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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 26 September 2025, has been considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 26 September 2025. As directed by the amendment: claims 1 and 14 have been amended, claims 3, 5, 7, 9, and 11-12 have been or remain canceled. Thus claims 1-2, 4, 6, 8, 10, and 13-14 are presently pending in this application. Applicant’s amendments to the Claims and Specification have overcome the drawing objections and 35 U.S.C. 112(a) rejection previously set forth in the Non-Final Office Action mailed 26 March 2025.
Response to Arguments
Applicant argues regarding claim 1, that Campbell teaches the use of an elongate shaft including a step-down in a region proximal to the proximal end of the balloon to distal to the distal end of the balloon. The examiner respectfully disagrees. Campbell teaches an elongate shaft with a step-down proximal to the proximal end of the balloon only. The cut off of the elongate shaft is not a step-down. Further the modification of Campbell in view of Schwager et al. would result in the cut off of the outer shaft being around the entire circumference. A step-down is a reduction in diameter, such as that shown in Fig 10B between regions c and b, not the cut off between b and a.
Applicant indicates support for the amendment was provided in Fig 32D where there are no step-downs in the outer elongate shaft in a region starting just proximal to the proximal end of the balloon 176 and extending to just distal the distal end of the balloon 176. However, the examiner notes the embodiment shown in Fig 32D does not include “a distal end of the inflatable balloon is secured to a section of the inner elongate shaft that extends beyond a distal end of the outer elongate shaft” as recited in claim 1. If applicant is arguing that the cut off of the outer elongate shaft of Campbell is a step down, the embodiment shown in Fig 32D does not incorporate “a distal end of the inflatable balloon is secured to a section of the inner elongate shaft that extends beyond a distal end of the outer elongate shaft”. It is not obvious how this would be achieved without also including a cut off.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4, 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2007/0055301 A1) in view of Schwager et al. (US 2002/0004666 A1) and Walker et al. (US 3,734,100 A).
Regarding claim 1, Campbell et al. discloses a balloon catheter (Fig 12A), comprising: an outer elongate shaft (See outer elongate shaft in annotated Fig 12A below); an inner elongate shaft (See inner elongate shaft in annotated Fig 8 below) with a delivery lumen therein (105 Fig 12A), the inner elongate shaft and extending distally beyond the outer elongate shaft (The portion of the catheter that extends beyond the outer elongate shaft is the section of tubing 119 in Fig 12B); an elastic inflatable balloon (133 Fig 12A) comprising a silicone material ([0121] “silicone-PTFE composite tubing 223”), the inflatable balloon having proximal and distal ends (See the proximal and distal ends in annotated Fig 12A below) secured to a distal end region of the catheter (the region shown in Fig 12A is a distal end region), wherein the outer elongate shaft defines a fluid lumen (107 Fig 12B) in fluid communication with an internal volume of the inflatable balloon to allow fluid to be advanced through the fluid lumen and into the internal volume of the balloon to inflate the balloon (“inflation lumen 107” the lumen opens to the inside of the balloon 133 Fig 12B), wherein a distal end of the inflatable balloon is secured to a section of the inner elongate shaft that extends beyond a distal end of the outer elongate shaft (See Fig 12A, the distal end of the balloon is secured to the shaft of tubing 119 that extends beyond the distal end of the shaft of the inflation lumen 107), and wherein the proximal end of the inflatable balloon is compressed radially within a proximal collar (125 on the proximal end Fig 12A), and wherein the distal end of the inflatable balloon is compressed radially within a distal collar (125 on the distal end Fig 12A), wherein at least one of the proximal collar and the distal collar comprises a heat shrink material ([0122] “porous PTFE film layer 125”, PTFE can shrink when heated), wherein the outer elongate shaft does not include a step-down in a region proximal to the proximal end of the balloon to distal to the distal end of the balloon (See the region in annotated Fig 12A below, the step-down is proximal to and not in the annotated boxed region proximal to the proximal end of the balloon to a distal end of the balloon), wherein the inflatable balloon has an unexpanded configuration (the configuration shown in Fig 12A) in which it is disposed radially at or radially below an outer surface of the outer elongate shaft (The balloon is disposed at or below the outer surface proximal to the region as annotated in Fig 12A), the diameter of the balloon is close to the diameter of the outer shaft ([0123] “Because of the reduced diameter region at the distal end of dual lumen tubing 103 and the very thin character of the porous PTFE film used for layers 125, the diameter of the catheter assembly 100 at the location of film layers 125 was very close to the diameter of catheter shaft 101 proximal to film layers 125”); a catheter extension section including a distal tip that extends distally beyond the distal end of the inflatable balloon (See the catheter extension section with the distal tip in annotated Fig 12A).
However, Campbell et al. fails to teach the inner elongate shaft is radially within the outer elongate shaft, wherein the outer elongate shaft and the inner elongate shaft define the fluid lumen. Campbell et al. further teaches that the diameter of the balloon is close to the diameter of the outer shaft, however, fails to explicitly teach that the balloon does not extend further radially outward than a radially outer surface of the outer elongate shaft.
Schwager et al. teaches a balloon catheter (Fig 1) comprising an outer elongate shaft (6 Fig 1), an inner elongate shaft (3 Fig 1), the inner elongate shaft is radially within the outer elongate shaft (As shown in Fig 1, at the proximal end) and extending distally beyond the outer elongate shaft (See Fig 1, the tube 6 ends at the fastening point 9, tube 3 extends distally to tip 2), wherein the outer elongate shaft and the inner elongate shaft define the fluid lumen ([0017] “The tube 6 that is connected to the balloon 7 serves to supply a suitable medium such as a saline solution into the hollow interior of the balloon 7” the lumen is within tube 6 and around tube 3 as shown in Fig 1). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the balloon catheter of Campbell et al. to have the outer and inner elongate shaft configuration as taught by Schwager et al. since such a modification is the result of a simple substitution of one known element (dual lumen tube with the shaft cut open to expose one of the lumens as taught by Campbell et al.) for another (two coaxial tubes terminating separately as taught by Schwager et al.) to achieve a predictable result (provide tubing with two lumens to inflate the balloon and to provide a guide wire lumen). Additionally using two separate tubes would reduce the amount of steps required to manufacture the tubing.
Walker et al. teaches a balloon that does not extend further radially outward than a radially outer surface of the outer elongate shaft (Figs 1-4, Col 6 lines 55-63 “the proximal and distal edges 16 and 17 of the cuff itself are flush with the outer surface of the tube 18, fit into recess 19 in the tube 1, and at each end abut against shoulders 20 and 21, respectively. The tube 1 thus presents a smooth, continuous surface which does not have any projecting shoulders which would cause irritation of tissues upon insertion or use.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the balloon to be dimensioned as taught by Walker et al. to provide a smooth surface which does not have any projecting shoulders which would cause irritation of tissues upon insertion or use (Col 6 lines 55-63).
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Regarding claim 2, modified Campbell et al. teaches the balloon catheter of claim 1. However, the embodiment of Campbell et al. in Fig 12A fails to explicitly teach wherein the distal collar has a length from 2 mm to 10 mm.
Another embodiment of Campbell et al. teaches a distal collar has a length from 2 mm to 10 mm ([0077] “approximately 1 cm length of shrink tubing 93.”, 1cm is 10mm). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the distal collar of the embodiment of Fig 12A to include the distal collar sized as taught by the embodiment of Fig 8 since such a length would be appropriate for securing a distal portion of a balloon to a catheter.
Regarding claim 4, modified Campbell et al. teaches the balloon catheter of Claim 1. Campbell et al. further teaches wherein the proximal collar comprises a heat shrink material and the distal collar comprises a heat shrink material (film layers 125 make up both the proximal and distal collars).
Regarding claim 6, modified Campbell et al. teaches the balloon catheter of Claim 1. Campbell et al. further teaches wherein the inflatable balloon consists of a silicone material ([0121] “silicone-PTFE composite tubing 223”).
Regarding claim 8, modified Campbell et al. teaches the balloon of Claim 1. Campbell et al. further teaches wherein the proximal end of the inflatable balloon is secured relative to the outer elongate shaft (the proximal end of the balloon 133 is secured under the proximal collar 125 as shown in Fig 12A).
Regarding claim 10, modified Campbell et al. teaches the balloon catheter of claim 1. However, modified Campbell et al. is silent to wherein the catheter extension has a length from 2mm-30 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 device of modified Campbell et al. such that the catheter extension has a length from 2mm-30 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of modified Campbell et al. would not operate differently with the claimed length and since the bent tip of Schwager et al. is at least 2mm [0020] the device would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating that the catheter extension “can be absent or can be of any length, typically 2 mm to 30 mm, more typically from 5 mm to 20 mm.” [0177]
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2007/0055301 A1) in view of Schwager et al. (US 2002/0004666 A1), Walker et al. (US 3,734,100 A) and Atsumi (US 6,733,459 B1).
Regarding claim 13, modified Campbell et al. teaches the balloon catheter of claim 1. However, modified Campbell et al. fails to teach further comprising a pressure sensor distal to the inflatable balloon.
Atsumi teaches a balloon catheter (Fig 1) further comprising a pressure sensor (11 Fig 1) distal (As shown in Fig 1) to the inflatable balloon (4 Fig 1). It would have been obvious to one of ordinary skill in the art at the time of effective filing to include the pressure sensor with the limitations as taught by Atsumi in the device of modified Campbell et al. to allow the device to measure accurate blood pressure at the indwelling position of a catheter introduced percutaneously (Col 1 lines 11-12).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Laguna et al. (US 7,892,201 B1) in view of Walker et al. (US 3,734,100 A) and Schwager et al. (US 2002/0004666 A1).
Regarding claim 14, Laguna et al. discloses a balloon catheter (Fig 14), comprising: an outer elongate shaft (6 Fig 14); an inner elongate shaft (16 Fig 3) with a delivery lumen therein (See the lumen of the inner elongate shaft in Fig 14), the inner elongate shaft radially within the outer elongate shaft (As shown in Fig 14, the inner elongate shaft is radially within the outer elongate shaft) and extending distally beyond the outer elongate shaft (As shown in Fig 14, the outer elongate shaft ends at the butt-joint 66 while the inner elongate shaft continues distally); an elastic inflatable balloon (60 Fig 14, Col 14 lines 9-10 “similar to that previously described with respect to FIGS. 1 through 4”, the embodiment of the sleeve 60 is similar to that in Figs 1-4: Col 4 lines 21-23 “The sleeve 12 should be constructed from a distensible material, such as an elastomer (e.g., silicone”) comprising a silicone material (Col 4 lines 21-23 “The sleeve 12 should be constructed from a distensible material, such as an elastomer (e.g., silicone”), the inflatable balloon having proximal (70 Fig 14) and distal ends (30 Fig 1) secured to a distal end region of the catheter (The end region shown in Fig 1 is a distal end region), wherein the outer elongate shaft and the inner elongate shaft define a fluid lumen (See the interior of 62 Fig 14) in fluid communication with an internal volume of the inflatable balloon to allow fluid to be advanced through the fluid lumen and into the internal volume of the balloon to inflate the balloon (Col 11 lines 17-38, see the inflation from Fig 2 to Fig 1), wherein a distal end of the inflatable balloon is secured to a section of the inner elongate shaft that extends beyond a distal end of the outer elongate shaft (Col 4 lines 20-21 “The second end 30 of the sleeve is attached to the inner member 16 at its distal (that is, "leading") end 32”), and wherein the outer elongate shaft does not include a step-down in a region proximal to the proximal end of the balloon to distal to the distal end of the balloon (See the outer elongate shaft in Fig 14, there is no step-down as the balloon is attached with a butt-joint 66 Fig 14, there is no step-down distal to the butt-joint as the outer elongate shaft does not extend distally), wherein a radially inner surface of the proximal end of the balloon is not attached to a radially outer surface of the outer elongate shaft (See the butt-joint 66 in Fig 14), wherein the inflatable balloon has an unexpanded configuration in which it is disposed radially at or radially below an outer surface of the outer elongate shaft (the balloon is positioned radially below the outer surface of the outer elongate shaft due to the butt-joint) such that the balloon does not extend further radially outward than a radially outer surface of the outer elongate shaft; a catheter extension section including a distal tip that extends distally beyond the distal end of the inflatable balloon.
However, Laguna et al. does not explicitly disclose that the balloon does not extend further radially outward than a radially outer surface of the outer shaft; a catheter extension section including a distal tip that extends distally beyond the distal end of the inflatable balloon.
Walker et al. teaches a balloon that does not extend further radially outward than a radially outer surface of the outer elongate shaft (Figs 1-4, Col 6 lines 55-63 “the proximal and distal edges 16 and 17 of the cuff itself are flush with the outer surface of the tube 18, fit into recess 19 in the tube 1, and at each end abut against shoulders 20 and 21, respectively. The tube 1 thus presents a smooth, continuous surface which does not have any projecting shoulders which would cause irritation of tissues upon insertion or use.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the balloon to be dimensioned as taught by Walker et al. to provide a smooth surface which does not have any projecting shoulders which would cause irritation of tissues upon insertion or use (Col 6 lines 55-63). Accordingly, Laguna et al. teaches “a smooth transition 24 is formed between the catheter shaft 14 and the balloon following mounting” (Col 4 lines 5-7).
Schwager et al. teaches a catheter extension section (the portion of 3 that extends distally beyond 4 Fig 1) including a distal tip (2 Fig 1) that extends distally beyond the distal end of the inflatable balloon ([0018] “a bent tip 2 which is an extension of the guide wire tube 3 projecting beyond the distal end 4 of the balloon 7.”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the catheter of modified Laguna et al. to include a catheter extension section with the limitations as taught by Schwager et al. to provide a length of the catheter that can be bent to help navigate the catheter through vessels easier [0021].
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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783