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 .
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on November 21, 2025. Claims 1-2 and 4-12 are currently pending.
Drawings
The drawings filed on 11/21/2025 are accepted. In view of the drawings filed on 11/21/2025 the objections made against the drawings in the office action of 5/21/2025 have been withdrawn.
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.
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(s) 1-2, 4-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0209758 to Tuval et al. (Tuval) in view of US 2018/0193615 to Nitzan et al. (Nitzan) (both previously cited), US Patent No. 5,843,050 to Jones (Jones), and US 2011/0152905 to Eaton (Eaton).
In reference to at least claim 1
Tuval discloses an intravascular blood pump (e.g. blood pump 27; “placed inside a blood vessel of the subject”, para. [0030]), comprising: an expandable blood conduit (e.g. tube 24) having an unexpanded delivery diameter (e.g. unexpanded diameter within delivery sheath, Fig. 1B) and an expanded deployed diameter (e.g. expanded diameter once released from delivery sheath, Fig. 1B); one or more expandable impellers disposed at least partially in the blood conduit (e.g. impeller 50); a drive shaft in operable communication with the one or more expandable impellers (e.g. axial shaft 92, para. [0468]), and an inflatable member disposed distal to the blood conduit (e.g. atraumatic distal portion 120 that includes a radially expandable portion 278/282), the inflatable member having an uninflated delivery configuration and an inflated configuration (e.g. atraumatic distal portion 120 that includes a radially expandable portion 278 or 282 has an inflated an uninflated configuration (e.g. para. [0563]-[0564]), a lumen in the drive shaft and extending through the inflatable member, the lumen being configured to accommodate a guidewire (e.g. lumen 132 within shaft 92 connects with lumen 122, Figs. 6A-C, 13 which is configured to accommodate a guidewire, “The distal tip portion of the ventricular assist device is then guided to the left ventricle by advancing the distal tip portion over the guidewire, with the guidewire disposed inside lumen 122.”, para. [04891], [0562]).
Tuval further discloses the inflatable member having a diameter that separates the inlet opening from structures of the heart or vessel (e.g. “ the inflated portion or the radially expanded portion of the distal tip portion separates one or more blood inlet openings 108 from inner structures of the left ventricle in three dimensions. In this manner, the inflated portion or the radially expanded portion of the distal tip portion separates one or more blood inlet openings 108 from the interventricular septum, chordae tendineae, papillary muscles, and/or the apex of the left ventricle.”, para. [0488], [0565]). However, Tuval does not explicitly disclose the diameter of the inflatable member including the inflatable member having a diameter in the inflated configuration that is greater than the expanded deployed diameter of the blood conduit or the lumen being configured to supply an inflation fluid to the inflatable member.
Nitzan, in the same field of catheters with intravascular impeller pumps, discloses an intravascular blood pump (e.g. catheter 300 defines a blood pump; para. [0129]), comprising an inflatable member (e.g. restrictor 302b; para. [0132]) disposed distal to the blood conduit (e.g. restrictor 302b is disposed distal to enlarged portion 315; para. [0132]), the inflatable member (e.g. restrictor 302b) having an uninflated delivery configuration (e.g. a relaxed configuration; para. [0100]) and an inflated configuration (e.g. activated, inflated configuration, Fig. 3; para. [0132]), the inflatable member (e.g. restrictor 302b) having a diameter in the inflated configuration (e.g. activated, inflated configuration, Fig. 3; para. [0132]) that is greater than the expanded deployed diameter of the blood conduit (e.g. the diameter of the restrictor 302b in the inflated configuration is greater than the diameter of the enlarged portion 315, Fig. 3; para. [0136]). Nitzan further discloses that the restrictors prevent the vessel from collapsing on the suction lumen and thus blocking the blood entrance (e.g. “because a restrictor in the form of a balloon is inflated over the entire vessel perimeter and the suction lumen is an integrated part of the balloon, the vessel is prevented from collapsing on the suction lumen and thus blocking the blood entrance.” para. [0195]). 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 blood pump of Tuval to include the inflatable member having a diameter in the inflated configuration that is greater than the expanded deployed diameter of the blood conduit, as taught by Nitzan, in order to prevent blocking the inlets from collapse of the vessel or tissue due to suction from the impeller (‘615, para. [0195]).
Regarding the lumen being configured to supply an inflation fluid to the inflatable member, it was well known in the art to use a single lumen instead of multiple lumens for providing an inflation fluid to an inflation element and for accommodating a guidewire as evidence by Jones (e.g. Col. 12, ll. 27-33) and Eaton (e.g. “The inflation lumen 112 and the guidewire lumen 114 may be formed by two catheter tubes arranged in a substantially coaxial configuration, as shown in FIGS. 1(b) and (c). Alternatively, the inflation lumen 112 and the guidewire lumen 114 may be integrally formed in a single catheter tube.”, para. [0045]). 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 the blood pump of Tuval to include utilizing the lumen extending through the inflatable member to also supply an inflation fluid to the inflatable member in order to provide a single lumen that has a smaller diameter than multiple lumens reducing the amount of spaced needed within the device resulting in a smaller profile for the implanted device (‘050, Col. 12, ll. 31-33).
In reference to at least claim 2
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses wherein the one or more impellers comprises an impeller disposed at a distal end of the blood conduit (e.g. impeller 50 at distal end of tube 24).
In reference to at least claim 4
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses an elongate member extending distally from a hub at a distal end of the blood conduit (e.g. atraumatic distal portion 120 extends from a “hub” which includes bearings 118 and portion around tube 126 at a distal end of the blood conduit, Figs. 6, 13, para. [0492] and includes an elongate member extending distally from the hub, Figs. 13 and 21C,D), the guidewire lumen extending through the hub and the elongate member (e.g. guidewire 10 extends through the implanted device including a lumen 122 of the atraumatic distal portion 120 that includes the elongate member, Fig. 1B, para. [0562]).
In reference to at least claim 5
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses wherein the elongate member is more flexible than the hub (e.g. atraumatic distal portion 120 extends from a “hub” which includes bearings 118 and portion around tube 126 at a distal end of the blood conduit, Figs. 6, 13, para. [0492] which is less flexible than an elongate member extending distally from the hub that includes inflatable member that is radially expanded relative to the distal tip 232 or 278 or 282, Figs. 13, 18 and 21C,D).
In reference to at least claim 6
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval modified by Nitzan discloses the claimed invention except for the inflatable member comprises an inelastic material. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the inflatable member include an inelastic material, 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, see MPEP 2144.07.
In reference to at least claim 7
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses wherein the inflatable member has a preformed shape (e.g. atraumatic distal tip portion 120 can include shape-memory material which is shape set “preformed shape”, para. [0555]; “self-expand” distal tip portion, para. [0564]).
In reference to at least claim 8
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses wherein the preformed shape is spherical (e.g. atraumatic distal tip portion 120 includes a spherical shape, Figs. 21C, 21D, 23B, 24B).
In reference to at least claim 9
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses wherein the inflatable member has a preformed shape (e.g. atraumatic distal tip portion 120 can include shape-memory material which is shape set “preformed shape”, para. [0555]; “self-expand” distal tip portion, para. [0564]). Nitzan discloses the restrictor having an ovoid shape (e.g. Fig. 6). 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 blood pump of Tuval to include the preformed shape being ovoid, as taught by Nitzan, in order to prevent blocking the inlets from collapse of the vessel or tissue due to suction from the impeller (‘615, para. [0195]). Additionally or alternatively, it would have been an obvious matter of design choice to make the preformed shape ovoid since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. Furthermore, absent a teaching as to criticality that the preformed shape is ovoid, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 10
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1. Tuval further discloses wherein the inflatable member has a preformed shape (e.g. atraumatic distal tip portion 120 can include shape-memory material which is shape set “preformed shape”, para. [0555]; “self-expand” distal tip portion, para. [0564]). Nitzan discloses the restrictor having an toroidal shape (e.g. Fig. 1-5). 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 blood pump of Tuval to include the preformed shape being toroidal, as taught by Nitzan, in order to prevent blocking the inlets from collapse of the vessel or tissue due to suction from the impeller (‘615, para. [0195]). Additionally or alternatively, it would have been an obvious matter of design choice to make the preformed shape toroidal since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. Furthermore, absent a teaching as to criticality that the preformed shape is toroidal, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement, see MPEP 2144.04.
In reference to at least claim 12
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 4. Tuval further discloses a bearing within the hub, the inflation fluid being configured to lubricate the bearing as it passes through the lumen (e.g. “For some applications, in this manner, some of the purging fluid flows to the interface between the axial shaft and distal bearing 118, thereby purging the interface, as indicated by purging-fluid-flow arrow 150 in FIG. 13”, para. [0524]-[0525]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0209758 to Tuval et al. (Tuval) in view of US 2018/0193615 to Nitzan et al. (Nitzan), US Patent No. 5,843,050 to Jones (Jones) and US 2011/0152905 to Eaton (Eaton) applied to claim 1 further in view of US Patent No. 5,820,595 to Parodi (Parodi) (previously cited).
In reference to at least claim 11
Tuval modified by Nitzan as evidence by Jones and Easton renders obvious a pump according to claim 1 but does not explicitly teach wherein the inflatable member is adapted and configured to be partially inflated during intravascular delivery to seal a distal end of a delivery sheath.
Parodi discloses providing an inflatable member (e.g. 240) on an end of an implantable catheter for sealing an end of a delivery sheath (e.g. 246) to prevent fluid from entering the sheath and disturbing the integrity and positioning of the prosthesis (e.g. “As shown in FIGS. 1 and 7, a third inflatable member 240 or balloon tip 252 may be disposed on the shaft 154 between the first inflatable member 170 and the first end 156 of the shaft 154 for sealing the end of the delivery sheath 246 to prevent body fluid from entering the sheath 246 and disturbing the integrity and positioning of the first and second inflatable members 170, 180, prosthesis 350 and securing means 300.”, Col. 8, ll. 12-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the blood pump of Tuval modified by Nitzan as evidence by Jones and Easton to configure the inflatable member to partially inflated during intravascular delivery to seal a distal end of a delivery sheath, as taught by Parodi, in order to prevent body fluid from entering the delivery sheath and disturbing the integrity and positioning of the blood pump (e.g. ‘595, Col. 8, ll. 12-19).
Response to Arguments
Applicant’s arguments, see pg. 6, filed 11/21/2025, with respect to the rejection(s) of claim(s) 1-10 under 35 USC 103 using Tuval in view of Nitzan have been fully considered and are persuasive in view of the claim amendments adding language regarding a lumen in the drive shaft that extends through the tubular member being configured to accommodate a guidewire and supply an inflation fluid. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Jones and Eaton, see claim rejection above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2006/0230476 to Atanasoska et al which discloses a single lumen for providing an inflation fluid to an inflation element and for accommodating a guidewire which are used with left ventricular assist hearts and pumps. US 2012/0277718 to Campbell et al. which discloses using a single lumen for a guidewire and inflation. US 2013/0237950 to Gianotti et al. which discloses a ballon catheter with a single lumen for inflation and a guidewire.
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.
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/JG/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796