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 Arguments
Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as expounded below.
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 16-21 and 27-36 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maher et al. (USP# 5,707,218; hereinafter “Maher”).
Regarding claim 16, Maher discloses an intravascular blood pump comprising: a shaft carrying an impeller, the shaft being rotatable (e.g.Fig. 3, #42/44); and a housing having an opening (e.g. Fig. 4, housing top figure with the opening) and an end wall having a sleeve (e.g. Fig. 5, where #40 extends until), a circumferential gap defined by a circumferential surface of the shaft and a surface of the sleeve (e.g. Fig. 5, #84); wherein the shaft extends through the opening with the impeller positioned outside the housing (e.g. Col 5, ll 45-65); and wherein the circumferential gap has a length and a width, the width having a minimum width selected to provide a physical barrier against ingress of red blood cells into the gap (e.g. Col 1, ll ~40 – “In order to prevent blood cells from entering the bearing and being hemolyized, the bearing clearance is made so small that blood cells are essentially precluded from entering the bearing”; Col 2, ll 20-60; Col 4, ll 55-60).
Regarding claims 17-21, Maher discloses construction of an intravascular blood pump where the housing comprises a plurality of elements composed of thermoconductive elements including radial outer thermoconductive sleeve composed of silicon carbide (e.g. Col 5, ll 18-45).
Regarding claims 27-29, Maher discloses the circumferential gap converges continuously and linearly over at least part of its length up to where the gap has the minimum width, towards an impeller-side end which is an end of the circumferential gap closest to the impeller (e.g. Fig. 3, element 38).
Regarding claims 30-32, Maher discloses an outer diameter of the shaft expands towards an impeller-side end which is an end of the circumferential gap closest to the impeller, wherein the outer diameter of the shaft has a circumferential groove stretching over an end of the gap opposite the impeller-side end of the circumferential gap, the outer diameter of the shaft expands from a constant diameter shaft section stretching over an end of the circumferential gap opposite the impeller-side end of the circumferential gap to a maximum outer diameter within the gap (e.g. Col 4, ll 1-14).
Regarding claims 33-38, Maher discloses the minimum width of the gap is 2 microns or less (Col 4, ll 55-60 – “gap between the mating surfaces of the balls and their respective cups is extremely small--on the order of 0.25-0.5.mu.”).
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Maher
Regarding claims 22-24, Carrier fails to specifically disclose the minimum width is a particular percentage over the length of the gap or present at the impeller side; however, the examiner notes that the prior art is clear in noting that the parameters and orientation can be adjusted based on the application. Accordingly, the examiner is of the position that it would have been obvious to have the minimum width extending over not more than 20% of the length of the gap, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 25-26, Carrier fails to expressly disclose the length or width of the gap. The examiner notes that the pump is sized to fit within similar vascular structures and is sized for the same purpose as the present invention – to prevent red cells from gathering and clotting. Accordingly, the examiner is of the position that it would have been obvious to have a length of the gap between 1.3-1.7mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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