DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/16/204 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the details of the primary and secondary flow channels, specifically the manner in which blood is to flow through the primary and secondary flow channels, the connections between the flow channels, and the directions of such flow as described in the specification. Furthermore, the drawings fail to show the connection between the secondary blood flow openings 285 and the secondary blood flow path 255, or how blood is to enter through the secondary blood flow openings. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 § 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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 14, 15, 23, and 24 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Antaki et al. (U.S. 2001/0031210, cited by Applicant). Regarding claim 14, Antaki discloses a paracardial blood pump, comprising: a tubular housing including a longitudinally extending primary flow channel 412; a drive unit, comprising a rotor 409 and a stator 406, arranged coaxially within the housing; an impeller 404 positioned at one end of the drive unit and connected to the rotor; a pump ring with an axial inlet positioned at one end of the housing and surrounding at least a portion of the impeller; a cannula 402 extending from an end of the housing nearest the impeller; a laterally branching outlet tube 400 positioned proximate an end of the housing opposite the impeller; and an axial magnetic bearing 410 positioned at one end of the housing (see annotated Figures 36 and 37 below).
PNG
media_image1.png
832
585
media_image1.png
Greyscale
Regarding claim 15, Antaki discloses that the axial magnetic bearing comprises an active magnetic bearing (the description of permanent magnet bias magnet 410 as part of “the thrust bearing” is considered to satisfy the broadest reasonable interpretation for “an active magnetic bearing”, which would be considered a magnetic bearing that is actively used or used for thrust in the case of Antaki).
Regarding claim 23, Antaki discloses that the rotor comprises a rotor motor magnet 409 and the stator comprises a stator motor magnet 408, wherein the rotor motor magnet and the stator motor magnet cooperate to cause the rotor to rotate and thereby rotate the impeller.
Regarding claim 24, Antaki discloses that the primary flow channel is formed between an interior wall of the housing and an exterior of the drive unit, a secondary flow channel is formed between the rotor motor magnet and the stator motor magnet, wherein the secondary flow channel is configured to direct a flow of blood in a direction generally opposite a direction of blood flow through the primary flow channel (“Fluid flow gap 412 provides for the primary blood flow through the pump. A secondary fluid flow gap 414 also provides blood flow therethrough”, paragraph [0151]).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 16, 17, and 19-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Antaki (U.S. 2001/0031210, cited above) in view of Prem (U.S. Patent No. 5,928,131). Regarding claim 16, Antaki discloses an intravascular blood pump, comprising: a catheter-based housing 506; a drive unit comprising a rotor 502 and a stator 504, arranged coaxially within the housing; an impeller 542 positioned at one end of the drive unit, the impeller connected to the rotor and configured to create a primary blood flow 550; primary blood flow opening 528 positioned in the housing downstream of the impeller to direct the primary blood flow out of the housing; and a secondary flow channel 552 formed between the rotor and the stator and configured to direct blood through the drive unit in a direction generally opposite that of the primary blood flow (see Annotated Figures 41 and 45 below). However, Antaki discloses a single opening 528 and not plural “openings” as claimed. Prem teaches an intravascular blood pump that includes a rotor, stator, and impeller 10 and including a primary blood flow opening 38/42 (see Figures 1-3). Prem teaches that a single-volute opening “inherently develops a radial force on the impeller which must be offset by the permanent magnet radial bearings” and proposes “an alternative, double volute, configuration” formed in the annular pump “by interposing a septum 56 in the single volute passage 37 (shown in FIG. 2) to form a pair of volute passages 39, 40 which are radially opposed” (see col. 7, ln. 48-56). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outlet of Antaki to comprise two outlets, as taught by Prem, in order to decrease the radial force on the impeller, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
PNG
media_image2.png
604
1047
media_image2.png
Greyscale
PNG
media_image3.png
600
866
media_image3.png
Greyscale
Regarding claim 17, Antaki discloses a first radial magnetic bearing 521 positioned near the impeller and a second radial magnetic bearing 562 positioned towards an end of the pump opposite the impeller (“Preferably, the thrust bearing 562 is an active magnetic bearing”, paragraph [0195]). It is respectfully submitted that the characterization of a bearing as being “axial” versus “radial” is relative to the plane of orientation chosen. As such, magnetic bearing 562 is considered axial when the plane of orientation is taken along the “axial plane” annotated above.
Regarding claim 19, Antaki discloses an axial magnetic bearing 562 (“Preferably, the thrust bearing 562 is an active magnetic bearing”, paragraph [0195]). It is respectfully submitted that the characterization of a bearing as being “axial” versus “radial” is relative to the plane of orientation chosen. As such, magnetic bearing 562 is considered axial when the plane of orientation is taken along the “axial plane” annotated above.
Regarding claim 20, Antaki discloses that the axial magnetic bearing is at least partially active (“Preferably, the thrust bearing 562 is an active magnetic bearing”, paragraph [0195]).
Regarding claim 21, Antaki discloses that the rotor comprises a rotor motor magnet and the stator comprises a stator motor magnet, wherein the rotor motor magnet and the stator motor magnet cooperate to cause the rotor to rotate and thereby rotate the impeller (“The secondary flow path 552 is necessitated by the use of magnetic bearings which permit the rotor 502 to levitate. The creation of a secondary flow path 552 across which the magnetic bearings communicate with the rotor to suspend the rotor 502 is significant because without a secondary flow path 552, the magnetic bearings must work across the primary or only flow path in the pump.”, paragraph [0179]).
Regarding claim 22, Antaki discloses that the secondary flow channel is formed between the rotor motor magnet and the stator motor magnet (“The secondary flow path 552 is necessitated by the use of magnetic bearings which permit the rotor 502 to levitate. The creation of a secondary flow path 552 across which the magnetic bearings communicate with the rotor to suspend the rotor 502 is significant because without a secondary flow path 552, the magnetic bearings must work across the primary or only flow path in the pump.”, paragraph [0179]).
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Antaki in view of Prem as applied to claims 16, 17, and 19-22 above, and further in view of Akdis (U.S. 2011/0238172). Antaki in view of Prem provides the invention substantially as claimed, but fails to provide axial hydraulic bearing. Akdis teaches a blood pump including a rotor, a stator, and an impeller, and various bearings of the impeller, including a hydraulic axial bearing (see paragraph [0102]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Antaki in view of Prem to include an axial hydraulic bearing, as taught by Akdis, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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, Carl Layno can be reached at 571-272-4949. 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.
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
Prosecution Insights