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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-10, claim 1 recites an electrosurgical device including a handle, one or more electrical elements and a shaft. But nested in the language about the shaft is that a conductor transmits electrical signals from a generator. The claim neither recites that the conductor is “configured to” transmit signals from a generator, which would be a functional recitation, nor that the device includes a generator, which would be a positive recitation. Therefore, it is not clear whether the claims require a generator or not. It is noted that the method claims (30 and 39) are understood to require a generator. Claims 2-10 depend on claim 1 and are therefore also indefinite.
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, 3, 6, 9, 10, 30, 31, 33, 35, 36 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suzuki (US 2007/0021749).
Regarding claims 1, 3, 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 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]).
Regarding claims 30, 31, 33, 35 and 36, the device of Suzuki as discussed above performs the recited methods during normal use. 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.
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 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).
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.
Claims 4 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Remiszewski (US 2007/0282358).
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.
Regarding claim 34, the device of Suzuki when modified as discussed above with respect to claim 4 performs the recited methods during normal use.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of Miyamoto (US 2008/0194910).
Regarding claim 5, 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)
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eggers (US 5,496,314) discloses an electrosurgical tool with a handle, flexible shaft and electrode (fig. 1, col. 3 lines 25-49).
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).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794