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 .
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.
Claims 1, 4, 5, 7-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siess et al (U.S. Patent Number: 6007478, hereinafter “Siess”).
Regarding claim 1, Siess teaches a cardiac support system (i.e. implantable intravascular blood pump e.g. Fig.1) comprising:
a housing (i.e. pump housing e.g. 14 Fig.1) comprising a pump configured to be introduced into a blood vessel through a catheter (e.g. 16 Fig.1) to pump blood from the left ventricle into the aorta (e.g. Col. 4 lines 38-42),
a hollow body (i.e. cannula) connected to the housing and comprising a flexible hose portion with a delivery channel extending therethrough to the pump (e.g. 22 Fig.1 Col. 4 lines 45-55),
a distal end portion (i.e. rigid tip component) connected to the hollow body (i.e. cannula), and an inlet portion located between the distal end portion and the hollow body, the inlet portion (e.g. 34 Fig.7) having at least one inlet opening configured to receive blood therethrough; and
a guide nozzle extending from a nozzle inlet opening (i.e. inflow end 71 Fig. 7), that is in fluid communication with the at least one inlet opening of the inlet portion (e.g. 34 Fig.7), to an outlet opening that is in fluid communication with the delivery channel of the flexible hose portion (e.g. 22 Fig. 7), the guide nozzle connected to a distal end of the hose portion and facing the distal end portion, wherein the guide nozzle protrudes radially-inwardly along a contour to form a minimum-width constriction located between the nozzle inlet opening and the nozzle outlet opening, and wherein the contour has a single, continuous concavity (e.g. 40 Fig.7 shows a concaved contour) or convexity along an entire length from the nozzle inlet opening to the nozzle outlet opening.
PNG
media_image1.png
292
619
media_image1.png
Greyscale
Regarding claims 4 and 5, Siess teaches that component (i.e. guide nozzle) may be a separate injection molded part or may be of integral construction (e.g. Col. 5 lines 61-65) and therefore they teach that the guide nozzle is inserted into the hose section (as seen in Fig. 7 reproduced above) and is formed as a one- piece, molded part.
Regarding claims 7 and 8, Siess teaches that guide nozzle defines a nozzle channel extending along a nozzle axis having circular cross-sectional areas as measured perpendicular to the nozzle axis, and wherein the cross-sectional areas decrease from the inlet opening to the constriction (Fig. 7 reproduced above shows a constriction where the channel is narrower) and increase from the constriction to the outlet opening.
Regarding claims 9-11 Siess teaches that the guide nozzle has a flow guide contour, which is located in the plane of a longitudinal section running along the nozzle axis in a Cartesian coordinate system with a coordinate origin lying on the nozzle axis and an abscissa lying on the nozzle axis as a line drawn in a first and/or second quadrant of the Cartesian coordinate system and is formed as a convex line and as a concave line extending in a third and/or fourth quadrant of the Cartesian coordinate system (as shown in Fig. 7 reproduced above) and wherein the flow guide contour has a rounded apex facing the distal end portion (as claimed in claim 10) and wherein the convex line and the concave line are each continuously differentiable (as claimed in claim 11).
Regarding claims 12-14, Siess teaches a flow guide body that has a guide contour which is rotationally symmetrical to the nozzle axis (as claimed in claim 13) connected to the distal end portion and projecting proximally into the inlet portion and that the flow guide body has a flow guiding contour, which is located in the plane of a longitudinal section extending along the nozzle axis in a Cartesian coordinate system with a coordinate origin lying on the nozzle axis and an abscissa lying on the nozzle axis as a line drawn in a first and/or second quadrant of the Cartesian coordinate system and is formed as a convex line and as a concave line extending in a third and/or fourth quadrant of the Cartesian coordinate system (as shown in Fig. 7 reproduced above).
Regarding claim 15, Siess teaches a first axial distance AE from the inlet opening to the constriction is greater than a second axial distance AA from the constriction to the outlet opening (as shown in Fig. 7 reproduced above).
Regarding claim 16, Siess teaches the guide nozzle comprises a stepped-down (depicted as “Step” in the reproduced Fig. 7 above) outer width configured to attach to an inner surface of the body.
Regarding claim 17, Siess teaches a cardiac support system (i.e. implantable intravascular blood pump e.g. Fig.1) comprising:
a pump (e.g. 14 Fig.1) configured to be introduced into a blood vessel through a catheter (e.g. 16 Fig.1) to pump blood from the left ventricle into the aorta (e.g. Col. 4 lines 38-42);
a body (i.e. cannula) having a proximal end fluidly connected with the pump and extending longitudinally to a distal end to at least partially define a flow channel (e.g. 22 Fig.1 Col. 4 lines 45-55); and
a guide nozzle located at the distal end of the body (i.e. cannula) and in fluid communication with the body to at least further partially define the flow channel, the guide nozzle protruding radially-inwardly into the flow channel with a curvature having a single concavity (e.g. 40 Fig.7 shows a concaved contour) or convexity along an entire length from an inlet (i.e. inflow end 71 Fig. 7) to an outlet of the guide nozzle (outlet is at end facing the cannula 22 Fig.7).
PNG
media_image2.png
305
646
media_image2.png
Greyscale
Regarding claim 19, Siess teaches the guide nozzle comprises a stepped-down (depicted as “Step” in the reproduced Fig. 7 above) outer width configured to attach to an inner surface of the body.
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 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.
Claims 2, 3, 6, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al (U.S. Patent Number: 6007478, hereinafter “Siess”).
Regarding claims 2, 3 and 20, Siess teaches the claimed invention as discussed above and while they teach that the distal opening edge of the guide nozzle at least partially defines the at least one inlet opening as claimed in claim 3 (e.g. 71 Fig.7), in the current embodiment, they do not specifically teach that the distal opening edge is a curved opening edge as claimed in claims 2 and 20.
In the embodiment of Fig. 8 Seiss teaches a curved distal opening edge (e.g. 732 Fig. 8 Col. 6 lines 4-19). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of the embodiment of Fig. 7 to have a curved distal opening edge as taught by the embodiment of Fig. 8 in order to provide the predictable results of mitigating the risk of thrombogenesis and easy molding.
Regarding claim 6, Seiss teaches that the guide nozzle may be an injection molded part (e.g. Col. 5 lines 61-65) but do not specifically teach that the guide nozzle is composed of a plurality of parts and therefore shell-shaped moldings. It would have been obvious to one or ordinary skill in the art to modify the guide nozzle to be separable as a plurality of shell shaped moldings since the mere fact that a given structure is integral does not preclude its consisting of various elements. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose." (MPEP 2144.04, Section V.(C)).
Regarding claim 18, Siess teaches a first axial distance AE from the inlet opening to the constriction is greater than a second axial distance AA from the constriction to the outlet opening (as shown in Fig. 7 reproduced above) but does not specifically teach that the first axial distance AE, measured from the inlet opening to a minimum-width constriction of the flow channel within the guide nozzle, is greater than a second axial distance AA, measured from the minimum-width constriction to the outlet opening. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Siess with the first axial distance AE, measured from the inlet opening to a minimum-width constriction of the flow channel within the guide nozzle, is greater than a second axial distance AA, measured from the minimum-width constriction to the outlet opening because Applicant has not disclosed that the distance being measured as claimed provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the co distances as taught by Siess, because it minimizes the risk of excessive shear and cavitation and thereby minimizes the risk of hemolysis and substantially eliminates areas of eddying or of low flow rates to thereby mitigate the risk of thrombogenisis (e.g. Col. 6 lines 4-16) and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Siess. Therefore, it would have been an obvious matter of design choice to modify Siess to obtain the invention as specified in the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stotz et al (International Publication Number: WO 2019/229214 A1, hereinafter “Stotz” ) teaches a cardiac support system comprising: a housing comprising a pump and comprising a flexible hose portion with a delivery channel extending therethrough to the pump, a distal end portion connected to the hollow body, and an inlet portion located between the distal end portion and the hollow body, the inlet portion having at least one inlet opening configured to receive blood therethrough (e.g. Fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm 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, BENJAMIN KLEIN can be reached at 571-270-5213. 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.
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792