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 .
Priority/Benefit
The application is a Continuation of PCT/US2023/013672 (23 February 2023), which claims benefit of US Provisional 63/314,961 (28 February 2022).
Formal Matters
Claims 1-20 are pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4 December 2024 and 12 February 2025 have been considered by the examiner. Signed copies are attached.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-10, and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duffy et al., US 20140142688 (22 May 2014).
Regarding independent claim 1, Duffy teaches a dilator (FIGs 2, 5; 18; ¶27) comprising:
an elongate shaft (introducer 25) configured to be received within an access sheath (introducer 25 is fully capable of being received within an access sheath as it is an elongate cylindrical medical shaft),
the elongate shaft (introducer 25) being tapered towards a distal end of the elongate shaft (FIG 2); and
an encapsulation feature (capsule 27) disposed on a distal portion of the elongate shaft (25),
the encapsulation feature (27) including a plurality of tabs (flaps 32) that extend toward a proximal end of the elongate shaft (FIG 6; edge 33 of capsule 27; ¶37),
the plurality of tabs (32) being configured to cover a distal end of the access sheath when the elongate shaft is disposed within the access sheath (FIG 6; edge 33 of capsule 27; ¶37).
Regarding claim 2, Duffy teaches the dilator of claim 1, as set forth above, wherein the elongate shaft includes a recessed portion (FIGs 4a-b, 5, shaft 29) configured to receive the plurality of tabs in a collapsed state (FIGs 5-6, flaps 32, edge 33 of capsule 27, attached to shaft 29; ¶¶36-37),
the recessed portion including a smaller outer diameter than an outer diameter of a portion of the elongate shaft that is adjacent to the distal portion (FIG 5; ¶35).
Regarding claim 3, Duffy teaches the dilator of claim 1, as set forth above, wherein the plurality of tabs are configured to collapse onto the elongate shaft to implement a collapsed state (FIG 6; ¶¶37, 41).
Regarding claim 6, Duffy teaches the dilator of claim 1, as set forth above, wherein the encapsulation feature (27) is integral with the elongate shaft (25; FIG 5, lumen; ¶29).
Regarding claim 7, Duffy teaches the dilator of claim 1, as set forth above, wherein the elongate shaft (25) includes a tapered portion (FIG 5, first portion 28, second portion 30; ¶41) between the distal end of the elongate shaft and the encapsulation feature (27), the tapered portion tapering toward the distal end of the elongate shaft (FIG 5, first portion 28, second portion 30; ¶41).
Regarding claim 8, Duffy teaches the dilator of claim 1, as set forth above, and further comprising a hub (FIG 2, 23; ¶27) coupled to the proximal end of the elongate shaft and configured to selectively engage with the access sheath to hold the access sheath in place between the hub and the encapsulation feature (¶32).
Regarding independent claim 9, Duffy teaches a medical system (FIG 2, delivery system 16) comprising: an access sheath (25; ¶33) including a lumen (19, 21), a distal end (FIG 2), and a proximal end (FIG 2); and
a dilator (18) configured to be received within the lumen (19), the dilator (18) including an elongate shaft (25) and an encapsulation feature (27) disposed on a distal portion of the elongate shaft (FIG 2), the encapsulation feature (27) including a plurality of tabs (32) that extend longitudinally (FIGs 5, 6), the dilator (18) being configured to implement an encapsulation state where the plurality of tabs are coupled to the distal end of the access sheath (FIG 6; edge 33 of capsule 27; ¶37) and a collapsed state where the plurality of tabs are radially collapsed on the elongate shaft (FIG 6; ¶¶37, 41).
Regarding claim 10, Duffy teaches the medical system of claim 9, as set forth above, wherein the elongate shaft (25) includes a recessed portion (FIGs 4a-b, 5, shaft 29) configured to receive the plurality of tabs in the collapsed state (FIGs 5-6, flaps 32, edge 33 of capsule 27, attached to shaft 29; ¶¶36-37),
the recessed portion including a smaller outer diameter than a portion of the elongate shaft that is adjacent to the distal portion (FIG 5; ¶35).
Regarding claim 12, Duffy teaches the medical system of claim 9, as set forth above, wherein the encapsulation feature (27) is integral with the elongate shaft (25; FIG 5, lumen; ¶29).
Regarding claim 13, Duffy teaches the medical system of claim 9, as set forth above, wherein the elongate shaft (25) is tapered between the encapsulation feature (FIG 5, first portion 28, second portion 30; ¶41) and a distal end of the elongate shaft (25).
Regarding claim 14, Duffy teaches the medical system of claim 9, as set forth above, and further comprising a hub (FIG 2, 23; ¶27) coupled to a proximal end of the elongate shaft (25) and configured to hold the access sheath in place between the hub (23) and the encapsulation feature (¶32) when the dilator (18) is disposed within the access sheath (25; ¶33).
Regarding independent claim 15, Duffy teaches a method (¶8) of accessing an anatomical feature (percutaneous delivery; ¶22), the method comprising:
attaching an encapsulation feature (27) of a dilator (18) to a distal end (FIG 2) of an access sheath (25; ¶33),
the encapsulation feature (27) including a plurality of tabs (32) configured to cover the distal end of the access sheath (FIG 6; 32, edge 33 of capsule 27; ¶37);
advancing the access sheath with the dilator attached thereto into anatomy (¶23);
distally translating the dilator to detach the encapsulation feature from the access sheath (¶25); and proximally translating the dilator to remove the dilator from the access sheath (¶25).
Regarding claim 16, Duffy teaches the method of claim 15, as set forth above, and further comprising attaching a hub (FIG 2, 23; ¶27) of the dilator to a proximal end of the access sheath to hold the access sheath between the hub and the encapsulation feature (¶32), wherein the advancing the access sheath occurs with the hub attached to the proximal end of the access sheath (¶¶32, 33).
Regarding claim 17, Duffy teaches the method of claim 15, as set forth above, wherein the dilator (18) includes a recessed portion (29) configured to receive the plurality of tabs (FIGs5-6, flaps 32, edge 33 of capsule 27, attached to shaft 29; ¶¶36-37).
Regarding claim 18, Duffy teaches the method of claim 17, as set forth above, wherein the distally translating the dilator causes the plurality of tabs to collapse into the recessed portion (FIG 6; ¶¶37, 41).
Regarding claim 19, Duffy teaches the method of claim 15, as set forth above, wherein the attaching the encapsulation feature (27) of the dilator (18) to the distal end of the access sheath (19) includes distally translating the dilator (18) through the access sheath (FIG 6), radially expanding the plurality of tabs (FIG 5), proximally translating the dilator (FIGs 3A-c, 4a-c), and collapsing the plurality of tabs onto the distal end of the access sheath (¶¶40-41).
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.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al., US 20140142688 (22 May 2014).
Regarding claim 5, Duffy teaches the dilator of claim 1, as set forth above.
Duffy does not teach a coupling feature as part of embodiment dilator 18, wherein the encapsulation feature (27) includes a coupling feature (FIG 10, lumen; ¶29) configured to couple the encapsulation feature (27) to the elongate shaft (25; ¶29).
However, Duffy teaches a separate embodiment comprising dilator 66 (FIGs 10 and 11, ¶50) wherein the encapsulation feature (68) includes a coupling feature (70) configured to couple the encapsulation feature (68) to the elongate shaft (74).
Although, embodiment dilator 18 discloses the claimed dilator with encapsulation feature, encapsulation feature (27) is integral with the elongate shaft (25; FIG 5, lumen; ¶29), it does not comprise a coupling feature. However, Duffy also teaches embodiment dilator 66 where the encapsulation feature 68 includes coupling feature 70. A person of ordinary skill in the art, seeking to control the loading of a medical device into a delivery catheter can include a securing coupler, as taught by Duffy at ¶51. The dilator tip 68 can also be secured to coupler 70 after the medical device is loaded into the shaft lumen (¶51). Duffy teaches that the configurations allow for variation in tip design for varying anatomy. One of ordinary skill in the art would reasonably understand that the different configurations taught by Duffy provide for variations in procedures and anatomy using embodiments of the same base design. Because Duffy addresses anatomical variation as an engineering problem and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a coupler to the encapsulation feature/tip, connected to the same elongate shaft and a different embodiment of the overall dilator system), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 4, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al., US 20140142688 (22 May 2014) in view of Gianotti et al., US 20180200490 (19 July 2018).
Regarding claim 4, Duffy teaches the dilator of claim 1, as set forth above.
Duffy does not teach wherein the encapsulation feature includes a memory metal. However, Duffy teaches that one or more parts may be made from suitable thermoplastics or suitable metals (¶53).
Gianotti teaches dilators comprising tips formed out of pseudoelastic or superelastic alloy including nitinol (¶85) so that beneficial memory shape effects can be utilized (¶85).
Duffy and Gianotti teach functionally enabled catheter systems including dilators. Although Duffy discloses the claimed base dilator, medical system comprising a dilator, and method of accessing an anatomical feature comprising a dilator (FIGs 2, 5; 18; ¶27) omprising: an elongate shaft (introducer 25) configured to be received within an access sheath (sheath 19; ¶27), the elongate shaft (introducer 25) being tapered towards a distal end of the elongate shaft (FIG 2); and an encapsulation feature (capsule 27) disposed on a distal portion of the elongate shaft (25), the encapsulation feature (27) including a plurality of tabs (flaps 32) that extend toward a proximal end of the elongate shaft (FIG 6; edge 33 of capsule 27; ¶37), the plurality of tabs (32) being configured to cover a distal end of the access sheath when the elongate shaft is disposed within the access sheath (FIG 6; edge 33 of capsule 27; ¶37), Duffy does not disclose the material out of which the encapsulation feature is formed.
Gianotti specifically addresses the material out of which a dilator tip may be formed, including pseudoelastic or superelastic alloy including nitinol (¶85) so that beneficial memory shape effects can be utilized (¶85). A person of ordinary skill in the art, seeking the beneficial memory shape effects found with pseudoelastic or superelastic alloys including nitinol in Duffy’s architecture would reasonably consult Gianotti’s memory metal solution. Gianotti’s nitinol can be incorporated alongside Duffy’s dilator tip (same architecture, device, and system structure, and same methods of use with advanced memory shape effects) using known assembly methods without redesigning Duffy’s core delivery path. Because the references address the same engineering problem (dilators for in vivo luminal procedures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (forming the tip of the dilator out of nitinol), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 11, Duffy teaches the medical system of claim 9, as set forth above.
Duffy does not teach wherein the encapsulation feature includes a memory metal. However, Duffy teaches that one or more parts may be made from suitable thermoplastics or suitable metals (¶53).
Gianotti teaches dilators comprising tips formed out of pseudoelastic or superelastic alloy including nitinol (¶85) so that beneficial memory shape effects can be utilized (¶85).
Duffy and Gianotti teach functionally enabled catheter systems including dilators. Although Duffy discloses the claimed base dilator, medical system comprising a dilator, and method of accessing an anatomical feature comprising a dilator (FIGs 2, 5; 18; ¶27) omprising: an elongate shaft (introducer 25) configured to be received within an access sheath (sheath 19; ¶27), the elongate shaft (introducer 25) being tapered towards a distal end of the elongate shaft (FIG 2); and an encapsulation feature (capsule 27) disposed on a distal portion of the elongate shaft (25), the encapsulation feature (27) including a plurality of tabs (flaps 32) that extend toward a proximal end of the elongate shaft (FIG 6; edge 33 of capsule 27; ¶37), the plurality of tabs (32) being configured to cover a distal end of the access sheath when the elongate shaft is disposed within the access sheath (FIG 6; edge 33 of capsule 27; ¶37), Duffy does not disclose the material out of which the encapsulation feature is formed.
Gianotti specifically addresses the material out of which a dilator tip may be formed, including pseudoelastic or superelastic alloy including nitinol (¶85) so that beneficial memory shape effects can be utilized (¶85). A person of ordinary skill in the art, seeking the beneficial memory shape effects found with pseudoelastic or superelastic alloys including nitinol in Duffy’s architecture would reasonably consult Gianotti’s memory metal solution. Gianotti’s nitinol can be incorporated alongside Duffy’s dilator tip (same architecture, device, and system structure) using known assembly methods without redesigning Duffy’s core delivery path. Because the references address the same engineering problem (dilators for in vivo luminal procedures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (forming the tip of the dilator out of nitinol), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 20, Duffy teaches the method of claim 15, as set forth above.
Duffy does not teach wherein the encapsulation feature includes a memory metal. However, Duffy teaches that one or more parts may be made from suitable thermoplastics or suitable metals (¶53).
Gianotti teaches dilators comprising tips formed out of pseudoelastic or superelastic alloy including nitinol (¶85) so that beneficial memory shape effects can be utilized (¶85).
Duffy and Gianotti teach functionally enabled catheter systems including dilators. Although Duffy discloses the claimed base dilator, medical system comprising a dilator, and method of accessing an anatomical feature comprising a dilator (FIGs 2, 5; 18; ¶27) omprising: an elongate shaft (introducer 25) configured to be received within an access sheath (sheath 19; ¶27), the elongate shaft (introducer 25) being tapered towards a distal end of the elongate shaft (FIG 2); and an encapsulation feature (capsule 27) disposed on a distal portion of the elongate shaft (25), the encapsulation feature (27) including a plurality of tabs (flaps 32) that extend toward a proximal end of the elongate shaft (FIG 6; edge 33 of capsule 27; ¶37), the plurality of tabs (32) being configured to cover a distal end of the access sheath when the elongate shaft is disposed within the access sheath (FIG 6; edge 33 of capsule 27; ¶37), Duffy does not disclose the material out of which the encapsulation feature is formed.
Gianotti specifically addresses the material out of which a dilator tip may be formed, including pseudoelastic or superelastic alloy including nitinol (¶85) so that beneficial memory shape effects can be utilized (¶85). A person of ordinary skill in the art, seeking the beneficial memory shape effects found with pseudoelastic or superelastic alloys including nitinol in Duffy’s architecture would reasonably consult Gianotti’s memory metal solution. Gianotti’s nitinol can be incorporated alongside Duffy’s dilator tip (same architecture, device, and system structure, and same methods of use with advanced memory shape effects) using known assembly methods without redesigning Duffy’s core delivery path. Because the references address the same engineering problem (dilators for in vivo luminal procedures) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (forming the tip of the dilator out of nitinol), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Barker et al., US 20080200943 (21 August 2008) teach dilators comprising elongate shafts and encapsulation features.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771