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 (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.
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 1-7, 10-14, 16-22, 25-27, 29, 30, 42, 43, 45-51 and 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US 2017/0071667) in view of Christian (US 5,240,437), Garito (US 5,984,918) and Cornacchia (US 2015/0342667).
Regarding claims 1-7, 10-13, 16-22, 25-27, 29, 45-51 and 53, Leung discloses what can be considered a generic electrosurgical guidewire system (fig. 1A) that includes an electrosurgical generator unit for generating monopolar energy through a connection ([0044]) and an assembly including an interventional guidewire for delivering the energy (100, [0159]) which has an insulated wire (114) and uninsulated tip electrode portion (112). Leung does not disclose the coupler for connecting the interventional wire to an elongated flexible conductive cable. Leung also does not specifically describe how the energy is controlled and so does not disclose the integrated activator.
Regarding the coupler, Christian discloses a guidewire apparatus and generally teaches that it is commonly known for a handle to be provided for operating electrically active guidewires such that the guidewires can be exchanged by disconnecting the proximal, uninsulated end of the guidewire from the handle using a collet (fig. 10, col. 11 lines 17-26), where the handle is connected to appropriate circuitry by a cable (123, fig. 8). The fact that Leung discloses that several different guidewire tips can be employed (figs. 9A-E) also suggests the system would benefit from interchangeability. Garito discloses an electrosurgical device with a physically and electrically disconnectable electrode (74, fig. 1) and teaches that the connection functionality is provided by an electrically conductive coupler in the form of a collet (24, fig. 2) that can be used to hold an electrically uninsulated proximal end of the electrode (col. 5 lines 1-15). The collet is connected at a proximal end to an electrosurgical generator by a cable for the transmission of RF energy between the generator and electrode (60, fig. 1), such that the coupler conducts RF energy between the generator and the electrode. The coupler further includes a housing containing the collet (10) and a cap that connects the collet to the housing (44) for tightening or loosening the collet on the proximal end of the electrode (see discussion associated with figures 3-6). It has been held that the combination of known elements according to know methods to yield predictable results is an obvious modification (MPEP 2141(III)). More specifically, making elements separable has been held to be an obvious modification (MPEP 2144.04(V)(C)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Leung to include a handle with a proximal end with a cable and a distal end with structure for connecting to the proximal, uninsulated end of the guidewire, such as taught by Christian, using any commonly known electrical/physical connection structure including the conductive coupler (with collet, cap and housing) taught by Garito, that would produce the predictable result of allowing a user to physically and electrically connect/disconnect/reconnect the guidewire from the handle for any reason a user might have for doing so. Regarding the integrated activator, control element location selection in medical systems is well within the level of ordinary skill in the art. Cornacchia discloses an electrosurgical system and teaches that the activator, integrated with one or more other elements, can be located anywhere along the current path between the treatment end and the electrosurgical unit ([0030]), including specifically along an elongated flexible conductive element (40 in fig. 5a). The activator includes a switch for controlling energy (36). Therefore, before the application was filed, it would have been obvious to further modify the apparatus of Leung to include an integrated activator anywhere along the current path, such as taught by Cornacchia, including between the ends of the elongated flexible conductive element, that would produce the predictable result of allowing a user to control energy delivered to the wire.
Regarding claims 14, 30, 42, 43, 54 and 55, the apparatus of Leung does not specifically include a disconnectable connection between the electrosurgical unit and the elongate flexible conductive element. However, this is a common feature of electrosurgical systems such as taught by Garito (62, fig. 1), where the connection interacts with a receptable of an electrosurgical unit (80). Therefore, before the application was filed, it would have been obvious to further modify the apparatus of Leung to include any commonly known features of electrosurgical units and elongate flexible conductive elements, including a plug as taught by Garito, that would produce the predictable results associated with those features.
Claims 15, 28 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Leung, Garito, Christian and Cornacchia, further in view of Harmouche (US 2019/0142509).
Regarding claims 15, 28 and 52, the apparatus of Leung does not disclose the use of an electroanatomical mapping system. However, using wires for electroanatomical mapping is common in the art, such as taught by Harmouche ([0066]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the apparatus of Leung with an electrical connector for connecting to an electroanatomic mapping system such as taught by Harmouche that would produce the predictable result of allowing a user to use the wire to map tissue locations.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted, however, that while the claim amendments push the claims beyond what can reasonably be considered disclosed by Christian regarding the collet, the arguments do rely substantially on a view of the combination that does not account for the level of ordinary skill in the art in view of what modification is occurring and would not be persuasive alone. Guidewires are ubiquitous in the art and electrosurgical guidewires are very common. Leung was selected as the base reference because it uses the claimed guidewire, and it is therefore Leung that is being modified. Further, this modification is being accomplished by a person of ordinary skill in the art where it is well established that “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton” as discussed in MPEP 2141(II)(C). A person of ordinary skill in the art would reasonably look to Christian when considering how to implement a handle for a detachable guidewire but is under no obligation to import all the structures of Christian into the device of Leung such as the various sensing elements. Christian was cited for the very clear teaching that a guidewire can be physically and electrically disconnected from a handle and a person of ordinary skill in the art would be able to implement those teachings in the monopolar ablation system of Leung without reference to whatever other features/elements Christian may have. It is also noted that teaching away requires a reference to “criticize, discredit, or otherwise discourage the solution claimed” (MPEP 2145(X)(D)(1)). Such a statement or sentiment is absent from Christian regarding whether Leung could reasonably be provided with a monopolar connection in a handle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the use of electrically conductive collets, see also figure 1 of US 3,746,814 to Lackey and figure 5 of US 3,532,095 to Miller.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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, Joseph Stoklosa can be reached at 571-272-1213. 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.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794