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 Arguments
Applicant's arguments filed 02 March 2016 have been fully considered but they are not persuasive.
With respect to amended limitations, the applicant argues that Malek does not teach amended limitation and specifically argues that Malek does not disclose obtaining a venogram or of otherwise imaging, a blood vessel during the endovascular procedure, rather Malek specifically discloses imaging is performed prior to the endovascular procedure to select drug delivery deployment site (page 13).
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.
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]).
Regards to argument for claim 3, the examiner submits 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], ratio of anchor diameter to the reference vessel diameter [0112], 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]).
Therefore, absent any evidence to the contrary, the examiner maintains that the combination of reference teaches and/or makes obvious the claimed limitations.
The examiner has modified rejection in view of amendment including new claims.
Applicant’s arguments, see pages 8-12, filed 02 March 2026, with respect to 101 and 112 rejections have been fully considered and are persuasive in view of amendment. The 101 rejection and 112 rejections of 13 February 2026 has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-10, 12-14, 16-18, and 22-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites limitations “a wall of the blood vessel” in preamble, line 2 page 2 and “traveling of the delivery catheter” in line 7 page 2. There is insufficient antecedent basis for this limitation in the claim, since “a blood vessel” and “traveling of a delivery catheter” were not previously recited in the claim.
Claim 5 recites limitation “the bony anatomy” in line 9 page 3. There is insufficient antecedent basis for this limitation in the claim, since “ a bony anatomy” was not previously recited in the claim.
Claim 14 recites limitations “a wall of the blood vessel” in preamble, line 4 page 5 and “traveling of the delivery catheter” in line 10 page 5. There is insufficient antecedent basis for this limitation in the claim, since “ a blood vessel” and “ traveling of a delivery catheter” were not previously recited in the claim.
Claims 2-3, 5-10, 12-13, 16-18, and 22-25 are rejected as they inherit the rejection of claims 1 and 14 due to their dependency.
Claims 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 20-21 are dependent upon claim 19, which is canceled and the respective dependency of claims 20-21 is unclear, therefore render their scope indefinite.
For a purpose of examination, the examiner will regard claims 20-21 depend on claim 14 and rejection will be written accordingly.
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 1-3, 5-10, 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]; IPS extends distally from the junction through a curvature of curved portions [0078])
determining that the curvature facilitates traveling of the delivery catheter, when advanced through a pathway of the blood vessel, will travel off-axis 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]);
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 5-10 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 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]); measuring in the other venogram a diameter of the blood vessel at the target penetration site; and assessing the measured diameter of the blood vessel to ensure that the blood vessel accommodates the delivery catheter at the target penetration site
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 claims 2-3, 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])
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]) a diameter of the blood vessel the target penetration site (diameter shown and measured in cross-sectional view of the head in Fig.2A [0074], [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], ratio of anchor diameter to the reference vessel diameter [0112], 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]);
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 facilitates traveling of the delivery catheter, when advanced through a pathway of the blood vessel, will travel off-axis 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]);
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])
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
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