DETAILED ACTION
Applicant’s election without traverse of Species C in the reply filed on 08/17/2026 is acknowledged. Claims 2-10 and 19-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/17/2026.
Applicant has amended claim 1 to include the support sheath of Species C. Applicant has cancelled claims 2-11 and 14-25 and added claims 26-38.
Claims 1, 12-13, and 26-38 are pending and hereby under examination.
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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph 0099 refers to a support sheath using reference characters “2450” and “2550”. As there is no reference character “2550” in the drawings, “2550” should be corrected to “2450”.
Appropriate correction is required.
Claim Objections
Claim 37 is objected to because of the following informalities:
Claim 37, line 2, “surface” should read “a surface”.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 32, 35, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Metchik (WO 2021202130) and Kassab (US 20100076405).
Regarding claim 1, Metchik discloses an interventional tool, comprising:
an outer sheath (Figs. 17-18, sheath 142);
a steerable sleeve disposed within the outer sheath and translatable relative thereto (Figs. 17-18, steerable catheter 140); and
an inner conduit disposed within the steerable sleeve and translatable relative thereto (Figs. 17-18, implant catheter 103, wherein the sheath 142, steerable catheter 140, and implant catheter 103 are all translatable relative to each other, see positions between Figs. 17-18).
Metchik discusses, in an alternate embodiment, that the catheter layers can be selected to provide characteristics such as rigidity/flexibility and resistance to compression (Paragraph 0178) and can include a reinforcement layer (Paragraph 0006). However, Metchik fails to disclose a stiffness-varying element disposed within the outer sheath and configured and arranged to transition the interventional tool between a first state having a first stiffness and a second state having a second stiffness, the first stiffness being greater than the second stiffness, wherein the stiffness-varying element comprises a support sheath disposed between the inner conduit and the steerable sleeve, the support sheath comprising at least two layers.
Metchik and Kassab are in the same field of catheters. Kassab teaches an endovascular sheath apparatus that comprises a stiffening component 20 (Fig. 1). The stiffening component lies within the inner and outer tubes 12/13. An actuating mechanism 18 moves the stiffening component 20 distally and proximally in a linear motion to create “soft” and “stiff” tubular sections (Paragraph 0072). Kassab discusses the stiffening can be performed by opening or closing a helical tube (Paragraph 0062) or through a braided/stranded wire/mesh 44 that can open or close (Paragraph 0070). Kassab further suggests these two embodiments can be combined (Paragraph 0075), which Examiner interprets the combination as two layers of the stiffening component. As Metchik is concerned with steering a catheter, Kassab introduces a stiffening component to minimize or prevent kinking of the apparatus. Metchik would benefit from a stiffening component to minimize/prevent kinking of the catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Metchik with the stiffening component as taught by Kassab, the benefit being a catheter that does not kink easily.
Regarding claim 32, the combination of Metchik and Kassab discloses the tool of claim 1. Kassab further discloses wherein the support sheath is translatable relative to the inner conduit and the steerable sleeve to transition the interventional tool between the first state and the second state (Paragraph 0072, wherein the stiffening component 20 moves distally and proximally in a linear motion and, “when the sliding mechanism 18 is in the proximal position (FIG. 10) the braided wire is open, thereby creating a "soft" tubular section. When the sliding mechanism 18 is in the distal position, the braided strands are relatively closed (FIG. 11), thereby creating a "stiff" tubular section”).
Regarding claim 35, the combination of Metchik and Kassab discloses the tool of claim 1. Kassab further discloses a handle operatively coupled to the support sheath, the handle comprising a lever configured to translate the support sheath relative to the outer sheath, the steerable sleeve, and the inner conduit (Paragraph 0072, wherein the actuating mechanism 18 moves the stiffening component 20 distally and proximally; Figs. 16-17 and paragraphs 0073-0074, wherein rotational handle 52 is shown in the “open position” and is rotated to the “closed”/”stiff” position).
Regarding claim 36, the combination of Metchik and Kassab discloses the tool of claim 1. Metchik further discloses wherein the catheter is retracted relative to the steerable sleeve to expose a distal portion of the inner conduit (Figs. 17-20, wherein the steerable catheter 140/sheath 142 are retracted to expose implant catheter 103 prior to implantation) for assessment of mitral or tricuspid regurgitation prior to release of a fixation device (Fig. 53, implant 200) coupled to the interventional tool.
Metchik fails to disclose that this step occurs such that that the support sheath in the second state is retracted.
However, Kassab teaches the stiffening component 20 as described above. The stiffening component 20, when actuated by actuating mechanism 18, constricts the inner tube 12 (Paragraph 0071). In order to easily retract the stiffening component 20, the stiffening component would be in the “soft”/open configuration, i.e., the “second state”, to retract it more easily and expose the inner tube 12. As such, the combination of Metchik and Kassab read on the limitations of claim 36.
Regarding claim 38, the combination of Metchik and Kassab discloses the tool of claim 1. Kassab further discloses wherein the second state corresponds to a default configuration of the interventional tool absent actuation by a user (Paragraph 0072, wherein the “open” or “soft” state is the default state prior to actuation from actuation mechanism 18).
Claims 12-13 and 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Metchik (WO 2021202130) and Kassab (US 20100076405) as applied to claim 1 above, and further in view of Lentz (US 20060200110).
Regarding claims 12-13 and 26-31, Metchik and Kassab disclose the tool of claim 1. Kassab discloses one braided wire/mesh, as described above. Metchik also discloses that an inner layer of the implant catheter should have a lower durometer compared to the outer layer to enhance the ability of the catheter to be bent to the positions illustrated by Figures 18-20, wherein the implant is being delivered into the heart valve (Paragraph 0187).
However, Metchik and Kassab fail to disclose wherein the support sheath comprises at least an inner liner layer made of PTFE, a coiled metal/wire layer made of stainless steel disposed between the inner and outer layers, a braided metal/wire layer made of stainless steel disposed between the coiled layer and the outer layer, and an outer covering made of nylon 11/12 or Pebax.
Metchik, Kassab, and Lentz are in the same field of catheters. Lentz teaches an introducer sheath with an inner liner layer 71 made of PTFE (Fig. 5 and paragraph 0028), a coiled reinforcement layer 54 made of stainless steel (Fig. 5 and paragraphs 0025-0026), a braided reinforcement layer 34 made of stainless steel (Fig. 5 and paragraphs 0025-0026), and an outer layer 78 made of PEBA (Fig. 5 and paragraph 0023). Lentz suggests that this sheath is designed such that it may stiff enough to permit it to be introduced into the vascular system, yet flexible and kink resistant enough to be directed into one or more small branch vessels (Paragraph 0010). As Metchik and Kassab are concerned with directing a catheter through the vascular system, Lentz introduces this sheath that is both stiff and flexible enough to navigate the vascular system. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stiffening component as disclosed by Metchik and Kassab with the introducer sheath as taught by Lentz, the benefit being a catheter that is both flexible and stiff enough to navigate the vascular system.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Metchik (WO 2021202130) and Kassab (US 20100076405) as applied to claim 1 above, and further in view of Dayton (US 20220039813).
Regarding claim 33, the combination of Metchik and Kassab disclose the tool of claim 1. Metchik further discloses that the implant catheter can be retracted and translated (Paragraph 0130). Metchik fails to disclose a retraction ring to limit translation of the implant catheter. Metchik, Kassa, and Dayton are in the same field of catheter systems. Dayton teaches a catheter system with a guide wire and a stiffening ride (Abstract). The system includes a stop 236 along lumen 216 that limits distal translation of the stiffening rod 14 through guidewire 236. This particular known technique of adding a stop is recognized as part of the ordinary capabilities of one skilled in the art. One of ordinary skill in the art would have been motivated in applying this known technique to the known device as disclosed by Metchik and Kassab, and the results of limiting translation of one layer of the system would have been predictable to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Metchik and Kassab with the stop as taught by Dayton, the results of limiting translation of one layer of the system would have been predictable to one of ordinary skill in the art.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Metchik (WO 2021202130) and Kassab (US 20100076405) as applied to claim 1 above, and further in view of Gomes (US 20250135159).
Regarding claim 37, the combination of Metchik and Kassab disclose the tool of claim 1. The combination fails to disclose wherein at least one of the support sheath and the inner conduit comprises a hydrophilic coating disposed on surface thereof to facilitate translation of the support sheath relative to the inner conduit.
Metchik, Kassab, and Gomes are in the same field of catheters. Gomes teaches a rigidizing device configured to have rigid and flexible configurations (Abstract). The innermost layer 115 can include a hydrophilic coating (Paragraph 0108). This coating can allow the bordering layers to more easily shear relative to each other to maximize flexibility. As Metchik and Kassab are concerned with creating a flexible enough catheter to navigate the vascular system, Gomes introduces a hydrophilic coating to allow the various layers of the catheter to more easily translate relative to each other to maximize the flexibility of the catheter. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Metchik and Kassab to incorporate the hydrophilic coating of Gomes, the benefit being a layer that can easily shear relative to its bordering layers to maximize flexibility.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to teach or suggest, alone or in combination, the limitations of claim 34, wherein the retraction ring comprises a first face configured to engage the inner conduit, a second face configured to serve as a stop for the support sheath, and a third face configured to serve as a stop for the steerable sleeve.
Metchik and Kassab fail to disclose any type of stop or limiting element to prevent translation of one of the layers of the catheter.
Dayton, as discussed above with respect to claim 33, discloses a tapered stop (Fig. 5, stop/shoulder 234/236). The tapered stop depicts only one face that one or more layers would stop against.
Laham (US 20070239066) discloses a stop 16 to constrain the movement of a stylet 20 (Fig. 1A), and multiple stops 120/122 to stop the movement of the stylet 14 (Fig. 1B). However, the stop only comprises one face, and the stops are not one singular component.
Goldfarb (US 20170239048) discloses a stop 1043. The catheter 1030 may advance and retract the until the stop 1043 contacts the distal end 1026 of the inner guiding catheter 1020, preventing further retraction (Fig. 60). However, Goldfarb is silent as to the amount of faces the stop 1043 comprises.
As such, the prior art fails to teach or suggest, alone or in combination, the limitations of claim 34.
Claim 34 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
