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
The amendment filed November 20th 2025 has been entered. Claims 21-40 are pending in the application. Applicant’s amendments to the Drawings and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed August 20th 2025.
Claim Rejections - 35 USC § 103
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 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) 21-24, 26, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stappenbeck (WO 2019038337 A1), in view of Sheps (US 20180228608 A1), and further view of Gibson (US 20110270173 A1).
Regarding claims 21 and 24, Stappenbeck discloses a delivery sheath (steerable sheath 105, see abstract), comprising: a canal body portion (body of steerable sheath 105, Fig. 16), wherein that the canal body portion comprises: an outer canal (outer body of sheath 105 considering sheath 105 is hollow, see Fig. 7 and 14) comprising a connecting canal (section Gr, Fig. 16), a canal body (sections 25D, 40D, and 72D, Fig. 16), and a distal end (distal end of the steerable sheath 105, Fig. 16), the canal body is located between the connecting canal and the distal end (the canal body is located between section Gr and the distal end of the sheath, see Fig. 16); the canal body comprises a first flexible canal (section 72D, Fig. 16), a spacer canal (section 40D, Fig. 16), and a second flexible canal (section 25D, Fig. 16); the spacer canal is provided between a distal end of the first flexible canal and a proximal end of the second flexible canal (section 40D is between sections 72D and 25D, Fig. 16); a hardness of the connecting canal is greater than that of the first and second flexible canals (section Gr is more stiff than sections 72D and 25D, see Page 10 lines 1-6); and a traction structure (pull rings 109 and 111 and cables 112 and 110, Fig. 17) comprising a first traction fiber (cable 112, Fig. 17) and a second traction fiber (cable 110, Fig. 17), the first traction fiber is connected to the first flexible canal (cable 112 is connected to section 72D, see Fig. 13 and 16), and the second traction fiber is connected to the second flexible canal (cable 110 is connected to section 25D, see Fig. 13 and 16); the first traction fiber and the second traction fiber both extend into the outer canal (cables 112 and 110 are disposed in the outer body of sheath 105, see Page 11 lines 17-27 & Fig. 14 and 17-18), and a free end of the first traction fiber and a free end of the second traction fiber extend out of a proximal end of the connecting canal (the cables pass into the handle of the device, Page 11 lines 22-27 & Fig. 16; this requires the cables to extend past section Gr); the first traction fiber may slide with respect to the canal body and may drive the first flexible canal to bend in a first plane; the second traction fiber may slide with respect to the canal body and may drives the second flexible canal to bend in a second plane; and the first plane intersects or is parallel to or is coplanar with the second plane (cable 112 bends section 72D into a fist plane when pulled and cable 110 bends section 25D into a second plane when pulled, see Page 11 third and fourth paragraphs and Page 19 second and fourth paragraphs & Fig. 13 and 16-17; two different steering points provided and spaced apart at an angle of 10-180 degrees, see Page 19 paragraph 2; steering points being 90 degrees apart resulting in bends in perpendicular planes and steering points being 180 degrees apart resulting in bends in a parallel plane).
Stappenbeck discloses the delivery sheath made of different materials “adapted to specific bending requirements as desired and which can be varied in order to achieve specific bending characteristics: Proximal Grilamid is used because it is a relatively stiff material. Further distal at defined sections different stiffness of Pebax is used. 72D, 40D and 25D refer to different stiffness of the material. Here it is chosen to be more and more soft in distal direction. A polymer jacket is thus formed and used including reinforcement which is chosen according to the bending requirements of the device, i.e. bending radius and bending angle” (Page 9 paragraph 5 – Page 10 paragraph 1.1) but fails to explicitly disclose a distal canal, a hardness of the spacer canal greater than that of the first and second flexible canals, and a hardness of the distal canal is greater than that of the first flexible canal and the second flexible canal.
However, Sheps teaches a delivery sheath (catheter 14, abstract and [0469] & Fig. 6) comprising a distal canal (pull ring section 1401, [0538] & Fig. 6) and a hardness of the distal canal is greater than that of the first flexible canal and the second flexible canal (section 1401 has a durometer of 55D, which is more than sections 1406 (45D) and 1403 (25D), which are being interpreted as a first and second flexible canal, [0538], [0541, and [0544] & Fig. 6).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sheath of Stappenbeck with Sheps to include a distal canal, with a hardness of the distal canal greater than that of the first flexible canal and the second flexible canal, since such a modification would impart more hardness and rigidity to the distal portion of the catheter in which a pull ring is disposed, such that the distal canal supports the pull ring and protects the distal portion of the catheter from the impact of forces applied thereto (see [0538] of Sheps).
As modified, distal section 1401 can be included distally of pull ring 109 of Stappenbeck, with pull ring 109 disposed in the distal section 1401, like pull ring 13 of Sheps. As combined, the canal body, sections 25D, 40D, and 72D of Stappenbeck, would be located between the connecting canal, section Gr of Stappenbeck, and the distal canal, section 1401 of Sheps.
Further, Gibson teaches a catheter (catheter 10, [0041] & Fig. 1 and 9) wherein a hardness of the spacer canal is greater than that of the first and second flexible canals (transition segment 48, which is being interpreted as a spacer canal, having a higher stiffness than the flexible distal tip 30, which includes distal bending segment 56 and proximal bending segment 58, [0050] and [0071] & Fig. 9; transition segment 48 positioned in-between segments 56 and 58, which are being interpreted as first and second flexible canals, [0071] & Fig. 9; the Examiner notes that distal tip 30 may include four or more bending segment, see [0063]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sheath of Stappenbeck with Gibson to include the hardness of the spacer canal being greater than that of the first and second flexible canals since such a modification would help in improving the reliability and ease of deflecting a bending segment and provide structural support for pull wires before entering a bending segment (see [0050]-[0051] and [0071]-[0072] of Gibson).
As modified, the spacer canal, section 40D of Stappenbeck, would have a hardness greater than sections 75D and 25D of Stappenbeck. This configuration is suitable considering Stappenbeck does not place criticality on the hardness of the different section of the sheath, disclosing that the sheath may be “adapted to specific bending requirements as desired and which can be varied in order to achieve specific bending characteristics…” (Page 9 paragraph 5 – Page 10 paragraph 1.1).
Regarding claim 22, Stappenbeck, as modified, discloses all the limitations of claim 21. Stappenbeck further discloses the delivery sheath wherein that the hardness of the first flexible canal is greater than that of the second flexible canal (section 72D having a greater stiffness than section 25D, see Page 10 paragraph 1 & Fig. 16).
Regarding claim 23, Stappenbeck, as modified, discloses all the limitations of claim 21. However, Stappenbeck fails to explicitly disclose the delivery sheath wherein that the canal body further comprises a transition canal; the transition canal is arranged between the spacer canal and the first flexible canal; a hardness of the transition canal is less than that of the spacer canal; the hardness of the transition canal is greater than that of the first flexible canal; or,
the transition canal is arranged between the spacer canal and the second flexible canal; the hardness of the transition canal is less than that of the spacer canal; the hardness of the transition canal is greater than that of the second flexible canal; or,
the transition canal is arranged between the connecting canal and the first flexible canal; the hardness of the transition canal is less than that of the connecting canal; the hardness of the transition canal is greater than that of the first flexible canal; or,
the transition canal is arranged between the distal canal and the second flexible canal; the hardness of the transition canal is less than that of the distal canal; the hardness of the transition canal is greater than that of the second flexible canal.
However, Gibson teaches a delivery sheath wherein that the canal body further comprises a transition canal (transition segment 49, [0072] & Fig. 9); the transition canal is arranged between the connecting canal and the first flexible canal (segment 49 arranged between main shaft 32 and proximal bending segment 58); the hardness of the transition canal is less than that of the connecting canal; the hardness of the transition canal is greater than that of the first flexible canal (transition segment 49 – transition segment 49 simply being an additional segment 48 – having a stiffness that is between main shaft 32 and distal tip 30, distal tip 30 consisting of proximal bending segment 58 and 56, [0050]-[0051], [0059], and [0072] & Fig. 9; distal tip 30 having a lower stiffness that shaft 32, see [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sheath of Stappenbeck with Gibson to include the canal body further comprises a transition canal, the transition canal is arranged between the connecting canal and the first flexible canal, the hardness of the transition canal is less than that of the connecting canal, and the hardness of the transition canal is greater than that of the first flexible canal, since such a modification would help in improving the reliability and ease of deflecting a bending segment and provide structural support for pull wires before entering a bending segment (see [0050]-[0051] and [0071]-[0072] of Gibson).
Regarding claim 26, Stappenbeck, as modified, discloses all the limitations of claim 21. Stappenbeck further discloses the delivery sheath wherein the canal body further comprises at least one supporting member arranged in the canal body; when there is only one supporting member, the supporting member is arranged in a section where the first flexible canal or the second flexible canal is located and when there are a plurality of supporting members, the plurality of supporting members are arranged in sections where the first flexible canal and the second flexible canal are located (hypotubes 115 are being interpreted as at least one supporting member, Page 10 paragraphs 2 and 4 & Fig. 14; hypotubes 115 arranged in sections where bending is intended, section(s) 25D and/or 72D, see Fig. 12-14).
Regarding claim 40, Stappenbeck discloses a medical device (a steerable sheath 105 and a catheter 102 having mounted thereon a medical device 103 such as a heart valve, see Page 6 first paragraph & Fig. 5 and 16), wherein the medical device comprising the delivery sheath according to claim 21 is used in minimally invasive surgery (the steerable sheath 105 as modified, see rejection of claim 21 above; “The steering sheath according to the current disclosure avoids at least partially or essentially entirely the disadvantages of known deployment systems for minimally invasive deployment of medical devices.”, page 16 paragraph 3).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stappenbeck (WO 2019038337 A1), in view of Sheps (US 20180228608 A1), in view of Gibson (US 20110270173 A1), and further in view of Diao (CN 110215593 A).
Regarding claim 25, Stappenbeck, as modified, discloses all the limitations of claim 21. Stappenbeck further discloses the delivery sheath wherein the traction structure further comprises a first fixed structure and/or a second fixed structure fixed in the canal body (pull rings 109 and 111, Fig. 11a and 17); the first fixed structure is arranged at the distal end of the first flexible canal (pull ring 111 arranged at a distal end of section 72D, see Fig. 12-13); the second fixed structure is arranged at the distal end of the second flexible canal (pull ring 109 arranged at a distal end of section 25D, see Fig. 12-13);
However, Stappenbeck fails to explicitly disclose a delivery sheath wherein a traction structure comprises a first connecting hole, a second connecting hole, and a third connecting hole are formed in a side wall of the first fixed structure and/or the second fixed structure; along a circumferential direction of the first fixed structure and/or the second fixed structure, the second connecting hole is located between the first connecting hole and the third connecting hole; connecting lines of hole centers of the first connecting hole, the second connecting hole, and the third connecting hole may form a triangle; an inner angle formed by the triangle at the hole center of the second connecting hole is an obtuse angle; the first traction fiber passes through the first connecting hole, the second connecting hole, and the third connecting hole in sequence to be connected with the first fixed structure; and/or, the second traction fiber passes through the first connecting hole, the second connecting hole, and the third connecting hole of the second fixed structure in sequence to be connected to the second fixed structure.
However, Diao teaches a delivery sheath (see Technical field paragraph on page 1) wherein a traction structure (pull ring 100, Fig. 1 and 9-10) comprises a first connecting hole (groove 102a, see embodiment 5 on pages 4-5 & Fig. 10), a second connecting hole (groove 101, see embodiment 5 on pages 4-5 & Fig. 10), and a third connecting hole (groove 102e, see embodiment 5 on pages 4-5 & Fig. 10) are formed in a side wall of the first fixed structure; along a circumferential direction of the first fixed structure (the wire receiving groove arranged along the outer wall of ring 100, see embodiment 5 on pages 4-5 & Fig. 10), the second connecting hole is located between the first connecting hole and the third connecting hole (groove 101 is being interpreted as located between groove 102a and 102e, see embodiment 5 on pages 4-5 & Fig. 10); connecting lines of hole centers of the first connecting hole, the second connecting hole, and the third connecting hole may form a triangle; an inner angle formed by the triangle at the hole center of the second connecting hole is an obtuse angle (see annotated Figure 10 below, the center of grooves 101, 102a, and 102e forming a triangle with an inner angle of the triangle at the center of groove 101 forming an obtuse angle, annotated as “OBTUSE”); the first traction fiber passes through the first connecting hole, the second connecting hole, and the third connecting hole in sequence to be connected with the first fixed structure (see embodiment 5 on pages 4-5 & Fig. 10).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the fixed structure of Stappenbeck, as modified, with Diao to include a first connecting hole, a second connecting hole, and a third connecting hole are formed in a side wall of the first fixed structure; along a circumferential direction of the first fixed structure, the second connecting hole is located between the first connecting hole and the third connecting hole; connecting lines of hole centers of the first connecting hole, the second connecting hole, and the third connecting hole may form a triangle; an inner angle formed by the triangle at the hole center of the second connecting hole is an obtuse angle; the first traction fiber passes through the first connecting hole, the second connecting hole, and the third connecting hole in sequence to be connected with the first fixed structure since Diao teaches this configuration to be an art effective means for connecting a pull wire to a pull ring and would yield predictable results pertaining to secure traction fiber connection (see page 2 paragraph 1 and page 3 paragraphs 1-3 of Daio).
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Response to Arguments
Applicant’s arguments with respect to claim(s) 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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