CTNF 18/856,785 CTNF 84406 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Specification The abstract of the disclosure is objected to because the current abstract is not in a proper format, i.e. the abstract is not on a separate sheet. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kalmann et al. (US 2015/0367123) in view of Makower et al. (WO 2005/117755) and one having ordinary skill in the art . Claim 1. A material removal device comprising: E.G. via the disclosed lead extraction device configured to separate and remove tissue adhered to an implanted medical lead during extraction procedures; (Kalmann, [0138]-[0149], Figs. 1-4). a housing E.G. via the disclosed extracting device 10 including a tubular member 12 forming the body/housing of the extraction; (Kalmann, [0138], [0143]-[0149], Figs. 1-4). defining an opening sized to receive an implantable medical lead of a medical device, wherein the housing is sealed when the implantable medical lead is advanced through the opening, and wherein the housing defines a chamber; E.G. via the disclosed lead ‘A’ that extends through the lumen of the tubular member 12; Kalmann, [0141]. Kalmann further teaches that a knife 50 has an inner diameter ‘slightly greater than the outside diameter D of the lead A’ such that the lead is received within the device lumen [0142]. and a removal element positioned within the housing, E.G. via the disclosed knife/cutter 50 positioned within tubular member 12 of the extractor device 10; Kalmann, [0142]-[0149]; Figs. 12A-13D. configured to remove material from an outer surface of the implantable medical lead, E.G. via the disclosed knife 50 that includes ‘angled cutting edge’ for cutting tissue adjacent the lead; Kalmann, [0142]. Kalmann teaches the following additional key elements: that the lead is engaged and cut, i.e. severed and/or dissected, by the knife 50, [0144]. that the tissue T engaging the cutting edge of knife cuts the tissue surrounding the lead A to thereby free the lead, [0148]. and, that the device ‘tunnels’ through tissue to separate tissue from the lead, [0147]. wherein the chamber is configured to retain the material. Kalmann et al. does not explicitly teach a chamber configured to retain material. Secondary reference, Makower et al., teaches forming a substantially fluid-tight operative field configured for retention and collection of blood, fluids and debris generated during a medical procedure (e.g., pp. 20-24). Specifically, Makower et al. teaches that the operative field ‘permits the retention and collection of any blood or flushing fluids released during the procedure,’ (e.g., pp. 21). Makower et al. further teaches preventing undesirable drainage of ‘blood or debris from the operative site,’ through utilizing aspiration/removal structures associated with said operative field, wherein working lumens are sealed across said structures and fluid containment regions are further configured to contain procedural debris/material within the operative environment (e.g., pp. 22-25). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the lead extraction device of Kalmann et al. with a chamber and/or sealed containment region configured to retain removed biological material/debris as taught by Makower et al. since such a modification would provide the predictable results pertaining to utilizing an improved containment of removed material during extraction procedures, reduce escape of biological debris from the operative field, improve procedural cleanliness/safety and facilitate removal and management of extracted material. In addition, the modification of the above references merely involves the application of a known debris-retention and operative containment technique to a known medical extraction device in order to achieve predictable results. See KSR Int’l Co. v. Telefax Inc, 550 U.S. 398, 417 (2007). Claim 2. The material removal device of claim 1, wherein the material removal device further comprises one or more rotary bearings configured to facilitate rotation of the removal element around the implantable medical lead. E.G. via the disclosed distal clamping ring 22 and proximal clamping ring 24 pivoting between perpendicular and angled positions relative to the longitudinal axis of extractor device 10 to engage and move relative to lead A; Kalmann, [0138]-[0146], Figs. 4-6. Kalmann et al. further teaches progressive alternating movement and relative movement of the extraction device 10 around and along lead A during tissue removal operations, [0145]-[0148]. It would have been obvious to one of ordinary skill in the art to utilize rotary bearing structures or equivalents rotational support mechanism to facilitate smoother rotational movement of the removal elements around the lead in order to reduce friction and improve operational efficiency, as rotational support structures are well known mechanical design choices, which would have merely involved predictable use of prior art elements according to their established functions to improve rotational movement efficiency and reduce friction during lead extraction. See KSR Int’l Co. v. Telefax Inc, 550 U.S. 398, 417 (2007). Claim 3. The material removal device of claim 1, wherein the material removal device further comprises one or more locking elements configured to secure the implantable medical lead so that the implantable medical lead is rotationally fixed relative to the housing. E.G. via the disclosed distal clamping ring 22 and proximal clamping ring 24 frictionally engaging and clamping lead A; Kalmann, [0138]-[0146]. Kalmann et al. further teaches that the lead is grasped while the extraction device advances and removes surrounding tissue, [0145]-[0148]. Claim 4. The material removal device of claim 1, wherein the removal element is as long or longer than a connector of the lead. E.G. via the disclosed elongated tubular member 12 and knife 50 extending along the lead extraction path over a substantial length of lead A during extraction, Kalmann, [0142]-[0148], Figs. 12A-13D. It would have been obvious that the removal element dimensions may be selected to accommodate connector lengths and procedural requirements, as sizing components relative to implant lead geometry is a routine design consideration. Claim 5. The material removal device of claim 1, wherein the material removal device further comprises one or more of a crank, a lever, or a handle configured to actuate the removal element to remove the material from the outer surface of the implantable medical lead. E.G. via the disclosed handle mechanism 80 including first and second actuator 82/84 operatively connected to cables 32/34 for actuating the extraction mechanism, Kalmann, [0149], Fig. 14. Kalmann et al. further teaches pivotable handles with finger loops used to actuate movement of the extraction device and cutting mechanism, [0149]. Claim 6. The material removal device of claim 1, wherein the material removal device further comprises a battery and a gearbox, wherein the battery and the gearbox are positioned within the housing and configured to actuate the removal element to remove the material from the outer surface of the implantable medical lead. Regarding claim 6, neither Kalmann et al. nor Makower et al. explicitly teach a battery/gearbox positioned within the housing…configured to actuate the removal element. However, it would have been obvious to one of ordinary skill in the art to incorporate a battery-powered motor and gearbox arrangement into the extraction device to automate or assist movement of the removal element because powered surgical tools utilizing batteries and gearboxes for rotational or reciprocating actuation were well known in the medical device arts at the time of the invention. The modification would predictably improve procedural efficiency and reduce manual operator effort. Claim 7. The material removal device of claim 1, wherein the removal element is biased towards a longitudinal axis of the material removal device. E.G. via the disclosed springs 36/38 biasing clamping rings 22/24 relative to tubular member 12 and lead A; Kalmann, [0138], [0145]-[0146]. Note: The clamping structures are biased inwardly toward the lead positioned along the longitudinal axis of the extractor device. Claim 8. The material removal device of claim 3, wherein the removal element comprises one or more drums having an outer surface configured to remove the material from the outer surface of the implantable medical lead. Regarding claim 8, neither Kalmann et al. nor Makower et al. explicitly teaches ‘the removal element comprises one or more drums…configured to remove material from the outer surface of the implantable medical lead.’ However, it would have been obvious to substitute rotation drums or cylindrical removal structures for Kalmann’s cutting structures because rotary drum removal mechanisms are well known equivalents for abrading, dissecting or removing material from elongated medical structures. Such substitution merely represents use of a known equivalent removal mechanism for predictable material removal results. See KSR. Claim 9. The material removal device of claim 8, wherein the one or drums are spring-loaded. It would have been obvious to spring-load the drums of claim 8 in order to maintain engagement pressure against the lead surface and accommodate dimensional tolerances during material removal, as spring-loaded mechanisms are well known in the mechanical and medical arts for maintaining controlled contact forces. See KSR. Claim 10. The material removal device of claim 8, wherein the removal element further comprises one or more gears configured to transmit power and motion to rotate the one or more drums. It would have been obvious to include gears configured to transmit power and motion to rotate the drum because gear mechanisms are conventional power transmission components routinely used with rotary medical tools and rotating removal elements. See KSR. Claim 11. The material removal device of claim 8, wherein the removal element further comprises a proximal stabilizing element configured to stabilize and support the implantable medical lead. E.G. via the disclosed proximal clamping ring 24 engaging and stabilizing lead A during extraction operations ([0138]-[0146]). Claim 12. The material removal device of claim 11, wherein the proximal stabilizing element comprises a connector pin spring-loaded collet. It would have been obvious to configure the proximal stabilizing element as a connector pin spring-loading collet because spring-loaded collet mechanisms are well known for securing elongated cylindrical medical components while permitting controlled insertion and removal. See KSR. Claim 13. The material removal device of claim 8, wherein the removal element further comprises a distal stabilizing element configured to stabilize and support the implantable medical lead. E.G. via the disclosed distal clamping ring 22 engaging and stabilizing lead A during extraction, Kalmann [0138]-[0146]. Claim 14. The material removal device of claim 13, wherein the proximal stabilizing element comprises a spring-loaded stabilizer. It would have been obvious to configured the proximal stabilizing element as a spring-loaded stabilizer members are well known for maintaining contact with elongated structures during medical extraction procedures. See KSR. Claim 15. The material removal device of claim 1, wherein the housing is configured to be opened and closed. Regarding claim 15, neither Kalmann et al. nor Makower et al. explicitly teaches the above claim limitation(s). However, it would have been obvious to provide an openable/closable housing to facilitate insertion and removal of leads and improve assembly and servicing access because hinged or separable housings are common mechanical design features in medical devices. See KSR. Claim 16. The material removal device of claim 1, wherein the opening is a first opening, and wherein the housing further defines a second opening sized to receive the implantable medical lead, E.G. via the disclosed multiple access ports/openings and working lumens for insertion of devices and fluids into sealed operative fields; Makower, pp. 22-25. wherein the housing is sealed when the implantable medical lead is advanced through the first opening and the second opening. E.G. via the disclosed substantially fluid-tight sealed operative regions utilizing access openings and seals to prevent escape of fluids and debris; Makower, pp. 20-24. It would have been obvious to apply Makower’s sealing structures to Kalmann’s extraction device in order to retain debris and prevent escape of biological material during lead extraction procedures. Claim 17. A method comprising: advancing an implantable medical lead of a medical device through an opening of a housing of a material removal device, E.G. via the disclosed insertion of the extractor device 10 over lead A, Kalmann, [0143]. wherein the housing is sealed when the implantable medical device is advanced through the opening, E.G. via the disclosed substantially fluid-tight sealed operative environments; Makower, pp. 20-24. and wherein the housing defines a chamber; E.G. via the disclosed operative chambers/regions configured for retaining debris and fluids, pp. 20-24. removing, by a removal element of the material removal device positioned within the housing, material from an outer surface of the implantable medical lead, E.G. via the disclosed knife 50 cutting and removing tissue from lead A; Kalmann, [0142]-[0148]. wherein the chamber is configured to retain the material; E.G. via the disclosed retention and collection of blood, fluids and debris; Makower, pp. 21-24. and inserting at least a portion of the implantable medical lead into a lumen of an extraction sheath. E.G. via the disclosed lead A being received within tubular member 12/lumen of extractor device 10; Kalmann, [0141]-[0148]. Claim 18. The method of claim 17, further comprising rotating, by one or more rotary bearings, the removal element around the implantable medical lead. E.G. via the disclosed rotational and pivoting engagement movement of extraction components around lead A during extraction procedures, [0138]-[0148]. Note: Use of rotary bearings would have been an obvious design optimization as discussed above regarding claim 2. Claim 19. The method of claim 17, further comprising securing, by one or more locking elements, the implantable medical lead so that the implantable medical lead is rotationally fixed relative to the housing. E.G. via the disclosed clamping rings 22/24 gripping and securing lead A during extraction, Kalmann [0138]-[0146]. Claim 20. The method of claim 17, wherein the removal element is as long or longer than a connector of the lead. E.G. via the disclosed elongated extraction structures extending longitudinally over lead A during extraction procedures, Kalmann, [0142]-[0148]. It would have been obvious to dimension the removal element relative to connector size depending upon procedural needs and lead geometry, as such dimensional optimization is a routine engineering consideration. See KSR. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-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, David Hamaoui can be reached at 571-270-5625. 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 (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NICOLE F JOHNSON/Primary Examiner, Art Unit 3796 Application/Control Number: 18/856,785 Page 2 Art Unit: 3796 Application/Control Number: 18/856,785 Page 3 Art Unit: 3796 Application/Control Number: 18/856,785 Page 5 Art Unit: 3796 Application/Control Number: 18/856,785 Page 6 Art Unit: 3796 Application/Control Number: 18/856,785 Page 7 Art Unit: 3796 Application/Control Number: 18/856,785 Page 8 Art Unit: 3796 Application/Control Number: 18/856,785 Page 9 Art Unit: 3796 Application/Control Number: 18/856,785 Page 10 Art Unit: 3796 Application/Control Number: 18/856,785 Page 11 Art Unit: 3796 Application/Control Number: 18/856,785 Page 12 Art Unit: 3796 Application/Control Number: 18/856,785 Page 13 Art Unit: 3796
Prosecution Insights