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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/29/26 has been entered.
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.
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) 1-2, 4-6, 8, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US 2020/0016378; hereinafter Williams) in view of Stigall et al. (US 2020/0000525; hereinafter Stigall), Carter et al. (US 2006/0142703; hereinafter Carter), and Grandt et al. (US 2005/0267408; hereinafter Grandt).
Williams shows a tissue treatment catheter (abstract, Figs. 1-2), comprising: a catheter shaft including a guidewire lumen and a fluid lumen, wherein the catheter shaft has a guidewire port extending through an outer shaft wall between the guidewire lumen and a surrounding environment ([0036]); and a port brace disposed in the guidewire lumen, wherein the port brace includes a proximal brace section having a solid circular cross-sectional area perpendicular to the longitudinal axis that blocks the guidewire lumen proximal to the guidewire port, and a distal brace section having an annular cross-sectional profile ([0058]-[0059]) in the guidewire lumen distal to the guidewire port, and wherein the proximal brace section is stiffer than the distal brace section (hypotube including stepped skive to provide improved support for proximal port; [0044]-[0054]).
Williams also shows a fluid lumen in the catheter shaft and a balloon mounted on the catheter shaft and having an interior in fluid communication with the fluid lumen ([0036]); wherein the catheter shaft includes one or more of a second fluid lumen or a cable lumen ([0036], [0053]); wherein a stiffness of the distal brace section decreases in a distal direction (stepped skive; [0045]-[0046]); wherein the distal brace section includes a brace tube having a slot (stepped skive including angled cuts, [0045]-[0046]; Fig. 2); wherein a cross-sectional area of the distal brace section decreases in the distal direction ([0046]; Fig. 2); wherein the solid cross-sectional profile and the annular cross-sectional profile are concentrically disposed about a longitudinal axis of the guidewire lumen ([0058]-[0059]).
Williams fails to show a port brace disposed in the guidewire lumen and separated from the fluid lumen by a lumen wall. Williams fails to show an ultrasound transducer mounted on the catheter shaft distal to the guidewire port.
Williams fails to show a reinforcement bridge extending distally from the proximal brace section to the distal brace section in the guidewire lumen to define a guidewire notch aligned with the guidewire port.
Williams fails to show wherein the proximal brace section that blocks the guidewire lumen has a guidewire ramp surface oblique to the longitudinal axis of the guidewire lumen to direct a guidewire through the guidewire port, a distal brace section having a circular annual cross-sectional area perpendicular to the longitudinal axis that forms an open central channel in the guidewire lumen, wherein the reinforcement bridge has a semi-circular annular cross-sectional area to define a guidewire notch.
Stigall discloses an ultrasound assisted therapeutic catheter. Stigall teaches a port brace disposed in the guidewire lumen and separated from the fluid lumen by a lumen wall (hypotube inserted into a guidewire lumen, [0083]; [0081]). Stigall teaches an ultrasound transducer mounted on the catheter shaft distal to the guidewire port ([0076], [0099], [0122]-[0124]).
Carter discloses a catheter aperture and related structures. Carter teaches a reinforcement bridge extending distally from the proximal brace section to the distal brace section in the guidewire lumen to define a guidewire notch aligned with the guidewire port (stiffening member 450’ [0036]; Fig. 4E).
Grandt discloses a catheter having guidewire tubes and stiffening members. Grandt teaches wherein the proximal brace section that blocks the guidewire lumen has a guidewire ramp surface oblique to the longitudinal axis of the guidewire lumen to direct a guidewire through the guidewire port, a distal brace section having a circular annual cross-sectional area perpendicular to the longitudinal axis that forms an open central channel in the guidewire lumen, wherein the reinforcement bridge has a semi-circular annular cross-sectional area to define a guidewire notch ([0074]-[0077]; Fig. 6)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Williams to provide a port brace disposed in the guidewire lumen and separated from the fluid lumen by a lumen wall as taught by Stigall, in order to provide additional support to the catheter structure in the region of the guidewire as taught by Stigall ([0081], [0083]). Furthermore, it would have been obvious to one of ordinary skill in the art to provide an ultrasound transducer as taught by Stigall, in order to provide diagnostic type imaging for the desired tissue ([0021], [0121]) or for ultrasound therapeutic purposes.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Williams and Stigall to utilize a reinforcement bridge to provide additional stiffness around the aperture as taught by Carter, as Carter teaches that providing additional stiffness around the aperture is desirable, as the aperture is prone to undesirable flexure, excessive bending, kinking, twisting, or binding in the region around the aperture, where the undesired flexure can have several negative consequences including causing one or more lumens to be closed off thereby preventing their use, or may cause a non-smooth edge to be formed adjacent the aperture that could cause damage ([0009], [0011]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Williams, Stigall, and Carter to provide a guidewire ramp and semi-circular reinforcement bridge with associated reinforcement regions as taught by Grandt, in order to provide an appropriate channel for the guidewire to exit from the device with a minimal size while having an appropriate amount of stiffness to provide support for the guidewire. Furthermore, it would be within the level of one of ordinary skill in the art to modify the size/shape of the guidewire lumen/notch, such as a circular or semi-circular shape, without undue experimentation, as changes in size/shape have been held to be within the level of one of ordinary skill in the art (In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Claim(s) 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US 2020/0016378; hereinafter Williams) in view of Stigall et al. (US 2020/0000525; hereinafter Stigall), Carter et al. (US 2006/0142703; hereinafter Carter), and Grandt et al. (US 2005/0267408; hereinafter Grandt) as applied to claims 2 and 6 above, and further in view of McIntosh et al. (US 2013/0023802; hereinafter McIntosh).
Williams fails to show an ultrasound transducer mounted on the catheter shaft and contained within the interior of the balloon, wherein the ultrasound transducer is configured to emit acoustic energy; wherein the slot defines a helical wall and has a pitch that decreases in the distal direction.
McIntosh discloses apparatus for destruction of vascular thrombus. McIntosh teaches an ultrasound transducer mounted on the catheter shaft and contained within the interior of the balloon, wherein the ultrasound transducer is configured to emit acoustic energy ([0038]); wherein the slot defines a helical wall and has a pitch that decreases in the distal direction ([0044], [0056], [0064]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Williams, Stigall, Carter, and Grandt to utilize an ultrasound transducer as taught by McIntosh, in order to provide additional therapeutic modalities to the target area, thereby achieving an improved treatment as described by McIntosh ([0038]). Furthermore, it would have been obvious to utilize helical cuts as described by McIntosh, in order to provide the support and flexibility characteristics due to the helical shape as desired for treatment within a patient’s vasculature.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US 2020/0016378; hereinafter Williams) in view of Stigall et al. (US 2020/0000525; hereinafter Stigall), Carter et al. (US 2006/0142703; hereinafter Carter), and Grandt et al. (US 2005/0267408; hereinafter Grandt) as applied to claim 1 above, and further in view of Bagaoisan et al. (US 2002/0177800; hereinafter Bagaoisan).
Williams also shows wherein the port brace includes a brace tube having a proximal collar proximal to the guidewire ramp (proximal side of hypotube in relation to port, [0054]); (due to the geometry of the hypotube and the location of the cuts; Fig. 2).
Williams fails to show wherein the port brace includes a brace mandrel having a guidewire ramp located at a distal mandrel end. Also, wherein the proximal brace section includes the brace mandrel and the proximal collar, and is stiffer than the reinforcement bridge
Bagaoisan discloses aspiration catheters. Bagaoisan teaches wherein the port brace includes a brace mandrel having a guidewire ramp located at a distal mandrel end (guidewire lumen with support mandrels positioned alongside the lumen to provide added stiffness, [0094]-[0095]); wherein the proximal brace section includes the brace and the proximal collar, and is stiffer than the reinforcement bridge (where the mandrel is considered to be stiffer than the reinforcement bridge).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Williams, Stigall, Carter, and Grandt to provide a supporting mandrel as taught by Bagaoisan, in order to provide added stiffness in desired regions of the catheter, such as in relation to the guidewire lumen as described by Bagaoisan ([0094]-[0095]).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US 2020/0016378; hereinafter Williams) in view of Stigall et al. (US 2020/0000525; hereinafter Stigall), Carter et al. (US 2006/0142703; hereinafter Carter), and Grandt et al. (US 2005/0267408; hereinafter Grandt) as applied to claim 1 above, and further in view of Berger et al. (US 2013/0345628; hereinafter Berger).
Williams fails to show an isolation tube extending through the guidewire lumen, wherein the isolation tube includes a proximal tube end located distal to the guidewire port; wherein the proximal tube end is located proximal to a distal brace end of the port brace; wherein the proximal tube end is located distal to a distal brace end of the port brace; wherein the isolation tube includes an internal support wire.
Berger discloses a narrow profile catheter with deformation resistant guidewire lumen. Berger teaches an isolation tube extending through the guidewire lumen, wherein the isolation tube includes a proximal tube end located distal to the guidewire port ([0122]-[0123], [0137]-[0138], [0192]-[0194]); wherein the proximal tube end is located proximal to a distal brace end of the port brace ([0122]-[0123], [0137]-[0138], [0192]-[0194]); wherein the proximal tube end is located distal to a distal brace end of the port brace ([0122]-[0123], [0137]-[0138], [0192]-[0194]); wherein the isolation tube includes an internal support wire ([0122]-[0123], [0137]-[0138], [0192]-[0194]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Williams, Stigall, Carter, and Grandt to utilize an isolation tube extending through the guidewire lumen as taught by Berger, in order to provide additional reinforcement to reduce deformation of the wall when hydrostatic pressure is applied to the inflation lumen thereby maximizing the transverse cross-sectional area of the guidewire lumen as described by Berger ([0122]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
