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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 July 2026 has been entered.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive for claims 1, 14, and 22.
With respect to amended limitations, the applicant argues that Malek does not teach amended limitation and specifically argues that Malek does not tach evaluating venogram, but rather uses imaging for improving visualization during the procedure, and not evaluated for a curvature of blood vessel to locate a target penetration site proximate to the curvature of the blood vessel. The applicant further argues that Malek’s curvature is not for evaluating the curvature at all to locate a penetration site and used to generate 3D reconstruction, which is distinct from claimed invention (pages 10-11).
Moreover, for claim 3, Malek merely discloses at [0077] for various dimensions of IPS and there is no disclosure of measuring the dimensions of a vessel diameter as claimed (pages 13-14).
However, the examiner respectfully disagrees.
Instant application’s specification [0039] teaches extent of vessel curvature of the IPS to evaluate whether vessel curvature is sufficient to allow the delivery catheter to travel off-axis from the vessel path of IPS and target penetration site on the IPS wall.
Accordingly, Malek teaches “determining that the curvature of the blood vessel, when the delivery catheter is advanced through a pathway of the blood vessel, will facilitate off-axis advancement of the delivery catheter from the pathway at the target penetration site to access the ISAS” since Malek discloses evaluating images (imaging to select one or more drug delivery device deployment location along the first curved portion and second curved portion of IPS and clinician can select IPS and a target penetration site along the first or second curve of the IPS based on the imaging [0214], off-axis through the first curved portion of the IPS and advancement of the delivery catheter can be confirmed via imaging [0223]). The examiner submits that in order to make selection, one has to determine whether curved portion is adequate for penetration and sequence of figures 55A-P show advancement of the delivery catheter travelling off axis from the pathway to penetrate proximate to curved portion 102A.
Malek teaches obtaining a venogram of the blood vessel during the endovascular procedure (imaging methods provide improved visualization during endovascular procedure [0086]; real-time fluoroscopy acquired during the procedure [0087]).
Regarding to claim 22, applicant argues that Malek’s cited paragraph [0231] fails to describe an approval process based on a measured distance from the target penetration site to critical structures within the ISAS, in fact, [0231] assumes that the endovascular procedure will proceed as normal regardless of critical structures within the ISAS (pages 13-14).
However, the examiner respectfully disagrees.
In paragraphs [0214], Male explicitly discloses that clinician can obtain CT and MRI imaging of intracranial anatomy to ascertain the sizing and proximity between right and left IPS, arterial structures and surrounding bony anatomy; such imaging can assess unobstructed space relative to a target penetration site and the clinician can use pre-procedure imaging to select one or more preferred location for drug delivery deployment and selects penetration sites, which requires approval of clinician to make selection of preferred location. The clinician would approve the preferred location, not non-preferred location.
In [0231], Male discloses that clinician continue the procedure or change based on the anatomies, which describes that clinician can either approve or not approve the procedure based on the anatomies.
Therefore, absent any evidence to the contrary, the examiner maintains that the combination of reference teaches and/or makes obvious the claimed limitations and the examiner has modified rejection in view of amendment.
New 103 rejections are written for claims 3 and 6 in view of argument.
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.
The following rejection has been modified in view of applicant's arguments and/or amendments.
Claims 1-2, 5, 7-10, 12-14, 16-18, and 20-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Malek et al.,” US 2020/0406018 (hereinafter Malek).
Regarding to claim 1, Malek teaches a method for performing an endovascular procedure to access an intracranial subarachnoid space (ISAS) through a wall of the blood vessel of a patient (endovascular drug delivery within an ISAS of the patient via the DVS [0005]), the method comprising:
obtaining a venogram of the blood vessel (venography [0085]) during the endovascular procedure (imaging methods provide improved visualization during endovascular procedure [0086]; real-time fluoroscopy acquired during the procedure [0087])
evaluating the venogram for a curvature of the blood vessel to locate a target penetration site proximate to the curvature of the blood vessel (penetration site for inserting the device through a curved portion of the DVS wall and into the ISAS [0010]; imaging method provides real-time imaging guidance of endovascular componentry relative to critical structures of interest and penetrating the wall of venous vessel, i.e. an inferior petrosal simus, to access a specific location within the intracranial subarachnoid space, and imaging can be used for any procedure constructed from within a venous or arterial lumen to access a location within the subarachnoid space, penetrating from vessel to access an intracranial subarachnoid space [0086]; imaging to select one or more drug delivery device deployment location along the first curved portion and second curved portion of IPS and clinician can select IPS and a target penetration site along the first or second curve of the IPS based on the imaging [0214], off-axis through the first curved portion of the IPS and advancement of the delivery catheter can be confirmed via imaging [0223]).
determining that the curvature of the blood vessel, when the delivery catheter is advanced through a pathway of the blood vessel, will facilitate off-axis advancement of the delivery catheter from the pathway at the target penetration site to access the ISAS (IPS pathway [0088]; operator can select a portion of the reconstruction that pinpoints the target location along IPS wall where the operator intends to penetrate the IPS and access CP angle cistern [0090] Figure 70A, off-axis trajectory for the penetrating element to pass through the IPS wall and access the intracranial SAS [0121], imaging to select one or more drug delivery device deployment location along the first curved portion and second curved portion of IPS and clinician can select IPS and a target penetration site along the first or second curve of the IPS based on the imaging [0214], off-axis through the first curved portion of the IPS and advancement of the delivery catheter can be confirmed via imaging [0223]);
advancing the delivery catheter along the pathway of the blood vessel prior to reaching the target penetration site (advancing a delivery catheter to portion 130P via elongate guide member Figure 73 [0091], advancing towards a target penetration site on the IPS wall [0118]);
advancing the delivery catheter off-axis from the pathway at the target penetration site through the wall of the blood vessel into the ISAS (catheter including penetrating element travel off-axis to puncture IPS wall and access CP angle cistern [0121]); and
performing the endovascular procedure in the ISAS with the delivery catheter (after penetration, the therapeutic agent administration and/or drug delivery device deployment step [0111]).
Regarding to claims 5, 7-10 and 12-13, Malek teaches all limitations of claim 1 as discussed above.
Malek further teaches following limitations:
Of claim 5, obtaining computed tomography (CT) imaging of the blood vessel and the ISAS; assessing the CT imaging to ensure that the bony anatomy near the target penetration site of the blood vessel does not frustrate or prevent the delivery catheter from accessing the ISAS from the blood vessel at the penetration site (CT imaging studies of patient’ intracranial anatomy to ascertain the sizing and relative proximity of target an surrounding bony anatomy [0214]; using 3D reconstruction to identify local bony anatomy that could obstruct a catheter passing through IPS wall into CP angle cistern [0089]).
Of claim 7, wherein obtaining the venogram comprises acquiring a cone-beam computed tomography (CT) imaging of the blood vessel and ISAS (cone-beam CT [0085])
Of claim 8, wherein the blood vessel is an intracranial venous sinus (intracranial venous sinus [0074]).
Of claim 9, wherein the intracranial venous sinus is an inferior petrosal sinus (IPS) (inferior petrosal sinus [0070]).
Of claim 10, wherein the ISAS comprises a cerebellopontine (CP) angle cistern (intracranial subarachnoid space, CP angle cistern [0196])
Of claim 12, wherein the endovascular procedure comprises deploying an endovascular cerebrospinal fluid (CSF) shunt within the ISAS (anchor deployed providing stable platform [0121]).
Of claim 13, wherein the endovascular procedure comprises administering a therapeutic agent into the ISAS (administering a therapeutic agent into a target site [0191]; intracranial subarachnoid space, CP angle cistern [0196])
Regarding to claim 22, Malek teaches all limitations of claim 1 as set forth above.
Malek further teaches following limitations:
Obtaining magnetic resonance imaging of the blood vessel and the ISAS (MRI imaging volumetric reconstruction of vasculature to a location within a subarachnoid space [0085]);
Measuring in the MRI imaging an unobstructed depth of ISAS at a target penetration site or a distance from a target penetration site of the blood vessel to one or more critical structure within the ISAS (unobstructed space to accommodate a penetrating element of a delivery catheter, measuring height, depth and width [0079]); and
Approving the patient for the endovascular procedure based on the measured unobstructed depth of the ISAS at the target penetration site or the measured distance from the target penetration site of the blood vessel to the one or more critical structures within the ISAS (Clinician can obtain CT and MRI imaging of intracranial anatomy to ascertain the sizing and proximity between right and left IPS, arterial structures and surrounding bony anatomy; such imaging can assess unobstructed space relative to a target penetration site and the clinician can use pre-procedure imaging to select one or more preferred location for drug delivery deployment and selects penetration sites [0214]; clinician continue the procedure or change based on the anatomies [0231]).
Regarding to claim 2, Malek teaches all limitations of claim 22 as set forth above.
Malek further teaches following limitations:
Of claim 2, wherein the one or more critical structures comprise an artery, a nerve, or a brainstem of the patient (Critical structures include artery, brain stem, and cranial nerves [0071])
Regarding to claim 14, Malek teaches a method for performing an endovascular procedure to access an intracranial subarachnoid space (ISAS) through a wall of the blood vessel of a patient, the method comprising:
Obtaining imaging of the blood vessel and the ISAS during the endovascular procedure (MRI imaging Fig. 55A [0214]);
Evaluating the imaging for a curvature of the blood vessel to locate a target penetration site proximate to the curvature of the blood vessel (penetration site for inserting the device through a curved portion of the DVS wall and into the ISAS [0010]; imaging method provides real-time imaging guidance of endovascular componentry relative to critical structures of interest and penetrating the wall of venous vessel, i.e. an inferior petrosal simus, to access a specific location within the intracranial subarachnoid space, and imaging can be used for any procedure constructed from within a venous or arterial lumen to access a location within the subarachnoid space, penetrating from vessel to access an intracranial subarachnoid space [0086]; IPS extends distally from the junction through a curvature of curved portions [0078])
determining that the curvature of the blood vessel, when the delivery catheter is advanced through a pathway of the blood vessel, will facilitate off-axis advancement of the delivery catheter from the pathway at the target penetration site to access the ISAS (IPS pathway [0088]; operator can select a portion of the reconstruction that pinpoints the target location along IPS wall where the operator intends to penetrate the IPS and access CP angle cistern [0090] Figure 70A, off-axis trajectory for the penetrating element to pass through the IPS wall and access the intracranial SAS [0121], imaging to select one or more drug delivery device deployment location along the first curved portion and second curved portion of IPS and clinician can select IPS and a target penetration site along the first or second curve of the IPS based on the imaging [0214], off-axis through the first curved portion of the IPS and advancement of the delivery catheter can be confirmed via imaging [0223]);
advancing the delivery catheter along the pathway of the blood vessel prior to reaching the target penetration site (advancing a delivery catheter to portion 130P via elongate guide member Figure 73 [0091], advancing towards a target penetration site on the IPS wall [0118]);
advancing the delivery catheter off-axis from the pathway at the target penetration site through the wall of the blood vessel into the ISAS (catheter including penetrating element travel off-axis to puncture IPS wall and access CP angle cistern [0121]); and
performing the endovascular procedure in the ISAS with the delivery catheter (after penetration, the therapeutic agent administration and/or drug delivery device deployment step [0111]).
Malek teaches clinicians monitor and continue the procedure or change the procedure based on the anatomies ([0214] and [0231]), but does not explicitly disclose approving the patient for the procedure.
Regarding to 23-25, Malek teaches all limitations of claim 14 as set forth above.
Malek further teaches performing at least one, two or three of the following diagnostic steps to obtain anatomic screening criteria:
measuring in the imaging an unobstructed depth of the ISAS at the target penetration (site sizing and relative proximity between the patient’s anatomy and the surrounding bony anatomy [0214], avoiding critical structures [0071]);
measuring in the imaging a distance from a target penetration site of the blood vessel to one or more critical structures within the ISAS (site sizing and relative proximity between the patient’s anatomy and the surrounding bony anatomy [0214], avoiding critical structures [0071]);
measuring in the imaging a diameter of the blood vessel the target penetration site (diameter of IPS [0077], reference vessel diameter [0112]);
assessing the imaging for the presence or absence of bony anatomy near the target penetration site of the blood vessel (bony anatomy [0089] and [0214]); and
evaluating the imaging for a curvature of the blood vessel proximate the target penetration site (clinician can obtain CT and/MRI imaging studies of the patient’s intracranial anatomies, clinician can use pre-procedure imaging to select drug delivery locations along the first and second curved portion in the patient’s right and left IPS [0214]); and
approving or disapproving the patient for the endovascular procedure based on the anatomic screening criteria (Clinician can select delivery locations [0214]; clinician continue the procedure or change based on the anatomies [0231]).
Regarding to claims 16-18 and 20-21, Malek and Khurana together teach all limitations of claim 14 as discussed above.
Malek further teaches following limitations:
Of claim 16, wherein the blood vessel is an intracranial venous sinus (intracranial venous sinus [0074]).
Of claim 17, wherein the intracranial venous sinus is an inferior petrosal sinus (IPS) petrosal sinus (IPS) (inferior petrosal sinus [0070]).
Of claim 18, wherein the ISAS comprises a cerebellopontine (CP) angle cistern (intracranial subarachnoid space, CP angle cistern [0196]).
Of claim 20, wherein the endovascular procedure comprises an endovascular cerebrospinal fluid (CSF) shunt deployment procedure (anchor deployed providing stable platform [0121]).
Of claim 21, wherein the endovascular procedure comprises administering a therapeutic agent into the ISAS (administering a therapeutic agent into a target site [0191]; intracranial subarachnoid space, CP angle cistern [0196])
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 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Malek as applied to claim 1 above, and further in view of “Jalgaonkar et al.,” US 2025/0032122 (hereinafter Jalgaonkar).
Malek teaches all limitations of claim 1 as set forth above.
Malek further discloses of claim 3, further comprising: measuring in the MRI imaging (MRI image shows additional valuable information about the anatomy surrounding target access locations to the subarachnoid space [0085]) and of claim 6, obtaining another venogram of the blood vessel including the target penetration site prior to the endovascular procedure (CT imaging of intracranial anatomy assessing surrounding near a target penetration site [0214]; a prior imaging study of the patient [0091]; pre-procedure imaging [0214]) and also teaches that diameter is measured in cross-sectional view of the portion of the head (Figure 2A [0074] and [0077]; reference vessel diameter [0112]); and assessing the measured diameter of the blood vessel to ensure that the blood vessel accommodates the delivery catheter at the target penetration site ([0077]), determine ratio of anchor diameter to the reference vessel diameter [0112] (which indicates that reference vessel diameter has to be determined and known for determining a ratio), and delivery catheter with suitable diameter to facilitate accessing intracranial venous vasculature ([0109]; Outer diameter of delivery catheter may have suitable dimension for delivering agents to the IPS, CP, angle cistern [0138]).
The examiner submits that Malek’s disclosure of catheter of suitable diameter for accessing vasculature is evaluated and selected by comparing diameter of the vasculature to catheter.
In the analogous field of endeavor in vascular procedures, Jalgaonkar teaches a physician can measure and/or estimate the size of vessel using pre-treatment angiograms, e.g. angiographic assessment of the diameter of the vessels, and use this information to select size of the implant and implant can be advanced through the microcatheter to target vascular location ([0075]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify pre-treatment imaging as taught by Malek to incorporate teaching of Jalgaonkar, since assessing vessel diameter in image was well known in the art as taught by Jalgaonkar. One of ordinary skill in the art could have combined the elements as claimed by Malek with no change in their respective functions, using its pre-procedure images to estimate vessel diameter, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to select right size of instrument/tool for vasculature procedure ([0075]), and there was reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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