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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 24, 2025 has been entered.
Claims 1-18 are currently pending.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sardesai et al. (US 2021/0220626, hereinafter “Sardesai”).
Regarding claim 1, Sardesai discloses a catheter driving assembly for use with a catheter (mother catheter 166; Figs 11-12; para [0075]; it is noted the catheter is not positively recited), the catheter driving assembly comprising: a sheath (inner support catheter 165) comprising a lumen and a proximal portion, where the sheath is configured to navigate through the catheter (it is noted the catheter is not positively recited) when positioned in tortuous anatomy (Figs 11-12; para [0075]); a shaft (transporter catheter 161) slidably located within the sheath and independently movable therein (Figs 11-12; para [0075]), the shaft comprising a first expandable member (169) spaced from a second expandable member (167) such that a portion of the shaft located therebetween can bend to allow the first expandable member to deflect independently of the second expandable member when expanded (Figs 11-12), the sheath configured for advancement within the catheter when located within a vessel (Figs 11-12), wherein the proximal portion of the sheath is configured for holding while applying a distally directed force on the proximal portion of the shaft where the distally directed force causes distal movement of the first expandable member and/or the second expandable member when expanded within an interior of the catheter causing advancement of the catheter within the vessel (Expandable members 167 and 169 of the shaft 161 are disclosed as being expanded against the inner lumen of the sheath 165 such that distally directed force on the proximal portion of the shaft causes distal movement of the first and/or second expandable member when expanded within an interior of the sheath causing advancement of the sheath within the vessel – Figs 11-12; para [0075]. Since the outer catheter 166, intermediate sheath 165, and inner shaft 161 are each independently movable with respect to each other and since the expandable members 167 and 169 are capable of expanding to a diameter larger than the catheter, the system is fully capable of being positioned such that the outer catheter 166 is positioned distal of the sheath 165 and expand the expandable members 167 and 169 against the outer catheter 166 such that the proximal portion of the sheath may be held while applying a distally directed force on the proximal portion of the shaft where the distally directed force causes distal movement of the first expandable member and/or the second expandable member when expanded within an interior of the catheter causing advancement of the catheter within the vessel. It is noted a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim).
Regarding claim 2, wherein the catheter (166) comprises a thin wall catheter (catheter interpreted as comprising a thin wall since it sized for the vasculature. It is noted the limitation “thin wall” is a term of degree without a special definition.).
Regarding claim 3, further comprising a guide wire (168; para [0075]).
Regarding claim 4, in an alternate embodiment, the device comprises first, second and third expandable members (see annotated Fig 5 below; para [0062]).
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Regarding claim 5, in an alternate embodiment, the device further comprises a distal expandable member (third expandable member or orienting balloon) that is configured to extend from a distal tip of the catheter where the distal expandable member comprises a curved distal surface due to the shape of the balloon (see annotated Fig 5 above; para [0062]).
Regarding claim 6, further comprising a fluid source coupled to the first expandable member (para [0062, 0075]; Fig 1).
Regarding claim 7, wherein the second expandable member is coupled to a second fluid source (para [0062, 0075]; Fig 1).
Regarding claim 8, further comprising a steering control configured to deflect or steer a distal end of the shaft (para [0081, 0094-0095]).
Regarding claim 9, wherein one or more of the expandable members is expandable and contractable using an actuator (inflatable actuator – para [0062, 0075]).
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 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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardesai (US 2021/0220626), as applied to claim 1 above, further in view of Goodin et al. (US 5,980,531, hereinafter “Goodin”). Sardesai discloses the invention substantially as claimed, as shown above. Sardesai additionally teaches “the anchor balloon may be made of materials and/or coated with materials that provide frictional resistance to reduce slippage” (para [0067]). However, Sardesai fails to disclose the balloon is a multilayer balloon with different durometers as claimed. Goodin teaches a balloon catheter (Figs 1-7) with a multilayer balloon, wherein the durometer of the outer inflation member (34) is less than a durometer of the inner inflation member (32) (col 2, ln 18-21 – outer balloon compliant material and inner balloon non-compliant material) and wherein the inner inflation member is fluidly isolated from the outer inflation member (col 2, ln 39-43 -- separate inflation lumens 24 and 26). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sardesai such that the at least one expandable member comprised a dual layer balloon having an inner inflation member and an outer inflation member exterior to the inner inflation member, where a durometer of the outer inflation member is less than a durometer of the inner inflation member, such that the expandable member increases friction against the catheter when expanded, and where the inner inflation member is fluidly isolated from the outer inflation member, since Sardesai teaches “the anchor balloon may be made of materials and/or coated with materials that provide frictional resistance to reduce slippage” (para [0067]) and since Goodin teaches it is known and advantageous in the art to have a dual balloon with a lower durometer outer layer that is fluidically isolated from an inner inflation member. Additionally, it would be obvious to modify the balloon of Sardesai as discussed, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sardesai (US 2021/0220626).
Regarding claims 11 and 16, Sardesai discloses the invention substantially as claimed including a method of navigating a catheter (mother catheter 166; Figs 11-12; para [0075]) through a vascular region, the method comprising: inserting the catheter (166) into a vessel having a tortuous anatomy (Fig 11);
inserting a catheter advancement assembly into the catheter, the catheter advancement assembly comprising a shaft (transporter catheter 161) slidably located within a sheath (inner support catheter 165), the shaft comprising at least one expandable member (167 or 169) at a distal section;
positioning the at least one expandable member in an interior of the catheter (“In one embodiment, the transporter catheter is inserted in the outer catheter and the orienting balloon is left partially protruding out of the tip of the outer catheter” – para [0075]); and
inflating the at least one expandable member to expand against the interior of the catheter at a region of the catheter within the vessel (“In one embodiment, the transporter catheter is inserted in the outer catheter and the orienting balloon is left partially protruding out of the tip of the outer catheter. The orienting balloon is then inflated with sufficient pressure using a fluid to achieve a certain diameter. In one embodiment, the diameter of the inflated orienting balloon is at least equal to the inner diameter of the outer catheter tip. In another embodiment, the diameter of the protruding portion of the orienting balloon is at least equal to the outer diameter of the outer catheter tip. In yet another embodiment, the diameter of the protruding portion of the orienting balloon is greater than the outer diameter of the outer catheter tip.” – para [0075]).
The expandable members 167 and 169 of the shaft 161 are disclosed as being expanded against the inner lumen of the sheath 165 such that distally directed force on the proximal portion of the shaft causes distal movement of the first and/or second expandable member when expanded within an interior of the sheath to cause advancement of the sheath within the vessel – Figs 11-12; para [0075]. Since the outer catheter 166, intermediate sheath 165, and inner shaft 161 are each independently movable with respect to each other and since the expandable members 167 and 169 are capable of expanding to a diameter larger than the catheter, the system is fully capable of being positioned such that the outer catheter 166 is positioned distal of the sheath 165 and expand the expandable members 167 and 169 against the outer catheter 166 such that the proximal portion of the sheath may be held while applying a distally directed force on the proximal portion of the shaft where the distally directed force causes distal movement of the first expandable member and/or the second expandable member when expanded within an interior of the catheter causing advancement of the catheter within the vessel. Furthermore, Sardesai teaches “In one embodiment, the transporter catheter is inserted in the outer catheter and the orienting balloon is left partially protruding out of the tip of the outer catheter. The orienting balloon is then inflated with sufficient pressure using a fluid to achieve a certain diameter. In one embodiment, the diameter of the inflated orienting balloon is at least equal to the inner diameter of the outer catheter tip. In another embodiment, the diameter of the protruding portion of the orienting balloon is at least equal to the outer diameter of the outer catheter tip. In yet another embodiment, the diameter of the protruding portion of the orienting balloon is greater than the outer diameter of the outer catheter tip.” – para [0075]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying Sardesai such that the outer catheter, intermediate sheath, and inner shaft were positioned such that the outer catheter was extended past the distal end of the sheath and the expandable members were inflated against the outer catheter and the method comprised applying a distally directed force to a proximal section of the shaft (or distally advancing a proximal section of the shaft) while holding a proximal portion of the sheath to cause movement of the distal section of the shaft, wherein a fit of the at least one expandable member against the interior the catheter applies a force at the region of the catheter within the vessel that causes movement of the catheter to further navigate the catheter within the vessel beyond the tortuous region in an attempt to provide an improved method of navigating the catheter, as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp. In other words, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use shaft and expandable members (transporter catheter system) to navigate the outer catheter within the vessel similar to how the shaft and expandable members are used to navigate the intermediate sheath since Sardesai teaches “In one embodiment, the transporter catheter is inserted in the outer catheter and the orienting balloon is left partially protruding out of the tip of the outer catheter” (para [0075]) and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 12, wherein the region of the catheter within the vessel comprises a distal region of the catheter (Figs 11-12; see also annotated Fig 5 below).
[AltContent: textbox (Distal region of catheter)][AltContent: textbox (Proximal region of catheter)]
[AltContent: connector][AltContent: textbox (At least one expandable member)][AltContent: connector][AltContent: textbox (Catheter)][AltContent: connector][AltContent: textbox (Shaft of catheter driving assembly)]
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Regarding claim 13, wherein the region of the catheter within the vessel comprises a mid region of the catheter located between a distal region and a proximal region of the catheter (Figs 11-12; the proximal and distal regions may alternatively be interpreted as shown below in annotated Fig 5).
[AltContent: textbox (Mid region of catheter)][AltContent: ][AltContent: ][AltContent: textbox (Distal region of catheter)][AltContent: textbox (Proximal region of catheter)]
[AltContent: connector][AltContent: ][AltContent: textbox (At least one expandable member)][AltContent: connector][AltContent: textbox (Catheter)][AltContent: connector][AltContent: textbox (Shaft of catheter driving assembly)]
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[AltContent: ][AltContent: ]Regarding claim 14, wherein positioning the at least one expandable member comprises positioning the at least one expandable member in a proximal region of the catheter (Figs 11-12; the at least one expandable member and the proximal and distal regions may alternatively be interpreted as shown below in annotated Fig 5).
[AltContent: textbox (Distal region of catheter)][AltContent: textbox (Proximal region of catheter)]
[AltContent: connector][AltContent: textbox (At least one expandable member)][AltContent: connector][AltContent: textbox (Catheter)][AltContent: connector][AltContent: textbox (Shaft of catheter driving assembly)]
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Regarding claim 15, further comprising repositioning the at least one expandable member in a second location in the catheter and moving the proximal section of the shaft relative to the sheath to cause movement of the distal section of the shaft, wherein the fit of the at least one expandable member against the interior the catheter at the second location applies the force at the second location to cause further movement of the catheter to navigate the catheter within the vessel (para [0063]).
Regarding claim 17, wherein positioning the at least one expandable member in an interior of the catheter occurs prior to insertion of the catheter within the vascular region (para [0075, 0083]).
Regarding claim 18, Sardesai teaches the shaft with the at least one expandable member may be inserted and withdrawn from the interior of the catheter (para [0075, 0083]). However, Sardesai does not explicitly teach wherein positioning the at least one expandable member in an interior of the catheter occurs after insertion of the catheter within the vascular region. It would have been obvious to try further modifying Sardesai such that positioning the at least one expandable member in an interior of the catheter occurs after insertion of the catheter within the vascular region for the purpose of delivering the catheter to vasculature first and subsequently using the catheter advancement assembly for fine movements within smaller target vessels or for the purpose of repositioning the catheter after withdrawing the catheter advancement tool to achieve more precise positioning since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success and as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-18 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771