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
The amendment filed 23 January 2026 has been entered. Claim(s) 1-4, 7-11, and 13-26 remain pending in the application, with claims 17-20 and 23 withdrawn as nonelected. Applicant’s amendments to the claims have overcome each and every objection to the claims, and each and every rejection under 35 U.S.C. 112(b) previously set forth in the Office Action mailed 23 October 2025.
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.
Claim(s) 1, 3-4, 13-16, and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Towne (US 5059177 A) in view of Lampropoulos (US 20160250444 A1), further in view of Stevens (WO 9630072 A1).
Regarding claim 1, Towne teaches catheter (See fig. 1, distal end of catheter with curvature) configured to measure a pressure proximal to a narrowing and a pressure distal to the narrowing (Col. 2, lines 12-19; Col. 4, line 2-6), comprising:
a double lumen proximal shaft segment (Catheter shaft 12, Fig. 1; see Fig. 3, Segment of catheter up to seal 39; Fig. 2—two lumens 16 and 18) defining a proximal pressure lumen (18) and a non-coaxial, distal pressure lumen (16);
a single lumen distal shaft segment (Distal tip 37; see Fig. 3, segment of catheter after seal 39) configured to be partially positioned across the narrowing (Col. 4, line 2-6) and having a portion that includes the distal pressure lumen but not the proximal pressure lumen (See Figs. 1 and 3);
at least one proximal orifice (36) in fluid communication with the proximal pressure lumen (See Fig. 3, 36 in communication with the proximal pressure lumen 18; Col. 3, line 46-51-- On the other hand, lumen 18 encounters an open port 36 at a position proximal to the distal end, so that the distal port 35 of lumen 16 is longitudinally spaced from the distal port 36 of lumen 18) and positionable proximal to the narrowing (Col. 4, line 2-6) along an outer catheter wall (See Fig. 3, along the outer catheter wall),
and at least one distal orifice (35) in fluid communication with the distal pressure lumen (See Fig. 3, 35 in fluid communication with the distal pressure lumen 16; Col. 3, line 45-46-- Lumen 16 extends to the distal end 22 of the catheter and defines an open port 35 there) and positionable distal to the narrowing along the outer catheter wall (Col. 4, line 2-6-- Particularly, the pressure differential across a heart valve such as the mitral valve may be measured if the catheter is positioned so that its distal end 22 passes through the mitral valve while port 36 remains on the other side thereof);
a shaft bend positioned between the at least one proximal orifice and the at least one distal orifice (See Fig. 1 and 3, bending of the shaft between 22 and 36).
However, Towne does not explicitly disclose the catheter is a pigtail catheter. Lampropoulos, in the same field of endeavor of a pressure sensing catheter, discloses the catheter has a pigtail tip (Paragraph 0029).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify Towne, which discloses a catheter having a distal tip including a curvature, with the pigtail of Lampropoulos as a simple substitution, where Lampropoulos discloses that a pigtail configuration is known in the art as a type of curved distal tip (Paragraph 0029 of Lampropoulos), and wherein such a modification would predictably improve the safety of the device by ensuring that as the catheter is advanced into a body the curved surface contacts the walls of the body lumen initially rather than the tip which may be sharp or otherwise cause discomfort (see paragraph 0064 of Lampropoulos).
However, Towne does not explicitly disclose a braided structure contained within the outer catheter wall and extending from the proximal shaft segment.
Stevens, in the same field of endeavor of a catheter, discloses a braided structure contained within the outer catheter wall and extending from the proximal shaft segment to a proximal portion of the distal shaft segment that is 0.5 cm to 4 cm, inclusive, distal to the shaft bend (A supporting coil 42 may be provided in the distal portion of the first inner lumen 40 to prevent the catheter shaft 39 from kinking and to enhance radial rigidity and to maintain the transverse dimensions of first inner lumen 40 as the catheter 10 is advanced… The use of wire braid or coil 42 to maintain lumen roundness allows the endovascular device profile to be maximized and allows endovascular devices to be advanced through the lumen with minimum interference; Fig. 7-8 braided structure 42 which extends from a proximal shaft segment over a bend of the catheter in a distal shaft segment).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the catheter of Towne with the braided structure of Stevens in order to predictably improve the maneuverability and durability of the device by providing enough rigidity to prevent kinking of the catheter shaft.
Regarding claim 3, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches further comprising a manifold (Connector 29) coupled to a proximal end of the proximal shaft segment (See Fig. 1), the manifold including a proximal pressure port in fluid communication with the proximal pressure lumen and a distal pressure port in fluid communication with the distal pressure lumen (Col. 3, line 36-39-- At its proximal end, catheter shaft 12 communicates with a Y connector 29, with lumen 16 communicating with connection tube 30 and lumen 18 communicating with connection tube 32).
Regarding claim 4, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 3. Towne additionally teaches wherein the manifold is configured to deliver a proximal pressure signal and a distal pressure signal to a transducer for determination of a pressure gradient across the narrowing (Col. 3, line 36-Col. 4, line 7--At this point, pressures may be measured through the open lumens 16, 18. Particularly, the pressure differential across a heart valve such as the mitral valve may be measured if the catheter is positioned so that its distal end 22 passes through the mitral valve while port 36 remains on the other side thereof…pressure data has been obtained…). While Towne does not explicitly note a transducer, one must be present in order for the pressure data to have been “obtained” as disclosed in order to guide the next actions of a user.
Regarding claim 13, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, Towne does not explicitly disclose wherein the shaft bend forms a shaft bend angle ranging from 145 degrees to 165 degrees, inclusive. Lampropoulos additionally teaches wherein the shaft bend forms a shaft bend angle ranging from 145 degrees to 165 degrees, inclusive (Paragraph 0068-- the distance between bends, the angle(s) traversed by one or more of the bends, and the number of bends may be altered based on the intended use of the catheter, the anatomy of the patient, etc. In some embodiments, the intermediate portion 306 forms an angle of between 130° and 170° (or more particularly between 140° and 160°) when the catheter is in an unconstrained state. NOTE: the embodiment of catheter 300 differs from catheter 100 in the arrangement of the lumens and connector and otherwise has the same general structure and materials making up the catheter shaft, see paragraph 0046).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the bend angle of Towne according to the disclosure of Lampropoulos in order to predictably improve the ability of the device to be used in different body lumens and with patients having different anatomy (see Lampropoulos, paragraph 0068).
Regarding claim 14, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches wherein the distal shaft segment includes a pigtail coil (See Fig. 1) having a diameter less than or equal to 1.5 cm (Col. 4, line 25-32-- Distal tip 37 may be of French size 7 in this case).
Regarding claim 15, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 14. Lampropoulos additionally teaches wherein a plane of the pigtail coil is non-coplanar with a plane of the shaft bend located in the distal shaft segment (See Fig. 1). It would have been obvious to one having ordinary skill in the art at the time of filing to modify Towne, which discloses a catheter having a distal tip including a curvature, with the pigtail of Lampropoulos as a simple substitution, where Lampropoulos discloses that a pigtail configuration is known in the art as a type of curved distal tip (Paragraph 0029 of Lampropoulos), and wherein such a modification would predictably improve the safety of the device by ensuring that as the catheter is advanced into a body the curved surface contacts the walls of the body lumen initially rather than the tip which may be sharp or otherwise cause discomfort (see paragraph 0064 of Lampropoulos).
Regarding claim 16, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches wherein one or both of the proximal pressure lumen and the distal pressure lumen has a hydraulic diameter of at least 0.018 inches (Col. 4, line 25-32-- The second and third lumens may be proportioned to receive a guidewire having a diameter of 0.038 inch, for example. Such a lumen diameter may be about 0.042 inch).
Regarding claim 24, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches further comprising an asymmetrically tapered junction portion defining a distal end of the proximal pressure lumen (Figs. 1 and 3—see the asymmetrically tapered junction defining a distal end of the proximal pressure lumen).
Regarding claim 25, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches wherein a common inner wall partitions the proximal pressure lumen from the distal pressure lumen within the double-lumen proximal shaft segment such that the proximal pressure lumen and the distal pressure lumen are arranged side- by-side (Figs. 2-3—common inner wall is found between the two lumens in the double-lumen segment such that the lumens are arranged side by side).
Regarding claim 26, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches wherein the distal pressure lumen is configured to accommodate passage of a guidewire therethrough (Guidewire 19; Col. 4, line 7-14).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Towne in view of Lampropoulos, further in view of Stevens, further in view of Lee (US 20130018307 A1).
Regarding claim 2, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Towne additionally teaches the distal pressure lumen has a circular cross-sectional shape (see Fig. 2). However, the combination fails to specifically disclose wherein wherein the proximal pressure lumen has a crescent or kidney cross-sectional shape that wraps partially around the distal pressure lumen.
Lee, in the same field of endeavor of a multi-lumen catheter, discloses wherein the distal pressure lumen has a circular cross-sectional shape, and wherein the proximal pressure lumen has a crescent or kidney cross-sectional shape that wraps partially around the distal pressure lumen (See Fig. 3A—crescent shaped lumen cross-section 314 wraps partially around circular lumen cross-section 312).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the lumen cross sections to have the shapes as disclosed by Lee as a matter of simple substitution for the lumen shapes of Towne which are both depicted as circular.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Towne in view of Lampropoulos further in view of Stevens, further in view of Guerra (US 20190175209 A1).
Regarding claim 7, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, the combination fails to specifically disclose wherein the outer catheter wall comprises a first wall fiber adjacent to the proximal pressure lumen, the first wall fiber extending in an axial direction and having a non-extensional characteristic.
Guerra, in the same field of endeavor of a multi-lumen catheter, discloses wherein the outer catheter wall comprises a first wall fiber adjacent to the proximal pressure lumen, the first wall fiber extending in an axial direction and having a non-extensional characteristic (Paragraph 0046-- The material of elongated catheter 20, second lumen 32 pigtail 50, second lumen or medical instrument exit aperture 25 may be reinforced with fibers, rings, or longitudinal ribs).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the catheter to include a wall fiber as disclosed by Guerra to predictably improve the durability and function of the device by enabling it to withstand forces exerted on the device (see Guerra, paragraph 0046).
Regarding claim 8, the combination of Towne, Lampropoulos and Stevens with Guerra discloses the pigtail catheter of claim 7.
Guerra, in the same field of endeavor of a multi-lumen catheter, discloses wherein the outer catheter wall comprises a second wall fiber adjacent to the distal pressure lumen, the second wall fiber extending in an axial direction and having a non-extensional characteristic (Paragraph 0046-- The material of elongated catheter 20, second lumen 32 pigtail 50, second lumen or medical instrument exit aperture 25 may be reinforced with fibers, rings, or longitudinal ribs).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the catheter to include a wall fiber as disclosed by Guerra to predictably improve the durability and function of the device by enabling it to withstand forces exerted on the device (see Guerra, paragraph 0046).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Towne in view of Lampropoulos, further in view of Stevens, further in view of Kuhle (US 6482169 B1).
Regarding claim 9, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, the combination fails to specifically disclose wherein an outer surface of the double-lumen proximal shaft has an oval cross-sectional shape defining a shaft major axis and a shaft minor axis, and wherein a center of the distal pressure lumen and a center of the proximal pressure lumen are located on the shaft major axis.
Kuhle, in the same field of endeavor of a multi-lumen catheter, discloses wherein an outer surface of the double lumen proximal shaft has an oval cross-sectional shape defining a shaft major axis and a shaft minor axis, and wherein a center of the distal pressure lumen and a center of the proximal pressure lumen are located on the shaft major axis (Fig. 10b, cross section showing lumens 1001 and 1002 centered on major axis of an oval cross-section).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the lumen cross sections to have the shapes as disclosed by Kuhle as a matter of simple substitution as Towne discloses only that the exterior is tubular without a particular requirement that the exterior have a given cross-sectional shape (see Col. 3, lines 36-54--tubes).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Towne in view of Lampropoulos, further in view of Stevens, further in view of Cribier (EP 0260711 A2).
Regarding claim 10, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, the combination fails to specifically disclose further comprising an elastic member positioned within a distal portion of the proximal pressure lumen and forming an attachment to the distal shaft segment.
Cribier, in the same field of endeavor of catheters for use in stenosed valves, discloses an elastic member positioned within a distal portion of the proximal pressure lumen and forming an attachment to the distal shaft segment (Sleeve extending from 45 to 43; Col. 16, line 39-56--The distal sleeve 43 and proximal sleeve 45 are integral continuations of the balloon, and serve to attach the balloon to the catheter itself. The balloon is attached to the catheter by heating the material of the sleeves and the underlying catheter to melt them together).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the pigtail catheter to include an elastic member as disclosed by Cribier in order to predictably improve the passage of the corresponding portion of the catheter through a valve and which may enable the device to include a balloon which can improve the ability of the device to not only measure but also treat valve stenosis (See Carbier—Col. 16, line 39-44--sleeve 43 which makes the corresponding portion of the catheter relatively more stiff than the tip portion to aid in the passage of the balloon when it crosses or re-crosses the valve).
Regarding claim 11, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 10.
Cribier additionally discloses wherein the elastic member extends along a length of the distal shaft segment, including a pigtail coil at the end of the distal shaft segment (Sleeve extending from 45 to 43 which extends along a length of the distal shaft segment including a pigtail coil at the end of the distal shaft segment).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the pigtail catheter to include an elastic member as disclosed by Cribier in order to predictably improve the passage of the corresponding portion of the catheter through a valve and which may enable the device to include a balloon which can improve the ability of the device to not only measure but also treat valve stenosis (See Carbier—Col. 16, line 39-44--sleeve 43 which makes the corresponding portion of the catheter relatively more stiff than the tip portion to aid in the passage of the balloon when it crosses or re-crosses the valve).
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Towne in view of Lampropoulos, further in view of Stevens, further in view of O'Connell (US 10688277 B2).
Regarding claim 21, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, the combination fails to specifically disclose wherein the at least one proximal orifice is located between openings of the braided structure.
O’Connell, in the same field of endeavor of a catheter having a lumen in fluid communication with an orifice, discloses a catheter having a braided structure contained in the outer catheter wall, wherein the at least one orifice is located between openings of the braided structure (Col. 3, line 33-38, Col. 10, line 46-54-- The distal shaft includes a jacket and a braided structure embedded in the jacket, the distal shaft defining a lumen. The braided structure includes a plurality of wire members woven together to form the braided structure. The plurality of perfusion openings are disposed through the jacket of the distal shaft between the wire members of the braided structure.).
It would have been obvious to one having ordinary skill in the art to modify the catheter of the combined Towne, Lampropoulos and Stevens to have a braid structure which enables the orificies to be disposed in the openings of the braid as disclosed by O’Connell in order to ensure that the orifices maintain fluid communication with the inner lumens and thus that the pressure may be accurately measured.
Regarding claim 22, the combination of Towne, Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, the combination fails to specifically disclose wherein the braided structure comprises metallic or polymeric fibers having a spacing of at least about 0.020 inches to allow for placement of the at least one proximal orifice within the spacing.
O’Connell discloses wherein the braided structure comprises metallic or polymeric fibers (Col. 10, line 58-61-- The wire members 338 of the braided jacket 318 may be formed from materials such as, but not limited to, stainless steel, Nitinol, or other materials suitable for the purposes described herein) having a spacing of at least about 0.020 inches to allow for placement of the at least one proximal orifice within the spacing (Col. 10, line 46-58-- Moreover, the braided jacket 318 forms the plurality of perfusion openings 306 between the adjacent woven wire members 338. The perfusion openings 306 extend from an outer surface to the lumen 324 of the distal shaft 304. The weave of the braided jacket 318 should be tight enough to maintain structural integrity of the distal shaft 304, but not too tight such that the distal shaft 304 becomes inflexible and/or the adjacent wire members 338 occlude the corresponding perfusion openings 306…).
It would have been obvious to one having ordinary skill in the art to modify the catheter of the combined Towne, Lampropoulos and Stevens to have a braid structure which enables the orificies to be disposed in the openings of the braid as disclosed by O’Connell in order to ensure that the orifices maintain fluid communication with the inner lumens and thus that the pressure may be accurately measured.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 7-11, and 13-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly cited reference Towne has been applied to teach the newly amended double-lumen proximal shaft segment and single lumen distal shaft segment, in addition to other limitations of the claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA ROBERTS/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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