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 .
Notice of Amendment
In response to the amendment filed on 1/10/2025, amended claims 1, 6-11, 13, and 17-19 are acknowledged. Claims 1-20 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 4-9, 12-14, 16-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soukup et al. (US Publication No. 2006/0089569 A1) (cited by Applicant), further in view of Besselink (US Publication No. 2019/0060612 A1).
Regarding claim 1, Soukup et al. discloses a device comprising:
a tubular member (102) with a longitudinal axis having a proximal end and a distal end;
at least one partial cut (126) located at, along or near the distal end of the tubular member, the at least one partial cut comprising an orientation that is angled relative to both the longitudinal axis and an axis transverse to the longitudinal axis (see Figure 1 and [0032]); and
a second member (104) positioned colinear to the tubular member and configured to selectively change a length of the at least one partial cut along the longitudinal axis and advance the distal end of the tubular member longitudinally (see DA in Figure 1 vs. DD in Figure 3 and [0033] and [0037]);
wherein the distal end of the tubular member is configured to longitudinally elongate along or near an area of the at least one partial cut (see DA in Figure 1 vs. DD in Figure 3 and [0033] and [0037]).
It is noted Soukup et al. does not specifically teach the distal end of the tubular member is configured to at least partially rotate around the longitudinal axis when the second member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network. However, Besselink teaches the distal end of the tubular member is configured to at least partially rotate around the longitudinal axis when the second member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network (see Figures 4-7 and 13 and [0006] – “an operator-induced axial force applied to the elongate control element can be used to cause the variation in the slot to produce at least one of a change of the flexibility, rotatability or pushability, rotation of the distal section and a distal end bending within the tubular sheath”; see also [0029], [0046], [0059], and [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. to include the distal end of the tubular member is configured to at least partially rotate around the longitudinal axis when the second member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network, as disclosed in Besselink, so as to reduce the total friction with the inner wall of the lumen in which the device is placed in comparison with a conventional device, which has to be rotated over its entire length (see Besselink: [0029]).
Regarding claim 2, Soukup et al. teaches the at least one partial cut (126) extends throughout an entire thickness of a wall of the tubular member (see Figures 1-2).
Regarding claim 4, Soukup et al. teaches the at least one partial cut comprises a spiral or helical shape (see Figure 1 and [0032]).
Regarding claim 5, Besselink teaches an angle of the at least one partial cut (12) relative to the longitudinal axis is between 10 and 80 degrees (see Figures 1-3 and [0031]).
Regarding claim 6, Soukup et al. teaches the second member is secured to the tubular member along the distal end of the tubular member (see [0039]).
Regarding claim 7, Soukup et al. teaches the second member is secured to the tubular member using at least one of an adhesive and a mechanical connection (see [0039]).
Regarding claim 8, neither Soukup et al. nor Besselink specifically teach the second member is not secured to the first member. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the second member not secured to the first member, since it has been held that making attached structures separable involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 9, Soukup et al. teaches the tubular member comprises a lumen (108) through which the second member is selectively moved (see Figures 1-2 and [0035]).
Regarding claim 12, Besselink teaches the device comprises a guidewire (see [0031]).
Regarding claim 13, Soukup et al. discloses a device comprising:
a tubular member (102) with a longitudinal axis having a proximal end and a distal end (see Figure 1 and [0032]);
at least one partial cut (126) located at, along or near the distal end of the tubular member, the at least one partial cut comprising an orientation that is angled relative to both the longitudinal axis and an axis transverse to the longitudinal axis (see Figure 1 and [0032]); and
an elongated member (104) positioned colinear to the tubular member and configured to selectively modify a length of the tubular member along the at least one partial cut (see DA in Figure 1 vs. DD in Figure 3 and [0033] and [0037]); and
wherein the distal end of the tubular member is configured to longitudinally elongate along or near an area of the at least one partial cut (see DA in Figure 1 vs. DD in Figure 3 and [0033] and [0037]).
It is noted Soukup et al. does not specifically teach movement of the elongated member relative to the tubular member converts longitudinal displacement into rotational movement, causing the distal end of the tubular member to at least partially rotate about the longitudinal axis when the elongated member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network. However, Besselink teaches movement of the elongated member relative to the tubular member converts longitudinal displacement into rotational movement, causing the distal end of the tubular member to at least partially rotate about the longitudinal axis when the elongated member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network (see Figures 4-7 and 13 and [0006] – “an operator-induced axial force applied to the elongate control element can be used to cause the variation in the slot to produce at least one of a change of the flexibility, rotatability or pushability, rotation of the distal section and a distal end bending within the tubular sheath”; see also [0029], [0046], [0059], and [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. to include movement of the elongated member relative to the tubular member converts longitudinal displacement into rotational movement, causing the distal end of the tubular member to at least partially rotate about the longitudinal axis when the elongated member is advanced relative to the tubular member so at to facilitate placement of the distal end in a particular branch of a subject's intraluminal network, as disclosed in Besselink, so as to reduce the total friction with the inner wall of the lumen in which the device is placed in comparison with a conventional device, which has to be rotated over its entire length (see Besselink: [0029]).
Regarding claim 14, Soukup et al. teaches the at least one partial cut (126) extends throughout an entire thickness of a wall of the tubular member (see Figures 1-2).
Regarding claim 16, Soukup et al. teaches the at least one partial cut comprises a spiral or helical shape (see Figure 1 and [0032]).
Regarding claim 17, Soukup et al. teaches the second member is secured to the tubular member along the distal end of the tubular member (see [0039]).
Regarding claim 18, neither Soukup et al. nor Besselink specifically teach the second member is not secured to the tubular member. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the second member not secured to the first member, since it has been held that making attached structures separable involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 20, Besselink teaches the device comprises a guidewire (see [0031]).
Claim(s) 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soukup et al. and Besselink, further in view of Heidner et al. (US Publication No. 2009/0177119 A1).
Regarding claims 3 and 15, it is noted neither Soukup et al. nor Besselink specifically teach the at least one partial cut does not extend throughout an entire thickness of a wall of the tubular member. However, Heidner et al. teaches the at least one partial cut does not extend throughout an entire thickness of a wall of the tubular member (see [0062]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. and Besselink to include the at least one partial cut does not extend throughout an entire thickness of a wall of the tubular member, as disclosed in Heidner et al., so as to enhance the flexibility of the tubular member while still allowing for suitable torque transmission characteristics (see Heidner et al.: [0058]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soukup et al. and Besselink, further in view of Soukup et al. (US Publication No. 2007/0135733 A1; hereinafter Soukup #2).
Regarding claim 10, it is noted neither Soukup et al. nor Besselink specifically teach a handle assembly, wherein a first portion of the handle assembly is secured to the tubular member and a second portion of the handle assembly is secured to the second member, wherein movement of the first portion relative to the second portion of the handle assembly facilitate movement of the tubular member relative to the second member. However, Soukup #2 teaches a handle assembly (200), wherein a first portion (204) of the handle assembly is secured to the tubular member (102) and a second portion (208) of the handle assembly is secured to the second member (104), wherein movement of the first portion relative to the second portion of the handle assembly facilitate movement of the tubular member relative to the second member (see Figures 1-3 and [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. and Besselink to include a handle assembly, wherein a first portion of the handle assembly is secured to the tubular member and a second portion of the handle assembly is secured to the second member, wherein movement of the first portion relative to the second portion of the handle assembly facilitate movement of the tubular member relative to the second member, as disclosed in Soukup #2, so as to articulate the device into and within various tortuous pathways (e.g. body lumens) to facilitate the performance of various minimally invasive procedures (see Soukup #2: [0049]).
Claim(s) 11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soukup et al. and Besselink, further in view of Salahieh et al. (US Publication No. 2010/0331776 A1) (cited by Applicant).
Regarding claims 11 and 19, Besselink teaches movement of the second/elongated member helps with rotation of the device (see Figures 4-7 and 13 and [0006] – “an operator-induced axial force applied to the elongate control element can be used to cause the variation in the slot to produce at least one of a change of the flexibility, rotatability or pushability, rotation of the distal section and a distal end bending within the tubular sheath”; see also [0029], [0046], [0059], and [0077]). It is noted neither Soukup et al. nor Besselink specifically teach at least one pull wire to facilitate steering of the device within an anatomy of a subject, wherein movement of the pull wire helps with bending of the device. However, Salahieh et al. teaches at least one pull wire (262, 264) to facilitate steering of the device within an anatomy of a subject, wherein movement of the pull wire helps with bending of the device (see Figure 14 and [0101]-[0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Soukup et al. and Besselink to include at least one pull wire to facilitate steering of the device within an anatomy of a subject, wherein movement of the pull wire helps with bending of the device, as disclosed in Salahieh et al., so as to guide and deliver a therapeutic, diagnostic, interventional, or any other type of medical device intraluminaly to a target location within a body (see Salahieh et al.: [0101]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
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 DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791