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 .
Specification
The disclosure is objected to because of the following informalities: the cross-references to related applications (page 1) is incomplete. Appropriate correction is required.
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)(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.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nitzan et al (US 2018/0126130).
Regarding claim 1, Nitzan discloses a device comprising: a catheter (catheter 702) with a proximal portion and a distal portion (shown in figure 7); an impeller assembly (impeller assembly 705) connected to the distal portion (figures 9A-B), the impeller assembly comprising an impeller operably disposed within the assembly (par 0159, fig 9A), wherein a proximal portion of the impeller assembly is configured to facilitate flow into an inlet of the impeller assembly without recirculation (par 159, figure 9A).
Regarding claim 2, Nitzan discloses the impeller operates within a blood vessel (figure 1), blood flows through a housing (housing 730, figure 9A) of the impeller assembly without recirculation (pars 159-160, 175).
Regarding claim 3, Nitzan discloses the impeller assembly comprises a cap secured to the distal portion (holder 713) and one or more struts extending from the cap to the housing (struts as in figure 20, par 174).
Regarding claim 4, Nitzan discloses the housing (figure 9A, element 730, figure 25, element 1030) has a diameter greater than a diameter of the cap (see holder 713 and equivalent 1013; Fig. 19, 25 and 26A), further wherein a proximal base of the housing, the cap, and the one or more struts define the inlet (see par. 174 and 203; Fig. 25).
Regarding claim 5, Nitzan discloses the strut comprises an inflation lumen (distal restrictor 712; Fig. 9A and 19) extending therethrough for inflating a balloon mounted on the impeller assembly (par 23, 174).
Regarding claim 6, Nitzan discloses the strut is substantially parallel to an axis of the impeller and protrudes radially inward from at least a portion of an inner surface of the impeller housing (figure 20, par 0174).
Regarding claim 7, Nitzan discloses the strut defines a vane within the impeller assembly that channels fluid flow when the impeller operates to thereby prevent the recirculation or vortices (pars 159-160, figures 9A, 11).
Regarding claim 8, Nitzan discloses the strut comprises a fluidic lumen extending therethrough (par 206), wherein the fluidic lumen is non-concentric with at least a portion of the body of the strut due to material of the strut forming the vane within the impeller assembly (pars 159-160, figures 9A, 11).
Regarding claim 9, Nitzan discloses three of the struts, wherein each of the three struts defines a vane within the impeller assembly that channels fluid flow when the impeller operates to thereby prevent the recirculation or vortices (par 106, 112, 123, 173-174).
Regarding claim 10, Nitzan discloses a medicament lumen extending through the catheter and terminating substantially within a proximal portion of the impeller assembly such that a medicament released from the medicament lumen flows through the inlet and impeller assembly (par 206).
Regarding claim 11, Nitzan discloses the catheter comprises a tube (tube 702) with a drive cable (drive shaft 703) extending there through with a cap connected around a terminal portion of the tube (holder 713), with the impeller housing mounted to the cap by a plurality of struts that define vanes that promote laminar flow of fluids through the impeller assembly (par 106, 112, 123, 173-174).
Regarding claim 12, Nitzan discloses the impeller housing includes one or more outlets around a distal portion of the impeller (outlet 614), wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlets (inlet 612) and out of the impeller assembly via the outlets such that the blood exhibits smooth laminar flow without the recirculation or vortices (par 106, 112, 123, 173-174).
Regarding claim 13, Nitzan discloses a method of treating edema, the method comprising: inserting into an innominate vein of a patient (par 27) a distal portion of a catheter (par 177), the catheter comprising an impeller assembly on the distal portion (impeller 715/815); and driving an impeller disposed within the impeller assembly to thereby decrease pressure at a lymphatic duct (par 143), wherein a proximal portion of the impeller assembly is configured to facilitate flow into an inlet of the impeller assembly without recirculation (par 151, 159).
Regarding claim 14, Nitzan discloses the catheter comprises a cap secured to the distal portion and one or more struts extending from the cap to support a housing of the impeller assembly (struts as in figure 20, par 174).
Regarding claim 15, Nitzan discloses the housing has a diameter greater than a diameter of the cap, further wherein a proximal base of the housing, the cap, and the one or more struts define the inlet (par. 174 and 203; Fig. 25).
Regarding claim 16, Nitzan discloses the struts extend substantially parallel to an axis of the impeller and protrude radially inward from at least a portion of an inner surface of the impeller housing (figure 20).
Regarding claim 17, Nitzan discloses the struts define vanes within the impeller assembly that channel fluid flow when the impeller operates to thereby prevent the recirculation or vortices (par 106, 112, 123, 173-174).
Regarding claim 18, Nitzan discloses at least one strut comprises a fluidic lumen extending therethrough (par 206), wherein the fluidic lumen is non-concentric with at least a portion of the body of the strut due to material of the strut forming the vane within the impeller assembly (par 0174).
Regarding claim 19, Nitzan discloses inflating an inflatable flow restrictor mounted on the impeller assembly by delivering an inflation fluid to the restrictor via an inflation lumen extending through the catheter ( restrictor 712; Fig. 9A and 19).
Regarding claim 20, Nitzan discloses the impeller housing includes one or more outlets around a distal portion of the impeller (outlet 614), wherein operation of the impeller within a blood vessel drives blood into the impeller assembly via the inlets (see inlet 612; Fig. 6) and out of the impeller assembly via the outlets such that the blood exhibits smooth laminar flow without the recirculation or vortices (see par. 141 and 159).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Heuring et al (US 2014/0128659 A1) details known methods for circulatory assistance with additional features that address recirculation (pars 0119, 0140).
Rodefeld et al (US 2011/0257462 A1) details known methods for circulatory assistance with additional features that prevent recirculation (pars 0033, 0103, 0119; figure 2)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799
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