PO4000USC8
`PATENT
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`Remarks
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`The Office Action dated May 30, 2024 has been carefully considered, and the present
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`Amendment and following remarks following are madein response.
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`Claims 1-17 are pending. Claims 1, 2, 3, 10, 14 and 16 are amended. Claims 4, 5, 11
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`and 12 are cancelled.
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`Claim Objection
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`Claim 10 is amended as suggested in the Office Action. Reconsideration and withdrawal
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`of the claim objection is accordingly requested.
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`Double Patenting
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`In view of the amended claims herein, reconsideration of the double patenting rejection
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`of claims 1-8, 10 and 14-16 over the commonly owned US Patent No. 11428236 is requested.
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`Rejections under 35 U.S.C. § 102
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`The rejection of claims 10 and 13 as allegedly being anticipated by US Patent No.
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`6533716 to Shmitz-Rode is respectfully traversed.
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`The Applicant’s invention addresses certain problems presented in known expandable
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`impellers for catheter pumps which may be used for support of the left ventricle of a patient’s
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`heart. See Specification JJ 2, 14.
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`In an embodimentof the Applicant’s invention, achieving a
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`stored configuration is facilitated by providing multiple blade rows, rather than, for example, a
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`single long blade curving around the hub becausea single long blade, continuous blade can be
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`considerably more difficult to fold in towards the hub. See Specification JJ 27, 32, 78, 79.
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`Independent claim 10 more specifically reflects the problem and solution reflected in the
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`Applicant’s invention and nowrecites:
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`A catheter heart pump comprising:
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`PO4000USC8
`PATENT
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`an elongate catheter body having a proximal end, and a distal end
`configured to be advanced to a heart of a patient;
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`an expandable impeller configured to be disposed within the expandable
`sleeve between the distal inlet port and the proximal outlet port when in the
`expanded configuration, and the expandable impeller configured to turn on a shaft
`to generate a fluid flow from the distal inlet port to the proximal outlet port and
`the expandable impeller configured as an axial flow impeller including multiple
`rows of foldable impeller blades to ease a bending of the impeller blades in a
`stored position relative to an expandable impeller having a single long,
`continuous, spiral blade; and
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`a storage sleeve configured to house both the expandable sleeve and the
`expandable impeller therein;
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`wherein the impeller and the expandable sleeve are caused to expand
`whenurgedoutof the storage sleeve.
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`Shmitz-Rode teaches a deployable rotor 7 with a helix 8 of memory metal that minimally
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`consists one complete winding (360°) about an elastic band, and that may also consist of 1.5 or 2
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`complete turns (1.e., 540° or 720°) or a plurality offull windings of the helix. See Shmitz-Rode
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`at col. 2, lines 45-48. As depicted in Fig. 3 of Shmitz-Rode below, such a rotoris clearly seen to
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`include the type of single long, continuous, spiral blade that is contrasted with the Applicant’s
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`invention.
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`PO4000USC8
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`PATENT
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`Shmitz-Rode nowhere, however, acknowledges the problem presented by a single long,
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`continuous, spiral blade in the context of the Applicant’s invention, and therefore does not
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`disclose the solution recited in the form of multiple rows of foldable impeller blades.
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`Further, Shmitz-Rode does not disclose the feature recited concerning “wherein the axial
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`flow impeller and the expandable sleeve are caused to expand when urged out of the storage
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`sleeve.”
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`At col. 2, lines 16-18, Shmitz-Rode teaches that “Deploying is effected by withdrawing
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`the cover hose 5 on the fixed catheter 4 until the tip of the cover hose has exposed the tube end
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`3.” Such deployment via withdrawing of the cover hose does not correspond to the recited
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`feature that the axial flow impeller and the expandable sleeve are caused to expand when urged
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`out of the storage sleeve.
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`The plain and ordinary meaning of “withdraw” is “to remove or take away” (a synonym
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`PO4000USC8
`PATENT
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`verb definition 1.
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`In contrast, the plain and ordinary meaning of “urged” is “to push or force
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`along”.
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`See https:/Avwwcollinsdictionary.convus/dictionary/english/urge at
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`transitive verb,
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`definition 1. Therefore, in the context of Shmitz-Rode a withdrawing of the cover hose causes
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`the expansion ofthe axial flow impeller and the expandable sleeve to occur. This is precisely the
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`opposite of the expansion of the axial flow impeller and the expandable sleeve caused when
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`urged out of the storage sleeve as recited in claim 10. Claim 10 is therefore not anticipated by
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`Shmitz-Rode in this aspect.
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`Claim 13 is likewise not anticipated when considered in combination with claim 10.
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`Reconsideration and withdrawal of the anticipations rejections are accordingly requested.
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`Rejections under 35 U.S.C. § 103
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`The rejection of claims 1-5, 7-9, 11-12 and 14-18 as allegedly being unpatentable over
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`Shmitz-Rode in view of US Patent No. 5851174 to Jarvik is respectfully traversed.
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`Independent claim 1 nowrecites:
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`A catheter heart pump comprising:
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`an elongate catheter body having a proximal end, and a distal end
`configured to be advanced to a heart ventricle of a patient;
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`an expandable sleeve coupled to the distal end, the expandable sleeve
`having a stored configuration in which the expandable sleeve is advanced to the
`heart, and an expanded configuration, and further comprising a distal inlet port
`and a proximaloutlet port;
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`an expandable axial flow impeller disposed within the expandable sleeve
`between the distal inlet port and the proximal outlet port, and the expandable axial
`flow impeller configured to turn on a shaft when expanded to generate an axial
`fluid flow from the distal inlet port to the proximal outlet port without a single
`long, continuous, spiral blade that is difficult to fold into a storage state; and
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`PO4000USC8
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`a storage sleeve configured to house both the expandable sleeve and the
`expandable impeller therein while the expandable axial flow impeller is in the
`storage state.
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`It is conceded in the Office Action that Shmitz-Rode does not teach an axial flow
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`impeller without a single long, continuous, spiral blade. Jarvik is cited for teaching the same and
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`the Examiner considers claim 1 to be obvious. The Applicant disagrees.
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`The_single long, continuous, spiral blade of Shmitz-Rodeis a significant feature of the
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`disclosed invention of Shmitz-Rode. Oneof ordinary skill in the art following the teachings of
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`Shmitz-Rode with common sense and ordinary skill would therefore have had good reason not to
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`eliminate the helix 8 because, as taught in Shmitz-Rode, the helix 8 is designed to realize a
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`“radially compressibility” which is “acceptable for” a percutaneous procedure while otherwise
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`providing a “relatively large” pump diameter. See Shmitz-Rodeat col. 1, lines 36-39. There is
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`no apparent reason to believe from the teachings of Shmitz-Rodethat the radially compressibility
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`of the rotor including the helix 8 in any way was problematic or needed improvementin an
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`aspect of being difficult to fold into a storage state. One in the art and following the teachings of
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`Shmitz-Rode with common sense and ordinary skill accordingly would not have sought to
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`modify the device of Shmitz-Rode to improve its compressibility to a storage state when it was
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`otherwise deemed acceptable in this aspect.
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`Importantly, and entirely overlooked in the Office Action, the device of Jarvik is_not a
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`percutaneously insertable device. See Jarvik at col. 7, lines 54 to col. 8, line 8. Jarvik nowhere
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`describes an expandability or compressibility of any component in the implantable device and
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`accordingly there is no storage state in the device.
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`In these aspects the rejection as articulated is
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`a type of impermissible analysis in a vacuum that is devoid ofall context of the cited art and the
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`fundamental differences in the types of devices described in each reference. The teachings of
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`Jarvik are accordingly much less relevant to the teachings of Shmitz-Rode than apparently
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`supposed by the Office. The teachings of the cited reference clearly fail to acknowledge the
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`problem which claim 1 addresses insofar as the single long, continuous, spiral blade is
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`PO4000USC8
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`concerned (and of which Shmitz-Rode is one example), and when the cited art does not disclose
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`the problem addressed by the invention it cannot suggest the solution.
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`From this perspective,
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`the proposed modification of the Shmitz-Rode impeller to include a feature of an impeller which
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`is not expandable and which runs contrary to the teachings of Shmitz-Rode concerning helix
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`turns which are “minimally” 360° or more actually makeslittle sense. It is therefore not believed
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`that the cited art presents a prima facie case of obviousness of the claimed subject matter of
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`claim 1 andits associated dependent claims that further define and delineate its subject matter.
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`At least claims 2 and 3 are distinguishable over Shmitz-Rode and Jarvik for reasons apart
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`from claim 1. As discussed above, Shmitz-Rode describes an oppositely directed cause of
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`expandability vis-a-vis the Applicant’s invention which is not obvious on the present record.
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`Likewise, the device of Shmitz-Rode has an oppositely directed cause of compression relative to
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`the Applicant’s invention that is not obvious.
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`Independent claim 14 now recites:
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`A catheter heart pump comprising:
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`an elongate catheter body having a proximal end, and a distal end
`configured to be advancedto a heart ofa patient;
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`an expandable sleeve coupled to the distal end, the expandable sleeve
`having a stored configuration in which the expandable sleeve is advanced to the
`heart, and an expanded configuration, and further comprising a distal inlet port
`and a proximaloutlet port;
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`an expandable axial flow impeller configured to be disposed within the
`expandable sleeve between the distal inlet port and the proximal outlet port when
`in the expanded configuration,
`the expandable axial flow impeller including
`multiple rows of foldable impeller blades configured to turn on a shaft to generate
`a fluid flow from the distal inlet port to the proximal outlet port when expanded;
`and
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`a storage sleeve configured to house both the expandable sleeve and the
`expandable impeller therein.
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`11
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`PO4000USC8
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`As apparent from the discussion above, Shmitz-Rodefails to disclose multiple rows of
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`foldable blades while Jarvik discloses blades that are not foldable.
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`It is accordingly doubtful
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`whether the combination of features alluded to in the rejection would have even been attempted
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`following the teachings of the cited art. Assuming arguendo that such a combination was
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`actually made, it is far from clear whether the modification suggested in the Office Action,
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`would haveactually satisfied the claimed subject matter, and as such claim 14 andits associated
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`dependentclaims are not obvious.
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`Claims 15 and 16 recite parallel subject matter to some of the claims above and are not
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`obvious for at least similar reasons.
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`The rejection of claim 6 as allegedly being unpatentable over Shmitz-Rode in view of US
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`Patent No. 5851174 to Jarvik and US Patent No. 5,376,114 to Jarvik is respectfully traversed.
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`Jarvik ‘114 is not believed to cure the deficiencies of Shmitz-Rode and Jarvik ‘174 with respect
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`to the subject matter of claim 1 from which claim 6 depends. Claim 6 is therefore allowable
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`overthe cited art at least when considered in combination with claim 1.
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`Reconsideration and withdrawal of the obviousness rejections is accordingly requested.
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`Conclusion
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`Applicant respectfully requests reconsideration and allowance of all pending claims. In
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`the event that the Examiner may disagree that the pending claims are now allowable,
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`the
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`Applicant requests the courtesy of an interview prior to the next communication from the Office
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`to provide the Applicant an opportunity to proactively discuss possible resolution with the
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`Examinerto avoid any further delay in allowance of the application.
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`12
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`Applicant authorizes the Commissioner to charge any additional fees which may be due
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`in connection with this Amendment to Deposit Account No. 01-2384 in the name of Armstrong
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`Teasdale LLP.
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`P04000USC8
`PATENT
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`Respectfully submitted,
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`/Christopher M. Goff/
`Christopher M. Goff
`Reg. No. 41,785
`ARMSTRONG TEASDALE LLP
`7700 Forsyth Blvd, Suite 1800
`St. Louis, MO 63105
`(314) 621-5070
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`CMG/BTA
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