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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-4, 7-11, 13-16, and 21-22) in the reply filed on 06 October 2025 is acknowledged.
Claims 17-20 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 October 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 16 is objected to because of the following informalities: "about least about" should likely be "at least about". Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 13-16, and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “generally” in claim 2 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is or is not encompassed in the limitations “generally circular" and "generally crescent or kidney". .
The term “about” in claim 13, 14, 16, and 22 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what range is encompassed in the various measurements followed by the term "about" in each of the listed claims.
Claim 15 is additionally rejected under 35 U.S.C. 112(b) as indefinite due to its dependence on claim 14, which has been rejected as indefinite.
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, and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampropoulos (US 20160250444 A1) in view of Stevens (WO 9630072 A1).
Regarding claim 1, Lampropoulos teaches a pigtail catheter (see Fig. 1) configured to measure a pressure proximal to a narrowing and a pressure distal to the narrowing (Paragraph 0020-- a catheter may be configured to detect and/or measure differences in blood pressure across an obstruction or valve), comprising:
a proximal shaft segment (104) including double lumen tubing defining a proximal pressure lumen (120) and a non-coaxial, distal pressure lumen (130);
a distal shaft segment (102) configured to be partially positioned across the narrowing and having a portion that includes the distal pressure lumen but not the proximal pressure lumen (Paragraph 0030-- the first separate lumen 120 may only extend from the proximal end of the catheter 100 to a point sufficiently past the two proximal ports 122 to allow fluid to enter the two proximal ports 122 and the first separate lumen 120);
at least one proximal orifice (122) in fluid communication with the proximal pressure lumen (Paragraph 0030-- the first separate lumen 120 may only extend from the proximal end of the catheter 100 to a point sufficiently past the two proximal ports 122 to allow fluid to enter the two proximal ports 122 and the first separate lumen 120) and positionable proximal to the narrowing along an outer catheter wall, and at least one distal orifice (132) in fluid communication with the distal pressure lumen (Paragraph 0030-- the second separate lumen 130 may only extend from the proximal end of the catheter 100 to a point sufficiently past the two distal ports 132 to allow fluid to enter the two distal ports 132 and the second separate lumen 130) and positionable distal to the narrowing along the outer catheter wall (Paragraph 0020, 0035);
a shaft bend positioned between the at least one proximal orifice and the at least one distal orifice (Intermediate portion 106 including bend 192).
However, Lampropoulos does not explicitly disclose 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.
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 Lampropoulos 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 Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Lampropoulos additionally teaches further comprising a manifold (160) coupled to a proximal end of the proximal shaft segment (see Fig. 3; paragraph 0039), the manifold including a proximal pressure port (124) in fluid communication with the proximal pressure lumen and a distal pressure port (134) in fluid communication with the distal pressure lumen (Paragraph 0038-- the catheter 100 includes a first inline pressure sensor 124 in communication with the first separate lumen 120, and a second inline pressure sensor 134 in communication with the second separate lumen 130).
Regarding claim 4, the combination of Lampropoulos and Stevens discloses the pigtail catheter of claim 3. Lampropoulos 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 (Paragraph 0038-0039, 0042-- may be configured to track a pressure wave form generated by the first and second inline pressure sensors 124,134 and/or differences between the pressures).
Regarding claim 13, the combination of Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Lampropoulos additionally teaches wherein the shaft bend forms a shaft bend angle ranging from about 145 degrees to about 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).
Regarding claim 14, the combination of Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Lampropoulos additionally teaches wherein the distal shaft segment includes a pigtail coil (158) having a diameter less than or equal to about 1.5 cm (Paragraph 0046-0047-- Any suitable combination of the features, and variations of the same, described with respect to the catheter 100 and related components illustrated in FIGS. 1-4 can be employed with the catheter 200 and related components of FIG. 5, and vice versa… the tip portion 250 may have a diameter of about 4-6 French).
Regarding claim 15, the combination of 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).
Regarding claim 16, the combination of Lampropoulos and Stevens discloses the pigtail catheter of claim 1. Lampropoulos additionally teaches wherein one or both of the proximal pressure lumen and the distal pressure lumen has a hydraulic diameter of about least about 0.018 inches (Any suitable combination of the features, and variations of the same, described with respect to the catheter 100 and related components illustrated in FIGS. 1-4 can be employed with the catheter 200 and related components of FIG. 5, and vice versa… the body portion 240 may have a diameter of about 5-7 French).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampropoulos in view of Stevens, further in view of Lee (US 20130018307 A1).
Regarding claim 2, the combination of Lampropoulos and Stevens discloses the pigtail catheter of claim 1. However, the combination fails to specifically disclose wherein the distal pressure lumen has a generally circular cross-sectional shape, and wherein the proximal pressure lumen has a generally 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 generally circular cross-sectional shape, and wherein the proximal pressure lumen has a generally 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 as Lampropoulos notes that the lumens may be the same or different (see paragraph 0026).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampropoulos in view of Stevens, further in view of Guerra (US 20190175209 A1).
Regarding claim 7, the combination of 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 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 Lampropoulos in view of Stevens, further in view of Kuhle (US 6482169 B1).
Regarding claim 9, the combination of 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 tubing 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 tubing 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 Lampropoulos notes that the lumens may be the same or different and that the exterior is merely tubular without a particular requirement that the exterior have a given cross-sectional shape (see paragraph 0026, 0037).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampropoulos in view of Stevens, further in view of Cribier (EP 0260711 A2).
Regarding claim 10, the combination of 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 Lampropoulos and Stevens with Cribier 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 Lampropoulos in view of Stevens, further in view of O'Connell (US 10688277 B2).
Regarding claim 21, the combination of 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 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 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 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.
Conclusion
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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