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)(5) because they include the following reference character(s) not mentioned in the description: “404”, as seen in Fig. 5. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 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.
Claims 1, 5-13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eby et al. (US 2020/0289835) in view of Makharinsky (US 11,000,689).
Regarding independent claim 1, Eby discloses biostimulator, such as a leadless cardiac pacemaker, including coaxial fixation elements to engage or electrically stimulate tissue. Eby further discloses a biostimulator ([0036]: “…a biostimulator, e.g., a leadless cardiac pacemaker”), comprising:
a body (housing 206 of the biostimulator 100 in Figs. 2A-2B) having a longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B) and an electronics compartment (electronics compartment 210 in Fig. 2A) containing pacing circuitry ([0043]: “…the electronics compartment 210 can contain circuits for sensing cardiac activity from the electrodes, circuits for receiving information from at least one other device via the electrodes, circuits for generating pacing pulses for delivery to tissue via the electrodes, or other circuitry.”); and
a header assembly (header assembly 320 in Fig. 3) mounted on the body (housing 206 of the biostimulator 100 in Figs. 2A-2B; [0063]: “…header assembly 320 mounted on the flange 214 of the housing 206.”) along the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B), wherein the header assembly (header assembly 320 in Fig. 3) includes
a header housing having a lateral surface (radially outward surface 329 of the helix mount flange 322 in Fig. 3) facing laterally outward from the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B).
Eby is silent to an electrode channel in the lateral surface, and
a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis.
However, Makharinsky teaches a leadless cardiac pacemaker. Makharinsky further teaches an electrode channel in the lateral surface (second plurality of channels 88 in Figs. 26-28; [pg. 20, li. 43-51]: “The first housing portion 81, in turn, includes a first plurality of individual electrodes 84 permanently affixed thereto and slidably residing in a second plurality of corresponding channels 85 of the second housing portion 82. In a similar fashion, the second housing portion 82 may include a second plurality of individual electrodes 87 permanently attached thereto and slidably residing in a first plurality of corresponding channels 88 of the first housing portion 81.”), and
a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis (second plurality of individual electrodes 87 in Figs. 26-28).
Makharinsky is of a similar pursuit to that of Eby and the instant application in teaching an implantable leadless pacemaker with a means of anchoring the implant into tissue. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Eby to include an electrode channel in the lateral surface, and a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis in order to allow the body to lie parallel to a septal wall when the pacing electrode extends into the septal wall.
Regarding claim 5, in view of the Eby/Makharinsky combination, Eby discloses a fixation element (secondary fixation elements 350 in Figs. 3 and 13-14; [0067]: “…Secondary fixation elements 350 can have radial and tangential components relative to the radially outward surface 329.”) mounted on the lateral surface (radially outward surface 329 in Fig. 3).
Regarding claim 6, in view of the Eby/Makharinsky combination, Eby discloses that the fixation element (secondary fixation elements 350 in Figs. 3 and 13-14; [0067]) includes a claw extending laterally outward from the lateral surface (radially outward surface 329 in Fig. 3), and wherein the claw is slidable on the lateral surface ([0115]: “…secondary fixation element 350 can be retained within the secondary fixation channel 1302. A first end of the secondary fixation element 350 can remain within the channel, and a second end of the secondary fixation element 350 may be exposed radially outward from the helix mount 321 to engage target tissue.”; See annotated Figs. 13-14.).
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Regarding claim 7, in view of the Eby/Makharinsky combination, Eby discloses that the claw is slidable on the lateral surface (radially outward surface 329 in Fig. 3) about the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B) to move a claw tip of the claw from a first radial location relative to the longitudinal axis to a second radial location relative to the longitudinal axis ([0115]: “…secondary fixation element 350 can be retained within the secondary fixation channel 1302. A first end of the secondary fixation element 350 can remain within the channel, and a second end of the secondary fixation element 350 may be exposed radially outward from the helix mount 321 to engage target tissue.”; See annotated Figs. 13-14.).
Regarding claim 8, in view of the Eby/Makharinsky combination, Eby discloses that the claw includes a claw base mounted within a claw channel (secondary fixation channel 1302 in Figs. 13-14) of the lateral surface (radially outward surface 329 in Fig. 3), and wherein the claw extends laterally outward from the claw base ([0115]: “…secondary fixation element 350 can be retained within the secondary fixation channel 1302. A first end of the secondary fixation element 350 can remain within the channel, and a second end of the secondary fixation element 350 may be exposed radially outward from the helix mount 321 to engage target tissue.”; See annotated Figs. 13-14.).
Regarding claim 9, in view of the Eby/Makharinsky combination, Eby discloses that the claw extends in a first circumferential direction about the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B) from a claw origin at the claw base, and wherein the claw includes a claw tab at a location on the claw base in a second circumferential direction about the longitudinal axis ([0115]; See annotated Figs. 13-14.).
Regarding claim 10, in view of the Eby/Makharinsky combination, Eby is silent to a plurality of radiopaque markers mounted on the body, wherein the plurality of radiopaque markers are aligned along a transverse axis, and wherein the transverse axis is orthogonal to the electrode axis.
However, Makharinsky teaches a plurality of radiopaque markers mounted on the body, wherein the plurality of radiopaque markers are aligned along a transverse axis, and wherein the transverse axis is orthogonal to the electrode axis ([col. 14, li. 17-20]: “Pacemaker implantation procedure may be aided by using one or more visualization modalities such as ultrasound, X-Ray, fluoroscopy, CT, MRI, TEE or others, such as known in the field as the invention is not limited in this regard.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Eby to include the plurality of radiopaque markers of Makharinsky in order to aid in orienting the biostimulator under medical imaging.
Regarding claim 11, in view of the Eby/Makharinsky combination, while the Eby/Makharinsky combination is silent to that the radiopaque markers include a first marker having a v-notch profile and a second marker having a bead profile, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Eby/Makharinsky combination to include a first marker having a v-notch profile and a second marker having a bead profile in order to align the markers in the visual projection.
Regarding claim 12, in view of the Eby/Makharinsky combination, Eby is silent to that the header assembly includes an electrode carrier, and wherein the electrode carrier is tubular and the pacing electrode extends through a carrier lumen of the electrode carrier.
However, Makharinsky teaches that the header assembly includes an electrode carrier, and wherein the electrode carrier is tubular and the pacing electrode (movable plurality of individual electrodes 97 in Figs. 29-30) extends through a carrier lumen (second channel 98 in Figs. 29-30) of the electrode carrier ([col. 22, li. 7-10]: “Also featured within the housing 90 is the second channel 98 with a similarly curved distal end containing a movable plurality of individual electrodes 97, initially residing entirely within the bounds of the housing 90.”; Figs. 29-30).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Eby to include an electrode carrier and electrode lumen in order to extend the pacing electrode to the target tissue.
Regarding independent claim 13, Eby discloses a biostimulator system ([0036]: “…a biostimulator, e.g., a leadless cardiac pacemaker”), comprising:
a biostimulator transport system ([0041]: “Leadless pacemakers or other leadless biostimulators can be delivered to or retrieved from a patient using delivery or retrieval systems. The leadless biostimulator system can include delivery or retrieval systems, which may be catheter-based systems used to carry a leadless biostimulator intravenously to or from a patient anatomy. The delivery or retrieval systems may be referred to collectively as transport systems.”); and
a biostimulator ([0036]: “…a biostimulator, e.g., a leadless cardiac pacemaker”) mounted on the biostimulator transport system, wherein the biostimulator includes a body (housing 206 of the biostimulator 100 in Figs. 2A-2B) having a longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B) and an electronics compartment (electronics compartment 210 in Fig. 2A) containing pacing circuitry ([0043]: “…the electronics compartment 210 can contain circuits for sensing cardiac activity from the electrodes, circuits for receiving information from at least one other device via the electrodes, circuits for generating pacing pulses for delivery to tissue via the electrodes, or other circuitry.”), and a header assembly (header assembly 320 in Fig. 3) mounted on the body (housing 206 of the biostimulator 100 in Figs. 2A-2B) along the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B), wherein the header assembly (header assembly 320 in Fig. 3) includes a header housing having a lateral surface (radially outward surface 329 of the helix mount flange 322 in Fig. 3) facing laterally outward from the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B).
Eby is silent to an electrode channel in the lateral surface, and wherein the header assembly includes a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis.
However, Makharinsky teaches a leadless cardiac pacemaker. Makharinsky further teaches an electrode channel in the lateral surface (second plurality of channels 88 in Figs. 26-28; [pg. 20, li. 43-51]: “The first housing portion 81, in turn, includes a first plurality of individual electrodes 84 permanently affixed thereto and slidably residing in a second plurality of corresponding channels 85 of the second housing portion 82. In a similar fashion, the second housing portion 82 may include a second plurality of individual electrodes 87 permanently attached thereto and slidably residing in a first plurality of corresponding channels 88 of the first housing portion 81.”), and
and wherein the header assembly includes a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis (second plurality of individual electrodes 87 in Figs. 26-28).
Makharinsky is of a similar pursuit to that of Eby and the instant application in teaching an implantable leadless pacemaker with a means of anchoring the implant into tissue. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Eby to include an electrode channel in the lateral surface, and a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis in order to allow the body to lie parallel to a septal wall when the pacing electrode extends into the septal wall.
Regarding claim 16, in view of the Eby/Makharinsky combination, Eby discloses a fixation element (secondary fixation elements 350 in Figs. 3 and 13-14; [0067]) mounted on the lateral surface (radially outward surface 329 in Figs. 3, 13).
Regarding claim 17, in view of the Eby/Makharinsky combination, Eby discloses that the fixation element (secondary fixation elements 350 in Figs. 3 and 13-14; [0067]) include a claw extending laterally outward from the lateral surface (radially outward surface 329 in Figs. 3, 13), and wherein the claw is slidable on the lateral surface ([0115]: “…secondary fixation element 350 can be retained within the secondary fixation channel 1302. A first end of the secondary fixation element 350 can remain within the channel, and a second end of the secondary fixation element 350 may be exposed radially outward from the helix mount 321 to engage target tissue.”; See annotated Figs. 13-14.).
Regarding independent claim 18, Eby discloses a method, comprising:
delivering a biostimulator ([0036]: “…a biostimulator, e.g., a leadless cardiac pacemaker”) to a target tissue ([0040]: “Attachment of the biostimulator 100 to the cardiac tissue…”), wherein the biostimulator ([0036]: “…a biostimulator, e.g., a leadless cardiac pacemaker”) includes a body (housing 206 of the biostimulator 100 in Figs. 2A-2B) having a longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B) and an electronics compartment (electronics compartment 210 in Fig. 2A) containing pacing circuitry ([0043]: “…the electronics compartment 210 can contain circuits for sensing cardiac activity from the electrodes, circuits for receiving information from at least one other device via the electrodes, circuits for generating pacing pulses for delivery to tissue via the electrodes, or other circuitry.”), and a header assembly (header assembly 320 in Fig. 3) mounted on the body (housing 206 of the biostimulator 100 in Figs. 2A-2B) along the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B), wherein the header assembly (header assembly 320 in Fig. 3) includes a header housing having a lateral surface (radially outward surface 329 of the helix mount flange 322 in Fig. 3) facing laterally outward from the longitudinal axis (central axis 208 in Figs. 2A-6A, 7A-7B).
Eby is silent to a header housing having a lateral surface facing laterally outward from the longitudinal axis, and an electrode channel in the lateral surface, and wherein the header assembly includes a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis; and advancing the pacing electrode through the electrode channel into the target tissue.
However, Makharinsky teaches a header housing having a lateral surface facing laterally outward from the longitudinal axis, and an electrode channel in the lateral surface (second plurality of channels 88 in Figs. 26-28; [pg. 20, li. 43-51]: “The first housing portion 81, in turn, includes a first plurality of individual electrodes 84 permanently affixed thereto and slidably residing in a second plurality of corresponding channels 85 of the second housing portion 82. In a similar fashion, the second housing portion 82 may include a second plurality of individual electrodes 87 permanently attached thereto and slidably residing in a first plurality of corresponding channels 88 of the first housing portion 81.”), and wherein the header assembly includes a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis (second plurality of individual electrodes 87 in Figs. 26-28); and
advancing the pacing electrode through the electrode channel into the target tissue ([col. 22, li. 7-10]: “Also featured within the housing 90 is the second channel 98 with a similarly curved distal end containing a movable plurality of individual electrodes 97, initially residing entirely within the bounds of the housing 90.”; Figs. 29-30).
Makharinsky is of a similar pursuit to that of Eby and the instant application in teaching an implantable leadless pacemaker with a means of anchoring the implant into tissue. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Eby to include an electrode channel in the lateral surface, and a pacing electrode extending through the electrode channel along an electrode axis substantially orthogonal to the longitudinal axis in order to allow the body to lie parallel to a septal wall when the pacing electrode extends into the septal wall.
Regarding claim 19, in view of the Eby/Makharinsky combination, Eby discloses that the header assembly (header assembly 320 in Fig. 3) includes a drive head mounted within the header housing (radially outward surface 329 of the helix mount flange 322 in Fig. 3), and wherein advancing the pacing electrode includes rotating the drive head to advance the pacing electrode through the electrode channel into the target tissue ([0041]: “Leadless pacemakers or other leadless biostimulators can be delivered to or retrieved from a patient using delivery or retrieval systems. The leadless biostimulator system can include delivery or retrieval systems, which may be catheter-based systems used to carry a leadless biostimulator intravenously to or from a patient anatomy. The delivery or retrieval systems may be referred to collectively as transport systems. …the leadless pacemaker includes an active engaging mechanism, such as the coaxial fixation elements described below, the transport system can include a docking cap or key at a distal end of the catheter, and the docking cap or key may be configured to engage the leadless pacemaker and apply torque to screw the active engaging mechanism into or out of the tissue. In other implementations, the transport system includes clips designed to match the shape of a feature on the leadless pacemaker and apply torque to screw the active engaging mechanism into or out of the tissue.”).
Regarding claim 20, in view of the Eby/Makharinsky combination, Eby discloses advancing a fixation element (secondary fixation elements 350 in Figs. 3 and 13-14; [0067]) mounted on the lateral surface (radially outward surface 329 in Fig. 3) into the target tissue ([0040]: “Attachment of the biostimulator 100 to the cardiac tissue…”).
Allowable Subject Matter
Claims 2-4 and 14-15 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
The Examiner has not found any references that teach or suggest in combination the limitations recited by dependent claims 2 and 14. Specifically, the prior art fails to disclose or render obvious that “the drive head includes a spool portion and a threaded portion, wherein the pacing electrode is wound about the spool portion, and wherein the threaded portion is threadably coupled to the header housing”, as disclosed in dependent claim 2 and similarly in dependent claim 14. Claims 3-4 and 15 depend from the dependent claims 2 and 14, thus would also be considered allowable by their dependency on claims containing allowable subject matter.
Claims 2-4 and 14-15 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Papsa et al. (US 2020/0129763);
Gaudiani (US 11,577,075); and
Nix et al. (US 2023/0321450).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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