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 .
Drawings
The drawings are objected to because item “3” is present in the drawings but not the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 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 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 structure bearing would have been obvious to substitute.
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Regarding claim 2 the Scheckel Tuval Combination teaches the pump of claim 1 substantially as is claimed,
wherein Scheckel further discloses the bearing sleeve (41) is fixedly connected to the flexible drive shaft (2) ([0081]).
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
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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 07/07/25