DETAILED ACTION
This action is in response to amendments received on 7/23/2026. Claims 1-2 and 4-21 were previously pending. Claims 1, 2, 13, 16, 18-19 have been amended, claim 21 canceled and new claim 22 added. A complete action on the merits of claims 1-2, 4-20 and 22 follows below.
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 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 § 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 4-6, 8-10 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Okada (US Pub. No. 2004/0210215) in view of Leeflang (US Pub. No. 2015/0273181).
Regarding Claim 1, Okada teaches a medical device (Fig. 1A and 13), comprising:
a handle 48, including a movable body 44;
a shaft 20 extending from the handle and including a lumen (Fig. 1A);
an outer coating 24 (Fig. 1A and [0048]); and
an end cap 30 positioned at a distal end of the shaft (Fig. 1A);
an electrode 64/80 at the distal end of the shaft (Fig. 1A, 13 and [0050]-[0053]), wherein a portion of the electrode is positioned within the lumen of the shaft (“the small-diameter electrode section 66 is electrically connected to the connector section 42 of the slider 44 for operation via the stopper receiving section 62 and operating wire 60, and is movable along the axial direction in an inner hole of the sheath 20 by an advance/retreat operation of the operating wire 60. Therefore, the small-diameter electrode section 66 is capable of projecting/retrojecting with respect to the tip end of the sheath 20” [0053]);
wherein movement of the movable body 44 of the handle controls a position of the electrode relative to the end cap 30 at the distal end of the shaft such that the electrode (section 66 of electrode 64/80) moves relative to the end cap (“the small-diameter electrode section 66 is capable of projecting/retrojecting with respect to the tip end of the sheath 20” [0053]),
wherein the medical device is an electrosurgical knife (“a cutter section 80. The cutter section 80 includes an electrode 64” [0052]);
wherein at least a portion of the shaft includes a coil 22 ([0048]-[0049] and Figs. 1A, 13) wherein the coil 22 terminates proximal to the end cap 30 (Fig. 1A); however, does not specifically teach or show wherein at least a portion of the shaft comprises a braiding wherein the braiding comprises a plurality of threads, wherein at least two threads of the plurality of threads are positioned adjacent to one another, and wherein the braiding is embedded within the outer coating, such that each thread of the braiding is entirely radially surrounded by the outer coating;
In the same field of invention, Leeflang teaches the use of “reinforcement layer 42” including “one or more reinforcing members, e.g., wound in a braided or other helical configuration around the inner liner 40a, and the outer jacket 44 may include one or more tubular layers surrounding the reinforcement layer 42 and/or between the reinforcement layer 42 and the inner liner 40a. In an exemplary embodiment, the reinforcement layer 42 may include one or more, or a plurality of, round or flat (e.g., rectangular, elliptical, or flat oval) wires, filaments, strands, or other reinforcement members 43, e.g., formed from metal, such as stainless steel, plastic, glass, woven or twisted fibers, such as aramid, and the like, or composite materials” [0055], the plurality of reinforcement members 43a or 43b are positioned adjacent to one another as seen in Figs. 1B-1C and “Exemplary materials for the jacket material 7 include plastics, e.g., thermoplastics, such as polyether block amide, nylon, or urethanes, thermoset plastics, metals, or composite materials. Alternatively, other processing may be used to bond or otherwise attach the jacket material 7 to the liner material 4 and/or embed the reinforcement members 43 in the jacket material 7, thereby resulting in an integral tubular body 8” [0091] such that each thread of the braiding is entirely radially surrounded by the outer coating as seen in Figs. 1B-1C. Figs. 11A-11B also shows at least two reinforcement wires 6 positioned adjacent to one another in a braided configuration.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make use a plurality of strands of reinforcement members braided together and entirely embedded within the outer coating of Okada in order to create a unitary structure of flexible catheter having a stiffness characteristic to enhance support of a steerable portion of the tubular devices as Leeflang teaches.
Regarding Claim 2, Okada in view of Leeflang teaches wherein the braiding is a polymer (plastic [0055] of Leeflang).
Regarding Claim 4, Okada in view of Leeflang teaches wherein each thread of the plurality of threads includes one or more wires ([0055] and Figs. 1B-1C of Leeflang).
Regarding Claim 5, Okada in view of Leeflang teaches further comprising an inner shaft, and wherein the plurality of threads are deposited over at least a portion of the inner shaft (inner liner 40/40a [0049], [0055] and Figs. 1B-1C of Leeflang).
Regarding Claim 6, Okada in view of Leeflang teaches wherein the braiding extends along an entire length of the inner shaft (inner liner 40/40a [0049], [0055] and Figs. 1B-1C of Leeflang).
Regarding Claim 8, Okada teaches wherein the handle includes a port and an electrical connection, wherein the handle and the shaft connect the port and the electrical connection to the electrode (Fig. 14 and [0050], [0124]-[0127] of Okada).
Regarding Claim 9, Okada in view of Leeflang teaches wherein movement of the movable body 44 of the handle controls a position of the electrode relative to the distal end of the shaft without delay ([0053]-[0058] of Okada).
Regarding Claim 10, Okada in view of Leeflang teaches wherein the braiding is configured to minimize kinking of the shaft ([0057] of Leeflang) or a drive element connecting the movable body to the electrode (Figs. 1A and 13 of Okada shows a drive element (connective operating wire 60) connecting the movable body to the electrode [0051]-[0053] of Okada).
Regarding Claim 14, Okada teaches wherein the handle includes one or more indicators, wherein the one or more indicators are indicative of at one or more configurations of the electrode relative to the distal end of the shaft (see the annotated figure below).
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Regarding Claim 15, Okada teaches wherein the one or more indicators includes a first indicator and a second indicator, wherein the first indicator is indicative of a retracted configuration of the electrode, and wherein the second indicator is indicative of an extended configuration of the electrode (see the annotated figure above).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Leeflang as applied above, in view of Bloom (US Pub. No. 2015/0173827).
Regarding Claim 7, Okada in view of Leeflang teaches wherein the outer coating is formed of “outer jacket 44 may be formed from multiple layers of like or different materials (not shown), e.g., to provide desired material properties in the different portions of the apparatus 10. In an exemplary embodiment, the outer jacket 44 may be formed from PEBAX, nylon, urethane, and/or other thermoplastic material” in [0053] of Leeflang, but not specifically a polyether ether ketone (PEEK) as claimed.
In the same field of invention, Bloom teaches “the outer shaft 130 [are] selectively covered or coated with an insulator … In one example, the coating includes polyaryletherketones (PAEK) polymer thermoplastic such as polyetheretherketone (PEEK) polymer thermoplastic.”
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the coating from PEEK polymer thermoplastic, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 11-13, 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Okada in view of Leeflang as applied above, in view of Davies (US Pub. No. 2015/0216620).
Regarding Claims 11 and 12, Okada in view of Leeflang teaches the invention as applied above, however, does not teach wherein a distal portion of the shaft further includes a ring partially encapsulated by a portion of the outer coating of the braiding.
In the same field of invention, Davies teaches “a radiopaque marker that is a ring-shaped hollow band” [0050] and “distal end of end member 10 includes a functional tip 15 that includes the aforementioned electrode 3 and a radiopaque marker 6 … Depending on how far distally insulating layer 5 extends along distal portion 4, part, all, or none of radiopaque marker 6 can be covered by the insulating layer” [0068].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a ring of radiopaque material embedded within the outer shaft (outer coating) of Okada to permit detection of the tip during fluoroscopy or related procedures as Davies teaches.
Regarding Claim 13, Okada in view of Leeflang and further in view of Davies teaches wherein a portion of the end cap extends distally of the distal end of the shaft to form an exposed portion of the end cap 30 (Figs. 1A, 13 of Okada), wherein the end cap 30 is at least partially insulative ([0049] of Okada), wherein the ring is positioned proximal of the exposed portion of the end cap (in view of Johnson to add a radiopaque ring to the shaft, proximal to the end cap) such that the plurality of threads extends along the shaft between the end cap and the ring (positioning the ring as disclosed by Davies at the distal end of the shaft of Okada spaced apart from the most distal end as Davies shows in various figures provides for the plurality of threads in view of Leeflang for element 22 of Okada extending along the shaft between the end cap and the ring).
Regarding Claim 16, Okada teaches a medical device (Figs. 1A and 13), comprising:
a handle 48; a shaft 20 extending from the handle; and
an electrosurgical knife 80 ([0052] and “power is supplied to the cutter section 80 to cut off the mucosa” [0058]) at a distal end of the shaft (Figs. 1A, 13), wherein the electrosurgical knife 80 is movable relative to the distal end of the shaft ([0053]);
an end cap 30 connected to the distal end of the shaft (Fig. 1A),
wherein at least a portion of the shaft includes a coil 22 ([0048]-[0049] and Figs. 1A, 13) and an outer coating 24 (Fig. 1A), but does not disclose braiding that includes a plurality of polymer threads and an outer coating, and wherein a distal portion of the shaft further includes a ring partially encapsulated by a portion of the outer coating, wherein the ring is a radiopaque marker band.
In the same field of invention, Leeflang teaches the use of “reinforcement layer 42” including “one or more reinforcing members, e.g., wound in a braided or other helical configuration around the inner liner 40a, and the outer jacket 44 may include one or more tubular layers surrounding the reinforcement layer 42 and/or between the reinforcement layer 42 and the inner liner 40a. In an exemplary embodiment, the reinforcement layer 42 may include one or more, or a plurality of, round or flat (e.g., rectangular, elliptical, or flat oval) wires, filaments, strands, or other reinforcement members 43, e.g., formed from metal, such as stainless steel, plastic, glass, woven or twisted fibers, such as aramid, and the like, or composite materials” [0055], the plurality of reinforcement members 43a or 43b are positioned adjacent to one another as seen in Figs. 1B-1C and “Exemplary materials for the jacket material 7 include plastics, e.g., thermoplastics, such as polyether block amide, nylon, or urethanes, thermoset plastics, metals, or composite materials. Alternatively, other processing may be used to bond or otherwise attach the jacket material 7 to the liner material 4 and/or embed the reinforcement members 43 in the jacket material 7, thereby resulting in an integral tubular body 8” [0091] such that each thread of the braiding is entirely radially surrounded by the outer coating as seen in Figs. 1B-1C. Figs. 11A-11B also shows at least two reinforcement wires 6 positioned adjacent to one another in a braided configuration.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make use a plurality of strands of polymer thread reinforcement members 43 braided together 43a/43b and entirely embedded within the outer coating of Okada in order to create a unitary structure of flexible catheter having a stiffness characteristic to enhance support of a steerable portion of the tubular devices as Leeflang teaches.
Davies teaches “a radiopaque marker that is a ring-shaped hollow band” [0050] and “distal end of end member 10 includes a functional tip 15 that includes the aforementioned electrode 3 and a radiopaque marker 6 … Depending on how far distally insulating layer 5 extends along distal portion 4, part, all, or none of radiopaque marker 6 can be covered by the insulating layer” [0068].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a ring of radiopaque material embedded within the outer shaft (outer coating) of Okada to permit detection of the tip during fluoroscopy or related procedures as Davies teaches;
Therefore, the plurality of threads extends along the shaft between the end cap and the ring (positioning the ring as disclosed by Davies at the distal end of the shaft of Okada spaced apart from the most distal end as Davies shows in various figures provides for the plurality of threads in view of Leeflang for element 22 of Okada extending along the shaft between the end cap and the ring).
Regarding Claim 17, Okada teaches wherein the handle includes a movable body 44, and wherein movement of the movable body controls a position of the electrosurgical knife 80 relative to the distal end of the shaft ([0053] of Okada).
Regarding Claim 19, Okada teaches a medical device (Figs. 1A, 13), comprising:
a handle 48, including a movable body 44; a shaft 20 extending from the handle (Figs. 1A, 13) and including an outer coating (insulating tube 24 [0048]); and
an end cap 30 positioned at a distal end of the shaft (Fig. 1A) wherein the end cap 30 is partially insulative (“insulating chip 30” [0049]);
an electrode 64/80 at a distal end of the shaft, wherein the electrode 64/66/80 is movable relative to the end cap 30 ([0053]), wherein movement of the movable body 44 of the handle controls a position of the electrode relative to the distal end of the shaft ([0053]), wherein at least a portion of the shaft includes a coil 22 ([0048]-[0049] and Figs. 1A, 13), but does not disclose at least a portion of the shaft includes a braiding that includes a plurality of threads over at least a portion of the shaft, wherein each thread of the plurality of threads is entirely radially surrounded by the outer coating, wherein at least two threads of the plurality of threads are positioned adjacent to one another and although Tu teaches a ring electrode that could be made of a radiopaque material, does not teach a ring, wherein the ring is partially encapsulated by a portion of the outer coating.
In the same field of invention, Leeflang teaches the use of “reinforcement layer 42” including “one or more reinforcing members, e.g., wound in a braided or other helical configuration around the inner liner 40a, and the outer jacket 44 may include one or more tubular layers surrounding the reinforcement layer 42 and/or between the reinforcement layer 42 and the inner liner 40a. In an exemplary embodiment, the reinforcement layer 42 may include one or more, or a plurality of, round or flat (e.g., rectangular, elliptical, or flat oval) wires, filaments, strands, or other reinforcement members 43, e.g., formed from metal, such as stainless steel, plastic, glass, woven or twisted fibers, such as aramid, and the like, or composite materials” [0055], the plurality of reinforcement members 43a or 43b are positioned adjacent to one another as seen in Figs. 1B-1C and “Exemplary materials for the jacket material 7 include plastics, e.g., thermoplastics, such as polyether block amide, nylon, or urethanes, thermoset plastics, metals, or composite materials. Alternatively, other processing may be used to bond or otherwise attach the jacket material 7 to the liner material 4 and/or embed the reinforcement members 43 in the jacket material 7, thereby resulting in an integral tubular body 8” [0091] such that each thread of the braiding is entirely radially surrounded by the outer coating as seen in Figs. 1B-1C. Figs. 11A-11B also shows at least two reinforcement wires 6 positioned adjacent to one another in a braided configuration.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make use a plurality of strands of polymer thread reinforcement members 43 braided together 43a/43b and entirely embedded within the outer coating of Okada in order to create a unitary structure of flexible catheter having a stiffness characteristic to enhance support of a steerable portion of the tubular devices as Leeflang teaches.
Davies teaches “a radiopaque marker that is a ring-shaped hollow band” [0050] and “distal end of end member 10 includes a functional tip 15 that includes the aforementioned electrode 3 and a radiopaque marker 6 … Depending on how far distally insulating layer 5 extends along distal portion 4, part, all, or none of radiopaque marker 6 can be covered by the insulating layer” [0068].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a ring of radiopaque material embedded within the outer shaft (outer coating) of Okada to permit detection of the tip during fluoroscopy or related procedures as Davies teaches;
Therefore, the plurality of threads extends along the shaft between the end cap and the ring (positioning the ring as disclosed by Davies at the distal end of the shaft of Okada spaced apart from the most distal end as Davies shows in various figures provides for the plurality of threads in view of Leeflang for element 22 of Okada extending along the shaft between the end cap and the ring).
Regarding Claim 20, Okada in view of Leeflang teaches further comprising an inner shaft, wherein the plurality of threads are deposited over at least a portion of the inner shaft, and wherein the braiding extends along an entirety of the shaft (threads 43 over inner liner 40/40a, [0049], [0055] and Figs. 1B-1C of Leeflang).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Okada, in view of Leeflang and Davies as applied above and further in view of Bloom.
Regarding Claim 18, Okada in view of Leeflang teaches including an inner shaft, and wherein the plurality of threads are deposited over at least a portion of the inner shaft (inner liner 40/40a [0049], [0055] and Figs. 1B-1C of Leeflang),
wherein the braiding is embedded within the outer coating such that each polymer thread is entirely radially surrounded by the outer coating, wherein at least two threads of the plurality of polymer threads are positioned adjacent to one another (“one or more reinforcing members, e.g., wound in a braided or other helical configuration around the inner liner 40a, and the outer jacket 44 may include one or more tubular layers surrounding the reinforcement layer 42 and/or between the reinforcement layer 42 and the inner liner 40a. In an exemplary embodiment, the reinforcement layer 42 may include one or more, or a plurality of, round or flat (e.g., rectangular, elliptical, or flat oval) wires, filaments, strands, or other reinforcement members 43, e.g., formed from metal, such as stainless steel, plastic, glass, woven or twisted fibers, such as aramid, and the like, or composite materials” [0055], the plurality of reinforcement members 43a or 43b are positioned adjacent to one another as seen in Figs. 1B-1C, also see at least two wires 6 positioned adjacent one another in Figs. 11A-B).
Furthermore, Leeflang teaches wherein the outer coating is formed of “outer jacket 44 may be formed from multiple layers of like or different materials (not shown), e.g., to provide desired material properties in the different portions of the apparatus 10. In an exemplary embodiment, the outer jacket 44 may be formed from PEBAX, nylon, urethane, and/or other thermoplastic material” in [0053] of Leeflang, but not specifically a polyether ether ketone (PEEK) as claimed.
In the same field of invention, Bloom teaches “the outer shaft 130 [are] selectively covered or coated with an insulator … In one example, the coating includes polyaryletherketones (PAEK) polymer thermoplastic such as polyetheretherketone (PEEK) polymer thermoplastic.”
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to make the coating from PEEK polymer thermoplastic, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Okada, in view of Leeflang and further in view of Okada (US Pub. No. 2004/0210284), hereinafter Okada’284.
Regarding Claim 22, Okada teaches “A needle for syringe (not shown) is introduced into the body cavity through the endoscope (not shown). Physiological saline is injected in a mucosa lower layer of a lesion mucosa portion 90 which is a target portion to be cut off in the body cavity, and the lesion mucosa portion 90 is raised” in [0060], but does not show the injection means to know if the handle further includes a port configured to connect to a fluid source, and wherein the electrode comprises a channel in fluid communication with the port of the handle via the lumen of the shaft as claimed.
In the same field of invention, Okada’284 teaches “a cock 17 for use as liquid feed means is provided on the proximal end portion of the sheath 2. As shown in FIG. 5B, the cock 17 is removably fitted with a syringe 20 that contains a liquid, such as a physiological saline solution. The liquid that is fed under pressure from the syringe 20 can be injected into an internal space 2a of the sheath 2 through the cock 17” in [0050] and as shown in Fig. 5B.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to inject the physiological saline as disclosed in Okada with the system disclosed by Okada’284 as it is a known method of injecting the physiological saline into tissue.
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive.
Applicant’s arguments directed to the Okada reference are on the grounds that Okada in view of Leeflang alone or in combination does not teach or suggested the newly amended limitation of “wherein the plurality of threads terminate proximal to the end cap”. Examiner respectfully disagrees and maintains that Okada teaches the use of a coil 22 that terminates proximal to the insulating chip 30 as disclosed in [0049] and shown in Fig. 1A and therefore by subsidizing the braided member of Leeflang for the coil 22 the threads making up the braided section would also terminate proximal to the element interpreted to be cap 30 of Okada. Therefore, applicant’s arguments are not found persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
