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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 18 recites the broad limitation "greater than a length of the frame" and the claim also recites “less than 10%” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The examiner will interpret claim 18 to include distances between bearings to comprise between 0-110% of the length of the frame. Appropriate correction for a definite range is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (US20200237986 referenced as Tuval ‘986).
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”) 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.”) a bearing housing that houses the bearing, 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. ([Figure 2C] distal conical portion (40) comprises the entirety of bearing frame (61) in [Figure 2E]; 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)
Regarding claim 2, Tuval ‘986 teaches all of 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, Tuval ‘986 teaches all of 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, Tuval ‘986 teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the bearing housing occupies at least 10% of a length of the distal conical portion of the frame. ([Figure 2C] distal conical portion (40) comprises the entirety of bearing frame (61) in [Figure 2E] 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)
Regarding claim 5, Tuval ‘986 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, Tuval ‘986 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, Tuval ‘986 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.”) and wherein the bearing housing is disposed at least partly within the cylindrical portion. ([0277] “distal bushing 58 of the impeller is coupled to the shaft via coupling element 65” and [Fig. 5A below] the bushing and it’s housing are within the cylindrical portion)
PNG
media_image1.png
266
156
media_image1.png
Greyscale
Regarding claim 8, Tuval ‘986 teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein at least 80% of the length of the bearing housing is disposed within the frame. ([Fig. 5A] bearing housing (116) length occupies the entire length of the frame’s coupling portion (31); 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)
Regarding claim 9, Tuval ‘986 teaches all of the limitations of claim 8. Tuval ‘986 also teaches wherein the bearing housing is disposed entirely within the frame. (see [Fig. 5A] and [0276])
Regarding claim 10, Tuval ‘986 teaches all of the limitations of claim 1. Tuval ‘986 also teaches wherein the bearing is a distal bearing and the bearing housing is a distal bearing housing, wherein the frame further comprises a proximal conical portion, ([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; and a proximal bearing housing that houses the proximal bearing and is disposed at least partly within the proximal conical portion of the frame. ([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”)
Regarding claim 11, Tuval ‘986 teaches all of the limitations of claim 10. Tuval ‘986 also teaches wherein at least 10% of a length of the proximal bearing housing is disposed within the frame. (see [Fig. 5A] and [0276])
Regarding claim 12, Tuval ‘986 teaches all of the limitations of claim 11. Tuval ‘986 also teaches wherein at least 50% of the length of the proximal bearing housing is disposed within the frame. (see [Fig. 5A] and [0276])
Regarding claim 13, Tuval ‘986 teaches all of the limitations of claim 12. Tuval ‘986 also teaches wherein at least 80% of the length of the proximal bearing housing is disposed within the frame. (see [Fig. 5A] and [0276])
Regarding claim 14, Tuval ‘986 teaches all of the limitations of claim 13. Tuval ‘986 also teaches wherein the proximal bearing housing is disposed entirely within the frame. (see [Fig. 5A] and [0276])
Regarding claim 15, Tuval ‘986 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, Tuval ‘986 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, Tuval ‘986 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, and wherein the proximal bearing housing is disposed at least partly within the cylindrical 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)
Regarding claim 18, Tuval ‘986 teaches all of the limitations of claim 14. 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)
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ismail et al. (WO2017196271A1) discloses a system containing radial and thrust bearings for a cardiac pump.
Hildebrand et al. (Pat.12220570) discloses a blood pump containing impeller bearings, including thrust and radial bearings. These bearings stabilize the axial forces from the shaft that rotates the impeller.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT ANTHONY SKROBARCZYK whose telephone number is (571)272-3301. The examiner can normally be reached Monday thru Friday 7:30AM -5PM CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.A.S/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792