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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “fixation structure” recited in claims 1 and 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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 1 recites the limitation “wherein the leadlet supports a fixation structure configured to resist motion of the leadlet in a proximal direction when the distal end is implanted in the tissue of the heart”.
The limitation fails to positively recite a fixation structure only that the leadlet supports a fixation structure. This raises questions, does the claim require a fixation structure or not. The broadest reasonable interpretation and the one taken for this examination is that the fixation structure is not required as it is not positively claimed and that the leadlet only requires a structure capable of supporting a fixation structure. Regardless, if this is applicant’s intended interpretation or not, applicant should clarify what is being claimed here. Claims 2-15 are also rejected under 35 USC 112(b) based on dependency to claim 1.
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 1-12 and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 7, 9-17 and 19-20 of U.S. Patent No. 12246181 hereafter known as Pat ‘181 in view of Koop et al (US 20190351236) hereafter known as Koop, because Pat ‘181 in view of Koop obviates all the limitations as outlined in the table below.
Claim in this Application
Where the limitation can be found in Pat ‘181
Modification and/or clarification (if any)
Claim 1
See claim 1
However, Pat ‘181 fails to disclose the implantable medical device has a housing as claimed and fails to disclose “circuitry supported by the housing, wherein the circuitry is configured to at least one of deliver stimulation signals to the heart using the electrode or sense signals from the heart using the electrode” as claimed.
Koop discloses in the analogous art of cardiac stimulation devices [see para 2… “The present disclosure generally relates to systems, devices, and methods for treating cardiac arrhythmias”] that circuitry supported by a housing of an implantable medical device are known structures for supporting the delivery of stimulation [see Figs. 1-2 and 5 and para 113… “processing module 710 may control switching circuitry by which communication module 702 and pulse generator module 704 deliver electrical communication pulses and/or electrical stimulation pulses to tissue of the patient.”] It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Pat ‘181 by including circuitry inside a housing of an implantable medical device and to include fixation structures similarly to that disclosed by Koop because these are known structures for supporting the delivery of stimulation in the field of cardiac stimulation devices.
Claim 2
See claim 1
Claim 3
See claim 7
Claim 4
See claim 4
Claim 5
See claim 12
Claim 6
See claim 10
Claim 7
See claim 12 and rejection to claim 1 above.
Claim 8
See rejection to claim 1 above
Claim 9
See claim 2
Claim 10
See claim 9
Claim 11
See claim 10
Claim 12
See claim 11
Claim 14
See claim 13
Claim 15
See claim 14
Claim 16
See claim 15
However, Pat ‘181 fails to disclose “a delivery catheter defining a catheter lumen, wherein the delivery catheter defines a lumen opening to the catheter lumen at a distal end of the delivery catheter, and wherein the catheter lumen and the lumen opening are sized to allow the implantable medical device, the leadlet, and the fixation device to translate through the catheter lumen and through the lumen opening”.
Koop discloses in the analogous art of cardiac stimulation devices [see para 2… “The present disclosure generally relates to systems, devices, and methods for treating cardiac arrhythmias”] a delivery catheter defining a catheter lumen to allow the implant device, the leadlet and the fixation device to translate the lumen to help with positioning [see para 86…“Rather, pacing device 500 may be delivered from a guide catheter, and the portion of the guide catheter surrounding body 502 may conform to body 502 to create a secure connection between the guide catheter and body 502. When in position, the guide catheter may be retracted, or a stylet or other pushing device may push body 502 out of the guide catheter. In these cases, docking hub 504 may further include a tether anchor. During delivery, a tether may be coupled to the tether anchor to allow a user to pull body 502 back within the guide catheter for further positioning. In some instances, the tether is a string, and the string may be coupled to the tether anchor by looping around the tether anchor.” And para 136… “Generally, extension 503 may be a thin and flexible member, particularly in relation to body 502.” And para 138… see “Extension 501 may be similar to extension 503 in that extension 501 may be a thin and flexible member, particular in relation to body 502.” These sections further imply that if the catheter can fit the medical device, it also has dimensions to fit the leadlet and fixation device. Thus, this guide catheter is at least a delivery catheter with a lumen inside capable of fitting implantable device, leadlet and fixation device].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Pat ‘181 by including a delivery catheter defining a catheter lumen similarly to that disclosed by Koop because this will help with positioning.
Claim 17
See claim 16
Claim 18
See claims 15 and 17
Claim 19
See Claims 19-20
However, Pat ‘181 fails to disclose the fixation device is attached to a housing specifically of an implantable medical device. Therefore Pat ‘181 fails to fully disclose the step of “affixing, using a fixation device attached to a housing of an implantable medical device, the implantable medical device to a heart as the implantable medical device is positioned within the heart”
Koop discloses in the analogous art of cardiac stimulation devices [see para 2… “The present disclosure generally relates to systems, devices, and methods for treating cardiac arrhythmias”] that a known location to attach a fixation device [see Fig. 1 and 5 elements 512 and para 90… “The distal end of extension 501 may include one or more fixation elements 512. Fixation elements 512 may help secure the distal end of extension 501 within coronary sinus 12 or great cardiac vein 13. Fixation elements 512 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material.”] to an implantable medical device is specifically at the housing of the implantable medical device [see Fig. 1 and 5 element 502 and para 83… “housing or body 502”].
Since a housing is a known structure for which to connect a fixation device to the rest of an implantable medical device as taught by Koop, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Pat ‘181 by specifically connecting the fixation device to a housing of the implantable medical device as this is a known structure for connecting both the fixation device and implantable medical device in the field of cardiac stimulation devices.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, 8-12, 14-15 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koop et al (US 20190351236) hereafter known as Koop.
Independent claim:
Regarding claim 1:
A medical system [see Fig. 1 and para 83…. “FIG. 1 depicts system 20 as including a pacing device 500”] comprising:
an implantable medical device [see Fig. 1 and 5 elements 502, 507] including a housing [see Fig. 1 and 5 element 502 and para 83… “housing or body 502”] configured to be positioned within a heart of a patient [see para 83… “Additionally, when implanted, body portion 502a may be fully or partially disposed within coronary sinus 11 of the patient's heart, while body portion 502b may be disposed fully or partially within right atrium 21.”];
a fixation device attached to the housing, wherein the fixation device is configured to affix the implantable medical device to the heart [see Fig. 5 elements 506 (i.e. fixation device) and element 502 (i.e. housing) and para 87… “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection. In other embodiments, fixation elements 506 may comprise one or more of a helical coil or talons.” And para 134… “pacing device 500 includes body 502”];
a leadlet including a proximal end attached to the housing and a distal end [see Fig.5 element 503 (i.e. leadlet) and para 83… “extension 503” and see labelled figures below rejection to this claim] configured to implant within tissue of the heart, wherein the leadlet supports an electrode [see Fig. 5 element 505 and para 88… “one or more electrodes 505a-505e”], and
wherein a body of the leadlet between the proximal end and the distal end is configured to flex when the distal end is implanted in the tissue of the heart, and wherein the leadlet supports a fixation structure configured to resist motion of the leadlet in a proximal direction when the distal end is implanted in the tissue of the heart [see Fig. 5 and labelled figure directly below rejection to this claim which shows the leadlet having space capable of supporting a fixation structure]; and
circuitry supported by the housing, wherein the circuitry is configured to at least one of deliver stimulation signals to the heart using the electrode or sense signals from the heart using the electrode [see para 113… “processing module 710 may control switching circuitry by which communication module 702 and pulse generator module 704 deliver electrical communication pulses and/or electrical stimulation pulses to tissue of the patient.”]
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Independent claim:
Regarding claim 19:
A method [see para 2… “The present disclosure generally relates to systems, devices, and methods for treating cardiac arrhythmias”] comprising:
affixing, using a fixation device [see Fig. 5 elements 506 (i.e. fixation device) and element 502 (i.e. housing) and para 87… “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection. In other embodiments, fixation elements 506 may comprise one or more of a helical coil or talons.”] attached to a housing of an implantable medical device [see Fig. 1 and 5 element 502 and para 83… “housing or body 502”], the implantable medical device to a heart as the implantable medical device is positioned within the heart [see Figs. 1 and 5 and para 136… “pacing device 500 is implanted within the coronary sinus of the heart 10”];
penetrating, using a distal end of a leadlet, tissue of the heart [see labelled figures below rejection to this claim and para 87… “When implanted, extension 503 may extend from body 502 to near septum 15 of heart 10.” and “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection. In other embodiments, fixation elements 506 may comprise one or more of a helical coil or talons.”],
wherein a proximal end of the leadlet is attached to the implantable medical device [see labelled figures below rejection to this claim], wherein a body of the leadlet between the proximal end and the distal end is configured to flex when the distal end is implanted in the tissue of the heart [see Fig. 1 and para 136…“Generally, extension 503 may be a thin and flexible member,” Fig. 1 shows element 503 (i.e. leadlet) as flexing as claimed when elements 512 (fixation device) is implanted], and wherein the leadlet carries an electrode [see Fig. 5 element 505 and para 88… “one or more electrodes 505a-505e”]; and
at least one of delivering stimulation signals to the heart or sensing signals from the heart using circuitry supported by the housing and the electrode [see para 113… “processing module 710 may control switching circuitry by which communication module 702 and pulse generator module 704 deliver electrical communication pulses and/or electrical stimulation pulses to tissue of the patient.”].
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Dependent claims:
Regarding claim 4, see Figs. 1 and 5 elements 507 and para 128 [see “The first set of electrodes may be any pair of electrodes from between electrodes 507a-507d, 505a-505e, and 510a-510e. As one example, pacing device 500 may deliver communication pulses via a first set of electrodes that includes electrodes 505a and 505e, or electrodes 505b and 507a, or some other combination. In some cases, the particular set of electrodes that is used may change over time. Although, in other embodiments, the first set of electrodes may comprise any combination of any number of electrodes from electrodes 507a-507d, 505a-505e, and 510a-510e.”] and para 113 [see… “processing module 710 may control switching circuitry by which communication module 702 and pulse generator module 704 deliver electrical communication pulses and/or electrical stimulation pulses to tissue of the patient.”] which discloses the limitation as claimed.
Regarding claim 5-6, see Figs. 1 and 5 of Koop which disclose the limitations as claimed.
Regarding claim 8, see para 88 [see “In some instances, some or all of electrodes 505a-505e may be used to deliver electrical stimulation to heart 10, and more particularly, to the right atrium of the heart. For instance, in the example shown in FIG. 1, pacing device 500 may deliver electrical stimulation to right atrium 21 of heart 10 through a set of one or more of the electrodes 505a-505e.”] and para 81 [see “Some example electrical stimulation therapies include bradycardia therapy, cardiac resynchronization therapy (CRT), anti-tachycardia pacing (ATP) therapy, defibrillation and/or cardioversion therapy, and the like. Some example cardiac arrhythmias include atrial fibrillation or atrial flutter, ventricular fibrillation, and tachycardia.”] which discloses electric stimulation including pacing being proved by as part of the stimulation signals.
Regarding claim 9, see Fig. 1 of Koop and para 136 of Koop [see “Generally, extension 503 may be a thin and flexible member, particularly in relation to body 502.”]. As described in these sections element 503 (i.e. the leadlet) is capable to flex when the fixation device (elements 506) is implantable as claimed.
Regarding claim 10, see Fig. 1 of Koop which shows at the very least capability of positioning the implantable medical device in the right atrium (element 21) when the fixation device (element 506) secures the distal end of the implantable medical device (identified in labelled figure below rejection to claim 1). Also, para 85 of Koop [see “In some instances, body 502 may include a docking hub 504 which extends generally from the proximal end of body 502. In the example shown in FIG. 1, docking hub 504 may extend from body portion 502a. During implantation, docking hub 504 may be releasably coupled to a positioning device (not shown). When coupled, movement of the positioning device may translate to body 502, thereby allowing a user, such as a physician, to maneuver body 502 into a proper position within heart 10, for example into or proximate coronary sinus 11.”] discloses how the medical device has a hub and can interact with a positioning device to position the medical that demonstrates further capability to position as claimed. Thus, at the very least Koop has a structural configuration to position the medical device as claimed.
Regarding claim 11, see Fig. 5 elements 505 (note multiple) of Koop which includes a second electrode which is shown as being positioned on the distal end of the leadlet.
Regarding claim 12, see para 87 of Koop [see “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection”] which describes how the friction between the fixation device (elements 506) and the tissue holds the element 503 and thereby the attached element 502 (i.e. the medical device).
Regarding claim 14, see Figs. 1 and 5 elements 506 and para 87 of Koop [see “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection. In other embodiments, fixation elements 506 may comprise one or more of a helical coil or talons.”] which clearly disclose on the distal tip of element 503 (i.e. the distal tip of the leadlet) are fixation elements that are capable of at least puncturing tissue so that at the very least the distal tip of the leadlet is capable of being inserted into tissue.
Regarding claim 15, see para 86 of Koop [see “Rather, pacing device 500 may be delivered from a guide catheter, and the portion of the guide catheter surrounding body 502 may conform to body 502 to create a secure connection between the guide catheter and body 502. When in position, the guide catheter may be retracted, or a stylet or other pushing device may push body 502 out of the guide catheter. In these cases, docking hub 504 may further include a tether anchor. During delivery, a tether may be coupled to the tether anchor to allow a user to pull body 502 back within the guide catheter for further positioning. In some instances, the tether is a string, and the string may be coupled to the tether anchor by looping around the tether anchor.”] and para 136 of Koop [see “Generally, extension 503 may be a thin and flexible member, particularly in relation to body 502.”] with para 138 of Koop [see “Extension 501 may be similar to extension 503 in that extension 501 may be a thin and flexible member, particular in relation to body 502.”] further implies that if the catheter can fit the medical device, it also has dimensions to fit the leadlet and fixation device. Thus, this guide catheter is at least a delivery catheter with a lumen inside capable of fitting implantable device, leadlet and fixation device.
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.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop.
Koop discloses the invention substantially as claimed, including all the limitations of claim 1. Also, Koop discloses a guide wire port in the housing of the implantable medical device through which a guidewire is placed implying a guidewire lumen [see Fig. 5 element 541 and paras 135-137… “body 502 may have guide wire port 541. In some cases, guide wire port 541 may be disposed proximate distal end 522 of body 502 and may be configured to receive a guide wire.”].
However, it is not clear how far the lumen extends and therefore if the lumen is in the leadlet. Therefore, Koop fails to disclose “wherein the leadlet defines a lumen configured to receive a guidewire, and wherein the leadlet is configured to translate over the guidewire when the guidewire extends through the lumen”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Koop’s lumen to extend into the Koop’s extension’s (i.e. includes element linked to Leadlet) which thereby recites the missing limitation because there are limited number of ways the lumen can be configured in the implantable medical device (lumen is in the housing only, lumen extends into both the extensions (i.e. includes leadlet) and housing, or lumen extends into one extension) and this is one of those limited choices.
Claim(s) 2-3 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Makharinsky et al (US 20200230396) hereafter known as Makharinsky,
Regarding claims 2-3:
Koop discloses the invention substantially as claimed, including all the limitations of claim 1.
However, Koop fails to disclose “wherein the leadlet includes a bearing structure configured to receive an elongate member, and wherein the distal end of the leadlet is configured to move in a distal direction when the bearing structure receives the elongate member and a distal force is exerted on the elongate member” as recited in claim 2 or “wherein the leadlet is configured to exhibit a first stiffness when the bearing structure receives the elongate member and a second stiffness when the elongate member is displaced from the bearing structure, wherein the first stiffness is greater than the second stiffness” as recited by claim 3.
Makharinsky discloses in the analogous art of cardiac pacemakers [see abstract… “An intraseptal multi-electrode cardiac pacemaker has a plurality of first individual electrodes implanted at an interventricular septum at varying depths and/or lateral distances from the distal end of a flexible conduit and configured to provide a cardiac pacing therapy by stimulating left bundle branch conduction fibers.”] a bearing structure [see Fig. 7 element 500 and para 61-62] that includes a channel (i.e. configured to receive an elongate member) [see Fig. 7 element 516 and para 61-62… “a central lumen 516”] that is configured to receive a stylet (i.e. elongate member) that provides a desired shape and increases stiffness (i.e. second stiffness which is greater than first stiffness) to help with implantation of the device into the body (i.e. move in distal direction when distal force exerted on the elongate member) [Para 62… “A further notable element of the design shown in this embodiment is a central lumen 516, which may extend from the proximal end of the flexible conduit to its distal end.” And “to insert a removable stylet inside the flexible conduit 510. Such removable stylet may be used to temporarily increase the stiffness of the flexible conduit during implantation procedure and/or apply a predetermined curve to the shape of the flexible conduit by using a malleable or pre-formed stylet having a desired shape suitable for a particular subject. Following insertion and implantation of the flexible electrode into the heart, the proximal end of the central lumen may be capped off.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Koop’s leadlet by including a bearing structure with a channel and stylet that changes stiffness similarly to that disclosed by Makharinsky (i.e. thereby reciting claims 2-3) because this will help aid in the implantation of the leadlet into the body.
Regarding claim 20:
Koop discloses the invention substantially as claimed, including all the limitations of claim 19.
However, Koop fails to disclose “causing the distal end of the leadlet to penetrate the tissue of the heart using an elongate member, wherein the leadlet is configured to receive the elongate member, and wherein the distal end of the leadlet is configured to move in a distal direction when the leadlet receives the elongate member and a distal force is exerted on the elongate member” as recited by claim 20.
Makharinsky discloses in the analogous art of cardiac pacemakers [see abstract… “An intraseptal multi-electrode cardiac pacemaker has a plurality of first individual electrodes implanted at an interventricular septum at varying depths and/or lateral distances from the distal end of a flexible conduit and configured to provide a cardiac pacing therapy by stimulating left bundle branch conduction fibers.”] a bearing structure [see Fig. 7 element 500 and para 61-62] that includes a channel (i.e. configured to receive an elongate member) [see Fig. 7 element 516 and para 61-62… “a central lumen 516”] that is configured to receive a stylet (i.e. elongate member) that provides a desired shape and increases stiffness (i.e. second stiffness which is greater than first stiffness) to help with implantation of the device into the body (i.e. move in distal direction when distal force exerted on the elongate member) [Para 62… “A further notable element of the design shown in this embodiment is a central lumen 516, which may extend from the proximal end of the flexible conduit to its distal end.” And “to insert a removable stylet inside the flexible conduit 510. Such removable stylet may be used to temporarily increase the stiffness of the flexible conduit during implantation procedure and/or apply a predetermined curve to the shape of the flexible conduit by using a malleable or pre-formed stylet having a desired shape suitable for a particular subject. Following insertion and implantation of the flexible electrode into the heart, the proximal end of the central lumen may be capped off.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Koop’s leadlet by including a bearing structure with a channel and stylet that changes stiffness similarly to that disclosed by Makharinsky (i.e. thereby reciting claim 20) because this will help aid in the implantation of the leadlet into the body.
Claim(s) 7 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Min et al (US 20200353249) hereafter known as Min.
Regarding claim 7:
Koop discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above and electrodes on the body [see Fig. 1 and 5 element 507 and para 84].
However, Koop fails to disclose a return electrode and therefore fails to disclose “a return electrode supported by the housing, wherein the circuitry is configured to at least one of deliver the stimulation signals using the electrode and the return electrode or sense the signals using the electrode and the return electrode” as recited by claim 7.
Min discloses in the analogous art of cardiac stimulation [see para 2… “This disclosure relates generally to implantable cardiac stimulating devices.”] a known way to use a pair of electrodes to provide stimulation includes the use of one of the two electrodes being used as a return electrode [see para 53… “The housing 40 may further be used as a return electrode alone or in combination with one or more of the coil electrodes 28, 36, and 38 (shown in FIG. 1) for shocking purposes.”]
Since Koop discloses stimulating using pairs of electrodes [see para 128… in particular… “The first set of electrodes may be any pair of electrodes from between electrodes 507a-507d, 505a-505e, and 510a-510e. As one example, pacing device 500 may deliver communication pulses via a first set of electrodes that includes electrodes 505a and 505e, or electrodes 505b and 507a, or some other combination. In some cases, the particular set of electrodes that is used may change over time. Although, in other embodiments, the first set of electrodes may comprise any combination of any number of electrodes from electrodes 507a-507d, 505a-505e, and 510a-510e.”], but is silent as to the details of the how the pairs of electrodes are configure to provide stimulation, and Min discloses a known way to provide stimulation in the field of cardiac stimulation includes one of the pair of electrodes being a return electrode, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the electrodes so each of them can be a return electrode in pairs similarly to that disclosed by Min (i.e. disclosing a return electrode as claimed).
Independent claim
Regarding claim 16:
A medical system [see Fig. 1 and para 83…. “FIG. 1 depicts system 20 as including a pacing device 500”] comprising:
an implantable medical device [see Fig. 1 and 5 elements 502, 507] comprising:
a housing [see Fig. 1 and 5 element 502 and para 83… “housing or body 502”], wherein the housing carries a first electrode on a distal end of the housing [see Fig. 5 elements 507 and para 84… “one or more electrodes 507a-507d. Although electrodes 507a-507d are depicted as disposed on both body portions 502a, 502b, in some cases, the number and location of electrodes disposed on body 502 may vary, depending on the application.”],
wherein the housing is configured to be positioned within a heart [see Figs. 1 and 5 and para 83… “Additionally, when implanted, body portion 502a may be fully or partially disposed within coronary sinus 11 of the patient's heart, while body portion 502b may be disposed fully or partially within right atrium 21.”],
a leadlet including a proximal end and a distal end [see labelled figures below rejection to this claim], wherein the proximal end is attached to the housing [see element 503 (leadlet) relative to the proximal end of the implantable device (element 520) in labeled figures below rejection to this claim],
wherein the distal end is configured to penetrate tissue of the heart [see labelled figures below rejection to this claim which show distal end and para 87… “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection”], wherein the leadlet carries a second electrode [see Fig. 5 element 505a and para 88… “extension 503 may include one or more electrodes 505a-505e.”], and wherein a body of the leadlet between the proximal end and the distal end is configured to flex when the distal end is implanted in the tissue of the heart [see labelled figures below rejection to this claim which identify body of leadlet and Fig. 12 and para 136…“Generally, extension 503 may be a thin and flexible member,” which demonstrate the body as having a structure capable of flexing as claimed],
circuitry supported by the housing, wherein the circuitry is configured to deliver stimulation signals to the heart [see para 113… “processing module 710 may control switching circuitry by which communication module 702 and pulse generator module 704 deliver electrical communication pulses and/or electrical stimulation pulses to tissue of the patient.”] using the one or more return electrodes and at least one of the first electrode or the second electrode, and
a fixation device attached to the implantable medical device, wherein the fixation device is configured to affix the distal end of the implantable medical device to the heart [see Fig. 5 elements 506 and para 87… “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection”]; and
a delivery catheter defining a catheter lumen, wherein the delivery catheter defines a lumen opening to the catheter lumen at a distal end of the delivery catheter, and wherein the catheter lumen and the lumen opening are sized to allow the implantable medical device, the leadlet, and the fixation device to translate through the catheter lumen and through the lumen opening [see para 86…“Rather, pacing device 500 may be delivered from a guide catheter, and the portion of the guide catheter surrounding body 502 may conform to body 502 to create a secure connection between the guide catheter and body 502. When in position, the guide catheter may be retracted, or a stylet or other pushing device may push body 502 out of the guide catheter. In these cases, docking hub 504 may further include a tether anchor. During delivery, a tether may be coupled to the tether anchor to allow a user to pull body 502 back within the guide catheter for further positioning. In some instances, the tether is a string, and the string may be coupled to the tether anchor by looping around the tether anchor.” And para 136… “Generally, extension 503 may be a thin and flexible member, particularly in relation to body 502.” And para 138… see “Extension 501 may be similar to extension 503 in that extension 501 may be a thin and flexible member, particular in relation to body 502.” These sections further imply that if the catheter can fit the medical device, it also has dimensions to fit the leadlet and fixation device. Thus, this guide catheter is at least a delivery catheter with a lumen inside capable of fitting implantable device, leadlet and fixation device]
However, Koop fails to disclose “and wherein the housing carries one or more return electrodes” or fully disclosing “wherein the circuitry is configured to deliver stimulation signals to the heart using the one or more return electrodes and at least one of the first electrode or the second electrode”
Min discloses in the analogous art of cardiac stimulation [see para 2… “This disclosure relates generally to implantable cardiac stimulating devices.”] a known way to use a pair of electrodes to provide stimulation includes the use of one of the two electrodes being used as a return electrode [see para 53… “The housing 40 may further be used as a return electrode alone or in combination with one or more of the coil electrodes 28, 36, and 38 (shown in FIG. 1) for shocking purposes.”]
Since Koop discloses stimulating using pairs of electrodes, but is silent as to the details of the how the pairs of electrodes are configured to provide stimulation [see para 128… in particular… “The first set of electrodes may be any pair of electrodes from between electrodes 507a-507d, 505a-505e, and 510a-510e. As one example, pacing device 500 may deliver communication pulses via a first set of electrodes that includes electrodes 505a and 505e, or electrodes 505b and 507a, or some other combination. In some cases, the particular set of electrodes that is used may change over time. Although, in other embodiments, the first set of electrodes may comprise any combination of any number of electrodes from electrodes 507a-507d, 505a-505e, and 510a-510e.”], and Min discloses a known way to provide stimulation in the field of cardiac stimulation includes one of the pair of electrodes being a return electrode, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the electrodes so each of them can be a return electrode in pairs similarly to that disclosed by Min (i.e. disclosing a return electrode and “the circuitry is configured to deliver stimulation signals to the heart using the one or more return electrodes and at least one of the first electrode or the second electrode” as claimed).
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Regarding claim 17, see Fig. 5 of Koop which shows elements 506 (i.e. a fixation structure) is directly on the distal end of element 503 (i.e. leadlet) and thus is supported by the leadlet. Para 87 of Koop [see “Fixation elements 506 may secure the distal end of extension 503 in right atrium 21 proximate septum 15, or, in some instances, directly to septum 15. In some embodiments, fixation elements 506 may include one or more tines made of silicon, a biocompatible polymer, a biocompatible metal, or another biocompatible material. In such embodiments, the tines may be embedded within trabeculae of right atrium 21 proximate septum 15 to help provide a stable connection. In other embodiments, fixation elements 506 may comprise one or more of a helical coil or talons.”] explicitly discloses securing element 503 (i.e. leadlet) relative to tissue of the body and thus is at least capable to resist motion as claimed. Additionally, as the fixation elements can different elements including tines and/or talons as stated in para 87, the tines of elements 506 are understood to be the fixation device, while the talons of elements 506 are understood to be a fixation structure.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koop in view of Min as applied to claim 16 above, and further in view of Makharinsky.
Koop in view of Min discloses the invention substantially as claimed including all the limitations of claim 16 as outlined above.
However, Koop in view of Min fails to disclose “wherein the leadlet includes a bearing structure configured to receive an elongate member, wherein the distal end of the leadlet is configured to move in a distal direction when the bearing structure receives the elongate member and a distal force is exerted on elongate member” , “wherein the leadlet is configured to exhibit a first stiffness when the bearing structure receives the elongate member and a second stiffness when the elongate member is displaced from the bearing structure, and wherein the stiffness is greater than the second stiffness” as recited by claim 18.
Makharinsky discloses in the analogous art of cardiac pacemakers [see abstract… “An intraseptal multi-electrode cardiac pacemaker has a plurality of first individual electrodes implanted at an interventricular septum at varying depths and/or lateral distances from the distal end of a flexible conduit and configured to provide a cardiac pacing therapy by stimulating left bundle branch conduction fibers.”] a bearing structure [see Fig. 7 element 500 and para 61-62] that includes a channel (i.e. configured to receive an elongate member) [see Fig. 7 element 516 and para 61-62… “a central lumen 516”] that is configured to receive a stylet (i.e. elongate member) that provides a desired shape and increases stiffness (i.e. second stiffness which is greater than first stiffness) to help with implantation of the device into the body (i.e. move in distal direction when distal force exerted on the elongate member) [Para 62… “A further notable element of the design shown in this embodiment is a central lumen 516, which may extend from the proximal end of the flexible conduit to its distal end.” And “to insert a removable stylet inside the flexible conduit 510. Such removable stylet may be used to temporarily increase the stiffness of the flexible conduit during implantation procedure and/or apply a predetermined curve to the shape of the flexible conduit by using a malleable or pre-formed stylet having a desired shape suitable for a particular subject. Following insertion and implantation of the flexible electrode into the heart, the proximal end of the central lumen may be capped off.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Koop’s leadlet by including a bearing structure with a channel and stylet that changes stiffness similarly to that disclosed by Makharinsky (i.e. thereby reciting claim 18) because this will help aid in the implantation of the leadlet into the body.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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