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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted 9/16/2022, 5/28/2024, and 02/06/2025 are being considered by the examiner.
Response to Arguments
In regards to Applicant’s response filed 04/17/2025, the amended Drawings and Specification have overcome the objections made in the Non-Final Office Action filed 12/18/2024. The objections are hereby withdrawn.
Applicant's arguments filed 04/17/2025 have been fully considered but they are not persuasive.
Rejections under 35 USC 102
On page 12 of Applicant’s Remarks, Applicant argues that Earles (US 20220080183 A1) fails to disclose a pump device with primary and secondary flow paths wherein, “the secondary blood flow outlet connects the at least one secondary blood flow passage to the primary blood flow passage at a location axially between the upstream and downstream ends of the primary impeller. Applicant recites, "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." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). Examiner respectfully disagrees and offers the following clarification:
As previously stated in the Non-Final Office Action files 12/18/2024, the primary blood flow passage (3A) and the secondary blood flow passage (3B) are connected via the secondary blood flow outlet (25), taught by Earle in paragraph [0121], “flow from both paths can be directed from the inlet 27 to the outlet 25.” Please see annotated Fig. 1B below illustrating the blood flow outlet 25 location axially between the upstream and downstream ends of the primary impeller 6.
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Please see annotated Fig. 7 below illustrating a cross-sectional view of the primary and secondary blood flow pathways connecting via outlet 25, location axially between the upstream and downstream ends of impeller 6.
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With this in consideration, the rejection of claims 1-9, 12-16, and 20 under 35 USC 102 is maintained.
Rejections under 35 USC 103
On page 13 of Applicant’s Remarks, Applicant argues that the combination of Earles (US 20220080183 A1) and Antaki (US 20200368415 A1) is not obvious since neither reference discloses a secondary blood flow outlet that connects the at least one secondary blood flow passage to the primary blood flow passage at a location axially between the upstream and downstream ends of the primary impeller.
As cited above by the Examiner, the blood pump as taught by Earle discloses a secondary blood flow outlet (25) that connects the at least one secondary blood flow passage (3B) to the primary blood flow passage (3A) at a location axially between the upstream and downstream ends of the primary impeller (6). Please see annotated Fig. 1B above. With this in consideration, the rejection of claims 10 and 11 under 35 USC 103 is maintained.
On page 14 of Applicant’s Remarks, Applicant argues that in regards to claims 17-19 Earles fails to describe the claimed secondary blood flow path that joins the primary blood flow path at an intermediate position within the impeller.
As cited above by the Examiner, the blood pump as taught by Earle discloses a secondary blood flow outlet (25) that connects the at least one secondary blood flow passage (3B) to the primary blood flow passage (3A) at a location axially between the upstream and downstream ends of the primary impeller (6). Please see annotated Fig. 1B above. With this in consideration, the rejection of claims 17-19 under 35 USC 103 is maintained.
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.
(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.
Claim(s) 1-9, 12-16, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Earles et al (US 20220080183).
Regarding claim 1, Earles teaches an intravascular blood pump (see pump 2, Fig. 6)-
comprising: a pumping device comprising:
-a pump casing (see pump housing 35, Fig. 1C) having a primary blood flow inlet (first fluid port(s) 27, [0073], Fig. 1C) and a primary blood flow outlet (second fluid port(s) 25, [0073], Fig. 1C) which are hydraulically connected by a primary blood flow passage (see primary or first flow pathway 3AFig. 9A-9B)
-a primary impeller having an upstream end and a downstream end (see first impeller 6, Fig. 7) and being configured to convey a primary blood flow from the primary blood flow inlet to the primary blood flow outlet along the primary blood flow passage (see primary or first flow pathway 3A, [0079], Fig. 7)
-a drive unit configured to rotate the primary impeller about an axis of rotation (see drive unit 9, Fig. 1C)
-an impeller bearing supporting the upstream end of the primary impeller (see sleeve bearing 15 can comprise an inner support structure including an inner sleeve 37, [0078], Fig. 2A)
-a central opening (see impeller shaft 5, secondary flow pathway 3B, Fig. 2A) axially extending through the impeller bearing (see longitudinal axis L, Fig. 2A); and
-at least one secondary blood flow passage in the primary impeller (see secondary flow pathway 3B, Fig. 2A), the at least one secondary blood flow passage having a secondary blood flow inlet (upstream opening of 3B, Fig. 2A) in axial alignment with the central opening of the impeller bearing (see longitudinal axis L, Fig. 2A) and each of the at least one secondary blood flow passage having a secondary blood flow outlet (see secondary flow path 3B, outlet 25, Fig. 9A-9B;) wherein the at least one secondary blood flow passage is configured to convey a secondary blood flow from the secondary blood flow inlet to the secondary blood flow outlet (see draws fluid through the secondary flow path 3B, e.g., a lumen or flow tube of the impeller shaft 5, [0121]), and wherein the secondary blood flow outlet (see outlet 25, Fig. 9A-9B) connects the at least one secondary blood flow passage to the primary blood flow passage (see flow from both flow paths can be directed from the inlet 27 to the outlet 25, [0121]) at a location axially between the upstream and downstream ends of the primary impeller (see outlet 25, Fig. 1B).
Regarding claim 2, Earles teaches the intravascular blood pump according to claim 1 wherein the central opening (see upstream opening of 3B, Fig. 2A) defines an outer impeller bearing surface of the impeller bearing (see inner sleeve 37 can have a bearing interface surface 41 [0080], Fig. 2C), by which the primary impeller is rotatably supported (see the impeller shaft 5 is rotated about the axis of rotation (aligned with the longitudinal axis L) [0081]; see sleeve bearing 15 can comprise an inner support structure including an inner sleeve 37, [0078], fig 2A).
Regarding claim 3, Earles teaches the intravascular blood pump according to claim 2 wherein the primary blood flow inlet is separated from the secondary blood flow inlet by a non-rotating inflow separator (see flow tube of the impeller shaft 5 of the pump rotor can fit inside a fixed (non-rotating) sleeve bearing 15, [0117]), the inflow separator forming the outer impeller bearing surface of the impeller bearing (see sleeve bearing 15 can comprise an inner support structure including an inner sleeve 37, [0078], Fig. 2A).
Regarding claim 4, Earles teaches the intravascular blood pump according to claim 3 wherein the inflow separator comprises an impeller bearing ring as a separate component forming the outer impeller bearing surface of the impeller bearing (see the inner sleeve 37 can have a bearing interface surface 41 extending between a proximal edge 37B and a distal edge 37A, [0080], Fig. 2C).
Regarding claim 5, Earles teaches the intravascular blood pump according to claim 3 wherein the inflow separator (37) is supported by at least one and preferably three struts (39) extending across the primary blood flow inlet (3A). See annotated figure below.
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Regarding claim 6, Earles teaches the intravascular blood pump according to claim 5 wherein the at least one strut (39) connects the inflow separator (37) to the pump casing (16). See annotated figure above.
Regarding claims 7 and 8, Earles teaches the intravascular blood pump according to claim 3 wherein the inflow separator comprises at least one cut-out at a downstream end of the inflow separator (as in claim 7) and wherein the at least one cut-out is in the outer impeller bearing surface (as in claim 8) (see in the exposed axial regions 42A, 42B, the bearing interface surface 41 is disposed about only a portion of a perimeter (e.g., circumference) of the impeller shaft, [0081], Fig. 2E).
Regarding claim 9, Earles teaches the intravascular blood pump according to claim 2 wherein one or more of the at least one secondary blood flow passage defines an edge moving over the outer impeller bearing surface upon rotation of the primary impeller so as to clean the outer impeller bearing surface (see bearing wash channel (secondary flow path) 3B, Fig. 9B).
Regarding claim 12, Earles teaches the intravascular blood pump according to claim 1 wherein a center of area of the primary blood flow inlet is arranged in the separated secondary blood flow inlet (see first flow pathway 3A and secondary flow pathway 3B, Fig. 2A).
Regarding claim 13, Earles teaches the intravascular blood pump according to claim 1 wherein one secondary blood flow inlet of the at least one secondary blood flow passage (3B) is arranged at a position of the axis of rotation (L). See annotated figure below.
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Regarding claim 14, Earles teaches the intravascular blood pump according to claim 1 wherein a secondary channel intake forming part of the at least one secondary blood flow passage is arranged upstream of a primary channel intake forming part of a primary impeller channel in the primary blood flow passage. See annotated figure below.
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Regarding claim 15, Earles teaches the intravascular blood pump according to claim 1 wherein the primary impeller comprises at least one blade (40) which has a primary pitch at the upstream end of the primary impeller and wherein the at least one secondary blood flow passage has a secondary pitch, the secondary pitch being approximately or exactly the same as the primary pitch. See annotated figure below.
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Regarding claim 16, Earles teaches the intravascular blood pump according to claim 1 wherein an exactly one of the at least one secondary blood flow passage has an upstream end (3B) arranged at a position of the axis of rotation (L). See annotated figure below.
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Regarding claim 20, Earles teaches the intravascular blood pump according to claim 1 wherein the primary impeller comprises an inlay in which the at least one secondary blood flow passage is formed (see second flow pathway 3B along a lumen of the impeller shaft 5, [0079]; Fig. 2A).
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.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Earles in view of Antaki (US 20200368415).
Earles teaches the intravascular blood pump according to claim 1. Earles does not teach wherein the impeller bearing is a sliding bearing or a blood purged sliding bearing.
Regarding claim 10, Antaki teaches the impeller bearing being a sliding bearing (see mechanical bearing 200 (also called a sliding bearing, Antaki [0051]).
Regarding claim 11, Antaki teaches the impeller bearing being a blood purged sliding bearing (see sliding bearing, is configured for immersion in blood during operation of the blood pump, Antaki [0013]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intravascular blood pump of Earles by adding the blood purged sliding bearing of Antaki. One of ordinary skill in the art would have been motivated to make this modification in order to minimize thrombus formation in the blood pump by promoting washing near the mechanical bearing (Antaki, [0015]). The art of Earles and Antaki are analogous because they both pertain to blood pumps.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Earles.
Regarding claims 17-19, Earles teaches the intravascular blood pump according to claim 1.
Earles is silent to pump configurations comprising exactly two secondary blood flow passages (as in claim 19), or at least two secondary blood flow passages arranged asymmetrically (as in claim 17) or opposite to each other (as in claim 18) in regard to the axis of rotation.
However, regarding claim 19, the differences between the claimed invention and the device of the prior art is the mere duplication of parts which would have been obvious to one of ordinary skill and has no patentable significance as no new and unexpected result is produced. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). Please see MPEP §2144.04.
Regarding claims 17 and 18, as illustrated above in relation to claim 19, the differences between the claimed invention and the device of the prior art is the mere duplication of parts which would have been obvious to one of ordinary skill and has no patentable significance as no new and unexpected result is produced. It would have been obvious to one of ordinary skill in the art that in a pump configuration comprising at least two secondary blood flow passages an orientation of the secondary blood flow passages must be chosen. In this scenario it would be obvious to try both asymmetrical and symmetrical (opposite) orientations as there are only a finite number of identifiable, predictable solutions, with a reasonable expectation of success. The orientation of additional secondary flow passages has no patentable significance as no new and unexpected result is produced. Please see MPEP §2143.01.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schuelke et al (US 20210379355) teaches an impeller housing for an implantable, vascular support system.
Alexander et al (US 11524153) teaches a mechanical circulatory support device with an axial flow turbomachine optimized for heart failure and cardio-renal syndrome by implantation in the descending aorta.
Siess et al (US 20180050140) teaches a blood pump utilizing an impeller and a wash out channel.
Taskin et al (US 9717832) teaches an axial flow rotor with downstream bearing wash flow.
Siess (US 20090118567) teaches a purge-free miniature rotary pump.
Bozeman, Jr. et al. (US 5527159) teaches a rotary blood pump.
Stotz et al (US 20220241580) teaches a sealed micropump including an integrated motr and at least one impeller.
Stotz et al (US 2022008714) teaches a bearing device for a heart support system and a method for rinsing a space in a bearing device for a heart support system.
Kanz (US 20210170081) teaches a percutaneous blood pump system and related method.
Hildebrand et al (US 20200246527) teaches an intravascular blood pump and related method of use.
Farago et al (US 20200121835) teaches a blood pump shaft bearing configured with a rotating impeller.
Higgins et al (US 20200030507) teaches an intravascular pump with centrifugal force-driven expansion of impeller blades and/or expandable and collapsible impeller housing.
Jarvik (US 20190175804) teaches a single inflow double suction centrifugal blood pump.
Lin et al (US 20150361897) teaches a centrifugal blood pump impeller and flow path.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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