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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
Misspelled title: “MUTLI-LUMEN TAPERED TIP”
The disclosure is objected to because of the following informalities:
a. In paragraph 0039, “This insures that first guidewire” should read “This ensures that first guidewire”
b. In paragraph 0058, “insures that first guidewire” should read “ensures that first guidewire”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dutta et al. (US 6458099).
Regarding claims 1 and 10, Dutta et al. discloses a multi-lumen tapered tip comprising: a primary guidewire lumen (20/60) (see Fig. 1; see Col. 4, lines 26-30 disclosing the components of the catheter shaft (12) and illustrating a tapered tip at the distal shaft (18) with reduced diameter); a secondary guidewire lumen (22) (see Col. 4, lines 31-35 disclosing the components of the catheter shaft (12); a shared guidewire lumen (68) (see Col. 5, lines 9-18 disclosing a single distal guide lumen (68) which is analogous of a shared guidewire lumen, where the first and second guide wire lumens (20/60 and 22/62) converge at the lumen y-junction (72)); and a first second guidewire junction at an intersection of the primary guidewire lumen, the secondary guidewire lumen, and the shared guidewire lumen; a primary guidewire lumen configured to receive a first guidewire; a shared guidewire lumen configured to receive a second guidewire preventing the first guidewire from entering the shared guidewire lumen. (see Fig. 4 illustrating the communication of the distal section lumen (68) at the lumen y-junction (72) and a second guide wire lumen (62) communicating with the distal section lumen (68) at the lumen y-junction, along with an insert jacket (70) located at the junction which can inherently me modified to prevent a guidewire from entering one of the lumen paths or to block communication between the proximal and distal sections).
Regarding claim 2, Dutta et al. discloses the multi-lumen tapered tip of claim 1 further comprising a distal guidewire lumen port (34), the shared guidewire lumen (68) extending between the distal guidewire lumen port (34) and the first second guidewire junction (72) (see Col. 4, lines 38-43; Col. 5, lines 11-20 disclosing the port in the distal end (34) extending from the lumen y-junction (72) which acts as a first second guidewire junction through the distal shaft section (58)).
Regarding claims 3 and 15, Dutta et al. discloses the multi-lumen tapered tip of claims 1 and 14 further comprising a proximal primary guidewire port (66), the primary guidewire lumen (60) extending between the proximal primary guidewire lumen port (66) and the first second guidewire junction (72); a first second guidewire junction at an intersection of the primary guidewire lumen, the secondary guidewire lumen, and the shared guidewire lumen (see Col. 5, lines 5-20 disclosing the RX guide wire port (66) similar to the first guide wire port for the entry point of one of the guidewire lumens located on the catheter shaft (52) which has a first guide wire lumen (60) communicating with the distal section lumen (68) at the lumen y-junction (72) which serves as the intersection point for lumens (60 and 62)).
Regarding claim 4, Dutta et al. discloses the multi-lumen tapered tip of claim 1 further comprising a proximal secondary guidewire lumen port (62), the secondary guidewire lumen extending between the proximal secondary guidewire lumen port (62) and the second guidewire junction (72) (see Col. 5, lines 16-20 disclosing the communication of second guidewire lumen (22/62) with the distal section lumen (68) at the lumen y-junction (72)).
Regarding claim 5, Dutta et al. discloses the multi-lumen tapered tip of claims 4, wherein the secondary guidewire lumen (62) curves inward to the first second guidewire junction (72); comprising a first second guidewire junction at an intersection of the primary guidewire lumen, the secondary guidewire lumen, and the shared guidewire lumen (see Figs. 4 and 6 illustrating the configuration of the lumens at their respective junctions).
Regarding claim 6, Dutta et al. discloses the multi-lumen tapered tip of claim 1, wherein the primary guidewire lumen (60) and the shared guidewire lumen (68) are linear (see Fig. 1 illustrating the guide wire lumens running in a linear manner along the length of the catheter shaft (12)).
Regarding claim 7, Dutta et al. discloses the multi-lumen tapered tip of claim 1, wherein the primary guidewire lumen (20) is offset from a central longitudinal axis of the multi-lumen tapered tip (see Fig. 2 illustrating the guide wire lumens (20 and 22) and an inflation lumen (24) being positioned eccentrically within the catheter shaft (12)).
Regarding claims 8, 9, 12 and 13, Dutta et al. discloses the multi-lumen tapered tip of claims 1 and 10, wherein the shared guidewire lumen comprises an open trench (94); the secondary guidewire lumen comprises an open trench; the shared guidewire lumen comprises a trench comprising an opening having a width; the width of the opening is less than a width of the guide tube and greater than a width of the second guidewire (see Fig. 9; Col. 3, lines 30-35; Col. 6, lines 58-67 disclosing the peel-away slit embodiment with a single guidewire lumen having a proximal (90) and distal (92) section and a guidewire lumen slit (94) having a width narrower than the wire, which serves the function of a shared lumen and open trench, as the guidewire is inserted into the proximal end of the lumen (90) and passes through the entire length of the distal section (92), to which the guidewire is retained within the lumen by the open trench/slit(94) during procedures).
Regarding claim 11, Dutta et. al discloses the multi-lumen tapered tip of claim 10 further comprising a guide tube (70) within the shared guidewire lumen (64), the second guidewire being within the guide tube (70) (see Fig. 4 illustrating the insert jacket (70) serving as a guide tube for the guidewire to pass through a transition zone and as a stop point preventing the second guidewire from entering the path of the first guidewire at the distal shaft section (58) where both lumens merge).
Regarding claim 14, Dutta et al. discloses the multi-lumen tapered tip of claim 10 further comprising a secondary guidewire lumen (62), the second guidewire being within the secondary guidewire lumen (26) (see Col. 3, lines 7-26 disclosing the over-the-wire path to which a second guidewire lumen (62) extends through the shaft of the catheter to receive a second guidewire, allowing it to move independently of the primary guidewire).
Claim(s) 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mewissen et al. (US 11883616).
Regarding claim 16, Mewissen et al. discloses a method comprising: positioning a first guidewire (88) within a primary guidewire lumen (50) of a multi-lumen tapered tip (35); and positioning a second guidewire (90) within a secondary guidewire lumen (52) and a shared guidewire lumen (66A and 66B) of the multi-lumen tapered tip, the second guidewire (90) preventing the first guidewire (88) from entering the shared guidewire lumen (66A and 66B) (see Figs. 10E and 10F; Col. 5, lines 55-64; Col. 12, lines 6-12 disclosing where the guidewire occupies the shared output lumen (35L), and a first guidewire (50) is withdrawn to a non-interference position so the second guidewire (52) can be deployed, thereby implying if the first guidewire (50) were not withdrawn, it would interfere with the full deployment of the second guidewire (52) into that exact same shared space (66A and 66B) at the tip (35)).
Regarding claim, 17 Mewissen et al. discloses the method of claim 16 further comprising: advancing a delivery system comprising the multi-lumen tapered tip (35) over the second guidewire (88) (see Fig. 10D; Col. 12, lines 1-5 disclosing the tip (35) advancing along the path of the withdrawn guidewire (90); and releasing the second guidewire (88) from the shared guidewire lumen (66A and 66B (see Col. 11, lines 11-15 disclosing the temporary withdrawal and re-insertion of guidewires within the catheter).
Regarding claim 18, Mewissen et al. discloses the method of claim 17 further comprising: advancing the first guidewire through and out of the shared guidewire lumen (see Col. 5, lines 35-50 disclosing a lumen convergence portion where independent guidewires are preloaded into its own lumen and advanced into a convergence portion serving as a single/shared path); and advancing the delivery system over the first guidewire to a deployment location (see Col. 8, lines 43-46 disclosing the deployment path to which the tapered tip (35) of the catheter delivery system can be tracked over a guidewire that has been advanced to a specific deployment location within the vascular system).
Regarding claim(s) 19-20, Mewissen et al. discloses the methods of claims 18 and further comprising deploying a main vessel stent graft from the delivery system, the second guidewire extends through a coupling or a fenestration of the main vessel stent graft; advancing a delivery system comprising a branch stent graft over the second guidewire and into the coupling or fenestration; and deploying the branch stent graft within the coupling or fenestration. (see Fig. 9A illustrating the independent path for the second guidewire that passes through a lumen (50 and 52) in order to advance the catheter system over any specific wire and control the guidewire independently of the first tracking guidewire, allowing one wire to track the main vessel while the second guidewire remains available for a specific branch, and can eventually enter the convergence portion (66), inherently functioning as the internal mechanical equivalent of a coupling or fenestration).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799