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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 67-74, 80, 81 and 83 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/018934 (Tilson et al.).
Regarding claim 67: Tilson discloses a method of performing a medical procedure, comprising:
inserting a guidewire into a body lumen to a desired location (Fig. 73A; [0347]; see guidewire 3885 in Figure 74A; [0350]; see guidewire 3985 in Figure 75A; [0350]);
inserting a rigidizing guiderail over the guidewire while the rigidizing guiderail is in a flexible configuration (see description of guidewire is used to steer and position the guiderail [0350]), wherein the rigidizing guidewire comprises a stiffening layer and a bladder layer (see description of bladder layer and braid layer at [0213]);
when the rigidizing guiderail is proximate to the desired location, activating pressure or vacuum to transition the rigidizing guiderail to a rigid configuration by driving the bladder layer against the stiffening layer (see description of rigidizing device 3700 of Fig. 73A being moved to rigid state at the treatment site [0347]; see description of filling bladder layer at [0214; 0222; 0225-0226]);
passing a catheter over the rigidizing guiderail while the rigidizing guiderail is in the rigid configuration (see description of an passing an instrument over the rigidizing catheter [0323]); used as an overtube for scopes [0326]-[0330]; Fig. 68-69), and
and performing a medical procedure using the catheter (used as an overtube for scopes [0326]-[0330]).
Regarding claim 68: Tilson discloses the rigidizing guiderail in the rigid configuration has a higher stiffness than the guidewire, and wherein the rigidizing guiderail in the flexible configuration has a lower stiffness than the guidewire (see description of guiderail being steered by guidewire at [0350]).
Regarding claim 69, Tilson discloses comprising steering the rigidizing guiderail with a steering element while the rigidizing guiderail is positioned over the guidewire (see description of a steerable spine [0048]; pullwire for bending [0049]; deflection segment 4646 [0263]; steerable distal section 4747 [0357]; Fig. 79).
Regarding claim 70: Tilson discloses rigidizing the catheter by activating pressure or vacuum (see description of filling bladder layer at [0214; 0222; 0225-0226]).
In regards to claims 71 and 72, Tilson discloses that an aspiration catheter can be inserted within the guiderail in combination with other tools disposed within a plurality of working channels [0237].
In regards to claim 73, Tilson discloses further comprising releasing the pressure or vacuum to transition the rigidizing guiderail back to the flexible configuration [0191].
Regarding claim 74, further comprising removing the rigidizing guiderail from the catheter prior to performing the medical procedure (see removing inner rigidizing device [0313]).
In regards to claim 80, Tilson discloses performing a medical procedure comprises performing transcatheter aortic valve replacement [0344].
In regards to claim 81, Tilson discloses the body lumen comprises an aortic bifurcation ([0356]; Fig. 78).
Regarding claim 83, Tilson discloses the body lumen is a portion of the neurovasculature ([0011]; [0308]).
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) 57, 60, and 62-65 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2007/0250149 (Von Oepen et al.) in view of USPAP 2014/0309661 (Sheps et al.).
Von Oepen discloses a method of performing a medical procedure, comprising:
inserting a guidewire (16) into a body lumen to a desired location (treatment site 172) (Fig. 4A; [0043]; [0054]; [0056]; [0063]; [0068]);
inserting a rigidizing guiderail (catheter 10) over the guidewire (16) while the rigidizing guiderail is in a flexible configuration [0043], wherein the rigidizing guidewire comprises a stiffening layer (32, 34, 42, 44) and a bladder layer (see description of elastomeric walls 36 40 and fluid inflating annular lumen 38) (see cross-section Fig. 1B; [0043-0044]);
activating pressure or vacuum when the rigidizing guiderail is proximate to the desired location to transition the rigidizing guiderail to a rigid configuration by driving the bladder layer against the stiffening layer [0044].
Von Oepen teaches that the rigidizing guiderail catheter (10) can be used in a variety of procedures involving other tools, such as puncturing a heart septum with a needle [0033]. Von Oepen fails to explicitly disclose the steps of removing the guidewire from the central lumen and performing a medical procedure through the central lumen.
Sheps discloses a method of puncturing a heart septum and teaches a step of removing a guidewire (202) from the guide catheter (12) lumen after reaching the interatrial septum (Fig. 14C; [0295]). This allows for a needle and dilator to then be advanced through the guide catheter (12) lumen and puncture the septum to create an opening for the catheter [0296]. One of ordinary skill in the art before the effective date of the claimed invention would have therefore found it obvious to modify the Von Oepen method to include the steps of removing the guidewire and performing a procedure through the central lumen, as taught by Sheps, as the modification merely combines known method steps that achieves the predictable result of a using a rigidizing guide sheath to perform a procedure after placement with a guidewire.
Regarding claim 60, Von Oepen discloses the rigidizing guiderail in the rigid configuration has a higher stiffness than the guidewire, and wherein the rigidizing guiderail in the flexible configuration has a lower stiffness than the guidewire (see description of “following the guidewire” in flexible configuration and inflating the device to stiffen the guiderail at [0063]).
Regarding claim 62, Von Oepen discloses releasing the pressure or vacuum to transition the rigidizing guiderail back to the flexible configuration [0064].
In regards to claim 63, Von Oepen discloses the guidewire lumen (see 246 in Figure 4B) has a size to define a radial gap around the guidewire, wherein the gap is defined between the outer surface of the guidewire and the inner surface of the catheter layer 244 [0058]. Von Oepen further discloses stiffening layers (such as 244) can be formed of wire with diameters in the range of 0.001 to 0.005 inch and [0041]. Although Von Oepen does not explicitly disclose the dimension of the radial gap about the guidewire, one of ordinary skill in the art before the effective filing date would have been capable of configuring the gap to be 0.0005” to 0.006” around the guidewire, as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 64, Von Oepen discloses the body lumen is a portion of the pulmonary vasculature see trachial-bronchial tree at [0030]).
Regarding claim 65, Von Oepen discloses the body lumen is a portion of the neurovasculature [0030].
Claim(s) 57 and 59-66 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/018934 (Tilson et al.) in view of USPAP 2014/0309661 (Sheps et al.).
Regarding claim 57: Tilson discloses a method of performing a medical procedure, comprising:
inserting a guidewire into a body lumen to a desired location (Fig. 73A; [0347]; see guidewire 3885 in Figure 74A; [0350]; see guidewire 3985 in Figure 75A; [0350]);
inserting a rigidizing guiderail (rigidizing device 3900) to the treatment site ([0347] – [0352]);
the guiderail being inserted through vasculature while it is in a flexible configuration ([0022]; [0322]), wherein the rigidizing guiderail comprises a stiffening layer (braid layer 2109) and a bladder layer (2121) (see description of bladder layer and braid layer at [0213]);
activating pressure or vacuum when the rigidizing guiderail is proximate to the desired location to transition the rigidizing guiderail to a rigid configuration by driving the bladder layer against the stiffening layer (see description of rigidizing device 3700 of Fig. 73A being moved to rigid state at the treatment site [0347]; see description of filling bladder layer at [0214; 0222; 0225-0226]);
and performing a medical procedure through the central lumen (see description of cardiac tool 3787 placed in the working channel of the rigidizing guiderail 3900 [0347]).
Tilson discloses a guidewire is used to puncture a septum through which the guiderail (3900) is advanced and/or a guidewire is used to steer and position the guiderail [0350], but Tilson fails to explicitly disclose that the guidewire is removed from the central lumen before performing a procedure through the central lumen. Sheps discloses a method of puncturing a heart septum and teaches a step of removing a guidewire (202) from the guide catheter (12) lumen after reaching the interatrial septum (Fig. 14C; [0295]). This allows for a needle and dilator to then be advanced through the guide catheter (12) lumen and puncture the septum to create an opening for the catheter [0296]. One of ordinary skill in the art before the effective date of the claimed invention would have therefore found it obvious to modify the Tilson method to include the steps of removing the guidewire from the lumen of the rigidizing guiderail and performing a procedure through the central lumen with another device, as taught by Sheps, as the modification merely combines known method steps that achieves the predictable result of a using a rigidizing guide sheath to perform a procedure after placement with a guidewire.
Regarding claim 59, Tilson discloses that the working channel can be used for insertion tools that performing cutting and/or suction [0237]. A vacuum tip 5354 of Fig. 46A-B is used for dissection and resection [0266] and/or total chronic occlusions [0324]. Therefore, it would have been obvious to aspirate a clot through the lumen of modified Tilson.
Regarding claim 60, Tilson discloses the rigidizing guiderail in the rigid configuration has a higher stiffness than the guidewire, and wherein the rigidizing guiderail in the flexible configuration has a lower stiffness than the guidewire (can be guided by a guidewire [0350].
Regarding claim 61: further comprising steering the rigidizing guiderail with a steering element while the rigidizing guiderail is positioned over the guidewire (see description of a steerable spine [0048]; pullwire for bending [0049]; deflection segment 4646 [0263]; steerable distal section 4747 [0357]; Fig. 79).
In regards to claim 62, Tilson discloses further comprising releasing the pressure or vacuum to transition the rigidizing guiderail back to the flexible configuration [0191].
Regarding claim 63, Tilson fails to explicitly disclose a gap about a guidewire but teaches that the inner dimension of the guiderail can be varied for different applications [0325] and a radial gap between layers can be 0.0002 – 0.04” [0202]. One of ordinary skill in the art before the effective filing date would have been capable of configuring a radial gap to be 0.0005” to 0.006” around a guidewire, as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 64, it would have been further obvious to perform the modified Tilson method in a portion of the pulmonary vasculature, as Tilson teaches the body lumen can be the heart, lungs, etc. [0011], cardiac anatomy ([0066], [0324]), and directed cardiology and heart procedures [0344].
Regarding claim 65, Tilson discloses the body lumen is a portion of the neurovasculature ([0011]; [0308]).
Regarding claim 66, Tilson discloses procedures in the cardiac anatomy [0066]; [0324]), cardiology and structural heart cases [0344] and coronary arteries [0348]. Therefore, it would have been further obvious to adapt the Tilson method for a myocardium, as the modification merely involves the use of the modified Tilson method in another location of the heart.
Claim(s) 58 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/018934 (Tilson et al.) in view of Sheps, as applied to claim 57 above, and further in view of US 9,808,597 (Vargas et al.).
Tilson discloses that the working channel can be used for insertion tools that performing cutting and/or suction [0237]), but Tilson fails to explicitly state the procedure involves gathering a tissue sample for biopsy. Vargas discloses another rigidizing guide sheath and teaches that it can be used in combination with a biopsy probe (column 4, lines 35 – 47). One of ordinary skill in the art before the effective date of the claimed invention would have therefore found it obvious to perform biopsy during the Tilson method, Vargas teaches that this is another procedure in which a rigidizing guiderail is advantageous.
Claim(s) 75 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/018934 (Tilson et al.)
Regarding claim 75, Tilson fails to explicitly disclose a gap about a guidewire but teaches that the inner dimension of the guiderail can be varied for different applications [0325] and a radial gap between layers can be 0.0002 – 0.04” [0202]. One of ordinary skill in the art before the effective filing date would have been capable of configuring a radial gap to be 0.0005” to 0.006” around a guidewire, as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
In regards to claim 79, Tilson discloses comprising puffing contrast through the rigidizing guiderail [0313] and [0332]. Since Tilson additionally discloses treating occlusions, it would have been obvious to use contrast fluid to identify a clot [0356].
Claim(s) 76-78 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/018934 (Tilson et al.) in view of WO 2014/081892 (Rosenbluth et al.).
Regarding claims 76, 77 and 84: Tilson discloses a method of performing a medical procedure, comprising:
inserting a guidewire into a body lumen to a desired location (Fig. 73A; [0347]; see guidewire 3885 in Figure 74A; [0350]; see guidewire 3985 in Figure 75A; [0350]);
inserting a rigidizing guiderail over the guidewire while the rigidizing guiderail is in a flexible configuration (see description of guidewire is used to steer and position the guiderail [0350]), wherein the rigidizing guidewire comprises a stiffening layer and a bladder layer (see description of bladder layer and braid layer at [0213]);
activating pressure or vacuum to transition the rigidizing guiderail to a rigid configuration by driving the bladder layer against the stiffening layer (see description of rigidizing device 3700 of Fig. 73A being moved to rigid state at the treatment site [0347]; see description of filling bladder layer at [0214; 0222; 0225-0226]);
passing a catheter over the rigidizing guiderail while the rigidizing guiderail is in the rigid configuration (see description of an passing an instrument over the rigidizing catheter [0323]); used as an overtube for scopes [0326]-[0330]; Fig. 68-69), and
and performing a medical procedure using the catheter (used as an overtube for scopes [0326]-[0330]).
Tilson discloses the procedures can be performed in various parts of the body, including the lungs, vasculature and heart [0324], but fails to explicitly disclose treating a pulmonary vasculature and/or pulmonary embolism. Rosenbluth teaches a method of treating a pulmonary embolism (abstract) by positioning a catheter (604) and an instrument (606), and removing the embolism through the catheter lumen (see Fig. 6A-F; [0048] – [0056]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine method of using the rigidizing guiderail of Tilson with the pulmonary embolism catheter of Rosenbluth, as the modification merely involves a combination of a known surgical guiderail with a known clot removal catheter that obtains predictable results of treating a pulmonary embolism.
Regarding claim 78: Furthermore, one of ordinary skill in the art would have found it obvious to use the modified Tilson method for treating chronic thromboembolic pulmonary hypertension, as the modification merely involves the adaptation of a known surgical procedure in pulmonary vasculature for a specific malady.
Claim(s) 82 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/018934 (Tilson et al.) in view of US Patent No. 9,808,597 (Vargas et al.).
Tilson fails to disclose an electrophysiology procedure. Vargas teaches a rigidizing guide sheath is advantageous for guiding an electrophysiology device so the surrounding tissue is not relied upon for steering the device to the treatment site (column 2, lines 29-45). One of ordinary skill in the art before the effective date of the claimed invention would have therefore found it obvious to perform an electrophysiology procedure during the Tilson method, Vargas teaches that this is another procedure in which a rigidizing guiderail is advantageous.
Conclusion
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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