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 responsive to the amendment filed on 05/29/2026. As directed by the amendment: Claims 1, 6-7, 9-10, 12, 15, 18, and 20 have been amended, claim 5 have been cancelled, and claim 21 has been added. Thus, claims 1-4 and 6-21 are presently under consideration in this application.
Response to Arguments
Applicant's arguments, see pages 7-12, filed 05/29/2026, regarding 35 U.S.C. 102/103 have been fully considered. The Applicant argues on pages 7-10 that the amendments to the claim obviate the rejection of record. Examiner agrees.
Applicant then argues on page 11 that “The flexible hinge region 360, however, does not couple the first portion 340 with the second portion 350, such as recited in claim 9. Schmidt teaches and illustrates that the first and second portions 340, 350 are formed as unitary structures. Rather, the flexible hinge region 360 is positioned at the tapered intersection between the first and second portions 340, 350 to ensure that the distal tip 358 of the second portion 350 maintains contact with the target tissue and the conical echogenic structure 352 does not deform.”
Examiner agrees because Kurth teaches the claimed limitations instead. Examiner notes that hinge 30 of Fig. 4A where first and second sections are pivoting off the hinge of Kurth teaches claims 9-11.
Applicant then argues on page 12 that “Fischer describes a tearaway introducer sheath assembly that includes an
integrated valve 300 positioned within a valve housing 222. A retention cap 210 includes
cup halves 212 that define the valve housing 222 to accommodate the valve 300. An
outer flange 214 of each half 212 is received into an associated proximal groove 320 of
a ring section 316 of the valve 300. The cup half members 212 are bonded or welded in
place to the respective hub half portions at overlapping flanges between the proximal end
of the hub and the outer periphery of the distal face of the cap half members. Stated
differently, Fischer teaches that flanges of a retention cap 210, in which a valve 300 is
positioned, can overlap with each other. The overlapping flanges, however, are not
sections of a back panel of a valve bypass tool, as recited in claim 1.
Additionally, Fischer is associated with a tearaway catheter introducer sheath for
the catheterization of a blood vessel, and has nothing to do with a valve bypass tool for
delivering an implantable medical device. While the tools broadly relate to medical
devices, design considerations for a VBT for deploying an IMD are considerably different
than design considerations for a blood vessel catheter introducer sheath. As such, a
person skilled in the art would not rely on the teachings of Fischer to amend Kurth in order
to arrive at the present invention as defined in claim 14.”
Examiner agrees.
However, upon further consideration, a new ground(s) of rejection is made in view of Kurth et al (2015/0080851) in view of Nardeo et al. (US 20090143739)(Hereinafter Nardeo).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-17 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the guide catheter" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the guide catheter" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
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, 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.
Claim(s) 1-3, 5-13, 15, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) in view of Nardeo et al. (US 20090143739)(Hereinafter Nardeo).
Regarding claims 1 and 15, Kurth teaches A valve bypass tool for an implantable medical device (IMD) delivery system/ A method for implanting an implantable medical device (Abstract “transvalvular insertion tool for providing a passage through a multiplicity of differently designed hemostatically valved introducers”), 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)
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 and an open state of the valve bypass tool ([0185] “The bypass sheath 12 is provided with an integrally molded tab 20 on its proximal hub end 22, a male snap molding 16 on one side of the proximal portion of sheath 12 and a female snap molding 18 on opposing side of the proximal portion of sheath 12.” [0198] “The hub portions are engaged by rotating [move] them together so that the curved fingers 46 are fully inserted into cavities 48 as shown in FIGS. 20a-20e in a partially assembled configuration as the swing latch is partially still open but is being closed and in FIGS. 21a-21e in the fully assembled configuration after the swing latch is fully closed.”
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wherein the first section includes a first curved member and a first flange member, and the second section includes a second curved member and a second flange member ([0185] “The bypass sheath 12 is provided with an integrally molded tab 20 on its proximal hub end 22 [first and second flange members], a male snap molding 16 on one side of the proximal portion of sheath 12 and a female snap molding 18 on opposing side of the proximal portion of sheath 12.”),
wherein the back panel is defined by the first flange member of the first section and the second flange member of the second section ([0185] “The matching and opposing half of hub 22 has a mating arrangement, namely male snap moldings 16 extending radially from the lower portion of half hub 22 with female snap moldings (not shown) defined into the upper portion of half hub 22 for receipt of male snap moldings 16 from the opposing half hub 22.”),
wherein the tube is defined by the first curved member of the first section and the second curved member of the second section ([0186] “The slotted embodiment has a single horizontally oriented tab 20 integrally formed with a half hub 22 and with half cylindrical sheath 12 [first and second half of the curved members].”
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wherein in the open state the first curved member of the first section is spaced apart from the second curved member of the second section to define at least one gap along a length of the tube ([0198] “The hub portions are engaged by rotating them together so that the curved fingers 46 are fully inserted into cavities 48 as shown in FIGS. 20a-20e in a partially assembled configuration as the swing latch is partially still open but is being closed and in FIGS. 21a-21e in the fully assembled configuration after the swing latch is fully closed.” See Fig. 20a-d where the first and second curved members are spaced apart at the proximal end.).
Although Kurth teaches two “hubs” that keep the sheaths (first and second curved members) in place, Kurth does not teach a first and second flange. Nardeo, in the same field of endeavor, teaches a hemostasis valve introducer for implanting device (Abstract and [0002]), and further teaches wherein the back panel is defined by the first flange member of the first section and the second flange member of the second section (Fig. 4 [0030] “Each valve portion 152A,152B includes a lateral flange or ear 164A,164B at its proximal end, which further includes a post-receiving aperture 166A,166B therethrough; preferably, a thick flange extends from the lateral flanges to surround the entrance to proximal cavity 160.”) to allow for easy removable attachment of the valve ([0011]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Kurth, with the first and second flange of Nardeo, because such a modification would allow to allow for easily removable attachment of the valve.
However, Kurth does not explicitly teach characterized in that the first and second curved members are composed of a metal material, and the first and second flange members are composed of a plastic material. Nevertheless, Kurth does suggest that the entire TVI tool can be made of metal or plastic ([0184]) allowing for the first and second curved members are composed of a metal material, and the first and second flange members are composed of a plastic material ([0184] “The TVI tool can be fabricated in numerous ways including machining, molding, casting, or forging and can be comprised of one or more materials including metal, plastic, ceramic, composite, rubber or elastomer,”) to provide rigid construction preventing collapse ([0183]). For a person of ordinary skill in the art, making such modifications would have required nothing more than a predictable application of a known technique to a known device ready for improvement. See KSR, 550 U.S. at 416-417. A skilled artisan would have understood how to modify Kurth’s metal for the first and second curved members and plastic for the first and second flange members (as shown in [0184]) to provide rigid construction preventing collapse. The metal for the first and second curved members and plastic for the first and second flange members would not have been “uniquely challenging or difficult for one of ordinary skill in the art” or “represented an unobvious step over the prior art” to modify Kurth in view of Nardeo as discussed above. Leapfrog Enters., Inc. v. Fisher- Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418-19).
Regarding claim 2, Kurth teaches 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)
Regarding claim 3, Kurth teaches 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.)
Regarding claim 6, Kurth teaches 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.)
Regarding claim 7, Kurth teaches 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)
Regarding claim 8, Kurth teaches 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)
Regarding claim 9, Kurth teaches 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. (Hinge 30 of Fig. 4A where first and second sections are pivoting off the hinge.)
Regarding claim 10, Kurth teaches The valve bypass tool of claim 9, wherein the mechanical hinge is secured to the first flange member and the second flange member. (Hinge 30 of Fig. 4A where first and second sections are pivoting off the hinge.)
Regarding claim 11, Kurth teaches 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. (A hinge has peg/pin what goes through the hole going through the first and second ear 12 of the flange members.)
Regarding claim 12, Kurth teaches 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)
Regarding claim 13, Kurth teaches 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.)
Regarding claim 17, Kurth teaches 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.)
Regarding claim 18, Kurth teaches The method of claim 17, 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.)
Regarding claim 19, Kurth teaches 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)
Regarding claim 20, Kurth teaches The method of claim 15, 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(s) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) in view of Nardeo et al. (US 20090143739)(Hereinafter Nardeo) and Rickheim et al (2022/0347429).
Regarding claim 4, claim 1 is obvious over Kurth and Nardeo. 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.)
Regarding claim 16, claim 15 is obvious over Kurth and Nardeo. 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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al (2015/0080851) in view of Nardeo et al. (US 20090143739)(Hereinafter Nardeo), and Rickheim et al. (US 20200345982)(Hereinafter Rickheim).
Regarding claim 21, claim 1 is obvious over Kurth and Nardeo. Kurth However, Kurth in view of Nardeo do not teach wherein the plastic material of the first flange member covers the metal material of the first curved member at a proximal end of the first curved member, and the plastic material of the second flange member covers the metal material of the second curved member at a proximal end of the second curved member. Rickheim, in the same field of endeavor, teaches a valve bypass tool for transporting an implantable device (Abstract), and further teaches the plastic material of the first flange member covers the metal material of the first curved member at a proximal end of the first curved member, and the plastic material of the second flange member covers the metal material of the second curved member at a proximal end of the second curved member ([0008] “The bypass sheath may be metallic, e.g., may be formed from a thin-walled metal tubing. By contrast, the tool body can be polymeric, and thus, may be overmolded onto the tubular wall.” [0054] “The rigid material can be a stiff polymer, such as nylon, e.g., nylon 8 or nylon 12, polyether ether ketone (PEEK), polyimide, etc.” [0075] “In an embodiment, the annular seal 608 includes a seal flange 1206 extending longitudinally from the annular disk 1202. For example, seal flange 1206 [must be made of a polymer as this is part of the rest of the tool] can be a tubular section extending in the distal direction from the annular disk 1202.”) to avoid buckling of the introducer while allowing the implantable through ([0008]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Kurth in view of Nardeo, with the plastic material of the first flange member covers the metal material of the first curved member at a proximal end of the first curved member, and the plastic material of the second flange member covers the metal material of the second curved member at a proximal end of the second curved member of Rickheim, because such a modification would allow to avoid buckling of the introducer while allowing the implantable through.
Conclusion
Claim 14 is 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 a statement of reasons for the indication of the claims overcoming the prior art:
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, 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 since 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 are not conventionally relied upon in valve bypass tools for implanting IMDs and are therefore allowable over the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eidenschink et al. (US 2023/0270992), O’Carrol (US 20180001062) and Bruszewski (US 20120271236 A1)
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 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 MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
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