3DETAILED 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 .
Election/Restrictions
Applicant’s election of Group II in the reply filed on June 15, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 304, 306.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “500” has been used to designate both a schematic graph (Fig. 9A) and a schematic view (Fig. 10B).
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.
Specification
The disclosure is objected to because of the following informalities:
Page 11, line 24 of the originally-filed specification recites “electrodes on one or more leads 214”, but the remainder of the specification refers to “leads 212” and “electrodes 214”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-12 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2015/0257670 to Ortega et al. (hereinafter referred to as “Ortega”) in view of US Patent Nos. 11,471,687 to Duray et al. (hereinafter referred to as “Duray”), 7,963,925 to Schecter and 6,754,532 to Ferek-Petric .
Regarding claim 10, Ortega discloses a method of implanting a pacing system (e.g., paragraph [0007]: inventive method optimizes the lead position and initial atrioventricular delay in patients undergoing an implantation of a pacemaker), the method comprising: delivering a first electrode to a first chamber of a heart (e.g., paragraphs [0009]: Dual chamber AV sequential pacing pacemakers usually use two electrodes: one in the right ventricular apex and [0095]: implantation of a left ventricular lead); delivering a second electrode to an atrial appendage of the heart (e.g., paragraph [0009]: Dual chamber AV sequential pacing pacemakers usually use two electrodes: and one in the atrial appendage); positioning an echocardiography system in the heart (e.g., paragraphs [0101]-[0102]: evaluation of electrical asynchrony showing an excellent correlation with Doppler echocardiography and Tissue Doppler Imaging optimizes the site of implantation of these devices and adjusts the AV and VV delay settings after implantation); delivering a first pacing therapy to the first chamber of the heart (e.g., paragraph [0009]: after an adjustable AV atrio-ventricular interval, the ventricle is stimulated); delivering a second pacing therapy to the left atrial appendage of the heart (e.g., paragraph [0009]: the atrial appendage is stimulated), the second pacing therapy delivered a period of time after the first pacing therapy (since the stimulation of the atrial appendage and the ventricle are continuous, second pacing therapy would necessarily be delivered a period of time after a first pacing therapy of the appendage); while delivering the first pacing therapy and the second pacing therapy measuring a flow of blood into and/or out of the atrial appendage; and repeatedly delivering the first pacing therapy to the first chamber of the heart, the second pacing therapy to the left atrial appendage of the heart and measuring the flow of blood into and/or out of the left atrial appendage while varying the period of time between the first pacing therapy and the second pacing therapy with each iteration of pacing therapy (e.g., paragraphs [0076]: information from the arterial pulse wave can be used to determine the optimum AV interval in order to accomplish varying the AV interval in standard cardiac pacing and in cardiac resynchronization therapy where the blood flow/arterial pulse pressure is measured for a number of beats; and [0102]: Doppler echocardiography is used to adjust the AV and VV interval settings). Ortega differs from the claimed invention in that it does not expressly disclose 1) delivering an electrode to the left atrial appendage of the heart; 2) positioning an echocardiography system to measure blood flow into and/or out of the left atrial appendage of the heart; and 3) selecting an operational period of time between the first pacing therapy and the second pacing therapy which maximizes a flow of blood into and/or out of the left atrial appendage; and providing pacing therapy to the heart using the operational period of time between the first pacing therapy and the second pacing therapy.
However, with respect to 1), Duray teaches in the cardiac therapy art that it was known to those skilled in the art to deliver an electrode to a left atrial appendage of the heart (e.g., column 5, lines 16-17: leadless stimulating device/electrode is delivered/positioned into the left atrial appendage; and column 10, line 26 – column 11, line 55). Consequently, one of ordinary skill in the art would have modified the method of Ortega to deliver an electrode to a left atrial appendage of the heart in view of the teachings of Duray that such was a well-known protocol in the cardiac therapy art in order to provide stimulation therapy to that area, and because the combination would have yielded a predictable result.
With respect to 2), Schecter teaches in the cardiac therapy art that it was known to those skilled in the art to position an echocardiography system to measure blood flow into and/or out of the left atrial appendage of the heart (e.g., column 8, lines 23-27: cardiac performance is optimized in patients with atrial arrhythmias by combining intrinsic properties with extrinsic properties; column 9, lines 44-47: velocity of blood flow within left atrial appendage is measured as an extrinsic property; and column 10, lines 9-36: measuring the actual blood flow (velocity) within the left atrial appendage (LAA) via echocardiography systems can assist in determining the risk of thromboembolism in atrial fibrillation). Consequently, one of ordinary skill in the art would have modified the method of Ortega in view of Duray to position an echocardiography system to measure blood flow of the left atrial appendage of the heart in view of the teachings of Schecter that such was a well-known protocol in the cardiac therapy art, and because the combination would have yielded a predictable result.
With respect to 3), Ferek-Petric teaches in the cardiac therapy art that the atrial and ventricular (AV) delay is continuously adjusted/selected to maximize the integral of the velocity signal from a sensor (e.g., abstract; column 1, line 43 – column 2, line 2: IMD maximizes the integral of the velocity signal received from a pacing lead or maximizes the blood flow sensed by adjusting the AV delay where pacing therapy uses the adjusted/selected AV delay to deliver the pacing therapy). Accordingly, one of ordinary skill in the art would have recognized the benefits of adjusting/selecting an AV delay or operational period of time between the first pacing therapy and the second pacing therapy to maximize a flow of blood into and/or out of a heart chamber in view of the teachings of Ferek-Petric. Consequently, at the very least one of ordinary skill in the art, upon reading Ferek-Petric, would have also recognized the benefits of adjusting/selecting the AV delay to maximize a flow of blood into and/or out of the left atrial appendage. Since Ferek-Petric generally teaches the use of a sensed blood flow signal, it would have been reasonably expected to be applicable to blood flow maximized in the left atrial appendage (LAA). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try maximizing the blood flow into and/or out of the LAA by adjusting/selecting an AV delay of Ortega in view of Duray and Schecter to maximize blood flow as taught by Ferek-Petric since a person with ordinary skill has good reason to pursue the known options within his or her grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (See KSR International Co. v. Teleflex Inc.).
With respect to claim 11, Ortega in view of Duray, Schecter, and Ferek-Petric teaches the method of claim 10, wherein repeatedly delivering the first pacing therapy to the first chamber of the heart, the second pacing therapy to the left atrial appendage of the heart and measuring the flow of blood into and/or out of the left atrial appendage while varying the period of time between the first pacing therapy and the second pacing therapy with each iteration of pacing therapy is performed at implantation of the first and second electrodes (e.g., Ortega paragraphs [0006]: the present disclosure is directed toward evaluation, during the implant procedure; and [0102]: disclosure allows for evaluation with Doppler echocardiograph that is useful to optimize the site of implantation of the devices).
As to claim 12, Ortega in view of Duray, Schecter, and Ferek-Petric teaches the method of claim 10, wherein the operational period of time between the first pacing therapy and the second pacing therapy is stored in a processing module in communication with the first electrode and the second electrode (e.g., paragraph [0086] of Ortega: smart device can also store asynchrony index information that includes AV delay of CRT device).
With respect to claim 14, Ortega in view of Duray, Schecter, and Ferek-Petric teaches the method of claim 10, wherein a timing of the first pacing therapy is based, at least in part, off a first timing fiducial (e.g., paragraph [0009] of Ortega: after an adjustable AV atrio-ventricular interval, the ventricle is stimulated).
As to claim 15, Ortega in view of Duray, Schecter, and Ferek-Petric teaches the method of claim 10, wherein the operational period of time between the first pacing therapy and the second pacing therapy is based, at least in part, off a first timing fiducial (e.g., paragraph [0009] of Ortega: the operational time period would be AV delay, first pacing, second pacing; AV delay first pacing, second pacing … which is based at least in part off a first timing fiducial or AV delay).
With respect to claim 16, Ortega in view of Duray, Schecter, and Ferek-Petric teaches the method of claim 10, wherein repeatedly delivering the first pacing therapy to the first chamber of the heart, the second pacing therapy to the left atrial appendage of the heart and measuring the flow of blood into and/or out of the left atrial appendage while varying the period of time between the first pacing therapy and the second pacing therapy with each iteration of pacing therapy is performed during a configuration mode (e.g., paragraph [0083] of Ortega: device is configured to calculate an index to help find the optimal pacing site for any pacing device, with any lead configuration).
As to claims 17-18, Ortega in view of Duray, Schecter, and Ferek-Petric teaches the method of claim 10 wherein providing pacing therapy to the heart using the operational period of time between the first pacing therapy and the second pacing therapy occurs in response to a predetermined detected condition (e.g., column 8, line 23 – column 10, line 36: therapy is provided in response to the patient having a detected condition such as atrial fibrillation).
Allowable Subject Matter
Claims 19-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Independent claim 19 recites that ablating a region of heart tissue between the first electrode in a first chamber of the heart and the second electrode delivered to a left atrial appendage. While ablating heart tissue is known to those skilled in the art (see Schecter column 3, line 41 – column 4, line 19: ablation of atrial arrhythmias), as of the date of this Office Action, the Examiner has not identified any reference that can be used singularly or in combination with another reference including the applied prior art above to render claim 19 anticipated or obvious to one of ordinary skill in the art. While it is known to place an electrode in a left atrial appendage and another electrode in another chamber of the heart (e.g., left or right ventricle, left or right atrium), a reference that teaches ablation between the electrode in the left atrial appendage and another chamber of the art has not been identified. Claim 20 is indicated as allowable as it depends from claim 19.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2025/0099161 to Liu et al. (EFD: 12/16/2022) is directed to an ablation device using electrophysiological mapping to ablate identified/mapped lesions (e.g., paragraph [0035]). The ablation device is a balloon type and is not delivered into an atrial appendage and a chamber of the heart.
US Patent Application Publication No. 2021/0369283 to O’Halloran discloses an ablation device with an element deployed and anchored in the LAA, with a RF coil 32 deployed with cage 12 but the ablating coil/electrode is within the LAA and not between two positioned electrodes in different chambers of the heart.
US Patent Application Publication No. 2019/0201696 to Koop et al. is directed to a dual chamber pacing medical device where one electrode is implanted in one chamber (right ventricle), and the other is implanted in another chamber of the heart (right ventricle) but does not disclose ablating heart tissue.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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