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 .
Response to Amendment
This office action is responsive to the argument filed on 06/09/2026. As directed by the amendment: claims 1, 10, 23-25, and 27 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-30 are presently pending in this application, with claims 4, 19-26, and 30 are being withdrawn from consideration. Applicant’s amendment to the claims have overcome each and every 112(b) rejection set forth in the Non-Final Office Action mailed on 03/09/2026.
Response to Arguments
Applicant’s arguments on p.10-11 of “Remarks” filed on 06/06/2026 with respect to the 103 rejection of claim 1 and 27 over Willard in view of Foreman have been considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Willard et al. (U.S Patent No. 4846174, “Willard”) in view of Sugiyama et al. (U.S Patent No. 4994032, “Sugiyama”).
In response to applicant's argument on p.8-9 “Remarks”, filed on 06/09/2026 that Willard’s core zone 132e fails to disclose a distal landing structure, it is not found persuasive. In response to applicant’s argument that “a structure denotes a physical feature with some defined form or configuration. Structure is not generally understood as merely a labeled zone or region of a continuous wire”, the examiner respectfully disagrees. A zone or region of a continuous wire would be referencing the structure of said wire in that region. Thus, it is a physical structure reading on the BRI of the term “structure”. Willard’s excerpt that the core wire zone 132 is a region under the balloon area does not teach away from this interpretation of the region of structure of the wire and balloon that attach to one another at this region being a physical structure. Examiner further disagrees that a glue or adhesive would not be considered a structure as being a bonding agent does not remove them from being physical features. The examiner appreciates applicant’s reference to the instant application, but the examiner is of the opinion that the term “structure” is broad, and that the interpretation of “structure” being discrete from the corewire must be positively recited to be interpreted as so.
Examiner further suggests applicant amend to more explicitly define the one or more infusion ports configured for providing fluid into the vessel to distinguish over the prior art (see instant app. para. 0049 – “One or more infusion port(s) 124 can provide for infusion of liquid from lumen 114 delivered from a liquid source attached to proximal fitting 120 into the patient's vessel”).
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.
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, 5, 9, 11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable Willard et al. (U.S Patent No. 4846174, “Willard”) in view of Sugiyama et al. (U.S Patent No. 4994032, “Sugiyama”).
Regarding claim 1, Willard discloses (Claim 1) a balloon/infusion catheter (see Fig. 13-16) comprising:
a corewire (132) comprising a shaft (shaft of 132, Fig. 13-14 and Col.11, lines 52-55), a distal landing structure and a proximal lever (170, see Fig. 14 and Col.13, lines 40-41 – distal portion 182 of balloon 180 is bonded to core zone 132e of core 132, the segment of core zone 132e having the bond being interpreted as the distal landing structure, see Fig. 13 and Col.12, lines 26-41 – examiner notes the proximal lever is interpreted as an elongated structure pivoting off or protruding from the proximal portion of the corewire, stop member 170 is a bent portion pivoted off the proximal end of core 132 and is interpreted as the proximal lever);
a tube (130) comprising a shaft (shaft of 130) with a single lumen (lumen of 130, see Fig. 14 and Col. 11, lines 52-55), a proximal end (proximal end of 130, see Fig. 13), and a distal end (distal end of 130, see Fig. 14), and one or more infusion ports (distal opening of 131 in Fig.14) near the distal end (distal end of 130, see Fig. 14 and Col.12, lines 52-59 – distal opening of inflation lumen 131 is interpreted as one infusion port for infusing inflation fluid into the balloon), wherein the corewire (132) extends through the tube (130) and wherein a gap (131) between the corewire (132) and a wall of the tube (130) allows fluid to flow through the single lumen (lumen of 130, see Fig. 13-14 and Col.12, lines 52-59);
a balloon (180) comprising a polymer sleeve in a fixed sealing engagement (see Fig. 14 and Col. 13, lines 31-34 for polymer sleeve), the fixed sealing engagement having a first sealed end (186) with the tube (130) and a second sealed end (182) with the distal landing structure such that a sealed enclosure is formed spanning between the distal end (distal end of 130) of the tube (130) and the distal landing structure (see Fig. 14 and Col.14, lines 1-3 for first sealed end 186, see Col.13, lines 40-42 for second sealed end 182 and distal landing structure, see Col.12, lines 52-59 – balloon can be inflated such that the sealed ends form a sealed enclosure) and translation of the corewire (132) corresponds to relative movement of the first sealed end (186) and the second sealed end (182) of the balloon (180, see Col.15, lines 7-21 and lines 34-38); and
a proximal hub (140) attached around the proximal end (proximal end of 130) of the tube (130) in a sealed configuration (see Fig. 13 and Col. 12, lines 1-14), the proximal hub (140) comprising a wall (wall of 160), a corewire slide and a connector (fitting 170) forming a continuous lumen through the proximal hub (140) extending the single lumen (lumen of 130) of the tube (130, examiner notes the corewire slide is being interpreted as any structure controlling the translation of the corewire, see Fig. 13 and Col.12, lines 1-19 and lines 26-28 and Col.15, lines 9-17 – corewire slide is being interpreted as the structures within manifold assembly 140 such as the housing 142, slot insert 162, stops 165 and 166 which together allow the operator to control the translation of the corewire, see Col.12, lines 52-61 – examiner notes the reference numeral is used twice in the reference Willard to denote both the stop member 170 and pressure fitting 170, for clarity examiner will refer to the connector as fitting 170), wherein the corewire slide comprises a distal stop (166) and a proximal stop (165) that are configured to engage the proximal lever (170) of the corewire (132) at corresponding positions of the corewire (132) relative to the tube (130) to limit the range of relative positions of the corewire (132) with the corewire (132) free to slide within the tube (130) between the proximal stop (165) and the distal stop (166, see Fig. 14 and Col.12, lines 26-37 and Col.15, lines 9-17 – corewire slide is being interpreted as the structures within manifold assembly 140 such as the housing 142, slot insert 162, stops 165 and 166 which together allow the operator to control the translation of the corewire), and wherein the connector (fitting 170) establishes a fluid channel from an opening (distal opening of fitting 170) into the connector (fitting 170) to an interior of the balloon (180) and to the one or more infusion ports (distal opening of 131) of the tube (130, see Fig. 13-14 and Col.12, lines 52-59).
While Willard discloses that the balloon (180) is formed from a variety of polyolefin tubing that form a controlled distensible material interpreted as the polymer sleeve, Willard fails to explicitly disclose the balloon comprising an elastomeric polymer sleeve.
Sugiyama discloses a balloon catheter (10 in Fig. 1) for use in PTA or PTCA (see Col. 5-18), wherein Sugiyama teaches (Claim 1) a balloon (3 in Fig. 1) of the balloon catheter (10) comprising an elastomeric polymer sleeve (see Col.4, lines 48-57 – balloon 3 may be formed from polyamide elastomers).
Since Willard discloses a PCTA balloon is formed from polyolefin tubing such that it forms a controlled distensible material, and Sugiyama discloses a PCTA balloon that is formed form a material exhibiting certain flexibility including polyolefins or polyamide elastomers, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of Willard to be the polyamide elastomer taught by Sugiyama. Both Willard and Sugiyama disclose balloon’s for use in PCTA procedures and the polymers used to form the balloons are known in the art as explicitly stated by Willard (see Willard, Col.13, lines 34-36). One of ordinary skill in the art could have substituted the polyolefin material of Willard with the polyamide elastomer material of Sugiyama as Sugiyama explicitly states both polyolefins and polyamide elastomers are alternative materials for the PCTA balloon (see Sugiyama, Col.4, lines 48-57), and thus the substitution would have been predictable.
Regarding claim 5, modified Willard discloses the catheter of claim 1, as discussed above. In modified Willard, Willard discloses (Claim 5) wherein the proximal lever (170) of the corewire (132) does not extend through the wall (wall of 160) of the proximal hub (140, see Fig. 13).
Regarding claim 9, modified Willard discloses the catheter of claim 1, as discussed above. In modified Willard, Willard discloses (Claim 9) wherein the corewire (132) further comprises a distal coil (134) positioned distal to the distal landing structure (see Fig. 14 and Col.13, lines 23-25 and lines 39-42).
Regarding claim 11, modified Willard discloses the catheter of claim 1, as discussed above. In modified Willard, Willard discloses (Claim 11) wherein the corewire (132) comprises a tapered section (132b) connecting a smaller diameter segment (132c) with a larger diameter segment (132a, see Fig. 14 and Col.12, lines 63-66).
Regarding claim 13, modified Willard discloses the catheter of claim 1, as discussed above. In modified Willard, Willard discloses (Claim 13) wherein the tube (130) has a distal annular opening from the single lumen (lumen of 130) around the corewire (132) into the interior of the balloon (180) and wherein the connector (fitting 170) of the proximal hub (140) is in fluid communication with a fluid reservoir (see Fig. 13-14 and Col.12, lines 52-59 – tube 130 has a distal annular opening around corewire 132 at the point 182 where tube 130 is bonded to balloon neck portion 184).
Regarding claim 14, modified Willard discloses the catheter of claim 13, as discussed above. In modified Willard, Willard discloses (Claim 14) wherein the fluid reservoir is associated with an infusion pump suitable to deliver fluid at a set pressure or flow rate (see Col.12, lines 55-59).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Herbert (U.S Patent Pub. No. 2014/0135736 A1).
Regarding claim 2, modified Willard discloses the catheter of claim 1, as discussed above. In modified Willard, Willard discloses the limitations of (Claim 2) wherein the proximal lever (170) of the corewire (132) comprises a bent section (see Fig. 13 and Col.12, lines 26-41).
However, modified Willard fails to disclose (Claim 2) a bent section of a flattened length of the corewire.
Herbert discloses a locking assembly for a hypotube manipulated within an outer catheter, wherein Herbert teaches a stainless steel hypotube (182) slidable within outer catheter 24, wherein the hypotube (182) comprises a proximal lever (188) in the form of a flattened length of the hypotube (182) with the proximal lever (188) constraining the movement of the hypotube (182) between two stop structures (see Fig. 16 and para. 0090-0091).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bent, circular stop member taught by modified Willard to a bent, flattened length of the corewire as taught by Herbert. The motivation for this modification is that Herbert teaches a universal control concept that can be easily implemented on any catheter component design by simply flattening a section of the component and overlaying the locking assembly thereon (see para. 0090-0091).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Slater et al. (U.S Patent Pub. No. 20050113798 A1, “Slater”).
Regarding claim 3, modified Willard discloses the catheter of claim 1, as discussed above. In modified Willard, Willard discloses the limitations (Claim 3) wherein the distal stop (166) and the proximal stop (165) of the corewire slide each comprise a flange extending into the continuous lumen of the proximal hub (140, see Col.12, lines 41-51 – stops 165 and 166 may be in the form of projections extending into the space of 160).
However, modified Willard fails to explicitly disclose the flange extending into the continuous lumen of the proximal hub from an intact portion of the proximal hub wall.
Slater discloses a vascular catheter system comprising stops for restricting the sliding range of a wire therewithin, wherein Slater teaches one or more stops (1372) in the form of flanges extending into the lumen (1378). The stops (1372) may also be formed within a proximal manifold such that they would extend into its lumen from an intact portion of the proximal manifold wall in a similar manner to that shown in Fig. 45 (see Fig. 45 and para. 0240).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal and distal stops taught by modified Willard to both be flanges extending from an intact portion of proximal hub wall as taught by Slater to restrict the sliding range of the wire, prevent accidental removal of the wire, and the flanges specifically help facilitate alignment of the wire within the lumen of the catheter (see para. 0240).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Fortson et al. (U.S Patent Pub. No. 2022/0152372 A1, “Fortson”).
Regarding claim 6, modified Willard discloses the catheter of claim 1, as discussed above.
However, modified Willard fails to disclose (Claim 6) wherein the balloon in an initial uninflated state is a cylindrical, non-prestretched elastomer.
Fortson a balloon/infusion catheter used for percutaneous closure of arterial and venous puncture sites and comprises a balloon for inflation to assist with infusion (see para. 0011), wherein Fortson teaches (Claim 6) the balloon (520) in an initial uninflated state is a cylindrical, non-prestretched elastomer (see Fig. 5C for uninflated cylindrical shape, see para. 0061 and 0094 - balloon is an elastomeric material which may have a cylindrical shape and is not disclosed as being pre-stretched after extrusion onto the mold).
Since modified Willard discloses a balloon/infusion catheter for angioplasties which comprises a balloon for inflation to assist with infusion, and Forston discloses a balloon/infusion catheter used for vascular access closure which comprises a balloon for inflation to assist with infusion, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon material taught by modified Willard to incorporate a cylindrical, non-prestretched elastomer as taught by Fortson. The motivation for this modification is that Fortson teaches that an elastomeric balloon which is extruded over a mold to form any number of shapes that are capable of sufficient flexibility to deform (see para. 0061).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 9 above, and further in view of Yonezawa (U.S Patent Pub. No. 2017/0368316 A1).
Regarding claim 10, modified Willard discloses the catheter of claim 9, as discussed above. In modified Willard, Willard discloses the limitations of (Claim 10) the distal coil (134) is connected to the corewire (132, see Fig. 14 and Col.13, lines 23-25 and lines 39-42).
However, modified Willard fails to disclose (Claim 10) the distal coil is connected to the corewire at a solder joint, the solder joint extending along a length that is from about 0.50% to 25% of a coil length. Examiner notes Willard discloses the distal coil (134) being connected to the corewire (132) by a brazed joint that extends only a small amount of the length of the distal coil (134, see Fig. 14 and Col.13, lines 23-25 and 39-42).
Yonezawa discloses a guidewire for insertion into the body, wherein Yonezawa teaches (Claim 10) the distal coil (5) is connected to the corewire (3) at a solder joint (17), the solder joint (17) extending along a length that is from about 0.5% to 25% of the coil length (length of 5, see Fig. 2 and para. 0024 – core shaft 3 comprises a distal coil 5 connected at tin-zinc based solder joint 17 that extends only a small amount of the length of distal coil 5).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the brazed joint taught by modified Willard be a solder joint as taught by Yonezawa. The motivation for this modification is that Yonezawa teaches a solder joint made from a tin-zinc combination which provides sufficient joining strength and can be easily used no matter the material of the core shaft and the coil body (see para. 0005-0006 and 0009).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Divino, Jr. et al. (U.S Patent No. 6676900 B1, “Divino”).
Regarding claim 12, modified Willard discloses the catheter of claim 1, as discussed above.
However, modified Willard fails to disclose (Claim 12) the corewire comprises two or more outwardly extending wings along at least a portion of its length to limit radial movement of the corewire within the shaft of the tube.
Divino discloses a vascular catheter system, wherein Divino teaches a line (76) slidably positioned within lumen (74), wherein the line (76) comprises one or more outwardly extending wings (72) along at least a portion of the line’s (76) length to limit radial movement of the line (76) within the lumen (74, see Fig. 4-4a and Col. 12, lines 19-29).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the corewire taught by modified Willard to incorporate the two or more outwardly extending wings as taught by Divino. The motivation for this modification is that Divino teaches the inclusion of wings on the guidewire help to orient the distal end within the lumen which is especially helpful if it is a stiffer material (see Col. 12, lines 19-33).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Alexander et al. (U.S Patent Pub. No. 20230309842 A1, “Alexander”).
Regarding claim 15, modified Willard discloses the catheter of claim 1, as discussed above.
However, modified Willard fails to disclose (Claim 15) the tube further comprises a pressure sensor configured to read a pressure external to the tube.
Alexander discloses a vascular, balloon catheter comprising a pressure sensor for sensing blood pressure, wherein Alexander teaches (Claim 15) the tube (304) further comprises a pressure sensor (310a) configured to read a pressure external to the tube (304, see Fig. 3a and para. 0079-0080).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter taught by modified Willard to incorporate a pressure sensor as taught by Alexander such that the inflation of the balloon can be optimized based upon the sensed blood pressure information to achieve a desired degree of occlusion (see para. 0005 and 0080-0081).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Cook et al. (U.S Patent Pub. No. 20210244473 A1, “Cook”) in view of Ainsworth et al. (U.S Patent No. 7532920 B1, “Ainsworth”).
Regarding claim 16, modified Willard discloses the catheter of claim 1, as discussed above.
However, modified Willard fails to disclose (Claim 16) the corewire comprises an optical fiber pressure sensor that is exposed in the interior of the balloon.
Cook discloses a vascular balloon catheter comprising an optical fiber for sensing pressure in the interior of the balloon, wherein Cook teaches (Claim 16) an optical fiber pressure sensor (258) that is exposed in the interior (246) of the balloon (204, see Fig. 2 and para. 0103 and 0106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter taught by modified Willard to incorporate an optical fiber sensor as taught by Cook such that the balloon pressure can be monitored to provide valuable information to the user or operator as to performance, reliability, and safety of the catheter system (see para. 0041 and 0075).
However, modified Willard does not explicitly disclose that the corewire comprises the optical fiber pressure sensor. Examiner notes Cook discloses the pressure sensing assembly can be positioned at any appropriate position within the catheter system for sensing balloon pressure (see para. 0041), and Cook illustrates in Fig. 2 that the pressure sensing assembly (242) including fiber optical sensor (258) are adjacent a guidewire lumen (218) within the balloon interior (246).
Ainsworth discloses a guidewire comprising an integral optical fiber for pressure sensing, wherein Ainsworth teaches (Claim 16) a corewire (10) comprising an optical fiber pressure sensor (30, see Fig. 1 and Col. 3, lines 35-41 and Col.4, lines 23-35). Examiner notes the optical fiber (30) can be used to sense pressure when used in a stent delivery system to optimize dilation of the stent (see Col.4, lines 32-35), and thus would be relevant in optimizing the inflation or deflation of a balloon in a similar manner.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the corewire and optical fiber pressure sensor as taught by modified Willard to have the corewire comprise the optical fiber pressure sensor as taught Ainsworth such that a singular device can be used both during the diagnostic and therapeutic phase for sensing and treatment of the patient without having to switch between systems (see Col. 1, lines 48-55) and allows a physician to optimize treatment decisions (see Col.4, lines 10-22).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama as applied to claim 1 above, and further in view of Salerno (WO Patent Pub. No. 2020/157648 A1).
Regarding claim 17, modified Willard discloses the catheter of claim 1, as discussed above.
However, modified Willard fails to disclose (Claim 17) the proximal hub comprises a flow meter.
Salerno discloses a vascular catheter having flow measuring capabilities, wherein Salerno teaches (Claim 17) the proximal hub (10) comprises a flow meter (76, see para. 0135).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal hub taught by modified Willard to incorporate a flow meter as taught by Salerno. The motivation for this modification is that Salerno teaches the inclusion of a flow meter allows for information on fluid flow to be obtained in the fluid paths (see para. 0135).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ogle (U.S Patent Pub. No. 20180098778 A1) in view of Willard in view of Sugiyama.
Regarding claim 18, Ogle discloses the limitations of (Claim 18) a system (650) for clot removal from a bodily vessel comprising (see para. 0099):
the balloon/infusion catheter (652, balloon/infusion catheter 652 is described in depth with embodiments of Figs. 1-22, examiner is interpreting catheter 652 as the embodiment of catheter 180 in Figs. 4-7);
a guide catheter (654); and
an aspiration catheter (656) having a length (see Fig. 25 for length of aspiration catheter 656), wherein the aspiration catheter (656) can be configured to pass through the guide catheter (654) with a distal section (distal section of 656) with an aspiration port (distal opening of 656) extending distally from the guide catheter (654, see Fig. 25 and para. 0099 – aspiration catheter 656 sits within guide catheter 654 with distal opening of 656 extending outside 654), and wherein the balloon/infusion (652) can pass through the length of the aspiration catheter (656) to have the balloon (balloon of 652) of the balloon/infusion catheter (652) and one or more infusion ports (infusion ports of 652) of the balloon/infusion catheter (652) extending distally from the aspiration catheter (656, see Fig. 25, see para. 0099 – balloon/infusion catheter 652 is being interpreted with the structure of catheter 180, catheter 652 sits within aspiration catheter 656 with balloon and infusion ports extending distally from 656, the system 650 can be any combination thereof of the catheters disclosed to meet particular therapeutic means).
With respect to “the balloon/infusion catheter of claim 1”, Ogle discloses a balloon/infusion catheter (180, see Fig. 4-7) comprising:
a corewire (188) comprising a shaft, a distal landing structure (see Fig. 6 and para. 0075 – distal end 198 of wire 188 can be secured at the end of lumen 192 and thus the portion of wire 188 secured to the distal end of balloon 186 is interpreted as the distal landing structure);
a tube (182) comprising a shaft with a single lumen (192, see Fig. 6), a proximal end, and a distal end (see Fig. 6 for ends of tube 182), and one or more infusion ports (196) near the distal end (see Fig. 6 and para. 0075), wherein the corewire (188) extends through the tube (182) and wherein a gap between the corewire (188) and a wall of the tube (182) allows fluid to flow through the single lumen (192, see para. 0075);
a balloon (186) comprising a sleeve (material of 186) in a fixed sealing engagement, the fixed sealing engagement having at a first sealed end with the tube (182) and at a second sealed end with the distal landing structure such that a sealed enclosure is formed spanning between the distal end of the tube (182) and the distal landing structure (see para. 0095 for polymer sleeve, see para. 0009 and 0075 – balloon 186 has a fixed sealing engagement between distal end of tube 182 and a section of the wire 188 interpreted as the distal landing structure such that a sealed enclosure is formed for inflating/deflating balloon 186); and
a proximal hub (190) attached around the proximal end of the tube (182) in a sealed configuration (see para. 0009), the proximal hub (190) comprising a wall, a connector (connector of 190) forming a continuous lumen through the proximal hub (190) extending the single lumen (192) of the tube (182, see para. 0009), wherein the connector (connector of 190) establishes a fluid channel from an opening (distal opening of 190) into the connector (connector of 190) to an interior of the balloon (186) and to one or more infusion ports (196) of the tube (192, see para. 0009).
While the embodiment of Fig. 4-7 of Ogle discloses the corewire (188) as a fixed wire (see para. 0075), examiner notes that several similar embodiments of Ogle such as Fig. 14’s corewire (356, see para 0083) or Fig. 16 discloses a corewire (404) as optionally a fixed or slidable corewire wherein the proximal end of the corewire (404) would extend out of the proximal hub for manipulation (see para. 0085). However, Ogle fails to disclose the limitations of a the balloon comprising an elastomeric polymer sleeve, the corewire comprising a proximal lever, translation of the corewire corresponds to relative movement of the first sealed end and the second sealed end of the balloon, and the proximal hub comprising a corewire slide, wherein the corewire slide comprises a distal stop and a proximal stop that are configured to engage the proximal lever of the corewire at corresponding positions of the corewire relative to the tube to limit the range of relative positions of the corewire with the corewire free to slide within the tube between the proximal stop and the distal stop.
Willard teaches a balloon/infusion catheter (see Fig. 13-16) comprising: a corewire (132) comprising a proximal lever (170, see Fig. 13 and Col.12, lines 26-41 – examiner notes the proximal lever is interpreted as an elongated structure pivoting off or protruding from the proximal portion of the corewire, stop member 170 is a bent portion pivoted off the proximal end of core 132 and is interpreted as the proximal lever); translation of the corewire (132) corresponds to relative movement of the first sealed end (186) and the second sealed end (182) of the balloon (180, see Col.15, lines 7-21 and lines 34-38); the proximal hub (140) comprising a corewire slide (examiner notes the corewire slide is being interpreted as any structure controlling the translation of the corewire, see Fig. 13 and Col.12, lines 1-19 and lines 26-28 and Col.15, lines 9-17 – corewire slide is being interpreted as the structures within manifold assembly 140 such as the housing 142, slot insert 162, stops 165 and 166 which together allow the operator to control the translation of the corewire), wherein the corewire slide comprises a distal stop (166) and a proximal stop (165) that are configured to engage the proximal lever (170) of the corewire (132) at corresponding positions of the corewire (132) relative to the tube (130) to limit the range of relative positions of the corewire (132) with the corewire (132) free to slide within the tube (130) between the proximal stop (165) and the distal stop (166, see Fig. 14 and Col.12, lines 26-37 and Col.15, lines 9-17 – corewire slide is being interpreted as the structures within manifold assembly 140 such as the housing 142, slot insert 162, stops 165 and 166 which together allow the operator to control the translation of the corewire).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon/infusion catheter taught by Ogle to incorporate a slidable corewire with a proximal lever and a corewire slide as taught by the balloon/infusion catheter of Willard. The balloon/infusion catheter of Willard provides an improved dilating catheter which can navigate very tight stenoses by having a balloon system that can substantially reduce its profile through the use of a slidable corewire (see Col. 2, lines 57-68). Thus, in a clot removal system such as Ogle, the balloon/infusion catheter would incorporate the components of Willard discussed above to provide a balloon/infusion catheter that is more advantageous for navigating tight lumens caused by stenoses or clots.
Sugiyama discloses a balloon catheter (10 in Fig. 1) for use in PTA or PTCA (see Col. 5-18), wherein Sugiyama teaches for the balloon/infusion catheter of claim 1, (Claim 18) a balloon (3 in Fig. 1) comprising an elastomeric polymer sleeve (see Col.4, lines 48-57 – balloon 3 may be formed from polyamide elastomers).
Since Ogle discloses a balloon/infusion catheter system for use in removing clots from patient’s vessels, and Sugiyama discloses a PCTA balloon that is formed form a material exhibiting certain flexibility including polyamide elastomers, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the balloon of modified Ogle to be the polyamide elastomer taught by Sugiyama. Both Ogle and Sugiyama disclose balloon’s for use in vascular clot removal procedures and the elastic materials used to form the balloons are known in the art. One of ordinary skill in the art could have substituted the elastic material of Ogle with the polyamide elastomer material of Sugiyama as Sugiyama explicitly states alternative materials for the PCTA balloon (see Sugiyama, Col.4, lines 48-57), and thus the substitution would have been predictable.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama in view of Salerno.
Regarding claim 27, Willard discloses (Claim 27) a balloon/infusion catheter (see Fig. 13-16) comprising:
a corewire (132) comprising a distal landing structure (see Fig. 14 and Col.13, lines 40-41 – distal portion 182 of balloon 180 is bonded to core zone 132e of core 132, the segment of core zone 132e having the bond being interpreted as the distal landing structure);
a tube (130) comprising a shaft (shaft of 130) with a single lumen (lumen of 130, see Fig. 14 and Col. 11, lines 52-55), a proximal end (proximal end of 130, see Fig. 13), and a distal end (distal end of 130, see Fig. 14), and one or more infusion ports (distal opening of 131 in Fig.14) near the distal end (distal end of 130, see Fig. 14 and Col.12, lines 52-59 – distal opening of inflation lumen 131 is interpreted as one infusion port for infusing inflation fluid into the balloon), wherein the corewire (132) extends through the tube (130) and wherein a gap (131) between the corewire (132) and a wall of the tube (130) allows fluid to flow through the single lumen (lumen of 130, see Fig. 13-14 and Col.12, lines 52-59);
a balloon (180) comprising a polymer sleeve in a sealing engagement at a first sealed end (186) with the tube (130) and at a second sealed end (182) with the distal landing structure such that a sealed interior is in fluid communication with the single lumen (lumen of 130) of the tube (130, see Fig. 14 and Col. 13, lines 31-34 for polymer sleeve, see Col.14, lines 1-3 for first sealed end 186, see Col.13, lines 40-42 for second sealed end 182 and distal landing structure, see Col.12, lines 52-59 – for sealed interior and fluid communication);
a proximal hub (140) attached around the proximal end (proximal end of 130) of the tube (130) in a sealed configuration (see Fig. 13 and Col. 12, lines 1-14), the proximal hub (140) comprising a wall (wall of 160) and a connector (fitting 170) forming a continuous lumen through the proximal hub (140) extending the single lumen (lumen of 130) of the tube (130, see Fig. 13 and Col.12, lines 1-19 and lines 26-28 for corewire slide 160, see Col.12, lines 52-61 – examiner notes the reference numeral is used twice in the reference Willard to denote both the stop member 170 and pressure fitting 170, for clarity examiner will refer to the connector as fitting 170) and wherein the connector (fitting 170) establishes a fluid channel from an opening (distal opening of fitting 170) into the connector (fitting 170) to the sealed interior of the balloon (180) and to the one or more infusion ports (distal opening of 131) of the tube (130, see Fig. 13-14 and Col.12, lines 52-59).
However, Willard fails to disclose the limitations (Claim 27) the balloon comprising an elastomeric polymer sleeve; a flow meter, wherein the flow meter is configured to provide a value related to a flow rate through the single lumen of the tube.
Sugiyama discloses a balloon catheter (10 in Fig. 1) for use in PTA or PTCA (see Col. 5-18), wherein Sugiyama teaches (Claim 27) a balloon (3 in Fig. 1) of the balloon catheter (10) comprising an elastomeric polymer sleeve (see Col.4, lines 48-57 – balloon 3 may be formed from polyamide elastomers).
Since Willard discloses a PCTA balloon is formed from polyolefin tubing such that it forms a controlled distensible material, and Sugiyama discloses a PCTA balloon that is formed form a material exhibiting certain flexibility including polyolefins or polyamide elastomers, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of Willard to be the polyamide elastomer taught by Sugiyama. Both Willard and Sugiyama disclose balloon’s for use in PCTA procedures and the polymers used to form the balloons are known in the art as explicitly stated by Willard (see Willard, Col.13, lines 34-36). One of ordinary skill in the art could have substituted the polyolefin material of Willard with the polyamide elastomer material of Sugiyama as Sugiyama explicitly states both polyolefins and polyamide elastomers are alternative materials for the PCTA balloon (see Sugiyama, Col.4, lines 48-57), and thus the substitution would have been predictable.
Salerno teaches (Claim 27) a flow meter (76), wherein the flow meter (76) is configured to provide a value related to a flow rate through the single lumen (11) of the tube (20, see para. 0079 and 0135 – single lumen of catheter shaft 20 splits into three handle paths 11, 12, and 13 which flow meter 76 monitors).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter taught by modified Willard to incorporate a flow meter as taught by Salerno to provide a value related to a flow rate through the single lumen of the tube of modified Willard. The motivation for this modification is that Salerno teaches the inclusion of a flow meter allows for information on fluid flow to be obtained in the fluid paths (see para. 0135).
Regarding claim 28, modified Willard discloses the catheter of claim 27, as discussed above. In modified Willard, Willard discloses (Claim 28) wherein the proximal hub (140) further comprises a corewire slide (examiner notes the corewire slide is being interpreted as any structure controlling the translation of the corewire, see Fig. 13 and Col.12, lines 26-28 and Col.15, lines 9-17 – corewire slide is being interpreted as the structures within manifold assembly 140 such as the housing 142, slot insert 162, stops 165 and 166 which together allow the operator to control the translation of the corewire), the corewire slide comprising a distal stop (166) and a proximal stop (165) wherein the distal stop (166) and the proximal stop (165) are configured to engage the proximal lever (170) of the corewire (132) at corresponding positions of the corewire (132) relative to the tube (130) to limit the range of relative positions of the corewire (132) with the corewire (132) free to slide within the tube (130) between the proximal stop (165) and the distal stop (166, see Fig. 14 and Col.12, lines 26-37 and Col.15, lines 9-17 – corewire slide is being interpreted as the structures within manifold assembly 140 such as the housing 142, slot insert 162, stops 165 and 166 which together allow the operator to control the translation of the corewire).
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over Willard in view of Sugiyama in view of Salerno as applied to claim 27 above, and further in view of Silverton et al. (U.S Patent Pub. No. 2020/0205718 A1, “Silverton”).
Regarding claim 29, modified Willard discloses the catheter of claim 27, as discussed above. In modified Willard, Salerno discloses the limitation of (Claim 29) the flow meter (76).
However, modified Willard fails to disclose (Claim 29) the flow meter comprises an optical fiber with a Bragg Grating and an LED within the proximal hub.
Silverton discloses a urinary catheter comprising an oxygen and flow sensing assembly for sensing characteristics of fluids such as blood, wherein Silverton teaches (Claim 29) the flow meter (122) comprises an optical fiber (132) with a Bragg grating and an LED within the proximal hub (104, see para. 0036 – the flowrate sensor 122 and oxygen sensor 120 may be combined into a single sensor located in the proximal assembly 104, see para. 0038 – the combined sensor may include an optical fiber 132 with a Bragg grating sensor for sensing pressure, see para. 0070 – the combined sensor may comprise an LED light source).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flow meter taught by modified Willard to incorporate an optical fiber with a Bragg grating and LED as taught by Silverton. The motivation for this modification is that Silverton teaches incorporating a Fiber Bragg grating sensor into a combined oxygen and flow meter allows for sensing various different parameters such as temperature, pressure, and strain and can improve the signal quality of the optical fiber (see para. 0038) and incorporating an LED provides light sensing capabilities for sensing parameters within the flowing fluid. Thus, the flow meter of modified Willard would be modified to incorporate an optical fiber with the Bragg grating and an LED to provide a more versatile flow sensor that can sense various different parameters including flow and has improved signal quality.
Allowable Subject Matter
Claims 7-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Willard et al. (U.S Patent No. 486174, “Willard”), Paz et al. (U.S Patent Pub. No. 20210244912 A1, “Paz”), Ogle (U.S Patent Pub. No. 20180098778 A1), Krolik et al. (U.S Patent Pub. No. 20140303554 A1, “Krolik”).
Willard discloses an angioplasty dilating guide wire usable through PCTA catheters (see Fig. 13-16), comprising a corewire (132 in Fig. 13-14) having a distal landing structure interpreted as the section of the corewire (132) in the core zone (132e) that is bonded to the distal portion (182) of the balloon (180) and a proximal lever (170 in Fig. 14, see Col.13, lines 40-41 and Col.12, lines 26-41). Willard further discloses a tube (130) with a single lumen (see Fig. 14 and Col.11, lines 52-55) and an infusion port interpreted as the distal opening of the annular lumen (131 in Fig. 14) for infusing fluid into the balloon (180, see Col.12, lines 52-61), wherein the corewire (132) extends through the tube (130, see Fig. 13-14 and Col.12, lines 52-59), and a balloon (180) formed from a polymer sleeve (see Col.13, lines 31-34) in a fixed sealing engagement such that a first sealed end (186) with the tube (130) and a second sealed end (182) with the distal landing structure form a sealed enclosure spanning between the distal end of the tube (130) and the distal landing structure (see Fig. 14 and Col.14, lines 1-3, Col.13, lines 40-42, and Col.12, lines 52-59). Further, translation of the corewire (132) corresponds to relative movement of the first sealed end (186) and the second sealed end (182) of the balloon (180, see Col.15, lines 7-21 and 34-38). Willard further discloses a proximal hub (140) attached around the proximal end of the tube (130) and comprising a wall (wall of 160), a corewire slide, and a connection (170) forming a continuous lumen through the proximal hub (140) and extending the single lumen of the tube (130, see Fig.13 and Col.12, lines 1-28 and 52-61). The corewire slide is interpreted as the structures within hub (140) such as housing (142), slot insert (162), stops (165 and 166) which allow the operator to control the translation of the corewire (132, see Col.15, lines 9-17). However, Willard fails to disclose the one or more infusion ports interpreted as the distal opening of the annular lumen (131 in Fig. 14) comprising a polymer valve covering said infusion port and which opens in response to an overpressure as claimed in claim 7.
Paz discloses an endo-urethral balloon catheter (100 in Fig. 1C-1D) wherein the annular lumen (130a, 130b in Fig. 1D) formed between the tubing walls (120 in Fig. 1D) are inflation lumens (130a, 130b) for inflating the balloons (106, 108 in Fig. 1C) in a similar manner to the PCTA balloon catheter of Willard. Paz teaches that the inflation lumens (130a, 130b) may comprise valves (142a, 142b in Fig. 1D) covering the inflation lumens (130a, 130b) of the tube (102, see para. 0088), wherein the valves (142a, 142b) open in response to an overpressure with respect to a pressure differential between the inflation lumen (130a, 130b) of the tube (102) relative to a pressure external to the tube (102, see para. 0088-0089 and 0126 – valves 142a/b are duckbill valves which open in response to a threshold pressure being reached within the inflation lumen 130a/b). However, Willard cannot be modified with Paz to teach the claimed structure in claim 7 as Willard discloses the infusion port as an annular lumen (131), and it would not be reasonable to modify a singular duckbill valve as taught by Paz into an annular lumen for controlling fluid flow as it would not cover the entire lumen.
Ogle discloses several embodiments of balloon/infusion catheters (100 in Fig. 1, 150 in Fig. 4, 180 in Fig. 6, 210 in Fig. 8) wherein the catheter (180 in Fig. 6) comprises the most similar structure to the instant invention. Catheter (180) comprises a corewire (188), a tube (182) with a single lumen (192) and one or more infusion ports (196) near its distal end, a balloon (186) formed from a polymer sleeve sealed at a first end with the tube (182), and a proximal hub (190) comprising a connector forming a continuous lumen through the hub (190) and extending the lumen (192) of the tube (182) and to the one or more infusion ports (196, see para. 0075). While Ogle does disclose the infusion ports may be covered by an elastic cover (268) that can function as a valve that opens to allow for infusion at a sufficient pressure within the lumen of the tube (see para. 0077), Ogle fails to disclose the distal landing structure, the proximal lever, the corewire slide, and the sealed enclosure of the elastomeric polymer sleeve of the balloon between the tube and the distal landing structure. Further, Ogle explicitly discloses that the wire (188) is a fixed wire (see para. 0075), thus it cannot be modified to be a movable wire without rendering Ogle inoperable for its intended use.
Krolik discloses a balloon/infusion catheter (10 in Fig. 1-5) for treating a body lumen, e.g. infusing fluid and/or removing obstructive material from within a blood vessel, etc… (see para. 0049). The catheter (10) comprises a corewire (30 in Fig. 1) having a distal landing structure interpreted as the distal section of the corewire (30) comprising the sealing members (38) where distal end (54) of the balloon (50) is secured between said members (38a, 38b, see para. 0057-0059). Krolik further discloses a tube (20) with a single lumen (26) wherein the corewire (30) extends through the tube (20, see para. 0050), and a balloon (50) comprising a sleeve in a sealing engagement at a first sealed end (52) with a tube (20) and at a second sealed end (54) with the distal landing structure of the corewire (30) such that a sealed enclosure is formed spanning between the distal end (24) of the tube (20) and the distal landing structure (see para. 0056 and 0059-0060). Further, translation of the corewire (30) corresponds to relative movement of the first sealed end (52) and the second sealed end (54) of the balloon (50, see Fig. 2-5 and para, 0060-0063). Krolik further discloses a proximal hub (60) comprising a connector (64) and a slider actuator for translating the corewire (30, see para. 0067 and 0069). However, Krolik fails to disclose the proximal lever of the corewire, the one or more infusion ports of the tube, and the fixed sealing engagement of the balloon as Krolik explicitly teaches that the sealing engagement of the balloon is removable by moving the corewire (30) and it sealing members (38a, 38b) out of engagement with the balloon (50, see para. 0060-0062). Therefore, Krolik cannot be modified to have a fixed sealing engagement as this would render its valve inoperable for its intended use. Further, modifying Krolik to have the one or more infusion ports would render its valve inoperable as in the closed configuration the valve is intended to seal its internal fluid from the outer environment and the presence of infusion ports would disrupt this valve mechanism.
Therefore, there is no reference that teaches or discloses a balloon/infusion catheter as claimed in claim 1 that incorporates one or more infusion ports having a polymer valve covering said infusion ports as claimed in claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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