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 § 102
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.
Claims 1, 6, 9, 10 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki (US 2007/0021749).
Regarding claims 1, 6, 9 and 10, Suzuki discloses an electrosurgical device that includes a handle (8, fig. 1), a shaft (3, fig. 2) and an electrical element which is an electrode (2). The shaft includes an outer structure defining a passageway between the handle and the electrical element (7), and a conductive wire forming a coil (one of 6a-d) which transmits electrical signals between a generator (power source, [0007]) and the electrical elements ([0048]-[0049]). The wire is insulated (at least by 7 so that the exterior surface of the shaft is not electrically conductive, fig. 2, although the claim does not even specifically recite an electrical insulation). The coil bends in response to a force relative to some threshold and determines the bended shape for the shaft (the shaft being flexible, [0043], due to the coil), where the coil being comprised of several metallic elements will provide greater resistance to bending than the outer structure which exits simply to cover the coil ([0043]). Further, Suzuki discloses an additional material (the other of 6a-d not the conductor as defined above), where the number of wires used to create the coil will determine the bending threshold for the coil (see also [0061]-[0062] regarding using wires of different materials to change the properties of the shaft). In the interest of compact prosecution, it is noted that while the cited embodiment of Suzuki employs an electrode configured as a forceps, there is an express teaching that other types of electrodes can be substituted including cutting electrodes ([0065]). The claims also recite that the coil is “sufficiently rigid” to maintain a bended shape during use of the device. This limitation only describes how any metallic wire would function. That is, given sufficient force, metallic wire transitions through a linear part of the stress-strain curve representing elastic deformation and arrives at the non-linear part of the curve representing the plastic deformation that occurs before failure. Since the device of Suzuki could in fact be bent with sufficient force to result in permanent deformation, even where such deformation may not even be desirable, the device of Suzuki reads on the claims.
Regarding claim 39, the method of making the device of Suzuki as discussed above includes the recited steps since any method of making will including such generic steps as “forming,” “positioning” and “coupling” the various elements disclosed by Suzuki into a functional device.
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, 6, 9, 10, 30, 31, 33, 36 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Aluru (US 2014/0200581).
Regarding claims 1, 6, 9, 10, 30, 31, 33 and 36 Suzuki discloses a method of using an electrosurgical device that includes a handle (8, fig. 1), a shaft (3, fig. 2) and an electrical element which is an electrode (2). The shaft includes an outer structure defining a passageway between the handle and the electrical element (7), and a conductive wire forming a coil (one of 6a-d) which transmits electrical signals between a generator (power source, [0007]) and the electrical elements ([0048]-[0049]). The wire is insulated (at least by 7 so that the exterior surface of the shaft is not electrically conductive, fig. 2, although the claim does not even specifically recite an electrical insulation). The coil bends in response to a force relative to some threshold and determines the bended shape for the shaft (the shaft being flexible, [0043], due to the coil), where the coil being comprised of several metallic elements will provide greater resistance to bending than the outer structure which exits simply to cover the coil ([0043]). Further, Suzuki discloses an additional material (the other of 6a-d not the conductor as defined above), where the number of wires used to create the coil will determine the bending threshold for the coil (see also [0061]-[0062] regarding using wires of different materials to change the properties of the shaft). In the interest of compact prosecution, it is noted that while the cited embodiment of Suzuki employs an electrode configured as a forceps, there is an express teaching that other types of electrodes can be substituted including cutting electrodes ([0065]). Further in the interest of compact prosecution, Suzuki will be interpreted more narrowly than the language requires to include structural elements that allow the steps of the method to be performed. Interpreted thus, Suzuki does not disclose the structural elements that would allow the shaft to be bended to a first shape that would be useful in maneuvering the device to a surgical site and conducting electrical signals (presumably to the site). However, shafts of various flexibility, including malleability (defined here as maintaining a shape after bending which includes by definition a threshold force resulting in the bend) are commonly known in the art. While this is generally true (see Conclusion below for example), it is also true with respect to endoscopic devices such as Suzuki. Aluru, for example, discloses an electrosurgical device with a shaft (100, fig. 2A) and teaches that the shaft can be flexible or rigid, or alternatively malleable to allow the device to be shaped appropriately relative to an endoscope ([0055]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the device and method of Suzuki to include a flexible shaft capable of maintaining a bent shape, such as taught by Aluru, to produce the predictable result of allowing a user to bend the shaft and have the shaft maintain that bended shape before, during and after using an endoscope to facilitate maneuvering the device to a surgical site and using the device there in conjunction with the endoscope. It is noted that one or more of the wires forming the coils in Suzuki are equivalent to the “inner support structure” of claim 31.
Regarding claim 39, the method of making the device of Suzuki as discussed above includes the recited steps since any method of making will including such generic steps as “forming,” “positioning” and “coupling” the various elements disclosed by Suzuki into a functional device.
Claims 2, 8, 32 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Harris (US 5,626,577), and/or in view of Suzuki, Aluru and Harris.
Regarding claim 2, Suzuki does not disclose the shaft is configured to move relative to the handle between extended and retracted positions to move the distal end of the device relative to the handle. However, telescoping portions are very common in the art and there is no evidence that such structure produces an unexpected result (within the meaning of MPEP 716.02(a)). Harris discloses an electrosurgical device with a telescoping shaft that moves the distal end of the device relative to a handle (compare figs. 2 and 3). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the shaft of Suzuki to be telescopic as taught by Harris that would produce the predictable result of allowing a user to configure the device in a manner that would allow the device to be used to interact with tissue in a desired manner by extending the shaft relative to the handle.
Regarding claim 8, Suzuki discloses an electrical connector on the handle for receiving signals from the generator but does not disclose the connector extends proximally from the handle. However, electrical connectors are ubiquitous in the electrosurgical device art and there is no evidence that the direction of the connector produces an unexpected result. Harris discloses an electrosurgical device and includes a connector extending proximally from the handle (fig. 1). It has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to modify the handle of Suzuki to have an electrical connector extending in any direction, including proximally as taught by Harris, that would produce the predictable result of allowing the device to be connected to a generator.
Regarding claim 32, the device of Suzuki when modified as discussed above with respect to claim 2 performs the recited methods during normal use.
Regarding claim 38, the device of Suzuki when modified as discussed above with respect to claim 8 performs the recited methods during normal use.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Albertal (US 2015/0359581) and/or in view of Suzuki, Aluru and Albertal.
Regarding claim 3, Suzuki does not disclose the use of a light source or an additional insulated connector that supplies power to the light source. However, coiled connectors are common in the art such as taught by Suzuki and discussed above. Further, using an optional light source connected by a wire to an independent power source is also common in the art such as taught by Albertal (fig. 10, [0066]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Suzuki to include a light source connected with a wire to an independent power source such as taught by Albertal, and to provide the wire in any commonly known configuration including as part of the coil as taught by Suzuki, that would produce the predictable result of allowing a user access to a light source.
Claims 4 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Remiszewski (US 2007/0282358), and/or in view of Suzuki, Aluru and Remiszewksi.
Regarding claim 4, Suzuki does not disclose that the outer structure is formed from a heat shrink material. However, using heat shrink material is very common in the art and there is no evidence that such structure produces an unexpected result. Further, the fact that Applicant has claimed two mutually exclusive configurations for outer structure suggests the opposite, that such elements are common and only do exactly what a person of ordinary skill in the art would expect. Remiszewski discloses an electrosurgical device and teaches that heat shrink tubing can be useful for friction resistance and electrical insulation ([0102]), both of which are relevant to the device of Suzuki (e.g. outer structure 7 is electrically insulating, [0048]). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the outer structure of Suzuki to have any commonly known configuration, including as a lubricious, insulating heat shrink material such as taught by Remiszewski, that would produce the predictable result of providing the device with desired electrical and mechanical properties. This includes insulating the conductors.
Regarding claim 34, the device of Suzuki when modified as discussed above with respect to claim 4 performs the recited methods during normal use.
Claims 5 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Miyamoto (US 2008/0194910), and/or in view of Suzuki, Aluru and Miyamoto.
Regarding claims 5 and 35, Suzuki does not disclose that the outer structure includes a second series of loops. However, using one or more series of loops to provide desired operational characteristics for medical device shafts is common in the art and there is no evidence that such structure produces an unexpected result. Further, the fact that Applicant has claimed two mutually exclusive structures for outer structure suggests the opposite, that such elements are common and only do exactly what a person of ordinary skill in the art would expect. Miyamoto discloses a device very similar to Suzuki and teaches that the outer structure can include a second (7, fig. 1) and in fact a third (83, fig. 10) series of loops. Miyamoto discloses these various embodiments allow improved mechanical performance during use of the device (e.g. [0047]-[0049]). Therefore, before the application was filed, it would have been obvious to provide the outer structure of Suzuki with a second series of loops as taught by Miyamoto to improve the mechanical performance of the shaft.
Claims 7 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Smith (US 2002/0060756), and/or in view of Suzuki, Aluru and Smith.
Regarding claim 7, Suzuki does not disclose the handle including a user input for operating the electrical elements. However, buttons on handles are very common in electrosurgical devices and there is no evidence that such structure produces an unexpected result. Smith discloses an electrosurgical device and teaches that switches for controlling energy can be connected to the generator or the handle ([0092]). Therefore, before the application was filed, it would have been obvious to modify the device of Suzuki to have switches anywhere they would be operable by a user, including on the handle as taught by Smith, that would produce the predictable result of allowing the user to control energy supplied by the device.
Regarding claim 37, the device of Suzuki when modified as discussed above with respect to claim 7 performs the recited methods during normal use.
Response to Arguments
Applicant’s arguments with respect to claims 30 and 39 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.
Applicant's arguments with respect to claim 1 have been fully considered but they are not persuasive. As noted in the interview, the claim language recites purely functional limitations that are capable of being performed by any metallic coil of the type found in medical devices (at least). However, in the interest of compact prosecution, an additional rejection of claim 1 is presented.
Further, it is noted that while the four-wire configuration of Suzuki does appear to be different from the disclosed invention, insulating the wires along the coil (such as by specifically reciting that each wire has a complete coating of insulation) does not prevent the advantages disclosed by Suzuki as long as all the wires are connected to both the electrode and the energy source. That is, the increased wire surface area and the shortening of the wire length will both still be true if the wires are insulated between the electrode and the energy source. Further, it is noted that Suzuki specifically contemplates other configurations including energized single-coil embodiments (e.g. [0102] which specifically notes single-coil 42 can be energized or replaced by the multiple-thread coil).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the general teaching that the shaft of a medical device can be polymer or metal, rigid or flexible, resilient or malleable, or any combination of those characteristics along the length of a shaft, see paragraph [0063] of US 2010/0125266 to Deem. Regarding the general teaching that wires for different uses can be provided together in the same coil, see column 5 lines 56-64 of US 9,986,949 to Govari.
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
Prosecution Insights