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 .
Claim Status: Claims 1-12 are 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 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.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tuval et al. (US 2021/0069394A1).
Re Claim 1, Tuval discloses an apparatus, comprising:
a solid axial shaft having a shaft diameter that is less than 0.8 mm (fig. 4, para. [0466], an axial shaft 92 passes through the axis of impeller 50, para. [0508], the axial shaft and the cable each have outer diameters of more than 0.6 mm (e.g., more than 0.8 mm), and/or less than 1.2 mm (e.g., less than 1 mm), e.g., 0.6-1.2 mm, or 0.8-1 mm.);
an impeller configured for insertion into a left ventricle of a heart of a subject and coupled to the axial shaft (fig. 4, para. [0466], an axial shaft 92 passes through the axis of impeller 50; para. [0473], impeller 50 is inserted into the left ventricle transcatheterally); and
a hollow drive cable coupled, at a distal end of the drive cable, to the axial shaft, and configured to rotate so as to rotate the axial shaft, thereby causing the impeller to pump blood of the subject from the left ventricle (para. [0110], a drive cable configured to extend from outside a body of the subject to the axial shaft, the drive cable being configured to impart rotational motion from the motor to the impeller by rotating, at least a portion of the drive cable including a plurality of wires disposed in a coiled configuration that is such that, in response to the drive cable rotating in the given direction of rotation, the plurality of wires disposed in the coiled configuration at least partially unwind, such that the portion of the drive cable shortens axially.).
Re Claim 3, Tuval discloses that an outer diameter of the drive cable is greater than 1 mm (para. [0508], For some applications, the axial shaft and the cable each have outer diameters of more than 0.6 mm (e.g., more than 0.8 mm), and/or less than 1.2 mm (e.g., less than 1 mm), e.g., 0.6-1.2 mm, or 0.8-1 mm.).
Re Claim 4, Tuval discloses that the drive cable comprises a plurality of coiled wires (para. [0110], a drive cable configured to extend from outside a body of the subject to the axial shaft, the drive cable being configured to impart rotational motion from the motor to the impeller by rotating, at least a portion of the drive cable including a plurality of wires disposed in a coiled configuration that is such that, in response to the drive cable rotating in the given direction of rotation, the plurality of wires disposed in the coiled configuration at least partially unwind, such that the portion of the drive cable shortens axially).
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 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US 2021/0069394A1).
Re Claim 2, Tuval discloses the claimed invention substantially as set forth in claim 1.
Tuval further discloses that the axial shaft 92 and the cable 130 each have outer diameters of more than 0.6 mm (e.g., more than 0.8 mm), and/or less than 1.2 mm (e.g., less than 1 mm), e.g., 0.6-1.2 mm, or 0.8-1 mm. For some applications, the diameter of lumen 132, defined by the shaft and the cable, is more than 0.3 mm (e.g., more than 0.4 mm), and/or less than 0.7 mm (e.g., less than 0.6 mm), e.g., 0.3-0.7 mm, or 0.4-0.6 mm (para. [0508], fig. 10C).
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Tuval is silent regarding wherein the shaft diameter is less than 0.4 mm.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Tuval, by configuring the shaft diameter to be less than 0.4 mm, since it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. MPEP 2144.05 I.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US 2021/0069394A1) in view of Muller et al. (US 2015/0290372 A1).
Re Claim 5, Tuval discloses a radial bearing surrounding the axial shaft and configured to radially stabilize the axial shaft while the axial shaft rotates (fig. 4, fig. 5A, para. [0466], The axial shaft itself is radially stabilized via a proximal radial bearing 116 and a distal radial bearing 118, defined by frame 34); and
the drive cable being coupled to the axial shaft within the radial bearing and a shoulder (fig. 26, para. [0574], drive cable 130, a shoulder 302, para. [0480], axial shaft 92, proximal bearing 116).
Tuval is silent regarding a bearing housing that houses the radial bearing.
Muller discloses a catheter pump (fig. 18B) and teaches a bearing housing that houses the radial bearing (para. [0175], FIG. 25 is a side cross-sectional view of the catheter assembly 500 of FIG. 24. As with the catheter assembly of FIG. 10, the catheter assembly 500 of FIG. 24 can include a bearing housing 546 (which may be similar to the bearing housing 146A of FIG. 10), a thrust bearing 547 (which may be similar to the thrust bearing 204 of FIG. 10), a thrust bearing brace 548 (which may be similar to the thrust bearing brace 208 of FIG. 10), a coupler 549 (which may be similar to the coupler 200 of FIG. 10), and an impeller shaft 538 attached to the impeller 512. As shown in FIG. 25, the elongate connector 541 can pass along the length of the catheter assembly 500, and the sensor tip 542 can emerge at the window 537 near the outlets 522.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Tuval, by adding a bearing housing that houses the radial bearing and configuring the drive cable to be coupled to the axial shaft within the bearing housing, as taught by Muller, for the purpose of providing support for radial bearing on a shaft to provide stability and load distribution.
Allowable Subject Matter
Claims 6-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 6 and claims dependent thereon in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with other limitations of the claim, an apparatus comprising: a proximal sleeve, which is less flexible than the axial shaft, disposed around the axial shaft such that the proximal sleeve contacts the proximal radial bearing as the axial shaft rotates; and a distal sleeve, which is less flexible than the axial shaft, disposed around the axial shaft distally from the proximal sleeve such that the distal sleeve contacts the distal radial bearing as the axial shaft rotates, wherein a ratio between a length of the axial shaft and a combined length of the proximal sleeve and distal sleeve is between 2:1 and 6:1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, September 12, 2026
Examiner, Art Unit 3792
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