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 .
Response to Arguments
Applicant's arguments filed 12/16/25 have been fully considered but they are not persuasive.
On pages 7-11 regarding prior art rejections Applicant argues the Examiner has not “sufficiently established that the structure identified in Modified-FIG. 5A comprises a sleeve bearing that ‘forms a radial bearing of the proximal bearing together with the outer bearing ring’” as the instant application requires because the Combination would not have a sleeve that is able to rotate within the ring. Applicant argues the Examiner doesn’t identify a proximal bearing that comprises both structures in which the sleeve rotates.
The Examiner respectfully points out that the rejection of record is based on Scheckel, who already teaches a bearing ring and outer bearing ring, and already teaches that the outer bearing ring and bearing sleeve are mobile with respect to the inner parts. There is no reason one of ordinary skill would adjust the function of the outer bearing ring 40 of Scheckel as Applicant is suggesting, to have it suddenly not function as a bearing.
On page 12 Applicant argues that if Tuval’s sleeve were to be substituted into Scheckel, it would not rotate within a bearing ring as the claim requires.
The Examiner respectfully disagrees, noting the Applicant appears to be arguing that the person of ordinary skill would change the function of the proximal bearing 44 of Scheckel, when this is not suggested by the rejection of record, and there is no reason presented by the Applicant that would require this to happen.
On page 12, Applicant argues further that there would not be predictable results to combine the radial bearing of Tuval with the axial bearing of Scheckel since neither reference “suggest a dual function bearing” and since there is a gap between the distal surface of the proximal portion 30a and proximal surface of the outer bearing ring 32 meaning results would not be predictable.
The Examiner respectfully notes no requirement in the claims for a “dual function bearing”, making this unpersuasive. Further, the Examiner notes no evidence in the record that suggests the presence (or absence) of a gap as is argued, and further notes no evidence in the record to suggest how this would or would not affect function to make something non-predictable.
On pages 15-16 regarding prior art rejections to claim 14, Applicant argues Dick describes a reduced diameter of the rotary drive shaft to improve lateral flexibility, whereas the Applicant’s reduced diameter shaft is done for a different purpose. Applicant concludes Dick does not teach the claimed invention.
The Examiner respectfully points out the claimed invention does not require a shaft of reduced diameter to be for any particular purpose, it only states the distal portion of the bearing sleeve is “arranged” at that section of reduced diameter. This is accordingly unpersuasive.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-6, 8-9, 11-12, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel et al. (US 20160256620 A1) hereinafter known as Scheckel in view of Tuval et al. (US 20190209758 A1) hereinafter known as Tuval.
Regarding claim 1 Scheckel discloses an intravascular blood pump (Figure 1; [0001]) comprising:
a catheter (1),
a housing (11) in which a rotor is housed (20; [0070]), the housing being attached to a distal end of the catheter (Figure 2; [0070]),
a flexible drive shaft (2; abstract) extending through the catheter and connected to the rotor (Figures 2, 10), the shaft (2) being rotatably supported in a proximal bearing (44) located proximally of the rotor (Figures 2, 9);
wherein the proximal bearing (44) comprises a bearing sleeve (41) and an outer bearing ring (40),
wherein the bearing sleeve (41) is fixedly connected to the flexible drive shaft (2) ([0081]),
wherein the sleeve comprises a proximal portion (41) located proximally of the outer bearing ring (Figure 9), the proximal portion (41) forming an axial bearing of the proximal bearing together with a proximal surface of the outer bearing ring (Figure 9 shows the proximal surface 45 of the outer bearing ring 40; [0081]) and
but is silent with regards to the sleeve comprising a distal portion extending from the proximal portion of the sleeve and distally into the outer bearing ring, so the distal portion forms a radial bearing of the proximal bearing with the outer ring.
However, regarding claim 1 Tuval teaches a pump in which a sleeve bearing (Figure 5a item 116) includes a first portion and a second portion (Annotated Figure 5a), the second portion extending from the first portion into an outer ring bearing (Annotated Figure 5a), so the second portion and outer ring form a radial bearing of the sleeve bearing (Annotated Figure 5a; [0483] bearing 116 is a radial bearing). Scheckel and Tuval are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of Scheckel so the bearing sleeve 41 includes a first and second portion (e.g. a proximal portion, as well as a distal portion), the second portion extending through the outer bearing ring 40 to form a radial bearing as is taught by Tuval since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the substitution of any shape bearing sleeve (including one with a proximal and a distal portion) would have been obvious to substitute.
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Regarding claim 3 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses the outer bearing ring (40) is located inside a distal end region of the catheter (Figure 9 shows the ring 40 located inside the sheath 7 of the catheter 1).
Regarding claim 8 the Scheckel Tuval Combination teaches the pump of claim 3 substantially as is claimed,
wherein Scheckel further discloses the proximal end region of the housing (11) contains one or more radial through-holes (see Figure 9 which shows openings within scaffolding of the housing 11).
Regarding claim 4 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses a restriction member (42) is capable of limiting axial movement of the bearing sleeve (41) relative to the outer bearing ring (40) is located proximally of the sleeve (41) inside the catheter (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Scheckel discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example Figure 9 which shows how the physical location of the restriction member 42 would inherently prevent axial movement of anything thereadjacent.).
Regarding claim 5 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses the flexible drive shaft (2) is at least partially filled with a sealant (Figures 6, 9 item 30; the reinforcement is considered a sealant (defined by Merriam-Webster as “a sealing agent”, wherein “seal” is defined as “something that secures (such as a wax seal on a document)”. Since the reinforcement 30 secures inside the drive shaft, it is considered a sealant)).
Regarding claim 6 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses the sleeve (41) or outer bearing ring (40) comprise ceramics or metals ([0084], [0042]).
Regarding claim 9 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses the flexible drive shaft (2) contains a reinforcement element (30) extending longitudinally within a central lumen of the drive shaft (Figures 6, 9).
Regarding claim 11 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the bearing sleeve 41 comprising a portion extending distally of the outer bearing ring (40), with the rotor being mounted thereon.
However, regarding claim 11 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of Scheckel to have the rotor mounted on a distal part of a bearing sleeve since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by the Combination.
Regarding claim 12 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the distance between the rotor and outer bearing ring.
However, regarding claim 12 it would have been obvious to one of ordinary skill at the time the invention was filed to modify the pump of the Combination to have the rotor and outer bearing ring located any distance from one another since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A). Notably, the distance between the two parts would be customizable or optimizable based on the patient and intended location being treated.
Regarding claim 15 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses the housing (11) is radially expandable ([0070]), and wherein the rotor is radially expandable ([0027]).
Claim 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel and Tuval as is applied above in view of Spanier et al. (US 20150051436 A1) hereinafter known as Spanier.
Regarding claim 7 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the bearing sleeve (41) or outer bearing ring (40) comprising a coating.
However, regarding claim 7 Spanier teaches that bearings elements of a pump can include a coating ([0021]). Scheckel and Spanier are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of the Scheckel Tuval Combination so that either the bearing sleeve (41) or outer bearing ring (40) of the Combination included a coating as is taught by Spanier in order to optimize the bearing surfaces to be especially wear-resistant and low-friction ([0021]).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel and Tuval as is applied above, further in view of Kirchhoff et al. (EP 3542837 A1) hereinafter known as Kirchhoff.
Regarding claim 10 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the size of the radial bearing gap between the bearing ring (40) and sleeve (41).
However, regarding claim 10 Kirchhoff teaches that a circumferential bearing gap between two bearing elements of a pump can be 2µm ([0025]). Scheckel and Kirchhoff are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the size of the bearing gap between the ring 40 and sleeve 41 of Scheckel as is taught by Kirchhoff since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would find it obvious to consider a gap of any amount to see if it achieves the intended bearing features.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel and Tuval as is applied above, further in view of Kerkhoffs et al. (EP 3542836 A1) hereinafter known as Kerkhoffs.
Regarding claim 13 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the pump including a purge fluid supply line.
However, regarding claim 13 Kerkhoffs teaches a pump which include a purge fluid supply line (15) arranged to supply purge fluid that is capable of flowing through a gap defined by the radial bearing (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the structure of the Scheckel Tuval Kerkhoffs Combination was considered capable of performing the cited intended use, since the use of the purging line 15 of Kerkhoffs would inherently allow the fluid to flow through any gap defined by any bearing of the Combination ([0029]). Scheckel and Kerkhoffs are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of the Scheckel Tuval Combination so that there is a purge fluid supply line as is taught by Kerkhoffs in order to allow cooling portions of the device and/or wash debris from portions of the device.
Claim 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel and Tuval as is applied above, further in view of Dick et al. (US 20090018393 A1) hereinafter known as Dick.
Regarding claim 14 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the drive shaft (2) having a section of reduced diameter.
However, regarding claim 14 Dick teaches a drive shaft for a medical device that has a section of reduced diameter ([0057]). Scheckel and Dick are involved in the same field of endeavor, namely blood pumps. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the pump of the Scheckel Tuval Combination to include an area of reduced diameter as is taught by Dick in order to ensure the lateral flexibility of the shaft at both the proximal and distal ends of the shaft are suitable for manipulation by the endovascular cardiologist and through the vasculature, respectively. Further, regarding claim 14, the Combination further renders it obvious for the distal portion of the sleeve to be arranged at the section of reduced diameter, since this part of the pump would be extending through the vasculature and requires more lateral flexibility than the areas at the proximal end.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 07/10/26
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