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 Amendment
The amendment filed 06/05/26 has been entered. Claims 1 and 13 have been amended. Claims 2-3, 5-12, and 15-22 are in the original form. Claims 4 and 14 are cancelled. Thus, claims 1-3, 5-13, and 15-22 remain pending in the application. Applicant’s reply has overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 01/05/26, hereinafter NFOA. Applicant confirms the axis of rotation is through the center of the device internal structure (see Applicant remarks page 6), rendering any channel extending on an xy plane “substantially perpendicular” thereto as previously interpreted by the examiner (see NFOA pages 2-5).
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.
(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 13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartmann et al. (U.S. Patent No. 12,226,595), hereinafter Hartmann.
Regarding claim 13, Hartmann discloses an apparatus, comprising:
a housing (device 400 with housing 406, see [0099]: device 400 is another example of a tube management device 36 as in [0042-0043] and FIG. 1)
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having a first port (416a, see ‘Modified FIG. 1’ above and ‘Modified FIG. 22’ below with [0100]: diametrically opposed tubing slots 416)
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and a second port (416b), the second port (416b) being coupleable to an indwelling vascular access device (30, see FIG. 1 and [0042-0043]: coupleable by way of tubing extending to device 30);
a catheter (28, see [0042]: tube management devices 36 have medication flowing through flexible tubing 28 that is delivered to cannula 24 and therefore tubing 28 reasonably a catheter) having a proximal end portion (portion of tubing 28 leading through spool and through first port toward reservoir 22, see ‘Modified FIG. 1’ above) and a distal end portion (portion of tubing 28 leading through second port toward vascular device 30, see ‘Modified FIG. 1’ above), the catheter (28) at least partially disposed in the housing (406, see [0104]) such that the proximal end portion (portion of tubing 28 leading through spool and through first port toward reservoir 22, see ‘Modified FIG. 1’ above) is received by the first port (416a, see [0104]: tubing inserted into slots 416);
an internal structure (404) disposed within a cavity of the housing (406), wherein the internal structure (404) comprises a conical structure (see ‘Modified FIG. 22’ above and [0101]: fillets on spindle 404 to form slot 422. A fillet has a roughly triangular cross-section and therefore is reasonably a conical structure) configured to support at least a portion of the catheter (tubing 28) between the conical structure (see [0101]: conical structure forms entrance to slot 422 that retains tubing. Therefore, conical structure also has tubing inserted therethrough and is “configured to support” catheter between the conical surface and internal surface of cavity) and an internal surface (inside face of 406, see ‘Modified FIG. 22’ above) of the cavity (see ‘Modified FIG. 22’ above); and
an actuator (402, see [0104]: turning 402 also rotates spindle 404) separate from the internal structure (404, see ‘Modified FIG. 22’ above. 404 and 402 are distinct elements), the actuator (402) configured to be rotated relative to the housing (see [0100]: 402 rotated relative to 406 and [0104]) to move the distal end portion of the catheter (portion of tubing 28 leading through second port toward vascular device 30, see ‘Modified FIG. 1’ above) a linear distance from a first position in which the distal end portion of the catheter is disposed in the housing, to a second position in which the catheter extends through the second port such that the distal end portion of the catheter is distal to the indwelling vascular access device when the second port is coupled thereto (configured to is functional language. Because Hartmann discloses the actuator 402 rotating relative to the housing such that the tubing length is extended or retracted outside of the housing, the device is capable of moving the distal end portion of the catheter a linear distance “from a first position in which the distal end portion of the catheter is disposed in the housing, to a second position in which the catheter extends through the second port such that the distal end portion of the catheter is distal to the indwelling vascular access device when the second port is coupled thereto”), and wherein the conical structure has a longitudinal axis (longitudinal axis extending through conical structure/fillet at 422 and through tube slot 422, see [0101]) substantially parallel to (see [0104]: tube slot 422 aligned with tube slots 416 and therefore slots 422&416 are parallel) a longitudinal axis (axis through tube slots 416, see [0104]) of the distal end portion of the catheter extending through the second port (416b, see ‘Modified FIG. 1’ above).
Regarding claim 15, Hartmann discloses the apparatus of claim 13, and Hartmann further discloses wherein at least a portion of the catheter (tubing 28) is configured to be wound around (See [0104]: tubing winds around spindle) the internal structure (404, see FIG. 22).
Regarding claim 16, Hartmann discloses the apparatus of claim 13, and Hartmann further discloses wherein the actuator (402, see ‘Modified FIG. 22’ above) is coupled to (see [0103]: rim 442 of actuator 402 mates with rim 410 of housing 406. See numeral 442 in FIG. 23) the housing (406) at a position proximate (rims are coupled together and second port 416b is on rim 410. Therefore the coupling is “proximate” the second port) the second port (416b) of the housing (406).
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-12, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Spataro et al. (U.S. Patent No. 12,226,595), hereinafter Spataro, in view of Toyoda et al. (U.S. Patent No. 6,038,362), hereinafter Toyoda.
Regarding claim 1, Spataro discloses an apparatus, comprising:
a housing (26) having a first port (51, see col. 7 lines 53-63 and FIG. 2H or ‘Modified FIG. 2I’ below)
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and a second port (48, see FIG. 2F and col. 6 lines 26-28 or ‘Modified FIG. 2I’ above), the second port (48) being coupleable to an indwelling vascular access device (24, see col. 3 line 60- col. 4 line 2: device 22 delivers instrument through 24 and therefore 22 including housing 26 must be coupleable to 24. And 24 disclosed as a tubing, such as a catheter);
a catheter (42, see col. 7 lines 44-52: blood draw tubing) having a proximal end portion (see col. 8 line 10) and a distal end portion (40, see FIG. 2F), the catheter (42) at least partially disposed in (see FIG. 2F) the housing (26) such that the proximal end portion (see col. 8 line 10) is received by the first port (see col. 7 line 53- col. 8 line 16: proximal end of 42 coupled to tubing 50 and tubing 50 connected to port 51 and therefore the proximal end of 42 is received by port 51); and
an actuator (49, see FIG. 2D), wherein the actuator (49) comprises an engagement portion (45, see FIG. 2D and col. 5 lines 36-38, col. 5 lines 62-63, and col. 5 line 64- col. 6 line 2: user grabs protrusion 45 to rotate the rotary element 28) disposed outside of (see ‘Modified FIG. 2I’ above) the housing (26) and a shaft portion (28) disposed within (see col. 4 lines 11-12: rotary element 28 disposed within housing 26) the housing (26), wherein the shaft portion (28) is configured to engage a portion of the catheter (42, see col. 5 lines 25-38: 42 disposed in groove 44 of shaft 28 and is thus configured to engage the tubing 42 as shown in FIG. 2F) in the housing (26), the actuator (49) configured to be rotated relative to the housing (26, see col. 6 lines 33-35: 28 rotates with respect to housing 26) to move the distal end portion (40) of the catheter (42) a linear distance from a first position (see col. 6 lines 33-38: rotation moves instrument 42 outside housing such as via port 48. Therefore, before rotation moves instrument 42, 42 is within the housing at a first position) in which the distal end portion (40) of the catheter (42) is disposed in the housing (26), to a second position (position in FIG. 2C) in which the catheter (42) extends through the second port (48, see ‘Modified FIG. 2I’ above) such that the distal end portion (40) of the catheter (42) is distal to (as seen in FIG. 2C) the indwelling vascular access device (24) when the second port (48) is coupled thereto (such as shown in FIG. 2C),
wherein the shaft portion (28) comprises a first spool structure (spool structure definition is a “reel” or a cylindrical structure for winding tubular structures, see ‘Modified FIG. 2G’ below with cylindrical structure of interior of 28)
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and
wherein a first channel (44, see col. 5 lines 25-38: 42 disposed in groove 44) is defined between (44 extends “between” the surfaces as shown in “Modified FIG. 2G’ above) an outer surface (see ‘Modified FIG. 2G’ above) of the first spool structure and an inner surface (see ‘Modified FIG. 2G’ above) of the housing (26), and wherein the catheter (42) traverses at least a portion of (see FIG. 2G and see col 7 lines 11-35: catheter 42 disposed in channel 44 and may extend to other locations) the first channel (44).
Spataro is silent to “and a second spool structure at least partially disposed within the first spool structure, wherein the first spool structure is rotatable with respect to the second spool structure,”, “a second channel is defined within the second spool structure, and a third channel is defined between the first spool structure and the second spool structure.”, and wherein the catheter traverses at least a portion of “each of” the first channel, “second channel, and the third channel.”
However, Toyoda teaches an apparatus (see FIG. 12) comprising a housing (500) and a shaft portion (see col. 14 lines 56-67: unillustrated support shaft has reels 300/400 easily rotatable about the center of shaft), wherein the shaft portion (not shown in FIG. 12) is configured to engage a portion (see best visual of the shaft in FIG. 6 and described again in col. 13 lines 19-25. Shaft not shown again in embodiment of FIG. 12 and thus FIG. is referred to only for visual clarity. Shaft portion “configured to” engage tubing within the housing because shaft located within housing and the reels upon which tubing is wrapped is wrapped around shaft) of a tubing (10,20) within the housing (500), wherein the shaft portion comprises a first spool structure (300) and a second spool structure (400) at least partially disposed within (see col. 14 lines 32-36: 400 accommodated within recess of 300) the first spool structure (300), wherein the first spool structure (300) is rotatable with respect to (see col. 15 line 38- col. 16 line 50: 300/400 mutually independently rotatable and windings of tubing with “winding direction-reversing means” would enable independent rotation) the second spool structure (400), and wherein a first channel (see ‘Modified FIG. 12 & 13C’ below and col. 15 lines 37-43)
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is defined between an outer surface (circumferential wall 306) of the first spool structure (300) and an inner surface (see ‘Modified FIG. 12 & 13C’ above) of the housing (500), a second channel (see ‘Modified FIG. 12 & 13C’ above and see col. 15 lines 51-63: cables wound into winding space 412 from coupler 22) is defined within the second spool structure (400), and a third channel (see ‘Modified FIG. 12 & 13C’ above and see col. 15 lines 43-50: fiber wound along winding-reversing means via guide strips 314/316) is defined between (400 overlays 300, see col. 14 lines 32-36: 400 accommodated within recess of 300 and therefore the third channel as shown is “between” 300/400) the first spool structure (300) and the second spool structure (400), wherein at least one of a tubular device traverses at least a portion of each of the first channel (see ‘Modified FIG. 12 & 13C’ above and col. 15 lines 37-43), the second channel (see ‘Modified FIG. 12 & 13C’ above and see col. 15 lines 51-63: cables wound into winding space 412 from coupler 22), and the third channel (see ‘Modified FIG. 12 & 13C’ above and see col. 15 lines 43-50: fiber wound along winding-reversing means via guide strips 314/316).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft portion disclosed in Spataro to include a first and second spool comprising the three channels as taught by Toyoda for the purpose of forming a reel system for housing an extended length of tubing in a compact form (see col. 1 lines 4-11. Such a modification which would be advantageous to Spataro for using the rotary element to house additional/ extended lengths of catheter such that the device could be used for many different procedures requiring different lengths of catheter), that has a winding direction-reversing section between the spool structures (see col. 11 line 60-67: note FIG. 12 also comprises the winding direction reversing section, see col 13 lines 53-59. Such a modification is advantageous to Spataro as the winding direction-reversing section allows for the tubing to enter/exit the reel from any position and thus would minimize stress at the ports and expand the placement options of the ports), thus achieving “and a second spool structure at least partially disposed within the first spool structure, wherein the first spool structure is rotatable with respect to the second spool structure,” and “a second channel is defined within the second spool structure, and a third channel is defined between the first spool structure and the second spool structure.”
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the first, second, and third channels taught by Spataro in view of Toyoda to traverse at least a portion of the tubing therethrough as taught by Toyoda for the purpose of winding an extended length of tubing through multiple coil channels such that the tubing is held in a compact form (see col 1 lines 4-11), thus achieving wherein the catheter traverses at least a portion of “each of” the first channel, “second channel, and the third channel.”
Regarding claim 2, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses wherein a portion (the interior housing rotary element 28) of the housing (26, see FIG. 2F) has a circular cross- sectional shape (such as shown in at least FIG. 2F and see col 4 lines 12-15: housing 26 has generally cylindrical inner and outer surface and therefore any cross section on the height of those cylinders would be circular).
Regarding claim 3, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses wherein the engagement portion (45, see FIG. 2D) of the actuator is one of a rotary switch, a rotary button, a tab, a knob, or a dial (see col. 5 line 67 – col. 6 line 2: user “takes hold” of 45 to rotate==turn the rotary. Therefore, the engagement portion 45 meets the definition of at least a knob).
Regarding claim 5, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses wherein at least a portion of the catheter (42, see FIG. 2F) is configured to be wound around (see col. 5 lines 25-38: 42 disposed in groove 44 of shaft 28 and is thus configured to “wound around” the shaft portion) the shaft portion (28) of the actuator (49).
Regarding claim 6, the modified system of Spataro teaches the apparatus of claim 5, but Spataro is silent to “wherein one or more 360° turns of the catheter are wound around the shaft portion of the actuator.”
However, Toyoda teaches an apparatus (see FIG. 12) comprising a housing (500) and a shaft portion (see col. 14 lines 56-67: unillustrated support shaft has reels 300/400 easily rotatable about the center of shaft) engaging a tubing (10,20), wherein one or more 360° turns of the tubing are wound around the shaft portion (see col. 15 lines 22-63: winding of tubing around reels 300/400 which are disposed on the shaft portion and therefore the tubing is wound around the shaft portion as well. See also col 1 lines 1-11 a predetermined number of turns).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft portion disclosed in Spataro to include one or more 360° turns of the tubing wound around the shaft portion as taught by Toyoda for the purpose of forming a reel system for housing an extended length of tubing in a compact form (see col. 1 lines 4-11), which would be advantageous to Spataro for using the rotary element to house additional lengths of catheter such that the catheter could be used in different procedures needing different lengths of catheter, thus achieving “wherein one or more 360° turns of the catheter are wound around the shaft portion of the actuator.”
Regarding claim 7, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses wherein the housing (26, see FIG. 2G) comprises one or more internal structures (housing wall as seen in FIG. 2G, see col 7 lines 25-35: housing blocks 42 from exiting device and is therefore “configured to” support the catheter 42) configured to support the catheter (42).
Regarding claim 8, the modified system of Spataro teaches the apparatus of claim 7, and Spataro further discloses wherein the one or more internal structures (housing wall as seen in FIG. 2G) comprise one or more walls (housing wall as seen in FIG. 2G, see col 7 lines 25-35: housing blocks 42 from exiting device), partitions, protrusions, ridges, ribs, channels, or rollers.
Regarding claim 9, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses wherein the proximal end portion of the catheter (42, see FIG. 2H) is coupled to the first port (51, see col. 7 line 53- col. 8 line 16: proximal end of 42 coupled to tubing 50 and tubing 50 connected to port 51 and therefore the proximal end of 42 is coupled to the port 51 by way of the tubing) and maintained in a fixed position when the catheter is moved from the first position to the second position (see col. 7 lines 60-67: devices coupled to tubing at connector may remain stationary in response to rotation of rotary element 28).
Regarding claim 10, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses wherein the catheter (42, see FIG. 2H) comprises a first section (proximal half of 42 with proximal end coupled to port 51, see col. 7 line 53- col. 8 line 16) and a second section (distal half of 42 including distal end 40 as shown in FIG. 2F).
Regarding claim 11, the modified system of Spataro teaches the apparatus of claim 10, and Spataro further discloses wherein the first section (proximal half including proximal end) of the catheter (42) is fixedly coupled (see col. 7 line 53- col. 8 line 16: proximal end of 42 coupled to tubing 50 and tubing 50 connected to port 51 and therefore the proximal end of 42 is coupled to the port 51 by way of the tubing and see col. 7 lines 60-67: devices coupled to tubing at connector may remain stationary in response to rotation of rotary element 28) to the first port (51) of the housing (26) and coupled to a port (see FIG. 2D and col 5 lines 25-38: groove extends to center of rotary element 28 of actuator 49 and see col 7 lines 11-25: groove leads to port, such as through central axis of rotation 29, to exit rotary element 28) of the actuator (49).
Regarding claim 12, the modified system of Spataro teaches the apparatus of claim 10, and Spataro further discloses wherein the second section (distal half including distal end 40) of the catheter (42) extends from the shaft portion (28) of the actuator (49) to the second port (48, see FIG. 2F) of the housing (26).
Regarding claim 21, the modified system of Spataro teaches the apparatus of claim 1, and Modified Spataro further teaches wherein the second channel (see ‘Modified FIG. 12 & 13C’ above) extends substantially perpendicular to an axis of rotation (z-axis shown by dashed exploded lines in Modified FIG. 12 above) of the first spool structure (any “channel” extending on the xy plane would be “substantially perpendicular” to an axis of rotation defined by the z-axis as confirmed by Applicant on page 6 in the remarks filed 06/05/26. Therefore, the second channel taught by Spataro in view of Toyoda meets the limitation as claimed).
Again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft portion disclosed in Spataro to include a first and second spool comprising the three channels as taught by Toyoda for the purpose of forming a reel system for housing an extended length of tubing in a compact form (see col. 1 lines 4-11. Such a modification which would be advantageous to Spataro for using the rotary element to house additional/ extended lengths of catheter such that the device could be used for many different procedures requiring different lengths of catheter), that has a winding direction-reversing section between the spool structures (see col. 11 line 60-67: note FIG. 12 also comprises the winding direction reversing section, see col 13 lines 53-59. Such a modification is advantageous to Spataro as the winding direction-reversing section allows for the tubing to enter/exit the reel from any position and thus would minimize stress at the ports and expand the placement options of the ports), thus achieving the “second channel” relevant to claim 21.
Regarding claim 22, the modified system of Spataro teaches the apparatus of claim 1, and Spataro further discloses the first spool structure (spool structure definition is a “reel” or a cylindrical structure for winding tubular structures, see ‘Modified FIG. 2G’ above with internal cylindrical structure of 28) rotating in a first direction (see col. 6 lines 33-35: 28 rotates with respect to housing 26), but Spataro is silent to “wherein rotation of the first spool structure in a first direction causes rotation of the second spool structure in a second direction opposite the first direction.”
However, Toyoda teaches an apparatus (see FIG. 12) comprising a housing (500) and a shaft portion (see col. 14 lines 56-67: unillustrated support shaft has reels 300/400 easily rotatable about the center of shaft), wherein the shaft portion comprises a first spool structure (300) and a second spool structure (400), wherein rotation of the first spool structure (300) in a first direction causes rotation of the second spool structure (400) in a second direction opposite the first direction (see col 13 lines 53-59 and col 15 lines 22-50: winding direction reversing section would change the rotation directions from one spool structure to the other).
Therefore, again, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft portion disclosed in Spataro to include a first and second spool comprising the three channels as taught by Toyoda for the purpose of forming a reel system for housing an extended length of tubing in a compact form (see col. 1 lines 4-11. Such a modification which would be advantageous to Spataro for using the rotary element to house additional/ extended lengths of catheter such that the device could be used for many different procedures requiring different lengths of catheter), that has a winding direction-reversing section between the spool structures (see col. 11 line 60-67: note FIG. 12 also comprises the winding direction reversing section, see col 13 lines 53-59. Such a modification is advantageous to Spataro as the winding direction-reversing section allows for the tubing to enter/exit the reel from any position and thus would minimize stress at the ports and expand the placement options of the ports), thus achieving “wherein rotation of the first spool structure in a first direction causes rotation of the second spool structure in a second direction opposite the first direction.”
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hartmann (U.S. PGPUB No. 2020/0276383) in view of Harrison et al. (U.S. Patent No. 7,533,841), hereinafter Harrison.
Regarding claim 17, Hartmann discloses an apparatus, comprising:
a housing (device 400 with housing 406, see [0099]: device 400 is another example of a tube management device 36 as in [0042-0043] and FIG. 1)
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having a first port (416a, see ‘Modified FIG. 1’ above and ‘Modified FIG. 22’ below with [0100]: diametrically opposed tubing slots 416)
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and a second port (416b), the first port (416a) being disposed in a central portion (406, see [0099-0100]) of the housing (406) and the second port (416b) being coupleable to an indwelling vascular access device (30, see FIG. 1 and [0042-0043]: coupleable by way of tubing extending to device 30);
a catheter (28, see [0042]: tube management devices 36 have medication flowing through flexible tubing 28 that is delivered to cannula 24 and therefore tubing 28 reasonably a catheter) having a proximal end portion (portion of tubing 28 leading through spool and through first port toward reservoir 22, see ‘Modified FIG. 1’ above) and a distal end portion (portion of tubing 28 leading through second port toward vascular device 30, see ‘Modified FIG. 1’ above), the catheter (28) at least partially disposed in the housing (406, see [0104]) such that the proximal end portion (portion of tubing 28 leading through spool and through first port toward reservoir 22, see ‘Modified FIG. 1’ above) is received by the first port (416a, see [0104]: tubing inserted into slots 416); and
an actuator (402, see [0104]: turning 402 also rotates spindle 404) comprising a first engagement structure (420a, see ‘Modified FIG. 22’ above and [0101]) and a second engagement structure (420a, see ‘Modified FIG. 22’ above) disposed in the housing (406, see [0099]), wherein the actuator (402) defines an inner channel (422, see [0102] & [0104]: channel 444 aligned with 416 and tubing inserted therein) extending between (see ‘Modified FIG. 22i’ below) the first engagement structure (420a) and the second engagement structure (420b),
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and an outer channel (see ‘Modified FIG. 22i’ above—the outer channel is the volume above the area filled in black. See [0104]: tubing winds around spindle and therefore the volume above the filled plate would be where the tubing rests after winding, forming a channel) extending between the actuator (402) and the housing (406, see [0104]: tubing winds around spindle), wherein the outer channel (see ‘Modified FIG. 22i’ above—the outer channel is the volume above the area filled in black.) has (i) a first portion defined between (the first portion would be the volume above the area filled in black and surrounding the outer surface of 420a) an outer surface (see ‘outer surface of 420a’ in ‘Modified FIG. 22i’ above) of the first engagement structure (420a) and the housing (406), and (ii) a second portion defined between (the second portion would be the volume above the area filled in black and surrounding the outer surface of 420b) an outer surface (see ‘outer surface 420b’ in ‘Modified FIG. 22i’ above) of the second engagement structure (420b) and the housing (406), and wherein the inner (422) and outer channels (first and second portions of channels as explained above) are each configured to receive at least a portion of the catheter (see [0102] & [0104]: tubing inserted into inner channel and see [0104]: tubing winds around spindle and thus the outer channels receive a portion of the catheter).
Hartmann is silent to “the first engagement structure being larger than the second engagement structure”.
However, Harrison teaches an apparatus for retaining tubular elements therein (see col. 1 line 60- col. 2 line 16), the apparatus comprising a first engagement structure (see ‘Modified FIG. 2’ below. the first engagement structure formed by base 114 extending to s-shaped channel, see col. 3 lines 18-29) and a second engagement structure (see ‘Modified FIG. 2’ below, the second engagement structure follows circumferential surface 307 extending to s-shaped channel, see col. 4 lines 10-16. FIG. 4 shows circumferential surface 307),
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the first engagement structure (see ‘Modified FIG. 2’ above. the first engagement structure formed by base 114 extending to s-shaped channel) being larger than (see ‘ Modified FIG. 2’ above) the second engagement structure (see ‘Modified FIG. 2’ above, the second engagement structure follows circumferential surface 307 extending to s-shaped channel).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator comprising the spool structure with first engagement and second engagement structures disclosed in Hartmann to include a spool structure with the first engagement structure being larger than the second engagement structure as taught by Harrison for the purpose of reducing the possibility of kinks in the tubing (see col. 4 line 65- col. 5 line 12: additional circumferential pathways—such as by circumferential path 307 provided on the second engagement structure—reduce kinking), thus achieving “the first engagement structure being larger than the second engagement structure”.
Regarding claim 18, the modified system of Hartmann teaches the apparatus of claim 17, and Hartmann further discloses wherein the outer channel (see ‘Modified FIG. 22i’ above—the outer channel is the volume above the area filled in black) is circular (circular area filled in is a cross-section of the channel—which is the cylindrical volume formed above the filled in area. Thus, the channel is circular in cross-section).
Regarding claim 19, the modified system of Hartmann teaches the apparatus of claim 17, and Hartmann further discloses wherein the actuator (402, see FIG. 22) is movably coupled to (see [0100]: 402 turns relative to housing 406 and is therefore movable coupled and [0104]: coupling of components 402/404/406) the housing (406).
Regarding claim 20, the modified system of Hartmann teaches the apparatus of claim 19, and Hartmann further discloses wherein the first (420a, see ‘Modified FIG. 22’ above) and second engagement structures (420b) are coupled to the proximal end portion of the catheter (proximal end portion of catheter 28 leads through spool and through first port toward reservoir 22, see ‘Modified FIG. 1’ above. Thus, the spool including first and second engagement structures as shown in ‘Modified FIG. 22’ is coupled to the proximal end portion of the catheter tubing).
Response to Arguments
Applicant's arguments filed 06/05/26 have been fully considered but they are not persuasive.
On pages 7-8 of Applicant remarks, Applicant argues that Hartmann fails to disclose a conical structure and instead discloses a “rounded cross-like cavity” and therefore the 35 U.S.C. § 102 claim rejections under Hartmann should be withdrawn. The examiner disagrees and has maintained the 35 U.S.C. § 102 claim rejections under Hartmann.
Hartmann discloses the conical structure (see ‘Modified FIG. 22’ above provided by the examiner) being a fillet (see [0101] as cited in the NFOA on page 8 and again in the final rejection of claim 13 above for the conical structure). The definition of a fillet forms an angle between two surfaces, forming a roughly triangular cross-section and therefore the examiner maintains that the cross-section (as shown in ‘Modified FIG. 22’ and described in [0101]) of the fillet is a “conical structure” and thus meets the limitation as claimed. Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 102 claim rejections under Hartmann.
Next, on page 10, Applicant argues that Toyoda fails to teach any “channels”. The examiner disagrees because Toyoda discloses the tubing being wound through the spools/ other “channels” as set forth by the examiner in the rejection of at least claim 1 above. Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 claim rejection under Spataro in view of Toyoda.
On pages 9-10, Applicant argues that Toyoda teaches away from a combination with Spataro because Toyoda has multiple internal spools/reels while Spataro only has one. However, Toyoda teaches the “multiple” reels 300/400 can be formed as one single unit (see col 17 lines 46-52). Thus, although the prior art teaching may have conflict (i.e.: Spataro generally teaches one spool/reel while Toyoda teaches two separate spools integrated into a single design), the disclosures may still be combined when the references would not have “deterred one of ordinary skill in the art from using” the teachings (see MPEP § 2143.01.II). A person of ordinary skill in the art would have found it obvious (as suggested by Toyoda in col 17 lines 46-52) to form the multiple spools as one integrated unit while maintaining the separately taught spool structures/ channels of Toyoda. Thus, a combination of a single reel disclosed in Spataro with a “one unit” design with multiple internal structures taught by Toyoda would have been obvious to one of ordinary skill in the art. Further, a person of ordinary skill in the art would have had a reasonable expectation of success for this combination since the “one unit” design is already suggested in the teachings of Toyoda. Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 claim rejection under Spataro in view of Toyoda.
On pages 9-10, Applicant further argues that Toyoda teaches away from a combination with Spataro because Toyoda winds multiple tubular elements while Spataro only winds one tubular element. However, “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art…” (see MPEP 2123.I). Generally, Toyoda teaches that winding tubular elements through different channels allows extended lengths of tubular elements to be confined within the device. Thus, a person of ordinary skill in the art would have found it obvious to use the multiple spool structures/ channels taught in Toyoda to wind the catheter of Spataro such that an extended length of a catheter could be housed internally within the device. Again, although the prior art teaching may have conflict (i.e.: Spataro generally winding one tubular element while Toyoda teaches windings multiple tubular elements), the disclosures may still be combined when the references would not have “deterred one of ordinary skill in the art from using” the teachings (see MPEP § 2143.01.II). There is nothing in Toyoda that would have deterred a person of ordinary skill in the art from using the structures/ channels for winding a single tubular element. Lastly, a person of ordinary skill in the art would have had reasonable expectation of success for the combination because Spataro also discloses using other structures on the reel to guide/wind the catheter therethrough (see col 6 lines 29-36: the groove and other channels such as a channel between the actuator and housing can guide the catheter 42 and see col 7 lines 11-35: “the instrument 42 may exit the rotary element 28 at another location other than the central axis of rotation 29, and the groove 44 may extend to the other location”. Thus, the groove 44 could extend to another channel such as taught in Toyoda with reasonable expectation for success). Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 claim rejection under Spataro in view of Toyoda.
On pages 11-12, Applicant submits that Hartmann’s key slot opening 424 cannot be a channel and therefore the 35 U.S.C. § 103 rejection of claim 17 under Hartmann in view of Harrison should be withdrawn. However, this is a mischaracterization of the rejection because the examiner has noted Hartmann’s inner channel being element 422 (see at least Modified FIG. 22i’ above and page 24 of the NFOA), not 424. Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 claim rejection under Hartmann in view of Harrison.
On page 12, Applicant argues that the symmetrical structures of 114 in Harrison must be used as the first and second engagement structures, but the examiner disagrees because this argument does not align with the breadth of the claim language. Harrison clearly teaches two separate engagement structures (as outlined by the examiner in ‘Modified FIG. 2’ and taught in the different column and line citations provided by the examiner). Harrison FIG. 3 and 4 also further show the smaller/second engagement structure 307 from a side view. Claim 17 does not require symmetrical structures and Harrison is only relied upon to teach the first engagement structure “larger” than the second. Thus, the examiner maintains that the combination of Hartmann in view of Harrison teaches the limitation as claimed. Further, this argument borders on a piecemeal analysis of the references and "one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references" (see MPEP § 2145.IV). Therefore, the examiner was not persuaded by this argument and maintained the 35 U.S.C. § 103 claim rejection under Hartmann in view of Harrison.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
