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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/03/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 09/03/2025, with respect to the rejection(s) of claim(s) 1, 9, and 21 under 35 USC 102 in view of Wang have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative embodiment of Wang.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-14 and 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US 2014/0018773).
Regarding claim 1, Wang et al. discloses a catheter advancement assistance device (14, FIG 3, [0036-0037], specifically the embodiment of 114, FIG 5-13) the device comprising: (a) an elongate shaft (16/116); and (b) an insertion body (126, FIG 5, [0048]) fixedly attached to a distal end of the elongate shaft (FIG 5), the insertion body comprising: (i) a tapered section (358, FIGs 17-18) disposed at and extending proximally from a distal end (360) of the insertion body ([0060] discloses that tip member 356 can be utilized with any of the guide extension catheters disclosed herein, such as 114. FIG 18 shows a section which tapers from the distal end of the insertion body), (ii) a guidewire lumen (Lumen through which 50 passes, FIGs 9-13) defined through the insertion body; (ii) an outer diameter sized such that the insertion body is positionable through a catheter (10, FIGs 8, 11, [0051, 0054]); and an attachment structure (24, FIG 3, [0038]) associated with a proximal portion of the elongate shaft (FIG 3).
Regarding claim 2, Wang et al. discloses the guidewire lumen has an inner diameter that is larger than an outer diameter of a standard guidewire such that the guidewire lumen is sized to allow fluid to flow through the lumen when the standard guidewire is positioned therein (FIG 10 and 12 show guidewire 50 received within the lumen such that substantial space surrounding the guidewire is provided, therefore allowing fluid to flow therethrough if the device were used in such a manner).
Regarding claim 3, Wang et al. discloses at least one visualization marker associated with the device ([0040-0041, 0068]).
Regarding claim 4, Wang et al. discloses the at least one visualization marker is disposed on the insertion body ([0040] discloses the radiopaque material on the distal sheath 26, equivalent to 126).
Regarding claim 5, Wang et al. discloses the attachment structure is coupleable to a proximal portion of the catheter (Hub 24 is at least configured to be coupled to a proximal portion of a catheter in at least some way, for example by abutting a proximal opening of the catheter. Examiner notes the catheter is not a positively recited element of the claim).
Regarding claim 6, Wang et al. discloses the attachment structure is coupleable to a valve of the catheter (Hub 24 is at least configured to be coupled to a valve of a catheter in at least some way, for example by abutting a hemostatic valve proximal opening of the catheter. Examiner notes the catheter and the valve are not positively recited elements of the claim).
Regarding claim 7, Wang et al. discloses the device is positionable within the catheter such that at least a portion of the tapered section is disposed out of a distal end of the catheter ([0061] discloses “while guide catheter 10 is not shown, it can be appreciated that distal sheath 326 (and therefore the tapered section) may extend outer from distal end 12 of guide catheter 10”).
Regarding claim 8, Wang et al. discloses the device is positioned within the catheter such that the device reduces a razor effect while the catheter is advanced through a blood vessel (The device is at least configured such that the tapered section can align with the distal opening of the catheter and therefore reduce the razor effect to some degree).
Regarding claim 9, Wang et al. discloses a vascular catheter advancement assistance device (14, FIG 3, [0036-0037], specifically the embodiment of 114, FIG 5-13) the device comprising: (a) an insertion body (126, FIG 5, [0048]) comprising: (i) a tapered section (358, FIGs 17-18) disposed at and extending proximally from a distal end (360) of the insertion body ([0060] discloses that tip member 356 can be utilized with any of the guide extension catheters disclosed herein, such as 114. FIG 18 shows a section which tapers from the distal end of the insertion body), (ii) a guidewire lumen (Lumen through which 50 passes, FIGs 9-13) defined through the insertion body, wherein the guidewire lumen is substantially coaxial with a longitudinal axis of the insertion body (The lumen extends along the axis of the device through which the guidewire passes) and has a diameter ranging from about 0.01 inches to about 0.05 inches ([0051] discloses an outer diameter of the insertion body being 0.03 to 0.10 inches and having a wall thickness of 0.001 to 0.010 inches, resulting in an inner diameter, or lumen diameter of 0.029 to 0.09 inches which overlaps the claimed range with sufficient specificity); and (iii) an outer diameter sized such that the insertion body is positionable through a vascular catheter (10, FIGs 8, 11, [0051, 0054]); and (b) an elongate proximal shaft (16/116) fixedly attached to a proximal portion of the insertion body such that the elongate proximal shaft is non-coaxial with the longitudinal axis of the insertion body (FIGs 4 and 5), wherein the device is configured to be positioned through the vascular catheter such that a portion of the tapered section is disposed out of a distal end of the vascular catheter (FIG 8 and 11 show the insertion body partially extending from the distal end of a catheter 10. The insertion body is at least configured to be further advanced such that the tapered section extends form the distal end as well), thereby reducing or eliminating a razor effect while the vascular catheter is advanced distally through a blood vessel (The device is at least configured such that the tapered section can align with the distal opening of the catheter and therefore reduce the razor effect to some degree).
Regarding claim 10, Wang et al. discloses an attachment structure (24, FIG 3, [0038]) associated with a proximal portion of the elongate shaft (FIG 3).
Regarding claim 11, Wang et al. discloses the attachment structure is coupleable to a proximal portion of the vascular catheter (Hub 24 is at least configured to be coupled to a proximal portion of a catheter in at least some way, for example by abutting a proximal opening of the catheter. Examiner notes the catheter is not a positively recited element of the claim).
Regarding claim 12, Wang et al. discloses the attachment structure is coupleable to a valve of the catheter (Hub 24 is at least configured to be coupled to a valve of a vascular catheter in at least some way, for example by abutting a hemostatic valve proximal opening of the catheter. Examiner notes the catheter and the valve are not positively recited elements of the claim).
Regarding claim 13, Wang et al. discloses at least one visualization marker disposed on the insertion body ([0040] discloses the radiopaque material on the distal sheath 26, equivalent to 126).
Regarding claim 14, Wang et al. discloses the guidewire lumen has an inner diameter that is larger than an outer diameter of a standard guidewire such that the guidewire lumen is sized to allow fluid to flow through the lumen when the standard guidewire is positioned therein (FIG 10 and 12 show guidewire 50 received within the lumen such that substantial space surrounding the guidewire is provided, therefore allowing fluid to flow therethrough if the device were used in such a manner).
Regarding claim 21, Wang et al. discloses a catheter advancement assistance device (14, FIG 3, [0036-0037], specifically the embodiment of 114, FIG 5-13) the device comprising: (a) an insertion body (126, FIG 5, [0048]) comprising: (i) a tapered section (358, FIGs 17-18) disposed at and extending proximally from a distal end (360) of the insertion body ([0060] discloses that tip member 356 can be utilized with any of the guide extension catheters disclosed herein, such as 114. FIG 18 shows a section which tapers from the distal end of the insertion body), (ii) a guidewire lumen (Lumen through which 50 passes, FIGs 9-13) defined through the insertion body, wherein the guidewire lumen is substantially coaxial with a longitudinal axis of the insertion body (The lumen extends along the axis of the device through which the guidewire passes); and (iii) an outer diameter sized such that the insertion body is positionable through a catheter (10, FIGs 8, 11, [0051, 0054]); (b) an elongate proximal shaft (16/116) fixedly attached to a proximal portion of the insertion body such that the elongate proximal shaft is non-coaxial with the longitudinal axis of the insertion body (FIGs 4 and 5); and (c) an attachment structure (24, FIG 3, [0038]) associated with a proximal portion of the elongate shaft (FIG 3), wherein the attachment structure is coupleable to a proximal portion of the catheter (Hub 24 is at least configured to be coupled to a proximal portion of a catheter in at least some way, for example by abutting a proximal opening of the catheter. Examiner notes the catheter is not a positively recited element of the claim), wherein the device is configured to be positioned through the catheter such that a portion of the tapered section is disposed out of a distal end of the catheter (FIG 8 and 11 show the insertion body partially extending from the distal end of a catheter 10. The insertion body is at least configured to be further advanced such that the tapered section extends form the distal end as well), thereby reducing or eliminating a razor effect while the catheter is advanced distally through a blood vessel (The device is at least configured such that the tapered section can align with the distal opening of the catheter and therefore reduce the razor effect to some degree).
Regarding claims 22-23, Wang et al. discloses at least one visualization marker associated with the device and disposed on the insertion body ([0040] discloses the radiopaque material on the distal sheath 26, equivalent to 126).
Regarding claim 24, Wang et al. discloses the attachment structure is coupleable to a valve of the catheter (Hub 24 is at least configured to be coupled to a valve of a vascular catheter in at least some way, for example by abutting a hemostatic valve proximal opening of the catheter. Examiner notes the catheter and the valve are not positively recited elements of the claim).
Regarding claim 25, Wang et al. discloses the guidewire lumen has a diameter ranging from about 0.01 inches to about 0.05 inches ([0051] discloses an outer diameter of the insertion body being 0.03 to 0.10 inches and having a wall thickness of 0.001 to 0.010 inches, resulting in an inner diameter, or lumen diameter of 0.029 to 0.09 inches which overlaps the claimed range with sufficient specificity).
Regarding claim 26, Wang et al. discloses the guidewire lumen has an inner diameter that is larger than an outer diameter of a standard guidewire such that the guidewire lumen is sized to allow fluid to flow through the lumen when the standard guidewire is positioned therein (FIG 10 and 12 show guidewire 50 received within the lumen such that substantial space surrounding the guidewire is provided, therefore allowing fluid to flow therethrough if the device were used in such a manner).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771