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 .
Response to Amendment
This office action is in response to the amendments filed on 3/6/2025. Claims 1-20 are canceled. Claims 21-40 are newly added. Claims 21-40 are pending and addressed below.
Response to Arguments
The applicant canceled all of the previous claims in the claim set filed on 3/6/2025 therefore the prior rejections are deemed to be moot.
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 of this title, 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.
Claims 21-23 and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US Pub No. 2010/0042118) in view of Falotico (US Pub No. 2005/0249775).
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Regarding claim 21, Garrison discloses (Figures 1-4B) a vessel closure device (5), comprising: a delivery shaft (7) having a proximal end region and a distal end region; an actuator (13) coupled to the proximal end region (Figures 1A-1C); a vessel wall locator (17) disposed adjacent to the distal end region of the delivery shaft, the vessel wall locator being configured to shift between a delivery configuration and a deployed configuration (Paragraphs 0057-0058); wherein a first longitudinally-extending channel (top 35 as shown in Figure 3A) is formed in the delivery shaft; a first suture capture rod (top 15 as shown in Figure 3A) disposed within the first longitudinally-extending channel; wherein a second longitudinally-extending channel (bottom 35 as shown in Figure 3A) is formed in the delivery shaft; a second suture capture rod (bottom 15 as shown in Figure 3A) disposed within the second longitudinally-extending channel; a suture (19) having a first end configured to be coupled to the first suture capture rod and a second end configured to be coupled to the second suture capture rod (clearly shown in Figures 4A-4B); a non-dilating distal tip (21) coupled to the distal end region of the delivery shaft (Paragraph 0061 discloses that the distal tip 21 is not required to be a dilating tip); wherein the non-dilating distal tip comprises a tapered distal end (clearly shown Figure 2); and wherein a guidewire lumen (inside channel of 21 where guidewire 33 is positioned as shown in Figure 2) is defined in the non-dilating distal tip, the guidewire lumen extending between a distal opening (see annotated figure above) formed in the tapered distal end of the non-dilating distal tip and a proximal opening (see annotated figure above) disposed adjacent to a proximal end of the non-dilating distal tip and positioned distally of the vessel wall locator.
Garrison fails to disclose wherein the non-dilating distal tip comprises a flexible material.
Falotico, in the analogous art of guidewire catheters having a distal tip, teaches (Figures 35-38) a delivery catheter (5010) that includes a distal tip (5028) (Figures 37-38) having a guidewire lumen (5034) where the distal tip comprising a flexible material (Paragraph 0327) (Figure 37).
Since the device of Garrison and the device of Falotico are both directed to distal tips having a guidewire lumen that are inserted into a blood vessel, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Garrison to have the distal tip to comprise a flexible material as taught by Falotico, in order to successfully follow the guidewire path and prevent overpowering the guidewire so that the distal tip is directed by the guidewire to successfully reach the target area (Falotico, Paragraph 0327).
Regarding claim 22, Garrison modified by Falotico further discloses wherein the first suture capture rod and the second suture capture rod are configured to pass the suture through a vessel wall (Garrison, Paragraph 0068).
Regarding claim 23, Garrison modified by Falotico further discloses wherein the suture is configured to form a knot between the first end and the second end thereof after the suture has passed through the vessel wall (Garrison, Paragraphs 0079-0080 and 0101).
Regarding claims 26-28, Garrison modified by Falotico further discloses the non-dilating distal tip is configured to conform to a curvature of a guidewire (Falotico, 8000) when advancing the non-dilating distal tip along the guidewire (Falotico, Paragraph 0327) (Figure 37) [Since the distal tip 5028 is designed with an extremely flexible leading edge and a gradual transition to a less flexible portion so that the distal tip does not overpower the guidewire path and gives the distal tip the ability to be directed by the guidewire, then this would result in the distal tip to conform to the curvature of the guidewire when advancing the distal tip along the guidewire] and wherein a flexibility of the distal tip (Falotico, 5028) varies along a length of the distal tip with the flexibility of the distal tip increasing distally (Falotico, Paragraph 0327) (Figures 37-38).
Regarding claim 29, Garrison modified by Falotico further discloses wherein the non-dilating distal tip is 3 cm or less in length (Garrison, Paragraph 0008 and Claim 10).
Regarding claim 30, Garrison modified by Falotico further discloses wherein the non-dilating distal tip is formed from a plurality of materials (Falotico, Paragraphs 0326-0327).
Regarding claim 31, Garrison modified by Falotico further discloses wherein the non-dilating distal tip defines a wall thickness between the guidewire lumen and an outer surface of the non-dilating distal tip, and wherein the wall thickness varies along the length of the non-dilating distal tip (clearly shown in Figure 2 of Garrison).
Regarding claim 32, Garrison modified by Falotico further discloses wherein the non-dilating distal tip is configured to be advanced through a procedural sheath [Fully configured in doing this since Garrison modified by Falotico discloses all of the structural elements in the same arrangement as claimed].
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US Pub No. 2010/0042118) in view of Falotico (US Pub No. 2005/0249775) as applied to claim 21 above, and further in view of Kontos (US Pub No. 2004/0210251).
Regarding claims 24-25, Garrison modified by Falotico discloses all of the elements of claim 21 above except for a valve being disposed within the guidewire lumen and wherein the valve is configured to limit blood flow through the guidewire lumen.
Kontos, in the same field of endeavor, teaches (Figures 2, 6, and 7) a device (Figure 2) for suturing punctures in blood vessels that includes a valve (550) positioned in a guidewire lumen (507) and wherein the valve is configured to limit blood flow through the guidewire lumen (Paragraphs 0033-0034). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Garrison modified by Falotico to have a valve positioned in the guidewire lumen as taught by Kontos, in order to prevent the flow of blood through the guidewire lumen that can cause an undesirable condition such as hematoma (Kontos, Paragraph 0033).
Claims 33-40 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison (US Pub No. 2010/0042118) in view of Falotico (US Pub No. 2005/0249775) and further in view of Kontos (US Pub No. 2004/0210251).
Regarding claim 33, Garrison discloses (Figures 1-4B) a vessel closure device (5), comprising: a delivery shaft (7) having a proximal end region and a distal end region; an actuator (13) coupled to the proximal end region (Figures 1A-1C); a vessel wall locator (17) disposed adjacent to the distal end region of the delivery shaft, the vessel wall locator being configured to shift between a delivery configuration and a deployed configuration (Paragraphs 0057-0058); wherein a first longitudinally-extending channel (top 35 as shown in Figure 3A) is formed in the delivery shaft; a first suture capture rod (top 15 as shown in Figure 3A) disposed within the first longitudinally-extending channel; wherein a second longitudinally-extending channel (bottom 35 as shown in Figure 3A) is formed in the delivery shaft; a second suture capture rod (bottom 15 as shown in Figure 3A) disposed within the second longitudinally-extending channel; a suture (19) having a first end configured to be coupled to the first suture capture rod and a second end configured to be coupled to the second suture capture rod (clearly shown in Figures 4A-4B); a non-dilating distal tip (21) coupled to the distal end region of the delivery shaft (Paragraph 0061 discloses that the distal tip 21 is not required to be a dilating tip); and wherein a guidewire lumen (inside channel of 21 where guidewire 33 is positioned as shown in Figure 2) is defined in the non-dilating distal tip, the guidewire lumen extending between a distal opening (see annotated figure above for claim 21) formed in the tapered distal end of the non-dilating distal tip and a proximal opening (see annotated figure above for claim 21) disposed adjacent to a proximal end of the non-dilating distal tip and positioned distally of the vessel wall locator.
Garrison fails to disclose wherein the non-dilating distal tip comprises a flexible material.
Falotico, in the analogous art of guidewire catheters having a distal tip, teaches (Figures 35-38) a delivery catheter (5010) that includes a distal tip (5028) (Figures 37-38) having a guidewire lumen (5034) where the distal tip comprising a flexible material (Paragraph 0327) (Figure 37).
Since the device of Garrison and the device of Falotico are both directed to distal tips having a guidewire lumen that are inserted into a blood vessel, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Garrison to have the distal tip to comprise a flexible material as taught by Falotico, in order to successfully follow the guidewire path and prevent overpowering the guidewire so that the distal tip is directed by the guidewire to successfully reach the target area (Falotico, Paragraph 0327).
Garrison also fails to disclose a valve being disposed within the guidewire lumen and wherein the valve is configured to limit blood flow through the guidewire lumen.
Kontos, in the same field of endeavor, teaches (Figures 2, 6, and 7) a device (Figure 2) for suturing punctures in blood vessels that includes a valve (550) positioned in a guidewire lumen (507) and wherein the valve is configured to limit blood flow through the guidewire lumen (Paragraphs 0033-0034). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Garrison to have a valve positioned in the guidewire lumen as taught by Kontos, in order to prevent the flow of blood through the guidewire lumen that can cause an undesirable condition such as hematoma (Kontos, Paragraph 0033).
Regarding claim 34, Garrison modified by Falotico and Kontos further discloses wherein the first suture capture rod and the second suture capture rod are configured to pass the suture through a vessel wall (Garrison, Paragraph 0068).
Regarding claim 35, Garrison modified by Falotico and Kontos further discloses wherein the suture is configured to form a knot between the first end and the second end thereof after the suture has passed through the vessel wall (Garrison, Paragraphs 0079-0080 and 0101).
Regarding claims 36-38, Garrison modified by Falotico and Kontos further discloses the non-dilating distal tip is configured to conform to a curvature of a guidewire (Falotico, 8000) when advancing the non-dilating distal tip along the guidewire (Falotico, Paragraph 0327) (Figure 37) [Since the distal tip 5028 is designed with an extremely flexible leading edge and a gradual transition to a less flexible portion so that the distal tip does not overpower the guidewire path and gives the distal tip the ability to be directed by the guidewire, then this would result in the distal tip to conform to the curvature of the guidewire when advancing the distal tip along the guidewire] and wherein a flexibility of the distal tip (Falotico, 5028) varies along a length of the distal tip with the flexibility of the distal tip increasing distally (Falotico, Paragraph 0327) (Figures 37-38).
Regarding claim 39, Garrison modified by Falotico and Kontos further discloses wherein the non-dilating distal tip is 3 cm or less in length (Garrison, Paragraph 0008 and Claim 10).
Regarding claim 40, Garrison modified by Falotico and Kontos further discloses wherein the non-dilating distal tip defines a wall thickness between the guidewire lumen and an outer surface of the non-dilating distal tip, and wherein the wall thickness varies along the length of the non-dilating distal tip (clearly shown in Figure 2 of Garrison).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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