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
The amendment filed 12/23/2025 has been entered. Claims 1-3 and 5-19 are pending and under consideration.
Response to Arguments
Applicant’s arguments, see pages 6-10, filed 12/23/2025, with respect to rejections under 112, 102 and 103 have been fully considered and are persuasive. The rejection of 09/24/2025 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Straub et al (US 5873882 A), Henley (US 5569178 A), Carson et al (US 20190175211 A1) and Mark (US 20100152533 A1).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 14, a drive element, …, which is configured such that the hollow body can be rotated via the drive, and will Interpreted as mechanical drive element, for example of a gearbox, or a magnetic coupling sleeve illustrated in [0024]
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 (US 5873882 A).
Regarding claim 1, Straub teaches a conveying device (figure 1) for body fluid comprising a catheter tube (figure 1, catheter 12) 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 1-2 col 2 lines 20-42, helical stator 14 having hollow space along its axis and rotatable along the axis) which is arranged at least one of longitudinally moveable or rotatable in the catheter tube, extends from the distal end to 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 over a length extending along the catheter tube (col 3 line 65 - col 4 line 8, the stator comprising flexible drive shaft 32 configured as a convey worm and forming a transport channel to transport the deposit along the catheter tube), wherein the catheter tube has at least one opening (figure 2, slots 16b and 16c) in the region of the distal end on a shell surface and the hollow body forming a scraping edge (col 4 lines 15-21) which interacts with the at least one opening.
Regarding claim 2, Staub teaches the conveying device according to claim 1.
Staub further teaches the hollow body is provided over the length with at least one radially extending scraping segment (figures 2-3, cutting edges 14d of the stator).
Regarding claim 3, Staub teaches the conveying device according to claim 1.
Staub further teaches the hollow body being formed by a helix (figure 8 and col 5 lines 9-16).
Regarding claim 5, Staub teaches the conveying device according to claim 1.
Staub further teaches the catheter tube having an axial stop for the hollow body at the distal end (figures 2 and 3, front end 12a having closed end).
Regarding claim 7, Staub teaches the conveying deice according to claim 1.
Staub further teaches comprising a coupling unit (figure 1, discharge chamber 18 with its housing) with a coupling housing having a catheter tube connection (figure 1, rear end 12b is connected to discharge chamber 18) and a suction line connection (col 3 line 45-65 figure 1, connection between collection container 28 and discharge chamber 18 which forms a flow channel allowing deposits flow from the catheter into the collection chamber) which communicate with a flow channel surrounded by the coupling housing.
Regarding claim 9, Staub teaches the conveying deice according to claim 7.
Staub 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 catheter tube connection as set forth in claim 7 has an opening for catheter tube 12 adapted for the passage of the catheter 12 and stator 14) 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 a drive element (figure 1, col 3 lines 20-30, the stator is coupled to a rotary drive mechanism 20a)
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, Staub, as modified by Henley, teaches the conveying device according to claim 6.
The combination further teaches comprising a drive (Staub; figure 1, drive unit 20) which can be drivingly coupled to the drive element (Staub; 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 Staub, 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.
Staub 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, Staub, 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 Staub, 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, Staub, 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 Staub, 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, Staub, 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 Staub, 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, Staub teaches a method for operating a fluid conveying device for body fluid comprising a catheter tube (figure 1, catheter 12) having a distal end and a proximal end (figure 1 front and rear ends 12a and b) and a hollow body (figures 1-2 col 2 lines 20-42 helical stator 14 having hollow space along its axis and rotatable along its axis) 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, stator comprising flexible drive shaft 32 configured as a convey warm gear to transport the deposit along the catheter tube) over its length extending in the extension direction of the catheter tube., wherein the catheter tube has at least one opening (figure 2, slots 16b and 16c) in the region of its distal end on its shell surface and the hollow body forming a scraping edge (col 4 liens 15-21) 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
Staub 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 tot each 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 ) 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. Examiner did not find any teachings/motivation to modify the device to incorporate the claimed limitation above. 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 involves a multi-part assembly involving a sleeve while Mark utilizes a single-piece catheter flow channel. This modification 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SETH HAN/Examiner, Art Unit 3781
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