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 § 102
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.
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 1-4 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ditter et al., US 20160128771, herein referred to as “Ditter”.
Regarding claim 1, Ditter discloses a ring electrode assembly (Figures 13-14) comprising: an insert comprising at least one lumen extending along a longitudinal axis (Figures 13-14: multi-lumened tubing 56); a ring electrode (Figure 13: AR and [0077]) disposed around a middle portion of the insert and having two ends (Figure 14: AR is disposed around a middle portion of multi-lumened tubing 56); and two collars (Figure 13: opposing end portions 66), each collar coupled to each of the two ends of the ring electrode and to the insert, fixing the ring electrode to the insert ([0085]: “The wires of each pair are electrically isolated from each other except at their distal ends where they are twisted together, fed through a hole formed in the second lumen 58 of the distal assembly 17, and soldered to their respective AR electrode (FIG. 14). ”).
Regarding claim 2, Ditter discloses the ring electrode assembly of claim 1, the ring electrode is tapered inward from a center portion toward each of the two ends (Figures 13-14: curved transitional regions 67).
Regarding claim 3, Ditter discloses the ring electrode assembly of claim 2, an inner circumference of each of the two ends of the ring electrode is approximately equal to an outer circumference of the middle portion of the insert (Figure 14: the inner circumference of opposing end portions 66 is approximately equal to the outer circumferences of tubing 56).
Regarding claim 4, Ditter discloses the ring electrode assembly of claim 2, each of the two collars tapers inward from a first end toward a second end (Figures 13-14: curved transitional regions 67), and an inner circumference of the first end of each collar is approximately equal to an outer circumference of the two ends of the ring electrode (Figure 14: the inner circumference of opposing end portions 66 is approximately equal to the outer circumferences of tubing 56).
Regarding claim 8, Ditter discloses the ring electrode of claim 2, the ring electrode comprises a plurality of irrigation holes (Figure 13: apertures 69), and an inner circumference of the center portion of the ring electrode is greater than an outer circumference of the middle portion of the insert (Figure 14: an inner circumference of side wall 65 is greater than an outer circumference of the middle portion of tubing 56), a resulting gap between the inner circumference of the center portion of the ring electrode and the outer circumference of the middle portion of the insert provides an irrigation reservoir ([0082]: “The fluid enters the third lumen 59 where it exits the lumen via the openings 68 into the reservoir R of the AR electrodes where it exits the reservoir via the apertures 69 to outside of the AR electrodes to minimize charring.”).
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 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.
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 5-7 and 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ditter in view of Iijima, US 20230248425, herein referred to as “Iijima”.
Regarding claim 5, Ditter discloses the ring electrode assembly of claim 4, but does not explicitly disclose a ring electrode assembly wherein each end of the insert comprises a first ledge, the first ledge having an outer circumference approximately equal to an inner circumference of the second end of each collar.
However, Iijima teaches a ring electrode assembly (Figure 2) wherein each end of the insert comprises a first ledge (Figure 4: distal end neck portion 331), the first ledge having an outer circumference approximately equal to an inner circumference of the second end of each collar (Figure 4: outer circumference of distal end neck portion 331 is approximately equal to an inner circumference of insulating coating 46).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ring electrode assembly disclosed by Ditter so that each end of the insert comprises a first ledge as taught by Iijima so that the device can apply a high frequency energy to the treatment site in a stable expansion shape (Iijima [0035]).
Regarding claim 6, Ditter in view of Iijima discloses the ring electrode assembly of claim 5, and Iijima further discloses a ring electrode assembly wherein each end of the insert further comprises a second ledge (Figure 4: distal end tip 333), the first ledge is provided between the second ledge and the middle portion of the insert at each end of the insert (Figure 4: distal end neck portion 331 is between distal end tip 333 and straight portion 31), and the outer circumference of the middle portion of the insert is greater than the outer circumference of the first ledge (Figure 4: outer circumference of straight portion 31 is greater than the outer circumference of distal end neck portion 331), and the outer circumference of the first ledge is greater than an outer circumference of the second ledge (Figure 4: outer circumference of distal end neck portion 331 is greater than the outer circumference of distal end tip 333).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ring electrode assembly disclosed by Ditter so that each end of the insert further comprises a second ledge as taught by Iijima to protect the distal end side of the assembly (Iijima [0034]).
Regarding claim 7, Ditter in view of Iijima discloses the ring electrode assembly of claim 6, and Iijima further discloses a ring electrode assembly wherein a length of the second ledge is approximately 0.5 mm ([0033]: “The outer diameter of the distal end tip 333 is, for example, 2.0 mm, and the inner diameter of the distal end tip 333 is same as the inner shaft 11 and is, for example, 1.1 mm.”; thus a length of distal end tip 333 is approximately 0.5 mm, wherein the word “approximately” is broad and therefore is interpreted broadly).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the ring electrode assembly disclosed by Ditter so a length of the second ledge is approximately 0.5 mm as taught by Iijima to protect the distal end side of the assembly (Iijima [0034]).
Regarding claim 9, Ditter discloses an end effector of a catheter (Figures 10A-B) comprising: two or more ring electrode assemblies (Figures 10A-B: there are many AR electrodes), each ring electrode assembly (Figures 13-14) comprising: an insert comprising at least one lumen extending along a longitudinal axis (Figures 13-14: multi-lumened tubing 56), a ring electrode (Figure 13: AR and [0077]) disposed around the middle portion of the insert and having two ends (Figure 14: AR is disposed around a middle portion of multi-lumened tubing 56); and two collars (Figure 13: opposing end portions 66), each collar coupled to each of the two ends of the ring electrode ([0085]: “The wires of each pair are electrically isolated from each other except at their distal ends where they are twisted together, fed through a hole formed in the second lumen 58 of the distal assembly 17, and soldered to their respective AR electrode (FIG. 14). ”); at least one bridge tube coupling adjacent ring electrode assemblies and comprising at least one lumen corresponding to the at least one lumen of the insert (Figure 11: nonconductive protective tubing 62); and a frame provided through the at least one lumen of each ring electrode assembly and through the at least one lumen of the at least one bridge tube (Figure 11: support member 50). Ditter does not explicitly disclose an end effector of a catheter comprising an insert, the insert further comprising a middle portion, a second ledge provided at each end of the insert, and a first ledge provided between each second ledge and the middle portion.
However, Iijima teaches an end effector of a catheter (Figure 2) comprising an insert (Figure 4: straight portion 31, distal end side cone portion 332, distal end neck portion 331, and distal end tip 333), the insert further comprising a middle portion (Figure 4: straight portion 31), a second ledge provided at each end of the insert (Figure 4: distal end tip 333), and a first ledge provided between each second ledge and the middle portion (Figure 4: distal end neck portion 331).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the end effector disclosed by Ditter so that the insert comprises a middle portion, a second ledge provided at each end of the insert, and a first ledge provided between each second ledge and the middle portion as taught by Iijima to protect the distal end side of the assembly (Iijima [0034]).
Regarding claim 10, Ditter in view of Iijima discloses the end effector of claim 9, and Ditter further discloses an end effector wherein the frame comprises nitinol ([0069]).
Regarding claim 11, Ditter in view of Iijima discloses the end effector of claim 9, and Ditter further discloses an end effector wherein the at least one bridge tube comprises two ends (Figure 11: nonconductive protective tubing 62), the two ends of the at least one bridge tube having an inner diameter being approximately equal to an outer diameter of the insert (Figure 12: nonconductive protective tubing 62 has a diameter approximately equal to the outer diameter of tubing 56, wherein the word “approximately” is broad and therefore is interpreted broadly). Iijima discloses an end effector wherein the insert comprises a second ledge Figure 4: distal end tip 333).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the end effector disclosed by Ditter so that the insert comprises a second ledge as taught by Iijima to protect the distal end side of the assembly (Iijima [0034]).
Regarding claim 12, Ditter in view of Iijima discloses the end effector of claim 9, and Ditter further discloses an end effector wherein the ring electrode (Figure 13) is tapered inward from a center portion toward each of the two ends (Figure 13: curved transitional regions 67), and an inner diameter of each of the two ends is approximately equal to an outer diameter of the middle portion of the insert (Figure 14: an inner diameter of end portions 66 is approximately equal to an outer diameter of tubing 56).
Regarding claim 13, Ditter in view of Iijima discloses the end effector of claim 9, and Ditter further discloses an end effector wherein each of the two collars tapers inward from a first end toward a second end (Figures 13-14: curved transitional regions 67), and an inner circumference of the first end of each collar is approximately equal to an outer circumference of the two ends of the ring electrode (Figure 14: the inner circumference of opposing end portions 66 is approximately equal to the outer circumferences of tubing 56).
Regarding claim 14, Ditter in view of Iijima discloses the end effector of claim 13, and Ditter further discloses an end effector wherein an inner diameter of the second end of each collar is approximately equal to an outer diameter of the insert (Figure 14: the inner circumference of opposing end portions 66 is approximately equal to the outer circumferences of tubing 56). Iijima discloses an end effector wherein the insert comprises a first ledge Figure 4: distal end neck portion 331).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the end effector disclosed by Ditter so that the insert comprises a first ledge as taught by Iijima to protect the distal end side of the assembly (Iijima [0034]).
Regarding claim 15, Ditter in view of Iijima discloses the end effector of claim 9, and Ditter further discloses an end effector further comprising an attachment between each collar and the insert ([0085]: “The wires of each pair are electrically isolated from each other except at their distal ends where they are twisted together, fed through a hole formed in the second lumen 58 of the distal assembly 17, and soldered to their respective AR electrode (FIG. 14). ”). Iijima discloses an end effector wherein the insert comprises a first ledge Figure 4: distal end neck portion 331).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the end effector disclosed by Ditter so that the insert comprises a first ledge as taught by Iijima to protect the distal end side of the assembly (Iijima [0034]).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to use overmolding as the type of attachment, since applicant has not disclosed that overmolding solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with soldering, as soldering and overmolding are equivalent in the art as taught by paragraph [0119] of Pedroni, US 20190224459.
Regarding claim 16, Ditter in view of Iijima discloses the end effector of claim 9, and Ditter further discloses an end effector wherein the at least one lumen of the insert comprises a lead wire lumen (Figure 11: second lumen 58), and the insert further comprises a lead wire hole extending from the lead wire lumen to an outer surface of the insert (Figure 14: wires 40, 41 extend to an outer surface of tubing 56 near end portion 66).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Iijima in view of Datta et al., US 20090088697, herein referred to as “Datta”.
Regarding claim 17, Iijima discloses a method for assembling an end effector of a catheter (Figure 2) comprising: assembling one or more ring electrode assemblies (Figure 2: balloon 30 and band-shaped electrodes 41 and 42 and ring electrode 45), assembling each ring electrode assembly comprises: providing an insert comprising at least one lumen extending along a longitudinal axis (Figure 4: straight portion 31, distal end side cone portion 332, distal end neck portion 331, and distal end tip 333), the insert further comprising a middle portion (Figure 4: straight portion 31), a second ledge provided at each end of the insert (Figure 4: distal end tip 333), and a first ledge provided between each second ledge and the middle portion (Figure 4: distal end neck portion 331); attaching an electrode onto the middle portion of the insert (Figure 4: electrodes 41 and 42); and attaching a collar onto each end of the electrode (Figure 4: insulating coating 46), each collar attaching onto a respective first ledge of the insert (Figure 4: insulating coating 46 is on distal end neck portion 331). Iijima does not explicitly disclose a method comprising sliding a ring electrode onto the middle portion of the insert, and sliding a collar onto each end of the ring electrode.
However, Datta teaches a method comprising sliding a ring electrode onto the middle portion of the insert ([0039]: “The ring electrode 38 is slid over the plastic housing 21 and fixed in place by glue or the like.”), and sliding a collar onto each end of the ring electrode ([0039]: “If desired, additional ring electrodes may be used and can be positioned over the plastic housing 21 or over the flexible tubing 19 of the tip section 14.”; in combination with Iijima, the insulating coating 46 of Iijima is also slid onto each end of the ring electrode).
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to assemble an end effector by sliding a ring electrode because applicant has not disclosed that sliding a ring electrode provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected an electrode that is a thin film electrode formed on the surface and applicant’s invention to perform equally well with either thin film electrodes formed on the surface taught by Iijima or the claimed sliding of a ring electrode because both methods of assembly would perform the same function of attaching electrodes to a catheter device. Therefore, it would have been prima facie obvious to modify Iijima to obtain the invention as specified in claim 17 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Iijima.
Regarding claim 18, Iijima in view of Datta discloses the method of claim 17, and Iijima further discloses a method wherein assembling the end effector further comprises attaching each electrode assembly over a frame (Figure 4: tubular inner shaft 11), such that the frame is provided through the at least one lumen of the insert (Figure 4: wire lumen 12). Datta teaches a method wherein assembling the end effector further comprises sliding a ring electrode ([0039]: “The ring electrode 38 is slid over the plastic housing 21 and fixed in place by glue or the like.”).
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to assemble an end effector by sliding a ring electrode because applicant has not disclosed that sliding a ring electrode provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected an electrode that is a thin film electrode formed on the surface and applicant’s invention to perform equally well with either thin film electrodes formed on the surface taught by Iijima or the claimed sliding of a ring electrode because both methods of assembly would perform the same function of attaching electrodes to a catheter device. Therefore, it would have been prima facie obvious to modify Iijima to obtain the invention as specified in claim 17 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Iijima.
Regarding claim 19, Iijima in view of Datta discloses the method of claim 17, and Datta further discloses a method wherein at least two ring electrode assemblies are assembled ([0039]: “The ring electrode 38 is slid over the plastic housing 21 and fixed in place by glue or the like. If desired, additional ring electrodes may be used and can be positioned over the plastic housing 21 or over the flexible tubing 19 of the tip section 14.”), and the method further comprises coupling adjacent ring electrodes assemblies together with a bridge tube (Figure 3A: tubing 19).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method disclosed by Iijima so that at least two ring electrode assemblies are assembled and adjacent ring assemblies are coupled together with a bridge tube as taught by Datta so that the electrodes are attached to a non-toxic material that is more flexible than the catheter bod (Datta [0029]) to provide suitable flexibility near the shaft tip while maintaining adequate overall shaft stiffness (Datta [0002]).
Regarding claim 20, Iijima in view of Datta discloses the method of claim 19, and Iijima further discloses a method wherein coupling the bridge tube to each ring assembly comprises sliding an end of the bridge tube over the second ledge of each insert (Figure 1: tubular outer tube 10A and [0022]: “The shaft 10 includes a tubular outer tube 10A that extends from the handle portion 20 to a proximal end portion (a proximal end side neck portion 351 described later) of the balloon 30, a tubular inner shaft 11 that communicates with the outer tube 10A ”, wherein tubular outer tube 10A must be slid over distal end tip 333), each end of the bridge tube comprises an inner circumference approximately equal to an outer circumference of the second ledge (Figures 1 and 4: approximately is a broad term and thus is interpreted broadly here).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794