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 .
Amendment
This action is in response to the Amendment filed on 4/28/2026.
Claims 1 and 4-19 are pending.
Response to Arguments
Applicant's arguments with respect to claims 1 and 4-19 have been considered.
Claim Rejections under 35 U.S.C. 102- U.S. Patent No. 6,007,478 to Siess et al. ("Siess").
Independent Claims 1 and 17 have been amended to recite inter alia "the guide nozzle comprising a distal portion extending into the at least one inlet opening of the inlet portion, the distal portion of the guide nozzle comprising a rounded opening edge".
Applicant argues that Siess is directed to a cannula with a rigid tip component 24 having elongated lateral ports formed in the sidewall of the tip itself. As Siess describes, "Figs. 7 and 8 illustrate the rigid tip component of the cannula... [a] number of large elongated openings extend along its length," and "the interior surface of the tip component directly adjacent the squared off proximal or inflow end of the openings is formed with an edge contour of generally parabolic cross-section." See, e.g., Siess, column 5, lines 61-67; column 6, lines 1-19; Figs. 7-8. They argue that the annotated version of Figure 7 provided in the Office Action appears to cite to the entire tip component 24 of Siess as a guide nozzle and Siess does not disclose a guide nozzle comprising "a distal portion extending into the at least one inlet opening of the inlet portion, the distal portion of the guide nozzle comprising a rounded opening edge." In contrast, Siess discloses a rigid tip having openings formed in the tip wall and lacks any disclosure of a guide nozzle that is structurally distinct from the inlet portion or that extends into inlet openings.
The examiner respectfully disagrees with the applicant’s arguments for the following reasons.
The embodiment of Fig. 7 does teach that the guide nozzle comprises a distal portion (e.g. 71 Fig. 7) extending into the at least one inlet opening as shown above and also teaches the portion distal to the constriction has a rounded edge (Note: the limitation states “a distal portion” extending to the at least one inlet opening) but does not specifically teach that the distal opening edge is a rounded opening edge as claimed.
The embodiment of Figure 8 shows a distal portion 73 with a rounded opening edge.
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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 distal portion 71 Fig. 7 extending into the at least one inlet opening as shown above teachings of the embodiment of Fig. 7 to have a rounded distal opening edge as taught by the embodiment of Fig. 8 in order to provide the predictable results of mitigating the risk of thrombogenesis by having curved edges and easy construction.
Therefore, the rejection is maintained.
Information Disclosure Statement
The information disclosure statements (IDS) submitted 5/13/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Applicant should note that the large number of references in the attached IDS have been considered by the Examiner in the same manner as other documents in Office search files are considered by the Examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any references in the IDS which Applicant believes may be of particular relevance to the claimed invention in response to this Office Action.
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 1 and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Siess et al (U.S. Patent Number: 6007478, hereinafter “Siess”- PERVIOUSLY CITED).
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 comprising an interior surface 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 a nozzle 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.
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The embodiment of Fig. 7 does teach that the guide nozzle comprises a distal portion (e.g. 71 Fig. 7) extending into the at least one inlet opening as shown above and also teaches the portion distal to the constriction has a rounded edge (Note” the limitation states “a distal portion” extending to the at least one inlet opening) but does not specifically teach that the distal opening edge is a rounded opening edge as claimed.
The embodiment of Figure 8 shows a distal portion 73 with a rounded opening edge.
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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 distal portion 71 Fig. 7 extending into the at least one inlet opening as shown above teachings of the embodiment of Fig. 7 to have a rounded distal opening edge as taught by the embodiment of Fig. 8 in order to provide the predictable results of mitigating the risk of thrombogenesis by having curved edges and easy construction.
Regarding claims 4 and 5, “modified” Siess teaches the claimed invention as discussed above and Siess further 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 claim 6, “modified” Siess teaches the claimed invention as discussed above and Siess further 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 claims 7 and 8, “modified” Siess teaches the claimed invention as discussed above and Siess further teaches that the 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 “modified” Siess teaches the claimed invention as discussed above and Siess further 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, “modified” Siess teaches the claimed invention as discussed above and Siess further 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, “modified” Siess teaches the claimed invention as discussed above and Siess further 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, “modified” Siess teaches the claimed invention as discussed above and Siess further teaches that 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
an inlet portion in fluid communication with the body having at least one inlet opening configured to receive blood therethrough; 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, wherein the guide nozzle protrudes 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 a nozzle inlet opening (i.e. inflow end 71 Fig. 7) to a nozzle outlet opening of the guide nozzle (outlet is at end facing the cannula 22 Fig.7).
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The embodiment of Fig. 7 does teach that the guide nozzle comprises a distal portion (e.g. 71 Fig. 7) extending into the at least one inlet opening as shown above and also teaches the portion distal to the constriction has a rounded edge (Note” the limitation states “a distal portion” extending to the at least one inlet opening) but does not specifically teach that the distal opening edge is a rounded opening edge as claimed.
The embodiment of Figure 8 shows a distal portion 73 with a rounded opening edge.
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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 distal portion 71 Fig. 7 extending into the at least one inlet opening as shown above teachings of the embodiment of Fig. 7 to have a rounded distal opening edge as taught by the embodiment of Fig. 8 in order to provide the predictable results of mitigating the risk of thrombogenesis by having curved edges and easy construction.
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.
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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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