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 .
Response to Pre-Appeal Brief Conference Request
Applicant’s arguments were considered and after further consideration of the prior art in the panel meeting, the prior rejection is withdrawn and an updated rejection based on a different interpretation of the prior art is presented below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
In claim 1, the limitation “the drive shaft is configured to pass through a bearing washer…” is unclear as to whether the bearing washer being referred to is the bearing washer previously positively recited in the claim, or if this is an additional / distinct bearing washer. In order to overcome this rejection, it is suggested to amend the claim language to clarify this component.
Claims 2-5 are rejected under the same rationale as being dependent upon claim 1 and its limitations.
Claim Rejections - 35 USC § 102
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(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.
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
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.
Claims 1-6 are rejected under 35 U.S.C. 102(b) as being anticipated by Khaw et al. (US 2003/0135086; hereinafter “Khaw”).
Regarding claim 1, Khaw discloses an intravascular blood pump device comprising: a rotor (e.g. Fig. 2 & 5 – where the examiner considers both the impeller #16 and impeller body #14 to be the claimed rotor) mounted on a drive shaft (where the examiner considers both elements 26 and 20 to be the claimed drive shaft) and configured to pump blood through a subject's body (e.g. ¶¶ 24), the rotor comprising at least a proximal bearing spacer sleeve and distal bearing spacer sleeve (e.g. ¶¶ 51 – “impeller 12 may be supported by two bearings at either end of the impeller 12 between impeller 12 and collets 48, 50. The bearings may be…plain bearings” – where the examiner is considering the sleeve of the proximal and distal plain bearings in this embodiment to be the claimed proximal and distal bearing spacer sleeves); a bearing washer positioned on the drive shaft adjacent and distal to the distal bearing spacer sleeve (e.g. Fig. 2, #28; ¶¶ 51 – “the impeller shaft 26 may be equipped with collars 28 that may be attached to each end of impeller 12 and inserted into collet 48, 50”); a pump housing configured to be disposed around the rotor mounted on the drive shaft (e.g. Fig. 5, #60/62 – where the examiner considers the mounting through the retaining ring to be indirectly mounted on the driveshaft), the pump housing comprising a proximal bushing disposed on a proximal side of the rotor mounted on the drive shaft and a distal bushing disposed on a distal side of the rotor mounted on the drive shaft (e.g. ¶¶ 41 – where the retainer rings 58 are the claimed bushings); wherein the drive shaft is configured to pass through the proximal and distal bushings of the pump housing (where the examiner notes the collets have openings in the middle for the driveshaft components #26 to pass through); the drive shaft is configured to pass through a bearing washer (¶¶ 51 – element 28 as referenced above) such that the distal bearing spacer sleeve is a sliding bearing that contacts the bearing washer to form a distal rotor bearing (e.g. ¶¶ 51 – “impeller 12 may be supported by two bearings at either end of the impeller 12 between impeller 12 and collets 48, 50. The bearings may be…plain bearings” – where the examiner notes plain bearings are a type of sliding bearing).
Regarding claim 2, Khaw discloses the rotor is configured to pump blood from a first location within the subject's body to a second location within the subject's body (e.g. ¶¶ 58 – “move blood in and out of the left ventricle into the aorta”).
Regarding claim 3, Khaw discloses the rotor is configured to pump blood from a left ventricle of the subject to an aorta of the subject (e.g. ¶¶ 58 – “move blood in and out of the left ventricle into the aorta”).
Regarding claim 4, Khaw discloses the rotor is configured to pump blood from a left ventricle of the subject (e.g. ¶¶ 58 – “move blood in and out of the left ventricle into the aorta”).
Regarding claim 5, Khaw discloses the intravascular blood pump device according to claim 1, further comprising: a motor configured to drive the rotor to pump blood through the subject's body, by rotating the rotor in a given direction of rotation (e.g. ¶¶ 36-38); and a drive shaft, a portion of which is configured to extend from outside the subject's body to a pump section of the drive shaft, the drive shaft being configured to impart rotational motion from the motor to the rotor by rotating, at least a portion of the drive shaft comprising a plurality of wires disposed in a wound configuration that is such that, in response to the drive shaft rotating in the given direction of rotation (e.g. ¶¶ 62 – “The metal coil in the first drive shaft may be rotated in the reverse direction, and impeller 12 may be adapted to operate in the reverse direction. Alternatively, the impeller may be rotated in the same direction as in the aortic valve embodiment with impeller blades reversed and adapted to move blood in the opposite direction.”).
Regarding claim 6, Khaw teaches a method comprising: placing an intravascular blood pump device inside a body of a patient (e.g. ¶¶ 24-25) the intravascular blood pump device including: an impeller (e.g. Fig. 2 & 5 – where the examiner considers both the impeller #16 and impeller body #14 to be the claimed impeller) with a frame disposed around the impeller (e.g. Fig. 5, #60/62), the impeller including proximal and distal spacer bearing sleeves (e.g. ¶¶ 51 – “impeller 12 may be supported by two bearings at either end of the impeller 12 between impeller 12 and collets 48, 50. The bearings may be…plain bearings” – where the examiner is considering the sleeve of the proximal and distal plain bearings in this embodiment to be the claimed proximal and distal bearing spacer sleeves) and the frame including a proximal bushing disposed on a proximal side of the impeller and a distal bushing disposed on a distal side of the impeller (e.g. ¶¶ 41 – where the retainer rings 58 are the claimed bushings), and an axial shaft that passes through the proximal and distal bushings of the frame and the proximal and distal spacer bearing sleeves of the impeller (where the examiner notes the collets have openings in the middle for the driveshaft component #26 to pass through) wherein a bearing washer is positioned on the axial shaft distal and adjacent to the distal spacer bearing sleeve (e.g. Fig. 2, #28; ¶¶ 51 – “the impeller shaft 26 may be equipped with collars 28 that may be attached to each end of impeller 12 and inserted into collet 48, 50”), the axial shaft being coupled to the bearing washer such that the distal bearing spacer sleeve is a sliding bearing that contacts the bearing washer to form a distal rotor bearing (e.g. ¶¶ 51 – “impeller 12 may be supported by two bearings at either end of the impeller 12 between impeller 12 and collets 48, 50. The bearings may be…plain bearings” – where the examiner notes plain bearings are a type of sliding bearing); and pumping blood through the patient's body, using the impeller (e.g. ¶¶ 58 – “move blood in and out of the left ventricle into the aorta”).
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.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796