coupled to (Fig. 8) a ventricular electrode (Fig. 8, Paragraph 0081, line 3, 44/46). Demmer teaches that the second controller (106) is operably coupled to (Fig. 8) a right atrial electrode (Fig. 8, Paragraph 0081, line 3, 40/42).
Demmer teaches that the RA capsule includes a telemetry module (Fig. 8, Paragraph 0089, line 3, 108), and that the RV capsule includes a telemetry module (Fig. 8, Paragraph 0087, line 5, 208). Demmer teaches that the first controller (206) is wirelessly operably coupled, via the two telemetry modules (Paragraph 0039, lines 14-16), to the second controller (106). Demmer teaches that the first and second controllers (206/106) both comprise processing circuitry (Paragraph 0075, lines 5-14).
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 device recited in Patent ’500 to include a first controller comprising processing circuitry and contained in the intracardiac housing, wherein the first controller is operably coupled to the ventricular electrode, and a second controller comprising processing circuitry and operably coupled to the right atrial electrode, wherein the first and second controller are configured to wirelessly communicate with each other. Doing so would also allow wireless communication between the capsules to transmit operating control parameters to coordinate dual chamber or multi-site pacing (Paragraph 0098, lines 1-8), as recognized by Demmer.
Claim 16 of the present application is anticipated by claim 3 of U.S. Patent No. 12,350,500 (reference patent).
Claim 19 of the present application is anticipated by claim 5 of U.S. Patent No. 12,350,500 (reference patent).
Claims 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-5 of U.S. Patent No. 12,350,500 in view of Bornzin et al. (U.S. PGPub No. 2013/0123872).
Regarding claim 17 of the present case, Patent ’500 recites the system (Claim 4, line 1) according to claim 16, further comprising a tissue-penetrating electrode assembly (Claim 4, line 2) comprising the right ventricular electrode (Claim 4, lines 2-3) and the ventricular electrode distal to the right ventricular electrode (Claim 4, lines 3-4).
The limitation “a tissue-penetrating electrode assembly coupled to and extending from the intracardiac housing” does not map to claim 4 of Patent ’500. Bornzin, however, teaches a leadless implantable medical device that includes a tissue-penetrating electrode assembly (Fig. 4A, Paragraph 0068, line 1, 409) coupled to and extending from an intracardiac housing (Fig. 4A, Paragraph 0068, lines 1-4).
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 device recited in Patent ’500 to include a tissue-penetrating assembly coupled to and extending from an intracardiac housing, as taught by Bornzin, to ensure that the ventricular electrode and right ventricular electrode are able to be properly secured in the desired cardiac tissue (Paragraph 0068, lines 4-12 and Paragraph 0069, lines 1-8), as recognized by Bornzin.
Regarding claim 18 of the present case, Patent ’500 recites the system (Claim 5, line 1) according to claim 16, wherein the right ventricular electrode (Claim 5, lines 1-2) is implantable at the patient’s heart proximate to the right bundle branch (Claim 5, lines 2-3) and the ventricular electrode (Claim 5, line 4) is implantable at the patient’s heart proximate to the left bundle branch (Claim 5, lines 4-5).
The limitations “the right ventricular electrode is implantable at the mid-septal portion of the patient’s heart” and “the ventricular electrode is implantable at the mid-septal portion of the patient’s heart” do not map to claim 5 of Patent ’500. Rather, claim 5 of Patent ’500 recites that the right ventricular electrode and ventricular electrode are implantable at the base of the patient’s heart. Bornzin, however, teaches a leadless implantable medical device that can be implanted near the middle of the septal wall of a patient’s heart (Fig. 3C, Paragraph 0066, lines 10-11, 356).
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 device recited in Patent ’500 to include that the right ventricular electrode and ventricular electrode are implantable at the base of the patient’s heart. Doing so would ensure that the IMD can provide right ventricle and left ventricle sensing and pacing from the right ventricle (Paragraph 0066, lines 10-11), as recognized by Bornzin.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, and 6 of U.S. Patent No. 12,350,500. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of Patent ’500 anticipates the majority of the limitations of claim 1 in the Instant Application. See below:
Regarding claim 20 of the present case, Patent ’500 recites a system (Claim 1,
line 1) comprising: an intracardiac housing implantable in the right ventricle of a patient's heart (Claim 1, lines 3-4); a tissue-penetrating electrode assembly coupled to the intracardiac housing comprising (Claim 4, lines 1-4 and Claim 6, lines 1-3): a left ventricular electrode implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart (Claim 1, lines 11-14); and a right ventricular electrode implantable in the ventricular septal wall of the patient's heart to deliver cardiac therapy to or sense electrical activity of the right ventricle of the patient's heart (Claim 3, lines 2-5); a right atrial electrode implantable to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart (Claim 1, lines 15-18); a therapy delivery circuit operably coupled to the ventricular, the right ventricular, and the right atrial electrodes to deliver cardiac therapy to the patient's heart (Claim 1, lines 19-21); a sensing circuit operably coupled to the ventricular, the right ventricular, and the right atrial electrodes to sense electrical activity of the patient's heart (Claim 1, lines 22-24); and a controller comprising processing circuitry operably coupled to the therapy delivery circuit and the sensing circuit (Claim 1, lines 25-27), the controller configured to: monitor electrical activity using one or more of the right atrial electrode, the right ventricular electrode, and the ventricular electrode (Claim 1, lines 28-29); and deliver cardiac therapy using one or more of the right atrial electrode, the right ventricular electrode and the ventricular electrode based on the monitored electrical activity (Claim 1, lines 30-31).
Conclusion
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/H.A.H./Patent Examiner, Art Unit 3796
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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