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 remarks and amendments filed on 1/22/26 have been entered. The previous objections and 112(b) rejections are withdrawn in light of the amendments filed. Claims 28-33 are new. Claims 15-33 are pending.
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.
Claims 15-19, 20-23, 26, 28-30 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Schulz-Stubner (U.S. 20070083100, April 12, 2007)(hereinafter, “Schulz”) in view of Querfurth (U.S. 20040230124, Novmber 18, 2004)(hereinafter, “Querfurth”).
Regarding Claim 15, Schulz teaches: A cerebrospinal fluid drainage system for ventricular draining (Fig. 1, [0020]), comprising:
an External Ventricular Drain (EVD) or Ventriculo-Peritoneal Shunt (VPS) probe comprising a flexible tube (Figs. 1-2, element 20 and Fig. 3 element 120, ventriculostomy catheter device, [0020] [0022]); and
a stylus comprising a rigid tube configured to be inserted into the flexible tube, the stylus including an ultrasound transducer at a distal end of the rigid tube, a diameter of the rigid tube corresponding to an inner diameter of the flexible tube, the rigid tube containing only one or more wires coupled with the ultrasound transducer and not containing an optical fiber, the ultrasound transducer having a diameter at least substantially identical to the diameter of said the rigid tube, the ultrasound transducer having an imaging depth extending along an axis of the rigid tube, the stylus comprising a feature located and configured to couple the stylus to the flexible tube, the distal end of the flexible tube being closed by a deformable tip (Fig. 2, element 26 and Fig. 3, element 126, stylet, [0021-0022], “A steering cable (not shown) in stylet 26 is used to provide lateral guidance to stylet 26 and also catheter 22 as catheter 22 is longitudinally advanced. Proximal portions of stylet 26 and catheter 22 (not shown) are coupled or in engagement such that they are advanced longitudinally together.” [0021]; “…ultrasonic probe 128 is positioned within lumen wall 124 of catheter 122 and is connected via cable(s) 24 (FIG. 1) to a processing device and display (not shown) for producing 2-D ultrasound images.…stylet 126 may be provided without fiber optics 130.” [0022]; “A separate ultrasound probe lumen defined in the catheter wall 124 may be open at the distal end to allow at least a portion of the ultrasound probe to be extended out the distal end of catheter 122. Alternatively, an ultrasound probe lumen may be partially closed in such a manner that the lumen fluidly communicates with the external environment but the ultrasound probe cannot extend from the lumen. Alternatively, an ultrasound probe lumen may be a closed or blind lumen such that there is no fluid communication between the probe and the brain environment.” [0025]”; See Figs. 2-3); and
with regards to limitations: an echograph comprising a screen for displaying an anatomical image calculated in B-mode as a function of signals supplied by the ultrasound transducer, Schulz further teaches: (“…a signal processor and an imaging device (such as a computer screen) is provided that is responsive to signals from the transducers to provide a substantially real time visual display. The display may be 2 dimensional or 3 dimensional and the display may be of local objects in the brain (e.g. tissue, blood or fluid flow) and/or the relative relationship between such objects and surgical instruments (such as the catheter or objects inserted there through).” [0031]).
Schulz does not explicitly teach the anatomical image is calculated in B-mode.
Querfurth in the field of intracranial pressure systems teaches: “…the CDI device 22 is multimodal, and one mode (B-mode) of the device 22 can provide an image of an organ; another mode (C-mode) of the device 22 can provide a visualization of the anterograde arterial flow; and another mode (D-mode) of the device 22 can measure arterial flow velocities.” [0044];“ …the Doppler probe 21 and CDI device 22 are structured and arranged to send a visual image, e.g., two-dimensional, black and white image, of the optic nerve head of the eye in the orbit 25 to the CDI device 22, e.g., using the B-mode; to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity.” [0045].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the displayed anatomical image in Schulz to be calculated in B-mode as taught in Querfurth to provide real-time representations of the organ(s) to aid in image diagnosis and guidance procedures.
Regarding Claim 16, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz furth teaches: wherein the deformable tip is hollow to form a pocket configured to receive a trans-echogenic fluid therein (“A separate ultrasound probe lumen defined in the catheter wall 124 may be open at the distal end to allow at least a portion of the ultrasound probe to be extended out the distal end of catheter 122…an ultrasound probe lumen may be partially closed in such a manner that the lumen fluidly communicates with the external environment but the ultrasound probe cannot extend from the lumen.” [0025]. See Fig. 4B).
Regarding Claim 17, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz furth teaches: wherein the feature located and configured to couple the stylus to the flexible tube comprises a recess, and wherein the flexible tube has a thread configured to interact with the recess for temporary engagement of the flexible tube with the stylus (A steering cable (not shown) in stylet 26 is used to provide lateral guidance to stylet 26 and also catheter 22 as catheter 22 is longitudinally advanced. Proximal portions of stylet 26 and catheter 22 (not shown) are coupled or in engagement such that they are advanced longitudinally together... As illustrated, the distal tip of stylet 26 is shown extending out the distal tip of catheter 22, but it is to be appreciated that stylet may be contained entirely within lumen 27 of catheter 22 during the advancement. Once catheter 22 has reached a desired location, stylet 26 may be removed to accommodate the insertion and use of various other instruments or fluid drainage through catheter 22.” [0021]. See Figs. 2-3) .
Regarding Claim 18, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz does not teach: wherein the echograph provides B-mode ultrasound imaging associated with at least one other imaging modality selected from among a color mode, a pulsed Doppler, a power mode, or a 3D mode.
Querfurth in the field of intracranial pressure systems teaches: “…the CDI device 22 is multimodal, and one mode (B-mode) of the device 22 can provide an image of an organ; another mode (C-mode) of the device 22 can provide a visualization of the anterograde arterial flow; and another mode (D-mode) of the device 22 can measure arterial flow velocities.” [0044];“ …the Doppler probe 21 and CDI device 22 are structured and arranged to send a visual image, e.g., two-dimensional, black and white image, of the optic nerve head of the eye in the orbit 25 to the CDI device 22, e.g., using the B-mode; to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity.” [0045].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the B-mode ultrasound imaging in the combination of Schulz and Querfurth to be associated with at least one other imaging modality selected from among a color mode, a pulsed Doppler, a power mode, or a 3D mode as taught in Querfurth “…to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity…” (Querfurth, [0045]).
Regarding Claim 19, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz furth teaches: wherein the transducer is a scanning transducer (See Figs. 1-3, “FIG. 1 illustrates a patient's brain 10 with a ventriculostomy catheter device 20 inserted… The cable 24 may include a bundle of cables and is used to send and receive signals to one or more ultrasonic transducers at the distal end of catheter 22...” [0020]).
Regarding Claim 21, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz further teaches: wherein the distal end of the rigid tube has a shape complementary to a shape of the ultrasound transducer (Fig. 2, element 26 and Fig. 3, element 126, stylet, [0021-0022], “A steering cable (not shown) in stylet 26 is used to provide lateral guidance to stylet 26 and also catheter 22 as catheter 22 is longitudinally advanced. Proximal portions of stylet 26 and catheter 22 (not shown) are coupled or in engagement such that they are advanced longitudinally together.” [0021]; “…ultrasonic probe 128 is positioned within lumen wall 124 of catheter 122 and is connected via cable(s) 24 (FIG. 1) to a processing device and display (not shown) for producing 2-D ultrasound images.…stylet 126 may be provided without fiber optics 130.” [0022]. See Figs. 2-3).
Regarding Claim 22, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz furth teaches: wherein the deformable tip of the flexible tube has a conical shape (“Device 220 includes a stylet 226 received in the generally centrally disposed lumen 225 of catheter 222.” [0027]; “…the inner dimension of lumen 225 is reduced by virtue of inwardly disposed tapered section 240. The outer diameter of stylet 226 is shaped in correspondence with the inner surface 227 of lumen 225 and includes transition regions 250 that abut sections 240 of catheter 222 in a positive stop relationship, thereby preventing the distal tip of stylet 226 from extending beyond the distal tip of catheter 222.” [0028]).
Regarding Claim 23, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz furth teaches: wherein the deformable tip of the flexible tube has a hemispherical shape (“Device 20 is inserted through hole 14, through skin and muscle layer 30 and bone layer 32, into ventricle 12. Device 20 includes a stylet 26 to assist in guidance of the catheter 22 into position, for example with the distal end 23 of catheter 22 in fluid communication with ventricle 12.” [0021]. See Fig. 2).
Regarding Claim 24, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz does not teach: further comprising a computer executing a computer program for applying digital processing to compensate for variations in the material and thickness of the deformable tip of the stylus.
Querfurth in the field of intracranial pressure systems teaches: “…the CDI device 22 is multimodal, and one mode (B-mode) of the device 22 can provide an image of an organ; another mode (C-mode) of the device 22 can provide a visualization of the anterograde arterial flow; and another mode (D-mode) of the device 22 can measure arterial flow velocities.” [0044];“ …the Doppler probe 21 and CDI device 22 are structured and arranged to send a visual image, e.g., two-dimensional, black and white image, of the optic nerve head of the eye in the orbit 25 to the CDI device 22, e.g., using the B-mode; to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity.” [0045].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to further comprise a computer executing a computer program for applying digital processing to compensate for variations in the material and thickness of the deformable tip of the stylus as taught in Querfurth “…to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity…” (Querfurth, [0045]).
Regarding Claim 26, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz further teaches: further comprising a securing mechanism configured to secure the stylus and the flexible tube together to produce a stable fluid space at a distal end of the stylus (“The central lumen passageway is configured to selectively and slideably receive a stylet instrument. Additionally, the medical device comprises an ultrasound device in fixed engagement with the lumen wall of the ventriculostomy catheter to provide ultrasound imaging and monitoring.” [0008]).
Regarding Claim 28, Schulz teaches: A cerebrospinal fluid drainage system (Fig. 1, [0020]), comprising:
A probe comprising: a flexible tube (Figs. 1-2, element 20 and Fig. 3 element 120, ventriculostomy catheter device, [0020] [0022]), comprising:
an inner diameter “Device 220 includes a stylet 226 received in the generally centrally disposed lumen 225 of catheter 222.” [0027]; “…the inner dimension of lumen 225 is reduced by virtue of inwardly disposed tapered section 240. The outer diameter of stylet 226 is shaped in correspondence with the inner surface 227 of lumen 225 and includes transition regions 250 that abut sections 240 of catheter 222 in a positive stop relationship, thereby preventing the distal tip of stylet 226 from extending beyond the distal tip of catheter 222.” [0028];
a distal end (“FIG. 3 illustrates a partial cross-sectional view of the distal end of a ventriculostomy catheter device 120 including a catheter 122 with lumen wall 124.” [0022]); and
a deformable tip closing the distal end of the flexible tube (“…an ultrasound probe lumen may be partially closed in such a manner that the lumen fluidly communicates with the external environment but the ultrasound probe cannot extend from the lumen. Alternatively, an ultrasound probe lumen may be a closed or blind lumen such that there is no fluid communication between the probe and the brain environment.” [0025]. See Figs. 2-3);
a stylus coupled to the flexible tube, the stylus comprising a rigid tube comprising a diameter and a distal end and an ultrasound transducer at the distal end of the rigid tube having a diameter at least substantially identical to the diameter of the rigid tube and having an imaging depth extending along an axis of the rigid tube (Fig. 2, element 26 and Fig. 3, element 126, stylet, [0021-0022], “A steering cable (not shown) in stylet 26 is used to provide lateral guidance to stylet 26 and also catheter 22 as catheter 22 is longitudinally advanced. Proximal portions of stylet 26 and catheter 22 (not shown) are coupled or in engagement such that they are advanced longitudinally together.” [0021]. See Figs. 2-3); and
with regards to limitations: an echograph comprising a screen for displaying an anatomical image calculated in B-mode as a function of signals supplied by the ultrasound transducer and one or more wires contained in the rigid tube and coupled to the ultrasound transducer and the echograph, wherein the one or more wires does not include an optical fiber, Schulz further teaches: (“…ultrasonic probe 128 is positioned within lumen wall 124 of catheter 122 and is connected via cable(s) 24 (FIG. 1) to a processing device and display (not shown) for producing 2-D ultrasound images.…stylet 126 may be provided without fiber optics 130.” [0022]; “…a signal processor and an imaging device (such as a computer screen) is provided that is responsive to signals from the transducers to provide a substantially real time visual display. The display may be 2 dimensional or 3 dimensional and the display may be of local objects in the brain (e.g. tissue, blood or fluid flow) and/or the relative relationship between such objects and surgical instruments (such as the catheter or objects inserted there through).” [0031]).
Schulz does not explicitly teach the anatomical image is calculated in B-mode.
Querfurth in the field of intracranial pressure systems teaches: “…the CDI device 22 is multimodal, and one mode (B-mode) of the device 22 can provide an image of an organ; another mode (C-mode) of the device 22 can provide a visualization of the anterograde arterial flow; and another mode (D-mode) of the device 22 can measure arterial flow velocities.” [0044];“ …the Doppler probe 21 and CDI device 22 are structured and arranged to send a visual image, e.g., two-dimensional, black and white image, of the optic nerve head of the eye in the orbit 25 to the CDI device 22, e.g., using the B-mode; to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity.” [0045].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the displayed anatomical image in Schulz to be calculated in B-mode as taught in Querfurth to provide real-time representations of the organ(s) to aid in image diagnosis and guidance procedures.
Regarding Claim 29, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz further teaches: wherein the probe comprises an External Ventricular Drain or a Ventriculo-Peritoneal Shunt (Figs. 1-2, element 20 and Fig. 3 element 120, ventriculostomy catheter device, [0020] [0022]).
Regarding Claim 30, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz further teaches: further comprises a distal fluid space between the deformable tip and the ultrasound transducer (“The central lumen passageway is configured to selectively and slideably receive a stylet instrument. Additionally, the medical device comprises an ultrasound device in fixed engagement with the lumen wall of the ventriculostomy catheter to provide ultrasound imaging and monitoring.” [0008]; “Device 20 includes a stylet 26 to assist in guidance of the catheter 22 into position, for example with the distal end 23 of catheter 22 in fluid communication with ventricle 12.” [0021]).
Regarding Claim 32, the combination of Schulz and Querfurth teach the claim limitations as noted above.
wherein the stylus is secured in the flexible tube to generate a fluid space distal to the ultrasound probe and adjacent the deformable tip (“The central lumen passageway is configured to selectively and slideably receive a stylet instrument. Additionally, the medical device comprises an ultrasound device in fixed engagement with the lumen wall of the ventriculostomy catheter to provide ultrasound imaging and monitoring.” [0008]; “Device 20 includes a stylet 26 to assist in guidance of the catheter 22 into position, for example with the distal end 23 of catheter 22 in fluid communication with ventricle 12.” [0021]; “A separate ultrasound probe lumen defined in the catheter wall 124 may be open at the distal end to allow at least a portion of the ultrasound probe to be extended out the distal end of catheter 122. Alternatively, an ultrasound probe lumen may be partially closed in such a manner that the lumen fluidly communicates with the external environment but the ultrasound probe cannot extend from the lumen. Alternatively, an ultrasound probe lumen may be a closed or blind lumen such that there is no fluid communication between the probe and the brain environment.” [0025]).
Regarding Claim 33, the combination of Schulz and Querfurth teach the claim limitations as noted above.
Schulz does not teach: wherein the echograph provides B-mode ultrasound imaging associated with at least one other imaging modality selected from among a color mode, a pulsed Doppler, a power mode, or a 3D mode.
Querfurth in the field of intracranial pressure systems teaches: “…the CDI device 22 is multimodal, and one mode (B-mode) of the device 22 can provide an image of an organ; another mode (C-mode) of the device 22 can provide a visualization of the anterograde arterial flow; and another mode (D-mode) of the device 22 can measure arterial flow velocities.” [0044];“ …the Doppler probe 21 and CDI device 22 are structured and arranged to send a visual image, e.g., two-dimensional, black and white image, of the optic nerve head of the eye in the orbit 25 to the CDI device 22, e.g., using the B-mode; to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity.” [0045].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the B-mode ultrasound imaging in the combination of Schulz and Querfurth to be associated with at least one other imaging modality selected from among a color mode, a pulsed Doppler, a power mode, or a 3D mode as taught in Querfurth “…to send a real time, spatially visualized color Doppler image of anterograde arterial flow in the B-mode image, e.g., using the C-mode; and to send a pulsed-wave, ultrasound signal of the arterial blood flow velocity and direction, e.g., using the D-mode. The D-mode signal can be digitized and used to calculate Doppler frequency shifts that, in turn, can be used to calculate arterial systolic and diastolic blood flow velocity…” (Querfurth, [0045])
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Schulz and Querfurth as applied to claim 15 above, and further in view of Ryan (U.S. 20110071386, March 24, 2011)(hereinafter, “Ryan”).
Regarding Claim 20, the combination of Schulz and Querfurth teach the claim limitations as noted above.
The combination of references does not teach: further comprising a sterile enclosure surrounding the stylus, an end of the sterile enclosure adjacent the ultrasound transducer containing an ultrasound gel.
Ryan in the field of catheter-based systems teaches: “Once the catheter shaft 116 is positioned in a desired location relative to a target tissue site in the body, an ultrasonic scanner 124 transmits a predetermined ultrasonic frequency. Specifically, a probe 126 generates the designated frequencies to the target area in the body via a path 132… The transducer 128 may be coupled to the probe 126 using a means known in the art and may employ a known material (e.g., water, jelly, etc.) to reduce impedance by the skin. Upon receipt of these frequencies, the beams 108 may resonate and return the frequencies to the ultrasonic scanner 124…” [0020]
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to include an enclosure adjacent the ultrasound transducer containing an ultrasound gel as taught in Ryan “…to reduce impedance by the skin.” (Ryan, [0020]).
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Schulz and Querfurth as applied to claim 15 above, and further in view of Zauner (U.S. 20080171990, July 17, 2008)(hereinafter, “Zauner”).
Regarding Claim 25, the combination of Schulz and Querfurth teach the claim limitations as noted above.
The combination of references does not teach: wherein the deformable tip of the flexible tube comprises an echogenic marker.
Zauner in the field of ventricular intracranial catheter systems teaches: “A stylet is typically used for inserting the distal end of the EVD catheter into the brain tissue and a trocar is used for the proximal subcutaneous insertion.” [0008];“Markers 24 on the EVD catheter 2 can be used to measure how far the EVD catheter 2 has been inserted. The distal tip 4 of the EVD catheter is also radiologically opaque and can be used to mark the depth of insertion of the EVD catheter 2 in the brain.” [0055].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the deformable tip of the stylus in the combination of references to comprise an echogenic marker as taught in Zauner “…to mark the depth of insertion of the…chatter…” (Zauner, [0055]).
Regarding Claim 27, the combination of Schulz and Querfurth teach the claim limitations as noted above.
The combination of references does not teach: further comprising drainage system including a drainage tube and a collection bag, a proximal end of the flexible tube comprising a connector for joining the flexible tube to the drainage tube of the drainage system.
Zauner in the field of ventricular intracranial catheter systems teaches: “"Port I" is the term for the central proximal branch conduit 20 and the associated ring connector 43. A catheter 37 for draining cerebrospinal fluid is connected to the ring connector 43. A thermocouple lead 35 runs in the wall of the conduit 37. Likewise, an ICP sensor lead 36 runs in the wall of the conduit 37. Alignment markers 45 and 46 are placed on each half of the ring connector 43 to help connect the leads 35 and 36 to the leads in the branch conduit 20. The catheter 37 has a ring connector 44 for connecting to a cerebrospinal collection bag…” [0051].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination to further comprise drainage system including a drainage tube and a collection bag, a proximal end of the flexible tube comprising a connector for joining the flexible tube to the drainage tube of the drainage system as taught in Zauner to regulate cerebral spinal fluid pressure and collect cerebral spinal fluid samples with a lower risk of infection.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Schulz and Querfurth as applied to claim 30 above, and further in view of Reiner (U.S. 20170367579, December 28, 2017)(hereinafter, “Reiner”).
Regarding Claim 31, the combination of Schulz and Querfurth teach the claim limitations as noted above.
The combination does not explicitly teach: further comprising a trans-echogenic fluid in the distal fluid space.
Reiner in the field of catheter systems teaches: “…an echogenic fluid could be injected and localized as it passes from each of the individual orifices.” [0108].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal fluid space in the combination of references to further comprise a echogenic fluid as taught in Reiner for further evaluation and verification (Reiner [0108]).
Response to Arguments
With regards to Applicant’s arguments regarding claim 15 limitation “…a probe comprising a flexible tube…the distal end of the flexible tube being disclosed by a deformable tip.” Not being taught by the combination of references Schulz in view of Querfurth (Remarks, pgs. 2-3).Examiner respectfully disagrees. First, the recited claim 15 limitation is a probe and stylus where the flexible tube limitation is correlated to the probe while the rigid tube and distal end of the flexible tube is correlated to the stylus limitations, Examiner respectfully feels Applicant’s arguments are to a narrower interpretation of the claims that does not consider the correlation of the probe and stylus to the various recited limitations as a whole. Further, Schulz in the cited paragraphs above such as “A separate ultrasound probe lumen defined in the catheter wall 124 may be open at the distal end to allow at least a portion of the ultrasound probe to be extended out the distal end of catheter 122. Alternatively, an ultrasound probe lumen may be partially closed in such a manner that the lumen fluidly communicates with the external environment but the ultrasound probe cannot extend from the lumen. Alternatively, an ultrasound probe lumen may be a closed or blind lumen such that there is no fluid communication between the probe and the brain environment.” [0025], indicates a closed end.
With regards to Applicant’s arguments regarding claim 16, “Claim 16 further recites, in part, "wherein the deformable tip is hollow to form a pocket configured to receive a trans-echogenic fluid therein." The Office argues that Shulz-Stubner teaches a "deformable tip is hollow" because "a separate ultrasound probe lumen defined in the catheter wall 124 may be open at the distal end." See, Office Action at p. 5. However, an opening, or a lumen "in the catheter wall 124" having an opening near a distal end thereof is not the same as the "deformable tip" as recited in claim 15 and which is further recited in claim 16. Furthermore, claim 16 does not recite the formation of a "pocket" in the wall of the "flexible tube" but rather "a pocket" in the "deformable tip" which is not taught by Shulz-Stubner or its combination with Querfurth. Therefore, claim 16 is also independently allowable over the 35 U.S.C. § 103 rejection.” (Remarks, pg. 3). Examiner again respectfully disagrees that the recited claim limitations are not taught. As seen from Fig. 4B from which the passage [0025] is illustrated appear to be hollow.
With regards to Applicant’s arguments regarding Claim 21, “Claim 21 recites, in part, "wherein the distal end of the rigid tube has a shape complementary to a shape of the ultrasound transducer." The combination of Shulz-Stuber and Querfurth fails to teach or suggest such recitations. The "ultrasound transducers" disclosed and taught by Shulz-Stuber are located in the lumen walls of the catheters thereof; they are not located in the stylets. In addition, nowhere in Shulz-Stuber is there any teaching that the stylets have a "shape complementary to a shape of the ultrasound transducer" included in another element of the reference. Thus, the recitations of claim 21 are not taught by Shulz-Suber or Querfurth and claim 21 is independently allowable under 35 U.S.C. § 103 because claim 21 is not obvious.” (Remarks, pg. 3), again Examiner respectfully disagrees. From figures 2-3 referenced above and the corresponding passages [0021-0022] teach the recited claim limitation “…wherein the distal end of the rigid tube has a shape complementary to a shape of the ultrasound transducer.”. Applicant’s arguments, respectfully appear to be a narrower interpretation of the recited claim limitations.
With regards to Applicant’s arguments regarding claim 20 reference Ryan not teaching “a flexible tube…the distal end of the flexible tube being closed by a deformable tip” (Remarks, pg. 5), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further again Applicant is respectfully not examining the recited claim limitations with respect to the various components and their correlation to the probe and/or stylus as recited in the claims but rather a narrower interpretation of the recited claim limitations.
With regards to Applicant’s arguments regarding claim 25 limitation of “echogenic marker” not being taught by Zauner, “While Zauner discloses "markers" on various portions of the probes and connectors it discloses, all such "makers" are alignment markers that are visible to an operator inserting the probes and connectors taught by Zauner. None of the disclosed markers are "echogenic marker[s]" as recited in claim 25. In addition, nowhere in Zauner is there any teaching of the use of, or the desire for, an "echogenic marker" that shows a visible reference on an ultrasound image rather than a marker on the devices that are visually monitored by a user. The lack of teaching or suggestion to include the recited "echogenic marker" as recited in claim 25 precludes aprimafacie case of obviousness and a rejection of claim 25 under 35 U.S.C. § 103.” (Remarks, pg. 6). Examiner again respectfully disagrees that Zauner does not teach the recited amended limitation “…wherein the deformable tip of the flexible tube comprises an echogenic marker.”. The recited claim 25 limitations do not make distinction to the marker with respect to the image and/or the device to be monitored by the user. Applicant’s arguments respectfully appear to be a narrower interpretation of the recited limitations.
Conclusion
THIS ACTION IS MADE FINAL. 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 AMAL FARAG whose telephone number is (571)270-3432. The examiner can normally be reached 8:30 - 5:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798
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