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 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.
Response to Amendment
Acknowledgement is made to the amendment received 03/11/2026.
Acknowledgement is made to the amendment of claims 21, 30-35, 37, 39-40, and 43.
Acknowledgement is made to the cancellation of claims 1-20, 29, 38, and 41.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 21-28, 30-37, 39-40, 42-43 are pending. A complete action on the merits appears below.
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.
Claim 21-24, 26-28, 30-31, 33, and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”) in view of U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”) and U.S. Patent No. 6193717 to Ouchi (herein after “Ouchi”) further in view of U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert”).
Regarding claim 21, Wake teaches a medical device (Fig. 1; treatment tool 1) comprising:
a shaft (Fig. 2; sheath 11) including a central lumen (Fig. 2; internal space 11a);
a support element (Fig. 2; cylindrical stopper member 25) movable within a distal portion of the central lumen of the shaft ([0035]), wherein a distal portion of the support element includes a cylindrical extension (Fig. 2; cylindrical stopper member 25 is shown to extend along a cylindrical direction), wherein the support element includes a lumen (Fig. 2; the cylindrical stopper member 25 is shown as being hollow so as to surround the electrode and manipulation member, further discussion is provided in [0054]) extending centrally through an entire longitudinal length of the support element from a proximal end of the support element to a distal end of the support element (Fig. 2; cylindrical stopper member 25 is shown as containing a lumen along its entire length so as to contain the manipulation member 12 at its proximal end and electrode member 21 at its distal end), wherein a proximal portion of the support element includes a drive element receiving portion (Fig. 2; the proximal portion of cylindrical stopper member 25 receives manipulation wire 12) to receive a portion of a drive element (Fig. 2; manipulation wire 12), wherein the drive element receiving portion extends through only a proximal portion of the length of the support element (Fig. 2; the distal portion of manipulation wire 12 is shown as being positioned within the proximal portion of the cylindrical stopper member 25), wherein movement of the drive element controls the movement of the support element within the distal portion of the central lumen of the shaft ([0034]- [0035], [0055]); and
an electrode (Fig. 2; electrode member 21) positioned at a distal portion of the shaft, wherein the electrode includes an electrode lumen (Fig. 2; conduit line 21a) configured to receive fluid via the lumen of the support element ([0063]), wherein a proximal portion of the electrode is received within the cylindrical extension of the support element (Fig. 2; the proximal portion of electrode member 21, also referred to as the proximal portion of small diameter section 23, is shown as being positioned within cylindrical stopper member 25), wherein the electrode includes a longitudinal portion (Fig. 2; small diameter section 23) and a distal tip (Fig. 2; large diameter portion 22), wherein the distal tip is positioned at a distal end of the longitudinal portion, wherein the distal tip is radially wider than the longitudinal portion (Fig. 2; small diameter section 23 is taught as having a smaller diameter than larger diameter section 22), and wherein the electrode lumen extends longitudinally through an entire length of the longitudinal portion of the electrode ([0040], [0045]), and
wherein the electrode and the support element are movable relative to the shaft based on movement of a drive element received within the drive element receiving portion ([0035]).
Wake further teaches the fluid traveling an uninterrupted flow path (Fig. 1-2 teach a path of flow which is uninterrupted as the term “uninterrupted” is defined as “not interrupted, stopped or blocked” and the term “interrupted is defined as “to stop or hinder”, therefore, as broadly as is currently claimed, the flow path of Wake meets this claim limitation).
However, Wake fails to teach the device wherein the drive element receiving portion is radially spaced away from the lumen of the support element.
Klumb teaches a catheter comprising a catheter body, a tip section having a tip electrode, at least one lumen, a wire which is preferably a puller wire which extends through the at least one lumen, and a control handle (Abstract).
Klumb further teaches the puller wire as having an anchoring structure which is either one where the puller wire is anchored within a lumen of the electrode (Fig. 3, Col. 6, Lines 18-22) or an alternative anchoring structure where the puller wire is anchored radially separate from the lumen for the electrode electrical connection (Fig. 5, Col. 7, Lines 47-49).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the manipulation member, as is taught by Wake with the puller wire being connected at a distal portion which is radially spaced away from the lumen for the electrode electrical connection as is taught by Klumb, to produce the predictable result of connecting a puller wire to a distal electrode element for distally moving the electrode, as is taught by Klumb, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Wake further fails to teach that fluid delivered by the electrode is received at a proximal most end of the electrode lumen and such that the fluid travels a fluid flow path through a central longitudinal axis of the support element and a central longitudinal axis of the longitudinal portion of the electrode.
Ouchi teaches a device for treating tissue having a sheath, an inlet port, and an electrode (Abstract, Col. 4, Lines 10-15).
Ouchi further teaches the device as having multiple configurations for providing fluid to the electrode, such as from the side of the device (Fig. 3) or the proximal most end of the device (Fig. 6).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the proximal most inlet port, as is taught by Ouchi with the side inlet port as is taught by Wake, to produce the predictable result providing fluid to a distal electrode, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Wake further fails to teach the distal tip of the electrode including one or more channels angled relative to the electrode lumen, wherein the one or more channels are in fluid communication with the electrode lumen to receive a flow of fluid from the electrode lumen, wherein the one or more channels are configured to divert the flow of fluid from the electrode lumen toward one or more outlets laterally offset from the electrode lumen, wherein the distal tip includes a closed distalmost end face, and wherein each of the one or more outlets are positioned proximal to the distalmost end face.
Geistert teaches an electrode for an ablation catheter including an electrode body extending along a longitudinal axis and an irrigation lumen extending parallel to the longitudinal axis through which a fluid is provided (Abstract).
Geistert further teaches the electrode as comprising a plurality of passages which provide flow of the fluid out of the electrode, wherein the plurality of passages are situated at an angle to the longitudinal axis ([0011], [0016], [0021]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the positioning of passages for providing fluid out of an electrode, as is taught by Geistert, into the electrode having a fluid lumen, as is taught by Wake, to produce the predictable result of providing fluid out of an electrode, as is taught by Geistert, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 22, Wake further teaches the medical device of claim 21, further including a handle (Fig. 1; manipulation unit 30) with a main part (Fig. 1; manipulation main body 31) and a movable part (Fig. 1; manipulation slider 32), wherein at least one of the main part and the movable part includes a slot (Fig. 1; slit 31a), and wherein (1) sliding of the movable part in a first direction relative to the main part extends the electrode ([0062]), and (2) sliding of the movable part in a second direction relative to the main part retracts the electrode ([0064]).
Regarding claim 23, Wake further teaches the medical device of claim 22, wherein at least one of the main part and the movable part includes a fluid port (Fig. 1; liquid sensing mouth piece 14) to couple a fluid source to the handle ([0038]- [0039]), and wherein at least one of the main part and the movable part includes a hub to couple an energy source to the handle (Fig. 1; connecting connector section 33 for electrically connecting to a high frequency generator [0059]).
Regarding claim 24, Wake further teaches the medical device of claim 23, further including the drive element, wherein the drive element extends from the handle to the support element ([0040], [0059]- [0060]) to (1) electrically connect the energy source to the support element and to the electrode ([0060]), and (2) move the support element and the electrode distally or proximally based on relative movement between the main part and the movable part ([0062]- [0064]).
Regarding claim 26, Wake further teaches the medical device of claim 21, further comprising an end cap (Fig. 2; insulation tip 13), wherein the end cap is electrically insulating ([0036]), wherein the end cap includes a passage (Fig. 2; cylindrical hole 13a) for slidably receiving at least a portion of the electrode ([0044]), wherein the shaft includes an electrically insulating sheath ([0035]), and wherein a distal portion of the sheath is coupled to the end cap ([0036]).
Regarding claim 27, Wake further teaches the medical device of claim 26, wherein a distal portion of the end cap extends distally beyond a distal end of the sheath ([0036] teaches insulation tip 13 being fixed to a distal end section of the sheath 11).
Regarding claim 28, Wake further teaches the medical device of claim 27, wherein the distal tip of the electrode is cylindrical (Fig. 3; outer circumferential surface 22b) with a flat distal end (Fig. 3; distal end surface 22a).
Regarding claim 30, in accordance with the above provided modifications, Geistert further teaches the medical device of claim 28, wherein one or more central longitudinal axes of the one or more channels extend transverse to the central longitudinal axis of the longitudinal portion of the electrode, and wherein the central longitudinal axis of the longitudinal portion of the electrode is aligned with a central longitudinal axis of the central lumen of the shaft ([0011], [0016], [0021], [0046]).
Regarding claim 31, in accordance with the above provided modifications, Geistert further teaches the medical device of claim 28, wherein the one or more channels extend in a V-shape to connect the electrode lumen to the two outlets ([0011], [0016], [0021], [0046]).
Regarding claim 33, Wake further teaches the medical device of claim 32, further including an insulating end cap (Fig. 2; insulation tip 13) surrounding at least a portion of the electrode, wherein the end cap includes a narrowed stop surface radially surrounding a portion of the electrode (Fig. 2; cylindrical hole 13a and stepped portion 13b).
Regarding claims 39-40, Wake/Klumb/Ouchi/Geistert further teaches the method as inherent to the ordinary use of the device as taught by claims 21-24, 26-28, 30-31, and 33.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”) in view of U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”) and U.S. Patent No. 6193717 to Ouchi (herein after “Ouchi”) and U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert” further in view of U.S. Patent Publication No. 20150272669 to Brucker et al. (herein after “Brucker”).
Regarding claim 25, Wake as modified teaches the medical device of claim 24.
However, Wake as modified fails to teach the medical device further including a one-way valve coupling the fluid source to the fluid port and preventing fluid from flowing proximally out of the fluid port.
Brucker teaches an irrigated ablation electrode device having a fluid pump for supplying fluid to a catheter comprising the electrode (Abstract, [0283]).
Brucker further teaches the device comprising a one way check valve directing flow towards the ablation catheter and preventing backflow in the direction of the fluid pump ([0283]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teaching of utilizing a one way check valve to direct flow to an ablation catheter, as is taught by Brucker, into the device of Wake as modified to produce the benefit of preventing backflow, as is taught by Brucker.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”) in view of U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”) and U.S. Patent No. 6193717 to Ouchi (herein after “Ouchi”) and U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert” further in view of U.S. Patent Publication No. 20090163912 to Wang et al (herein after “Wang ”).
Regarding claim 32, Wake teaches the medical device of claim 27.
However, Wake fails to teach the medical device of claim 27, wherein the one or more channels includes a plurality of indentations that connect a radial exterior of the distal tip to the electrode lumen, and wherein the electrode further includes an electrode cap that extends over a distal end of the electrode lumen such that fluid delivered through the electrode lumen flows through the indentations at an angle relative to a central longitudinal axis of the electrode lumen.
Wang teaches a medical device including an irrigated ablation electrode assembly including one or more channels to deliver fluid from within an electrode to provide fluid to target tissue (Abstract, [0022], [0025]).
Wang further teaches the medical device of claim 21, wherein the one or more channels includes a plurality of indentations (Fig. 2B-3; sides 30) that connect a radial exterior of the distal tip to the electrode lumen, and wherein the electrode further includes an electrode cap (Fig. 2B; distal member 18) that extends over a distal end of the electrode lumen such that fluid delivered through the electrode lumen flows through the indentations at an angle relative to a central longitudinal axis of the electrode lumen ([0022], [0025]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute the fluid passageways as are taught by the modified device of Wake for those of Wang as a simple substitution of one fluid distribution system located within a distal electrode for treating tissue for another to produce the predictable result of fluid delivery.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”) in view of U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”) and U.S. Patent No. 6193717 to Ouchi (herein after “Ouchi”) and U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert” further in view of U.S. Patent Publication No. 20070038213 to Machiya et al. (herein after “Machiya”).
Regarding claim 34, Wake teaches the medical device of claim 33.
Wake further teaches the medical device wherein the electrode extending assembly includes a widened portion (Fig. 2; stopper member 25) proximal to the distal tip of the electrode (Fig. 2; large diameter section 22), and wherein the narrowed stop narrowed surface of the end cap (Fig. 2; insulation tip 13) and the widened portion of the electrode extending assembly limit the distal extension of the electrode, such that, when the electrode is in an extended position, the widened portion of the longitudinal portion abuts the narrowed stop surface of the end cap to limit the distal extension of the electrode relative to the shaft ([0007]).
However, Wake fails to teach this widened portion as specifically being a widened portion of the electrode.
Machiya teaches a high frequency treatment tool having a sheath and a treatment tool comprising a high-frequency knife to which a high-frequency current is applied (Abstract).
Machiya further teaches the high-frequency knife comprising blade portions radially provided in an axial direction for abutting against a rear end of the sheath (Abstract, [0023])
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute the teaching of an electrode having radially extending blades for abutting an inner sheath surface, as is taught by Machiya, for the widened electrode assembly for limiting distal extension, as is taught by Wake, to produce the predictable result of limiting electrode extension.
Claim 35 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”) in view of U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”), further in view of U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert”).
Regarding claim 35, Wake teaches a medical device (Fig. 1; treatment tool 1) comprising:
a shaft (Fig. 2; sheath 11) including a central lumen (Fig. 2; internal space 11a);
a proximal support movable (Fig. 2; cylindrical stopper member 25) within a distal portion of the central lumen of the shaft, wherein the proximal support includes a lumen (Fig. 2; the cylindrical stopper member 25 is shown as being hollow so as to surround the electrode and manipulation member, further discussion is provided in [0054]) extending centrally through an entire longitudinal length of the proximal support from a proximal end of the proximal support to a distal end of the proximal support (Fig. 2; cylindrical stopper member 25 is shown as containing a lumen along its entire length so as to contain the manipulation member 12 at its proximal end and electrode member 21 at its distal end), wherein a proximal portion of the proximal support includes a drive element receiving portion (Fig. 2; the proximal portion of cylindrical stopper member 25 receives manipulation wire 12) to receive a portion of a drive element (Fig. 2; manipulation wire 12), wherein the drive element receiving portion extends through only a proximal portion of the length of the support element (Fig. 2; the distal portion of manipulation wire 12 is shown as being positioned within the proximal portion of the cylindrical stopper member 25), wherein movement of the drive element controls the movement of the proximal support within the distal portion of the central lumen of the shaft ([0034]- [0035], [0055]),
an electrode (Fig. 2; electrode member 21) positioned at a distal portion of the shaft and including an electrode lumen (Fig. 2; conduit line 21a) in fluid communication with the lumen of the proximal support, wherein a proximal end of the electrode lumen is configured to receive a flow of fluid from the lumen of the proximal support ([0063]), wherein the central lumen of the shaft, the lumen of the support element, and the electrode lumen are aligned with and coaxial relative to each other, and
wherein the electrode includes a longitudinal portion (Fig. 2; small diameter section 23) and a distal tip (Fig. 2; large diameter portion 22) at a distal end of the longitudinal portion, and
wherein the distal tip includes a radial thickness that is greater than a radial thickness of the longitudinal portion (Fig. 2; small diameter section 23 is taught as having a smaller diameter than larger diameter section 22).
However, Wake fails to teach the device wherein the drive element receiving portion of the proximal support as being radially spaced away from and extends parallel to a proximal portion of the lumen of the support element.
Klumb teaches a catheter comprising a catheter body, a tip section having a tip electrode, at least one lumen, a wire which is preferably a puller wire which extends through the at least one lumen, and a control handle (Abstract).
Klumb further teaches the puller wire as having an anchoring structure which is either one where the puller wire is anchored within a lumen of the electrode (Fig. 3, Col. 6, Lines 18-22) or an alternative anchoring structure where the puller wire is anchored radially separate from the lumen for the electrode electrical connection (Fig. 5, Col. 7, Lines 47-49).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have substituted the manipulation member, as is taught by Wake with the puller wire being connected at a distal portion which is radially spaced away from the lumen for the electrode electrical connection as is taught by Klumb, to produce the predictable result of connecting a puller wire to a distal electrode element for distally moving the electrode, as is taught by Klumb, as it has been held that the substitution of one known element for another according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
However, Wake fails to teach the device wherein the distal tip of the electrode includes a closed distalmost end face and one or more fluid outlets, and wherein each of the one or more fluid outlets is positioned proximal to the distalmost end face.
Geistert teaches an electrode for an ablation catheter including an electrode body extending along a longitudinal axis and an irrigation lumen extending parallel to the longitudinal axis through which a fluid is provided (Abstract).
Geistert further teaches the electrode as comprising a plurality of passages which provide flow of the fluid out of the electrode, wherein the plurality of passages are situated at an angle to the longitudinal axis ([0011], [0016], [0021]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the positioning of passages for providing fluid out of an electrode, as is taught by Geistert, into the electrode having a fluid lumen, as is taught by Wake, to produce the predictable result of providing fluid out of an electrode, as is taught by Geistert, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 42, in accordance with the above provided modifications, Geistert further teaches the medical device of claim 35, wherein the distal tip of the electrode includes one or more channels angled relative to the electrode lumen, wherein the one or more channels are in fluid communication with the electrode lumen to receive a flow of fluid from the electrode lumen, and wherein the one or more channels are configured to divert the flow of fluid from the electrode lumen toward the one or more outlets laterally offset from the electrode lumen ([0011], [0016], [0021], [0046]).
Claim 36 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”), U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”), and further in view of U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert”) in view of U.S. Patent Publication No. No. 20070038213 to Machiya et al. (herein after “Machiya”).
Regarding claim 36, Wake as modified teaches the medical device of claim 35.
However, Wake fails to teach wherein the longitudinal portion includes a first longitudinal portion, a second longitudinal portion, and a widened portion between the first longitudinal portion and the second longitudinal portion, and wherein the electrode lumen includes a central longitudinal axis, wherein the distal tip includes a plurality of channels fluidly connected to the electrode lumen, wherein each of the plurality of channels includes a central longitudinal axis, and wherein each central longitudinal axis of the plurality of channels is angled relative to the central longitudinal axis of the electrode lumen.
Machiya teaches a high frequency treatment tool having a sheath and a treatment tool comprising a high-frequency knife to which a high-frequency current is applied (Abstract).
Machiya further teaches the high-frequency knife comprising blade portions radially provided in an axial direction for abutting against a rear end of the sheath (Abstract, [0023])
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to substitute the teaching of an electrode having radially extending blades for abutting an inner sheath surface, as is taught by Machiya, for the widened electrode assembly for limiting distal extension, as is taught by Wake, to produce the predictable result of limiting electrode extension.
Regarding claim 43, Wake further teaches the medical device of claim 35, further comprising an end cap (Fig. 2; insulation tip 13), wherein the electrode includes a first longitudinal portion, a widened portion, and a second longitudinal portion each positioned proximal to the distal tip of the electrode (Fig. 2; large diameter section 22 is shown as being wider than the distalmost portion of the electrode 21 as the electrode distal portion is tapered), wherein the end cap includes a narrowed stop surface radially surrounding a portion of the electrode (Fig. 2; cylinder hole 13a contains small diameter section 23 of the electrode member 21), and wherein the stop surface of the end cap and the widened portion of the electrode limit a distal extension of the electrode relative to the end cap ([0036]- [0037]).
In accordance with the above rejection of claim 34, Machiya teaches the widened portion as being a widened portion of the electrode (Abstract, [0023]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 20160008063 to Wake et al. (herein after “Wake”), U.S. Patent No. 5935124 Klumb et al. (herein after “Klumb”), and further in view of U.S. Patent Publication No. 20110257649 A1 to Geistert (herein after “Geistert”) in view of U.S. Patent Publication No. 20080125809 to Suzuki et al. (herein after “Suzuki”).
Regarding claim 37, Wake as amended further teaches the medical device of claim 36, further including a handle (Fig. 1; manipulation unit 30) with a main part (Fig. 1; manipulation unit main body 31) and a movable part (Fig. 1; manipulation slider 32), wherein movement of the movable part in a first direction relative to the main part extends the proximal support and the electrode ([0062]), and wherein movement of the movable part in a second direction relative to the main part retracts the proximal support and the electrode ([0064]),
wherein at least one of the main part and the movable part includes a hub to couple an energy source to the handle ([0059]).
However, Wake fails to teach at least one of the main part and the movable part includes a fluid port to couple a fluid source to the handle.
Suzuki teaches a treatment tool for an endoscope (Abstract) including an operation portion with a main body and a slidable handle ([0041]) for providing control of the distal treatment element ([0046]).
Suzuki further teaches at least one of the main part and the movable part including a fluid port to couple a fluid source to the handle ([0042]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of the handle of the endoscope treatment tool as having a fluid port to couple a fluid source to the handle, as is taught by Suzuki, into the device of Wake, as a simple substitution of one known placement of a fluid port for connecting a fluid source to a handle of an endoscope for another to produce the predictable result of connecting a fluid source to a handle.
Response to Arguments
Applicant’s arguments dated 03/11/2026 are currently unpersuasive.
First, applicant’s arguments relevant to the number of references are currently unpersuasive as in response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
In response to applicant’s arguments that Wake does not teach the limitation of the “lumen extending centrally through its entire longitudinal length”, attention is being brought to the current and previously provided rejection of this limitation of the claim language as explaining that as the stopper member is shown as being hollow along its entire longitudinal length, specifically so as to surround elements such as the electrode and the manipulation member, this element teaches the requirement of a ”lumen extending centrally through its entire longitudinal length” as broadly as is currently claimed.
Applicant’s arguments that Ouchi does not disclose the uninterrupted fluid flow path is currently unpersuasive, as this claim limitation is being taught by Wake in view of the definition of uninterrupted, as broadly as is currently claimed.
Applicant’s arguments that any modifications of Wake to include the fluid flow paths of Ouchi would destroy the arrangements of component of Wake as Wake requires the manipulation wire and if the fluid flow path was modified to extend through the proximal portion there would be no opening for the manipulation wire or for the cylindrical stopper member to be imparted by movement is currently unpersuasive. Specifically, as both references teach a hollow distal element for receiving electric current, as Ouchi contains a needle 23 for receiving high-frequency electric current and Wake teaches electrode member 21, and a proximal member which is attached to the hollow distal element for manipulation of the hollow distal element, as Ouchi teaches a fluid transfer tube 22 which is attached to the proximal end of the needle and is axially moveable within the sheath 32 to cause axial movement of the needle 23 and Wake teaches manipulation wire 21 to control the movement of electrode member 21, and therefore, having a modification of the position of the fluid flow path as being one which is provided at a radial position surrounding the moveable member or at a proximal-most position and extending through the moveable member would not have destroyed this arrangement, as both references teach the function of imparting movement on and by these recited elements.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794
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