DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/612709 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 12/20/2023.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “71” in Fig. 2.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 3 is objected to because of the following informalities: amend “tip distal” to -a tip distal- in ll. 3. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: delete “the operation of” in ll. 7 & 9. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “is the choke” to -in the choke- in ll. 8. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: delete “the operation of” in ll. 1. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: delete “the operation of” in ll. 2. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: delete “into the interior volume of the balloon” in ll. 1-2. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: delete “the operation of” in ll. 2. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: delete “the operation of” in ll. 1 & 3. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: delete “the operation of” in ll. 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a proximal passage” in ll. 24 & 27. It is unclear if the “proximal passage[s]” are the same as or different from one another. For purposes of examination, “a proximal passage” in ll. 27 will be interpreted as a “a distal passage”.
Claims 2-14 depend from claim 1 and are thus also rejected.
Claim 14 recites the limitation "the operation of disposing the balloon entirely in the guide-catheter lumen" in ll. 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 13, upon which claim 14 depends, only recites “withdrawing the electrophysiology catheter into the guide-catheter lumen”. The claim will be interpreted as -wherein withdrawing the electrophysiology catheter into the guide-catheter lumen comprises withdrawing the electrophysiology catheter entirely into the guide-catheter lumen in less than about fifteen seconds after lessening the volume flow rate-.
Claim 15 recites “a proximal passage” in ll. 24 & 27. It is unclear if the “proximal passage[s]” are the same as or different from one another. For purposes of examination, “a proximal passage” in ll. 27 will be interpreted as a “a distal passage”.
Claims 16-25 depend from claim 15 and are thus also rejected.
Claim 23 recites the limitation "the tip wall" in ll. 2. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beeckler et al. (2017/0312022) in view of Samson (5,304,198).
Concerning claims 1 & 3, as illustrated in Fig. 2-3, Beeckler et al. disclose an electrophysiology catheter (electrophysiology catheter 24; [0056]) comprising
a shaft assembly (shaft 70; [0056]) comprising:
a plurality of tubular components having respective walls that together define an interior of the shaft assembly that includes a shaft-assembly lumen (proximal shaft portion 82, distal shaft portion 88; [0056]);
a second of the plurality of tubular components comprising a second shaft including a second-shaft wall that forms a second one of the respective walls, a second-shaft proximal portion, a second-shaft distal portion, and a second-shaft lumen extending through the second shaft such that the second-shaft lumen forms a second portion of the interior of the shaft assembly (proximal shaft portion 82 comprises a shaft wall, a proximal portion, and a distal portion, and permits a catheter 72/99 to pass therethrough thereby having a lumen; [0056]);
a third of the plurality of tubular components comprises a tip including a tip wall that forms a third one of the respective walls, a tip proximal portion, tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly, the tip being connected to the first shaft such that the tip distal portion is disposed distal of the first-shaft distal portion and the tip proximal portion (distal shaft end 88 comprises a shaft wall, a proximal portion, and a distal portion, and permits a 72/99 catheter to pass therethrough thereby having a lumen; [0056]); and
a balloon defining an interior volume connected to the shaft assembly (inflatable balloon defines an interior volume and connects to shaft 70; [0057]).
Beeckler et al. fail to disclose the specifics of the shaft assembly, and specifically, wherein the plurality of tubular components comprises: a first of the plurality of tubular components comprising a first shaft including a first-shaft wall that forms a first one of the respective walls, a first-shaft proximal portion, a first-shaft distal portion, and a first-shaft lumen extending through the first shaft such that the first-shaft lumen forms a first portion of the interior of the shaft assembly; the second shaft being connected to the first shaft such that the first-shaft distal portion is disposed distal of the second-shaft distal portion and the first-shaft proximal portion; the tip distal portion being disposed distal of the first-shaft distal portion and the tip proximal portion; and a choke region disposed in the shaft-assembly lumen, the choke region including a choke lumen having a choke width that is less than a width of a portion of the shaft-assembly lumen that is located proximal to the choke lumen, wherein a proximal portion of the balloon is connected to the second-shaft distal portion and a distal portion of the balloon is connected to the first-shaft distal portion; a proximal port located inside the balloon and disposed through one of the respective walls, such that the proximal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon; and a distal port located inside the balloon, and disposed through the one of the respective walls or another of the respective walls, such that the distal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon. However, as illustrated in 1A-1B & 3C-D, Samson discloses a catheter (catheter assembly; Col. 3, ll. 30-38), comprising: a shaft assembly comprising: a plurality of tubular components having respective walls that together define an interior of the shaft assembly that includes a shaft-assembly lumen (body section 109 made up of outer tubing 108 and/or inner tubing member 110, balloon inner member 114/314 having spring 118/inner tube 308 and valve section 106 form a shaft lumen; Col. 3, ll. 39-66, Col. 4, ll. 43-65, Col. 6, ll. 20-34); a first of the plurality of tubular components comprising a first shaft including a first-shaft wall that forms a first one of the respective walls, a first-shaft proximal portion, a first-shaft distal portion, and a first-shaft lumen extending through the first shaft such that the first-shaft lumen forms a first portion of the interior of the shaft assembly (balloon inner member 114/314 containing inner tube 308 forms a respective wall of the shaft assembly 108/110, 114/314, 106, has a proximal portion, distal portion, and lumen such that the lumen forms a first portion of the interior of the shaft assembly 108/110, 114/314, 106; Col. 6, ll. 20-34); a second of the plurality of tubular components comprising a second shaft including a second-shaft wall that forms a second one of the respective walls, a second-shaft proximal portion, a second-shaft distal portion, and a second-shaft lumen extending through the second shaft such that the second-shaft lumen forms a second portion of the interior of the shaft assembly (outer tubing 108/inner tubing member 110 has a proximal portion, distal portion, and lumen such that the lumen forms a second portion of the interior of the shaft assembly 108/110, 114/314, 106 Col. 3, ll. 39-66), the second shaft being connected to the first shaft such that the first-shaft distal portion is disposed distal of the second-shaft distal portion and the first-shaft proximal portion (outer tubing 108/inner tubing member 110 connects to balloon inner member 114/314 such that the distal portion of balloon inner member 114/314 is disposed distal of the outer tubing 108/inner tubing member 110 distal portion and the balloon inner member 114/314 proximal portion; Col. 3, ll. 39-66); a third of the plurality of tubular components comprises a tip including a tip wall that forms a third one of the respective walls, a tip proximal portion, a tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly (valve region 106 comprises a tip including a tip wall that forms a third one of the shaft assembly walls, a tip proximal portion, a tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly; Col. 3, ll. 39-50), the tip being connected to the first shaft such that the tip distal portion is disposed distal of the first-shaft distal portion and the tip proximal portion (valve region 106 connects to balloon inner member 114/314 such that valve region distal portion is disposed distal to the distal portion of the balloon inner member 114/314 and the valve region 106 proximal portion; Col. 3, ll. 39-50); and a choke region disposed in the shaft-assembly lumen, the choke region including a choke lumen having a choke width that is less than a width of a portion of the shaft-assembly lumen that is located proximal to the choke lumen (distal end 116 of inner member 114/314 // or // valve region 106 with metal band/ring 120 forms a smaller diameter lumen; Col. 4, ll. 43-65); where the balloon connects to the shaft assembly, such that a proximal portion of the balloon is connected to the second-shaft distal portion and a distal portion of the balloon is connected to the first-shaft distal portion (balloon body 112 connects to distal portion of outer tubing 108/inner tubing member 110 and distal portion of balloon inner member 114/314 at end sections 116; Col. 3, ll. 39-50); a proximal port located inside the balloon and disposed through one of the respective walls, such that the proximal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon (inner tubing 308 has a number of orifices 312 to permit fluid flow between the lumen and balloon; Col. 6, ll. 20-34); and a distal port located inside the balloon, and disposed through the one of the respective walls or another of the respective walls, such that the distal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon (inner tubing 308 has a number of orifices 312 to permit fluid flow between the lumen and balloon; Col. 6, ll. 20-34 // or // proximal end of valve region 106 comprises a port within balloon 112 and through the circumferential wall and defines a passage between the interior of the shaft assembly and the interior of balloon 112 indirectly through end 116 and orifices 312; Fig. 1A-B). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Beeckler et al. such that the plurality of tubular components comprises: a first of the plurality of tubular components comprising a first shaft including a first-shaft wall that forms a first one of the respective walls, a first-shaft proximal portion, a first-shaft distal portion, and a first-shaft lumen extending through the first shaft such that the first-shaft lumen forms a first portion of the interior of the shaft assembly; a second of the plurality of tubular components comprising a second shaft including a second-shaft wall that forms a second one of the respective walls, a second-shaft proximal portion, a second-shaft distal portion, and a second-shaft lumen extending through the second shaft such that the second-shaft lumen forms a second portion of the interior of the shaft assembly, the second shaft being connected to the first shaft such that the first-shaft distal portion is disposed distal of the second-shaft distal portion and the first-shaft proximal portion, a third of the plurality of tubular components comprises a tip including a tip wall that forms a third one of the respective walls, a tip proximal portion, a tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly, the tip being connected to the first shaft such that the tip distal portion is disposed distal of the first-shaft distal portion and the tip proximal portion; and a choke region disposed in the shaft-assembly lumen, the choke region including a choke lumen having a choke width that is less than a width of a portion of the shaft-assembly lumen that is located proximal to the choke lumen, wherein a proximal portion of the balloon is connected to the second-shaft distal portion and a distal portion of the balloon is connected to the first-shaft distal portion; a proximal port located inside the balloon and disposed through one of the respective walls, such that the proximal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon; and a distal port located inside the balloon, and disposed through the one of the respective walls or another of the respective walls, such that the distal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon in order to provide the benefit of a smaller diameter catheter usable with a guidewire as taught by Samson (Col. 1, ll. 36-46)
Concerning claim 2, Samson further discloses the width of the portion of the shaft-assembly lumen (108/110, 114/314, 106) that is positioned proximal (108/110, 114/314), to the choke lumen (106) is between about 0.5 mm and 0.89 mm (Col. 5-6, ll. 53-14) and thus fail to specifically disclose the width to be between about 1.0 mm and 1.75 mm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width of Beeckler et al. in view of Samson from between 0.5 mm and 0.89 mm to between 1.0 mm and 1.75 mm as Applicant appears to have placed no criticality on the claimed range (see pp. [0045] indicating the range “may” be between the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 4, Samson disclose, in which the tip (106) proximal portion is directly connected to the first-shaft distal portion (114/214) (Fig. 1A-B).
Concerning claim 5, Samson disclose in which the distal port (312) is disposed through the first-shaft (114/314) wall (Col. 6, ll. 15-34; Fig. 3C-D).
Concerning claim 6, Samson discloses in which the first-shaft (114/314, 308) lumen (116) defines at least a portion of the choke lumen (116) (Fig. 1A-3D).
Concerning claim 7, Samson discloses the distal port (distal most end of valve region 106) is disposed through the tip (106) wall (distal-most end of circumferential wall defines an opening) (Fig. 1A-B).
Concerning claim 8, Samson discloses in which the tip lumen (106) defines at least a portion of the choke lumen (120) (Col. 3, ll. 39-50; Fig. 1A-B).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beeckler et al. (2017/0312022) in view of Samson (5,304,198), as applied to claim 1, in further view of Long et al. (2020/0093539) and Bencini et al. (2009/0299355).
Concerning claim 9, Beeckler et al. disclose a method of using the electrophysiology catheter of claim 1, the method comprising: flowing a liquid; expanding the balloon with liquid such that the balloon has an ellipsoidal configuration; and withdrawing the electrophysiology catheter into a guide-catheter lumen of a guide catheter (balloon 80 is deployed, in a collapsed uninflated configuration, via the lumen 23 of the probe 20 through guiding sheath 21 that is pre-positioned in the patient’s lumen, and may be inflated after exiting from the distal end 22 whereupon, the balloon 80 may be inflated and deflated by injection and expulsion of a fluid such as saline solution through the shaft 70 to treat tissue, and then withdraw through guiding sheath 21; [0052], [0057]).
Beeckler et al. fail to disclose the method comprising activating an irrigation pump to expand the balloon with the liquid. However, Long et al. disclose a method of operating a balloon catheter where the balloon may be pressurized with a pump. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Beeckler et al. such that the method comprises activating an irrigation pump; flowing a liquid; expanding the balloon with the liquid in order to provide the benefit of a suitable means to inflate the balloon as taught by Long et al. ([0056])
Beeckler et al. in view of Samson and Long et al. fail to disclose flowing the liquid while a portion of a guidewire is disposed in the choke lumen and expanding the balloon with the liquid; and after the operation of expanding the balloon, displacing the guidewire proximally such that the portion of the guidewire is not disposed is the choke lumen. However, Samson further discloses flowing the liquid while a portion of a guidewire is disposed in the choke lumen and expanding the balloon with the liquid; (catheter body is tracked over the guidewire, and once the balloon is at the desired site within the vessel, the catheter lumen is flushed by injecting fluid through the catheter lumen while valve plug 104 is seated against the distal 124 or proximal 122 valve surface to inflate the balloon; Col. 6, ll. 40-60); and after the operation of expanding the balloon, displacing the guidewire proximally such that the portion of the guidewire is not disposed is the choke lumen (controlled distal leakage of the fluid from the catheter tip may be achieved by a slight adjustment in the tightness of the seating between valve plug and the respective valve surface; Col. 6, ll. 40-60). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Beeckler et al. in view of Samson and Long et al. such that the method comprises flowing the liquid while a portion of a guidewire is disposed in the choke lumen and expanding the balloon with the liquid; and after the operation of expanding the balloon, displacing the guidewire proximally such that the portion of the guidewire is not disposed is the choke lumen in order to provide the benefit of controlling distal leakage of fluid as taught by Samson. (Col. 6, ll. 40-60
Beeckler et al. in view of Samson and Long et al. fail to disclose after the operation of displacing the guidewire proximally, withdrawing the electrophysiology catheter into a guide-catheter lumen of a guide catheter. However, Bencini et al. disclose a method of using a balloon catheter comprising withdrawing the electrophysiology catheter into a guide-catheter lumen of a guide catheter (balloon 103 is deflated and withdrawn into the introducer sheath; [0064], [0066]). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Beeckler et al. in view of Samson and Long et al. in order to provide the benefit of removing the catheter from the patient at the end of the procedure. The modified invention of Beeckler et al. in view of Samson and Long et al. and Bencini et al. teach withdrawing the catheter into the guide-catheter lumen of a guide catheter at the end of the procedure as thus after the operation of displacing the guidewire proximally.
Claim(s) 15-21 & 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beeckler et al. (2017/0312022) in view of Samson (5,304,198) and Wiesner et al. (5,348,537).
Concerning claims 15 & 24, as illustrated in Fig. 2-3, Beeckler et al. disclose an electrophysiology catheter (electrophysiology catheter 24; [0056]), comprising:
a shaft assembly (shaft 70; [0056]) comprising:
a plurality of tubular components having respective walls that together define an interior of the shaft assembly that includes a shaft-assembly lumen (proximal shaft portion 82, distal shaft portion 88; [0056]);
a second of the plurality of tubular components comprising a second shaft including a second-shaft wall that forms a second one of the respective walls, a second-shaft proximal portion, a second-shaft distal portion, and a second-shaft lumen extending through the second shaft such that the second-shaft lumen forms a second portion of the interior of the shaft assembly (proximal shaft portion 82 comprises a shaft wall, a proximal portion, and a distal portion, and permits a catheter 72/99 to pass therethrough thereby having a lumen; [0056]); and
a balloon defining an interior volume connected to the shaft assembly (inflatable balloon defines an interior volume and connects to shaft 70; [0057]).
Beeckler et al. fail to disclose the specifics of the shaft assembly, and specifically, wherein the plurality of tubular components comprises: a first of the plurality of tubular components comprising a first shaft including a first-shaft wall that forms a first one of the respective walls, a first-shaft proximal portion, a first-shaft distal portion, and a first-shaft lumen extending through the first shaft such that the first-shaft lumen forms a first portion of the interior of the shaft assembly; the second shaft being connected to the first shaft such that the first-shaft distal portion is disposed distal of the second-shaft distal portion and the first-shaft proximal portion; the tip distal portion being disposed distal of the first-shaft distal portion and the tip proximal portion; and a choke region disposed in the shaft-assembly lumen, the choke region including a choke lumen having a choke width, wherein a proximal portion of the balloon is connected to the second-shaft distal portion and a distal portion of the balloon is connected to the first-shaft distal portion; a proximal port located inside the balloon and disposed through one of the respective walls, such that the proximal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon; and a distal port located inside the balloon, and disposed through the one of the respective walls or another of the respective walls, such that the distal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon. However, as illustrated in 1A-1B & 3C-D, Samson discloses a catheter (catheter assembly; Col. 3, ll. 30-38), comprising: a shaft assembly comprising: a plurality of tubular components having respective walls that together define an interior of the shaft assembly that includes a shaft-assembly lumen (body section 109 made up of outer tubing 108 and/or inner tubing member 110, balloon inner member 114/314 having spring 118/inner tube 308 and valve section 106 form a shaft lumen; Col. 3, ll. 39-66, Col. 4, ll. 43-65, Col. 6, ll. 20-34); a first of the plurality of tubular components comprising a first shaft including a first-shaft wall that forms a first one of the respective walls, a first-shaft proximal portion, a first-shaft distal portion, and a first-shaft lumen extending through the first shaft such that the first-shaft lumen forms a first portion of the interior of the shaft assembly (balloon inner member 114/314 containing inner tube 308 forms a respective wall of the shaft assembly 108/110, 114/314, 106, has a proximal portion, distal portion, and lumen such that the lumen forms a first portion of the interior of the shaft assembly 108/110, 114/314, 106; Col. 6, ll. 20-34); a second of the plurality of tubular components comprising a second shaft including a second-shaft wall that forms a second one of the respective walls, a second-shaft proximal portion, a second-shaft distal portion, and a second-shaft lumen extending through the second shaft such that the second-shaft lumen forms a second portion of the interior of the shaft assembly (outer tubing 108/inner tubing member 110 has a proximal portion, distal portion, and lumen such that the lumen forms a second portion of the interior of the shaft assembly 108/110, 114/314, 106 Col. 3, ll. 39-66), the second shaft being connected to the first shaft such that the first-shaft distal portion is disposed distal of the second-shaft distal portion and the first-shaft proximal portion (outer tubing 108/inner tubing member 110 connects to balloon inner member 114/314 such that the distal portion of balloon inner member 114/314 is disposed distal of the outer tubing 108/inner tubing member 110 distal portion and the balloon inner member 114/314 proximal portion; Col. 3, ll. 39-66); a third of the plurality of tubular components comprises a tip including a tip wall that forms a third one of the respective walls, a tip proximal portion, a tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly (valve region 106 comprises a tip including a tip wall that forms a third one of the shaft assembly walls, a tip proximal portion, a tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly; Col. 3, ll. 39-50), the tip being connected to the first shaft such that the tip distal portion is disposed distal of the first-shaft distal portion and the tip proximal portion (valve region 106 connects to balloon inner member 114/314 such that valve region distal portion is disposed distal to the distal portion of the balloon inner member 114/314 and the valve region 106 proximal portion; Col. 3, ll. 39-50); and a choke region disposed in the shaft-assembly lumen, the choke region including a choke lumen having a choke width (distal end 116 of inner member 114/314 // or // valve region 106 with metal band/ring 120 forms a smaller diameter lumen that is a choke; Col. 4, ll. 43-65); where the balloon connects to the shaft assembly, such that a proximal portion of the balloon is connected to the second-shaft distal portion and a distal portion of the balloon is connected to the first-shaft distal portion (balloon body 112 connects to distal portion of outer tubing 108/inner tubing member 110 and distal portion of balloon inner member 114/314 at end sections 116; Col. 3, ll. 39-50); a proximal port located inside the balloon and disposed through one of the respective walls, such that the proximal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon (inner tubing 308 has a number of orifices 312 to permit fluid flow between the lumen and balloon; Col. 6, ll. 20-34); and a distal port located inside the balloon, and disposed through the one of the respective walls or another of the respective walls, such that the distal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon (inner tubing 308 has a number of orifices 312 to permit fluid flow between the lumen and balloon; Col. 6, ll. 20-34 // or // proximal end of valve region 106 comprises a port within balloon 112 and through the circumferential wall and defines a passage between the interior of the shaft assembly and the interior of balloon 112 indirectly through end 116 and orifices 312; Fig. 1A-B). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Beeckler et al. such that the plurality of tubular components comprises: a first of the plurality of tubular components comprising a first shaft including a first-shaft wall that forms a first one of the respective walls, a first-shaft proximal portion, a first-shaft distal portion, and a first-shaft lumen extending through the first shaft such that the first-shaft lumen forms a first portion of the interior of the shaft assembly; a second of the plurality of tubular components comprising a second shaft including a second-shaft wall that forms a second one of the respective walls, a second-shaft proximal portion, a second-shaft distal portion, and a second-shaft lumen extending through the second shaft such that the second-shaft lumen forms a second portion of the interior of the shaft assembly, the second shaft being connected to the first shaft such that the first-shaft distal portion is disposed distal of the second-shaft distal portion and the first-shaft proximal portion, a third of the plurality of tubular components comprises a tip including a tip wall that forms a third one of the respective walls, a tip proximal portion, a tip distal portion, and a tip lumen extending through the tip such that the tip lumen forms a third portion of the interior of the shaft assembly, the tip being connected to the first shaft such that the tip distal portion is disposed distal of the first-shaft distal portion and the tip proximal portion; and a choke region disposed in the shaft-assembly lumen, the choke region 15 including a choke lumen having a choke width, wherein a proximal portion of the balloon is connected to the second-shaft distal portion and a distal portion of the balloon is connected to the first-shaft distal portion; a proximal port located inside the balloon and disposed through one of the respective walls, such that the proximal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon; and a distal port located inside the balloon, and disposed through the one of the respective walls or another of the respective walls, such that the distal port defines a proximal passage between the interior of the shaft assembly and the interior volume of the balloon in order to provide the benefit of a smaller diameter catheter usable with a guidewire as taught by Samson (Col. 1, ll. 36-46)
Beeckler et al. in view of Samson fail to disclose the choke region including a seal disposed in the choke lumen. However, Wiesner et al. disclose a catheter (10) comprising a shaft assembly (11, 16) having an inner lumen (12) and a choke region (15) including a seal (15) disposed in a choke lumen (12). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Beeckler et al. in view of Samson to substitute the valve plug of Samson with the choke lumen seal of Wiesner et al. located at the tip lumen constriction in order to provide the benefit of excellent sealing of catheter components to prevent the loss of inflation liquid while also allowing easy movement of catheter components such as a guidewire or guiding member within a passageway of the sealing element as taught by Wiesner et al. (Col. 4, ll. 10-19 & 44-65, Col. 5, ll. 1-4 & 33-55; Fig. 1-4) whereby doing so provides the predictable result of sealing the inflation lumen of the balloon.
Concerning claim 16, Wiesner et al. disclose in which the seal (15) has a tubular form and includes a seal lumen (21) (Col. 5, ll. 1-4 & 33-55; Fig. 4).
Claim 17 is rejected upon the same rationale as applied to claim 2.
Concerning claim 18, Samson discloses in which a constriction (120) in the seal lumen defines a bore (Fig. 1A-B).
Concerning claim 19, Samson discloses in which the constriction (120) is disposed distal of the distal port (port at proximal end of valve region 106) (Fig. 1A-B).
Concerning claim 20, Beeckler et al. in view of Samson and Wiesner et al. fail to disclose in which a width of the bore is between about 0.38 mm and about 0.95 mm. However, one of ordinary skill in the art would recognize the bore width to be at least less than the width/diameter of the seal lumen since the width/diameter is constricted. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Beeckler et al. in view of Samson and Wiesner et al. by making a width of the bore is between about 0.38 mm and about 0.95 mm as a matter of routine optimization as Applicant appears to have placed no criticality on the claimed range (see Par. [0052] stating “[a]ppropriate exemplary dimensions include the width of bore 174 being about 0.38 mm to about 0.95 mm, e.g., about .60 mm, for a non-uniform device 148 having a minimum width, i.e., the width of minimal-width portion 178, that ranges between those same dimensions, i.e., between about .38 mm to about 0.95 mm, e.g., about .60 mm”) and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Concerning claim 21, Wiesner et al. disclose the seal comprises an elastomer, and specifically Tecoflex polyurethane, where varying grades can have a Shore A hardness range of 20-90. Beeckler et al. in view of Samson and Wiesner et al. fail disclose in which the seal shore A durometer hardness between about 25 and about 40. However, since the modified in invention of Beeckler in view of Samson and Wiesner et al. is navigated through vasculature to tissue, one of ordinary skill in the art would recognize a need for a lower Shore A durometer hardness. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Beeckler et al. in view of Samson and Wiesner et al. such that the seal shore A durometer hardness is between about 25 and about 40 in order to provide the benefit of a flexible catheter, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 22-23 & 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beeckler et al. (2017/0312022) in view of Samson (5,304,198) and Wiesner et al. (5,348,537), as applied to claim 15, in further view of Kletschka et al. (2002/0173817).
Concerning claim 22, Beeckler et al. in view of Samson and Wiesner et al. fail to disclose the seal comprises a wiper seal. However, Kletschka et al. teach a catheter comprising a seal (130) around a guidewire (44), the seal comprising a wiper seal that prevents fluid from leaking through the guidewire port (34) while still allowing the guidewire (44) to move ([0143]). It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Beeckler et al. in view of Samson and Wiesner et al. such that the seal comprises a wiper seal in view of the teachings of Kletshka et al. since a wiper seal , since Applicant has not disclosed that a wiper seal solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a wiper seal as Kletshka et al. teach a wiper seal to be an equivalent in the art for the purposes of preventing fluid from leaking through the guidewire port while still allowing movement of the guidewire through the port.
Claim 23 is rejected upon the same rationale as applied to claim 7.
Concerning claim 25, Samson discloses in which the choke lumen (120) comprises at least a portion of the tip lumen (106). The modified invention of Beeckler et al. in view of Samson and Wiesner et al. and Kletshka et al. teach the seal is disposed in a portion of the choke lumen that comprises at least the portion of the tip lumen.
Allowable Subject Matter
Claims 10-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination, teaches “withdrawing the electrophysiology catheter into the guide-catheter lumen comprises compressing the balloon against a distal end of the guide catheter such that at least some of the liquid in the balloon is forced into the distal port and out of the tip distal portion.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Taylor et al. (5,324,259) and Levine et al. (6,074,407) teach guidewires that block a distal catheter lumen.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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