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 .
Claim Rejections - 35 USC § 102
Claim(s) 1,5,7,8,12,13,15,20 is/are rejected under 35 U.S.C. 102(a)(1),102(a)(2) as being anticipated by Kurth et al (2015/0080851).
1. A valve bypass tool for an implantable medical device (IMD) delivery
system, the valve bypass tool comprising:
a back panel that defines an inlet opening; (see at least figure 2b which shows a back panel (20) and an inlet opening therein)
a tube connected to the back panel and extending from the back panel to a
distal end of the tube, (see at least figure 2b,3 which shows tube 12)
wherein the tube is cylindrical and the distal end of the tube
is configured to dilate a seal of an access introducer, (see at least ¶188 which teaches that the tube allows for a lead to pass thru the tube without friction from a valve membrane of an introducer. The membrane is dilated when the VBT is inserted into the introducer)
the tube defining a channel therethrough that aligns with and is open to the inlet opening in the back panel, (see at least figure 2b)
wherein the inlet opening and the channel of the tube are sized to receive an IMD
therethrough. (at least ¶188 teaches an intravascular device, which is the IMD)
5. The valve bypass tool of claim 1, wherein the back panel and the tube
are defined by at least a first section and a second section, the first section and
the second section selectively movable relative to each other to define a closed
state of the valve bypass tool (Figs. 8A-8D) and an open state of the valve bypass tool (Figs. 9A-9D), wherein
in the open state a first curved member (vertically oriented tab 20) of the first section is spaced apart from a second curved member (vertically oriented tab 20) of the second section to define at least one gap (open slit 28) along a length of the tube. (see at least figure 9a and ¶187 which shows two parts of the back panel in an open configuration and two curved members creating a gap)
7. The valve bypass tool of claim 5, wherein the first section is connected
to the second section via a living hinge, and the first and second sections are
pivotable about the living hinge. (see at least ¶24,187 which teach a living hinge)
8. The valve bypass tool of claim 7, wherein the living hinge extends along
the length of the tube and connects the first curved member to the second curved
member. (see at least figures 4a,4b and ¶187)
12. The valve bypass tool of claim 5, wherein the first section and the
second section are movable relative to one another along a mating axis to
transition between the open state and the closed state. (see at figure 8a which show living hinge 30,which is considered to be a mating axis)
13. The valve bypass tool of claim 12, wherein the first section includes at
least a first pin and the second section includes at least a first pinhole that is sized
and positioned to align with the first pin, such that the first pin is received within the
first pinhole as the first and second sections are moved along the mating axis to
the closed state. (see at least ¶195 which teaches mating fingers and indentations which are considered to be the pin and pinhole.)
15. A method for implanting an implantable medical device, the method
comprising:
inserting a valve bypass tool (VBT) into a first inlet opening of an access
introducer, wherein the VBT includes a back panel and a tube connected to the
back panel and extending from the back panel to a distal end of the tube, (see at least figure 2b which shows a back panel (20) and an inlet opening therein. Further, see at least ¶188 which teaches that the tube allows for a lead to pass thru the tube without friction from a valve membrane of an introducer)
wherein
the tube is cylindrical and defines a channel therethrough that aligns with and is
open to a second inlet opening defined through the back panel, (see at least figure 2b,2a which shows cylindrical tube 12)
wherein
inserting the VBT comprises advancing the tube into the first inlet opening such that the
distal end of the tube dilates a seal of the access introducer; (see at least ¶188 which teaches inserting the tool into an introducer, wherein the introducer has a valve membrane that is dilated by the VBT)
inserting an IMD and a guide catheter through the second inlet opening and
the channel of the VBT while the tube is within the access introducer such that the
IMD and the guide catheter pass beyond the seal of the access introducer. (see at least ¶188 of Kurth which teaches use with an introducer, and ¶189,190 which teach insertion of an intravascular tool. Also, At least the abstract of Kurth teaches that a lead or vascular device is inserted thru the VBT. The vascular device of Kurth is considered to be an IMD since it is a medical device)
20. The method of claim 15, wherein the back panel and the tube of the
VBT are defined by at least a first section and a second section such that the tube
is defined by at least a first curved member of the first section and a second curved
member of the second section, wherein removing the VBT comprises separating
the first and second sections along a mating axis to disconnect the first section
from the second section. (see at least ¶191 which teaches a snap and peg configuration that allows for the two halves to be separated and rejoined along an axis)
Claim Rejections - 35 USC § 103
Claim(s) 2,3,6,17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851).
2. The valve bypass tool of claim 1, wherein the inlet opening and the
channel of the tube are sized to receive a leadless IMD as the IMD. (it is considered to have been obvious design choice to increase the diameter of the tube, if needed, in order to accommodate the device that is being inserted, yielding only predictable results)
3. The valve bypass tool of claim 1,wherein a diameter of the channel of the tube is 15-35F. (Kurth teaches the valve bypass tool of claim 1, but fails to specifically state that a diameter of the channel of the tube is 15-35 F. Kurth [0186] does however teach that the diameter (i.e. width of slot 26) can be varied according to the application at hand. Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to choose the size of channel according to the maximal diameter of transvascular tool to be used.)
6. The valve bypass tool of claim 5, wherein the at least one gap in the
open state is larger than a diameter of a guide catheter inserted through the valve
bypass tool. (It is not clear if the gap is larger. However, even if not, making the gap large enough for a guide catheter would have been obvious since it would allow the bypass tool to be removed from around the catheter when no longer needed.)
17. The method of claim 15, further comprising removing the VBT from
around the guide catheter while a portion of the guide catheter is located within the
access introducer. (at least ¶188 teaches that the device can be separated and taken off the intravascular device. It would have been obvious to remove the VBT while the guide catheter is still in the introducer since it simplifies the process so that the guide catheter does not have first be removed completely. Separating into two halves allows for the device to be removed and reused, if needed, without removing the lead as well)
18. The method of claim 17, wherein the back panel and the tube of the
VBT are defined by at least a first section and a second section such that the tube
is defined by at least a first curved member of the first section and a second curved
member of the second section, wherein removing the VBT comprises pivoting the
first section of the VBT relative to the second section of the VBT about a hinge to
cause at least one gap along a length of the tube between the first curved member
and the second curved member. (see at least ¶187 which teaches a living hinge along the length of the tube, and allows for opening the of the tube vertically)
19. The method of claim 18, wherein the hinge is a living hinge that extends
along the length of the tube and connects the first curved member to the second
curved member. (see at least ¶187)
Claim(s) 4,16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) and Rickheim et al (2022/0347429).
4. The valve bypass tool of claim 1, wherein the back panel is planar and
includes a secondary seal configured to seal around a guide catheter inserted
through the valve bypass tool. (as shown in at least figure 2b, the back panel is planar. Kurth is silent as to a seal around a guide catheter. At least ¶61 of Rickheim teaches a valve bypass tool 312 that has a seal between the valve tool 312 and sheath (catheter) 308. It would have been obvious to use such seal with the device of Kurth sicne it would allow for a more secure hemostatic seal, as taught in Rickheim)
16. The method of claim 15, wherein inserting the IMD and the guide
catheter comprises inserting a leadless IMD through the second inlet opening and
the channel of the VBT. (Kurth is silent as to leadless IMD. Rickheim teaches a leadless IMD, see at least figure 1. It would have been obvious to insert leadless IMDs thru the device of Kurth since it would be an effective way of placing the device in the most accurate manner)
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) and Schmidt et al (2022/0257283).
9. The valve bypass tool of claim 5, wherein the first section is coupled to
the second section via a mechanical hinge, and the first and second sections are
pivotable about the mechanical hinge. (Kurth is silent as to a mechanical hinge. Schmidt teaches a mechanical hinge, see at least ¶49, figure 4. It would have been obvious to use such since they are well known for their strength and durability)
10. The valve bypass tool of claim 9, wherein the back panel is defined by
at least a first flange member of the first section and a second flange member of
the second section, wherein the mechanical hinge is secured to the first flange
member and the second flange member. (see at least figure 4 of Schmidt which is considered to show flanges 362a,362b. It would have been obvious to use such since they provide a secure connection to the back panel in a predictable manner)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) and Schmidt et al (2022/0257283), and further in view of Heide et al (4,840,178).
11. The valve bypass tool of claim 10, wherein the mechanical hinge
includes a pin that projects through a first ear of the first flange member and a
second ear of the second flange member. (as mentioned supra, Schmidt teaches a mechanical hinge. However, is silent as to a pin. Heide teaches a mechanical hinge with a pin, see at least col. 9:34-40. It would have been obvious to use a pin since it would fasten the two sections together in a secure manner, yielding predictable results)
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) and Fisher et al (2009/0234290).
14. The valve bypass tool of claim 12, wherein the first section includes a first front flange and a first back flange extending from the first curved member, and the second section includes a second front flange and a second back flange extending from the second curved member, wherein the first front flange overlaps and contacts the second back flange and the first back flange overlaps and contacts the second front flange as the first and second sections are moved along the mating axis to the closed state. (at least ¶195 of Kurth teaches that the connections between the two halves can be various mechanical means. Kurth is silent as to overlapping flanges. Fischer teaches overlapping flanges, see at least ¶31. It would have been obvious to use two overlapping flanges in the claimed orientations since they would produce the predictable result of securely fastening the two halves together such that they can be opened and closed easily)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Scott M. Getzow whose telephone number is (571)272-4946. The examiner can normally be reached M-F 9-5.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792
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