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 .
Status of the Claims
Claims filed 07/10/2026 has been entered. Claims 1-3 and 5-19 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed 07/10/2026, with respect to the rejection(s) of claim(s) 1-3, 5, 7 and 9 under 35 USC 102 as being anticipated by Straub et al (US 5873882 A) have been fully considered and are persuasive. Specifically, the previous rejection incorrectly relied upon stator 14 as corresponding to the claimed hollow body. The drive shaft 32, which supposedly corresponds to the hollow body of the current claim, and the catheter 12 including cutting tool which consists of a stator 14 and rotor 16, which corresponds to the catheter tube of the current claim, were inadvertently transposed. Accordingly, the rejection has been withdrawn, and the remaining argument toward the hollow body and catheter tube are moot in light of new interpretation of Straub as presented below.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 (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)(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.
Claims 1-3, 5, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Straub et al (US 5873882 A).
Regarding claim 1, Straub teaches a conveying device for body fluid comprising a catheter tube (figure 1, col 3 lines 19 -30 catheter 12 including a cutting tool at front end 12a including stator 14 and rotor 16, the catheter 12 with stator 14 forming an continuous catheter tube) having a distal end (figure 1, front end 12a) to be inserted into a body and a proximal end (figure 1, opposite rear end 12b), wherein a hollow body (figures 2-4 and 8, flexible drive shaft 32, the drive shaft being hollow along its central axis and configured to be rotatable within the catheter 12) which is arranged at least one of longitudinally moveable or rotatable in the catheter tube (col 4 lines 1-10 and col 5 lines 1-10, the drive shaft 32 configured to be rotate within the catheter 12 extend from the front end 12a and to the opposite rear end 12b, and ultimately to a rotary drive mechanism 20a), extends from the distal end to at least up to the proximal end, and forms a transport channel (col 3 line 65 - col 4 line 8, the drive shaft 32 extends along the catheter 12 and configured to transport dislodged deposit from the front end 12a and along the length of the catheter) over a length extending along the catheter tube, wherein the catheter tube has at least one opening (figures 2-3, openings formed by shearing slots 14b and 14c in the front end 12a on a surface of the catheter 12) in the region of the distal end on a shell surface and the hollow body forming a scraping edge which interacts with the at least one opening (figures 2-7 col 4 lines 40-51, the flexible drive shaft 32 interact with shearing slots 14b and 14c and scraping the dislodged deposit into the catheter).
Regarding claim 2, Straub teaches the conveying device according to claim 1.
Straub further teaches the hollow body is provided over the length with at least one radially extending scraping segment (annotated figure, the drive aft 32 is provided with at least one scraping element).
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Regarding claim 3, Straub teaches the conveying device according to claim 1.
Straub further teaches the hollow body being formed by a helix (figure 8 and col 5 lines 9-16, helical drive shaft 32).
Regarding claim 5, Straub teaches the conveying device according to claim 1.
Straub further teaches the catheter tube having an axial stop for the hollow body at the distal end (figures 2 and 3 and col 4 line 55-67, front end 16a provides an axial stop for the drive shaft 32 from escaping).
Regarding claim 7, Straub teaches the conveying device according to claim 1.
Straub further teaches comprising a coupling unit (figure 1, discharge chamber 18) with a coupling housing (figure 1, housing of the discharge chamber 18) having a catheter tube connection (figure 1, rear end 12b is connected to discharge chamber 18) and a suction line connection (figure 1, pipe 26) which communicate with a flow channel surrounded by the coupling housing (col 3 line 45-65 figure 1, a flow channel formed within the discharge chamber 18 at least communicates with the catheter 12 allowing the collected deposit flows into the container 28)
Regarding claim 9, Straub teaches the conveying device according to claim 7.
Straub further teaches the suction line connection, the catheter tube connection and/or the drive element having an internal diameter (figure 1 and col 3 lines 19-30, the drive shaft 32 is configured to be coupled to the drive unit 20 through the discharge chamber 18. Accordingly, the discharge chamber 18 include at least one opening that allows the passage of the drive shaft 32), which is configured to a manner adapted for the passage of the hollow body.
Claim Rejections - 35 USC § 103
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, 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 6, 8, 13, 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Straub (US 5873882 A) in view of Henley (US 5569178 A).
Regarding claim 6, Straub teaches the conveying device according to claim 1.
Straub further teaches the hollow body being coupled to the drive element (figure 1 col 3 line 20-30, the drive shaft 32 coupled to drive unit 20)
Straub does not expressly teach the hollow body being insertable into the drive element.
In the same field of endeavor, namely a power assisted suction lipectomy device, Henley teaches a hollow body being insertable into the drive element (figures 3 and 6, proximal end 21 of rotatable member 13 being insertable into drive shaft connector means 15a).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub to incorporate the teachings of Henley and provide the drive element and hollow body as claimed for the purpose of releasably connecting the hollow body to a motor and effectively transferring rotation from the motor to the hollow body as taught by Henley (col 5 lines 14-45).
Regarding claim 8, Straub teaches the conveying device according to claim 7.
Straub does not expressly teach comprising a drive element rotatably supported on the coupling housing for driving the hollow body.
In the same field of endeavor, namely a power assisted suction lipectomy device, Henley teaches a drive element (figures 3 and 6, drive shaft connector means 15a rotatably supported on the handle portion housing 11 for driving the shaft 17) rotatably supported on the coupling housing for driving the hollow body.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub to incorporate the teachings of Henley and provide the drive element as claimed for the purpose of releasably connecting the hollow body to a motor and effectively transferring rotation from the motor to the hollow body as taught by Henley (col 5 lines 14-45).
Regarding claim 13, Straub teaches the conveying device according to claim 1.
Straub does not teach a flushing line communicating with at least one of the catheter tube, the suction line, or with the flow channel.
In the same field of endeavor, namely a power assisted suction lipectomy device, Henley teaches a flushing line (figure 6, irrigation lumen 67 in fluid communication with cannula 12) communicating with at least one of the catheter tube, the suction line, or with the flow channel.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, to incorporate the teachings of Henley and provides the flushing line as claimed for the purpose of delivering an irrigation solution to provide lubrication for the mechanical parts and facilitate transport of the fragments of avulsed tissue through the cannula as taught by Henley (col 3 line 34- 44).
Regarding claim 14, Straub, as modified by Henley, teaches the conveying device according to claim 6.
The combination further teaches comprising a drive (Straub; figure 1, drive unit 20) which can be drivingly coupled to the drive element (Straub; figure 1 and col 3 lines 20-25, rotary drive mechanism 20a drivingly coupled to drive unit 20).
The combination does not teach the device comprising a drive control associated with the drive, which is configured such that the hollow body can be rotated via the drive.
In the same field of endeavor, namely a power assisted suction lipectomy device, Henley teaches a drive control (col 5 line 10-36, speed control device controls speed of rotary motor) associated with the drive, which is configured such that the hollow body can be rotated via the drive.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, as modified by Henley, to incorporate the teachings of Henley and provides the drive control associated with the drive for the purpose of control speed of rotation of the hollow body as taught by Henley (col 5 lines 10-36).
Regarding claim 19, Straub teaches the conveying device according to claim 1.
Straub does not teach further comprising a flushing line communicating with the catheter tube and with a suction line and with a flow channel.
In the same field of endeavor, namely a power assisted suction lipectomy device, Henley teaches a flushing line (figure 6, irrigation lumen 67 in fluid communication with cannula 12, suction port 68 and an aperture 19) line communicating with the catheter tube and with a suction line and with a flow channel.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, to incorporate the teachings of Henley and provides the flushing line as claimed for the purpose of delivering an irrigation solution to provide lubrication for the mechanical parts and facilitate transport of the fragments of avulsed tissue through the cannula as taught by Henley (col 3 line 34- 44).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Straub (US 5873882 A) in view of Henley (US 5569178 A), and in further view of Carson et al (US 20190175211 A1)
Regarding claim 15, Straub, as modified by Henley, teaches the conveying device according to claim 14.
The combination does not teach the drive control having a torque detection and in that the detected torque enters the drive control.
In the same field of endeavor, namely a rotational medical device, Carson teaches a drive control having a torque detection and in that the detected torque enters the drive control ([0064]-[0065] motor state estimator 50 calculate or determine one or more states including a torque of motor and the calculated value enters the controller 52 to control motor).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, as modified by Henley, to incorporate the teachings of Carson and provides the drive control as claimed for the purpose of determining condition of the device including jam or stall condition as taught by Carson (abstract).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Straub (US 5873882 A) in view of Henley (US 5569178 A), and in further view of Mark (US 20100152533 A1)
Regarding claim 16, Straub, as modified by Henley, teaches the conveying device according to claim 14.
The combination does not teach the drive control being in a structural unit with a suction control of a suction pump which is assigned to a collection container which can be connected to the suction line.
In the same field of endeavor, namely a tissue removal device, Mark teaches the drive control (figure 21a, controller 132) being in a structural unit with a suction control (figure 21a, aspiration valve control line 150 of vacuum generator 153) of a suction pump which is assigned to a collection container (figure 21a, container 192 connected to suction line 151) which can be connected to the suction line.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, as modified by Henley, to incorporate the teachings of Mark and provides the drive control as claimed for the purpose of electrically controlling the conveying device as taught by Mark ([0086])
Regarding Claim 17, Straub, as modified by Henley, teaches the conveying device according to claim 14.
The combination does not teach the drive control being connected data-wise to a pressure sensor measuring a suction pressure in the suction line.
In the same field of endeavor, namely a tissue removal device, Mark teaches the drive control being connected data-wise to a pressure sensor ([0089]-[0091] and figure 22, vacuum sensor 164 positioned within the vacuum line 151 that measures the pressure and configured to be data-wise connected to control device 132) measuring a suction pressure in the suction line.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub, as modified by Henley, to incorporate the teachings of Mark and provide the pressure sensor as claimed for the purpose of providing a controllable vacuum level to the conveying device as taught by Mark ([0089]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Straub (US 5873882 A) in view of Mark (US 20100152533 A1)
Regarding claim 18, Straub teaches a method for operating a fluid conveying device for body fluid comprising a catheter tube (figure 1, catheter 12 including a cutting tool at front end 12a including stator 14 and rotor 16, the catheter 12 with stator 14 forming an continuous catheter tube) having a distal end and a proximal end (figure 1 front and rear ends 12a and b) and a hollow body (figures 2-4 and 8, flexible drive shaft 32, the drive shaft being hollow along its central axis and configured to be rotatable within the catheter 12) which hollow body is arranged longitudinally moveable and/or rotatable in the catheter tube, which hollow body extends from the distal end at least up to the proximal end (figure 1 col 3 lines 19-30, the stator extends from the front end to opposite rear end to be connected to drive unit 20), and forms a transport channel (col 3 line 65 – col 4 line 8, the drive shaft 32 extends along the catheter 12 and configured to transport dislodged deposit from the front end 12a to rear end 12b) over its length extending in the extension direction of the catheter tube., wherein the catheter tube has at least one opening (figure 2, figures 2-3, openings formed by slots 14b and 14c in front end 12a on a surface of the catheter 12) in the region of its distal end on its shell surface and the hollow body forming a scraping edge (figures 2-7 col 4 lines 40-51, the flexible drive shaft 32 interact with the slots 14b and 14c and scraping the dislodged deposits into the catheter) which interacts with the at least one opening which method the hollow body is moved longitudinally and/or rotated within the catheter tube while the catheter tube is held in place
Straub does not teach a negative pressure is applied at the proximal end of the catheter tube to convey by means of a suction pressure liquid through the transport channel and into a collection container.
In the same field of endeavor, namely tissue removal device, Mark teaches a negative pressure is applied at the proximal end of the catheter tube (figure 21a and [0061] vacuum is applied at the proximal end of catheter tube 44) to convey by means of a suction pressure liquid through the transport channel and into a collection container ([0062] removed tissue is conveyed by vacuum through the transport channel within the catheter tube and into a tissue collector 58).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Straub to incorporate the teachings of Mark and provide the method as claimed for the purpose of providing traction that pulls target tissue into the at least one opening thereby enabling cutting tissue by interaction between the aperture and hollow body as taught by Mark ([0081]).
Allowable Subject Matter
Claims 10-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art, alone or in combination, could be found to teach a conveying device comprising a coupling unit with a coupling housing having a catheter tube connection and a suction line connection which communicate with a flow channel surrounded by the coupling housing, and (claim 10) the flow channel being at least partially formed by a sleeve which is rotatably supported in the coupling housing and can be detachably connected to the hollow body in a non-rotating manner. Mark (US 20100152533 A1 ) and Noda (US 20010009645 A1) teaches the sleeve. Specifically, Mark teaches a sleeve (figure 20, cannula transfer 74 rotatably supported in housing connector 96 which can be detachably connected to outer cannula 44) which is rotatably supported in the coupling housing and can be detachably connected to the hollow body in a non-rotating manner. However, Mark fails to teach the flow channel (figure 20, flow channel defined by cannula 44) being at least partially formed by the cannula transfer 74. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design, because forming the flow channel at least partially by a sleeve which is rotatably supported in the coupling housing and can be detachably connected to the hollow body in a non-rotating manner as claimed would require necessitates additional seals and connectors to prevent risk of leakage and biological contamination without an improvement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/Examiner, Art Unit 3781