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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/31/2025 and 02/15/2024 was filed after the mailing date of the application on 02/06/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 19 recites the limitation "and operatively engaged with the actuatable body" in the last limitation. There is insufficient antecedent basis for this limitation in the claim. Claim 19 depends on claim 17, and an actuatable body is only introduced in claim 18. The Examiner cannot determine if this is an additional actuatable body or the same limitation cited in claim 18. Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Long (US Patent Publication 2011/098704).
Regarding claim 17, Long teaches “(a) a shaft assembly (20) defining a working lumen (26,27, p.[0030]) and terminating into a distal open end”, “(b) a variable displacement electrode assembly (24, 25) configured to ablate tissue, comprising: (i) a first electrode (24), and (ii) a second electrode (25) configured to translate relative to the shaft assembly and the first electrode (p.[0031] "previously discussed, either one or both electrodes 25, 25 may be adapted and configured to slideably move in and out of lumens 26,27", see also Figures 2A, 2C, and p.[0033])”, and “the first electrode and the second electrode configured to cooperatively ablate tissue while the second electrode and the first electrode translate relative to each other while directly engaging tissue.(Fig. 2A, 2D, p.[0044], p.[0036])”.
Regarding claim 18, the limitations of claim 17 are taught as described above. Long teaches “the second electrode (25) being attached to an actuatable body slidably contained within the shaft assembly (“The electrode 25 can be slideably moved in and out of the distal end of the second lumen 27 using a slide member 31 to retract and/or advance the second electrode 25.”, p.[0033])”.
Regarding claim 19, the limitations of claim 17 are taught as described above. Long teaches “further comprising a handle assembly, the handle assembly comprising: (a) a body, (b) a first slider, slidably attached to the body and operatively engaged with the actuatable body (p.[0033], “In one embodiment, the first and second electrical conductors 18, 19 may be provided through the handle 28. In the illustrated embodiment, the electrode 24 can be slideably moved in and out of the distal end of the first lumen 26 using a slide member 30 to retract and/or advance the first electrode 24. The electrode 25 can be slideably moved in and out of the distal end of the second lumen 27 using a slide member 31 to retract and/or advance the second electrode 25. In various embodiments either or both electrodes 24, 25 may be coupled to a single slide member, or additional slide members, to advance and retract the electrodes 24, 25, e.g., position the electrodes 24, 25. In the illustrated embodiment, the first electrical conductor 18 coupled to the first electrode 24 is coupled to the slide member 30. In this manner, the first electrode 24, which is slidably movable within the cannula, lumen, or channel defined by the first lumen 26, can be advanced and retracted with the slide member 30. In the illustrated embodiment, the second electrical conductor 19 coupled to the second electrode 25 is coupled to the slide member 31. In this manner, the second electrode 25, which is slidably movable within the cannula, lumen, or channel defined by the second lumen 27, can be advanced and retracted with the slide member 31. In one embodiment, various slide members, such as the slide member 31, are rotatable. Thus rotation of the slide member 30, 31 rotates the corresponding electrode 24, 25, respectively, at the distal end of the electrical ablation device 20.”)”.
Regarding claim 20, Long teaches “An apparatus, comprising: (a) a shaft assembly (20) defining a working lumen (26, 27, see p.[0030]) and terminating into a distal open end;” and “(b) a variable displacement electrode assembly (24,25) configured to ablate tissue, comprising: (i) a first electrode (24), and (ii) a second electrode (25) configured to translate relative to the shaft assembly and the first electrode (p.[0031], "previously discussed, either one or both electrodes 24, 25 may be adapted and configured to slideably move in and out of lumens 26, 27", as further shown in Figure 2A, 3C, and p.[0033]), the first electrode or the second electrode configured to drag across tissue while cooperatively ablating tissue to define an elongated ablation section (p.[0044], Figure 2A, "the distal end 46 of the first lumen 26 may comprise a cutting edge, such as a bevel or other sharp edge, to aid in the puncturing/piercing of tissue. The distal end 47 of the second lumen 27 may have a similar configuration.")”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US Patent Publication 2009/0118728).
Regarding claim 1, Ostrovsky teaches the method in the Abstract, which states “A method of ablating a tissue comprises inserting first and second electrodes to desired initial positions relative to a tissue mass to be ablated and applying electrical energy to the first and second electrodes to ablate a first portion of tissue between the first and second electrodes in combination with the step of applying electrical energy to desired second positions separated from the desired initial positions by a distance selected to transfer electrical energy around the first portion of tissue through a second portion of tissue to be ablated, the second portion of tissue surrounding the first portion of tissue."
Ostrovsky does not explicitly teach “inserting a variable distance electrode assembly within a patient”, though it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of Ostrovsky is inserted into a patient to treat tissue. It is understood that bodily tissues are internal to the human body and are typically accessed via an insertion into a patient and produces predictable results.
Regarding claim 2, the limitations of claim 1 are taught as described above. Ostrovsky teaches “further comprising inserting a shaft assembly containing the variable distance electrode assembly within the patient while inserting the variable distance electrode assembly” in p.[0067] which states "According to embodiments of the present invention, the operational sequence for the dual mode RF ablation device 100 comprises first inserting the shaft 106, with positive and negative electrodes 102, 104, into the target tissue mass 34 and then deploying the electrode arrays 108, 110 within the target tissue mass 34."
Regarding claim 3, the limitations of claim 2 are taught as described above. Ostrovsky teaches “the first electrode being fixed to the shaft assembly” in Figure 11-12 shows electrode 104 on the shaft assembly and therefore teaches the limitation as described.
Regarding claim 4, the limitations of claim 3 are taught as described above. Ostrovsky teaches “the first electrode being annular shaped and fixed to an open distal end of the shaft assembly” in Figure 11, which shows that the electrode is fixed to an “open” (wherein the Examiner interprets open to mean it is not enclosed by another structure) distal end of the shaft assembly. Ostrovsky does not explicitly teach that the electrode is annular shaped, however, Ostrovsky does state “Since the distance between the electrodes and the size and shape of the electrodes may be specified, damage to nearby organs can be minimized” (p.[0069]). It is the Examiner’s position that because Ostrovsky contemplates that the shape of the electrode can be changed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ostrovsky into an annular-shaped electrode. As stated in Ostrovsky, different electrode shapes can be chosen to minimize damage to nearby organs, and produces predictable results. Moreover, since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See In re Dailey, 149 USPQ 47 (CCPA 1976). It appears that the disclosed device would perform equally well shaped as disclosed by Ostrovsky.
Regarding claims 5 and 6, the limitations of claim 3 are taught as described above. Ostrovsky teaches the claimed limitations in p.[0057], which states “Alternatively, pneumatic or hydraulic power may be used to achieve or control the movement of the electrodes 102, 104 as they are displaced to compress selected portions of the target tissue mass 150. In different embodiments, piezoelectric actuators or other electric actuators may be utilized to move the electrodes 102, 104 relative to one another and to provide and maintain the desired tissue compression." It is the Examiner’s position that the system of Ostrovsky would be capable of translating the first and second electrode via the piezoelectric actuators adjacent to the targeted tissue and therefore teaches the limitations.
Regarding claim 7, the limitations of claim 6 are taught as described above. The Examiner is unable to determine the meets and bounds of the phrase "dragging" the electrode across the tissue, however, under broadest reasonable interpretation, dragging is defined as to pull along forcefully or pass slowly. In view of this interpretation, Ostrovsky teaches the limitation in p.[0057] which states "Alternatively, pneumatic or hydraulic power may be used to achieve or control the movement of the electrodes 102, 104 as they are displaced to compress selected portions of the target tissue mass 150. In different embodiments, piezoelectric actuators or other electric actuators may be utilized to move the electrodes 102, 104 relative to one another and to provide and maintain the desired tissue compression." It is the Examiner's position that the first or second electrode could be "dragged" or otherwise moved across the targeted tissue area while the second or first electrode could also be translated simultaneously to define a distance to maintain the desired tissue compression in the procedure, and such a procedure produces predictable results.
Regarding claim 16, the limitations of claim 1 are taught as described above. Ostrovsky teaches “further comprising applying RF energy to ablate the targeted tissue area while activating the first electrode and the second electrode” in the abstract, which states “Abstract "A method of ablating a tissue comprises inserting first and second electrodes to desired initial positions relative to a tissue mass to be ablated and applying electrical energy to the first and second electrodes to ablate a first portion of tissue between the first and second electrodes in combination with the step of applying electrical energy to desired second positions separated from the desired initial positions by a distance selected to transfer electrical energy around the first portion of tissue through a second portion of tissue to be ablated, the second portion of tissue surrounding the first portion of tissue." Note that electrical energy encompasses RF energy, and therefore teaches the limitation as described.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US Patent Publication 2009/0118728) in view of Townley (US Patent Publication 2022/0079656).
Regarding claim 8, the limitations of claim 1 are taught as described above. Ostrovsky does not teach the use of connecting fluid to a targeted tissue area, but Townley does in an analogous electrosurgical device. Townley teaches in p.[0151] " The handheld device 102 may further include an auxiliary line 121, which may provide a fluid connection between a fluid source, for example, and the shaft 116 such that fluid may be provided to a target site via the distal end of the shaft 116". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Townley in view of Ostrovsky. It is known in the art to use irrigation or fluid delivery in electrosurgical devices to either remove debris from ablation, cool treated tissue from ablation, or otherwise deliver therapeutic agents to a treatment site, all of which produce predictable results.
Claims 9-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US Patent Publication 2009/0118728) in view of Townley (US Patent Publication 2022/0079656) and Salahieh (US Patent Publication 2017/0080184).
Regarding claim 9, the limitations of claim 8 are taught as described above. Ostrovsky/Townley does not teach the claimed limitation “further comprising actuating a fluid delivery member toward the targeted tissue area”, but Salahieh does in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0063] which states " Handle 11 includes at least one delivery member actuation element 12 (two shown), and at least one fluid control actuation element 15 (two shown). Delivery member actuation element 12 can be adapted to steer delivery member 13, including distal delivery region 14, to a target location within the body. Delivery member actuation element 12 can also be adapted to reconfigure distal delivery region 14 between a delivery configuration and one or more procedural configurations. Fluid control actuation element 15 is adapted to actuate fluid controls 16 to effect peripheral tissue remodeling." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Ostrovsky/Townley. It is known in the art to use fluid as an irrigate or for treating tissue in the art, and such use of fluid produces predictable results.
Regarding claim 10, the limitations of claim 9 are taught as described above. Ostrovsky/Townley does not teach the claimed limitation “the fluid delivery member being slidably disposed within a shaft assembly, the method further comprising actuating the fluid delivery member distally past the shaft assembly while actuating the fluid delivery member within the anatomical passageway”, but Salahieh does in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0065-0057], specifically "After the treatment has been administered, control member 33 is advanced distally with respect to the proximal portion of sheath 36 to move the ends of the tubular elements away from one another, reconfiguring the tubular elements back towards their delivery configurations. When the tubular elements are in their expanded configurations, ejection ports 35 are disposed in a plane substantially normal to that of the longitudinal axis of elongate delivery member 13" Note that the control member may also include the fluid delivery member. It would have been obvious to one of orindary skill in the art before the effective filing date of the claimed invention to use Salahieh in view of Ostrovsky. It is known in the art to use irrigate or fluid to treat tissue, and the use of such fluid delivery produces predictable results.
Regarding claim 11, the limitations of claim 10 are taught as described above. Ostrovsky/Townley does not teach the claimed limitation, however, Salahieh does in an analogous tissue treatment device. Salahieh teaches this limitation in p.[0088] which states " In yet another embodiment as depicted in FIG. 38, a penetrating remodeling element 19 is a needle. The needle has a helical configuration and delivered while contained with an outer sheath of a delivery section 13 of a delivery system, not shown. In this configuration, the outer sheath of the delivery section has a stiffness sufficient to maintain the spring element in a straightened configuration. On delivery the remodeling element is pushed distally out of the distal end of the outer sheath of the delivery system until the distal end of the remodeling element has passed into the vessel wall. The remodeling element is then twisted, which in combination with the pre-set spiral configuration allows the remodeling element 16 to screw its way around the vessel within the adventitial layer." Note that adventitial tissue constitutes as a type of tissue that is being penetrated. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Salahieh in Ostrovsky/Townley. As stated in Salahieh, the use of the needle allows for greater penetration of the fluid as desired during the procedure and produces predictable results (p.[0088-0090]).
Regarding claim 14, the limitations of claim 10 are taught as described above. Ostrovsky teaches this limitation in Figure 1 shows that electrode 16 can be attached to outer tube 26, wherein a tube is considered to be probe given the cylindrical shape, and teaches the limitation as described.
Regarding claim 15, the limitations of claim 14 are taught as described above. Ostrovsky teaches the limitation in p.[0040], which describes that the first electrode can be attached to outer tube 26, and a second electrode can be attached to inner tube 28, wherein both tubes are actuatable relative to one another. Note that the Examiner is interpreting a probe to be synonymous to a tube and therefore teaches the limitation as described.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ostrovsky (US Patent Publication 2009/0118728) in view of Townley (US Patent Publication 2022/0079656), Salahieh (US Patent Publication 2017/0080184), and Palushi (US 2022/0054188).
Regarding claim 12, the limitations of claim 10 are taught as described above. Neither Salahieh nor Ostrovsky nor Townley teach the use of an electrode being attached to a fluid delivery member, but Palushi does in an analogous electrosurgical device. Palushi teaches in p.[0104] that a delivery cannula may be used to provide irrigation at the site, and the delivery cannula also includes loop electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Palushi in view of Salahieh/Ostrovsky/Townley. As stated in Palushi, doing so allows the device “to deliver therapeutic agent, loop electrode assembly (240) may be used to provide electroporation of tissue to thereby facilitate delivery of the therapeutic substances, etc. from cannula (260) to the tissue" and produces predictable results.
Regarding claim 13, the limitations of claim 12 are taught as described above. Ostrovsky teaches “the second electrode being attached to a probe, the probe being actuatable relative to the fluid delivery member” in Figure 1, which shows electrode 16 can be attached to outer tube 26, wherein a tube is considered to be probe given the cylindrical structure, and teaches the limitation as described. The tube 26 is actuatable, so in combination with Palushi, would be actuatable relative to the fluid delivery member.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794