DETAILED ACTION
Applicant's preliminary amendments and remarks, filed 10/1/25, are fully acknowledged by the Examiner. Currently, claims 1, 3-5, 8-15, 17-25 are pending. The following is a complete response to the 10/1/25 communication.
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.
Claim(s) 6-8, 12, 13, 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by West (US 2007/0161966).
Regarding claim 6, West teaches an irrigation system for a medical device, the irrigation system comprising:
an irrigation manifold comprising (manifold 122):
a housing defining a housing conduit and extending along a longitudinal axis (134 with housing conduit 130); and
a diverter connecting with the housing to define an annular irrigation chamber and defining a plurality of diverter conduits (diverter defining conduits 128); a main line irrigation tube connected to the housing conduit and configured to connect with a fluid source (main line tube 124); and a plurality of diverter irrigation tubes (diverter irrigation tubes 82), each connected to a respective diverter conduit (plurality of diverter conduits 128 connected to 82), the plurality of diverter irrigation tubes being configured to route a fluid to an end effector of the medical device (fluid routed to end effector 36).
Regarding claim 7, West teaches further comprising the end effector, the end effector comprising a plurality of spines disposed about the longitudinal axis (spines 58), each spine comprising a proximal end connected to the irrigation manifold (proximal portions of 58 connected to the manifold via L3 and 82).
Regarding claim 8, West teaches the end effector further comprising a plurality of jackets (jackets 96 as in Fig. 6), each jacket defining: a spine channel receiving a respective spine of the plurality of spines (channel inserting into L1); and an irrigation conduit that receives a respective diverter irrigation tube of the plurality of the plurality of diverter irrigation tubes (L3).
Regarding claim 12, West teaches further comprising an annulus connected to a distal end of the plurality of spines, the annulus occluding a distal end of each irrigation conduit (60).
Regarding claim 13, West teaches at least one electrode connected to each spine, at least a portion of the plurality of diverter irrigation tubes being configured to route the fluid through at least one outlet defined in or proximal the at least one electrode (electrodes 66 with fluid releasing at 120 proximal the electrode as in Fig. 8).
Regarding claim 16, West teaches an end effector for a medical device (36 of medical device 26), the end effector comprising: an irrigation manifold extending along a longitudinal axis (manifold 122) and comprising: a housing defining a housing lumen and a housing conduit (134 with housing conduit 130); and a diverter defining a diverter lumen, connecting with the housing to define an irrigation chamber (diverter 126 with lumen connecting to 134 to define an irrigation chamber), and defining at least one diverter conduit (plurality of diverter conduits 128), with fluid being configured to flow into the irrigation chamber via the housing conduit and out of the irrigation chamber via the at least one diverter conduit (128 connecting to diverter irrigation tubes 82 to deliver to end effector 36); at least one spine connected to the irrigation manifold at a proximal end of the at least one spine and configured to bow radially outward from the longitudinal axis and to move between an expanded configuration and a collapsed configuration (spines 58 bows radially outward to expand and collapse as in Fig. 2-3 and Fig. 6), the at least one diverter conduit being configured to route the fluid along the at least one spine (via L3); an actuator rod passing through the housing lumen and the diverter lumen and connected to a distal end of the at least one spine (rod shown in Fig. 3 through balloon to carrier 88), the actuator rod being configured to move the at least one spine between the expanded configuration and the collapsed configuration (68 to actuate the spines as in par. [0055]).
Regarding claim 17, West teaches further comprising at least one electrode connected to the at least one spine (66 connected to 96), the at least one electrode comprising an outlet configured to permit the fluid to exit therethrough (66 with an outlet for fluid as in Fig. 8).
Regarding claim 18, West teaches at least one jacket (58), the at least one jacket defining: a spine channel receiving the at least one spine (L1); and an irrigation conduit that connects with the at least one diverter conduit (L2 connecting to 82).
Regarding claim 19, West teaches the at least one jacket comprising a wall separating the spine channel and the irrigation conduit (Fig. 6 with 82 separated from the spine channel L1).
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.
Claim(s) 1-5 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over West (US 2007/0161966) in view of Nguyen (US 2014/0276788).
Regarding claim 1, West teaches an irrigation manifold for a medical device (manifold 122), the irrigation manifold comprising:
a housing extending along a longitudinal axis defining a housing lumen (134 with lumen through the housing as in at least Fig. 20) and a housing conduit (port 130), the housing conduit being configured to connect with a main line irrigation tube (130 connecting to irrigation tube 124); and
a diverter defining a diverter lumen connecting with the housing to define an irrigation chamber (diverter 126 with lumen connecting to 134 to define an irrigation chamber), and comprising:
a first shaft nesting within the housing lumen (shaft 130);
a diverter ring defining a plurality of diverter conduits disposed radially about the longitudinal axis and connecting with a distal end of the housing (plurality of diverter conduits 128), each diverter conduit being configured to connect with a diverter irrigation tube that routes a fluid to an end effector of the medical device (128 connecting to diverter irrigation tubes 82 to deliver to end effector 36).
West is not explicit regarding and a housing conduit offset from the housing lumen.However, Nguyen teaches a housing conduit offset from a main fluid housing (par. [0050] with irrigation 8).It would have been obvious to one of ordinary skill in the art to modify West such that the housing conduit is offset from the housing lumen, as in Nguyen, as a known possible orientation of the irrigation lumen.
Regarding claim 2, West teaches the irrigation chamber being annular in form (irrigation chamber is round in shape as in at least Figs. 17-19).
Regarding claim 3, West teaches the diverter ring defining a lip that nests with an inner annular surface of the housing (edge of 128 nests within annular surface of housing 134).
Regarding claim 4, West teaches the plurality of diverter conduits being spaced about a circumferential periphery of the diverter ring (diverter conduits 128 spaced about a periphery of diverter ring 134).
Regarding claim 5, West teaches the diverter further comprising a second shaft (second shaft 60), the first shaft and the second shaft being disposed on opposing sides of the diverter ring (60 on opposite side of diverter ring).
Regarding claim 20, West is silent regarding the housing conduit and the at least one diverter conduit being laterally offset from the longitudinal axis and extending parallel to the longitudinal axis.However, Nguyen teaches a housing conduit offset from a main fluid housing (par. [0050] with irrigation 8).It would have been obvious to one of ordinary skill in the art to modify West such that the housing conduit is offset from the housing lumen, as in Nguyen, as a known possible orientation of the irrigation lumen.
Allowable Subject Matter
Claims 9-11, 14-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record found are West. However, West does not teach the plurality of diverter irrigation tubes comprising first diverter irrigation tubes and second diverter irrigation tubes, each first diverter irrigation tube being received by the irrigation conduit of a respective jacket of the plurality of jackets, and each second diverter irrigation tube comprising a distal end disposed outside the plurality of jackets.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Oliverius (US 2017/0319269) teaches electrode spines with irrigation. Basu (US 2017/0100187) teaches an annular surface for irrigation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794