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 May 4, 2026 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 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) 1-9 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 filed May 4, 2026 have been fully considered but they are not persuasive.
Regarding the rejection of claims 1-9 under 35 USC 102(a)(1) as being anticipated by Sardesai (US 2021/0220626), Applicant argues Sardesai fails to disclose a device that is configured to have a shaft with expandable members that expand within an interior of a catheter located in a vessel and that advancement of the shaft relative to the sheath applies a driving force at a region within the vessel to advance the catheter within the vessel as claimed.
In response to applicant's argument that Sardesai does not teach such a configuration, 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. As noted above, claims 1-9 fail to positively recite the catheter. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The shaft (transporter catheter 161) of Sardesai which comprises first and second expandable members (167, 169) is fully capable of expanding within an interior of a catheter and is fully capable of applying the claimed driving force. It is further noted Sardesai teaches at least the distal expandable member expands against the interior of an outer 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. 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]).
Applicant has provided no evidence to establish an unobvious difference between the claimed product and the prior art, but rather has merely argued such alleged difference. Specifically, Applicant has not provided evidence that the transport catheter of Sardesai would likely collapse upon itself or kink when a push force and/or torque is applied to the introducer catheter. Mere arguments cannot take the place of evidence. In re Walters, 168 F.2d 79,80, 77 USPQ 609,610 (CCPA 1948); In re Cole, 326 F.2d. 769,773, 140 USPQ 230,233 (CCPA 1964); In re Schulze, 346 F.2d 600,602, 145 USPQ 716,718 (CCPA 1965); In re Lindner, 457 F.2d 506,508, 173 USPQ 356,358 (CCPA 1972); In re Pearson, 494 F.2d 1399,1405, 181 USPQ 641,646 (CCPA 1974); Meitzner v. Mindick, 549 F.2d 775,782, 193 USPQ 17,22 (CCPA), cert. Denied, 434 U.S. 854 (1977); In re DeBlauwe, 736 F.2d 699,705, 222 USPQ 191,196 (Fed. Cir. 1984). Applicant cites paragraphs 72 and 73 of Sardesai to support this point, but the Examiner notes in these paragraphs Sardesai teaches the introducer catheter (924) in this example is a thin-walled catheter for smaller vessels that may collapse when pushed from a proximal end thereof. Sardesai does not teach the transport catheter (901) with the expandable members (907, 909), which is interpreted as the claimed shaft, will collapse upon itself or kink when a push force and/or torque force is applied.
Applicant argues the language “wherein the proximal portion of the sheath is configured for holding while applying a distally directed force on the proximal portion of the shaft” is not intended use. It is noted the only structural requirement is that the proximal portion of the sheath must be accessible to the user such that it is capable of being held while applying a distally directed force on the shaft. The Examiner disagrees that Sardesai teaches the opposite of such a requirement and is not capable of performing this requirement. 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 the expandable members 167 and 169 expand 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.
Regarding the rejection of claim 10 under 35 USC 103 as being unpatentable over Sardesai in view of Goodin (US 5,980,531), Applicant argues Goodin is not analogous art because it teaches balloons for stent deployment. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Goodin and Sardesai teach balloon catheters for use within the vasculature. It is further noted Goodin is not being modified to increase grip between an outer balloon and a stent. Rather, Goodin is relied upon to teach 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.
Regarding the rejection of claims 11-18 under 35 USC 103 as being unpatentable over Sardesai, Applicant argues the Office does not establish a proper prima facie case of obviousness to modify Sardesai as claimed. Although Sardesai teaches the transport catheter (161 – interpreted as the claimed shaft) is used to advance a thin-walled catheter (165 – interpreted as the claimed sheath), Sardesai also 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]). Thus, as discussed above, since at least the distal expandable member of the shaft (161) can expand against the outer catheter (166), it is obvious a distal force can be applied to the shaft to also move the outer catheter. 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
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