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 10/16/25 have been fully considered but they are not persuasive.
On pages 5-6 Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Claim Objections
Claims 19 are objected to because of the following informalities:
Claim 19 is objected to for claiming “an end of the coil winding disposed around each of the posts extend to the space” when it appears this is grammatically incorrect.
Appropriate correction is required.
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, 4, 7-8, 15, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seiss et al. (WO 2017162619 A1) hereinafter known as Seiss in view of Ozaki et al. (JP 2010136862 A) hereinafter known as Ozaki.
Regarding claim 1 Seiss discloses an intravascular blood pump (1) for percutaneous insertion into a patient’s blood vessel (this is stated as an “intended use” (see the explanation above). See also [0001]) comprising:
a pump casing (2) having a blood flow inlet (21) and outlet (22);
an impeller arranged in the pump casing (3) configured to be rotatable about an axis of rotation (this is stated as a “functional limitation” (see the explanation above). See also the Abstract) and having blades (31) configured to convey blood from the inlet to the outlet (this is also stated as a “functional limitation” (see the explanation above). See also the Abstract);
a drive unit (4) for rotating the impeller (this is also stated as a “functional limitation” (see the explanation above). See also the Abstract) which comprises a plurality of posts arranged about the axis of rotation (41) and a back plate (50) connecting rear ends of the posts (Figure 2), wherein each of the rear ends of the posts has a rear end surface (Figures 1-2) and a spacer separating the posts from one another (42, collectively, for example as is seen in Figure 5), the spacer including a through hole in a center thereof (54), and distancing spokes between the plurality of openings ([0015] the “spokes” are understood to be the insulating material between the head portions 42); and
a coil winding disposed around each of the posts (47) which are configured to create a rotating magnetic field (this is also stated as a “functional limitation” (see the explanation above). See also the Abstract),
wherein the impeller comprises a magnetic structure ([0005]) arranged to interact with the rotating magnetic field to cause the impeller to rotate (this is also stated as a “functional limitation” (see the explanation above). See also [0005]), and
wherein the back plate comprises a through hole (51) in which at least one of the posts is inserted ([0040]).
As regards the “plurality of openings for each of the plurality of posts”, Seiss is silent. While Seiss is silent with regards to how the head portions 42 are connected to the shaft portions 41 of the posts 40, the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the posts 40 of Seiss so that they are separate. See MPEP 2144.04(V)(C). This person of ordinary skill would have also found it obvious to connect the two parts of the posts 41, 42 via any known means. Since Seiss teaches how connections between posts 41 and a back plate 50 include a plurality of openings within the back plate 50, the person of ordinary skill would have found it obvious to modify the connection between the shaft 41 and head 42 of the posts 40 so that the heads 42 of the posts 40 include openings for each of the plurality of posts, as a known mechanism to connect two parts together. 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). Any known mechanism of connection would have been obvious to try.
As regards the back plate including a “first layer” and “second layer” that closes one end of the opening to accommodate the rear end surface of one of the posts, the Examiner refers Applicant to [0040] which states that although the “apertures 51 are shown as extending completely through the back plate 50 in the cross-sectional view of Fig. 9c”, but they can alternatively “extend into the back plate 50 only up to a certain depth rather than completely through the back plate 50.” In this way, the Examiner understands the “first layer” of the back plate to be that part with the apertures 51, and is delineated at the location where the apertures stop extending through the plate 50 at “a certain depth”. The apertures end at this “depth” to form a closed end where the aperture fails to continue through the plate 50. The second layer is understood to start at that “certain depth” where the apertures stop, and extend to the terminal end of the back plate. This results in the top surface of the second layer of the plate 50 having a contact surface which contacts the surface of the posts 40 as they meet at the “certain depth” to form a closed end.
However, regarding claim 1 Seiss is silent with regards to the back plate (and both its layers) comprising a plurality of sheets. Ozaki teaches a blood pump (1) which includes a back plate (19) which contacts rear end surfaces of posts (18) (page 7 lines 17-29; Figures 3, 7), where the back plate can be made of a plurality of sheets (page 17 lines 12-24). Seiss and Ozaki 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 Seiss so that the back plate included a plurality of sheets as is taught by Ozaki in order to reduce eddy current loss in the back plate (Ozaki page 7 lines 12-18).
Regarding claim 4 the Seiss Ozaki Combination teaches discloses the pump of claim 1 substantially as is claimed,
wherein Seiss further discloses the opening and second layer form a recess in the back plate (51; [0038], with reference to [0040] and the rejection explained in claim 1, for the contact surface)
Regarding claim 8 the Seiss Ozaki Combination teaches the pump of claim 4 substantially as is claimed,
wherein Seiss further discloses a cross-section of the recess corresponds to a cross-section of the rear end of the posts that is inserted therein (see [0040], along with Figures 6-7 which show the posts and recesses corresponding).
Regarding claim 7 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
wherein Seiss further discloses a contact plane arranged between the first and second layers extends transverse to the axis of rotation (see the annotated figure below, which shows an example at where the two layers can demarcate).
PNG
media_image1.png
410
254
media_image1.png
Greyscale
Claims 2-3 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seiss in view of Ozaki as is applied above, further in view of Chen et al. (US 20050147512 A1) hereinafter known as Chen.
Regarding claims 2-3 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the posts comprising a soft magnetic material which is discontinuous in its electrical conductivity transverse to a longitudinal axis of the post and to the axis of rotation.
However, regarding claims 2-3 Chen teaches a blood pump which includes posts (136) which are made of a soft magnetic material ([0060] laminated silicon steel) which is discontinuous in its electrical conductivity in a cross-section transverse to the post’s longitudinal axis and an axis of rotation ([0060]). Seiss and Chen 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 Seiss Ozaki Combination so that the posts are made of a soft magnetic material with discontinuous electrical conductivity as is taught by Chen in order to reduce eddy current losses during operation of the pump (Chen [0065]).
Regarding claim 11 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to the posts comprising laminated sheets of soft magnetic material.
However, regarding claim 11 Chen teaches a blood pump that includes posts (136) of laminated sheets of soft magnetic material ([0060]). Seiss and Chen 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 Seiss Ozaki Combination so that the posts are made of a soft magnetic material with discontinuous electrical conductivity as is taught by Chen in order to reduce eddy current losses during operation of the pump (Chen [0065]).
Regarding claim 12 the Seiss Ozaki Combination teaches the pump of claim 11 substantially as is claimed,
wherein Chen further teaches the laminated sheets are parallel to a longitudinal axis of the post (Figure 4a-b; [0060]).
Regarding claim 15 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
wherein Seiss further discloses the drive unit further include a spacer separating the posts from one another ([0015]; [0036] insulation between the head portions of the posts 40).
Regarding claim 18 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
wherein Seiss further discloses the spacer includes an outer rim (Figure 4b shows ledge 49) and an inner rim (Figure 4b: the apex point that connects surface 43 and the vertical surface of 42) that connects neighboring distancing spokes (Figures 2 and 5, [0015] the inner ledge is adjacent (i.e. connects) neighboring insulating spokes).
Regarding claim 19 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
wherein Seiss further discloses an end of the coil winding disposed around each of the posts extend to the spacer (Figures 7-8).
Claim 9-10 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seiss in view of Ozaki as is applied above, further in view of Dorman (US 5079467 A).
Regarding claims 9-10 and 14 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
wherein Seiss further discloses the back plate is made of a soft magnetic material ([0010] cobalt steel),
but is silent with regards to the sheets being laminated and including a non-ferromagnetic material.
However, regarding claims 9-10 and 14 Dorman teaches a blood pump which includes a back plate (66) which is made of laminated sheets of a soft magnetic material (page 2 line 66 to page 3 line 4) (claim 9) with a non-ferromagnetic material (Column 6 lines 40-49) (claim 14) which are perpendicular to the axis of rotation (Figures 1, 3 item 66) (claim 1). Seiss and Dorman 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 Seiss Ozaki Combination so that the back plate is made of laminated sheets of the soft magnetic material and a non-ferromagnetic material, perpendicular to the axis of rotation as is taught by Dorman in order to reduce eddy current losses during operation of the pump (Dorman Column 2 line 4).
Regarding claim 13 the Seiss Ozaki Combination teaches the pump of claim 1 substantially as is claimed,
but is silent with regards to a thickness of one of the sheets.
However, regarding claim 13 Dorman teaches a blood pump which includes a back plate (66) which is made of laminated sheets of a soft magnetic material which has a thickness between 350µm to 1mm (page 2 line 66 to page 3 line 4 (0.02 inches=508µm)).
Allowable Subject Matter
Claims 16-17 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.
While the prior art teaches a spacer as is required by the claims (see the rejection to claim 1 above), the prior art fails to teach the spacer material being paramagnetic. The material of the head 42 is magnetic, and must be magnetic. The material between the heads 42 is an insulator, and must be an insulator. Accordingly, it would not be obvious to modify the materials of any part of the spacer to be paramagnetic.
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.
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, 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.
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.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 10/30/25
Prosecution Insights