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 .
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirza (US 8679107 B2) in view of Davies US 2017/0360498 A1)
Regarding claims 1, 15, and 20, Mirza discloses a medical system for creating a channel between two anatomical structures (Eg. Abstract), the system comprising: an outer member having a proximal portion and a tapered distal portion (eg. Abstract, Col. 4, Ln. 30 – Col. 5, Ln. 46), and a lumen extending from the proximal portion to the tapered distal portion (eg. Col. 5, Ln. 15-46, Col. 6, Ln. 12-40), at least a portion of the lumen having an electrically conductive surface extending to a distal end of the tapered distal portion; an inner member having a proximal portion and a distal portion (eg. Col. 12, Ln. 1-28, Col. 15, Ln. 24-39, Claim 1), the inner member being configured to translate within the lumen and to deliver a therapy to a target tissue (eg. Col. 5, Ln. 47 – Col. 6, Ln. 40, Col. 9, Ln. 60 – Col. 10, Ln. 20, Col. 11, Ln. 20-44, Col. 19, Ln. 3-65); wherein the inner member distal portion includes a conductive distal tip configured to electrically couple with the electrically conductive surface of the outer member and the proximal portion is adapted to electrically couple the conductive distal tip to an auxiliary device (eg. Col. 13, Ln. 1-51). Mirza does not specifically discloses an EAM device.
Davies teaches a EAM system (eg. Abstract) with a needle operable to conduct electricity at a distal end (eg. EAM system 130 electrode 119 of needle 120) that can be inside a catheter (eg. Fig. 3, Para. 25, 42, 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of Mirza to accommodate an EAM system to be used through the lumen since the Mirza RF perforation apparatus already comprises a proximal hub electrically connectable to an energy source. Modifying the hub to be an EAM system as taught by Davies would provide the predictable result of enabling real-time visualization and localization of the distal tip electrode.
Regarding claims 2 and 16, the combined invention of Mirza and Davies discloses the outer member is a hypotube (eg. Mirza, Col. 2, Ln. 9-10, Col. 7, Ln. 35 – Col. 8, Ln. 2, stainless steel tube).
Regarding claims 3 and 17, the combined invention of Mirza and Davies discloses the electrically conductive surface includes a coating (eg. Mirza, Col. 10, Ln. 32-45).
Regarding claim 4, the combined invention of Mirza and Davies discloses the electrically conductive surface extends from the outer member proximal portion to the distal end of the tapered distal portion (eg. Mirza, Col. 8, Ln. 3-60, Col. 12, Ln. 1-36, Col. 15, Ln. 24-40).
Regarding claim 5, the combined invention of Mirza and Davies discloses the therapy delivered by the inner member is to puncture the target tissue (eg. Mirza, Abstract, Fig. 1A, Col. 10, Ln. 44 – Col. 11, Ln. 20 perforation apparatus and Davies, Para. 31).
Regarding claim 6, the combined invention of Mirza and Davies discloses the outer member includes a layer of insulation surrounding the electrically conductive surface (eg. Mirza, Col. 1, Ln. 24-32, Col. 12, Ln. 29-36, Fig 1A insulator 104).
Regarding claim 7, the combined invention of Mirza and Davies discloses auxiliary device is an EAM system adapted to identify and display a location of the distal end (eg. Davies, Para. 46).
Regarding claim 8, the combined invention of Mirza and Davies discloses the outer member distal portion includes an electrode (eg. Mirza, electrode 106 and Davies electrode 119 of needle 120).
Regarding claim 9, the combined invention of Miurza and Davies discloses the electrode is formed by the electrically conductive surface (eg. Mirza, Col. 8, Ln. 30-60, Col. 12, Ln. 29-36).
Regarding claim 10, the combined invention of Mirza and Davies discloses the electrode is flush with an outer surface of the outer member (eg. Mirza, Col. 11, Ln. 20-45, one of ordinary skill would have been able to change the size, shape, and/or position of the electrode to be flush with an outer surface as a design choice, see MPEP 2144.04).
Regarding claims 11 and 18, the combined invention of Mirza and Davies discloses the inner member includes a proximal contact configured to electrically couple with the electrically conductive surface (eg. Mirza, Col. 5, Ln. 47 – Col. 6, Ln. 11, Col. 13, Ln. 9-25).
Regarding claim 12, the combined invention of Mirza and Davies discloses proximal contact includes an enlarged portion (eg. Mirza, Col. 13, Ln. 9-25, banana jack, one of ordinary skill could have changed the size of a component as desired since enlarging connectors are common in the art, see MPEP 2144.04).
Regarding claim 13, the combined invention of Mirza and Davies discloses the proximal contact includes a retrograde wire (eg. Mirza, Col. 13, Ln. 9-25, conductive wire 500).
Regarding claim 14, the combined invention of Mirza and Davies discloses the outer member distal portion includes a distal tip, and the electrically conductive surface extends beyond the distal tip (eg. Mirza, Col. 8, Ln. 63 – Col. 9 Ln. 25, external component 400).
the combined invention of Mirza and Davies discloses includes a proximal contact configured to electrically couple with the conductive surface
Regarding claim 19, the combined invention of Mirza and Davies discloses the proximal contact includes an enlarged portion or a retrograde wire (eg. Mirza, Col. 13, Ln. 9-25).
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796
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