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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19) in the reply filed on 06 July 2026 is acknowledged.
Status of Claims
Claims 1-20 are pending; claim 20 has been withdrawn; and claims 1-19 are currently under consideration for patentability.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 20 November 2024 has been acknowledged and considered by the Examiner.
Claim Objections
Claims 6 and 16 are objected to because of the following informalities.
Claims 6 and 16 contain minor typographical and/or grammatical errors.
Claim 6, line 1: Applicant is advised to remove the second instance of “of claim”
Claim 16, line 6: Applicant is advised to change “end the collet” to “end of the collet”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 4, 5, 7-12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Geistert (US 2013/0116704 A1) in view of Westlund et al. (US 2002/0077686 A1).
Regarding claim 1, Geistert describes a system for extracting a transvenous endocardial lead ([0020] - [0021]), the transvenous endocardial lead comprising a lead body having a proximal end with a connector configured for electrical connection to an implantable medical device and a distal end configured to contact endocardial tissue ([0019]), the system comprising a lead extender ([0057]) comprising a collet ([0059]) and a lead extraction sheath (16) comprising a sheath body with a tapered distal region (16B), wherein a wall of the tapered distal region and a wall of the sheath body comprise an arrangement of openings configured to allow insertion of the lead extender and the body of the endocardial lead ([0059], [0063]; figures 1A and 2A, openings on distal side of figures).
Regarding claim 1, although Geistert describes the use of a collet ([0059]), Geistert does not explicitly disclose wherein the collet is configured to releasably engage a pin of the connector and wherein a locking ring is configured to maintain the engagement of the collet on the pin of the connector. However, Westlund also describes a system for extracting a guidewire of a transvenous lead ([0037]), including the use of a collet configured to releasably engage a pin of a connector ([0042]) and a locking ring configured to maintain the engagement of the collet on the pin ([0042], locking connection 80, for example). As Westlund is also directed towards extracting a transvascular component and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a pin and locking mechanism similar to those described by Westlund when using the system described by Geistert, as doing so advantageously allows the resulting system to ensure a tight connection between the components and minimize the occurrence of dislodgement or displacement of the lead.
Regarding claim 2, Westlund describes wherein the collet has a first end and a second end, and the second end of the collet is mechanically engaged with the pin of the connector ([0047], [0015], the locking means can be proximal, distal, or both).
Regarding claim 4, Geistert describes wherein the second end of the collet comprises an arrangement of cantilevered arms and each cantilevered arm in the arrangement of cantilevered arms is separated by a longitudinal slot (figures 1B, 1C).
Regarding claim 5, Geistert describes wherein the collet comprises an arrangement of four cantilevered arms spaced at 90° about a circumference of the second end of the collet (figures 1B, 1C).
Regarding claim 7, Geistert describes wherein the tapered distal region comprises a first slot that extends parallel to a longitudinal axis of the sheath body (figure 1A).
Regarding claim 8, Geistert describes wherein a distal region of the sheath body comprises a wall with a second slot contiguous with the first slot in the tapered distal region and, optionally, the second slot extends parallel to the longitudinal axis of the body of the extraction sheath (figures 2A, 4A-B, 5A-B provide embodiments of this).
Regarding claims 9-11, although neither Geistert nor Westlund explicitly disclose the diameters and widths of the sheaths, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to adjust the size, shape, and/or proportions of the inner diameters, widths, and tapers as necessary in order to meet the goal of extracting the lead, as doing so would be a matter of changing the size, shape, and/or proportion of the device and/or optimizing the result-effective variables of the diameters and widths, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.04 and 2144.05).
Regarding claim 12, Geistert describes wherein a distal region of the tapered distal tip of the sheath body comprises a cutting element ([0019]).
Regarding claim 14, Geistert describes wherein the first end of the collet comprises an aperture and an extension wire is attached to the collet within the aperture ([0089]).
Regarding claim 16, Geistert describes a method for extracting a transvenous endocardial lead from vasculature of a patient ([0020] - [0021]), the transvenous endocardial lead comprising a lead body having a proximal end with a connector configured for electrical connection to an implantable medical device and a distal end contacting endocardial tissue ([0019]), the method comprising, in a lead extender comprising a collet and a locking ring ([0057], [0059]), wherein a first end of the collet comprises an extension wire ([0089]), inserting the extension wire and the endocardial lead having the lead extender thereon into a lead extraction sheath comprising a sheath body with a tapered distal region ([0059], [0063]), wherein a wall of the tapered distal region and the wall of the sheath body comprise an arrangement of openings configured to allow insertion of the endocardial lead with the lead extender thereon ([0059], [0063]; figures 1A and 2A, openings on distal side of figures).
Regarding claim 16, although Geistert describes the use of a collet ([0059]), Geistert does not explicitly disclose releasably attaching a second end the collet to a pin of the connector and sliding a locking ring over the collet and the extension wire to retain the collet on the pin of the connector. However, Westlund also describes a system for extracting a guidewire of a transvenous lead ([0037]), releasably attaching a second end the collet to a pin of a connector ([0042]) and sliding a locking ring over the collet and the extension wire to retain the collet on the pin of the connector ([0042], locking connection 80, for example). As Westlund is also directed towards extracting a transvascular component and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a pin and locking mechanism similar to those described by Westlund when using the method described by Geistert, as doing so advantageously allows the resulting system to ensure a tight connection between the components and minimize the occurrence of dislodgement or displacement of the lead.
Regarding claim 17, Geistert describes advancing the tapered distal region of the extraction sheath over extended endocardial lead and into the vasculature of the patient ([0035]).
Regarding claim 18, Geistert describes removing, with the extraction sheath, scar tissue around a previous implantation site of the endocardial lead ([0008] - [0009], removing infected tissue or adhering tissue).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Geistert in view of Westlund, further in view of Flaherty (US 2010/0152811 A1).
Regarding claim 3, Geistert in view of Westlund suggests the system of claim 2, but neither Geistert nor Westlund explicitly disclose wherein the second end of the collet comprises a snap-fit connector. However, Flaherty also describes the use of a collet as part of a lead, including wherein one end of the collet comprises a snap-fit connector ([0133]). As Flaherty is also directed towards medical leads and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a snap-fit connector on the collet, in a manner similar to that described by Flaherty, when using the system described by Geistert and Westlund, as doing so advantageously allows the resulting system to have a secure connection for the collet.
Claims 13, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Geistert in view of Westlund, further in view of Fifer et al. (US 2011/0112548 A1).
Regarding claim 13, Geistert in view of Westlund suggests the system of claim 1, but neither Geistert nor Westlund explicitly discloses a snare element configured to engage a proximal end of the endocardial lead. However, Fifer also describes a system for extracting a lead ([0016]), including the use of a snare element configured to engage a proximal end of the lead ([0017]). As Fifer is also directed towards extracting a lead and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a snare similar to that described by Fifer when using the system described by Geistert and Westlund, as doing so advantageously allows the resulting system to remove the tissue components that are cut or dislodged by the tip of the device.
Regarding claim 15, Geistert in view of Westlund suggests the system of claim 1, including the use of a collet, and Fifer describes a snare element configured to engage an extension wire ([0017], [0059]).
Regarding claim 19, Geistert in view of Westlund suggests the method of claim 17, but neither Geistert nor Westlund explicitly discloses attaching a snare element to at least one of the endocardial lead or the extension wire and exerting a force with the snare element to remove the endocardial lead from the vasculature of the patient. However, Fifer also describes a method for extracting a lead ([0016]), including attaching a snare element to a lead or extension wire and exerting a force with the snare element to remove the lead from the vasculature of the patient ([0017], [0059]). As Fifer is also directed towards extracting a lead and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a snare similar to that described by Fifer when using the method described by Geistert and Westlund, as doing so advantageously allows the resulting system to remove the tissue components that are cut or dislodged by the tip of the device.
Allowable Subject Matter
Claim 6 is 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.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 6, Geistert in view of Westlund suggests the system of claim 4. Geistert further describes wherein a distal end of the at least some of the cantilevered arms comprises an undercut (figures 2B-C) and the optional limitation that at least some of the undercuts form a tab which extends in a direction normal to a longitudinal axis of the collet (figures 4A and 5A). However, Geistert, Westlund, and the other prior art of record do not disclose or suggest the specific configuration of “an undercut configured to engage a shoulder of the pin of the connector.”
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel, can be reached by telephone at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
Prosecution Insights