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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/11/2026 and 8/12/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 6/10/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s amendments to the drawings made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant's arguments, see section A, alleging that there is insufficient motivation and/or conditions are lacking (as taught in Inoue) from the potential benefits of Inoue to be incorporated into Crittenden have been fully considered but they are not persuasive. It is the Examiner’s position that Applicant’s arguments assert an overly narrow interpretation and appear to assert an “either/or” argument wherein an internal wire can only be used as either provide the function of an internal steering wire or provide the function of an external guidewire. Such functions are not mutually exclusive. Therefore, the teachings of Inoue in combination with Crittenden expressly provide additional functionality and more options from which a practitioner may choose for advancing a catheter through vasculature (i.e., wire steering of the catheter when the wire is disposed inside the catheter lumen and/or catheter advancement along a guidewire/rail when the wire is disposed distal and external to the catheter lumen). For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see section B, alleging that the combination of Crittenden in view of Inoue would made Crittenden would change the principle of operation and make it inoperable for its intended purpose have been fully considered but they are not persuasive. It is the Examiner’s position, as similarly set forth above, that the teachings of Inoue in combination with Crittenden expressly provide additional functionality and more options from which a practitioner may choose for advancing a catheter through vasculature (i.e., wire steering of the catheter when the wire is disposed inside the catheter lumen and/or catheter advancement along a guidewire/rail when the wire is disposed distal and external to the catheter lumen). Such functions/uses are not mutually exclusive. Additionally, as set forth in the previous office action, Inoue expressly teaches bendable internal wires for guiding a catheter system that may comprise either a pre-bent curving part when in its natural state ([0006]-[0009]) or a linear wire wherein a curvature can be selectively initiated and/or manually changed by a user as needed ([0014]-[0016]). An internal wire that is selectively bendable when desired to initiate and/or alter the amount of curvature allows for the original function of the system of Crittenden while further still providing additional beneficial navigation options to the practitioner. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see section C(1), alleging that the structural configuration providing for the functional language/ intended use of “adapted for engaging” either a vessel wall or an endovascular implant is missing from Inoue have been fully considered but they are not persuasive. It is the Examiner’s position that Applicant’s arguments provide for only conclusory states and Applicant fails to allege which “structural configuration” as claimed is missing from Inoue. Crittenden in view of Inoue, as set forth in the previous office action, discloses and/or teaches each claimed structure. With regard the statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over Crittenden in view of Inoue which is capable of being used as claimed if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Furthermore, the law of anticipation does not require that the reference “teach” what the subject patent teaches, but rather it is only necessary that the claims under attack “read on” something in the reference. Kalman v. Kimberly Clark Corp., 218 USPQ 781 (CCPA 1983). Still further, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). The distal wire end of Crittenden in view of Inoue is fully capable of engaging/contacting/touching a vessel wall and/or implant, and still further the curved distal wire end of Inoue teaches a conventional and well-known atraumatic distal tip wherein the surface of the curvature may atraumatically engage with a vessel wall or implant. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see section C(2), alleging that Crittenden in view of Inoue fails to expressly disclose or teach two curved portions in a U-shaped bend disposed proximal to the distal end of the wire have been fully considered and are persuasive. It is the Examiner’s position that Inoue expressly teaches a single curved portion in C-shaped bend that continues to read on claims 23-24. For at least these reasons, Applicant’s arguments are persuasive as to claim 8-9 and the previous prior art rejections of claims 8-9 have been withdrawn.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 4-7, 10-11, 13-19 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Crittenden et al. (EP 0282143) in view of Inoue (US 2015/0141855).
Crittenden discloses (see Figs. 1-10) a balloon catheter surgical system comprising the following claim limitations:
(claim 1) An apparatus for positioning an endovascular implant adjacent a junction including a branch from a vessel (as shown in Fig. 1, a balloon catheter system capable of delivery an endovascular implant is expressly disclosed), comprising: a sheath (12, Fig. 1) including a first lumen (46, Figs. 3 and 7) and a second lumen (42, Fig. 7), the first lumen (46) adapted for (i.e., capable of) receiving a catheter (10, Figs 1, 3 and 9) adapted for positioning the endovascular implant within the branch (as shown in Fig. 1, balloon catheter 10 expressly disclosed); and a wire (14, Fig. 1) located in the second lumen (42) (as shown in Figs. 1, 3 and 9), the wire (14) including a pre-shaped portion (16, Fig. 1) for positioning at the junction for use in guiding the endovascular implant into position within the branch (as shown in Fig. 1, pre-shaped bent guidewire 14 distal end 16 is fully capable of guiding balloon catheter thereon through vasculature for implant delivery);
(claims 2 and 11) wherein the first lumen (46) has a larger diameter than the second lumen (42) (as expressly shown in Figs. 3 and 7);
(claims 6 and 15) wherein an opening (i.e., adjacent 36, as shown in Fig. 7) of the second lumen (42) is at a distal end (36) of the sheath (12) (bore 42 extends into passage 44 with the guidewire 14 exiting at the distal end 36 of the sheath 12);
(claims 7 and 16) wherein an opening (i.e., proximal opening of bore 42 adjacent 38, as shown in Figs. 1 and 7) of the second lumen (42) is proximal of a distal end (36) of the sheath (12) (as expressly shown in Figs. 1 and 7);
(claim 10) An apparatus for positioning an endovascular implant adjacent a junction including a branch from a vessel (as shown in Fig. 1, a balloon catheter system capable of delivery an endovascular implant is expressly disclosed), comprising: a sheath (12, Fig. 1) including a first lumen (46, Figs. 3 and 7) and a second lumen (42, Fig. 7); a catheter (10, Figs 1, 3 and 9) at least partially positioned in the first lumen (46) (as shown in Figs. 1, 3 and 9), the catheter (10) adapted for positioning the endovascular implant within the branch (as shown in Fig. 1, balloon catheter 10 expressly disclosed); and a wire (14, Fig. 1) located in the second lumen (42) (as shown in Figs. 1, 3 and 9), the wire (14) including a pre-shaped portion (16, Fig. 1) for positioning at the junction for use in guiding the endovascular implant into position within the branch (as shown in Fig. 1, pre-shaped bent guidewire 14 distal end 16 is fully capable of guiding balloon catheter thereon through vasculature for implant delivery); and
(claim 19) An apparatus for positioning an endovascular implant adjacent a junction including a branch from a vessel (as shown in Fig. 1, a balloon catheter system capable of delivery an endovascular implant is expressly disclosed) using a (12, Fig. 1) including a first lumen (46, Figs. 3 and 7) and a second lumen (42, Fig. 7), the first lumen (46) adapted for (i.e., capable of) receiving a catheter (10) adapted for positioning the endovascular implant within the branch (as shown in Fig. 1, balloon catheter 10 expressly disclosed), comprising: a wire (14, Fig. 1) adapted to be located in the second lumen (42) (as shown in Figs. 1, 3 and 9), the wire including a pre-shaped portion (16, Fig. 1) adapted for positioning at the junction for use in guiding the endovascular implant into position within the branch (as shown in Fig. 1, pre-shaped bent guidewire 14 distal end 16 is fully capable of guiding balloon catheter thereon through vasculature for implant delivery).
Crittenden, as applied above, discloses a balloon catheter surgical system comprising all the limitations of the claim except for the wire being a radiopaque shape memory material, wherein an extension or bend of the at least partially radiopaque wire is adapted for engaging a wall adjacent the branch and/or an end of a vascular implant, and wherein the pre-shaped portion comprises a bend.
However, Inoue teaches (see Figs. 1-2) a similar a balloon catheter surgical system comprising a wire (1, Figs. 1-2; and/or 2, Figs. 1-2) being a radiopaque shape memory material ([0065]; Nitinol and stainless steel are both expressly disclosed), wherein an extension or bend of the at least partially radiopaque wire (1/2) is adapted for (i.e., capable of) engaging a wall adjacent the branch and/or an end of a vascular implant (as expressly shown in annotated Fig. 2 below, wherein the deflectable shape memory extension of the wire is fully capable of atraumatically engaging a wall or implant if one so desires), and wherein the pre-shaped portion comprises a bend (as expressly shown in annotated Fig. 2 below) in order to beneficially allow for a catheter tube to be curved into one or more desired curved positions so that the catheter tube can be can be looped in order to make the catheter tube pass through desired vasculature wherein operability is significantly improved and enables a surgical procedure to be easily and surely performed ([0005]-[0009; [0014]-[0016]; [0024]-[0025]; [0028]-[0029]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Crittenden to have a wire being a radiopaque shape memory material, wherein an extension or bend of the at least partially radiopaque wire is adapted for engaging a wall adjacent the branch and/or an end of a vascular implant, and wherein the pre-shaped portion comprises a bend in order to beneficially allow for a catheter tube to be curved into one or more desired curved positions so that the catheter tube can be can be looped in order to make the catheter tube pass through desired vasculature wherein operability is significantly improved and enables a surgical procedure to be easily and surely performed, as taught by Inoue.
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Allowable Subject Matter
Claims 8-9 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 an examiner’s statement of reasons for indicating allowable subject matter: the art of record does not teach or render obvious a device as claimed that includes, in combination with the claim(s) as a whole, the pre-shaped portion comprising a U- shaped bend with two curved portions having a depth and a width proximal of a distal end of the at least partially radiopaque wire (emphasis added). The closest prior art appears to be Crittenden et al. (EP 0282143) and/or Inoue (US 2015/0141855) wherein each discloses/teaches a similar catheter and wire system, but fails to specifically disclose or teach the claimed U-shape having two separate curved portions disposed proximal to the distal end of the wire.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see (from recent Applicant’s IDS filings):
Arnault De La Menardiere et al. (US 10,105,249), see at least Fig. 8C-8E teaching a guidewire comprising a pre-shaped bend (at 154) at the distal end for guiding an implant into a branch vessel (as shown in Figs. 8C-8E); and
Chou et al. (US 2018/0242978), see at least Figs. 1B-1C, 2B-2C and 5H (selectively bendable in Fig. 5H) teaching a variety of curved anchor components disposed at the distal end of an internal tether/wire.
THIS ACTION IS MADE FINAL. 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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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