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 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.
(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 18-31 and 33-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanner et al. (US 2016/0213826; hereinafter “Tanner”).
Regarding claim 18, Tanner discloses a device comprising: an impeller dimensioned for insertion into vasculature of a patient (e.g. ¶¶ 33, 35); a guidewire lumen extending to a distal end of through the impeller (e.g. ¶¶ 49-52); and a drive mechanism operable to rotate the impeller while the impeller is in the vasculature with a guidewire extending through the lumen (e.g. ¶¶ 15 – “drive shaft disposed inside the catheter body and coupled with the impeller at a distal portion of the drive shaft, the drive shaft configured such that rotation of the drive shaft causes the impeller to rotate”; ¶¶ 55-56, etc.).
Regarding claim 19, Tanner discloses the drive mechanism includes a driveshaft extending proximally from the impeller to a motor, wherein the motor is operable to rotate the impeller within the vasculature when the impeller is inserted over the guidewire into the vasculature (e.g. ¶¶ 55-57).
Regarding claim 20, Tanner discloses the driveshaft extends through a catheter having a proximal portion and a distal portion, wherein the impeller is distal to the distal portion and the motor is proximal to the proximal portion (e.g. Fig.1B – where the motor is clearly positioned proximally and the impeller is positioned distally).
Regarding claim 21, Tanner discloses the motor sits in a housing connected to the proximal portion of the catheter (e.g. ¶¶ 54).
Regarding claim 22, Tanner discloses the motor comprises a stator housed within the housing and a rotor disposed within the stator (e.g. ¶¶ 54), wherein the guidewire lumen extends through the impeller, through the driveshaft, and through the rotor (e.g. ¶¶ 56).
Regarding claim 23, Tanner discloses the guidewire lumen opens to a tapered port at a proximal portion of the housing (e.g. ¶¶ 72 – “distal portion of the output shaft 13 can comprise a radially-inward taper”).
Regarding claim 24, Tanner discloses a hollow atraumatic tip extending distally from the impeller (e.g. ¶¶ 52-56).
Regarding claim 25, Tanner discloses the driveshaft extends through an extended catheter, wherein the impeller is disposed at a distal portion of the catheter (e.g. Fig. 1B, #116A; ¶¶ 43).
Regarding claim 26, Tanner discloses the motor is disposed at a proximal portion of the catheter (e.g. ¶¶ 54-56).
Regarding claim 27, Tanner discloses an impeller housing connected to the distal portion of the catheter (e.g. Fig. 1B – 116A).
Regarding claim 28, Tanner discloses at least one inlet port proximal to the impeller and at least one outlet port distal to the impeller, wherein rotation of the impeller impels liquid through the impeller housing (e.g. ¶¶ 60, 47, etc.).
Regarding claim 29, Tanner discloses at least one expandable member on the distal portion of the catheter and at least one inflation lumen extending through the catheter, wherein the at least one expandable member is in fluid communication with the inflation lumen (e.g. ¶¶ 38, 45, etc.).
Regarding claim 30, Tanner discloses the expandable member comprises a substantially toroidal balloon connected to the catheter or the impeller, wherein, when in an inflated state, the balloon forms a torus at least partially surrounding the catheter or the impeller housing (e.g. ¶¶ 45, 59-62, etc.).
Regarding claim 31, Tanner discloses when the catheter is inserted over a guidewire into the vasculature, the balloon can be inflated and the impeller can be rotated by operation of the motor while the guidewire extends through the device (e.g. ¶¶ 52-56).
Regarding claim 33, Tanner discloses a tube housing a portion of the drive shaft, the tube comprising a distal end face (e.g. ¶¶ 56 – Fig. 4A).
Regarding claim 34, Tanner discloses the tube further comprises an infusion channel in fluid communication with the drive shaft and arranged such that a purge fluid is discharged through a longitudinal channel between the tube and drive shaft and through an annular gap between an impeller proximal face and the tube distal end face (e.g. ¶¶ 47, 60-61, etc.).
Regarding claim 35, Tanner discloses the annular gap is positioned between the rotating impeller proximal face and the static tube distal end face (e.g. ¶¶ 61-63, etc.).
Regarding claim 36, Tanner discloses the impeller is inserted into the vasculature of a patient, the purge fluid purges the catheter by hydrostatic pressure while the impeller is not being rotated and the purge fluid purges the catheter by centrifugal force while the impeller is being rotated (e.g. ¶¶ 47, 68, etc.).
Regarding claim 37, Tanner discloses the impeller is seated within the impeller housing by at least one support ring, wherein the support ring comprises an open central ring supported within an outer ring by multiple spokes (e.g. ¶¶ 60-61).
Regarding claim 38, Tanner discloses when the motor is rotating, the purge fluid is subject to centrifugal force along the drive shaft preventing the bodily fluid from approaching the proximal portion of the catheter (e.g. ¶¶ 47).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
Prosecution Insights