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 .
Priority
This application is a national stage entry under 35 USC 371 of PCT/IL2023/051150 filed 8 November 2023, which claims the benefit of foreign priority from Israel Application no. IL28036 filed 8 November 2022.
Response to Amendment
The preliminary amendment filed 24 April 2025 has been acknowledged. Claims 1-5, 8, 12, 13, 15, 16, 19-23, and 25-28 are pending.
Claim Objections
Claim 19 is objected to because of the following informalities: line 2 recites “…angular positon…” wherein it is considered to be position. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 2, 12, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haasl et al. (US Publication no. 2018/0264272) in view of Yankelson (US Publication no. 2018/0272121).
In regard to claim 1, Hassl et al. disclose an apparatus for artificial stimulation of the heart of a subject (see figures 1 and 2), comprising:
an elongated body 22 having a cylindrical structure (para 51), describes as a capsule which is considered to have cylindrical shape) with flow-therein (para 91, lumen 76 shown in figure 4) configured to be located in the coronary sinus of the subject (para 55 and 58, housing 22 may be fully or partially disposed within coronary sinus);
a first electrode 28 assembly mechanically coupled to the body and oriented for electrifying the left atrium of the subject when the body is located in the coronary sinus (para 59, 60, and 73);
a second electrode 30-36 assembly mechanically coupled to the body 22 (via extension 24 electrically and mechanically coupled to housing 22) sufficiently distant from the first electrode 28 assembly and oriented for electrifying the left ventricle of the subject when the body is located in the coronary sinus and the first electrode assembly is oriented for electrifying the left atrium (para 73, the second electrode 28 may sense near-field signals of atrial activation events in and provide pacing pulses to cardiac tissue of the left atrium 12, and the electrodes 30-36 supported by the distal extension 24 may sense near-field signals of ventricular activation events (R-waves) originating from atria and conducted through the atrioventricular node and His-Purkinje path in and provide pacing pulses to cardiac tissue of the left ventricle 14); and
a controller assembly 58 electrically coupled to the first electrode assembly and to the second electrode assembly, the controller assembly is configured to drive a pacing electrical signal to the first electrode assembly and/or to the second electrode assembly (para 91 and 99, processing module 58 read as a controller is coupled to a pulse generator and sensing module);
wherein the first electrode assembly 28 and/or the second electrode assembly 30-36 penetrate the left atrium and/or the left ventricle respectively (para 73 and 77).
Hassl et al. is considered to substantially describe the invention as claimed, including a lumen 76 for allowing insertion of the guidewire. Hassl et al. also teach about the potential obstruction the housing may create with respect to blood flow in the coronary sinus, wherein it is suggested that a flow path be created when implanting (para 115). However, Hassl et al. does not address a flow through lumen as recited. Yankelson describes a device for implantation in the coronary sinus (para 427-436). Figure 4A depicts the exemplary embodiment of the device comprising a body constructed from a stent with attached tube 404 for encapsulating the processor, batteries, and pulse generator (para 443). The stents 402 and 418 form a flow lumen of the device to enable blood to flow through the coronary sinus once implanted (para 442).
Hassl et al. is directed to a leadless cardiac device implanted within the coronary sinus, and expressly recognizes the desirability of maintaining sufficient blood flow around the implanted housing. Yankelson provides a known structural solution for implanting an electrode bearing device in the coronary sinus with a tubular anchor, such as a stent. This solution also preserves coronary sinus blood flow and permits electrodes to be firmly affixed within the coronary sinus.
Yankelson supplies an alternative known coronary sinus implant structure that advances the features of Hassl et al. in maintaining coronary sinus blood flow while securely anchoring the device. Therefore, it is considered to have been obvious to modify the body structure of the device of Hassl et al. in the manner described by Yankelson to incorporate the open, stent body configuration because Yankelson teaches that such a configuration is suitable structure for securely supporting and anchoring electrodes within the coronary sinus, wherein the modification would include the application known alternative design of a coronary sinus implant to a known coronary sinus implant yielding the predictable result of permitting blood flow therethrough.
In regard to claim 2, Hassl et al. teach that the controller assembly 58 is further configured to: receive cardiac pacing signal sensed via the first electrode assembly and/or the second electrode assembly, and drive the pacing electrical signal to the first electrode assembly and/or to the second electrode assembly according to the sensed cardiac pacing data (para 93, 99-104).
In regard to claim 12, Hassl et al. include at least one anchor element 52 for anchoring the body 22 in place when located in the coronary sinus (para 82-86).
In regard to claim 13, Hassl et al. in view of Yankelson describe the body of the pacing device having a stent-like design (see Yankelson figure 4A, para 33).
In regard to claim 15, Hassl et al. teach that the controller assembly 58 is encapsulated in a capsule (para 51, describes capsule shape) mechanically coupled to the body, the capsule comprises at least one battery 56 electrically connected to the controller assembly for powering the controller assembly 58 (para 108).
Claim(s) 19, 20, 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haasl et al. (US Publication no. 2018/0264272) in view of Yankelson (US Publication no. 2018/0272121), further in view of Liu et al. (WO 2020/205397).
In regard to claim 19, Hassl et al. in view of Yankelson teach the device of claim 1 (see above), and includes an intravenous delivery system (para 125-127, guide catheter 80 with guide wire 96 and positioning device 98 ) comprising a guiding element 96 shaped to mechanically interlock with the body and operable to rotate the body for placing the body in a determined angular position around a longitudinal axis of the body (para 125-127, guide catheter 80 with guide wire 96 and positioning device 98 that serves to maneuver device 20 into the desired implant location, the maneuvering considered to comprise the act of determining angular positions etc).
While Hassl et al. discuss maneuvering the device using the positioning device, there is no express teaching for rotating the body for placing in the determined angular position. Liu et al. describes structures and technique for implanting a capsule pacemaker within the coronary sinus (page 7 lines 30-33 and page 8 lines 23-25). A leadless pacing device 20, similar to Hassle et al. with housing 22, is delivered from a positioning device, and in some cases a delivery catheter, wherein the positioning device coupled to housing 22, movement of the positioning device may translate to the housing 22, thereby allowing a user, such as a physician, to maneuver the housing 22 into a proper position within the heart, for example into or proximate the coronary sinus. The positioning device may be capable of longitudinally and/or rotationally manipulating the housing 22 (page 11 lines 2-15). The step of maneuvering and positioning of the device in this manner is considered to imply that the device is placed at a proper angular position.
Modification of Hassl et al. to permit rotation of the device using the positioning device is considered to have been obvious to one of ordinary skill in the art as Liu et al. expressly demonstrates this maneuver as a common manipulation for implanting a leadless pacing device in the coronary sinus. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 20, Hassl et al. teach that the guiding element comprises mechanical provisions shaped to receive and accommodate mating mechanical provisions disposed on the body and interlock with the body in a rotational axis around the longitudinal axis of the body to induce rotation of the body when rotating the guiding element (para 81, 125, 127-131), thereby allowing the user to position the device during implantation. Liu et al. incorporates a similar interlocking mechanism, wherein the guiding element of Liu et al. (e.g., the positioning device and delivery catheter) permit rotational forces to be imparted on the device. Modification of Hassl et al. to permit rotation of the device using the positioning device is considered to have been obvious to one of ordinary skill in the art as Liu et al. expressly demonstrates this maneuver as a common manipulation for implanting a leadless pacing device in the coronary sinus. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
In regard to claim 23, Hassle et al. in view of Yankelson and Liu et al. are considered to substantially describe the invention as claimed, however neither teach the intravenous delivery system further comprises at least one mapping element comprising a plurality of mapping electrodes configured to drive stimulating electrical signals to the left atrium and/or to the left ventricle, a muscular activity of the left atrium and/or to the left ventricle in response to the stimulating electrical signals is analyzed to map stimulation effect of the stimulating electrical signals. Yankelson incorporates mapping electrodes to drive stimulating current into tissue to map whether the stimulating current induces a desired effect (para 283). The mapping technique is used to determine optimal stimulation electrode configurations by determining when electrodes are properly aimed at target tissue (para 292). The techqniue relies on heart activity signals obtained from heart activity sensors, wherein the heart activity pertains to sensing the contractions of either the atria or ventricles (para 367). Atrial and ventricular contractions sensed in this manner are considered to comprise muscular activity because they result from the contraction of cardiac muscle tissue (myocardium).
It would have been obvious to one of ordinary skill in the art to incorporate the mapping electrodes and mapping functionality of Yankelson into the delivery device of Hassl et al. because doing so would predictably permit evaluation of the physiological effect of stimulation at different locations and facilitate determination of an appropriate location for implantation of the stimulation device.
In regard to claim 25, Hassl et al. describe a method of positioning a heart stimulation apparatus in a coronary sinus of a subject, comprising:
operating an intravenous delivery system 22 to deliver a heart stimulation apparatus to the coronary sinus of the subject (para 55 and 58, housing 22 may be fully or partially disposed within coronary sinus),
selecting an angular position of a guiding element of the intravenous delivery system interlocked with the heart stimulation (para 125-127, guide catheter 80 with guide wire 96 and positioning device 98 that serves to maneuver device 20 into the desired implant location, the maneuvering considered to comprise the act of determining angular positions etc), and
operating the intravenous delivery system to place the heart stimulation apparatus in the coronary sinus in the determined angular position such that a first electrode and/or a second electrode of the heart stimulation apparatus penetrate the left atrium and/or the left ventricle respectively (para 73, the second electrode 28 may sense near-field signals of atrial activation events in and provide pacing pulses to cardiac tissue of the left atrium 12, and the electrodes 30-36 supported by the distal extension 24 may sense near-field signals of ventricular activation events (R-waves)
originating from atria and conducted through the atrioventricular node and His-Purkinje path in and provide pacing pulses to cardiac tissue of the left ventricle 14).
Hassl et al. do not teach mapping a location of the left atrium and the left ventricle of the subject or mapping a stimulation effect of muscle tissue of the left atrium and/or the left ventricle based on analysis of a response to stimulation electrical signals injected at a plurality of locations of the left atrium and/or the left ventricle using at least one mapping element coupled to the intravenous delivery system; selecting an angular position of a guiding element of the intravenous delivery system interlocked with the heart stimulation apparatus according to the mapping. Yankelson incorporates mapping electrodes to drive stimulating current into tissue to map whether the stimulating current induces a desired effect (para 283). The mapping technique is used to determine optimal stimulation electrode configurations by determining when electrodes are properly aimed at target tissue (para 292). The techqniue relies on heart activity signals obtained from heart activity sensors, wherein the heart activity pertains to sensing the contractions of either the atria or ventricles (para 367). Atrial and ventricular contractions sensed in this manner are considered to comprise muscular activity because they result from the contraction of cardiac muscle tissue (myocardium).
It would have been obvious to one of ordinary skill in the art to incorporate the mapping electrodes and mapping functionality of Yankelson into the delivery device of Hassl et al. because doing so would predictably permit evaluation of the physiological effect of stimulation at different locations and facilitate determination of an appropriate location for implantation of the stimulation device.
Neither Hassl et al. nor Yankelson describe operating the intravenous delivery system rotate the guiding element according to the selected angular position to position the heart stimulation apparatus in a determined angular position. While Hassl et al. and Yankelson both discuss maneuvering the device using the positioning device, there is no express teaching for rotating the body for placing in the determined angular position. Liu et al. describes structures and technique for implanting a capsule pacemaker within the coronary sinus (page 7 lines 30-33 and page 8 lines 23-25). A leadless pacing device 20, similar to Hassle et al. with housing 22, is delivered from a positioning device, and in some cases a delivery catheter, wherein the positioning device coupled to housing 22, movement of the positioning device may translate to the housing 22, thereby allowing a user, such as a physician, to maneuver the housing 22 into a proper position within the heart, for example into or proximate the coronary sinus. The positioning device may be capable of longitudinally and/or rotationally manipulating the housing 22 (page 11 lines 2-15). The step of maneuvering and positioning of the device in this manner is considered to imply that the device is placed at a proper angular position.
Modification of technique suggested by Hassl et al. and Yankelson to permit rotation of the device using the positioning device is considered to have been obvious to one of ordinary skill in the art as Liu et al. expressly demonstrates this maneuver as a common manipulation for implanting a leadless pacing device in the coronary sinus. The modification is considered to comprise the application of a known technique to a known device to yield a predictable result.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haasl et al. (US Publication no. 2018/0264272) in view of Yankelson (US Publication no. 2018/0272121) and Liu et al. (WO 2020/205397), further in view of Khairkhahan et al. (US Publication no. 2012/0197373).
In regard to claim 21, Hassl et al. in view of Yankelson and Liu et al. substantially suggest the invention as claimed, except do not teach the mechanical provisions of the guiding element comprise at least one depression and the mating mechanical provisions of the body comprise at least one protrusion shaped to fit into the at least one depression and/or vice versa. Khairkhahan et al. in figure 4A show a delivery system 400 for an implantable leadless pacemaker 402. The delivery system includes a depression 418 (docking cap) for making a mechanical connection to a protrusion 424 (attachment feature), wherein the docking cap 418 receives the attachment feature 424 which is shaped to fit within the docking cap 418 (para 50, once the tethers are locked within the attachment feature, the tethers can be pulled proximally to pull attachment feature 424 and the pacemaker towards the catheter and to attach the pacemaker to the delivery catheter, thereby engaging torque slot 430 with torque key 432). This attachment mechanism is considered to comprise an alternative design to the mechanisms suggested by either Hassl et al. or Liu et al. Therefore, it is considered to have been obvious to utilize the interlock mechanism of Khairkhahan et al. in place of the those of either Hassl et al. or Liu et al. since the interlock mechanism of Khairkhahan et al. provides a known alternative for securing a leadless device to a delivery catheter while permitting rotational torque to be applied through the guiding element to the device during implantation.
In regard to claim 22, Hassl et al. in view of Yankelson and Liu et al. substantially suggest the invention as claimed, except do not teach the guiding element further comprises a limiting element disposed at a distal end of the guiding element for limiting a movement of the body along its longitudinal axis. Khairkhahan et al. in figure 4A show a delivery system 400 for an implantable leadless pacemaker 402. The delivery system includes a depression 418 (docking cap) for making a mechanical connection to a protrusion 424 (attachment feature), wherein the docking cap 418 receives the attachment feature 424 which is shaped to fit within the docking cap 418 (para 50). Under the broadest reasonable interpretation of the structures of Khairkhahan et al., the docking cap 418 at the distal end of the catheter shaft 406 serves to physically limit further longitudinal movement of the pacemaker device toward the catheter once the pacemaker body is seated in the docking cap as in figure 4G. Moreover, the torque slot 430 and torque key 432 serve as locking features to prevent relative longitudinal movement.
Therefore, it would have been obvious to one of ordinary skill in the art to provide the guiding element with a distal structure to limit longitudinal movement of the implant in order to predictable maintain the implant in a controlled position relative to the guiding element during delivery, thereby facilitating accurate and stable placement of the implant.
Allowable Subject Matter
Claims 3-5, 8, 11, 16, and 26-28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claims 3-5, 8, and 11, the prior art fails to teach the arrangement of the struts with at least one electrical lead for delivering the pacing electrical signal.
In regard to claim 16, the prior art fails to describe the features of the snap-fit element to permit detaching the battery,
In regard to claims 26-28, the prior art fails to teach battery capsule replacement element.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 16 September 2026
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