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 .
Priority
The current application claims benefit of parent application PCT/IB2023/059141, filed on September 14th, 2022. Examiner acknowledges the applicant’s claim for priority.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 18th, 2024 and November 7th, 2024 is being considered by the examiner.
Status of Claims
In the response dated July 6th, 2026, no claims have been added or canceled. Claim 18 has been amended. Claims 1-18 are pending.
Response to Arguments
In response to the arguments put forward in the amendment, Examiner will address Applicant’s five arguments in the order they were presented.
Rejections under 35 U.S.C. 112
Regarding page 5, Applicant' s arguments have been considered and claim 18’s rejection under 35 U.S.C. 112(b) is withdrawn.
Rejections under 35 U.S.C. 102
Regarding argument 1, Applicant' s arguments have been considered but is not persuasive to the extent that it assorts that Tuval ‘986 discloses no bearing housing whatsoever, and that “there is no intermediate bearing housing structure that houses the bearing.” The claim term “bearing housing” is not specifically defined by Applicant and under the broadest reasonable interpretation (MPEP 2111), a bearing housing encompasses and structure that surrounds, receives, and retained a bearing. Tuval ‘986 expressly discloses this structure. Paragraph [0276] and Figure 5A disclose a distal-tip element 107, including axial-shaft-receiving tube 126, surrounding and retaining distal radial bearing 118. Distal-tip element 107 thus houses bearing 118 within the meaning of the claim.
Applicant arguments are persuasive only as to the narrower point that in the embodiment of Figs. 2A-2C, this bearing housing is disposed distally of frame 34, rather than being disposed at least partially within distal conical such that at least 50% of its length is within the frame, as claim 1 requires. The deficiency is accordingly one of the positions of a disclosed bearing housing, not the absence of a bearing housing. The positional difference is addressed under the new ground of rejection set forth below.
Regarding Argument 2, Applicant’s arguments have been considered but are not persuasive. As an initial matter, Applicant is correct that the bearing frame (61) arrangement appears in Figure 2D, of Tuval, not Figure 2E as inadvertently stated in the prior Office Action. Examiner notes that the nomenclature and functional language of a reference are not controlling of how an element may be mapped under the broadest reasonable interpretation, and that Tuval ‘986 elsewhere applies bearing-function language to the surrounding sleeve structures. Nevertheless, the new ground of rejection set forth below does not rely on bearing frame 61 as the claimed bearing housing.
Regarding Argument 3, Applicant’s arguments have been considered but are not persuasive. The prior Office Action did not map impeller housing 60 to the claimed bearing housing to the claimed frame, and the new ground of rejection set forth likewise does not rely on impeller housing 60.
Regarding Argument 4, Applicant’s arguments have been considered and are persuasive as applied to anticipation. MPEP 2131 states “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference”. The prior rejection relied upon distal conical portion 40 of the frame 34 embodiment together with bearing frames of the inflatable-housing embodiment (Fig. 2D). The rejection under 35 U.S.C. 102 of claims 1-18 is withdrawn. The Examiner notes, however, that Applicant’s characterization of the two configurations as “mutually exclusive” overstates the disclosure. Examiner’s reference did not rest on two configurations in Tuval’s description of [0240] that are mutually exclusive.
Regarding Argument 5, Applicant’s arguments have been considered and are persuasive as applied to anticipation. Paragraph [0235] describes coupling portion 31 and a portion defined by the frame itself, and coupling portion 31 is in any event located at the proximal end of the frame, whereas claim 1 requires the bearing housing to disposed partially within the distal conical portion.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US20200237986), referenced as Tuval ‘986, in view of Hildebrand et al. (US20200246527).
Figure 5 of Tuval is referenced below
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Regarding claim 1, Tuval ‘986 teaches an apparatus, comprising: a blood pump, comprising: an axial shaft configured for insertion into, and rotation within, a body of a subject; an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject; ([0010] “a ventricular assist device includes an impeller disposed upon an axial shaft, with a frame disposed around the impeller… the impeller is configured to pump blood from the left ventricle into the aorta by rotating”) a frame surrounding the impeller and comprising a distal conical portion; ([0228] “frame 34 is shaped such that the frame defines a proximal conical portion 36, a central cylindrical portion 38, and a distal conical portion 40” [0235]) a bearing adjacent to the axial shaft and configured to stabilize the axial shaft while the axial shaft rotates; and ([0274] “The radial bearing is configured to reduce radial motion of the impeller, by maintaining the axis of the impeller at a given radial position.” [0275] “axial shaft itself is radially stabilized via a proximal radial bearing 116 and a distal radial bearing 118”; [0277]) a bearing housing that houses the bearing, ([Figure 2C] distal conical portion (40) comprises the entirety of bearing frame (61) in [Figure 2D]; see also [0276] Typically, coupling portion 31 of frame 34 is coupled to proximal radial bearing 116, for example, via snap-fit coupling, and/or via welding.” Where a snap-fit coupling and/or welding disposes the housing entirely within the frame)
For the purposes of applying art, Figure 5 of Hildebrand is depicted below.
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Regarding claim 1, Tuval does not explicitly teach the bearing housing being disposed at least partly within the distal conical portion of the frame such that at least 50% of the length of the bearing housing is disposed within the frame.
Hildebrand and Tuval are in the same field of endeavor of percutaneous blood pumps. Hildebrand teaches the bearing housing (267 in annotated FIG. 5) being disposed at least partly within the distal conical portion (see annotated FIG. 5 above) of the frame (265 in annotated FIG. 5) such that at least 50% of the length of the bearing housing is disposed within the frame. ([0204] “FIG. 5 illustrates a working portion that is similar to the working portion shown in FIG. 1. Working portion 265 includes … drive shaft 278, which extends into distal bearing housing 272. There is a similar proximal bearing housing at the proximal end of the working portion.” Where the bearing housing is disposed completely within the expandable member [i.e., the frame]) Hildebrand’s device achieves a smaller delivery profile while maintaining sufficiently high flow rates, while creating a more deformable and flexible central region of the working portion, the exemplary benefits of which are described above ([0203]).
It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Tuval to explicitly configure its bearing housing to dispose the housed bearing completely within the portion of the frame, in the manner taught by Hildebrand, with a reasonable expectation of success. This would have created a smaller delivery profile to access cardiac regions while maintaining sufficiently high flow rates.
Regarding claim 2, Modified Tuval teaches all the limitations of claim 1. Tuval ‘986 also teaches a drive cable, wherein the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable. ([0311] “the rotational motion of the impeller (which is imparted via the axial shaft) … is transmitted to the axial shaft via the drive cable … FIG. 10C, which shows the connection between the distal end of the drive cable and the proximal end of the axial shaft).”)
Regarding claim 3, Modified Tuval teaches all the limitations of claim 1. Tuval ‘986 also teaches a drive cable, wherein the axial shaft is a distal portion of the drive cable. [0311]
Regarding claim 4, Modified Tuval teaches all of the limitations of claim 1. Hildebrand also teaches the bearing housing ([0204] “FIG. 5 illustrates … bearing housing … expandable member … extends almost the entire length of expandable member.” Where the bearing housing is disposed completely within the expandable member [i.e., the frame]) Tuval also teaches occupies at least 10% of a length of the distal conical portion of the frame. ([Fig. 5A] bearing housing (116) length occupies the entire length of the frame's coupling portion (31)). It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to modify the bearing of Tuval to explicitly the contain a bearing housing, in the manner taught by Hildebrand, with a reasonable expectation of success. This would have created a smaller delivery profile to access cardiac regions.
There is no indication that occupying at least 10% of a length of the distal conical portion establishes any different functional properties from this range and thus the range does not have any criticality to the claimed range. Where the general conditions of a claim are disclosed in the prior art, discovering the optimal workable ranges of a result-effective variable involves only routine skill in the art (MPEP 2144.05).
Regarding claim 5, Modified Tuval teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the bearing comprises a radial bearing configured to radially stabilize the axial shaft while the axial shaft rotates. ([0274] “As shown in FIG. 5C, a bearing assembly typically includes a radial bearing (indicated by ellipse 200) and a thrust bearing (indicated by circle 202) … The radial bearing is configured to … maintain the axis of the impeller at a given radial position”)
Regarding claim 6, Modified Tuval teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the bearing comprises a thrust bearing configured to axially stabilize the axial shaft while the axial shaft rotates. ([0274] “As shown in FIG. 5C, a bearing assembly typically includes a radial bearing (indicated by ellipse 200) and a thrust bearing (indicated by circle 202) … the purpose of a thrust bearing is to oppose such motion of the impeller and to maintain the axial position”)
Regarding claim 7, Modified Tuval teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the frame further comprises a cylindrical portion proximal to the distal conical portion, (Fig. 1C] “frame 34 is shaped such that the frame defines a proximal conical portion 36, a central cylindrical portion 38, and a distal conical portion 40.”) Hildebrand also teaches and wherein the bearing housing is disposed at least partly within the cylindrical portion. ([0204] “FIG. 5 illustrates … bearing housing … expandable member … extends almost the entire length of expandable member.” Where the bearing housing is disposed completely within the expandable member [i.e., the frame]) Hildebrand and Tuval are in the same field of endeavor of percutaneous blood pumps. It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Tuval to explicitly configure its bearing housing to dispose the housed bearing completely within the portion of the frame, in the manner taught by Hildebrand, with a reasonable expectation of success. This would have created a smaller delivery profile to access cardiac regions.
Regarding claim 8 and 9, Modified Tuval also teaches wherein the bearing housing is disposed entirely within the frame. ([0204] “FIG. 5 illustrates … bearing housing … expandable member … extends almost the entire length of expandable member.” Where the bearing housing is disposed completely within the expandable member [i.e., the frame])
Regarding claim 10, Modified Tuval teaches all of the limitations of claim 1. Tuval ‘986 also wherein the frame further comprises a proximal conical portion, ([0320]; [0228] “frame 34 is shaped such that the frame defines a proximal conical portion 36”) and wherein the blood pump further comprises: a proximal bearing adjacent to the axial shaft proximally to the distal bearing, and configured to stabilize the axial shaft while the axial shaft rotates; ([0320] “The axial shaft itself is radially stabilized via proximal radial bearing 116 and distal radial bearing 118. Proximal and distal ends of frame 34 are rigidly coupled to the proximal and distal bearings”). Hildebrand also teaches wherein the bearing is a distal bearing and the bearing housing is a distal bearing housing, and a proximal bearing housing that houses the proximal bearing and is disposed at least partly within the proximal conical portion of the frame. (see annotated FIG. 5 above and “FIG. 5 illustrates a working portion that is similar to the working portion shown in FIG. 1. Working portion 265 includes … drive shaft 278, which extends into distal bearing housing 272. There is a similar proximal bearing housing at the proximal end of the working portion.” In [0204]).
Regarding claims 11-14, Modified Tuval teaches all of the limitations of claim 10. Hildebrand also teaches wherein at least 50% of the length of the proximal bearing housing is disposed within the frame. ([0204] “FIG. 5 illustrates … bearing housing … expandable member … extends almost the entire length of expandable member.” Where the bearing housing is disposed completely within the expandable member [i.e., the frame]).
Regarding claim 15, Modified Tuval teaches all of the limitations of claim 14. Tuval ‘986 also teaches wherein the proximal bearing comprises a proximal radial bearing configured to radially stabilize the axial shaft while the axial shaft rotates. ([Fig. 5C proximal radial bearing (200) and [0274] “The radial bearing is configured to reduce radial motion of the impeller, by maintaining the axis of the impeller at a given radial position.”)
Regarding claim 16, Modified Tuval teaches all of the limitations of claim 14. Tuval ‘986 also teaches wherein the proximal bearing comprises a proximal thrust bearing configured to axially stabilize the axial shaft while the axial shaft rotates. ([0274] “in FIG. 5C, in response to the impeller pumping blood in the direction of arrow 204, the impeller gets pushed in the direction of arrow 206, and the thrust bearing opposes this motion.”)
Regarding claim 17, Modified Tuval teaches all of the limitations of claim 14. Tuval ‘986 also teaches wherein the frame further comprises a cylindrical portion between the proximal conical portion and the distal conical portion, ([0246] “helical elongate elements 52 extend from a proximal bushing (i.e., sleeve bearing) 64 of the impeller, such that the proximal ends of spring 54 and helical elongate elements 52 are disposed at a similar radial distance from the longitudinal axis of the impeller” and [Fig. 6B] where the bushing [comprising a bearing housing] is partially within the cylindrical portion). Hildebrand also teaches wherein the proximal bearing housing is disposed at least partly within the cylindrical portion. ([0204] “FIG. 5 illustrates … bearing housing … expandable member … extends almost the entire length of expandable member.” Where the bearing housing is disposed completely within the expandable member [i.e., the frame])
Regarding claim 18, Modified Tuval teaches all of the limitations of claim 14. Hildebrand also teaches a bearing housing. Tuval ‘986 also teaches wherein a distance between a proximal end of the proximal bearing housing and a distal end of the distal bearing housing is less than 10% greater than a length of the frame. ([Fig. 6F-G] and [0276] “Typically, coupling portion 31 of frame 34 is coupled to proximal radial bearing 116, for example, via snap-fit coupling, and/or via welding. Typically, at the distal end of frame 34 distal strut junctions 33 are placed into grooves defined by the outer surface of distal radial bearing 118” where the frame 34 being coupled adjacent to the proximal and distal ends of the bearings comprises the distance of bearing housings is less than 10% greater than the length of the frame). It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to modify the bearing of Tuval to explicitly the contain a bearing housing, in the manner taught by Hildebrand, with a reasonable expectation of success. This would have created a smaller delivery profile to access cardiac regions.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yuval et al. (WO2021198881) discloses a left-ventricular assist device that includes a pump-outlet tube and a mixed-flow impeller.
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
