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 Therefore, the rejection has been withdrawn.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 § 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel et al. (US 2016/0279310; hereinafter “Scheckel”).
Regarding claim 1, Scheckel discloses a catheter device, comprising a drive shaft extending from a driving region of the catheter device to a distal end region of the catheter device (e.g. ¶¶ 29-32), a rotor which is attached to the drive shaft in the distal end region (e.g. Fig. 9), a distal bearing for bearing a distal end of the drive shaft (e.g. ¶¶ 67), wherein the distal bearing comprises a drive shaft cover, the drive shaft cover being configured to cover a section of the drive shaft, which section extends distally of the rotor, characterized in that on a distal side of the rotor, a radially inner part of the rotor is recessed with respect to radially outer parts of the rotor to form a hollow space surrounding the drive shaft, wherein a proximal end of the drive shaft cover lies in said hollow space (e.g. ¶¶ 61-66 – specifically bearing 91). The examiner notes it is unclear as to whether there is a hollow space; however, the examiner notes that bearing spaces generally have a minimal gap present between the two surfaces. Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have a gap or hollow space between the two bearing surfaces of Scheckel, in order to yield the predictable results of providing minimal friction for the rotating pieces while maintaining the appropriate durability based on the surface materials.
Regarding claim 3, Campbell discloses the device designed as an expandable pump, wherein the rotor is located in a housing, the housing and the rotor being configured to be compressed at least along a radial direction extending transversely to a longitudinal direction, from an expanded state into a compressed state, and wherein upon compression of the housing, a relative motion of the rotor with respect to the distal bearing is effected, and wherein a penetration depth of the drive shaft cover over which it extends axially into the hollow space is chosen such that the proximal end of the drive shaft cover remains within the hollow space in the compressed state (e.g. ¶¶ 20-23).
Regarding claims 2, 5, and 6, Campbell fails to expressly disclose that a diameter of the hollow space is at least 0.5 mm and/or at most 2 mm; and/or in that a length of the hollow space is at least 0.5 mm and/or at most 2.5 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to design the diameter of the hollow space is at least 0.5 mm and/or at most 2 mm; and/or in that a length of the hollow space is at least 0.5 mm and/or at most 2.5 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 4, Campbell discloses the penetration depth of the drive shaft cover, over which it extends into the hollow space is at least 0.3 mm and/or at most 2.2 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the penetration depth of the drive shaft cover, over which it extends into the hollow space is at least 0.3 mm and/or at most 2.2 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 5, Campbell fails to expressly disclose a wall thickness of a portion of the drive shaft cover extending into the hollow space is at least 0.03 mm and/or at most 0.3 mm, preferably at most 0.08 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a wall thickness of a portion of the drive shaft cover extending into the hollow space is at least 0.03 mm and/or at most 0.3 mm, preferably at most 0.08 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 6, Campbell fails to expressly disclose an outer diameter of a proximal section of the drive shaft cover is smaller than an outer diameter of a section of the drive shaft cover lying distally thereof, wherein a portion of the proximal section extends into the hollow space, the outer diameter of the proximal section of the drive shaft cover preferably being at least 0.1 mm smaller than the outer diameter of the section of the drive shaft cover lying distally thereof and/or at most 0.6 mm smaller than the outer diameter of the section of the drive shaft cover lying distally thereof. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the outer diameter of the proximal section of the drive shaft cover preferably being at least 0.1 mm smaller than the outer diameter of the section of the drive shaft cover lying distally thereof and/or at most 0.6 mm smaller than the outer diameter of the section of the drive shaft cover lying distally thereof, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 7, Campbell fails to expressly disclose the proximal section has a length of at least 0.6 mm and/or at most 2 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the proximal section has a length of at least 0.6 mm and/or at most 2 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 8, Campbell fails to expressly disclose a radial gap which is formed inside the hollow space, between the drive shaft cover and the rotor, has a gap size of at least 0.01 mm and/or at most 0.2 mm; and/or characterized in that an axial gap of at least 0.2 mm and/or at most 1.5 mm remains between the proximal end of the drive shaft cover and a hub of the rotor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a radial gap size of at least 0.01 mm and/or at most 0.2 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 9, Campbell discloses the rotor comprises a stiffening element surrounding the hollow space (e.g. ¶¶ 76).
Regarding claim 10, Campbell discloses the distal bearing comprises an end part, wherein a distal end of the drive shaft cover lies within the end part, the drive shaft cover preferably comprising a distal section with a diameter that is larger than a diameter of a section of the drive shaft cover lying proximally thereof, wherein said distal section lies in part inside the end part (e.g. ¶¶ 54-57).
Regarding claim 11, Campbell discloses the drive shaft cover comprises a pliable section, the pliable section preferably being arranged between a distal end of the rotor and a proximal end of an end part of the distal bearing (e.g. ¶¶ 76).
Regarding claim 12, Campbell discloses the pliable section is provided by having at least one opening in the drive shaft cover in said pliable section, the at least one opening connecting an inside of the drive shaft cover to an outside of the drive shaft cover, the at least one opening preferably comprising one or more slits (e.g. ¶¶ 20-23).
Regarding claim 13, Campbell discloses a flexible tube is provided around the pliable section of the drive shaft cover, covering the at least one opening at least in part (e.g. ¶¶ 20-23).
Regarding claim 14, Campbell discloses the flexible tube leaves a distal portion of the at least one opening uncovered and/or in that the flexible tube comprises one or more holes to allow fluid communication with a portion of the at least one opening and/or in that the drive shaft cover comprises one or more venting holes to allow fluid communication between the inside of the drive shaft cover and the outside of the drive shaft cover (e.g. ¶¶ 64-68).
Regarding claim 15, Campbell discloses an inner diameter of the drive shaft cover at the proximal end of the drive shaft cover is reduced with respect to an inner diameter of the drive shaft cover at the distal end of the drive shaft cover (e.g. ¶¶ 20-23).
Regarding claim 16, Campbell discloses the drive shaft cover comprises 35NLT and/or ceramics and/or a diamond-like-carbon coating and/or in that the drive shaft cover is manufactured from a single piece (e.g. ¶¶ 51-59).
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