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
Amendments to claims 1, 14, 24 of 4/2/2026 acknowledged and entered.
Response to Arguments
Applicant's arguments filed 4/2/2026 have been fully considered but they are not persuasive. Regarding p. 20, para. 1, applicant asserts that the claim limitations require a visualization of the guidewire during navigation of the guidewire to its final location. Hence, Jansen, which discloses navigation of the guidewire prior to insertion of the catheter and visualization probe, does not teach the limitations of claims 1, 14, 24. Examiner is not in accordance with applicant’s assertion. Claim 1 does recite “ a camera connected to the fiber-optic probe adjacent the proximal end of the microcatheter thereby enabling real-time visualization of the portion of the guidewire that extends beyond the distal end of the microcatheter and an area adjacent the distal end and guidewire during navigation of the distal end of the microcatheter via the guidewire”. The claim does not explicitly disclose visualization of navigating the guidewire per the remarks, but rather the visualization of the guidewire while the catheter is navigated. The navigation of the guidewire per the standing claim language, is not necessarily tied to the navigation of the catheter. Per broadest reasonable interpretation of the claim language, the procedure of Jansen, wherein the guidewire is navigated to the targe location prior to the insertion of catheter or endoscope, teaches the limitation of visualizing the guidewire during navigation of the catheter by virtue of visualizing the distal end of the catheter from which the guidewire extends. Further to this, claims 14 and 24 recite a “navigation step” which refers to “navigating the distal end of the microcatheter within a spinal canal of the patient” and not explicitly the guidewire. While the limitation “as the guidewire is extended from the distal end to ensure that contact with the spinal cord, spinal nerves, and spinal ganglia is avoided” does begin to insinuate that the guidewire is actively being extended during the navigation process, the limitation fails to comply with the enablement requirement as explained below and cannot be considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14, 15, 17, 19-21, 24, 25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Regarding claims 14, 24, claims recite a limitation of the navigation step wherein the guidewire avoids contacting and injuring the spinal cord, spinal nerves, and spinal ganglia. This limitation presents a negative limitation, in that the guidewire explicitly does not contact these sections of the spine, without supporting that negative limitation in the specification. While the specification mentions that a limitation of current designs is potential injury to the spinal cord, the spinal cord is not recited with regards to navigation within the specification. Further, the term “contact” does not appear within the specification, and “avoid” appears in only unrelated contexts.
Claims 15, 17, 19-21, 25 similarly rejected for dependence upon claims 14, 24.
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.
Claim(s) 1-4, 6, 8-10, 14-15, 17, 19-21, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand (WO 2018119179 A1) in view of Kagan (US 5396880 A) and Purdy (US 20030130577 A1) and Jansen (US 20120016192 A1).
Regarding Claim 1, Anand teaches A minimally-invasive access and delivery medical device, comprising:
an elongate, flexible microcatheter (fig. 2, element 102) having proximal (fig. 2, element 116) and distal ends (fig. 2, element 114);
a guidewire (fig. 2, element 124) extending through the microcatheter and being slidable relative the microcatheter such that the guidewire is freely extendable from the distal end of the microcatheter to a position beyond the distal end so that the microcatheter is advanceable along the guidewire when the guidewire is extended beyond the distal end of the microcatheter ([0095], guidewire 124 is receivable in lumen 126. Lumen 126 may have an open end at tip 112, which would by necessity allow the guidewire to extend beyond the distal end of the catheter 102. Catheter is inserted over the guidewire to be steered by it);
a fiber-optic probe ([00111], a camera or imaging device that can be inserted through a working channel is contemplated) extending through the microcatheter from the distal end to the proximal end such that the fiber-optic probe and the guidewire are both present within the microcatheter ([00111, 00113], catheters may include a camera or imaging device inserted through a working channel of the catheter, tip 112 can include a separate guidewire lumen),
wherein said microcatheter includes a path for delivery of at least one of a therapy, a gene therapy, and a drug to the distal end of the microcatheter (fig. 12, element 120A/B, [00119], fluid lumens can be used to deliver a drug or other fluid); and
wherein said flexible microcatheter is of a size of 3 French (Fr) to 5 French (Fr), has an outer diameter of 1 mm (0.039 inch) to 1.66 mm (0.07 inch) ([0097], tip can have a diameter of about 3-5 French, 1-3mm),
such that the flexible microcatheter is of sufficient flexibility, size, and length for navigation from a lumbar puncture in a lower back of a patient within the subarachnoid space through cerebrospinal fluid to the cisterna magna for aspiration of cerebrospinal fluid and infusion of the at least one of a therapy, a gene therapy, and a drug to the cisterna magna ([00149], fig. 26, puncture can be formed in the lumbar region and the catheter may be inserted and guided along the spinal cord to the cisterna magna).
Anand does not explicitly teach the device wherein the fiber-optic probe having a tip extending adjacent and beyond the distal end of the microcatheter and being movable and adjustable relative to the distal end and guidewire of the microcatheter such that the tip provides an end viewing face that is movable and adjustable relative to the distal end of the microcatheter and a portion of the guidewire extending beyond the distal end of the microcatheter;
and a camera connected to the fiber-optic probe adjacent the proximal end of the microcatheter thereby enabling real-time visualization of an area adjacent the distal end and guidewire during navigation of the distal end of the microcatheter via the guidewire;
and has a length from the proximal end to the distal end of at least 1.5 meter (59 inches)
However, Kagan teaches the device wherein the fiber-optic probe having a tip extending adjacent the distal end of the microcatheter and being movable and adjustable relative to the distal end of the microcatheter such that the tip provides an end viewing face (fig. 4, element 73) that is movable and adjustable relative to the distal end of the microcatheter (col. 8, ln. 67 – col. 9, ln. 18, col. 9, ln. 38-61);
and a camera (fig. 1, element 23) connected to the fiber-optic probe adjacent the proximal end of the microcatheter thereby enabling real-time visualization of an area adjacent the distal end (12 and guidewire during navigation of the distal end of the microcatheter via the guidewire (col. 5, ln. 34-56).
However, Purdy teaches the microcatheter that has a length from the proximal end to the distal end of at least 1.5 meter (59 inches) (fig. 3, element L1-3, [0069,71,76], L3 is upwards of 90 cm, L2 is upwards of 12cm, and L1 is upwards of 70 cm, the sum of which is above 150cm, or 1.5m).
However, Jansen teaches wherein the fiber-optic probe (fig. 18d, element 4418, [0059], endoscope 4418) having a tip extending adjacent and beyond the distal end and guidewire of the microcatheter (fig. 18a, element 4411, [0058], outer sheath 4411) that is movable and adjustable relative to a portion of the guidewire extending beyond the distal end of the microcatheter ([0039], endoscope may be inserted over the guidewire) and a camera enabling real-time visualization of the portion of the guidewire that extends beyond the distal end of the microcatheter ([0039], endoscope may be inserted over the guidewire).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to contain an actuatable imaging probe as taught in Kagan in order to capture a variety of imaging angles (col. 4, ln. 41-50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to be at least 1.5m as taught in Purdy in order to provide access to the brain regardless of patient height or entry location (Purdy [0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to extend the imager beyond the distal end of the sheath as taught in Jansen in order to support and retain the endoscope during navigation (Jansen [0007]).
Regarding Claim 2, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1.
Further, Anand teaches a device further comprising a steering wire extending through the microcatheter from the proximal end to the distal end, the steering wire being fixed to the distal end to enable steering of the distal end ([0095], steering mechanism can include one or more steering wires that terminate at the tip 112 that extend to a proximal end of the catheter).
Regarding Claim 3, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 2,
Wherein Kagan teaches a device further comprising a handle (fig. 1, element 15) connected to the proximal end of the microcatheter, said handle providing a housing for the camera and a control lever (fig. 2, element 26; col. 6, ln. 4-26) interconnected to the steering wire (fig. 3, element 57) for controlling steering of the distal end of the microcatheter (col. 7, ln. 21-41).
Regarding Claim 4, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Anand teaches the device further comprising first and second steering wires ([0095], first and second steering cables that terminate at the tip and extend to the proximal end) extending through the microcatheter from the proximal end to the distal end.
Kagan teaches a handle (fig. 2, element 15) connected to the proximal end of the microcatheter, said handle having a control lever (fig. 2, element 26; col. 6, ln. 4-26) interconnected to the first and second steering wires for controlling steering of the distal end of the microcatheter (col. 5, ln. 22-28).
Regarding Claim 6, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Kagan further teaches the device further comprising a fiber-optic light element extending through the microcatheter (fig. 2, element 20) from the proximal end to the distal end for projecting light from the distal end (col. 5, ln. 35-56, fiber optic bundle 20 is engaged with both a camera and a light source 23).
Regarding Claim 8, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Further, Anand teaches the device wherein said distal end of said microcatheter is in the form of multi-lumen tubing defining separate lumens for at least each of said guidewire and said fiber-optic probe ([0023], guidewire lumen, fluid lumen, [00111], working channel for camera or imaging device).
Regarding Claim 9, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 8,
Further, Anand teaches the device wherein the multi-lumen tubing interconnects to intermediate tubing (fig. 2, element 116, [0093], hub 116 connects catheter body 114 to various tubing) extending to the proximal end of the microcatheter, the multi-lumen tubing forming the distal end of the microcatheter being more flexible than the intermediate tubing ([00102-103], fluid tubing can pass through hub 116 uninterrupted into the catheter, hence the hub must be less flexible due to having more material in addition to the tubing).
Regarding claim 10, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Further, Kagan teaches the device wherein the microcatheter includes a path for delivery of at least one of a probe, a medical tool, a lasso, an electrode, and a laser ablation element to the distal end of the microcatheter (col. 4, ln. 9-26, a third optional channel for working instruments or laser fiber is provided while maintaining a 1mm diameter per col. 8, ln. 14-30).
Regarding Claim 14, Anand teaches A method of accessing and providing a path of delivery to a subarachnoid space of a patient, comprising:
extending a distal end (fig. 2, element 114) of an elongate, flexible, multi-lumen microcatheter ((fig. 2, element 102) through a puncture in the subarachnoid space of the patient,
the microcatheter being of a size of 3 French (Fr) to 5 French (Fr), having an outer diameter of 1 mm (0.039 inch) to 1.66 mm (0.07 inch) ([0097], tip can have a diameter of about 3-5 French, 1-3mm),
and the microcatheter providing a path for delivery of at least one of a therapy, a gene therapy, and a drug to the distal end of the microcatheter (fig. 12, element 120A/B, [00119], fluid lumens can be used to deliver a drug or other fluid);
navigating the distal end of the microcatheter within a spinal canal of the patient from a lumbar puncture in a lower back of the patient within the subarachnoid space of the patient through cerebrospinal fluid to the cisterna magna ([00149], fig. 26, puncture can be formed in the lumbar region and the catheter may be inserted and guided along the spinal cord to the cisterna magna);
aspirating cerebrospinal fluid through a lumen of the microcatheter ([0016]); and
infusing at least one of a therapy, a gene therapy, and a drug to the cisterna magna through the path of delivery (fig. 12, element 120A/B, [00119], fluid lumens can be used to deliver a drug or other fluid);
wherein the microcatheter includes a guidewire (fig. 2, element 124) extendable through and slidable relative to the microcatheter from a proximal end (fig. 2, element 116) through the distal end of the microcatheter along which the microcatheter may be advanced or retracted during said navigating step;
wherein, during said navigation step, the guidewire is extended from the distal end of the microcatheter to a position beyond the distal end such that the guidewire avoids contacting and injuring the spinal cord, spinal nerves, and spinal ganglia (See 112a enablement rejection), and thereafter the microcatheter is advanced along the guidewire ([0095], guidewire 124 is receivable in lumen 126. Lumen 126 may have an open end at tip 112, which would by necessity allow the guidewire to extend beyond the distal end of the catheter 102. Catheter is inserted over the guidewire to be steered by it);
wherein the microcatheter includes a fiber-optic probe ([00111], a camera or imaging device that can be inserted through a working channel is contemplated) extending through the microcatheter from the distal end to the proximal end of the microcatheter;
visualization as the guidewire is extended from the distal end to ensure that contact with the spinal cord, spinal nerves, and spinal ganglia is avoided (See 112a rejection).
Anand does not explicitly teach the device having a length from the proximal end to the distal end of at least 1.5 meter (59 inches), and
the fiber-optic probe having a tip extending adjacent the distal end of the microcatheter and being movable and adjustable relative to the distal end of the microcatheter such during said navigation step, that the tip provides an end viewing face that is positioned relative to and beyond the distal end of the microcatheter and a portion of the guidewire extending beyond the distal end of the microcatheter; and
wherein the microcatheter includes a camera connected to the fiber optic probe adjacent the proximal end of the microcatheter such that real-time visualization of the contents of the subarachnoid space and guidewire via the end viewing face of the fiber-optic probe is provided during said navigating step.
However, Kagan teaches the device wherein the fiber optic prove being movable and adjustable beyond the distal end of the microcatheter the fiber-optic probe having a tip extending adjacent the distal end of the microcatheter and being movable and adjustable relative to the distal end of the microcatheter such that during said navigation step the tip provides an end viewing face (fig. 4, element 73) that is positioned relative to the distal end of the microcatheter in a and a portion of the guidewire (col. 8, ln. 67 – col. 9, ln. 18);
and a camera (fig. 1, element 23) connected to the fiber-optic probe adjacent the proximal end of the microcatheter thereby enabling real-time visualization of an area adjacent the distal end (12 and guidewire during navigation of the distal end of the microcatheter via the guidewire (col. 5, ln. 34-56).
However, Purdy teaches the microcatheter that has a length from the proximal end to the distal end of at least 1.5 meter (59 inches) (fig. 3, element L1-3, [0069,71,76], L3 is upwards of 90 cm, L2 is upwards of 12cm, and L1 is upwards of 70 cm, the sum of which is above 150cm, or 1.5m).
However, Jansen teaches wherein the fiber-optic probe (fig. 18d, element 4418, [0059], endoscope 4418) having a tip extending adjacent and beyond the distal end and guidewire of the microcatheter (fig. 18a, element 4411, [0058], outer sheath 4411) that is movable and adjustable relative to a portion of the guidewire extending beyond the distal end of the microcatheter ([0039], endoscope may be inserted over the guidewire) and a camera enabling real-time visualization of the portion of the guidewire that extends beyond the distal end of the microcatheter ([0039], endoscope may be inserted over the guidewire).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to contain an actuatable imaging probe as taught in Kagan in order to capture a variety of imaging angles (col. 4, ln. 41-50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to be at least 1.5m as taught in Purdy in order to provide access to the brain regardless of patient height or entry location (Purdy [0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to extend the imager beyond the distal end of the sheath as taught in Jansen in order to support and retain the endoscope during navigation (Jansen [0007]).
Regarding claim 15, Anand in view of Kagan and Purdy and Jansen teaches The method according to claim 14,
Further, Anand teaches a device further comprising a steering wire extending through the microcatheter from the proximal end to the distal end, the steering wire being fixed to the distal end to enable steering of the distal end ([0095], steering mechanism can include one or more steering wires that terminate at the tip 112 that extend to a proximal end of the catheter).
Regarding claim 17, Anand in view of Kagan and Purdy and Jansen teaches The method according to claim 14,
Further, Kagan teaches the method further comprising a step of delivering at least one of a probe, a medical tool, a laser ablation element, an electrode, and a lasso to the distal end of the microcatheter (col. 4, ln. 9-26, a third optional channel for working instruments or laser fiber is provided while maintaining a 1mm diameter per col. 8, ln. 14-30).
Regarding Claim 19, Anand in view of Kagan and Purdy and Jansen teaches the method according to claim 14,
Kagan further teaches the method further comprising a step of steering the distal end of the microcatheter during said navigating step by toggling a control lever (fig. 2, element 26; col. 6, ln. 4-26) on a handle (fig. 1, element 15) at the proximal end of the microcatheter wherein said control lever is interconnected to a steering wire (fig. 3, element 57) for pulling or releasing the steering wire during said steering step (col. 7, ln. 21-41).
Regarding claim 20, Anand in view of Kagan and Purdy and Jansen teaches The method according claim 19,
Further, Anand teaches the device wherein said distal end of said elongate, flexible microcatheter is formed into a 180 degree curve during said steering step within the subarachnoid space (fig. 20a, element 102p faces downward, while the catheter extends upward through the spine).
Regarding Claim 21, Anand in view of Kagan and Purdy and Jansen teaches The method according to claim 14,
Kagan further teaches the method further comprising a step of projecting light from the distal end of the microcatheter with a fiber-optic light element (fig. 2, element 20) extending through the microcatheter from the proximal end to the distal end (col. 5, ln. 35-56, fiber optic bundle 20 is engaged with both a camera and a light source 23).
Regarding claim 24, Anand teaches A method of accessing and providing a path of delivery to a subarachnoid space of a patient, comprising:
extending a distal end (fig. 2, element 114) of an elongate, flexible, multi-lumen microcatheter (fig. 2, element 102) through a puncture formed in a lumbar puncture in a lower back of the patient ([00149], fig. 26, puncture can be formed in the lumbar region and the catheter may be inserted and guided along the spinal cord to the cisterna magna); and
navigating the distal end of the microcatheter to a surface of a brain within the subarachnoid space of the patient ([00149], fig. 26, puncture can be formed in the lumbar region and the catheter may be inserted and guided along the spinal cord to the cisterna magna);
wherein the microcatheter includes a guidewire (fig. 2, element 124) extendable through and slidable relative to the microcatheter from a proximal end (fig. 2, element 116) through the distal end of the microcatheter along which the microcatheter may be advanced or retracted;
wherein, during said navigation step, the guidewire is extended from the distal end of the microcatheter to a position beyond the distal end such that the guidewire avoids contacting and injuring the spinal cord, spinal nerves, and spinal ganglia (see 112a rejection), and thereafter the microcatheter is advanced along the guidewire ([0095], guidewire 124 is receivable in lumen 126. Lumen 126 may have an open end at tip 112, which would by necessity allow the guidewire to extend beyond the distal end of the catheter 102. Catheter is inserted over the guidewire to be steered by it);
wherein the microcatheter includes a fiber-optic probe ([00111], a camera or imaging device that can be inserted through a working channel is contemplated) extending through the microcatheter from the distal end to the proximal end of the microcatheter, and
wherein the microcatheter is of a size of 3 French (Fr) to 5 French (Fr), has an outer diameter of 1 mm (0.039 inch) to 1.66 mm (0.07 inch) ([0097], tip can have a diameter of about 3-5 French, 1-3mm), and
is sufficiently flexible to form a 180 degree curve (fig. 2, 20a/b show the catheter coiled into at least 180 degree curves if not multiple 360 degree loops), and
the microcatheter provides a path for delivery of at least one of a therapy, a gene therapy, and a drug to the distal end of the microcatheter (fig. 12, element 120A/B, [00119], fluid lumens can be used to deliver a drug or other fluid);
visualization as the guidewire is extended from the distal end to ensure that contact with the spinal cord, spinal nerves, and spinal ganglia is avoided (See 112a rejection).
Anand does not explicitly teach the fiber-optic probe having a tip extending adjacent the distal end of the microcatheter and being movable and adjustable relative to and beyond the distal end of the microcatheter such that the tip provides an end viewing face that is adjustable in direction toward the guidewire;
wherein the microcatheter includes a camera connected to the fiber optic probe adjacent the proximal end of the microcatheter such that real-time visualization of the contents of the subarachnoid space and guidewire via the end viewing face of the fiber-optic probe is provided during said navigating step;
and has a length from the proximal end to the distal end of at least 1.5 meter (59 inches).
However, Kagan teaches the device wherein the fiber-optic probe having a tip extending adjacent the distal end of the microcatheter and being movable and adjustable relative to the distal end of the microcatheter such that during said navigation step the tip provides an end viewing face (fig. 4, element 73) that is positioned relative to the distal end of the microcatheter and a portion of the guidewire (col. 8, ln. 67 – col. 9, ln. 18) extending beyond the distal end of the microcatheter;
and a camera (fig. 1, element 23) connected to the fiber-optic probe adjacent the proximal end of the microcatheter thereby enabling real-time visualization of an area adjacent the distal end (12 and guidewire during navigation of the distal end of the microcatheter via the guidewire (col. 5, ln. 34-56).
However, Purdy teaches the microcatheter that has a length from the proximal end to the distal end of at least 1.5 meter (59 inches) (fig. 3, element L1-3, [0069,71,76], L3 is upwards of 90 cm, L2 is upwards of 12cm, and L1 is upwards of 70 cm, the sum of which is above 150cm, or 1.5m).
However, Jansen teaches wherein the fiber-optic probe (fig. 18d, element 4418, [0059], endoscope 4418) having a tip extending adjacent and beyond the distal end and guidewire of the microcatheter (fig. 18a, element 4411, [0058], outer sheath 4411) that is movable and adjustable relative to a portion of the guidewire extending beyond the distal end of the microcatheter ([0039], endoscope may be inserted over the guidewire) and a camera enabling real-time visualization of the portion of the guidewire that extends beyond the distal end of the microcatheter ([0039], endoscope may be inserted over the guidewire).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to contain an actuatable imaging probe as taught in Kagan in order to capture a variety of imaging angles (col. 4, ln. 41-50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to be at least 1.5m as taught in Purdy in order to provide access to the brain regardless of patient height or entry location (Purdy [0069]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Anand to extend the imager beyond the distal end of the sheath as taught in Jansen in order to support and retain the endoscope during navigation (Jansen [0007]).
Regarding claim 25, Anand in view of Kagan and Purdy and Jansen teaches The method according to claim 14,
Further, Kagan teaches wherein the tip of the fiber- optic probe is rotated relative to the distal end of the microcatheter during said navigating step (Col. 9, ln. 38-61).
Regarding claim 26, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Further, Kagan teaches wherein the tip of the fiber-optic probe is rotatable relative to the distal end of the microcatheter (Col. 9, ln. 38-61).
Regarding claim 27, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Further, Kagan teaches wherein the fiber-optic probe is movable in a longitudinal direction relative to the distal end of the microcatheter (Col. 9, ln. 38-61).
Regarding claim 28, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 1,
Further, Anand teaches wherein said flexible microcatheter is sufficiently flexible to form a 180 degree curve within the subarachnoid space (fig. 2, 20a/b show the catheter coiled into at least 180 degree curves if not multiple 360 degree loops).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anand in view of Kagan and Purdy and Jansen as applied to claim 4 in further view of McWeene (US 7922650 B2).
Regarding Claim 5, Anand in view of Kagan and Purdy and Jansen teaches The minimally-invasive access and delivery medical device according to claim 4,
Anand in view of Kagan and Purdy and Jansen does not explicitly disclose a device wherein the first steering wire connects to or is integral with the second steering wire within the handle.
However, McWeene teaches a device wherein the first steering wire connects to or is integral with the second steering wire within the handle (col. 19, ln. 19-37 discloses the proximal ends of each steering wire 1968 are connected to the pulley 1982, hence both wires are connected indirectly via the pulley).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the steering mechanism of Anand to include steering wires connected to a pulley as taught in McWeene in order to improve control over the distal tip from a proximal position (McWeene col. 19, ln. 19-37).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights