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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/14/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/14/2026 have been fully considered but they are not persuasive.
Applicant argues that Roseman discloses slots cut into the tube which are distinct from the claimed cutouts as a cutout removes material over a finite width and area which the slots of Rosenman do not. This argument is not convincing. Rosenman fig. 4 clearly shows slots formed from removed material. Rosenman further discloses that the slots are cut to varying widths (col. 5, lines 52-53) which implies that material is removed thereby forming the width, rather than just a slit in the material having no width dimension as implied by applicant. A person of ordinary skill in the art would recognize that the “slots” of Rosenman could be otherwise called cutouts as they have the same structure as the cutouts of the instant invention.
Applicant argues that Rosenman has unilateral slots which do not produce the same mechanical behavior of the claimed invention. This argument is not convincing as Von Oepen was relied upon to teach the second slots, the resulting structure being the same as the claimed structure and therefore having the same mechanical behavior.
Applicant argues that if slots were truly equivalent to cutouts the reference would inherently permit catheter miniaturization without loss of strength. This argument is not convincing as it is a conclusion for which applicant has provided no evidence. Additionally, this argument is not commensurate in scope with the claimed invention which recites the first and second cutouts, but does not require miniaturization. Further, there is nothing in the claims nor the disclosure that would distinguish a “narrow cutout” from a slot having a defined width as disclosed by Rosenman.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenman et al (US 10,874,831) in view of Sampognaro (US 9,211,099) in view of von Oepen et al (US 2018/0028779) in view of Burquest et al (US 2024/0206982).
Regarding claim 1, Rosenman discloses a medical method of accessing a site in or on a heart of a patient through the vasculature of the patient (col. 15, lines 63-65) comprising navigating a unilateral catheter for delivering and sampling to an endocardial site (fig. 11; unilateral catheter: figs. 1, 2, 4; col. 1, lines 25-30: guide catheter to provide insertion of an interventional catheter), advancing the catheter through an opening punctured in a vessel (col. 15, lines 63-65; fig. 11), when reaching a curve of bifurcation in a blood vessel with a distal end of the catheter, pulling a pull wire 11 of the catheter until a bend of the distal end is detectable (col. 5, lines 20-24; col. 14, lines 31-38: steering the catheter under fluoroscopic guidance allows the bend in the catheter to be detected visually), rotating the catheter by rotating the handle of the catheter for aligning the orientation of the bend of the distal end of the catheter to correspond to a radial orientation of the curve or bifurcation (col. 14, lines 31-38; col. 7, lines 31-33), pulling the pull wire by manually operating the handle of the catheter until the radius of the bend in the distal end of the catheter corresponds to a radius of the curve or bifurcation in the blood vessel (col. 5, lines 22-24; col. 7, lines 15-20; col. 14, lines 31-38), and pushing the handle for advancing the catheter through the curve or bifurcation (col. 14, lines 32-38), wherein the catheter comprises a flexible and cylindrical hollow tube 9 at a distal end (fig. 5), the flexible tube has two opposite ends, a first side and a second side, the first side opposing the second side (figs. 4, 5), wherein the first side has cutouts along at least a part of its length (fig. 4; col. 5, lines 57-52), wherein a pull wire 11 is arranged at the most distal end on the first side of the flexible tube (fig. 5).
Claim 1 calls for the catheter to be inserted through the radial or cubital vessel including the step of advancing the catheter through an opening punctured in a radial access opening or in a cubital vein toward the desired site. Rosenman discloses accessing the vasculature through an opening punctured in the jugular vein. Sampognaro teaches a method of accessing the heart with a catheter through an opening provided in the radial artery which is understood to be convenient and reduce the length of the procedure and the risk of complications during the procedure (col. 1, lines 24-28). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rosenman to include inserting the catheter via a radial access opening as taught by Rosenman because access via a radial access opening is convenient and reduces the risk of complications.
Claim 1 further calls for the flexible cylindrical hollow tube to have a second side with cutouts along a corresponding length to the first side and wherein the cutouts on the first side are wider than the cutouts on the second side. Rosenman fails to discloses that the second side has cutouts along a corresponding length to the first side and the cutouts on the first side are wider than the cutouts on the second side. Von Oepen teaches a steerable catheter including cutouts 136 on a first side and cutouts 134 on a second side, the first cutouts are wider than the second cutouts to provide compression of one side and expansion of the other during bending to create the desired bend without stressing the material of the tube (fig. 4A; page 4, para. 0050). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter tube of Rosenman to include second slits, the first slits being wider than the second slits as taught by von Oepen to allow the tube to bend in the predetermined direction without stressing the material of the tube.
Claim 1 further calls for at least one guard wire arranged on the catheter to hold the pull wire adjacent the flexible and hollow tube. Burquest teaches a deflectable catheter having a pull wire 211 located on a flexible hollow tube, and a guard wire 210 arranged on the catheter to hold the pull wire adjacent the flexible and hollow tube (abstract; fig. 2) to prevent the pull wire from tearing through the catheter wall when the pull wire is placed under tension (page 1, para. 0014). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Rosenman to include a guard wire around the hollow flexible member to restrain the pull wire as taught by Burquest to prevent the wire from tearing through the catheter sidewall when the pull wire is under tension.
Regarding claim 2, Rosenman discloses that releasing the pull wire straightens the catheter (col. 8, lines 12-14). The act of steering the catheter as disclosed by Rosenman is understood to include the steps of bending and releasing the catheter as needed to match the tortuous pathways of the vasculature.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenman in view of Sampognaro in view of von Oepen in view of Burquest as applied to claim 1 above, and further in view of West et al (US 5,545,200).
Regarding claim 4, Rosenman discloses a handle comprising an elongate hosing having an opening at the distal end to allow the wire to extend into the catheter body, a pull wire control on the exterior of the housing, such that when the control is in the distal position, the wire is in the relaxed state (fig. 1), and when the control is in the tense state, the catheter is bent (fig. 2). However, Rosenman fails to disclose the pull wire control and holding device as claimed. West teaches a steerable catheter comprising a housing, a holding device 94 slidably arranged along the inside of the housing and arranged to be fixed to the pull wire (col. 10, lines 25-28; fig. 5A), a pull wire control 40 accessible on the outside of the housing and connected through a side opening 90 in the housing to a holding device (fig. 10, lines 16-20; fig. 5A), the pull wire control movable between a distal position and a proximal position, the pull wire control arranged circumferentially around the distal end of the housing (fig. 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Rosenman to include the configuration taught by West including the pull wire control connected through a side opening in the housing to the holding device, the pull wire control arranged circumferentially around the distal end of the handle. This configuration provides the benefit of being accessible around the circumference of the handle thereby increasing ease of use as the pull wire control mechanism can be accessed as the catheter handle is rotated.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783