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 .
Status of Claims
Claims 2-14 are pending and currently under consideration for patentability.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/17/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Regarding Claim 2, the applicant argues that Glenn does not teach or suggest an endovascularly deployed CSF shunt. The rejection acknowledges this and cites Glenn fails to explicitly teach that the CSF shunt is endovascular. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). The Glenn is capable of being used as an endovascular device and does not structurally differentiate from the claimed device. Further it would be obvious that the Glenn device could be used as an endovascular device.
Regarding the applicant’s agreement that Glenn fails to teach wherein the anchor arms are disposed in an elongated linear configuration when the anchor is constrained in a collapsed delivery configuration, and in a foreshortened radially-outward curved configuration when the anchor is unconstrained in an expanded deployed configuration, the examiner disagrees. The anchor (86 and 88) is clearly collapsable as seen in figure 13A in additionally the anchor is foreshortened radially-outward and curved, and the applicant has not offered any explanation as to why the art as pictured cannot be interpreted this way.
Regarding the applicant’s agreement that Glenn does not teach or suggest the shunt having the claimed an elongate retaining element. There is no claim language that requires the retaining element does not have fluid moving in and out. There is no limiting language that can be used to specify why Glenn does not apply.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Glenn (US 20060224102 A).
Regarding Claim 2, Glenn teaches an cerebrospinal fluid (CSF) shunt (paragraph [0003]) configured for being deployed in a venous system of a patient (paragraph [0004]) , the shunt comprising:
a self-expanding anchor configured for being introduced into (paragraph [0058]), and disposed within, an intracranial subarachnoid space (ISAS) of the patient via a venous sinus (paragraph [0058]), the anchor comprising a tubular proximal portion (22, figure 5), a tubular distal portion (22d), and a plurality of resilient anchor arms (86) extending therebetween( FIGS. 13A and 13B), wherein the anchor arms (86, 88) are disposed in an elongated linear configuration when the anchor is constrained in a collapsed delivery configuration (paragraph [0058]), and in a foreshortened radially-outward curved configuration when the anchor is unconstrained in an expanded deployed configuration ( FIGS. 13A and 13B);
a shunt body (30) having a CSF drainage lumen (paragraph [0039]), the shunt body configured for being at least partially disposed within the sinus when the anchor is disposed within the ISAS (paragraph [0041]; and
an elongate retaining element (80) having an open distal end, an open proximal end, and a lumen extending therebetween (figure 13A-13B),
wherein a proximal portion (80o) of the retaining element is disposed within the CSF drainage lumen (90) (paragraph [0057]) , and a distal portion (80i) of the retaining element extends out of an open distal end of the shunt body within an open interior of the anchor defined by the anchor arms (86), such that the open distal end of the retaining element comprises a CSF intake opening in fluid communication with the CSF drainage lumen via the retaining element lumen (paragraph [0058]), and
wherein a wall of the distal portion of the shunt body (wall of 22) is secured between an outer surface of the proximal portion of the retaining element and an inner surface of the proximal portion of the anchor (figure 13A-13B).
Glenn fails to explicitly teach that the CSF shunt is endovascular. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). The Glenn is capable of being used as an endovascular device and does not structurally differentiate from the claimed device. Further it would be obvious that the Glenn device could be used as an endovascular device.
Regarding Claim 8, Glenn teaches the endovascular CSF shunt of claim 2. The primary embodiment fails to teach wherein a proximal end of the CSF drainage lumen is fluidly sealed, and wherein the shunt body comprises one or more longitudinal slits configured to allow egress therethrough of CSF from the CSF drainage lumen if a fluid pressure within the CSF drainage lumen exceeds a venous system pressure external of the one or more slits An alternative embodiment of Glenn further teaches wherein a proximal end of the CSF drainage lumen is fluidly sealed (hub, paragraph [0045]), and wherein the shunt body comprises one or more longitudinal slits(paragraph [0040]) configured to allow egress therethrough of CSF from the CSF drainage lumen if a fluid pressure within the CSF drainage lumen exceeds a venous system pressure external of the one or more slits (paragraph [0040]).
Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the primary embodiment of Glenn to include wherein a proximal end of the CSF drainage lumen is fluidly, and wherein the shunt body comprises one or more longitudinal slits configured to allow egress therethrough of CSF from the CSF drainage lumen if a fluid pressure within the CSF drainage lumen exceeds a venous system pressure external of the one or more slits so that the flow through the slits with controlled fluid flow (paragraph [0045]).
Regarding Claim 10, Glenn teaches the endovascular CSF shunt of claim 2. Glenn further teaches wherein the distal portion of the retaining element is disposed within the anchor interior in a configuration (paragraph [0058]), that maintains the CSF intake opening in a position that is separated, apart and/or directed away from an arachnoid layer of the ISAS (paragraph [0005]).
Regarding Claim 11, Glenn teaches the endovascular CSF shunt of claim 2. Glenn further teaches the retaining element comprising a tapered portion that prevents the retaining element from slipping through the proximal portion of the anchor (annotated figure 6) (flange, 42) (paragraph [0047]).
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Regarding Claim 12, Glenn teaches the endovascular CSF shunt of claim 2. Glenn further teaches wherein the outer surface of the proximal portion of the retaining element (80) includes retaining features configured to secure the distal portion of the shut body portion onto the proximal portion of the retaining element (paragraph [0058]).
Regarding Claim 13, Glenn teaches the endovascular CSF shunt of claim 12. Glenn further teaches wherein the retaining features comprise circumferential threads (paragraph [0054]).
Claim(s) 3, 4, 7, 9, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glenn (US 20060224102 A) in view of Henderson(US 20100076366 A1).
Regarding Claim 3, Glenn teaches the endovascular CSF shunt of claim 2. Glenn fails to teach wherein a proximal portion of the shunt body comprises a radiopaque marker. Henderson teaches a shunt system for telemetrically measuring, regulating and/or adjusting cerebrospinal fluid flow rate, intercranial pressure, intraspinal pressure and/or intraventricular pressure and a method for use wherein the tubular connector is radiopaque or otherwise has one or more radiopaque elements coupled thereto (paragraph [0035]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shunt body of Glenn wherein the tubular connector is radiopaque or otherwise has one or more radiopaque elements coupled thereto similar to Henderson to provide a viewable target for the surgeon under fluoroscopy (Henderson, paragraph [0061]).
Regarding Claim 4, Glenn in view of Henderson teaches the endovascular CSF shunt of claim 3. The combination of Glenn and Henderson further teaches the distal portion of the anchor (Glenn, 86, 88) comprises a radiopaque marker (Henderson, paragraph [0061]) that moves proximally towards the tubular proximal portion of the anchor as the anchor self-expands from the collapsed delivery configuration to the unconstrained deployed configuration (Glenn, paragraph [0058]).
Regarding Claim 7, Glenn teaches the endovascular CSF shunt of claim 2. Glenn fails to teach wherein a proximal portion of the shunt body comprises a radiopaque marker. Henderson teaches a shunt system for telemetrically measuring, regulating and/or adjusting cerebrospinal fluid flow rate, intercranial pressure, intraspinal pressure and/or intraventricular pressure and a method for use wherein a proximal portion of the shunt body comprises a radiopaque marker (paragraph [0035]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shunt body of Glenn a proximal portion of the shunt body comprises a radiopaque marker similar to Henderson to provide a viewable target for the surgeon under fluoroscopy (Henderson, paragraph [0061]).
Regarding Claim 9, Glenn teaches the endovascular CSF shunt of claim 2. Glenn fails to teach wherein the one or more longitudinal slits in the shunt body are configured and dimensioned to achieve a target flow rate of 5 ml of CSF per hour to 15 ml of CSF per hour through the CSF drainage lumen under normal differential pressure conditions between the ISAS and venous system of the patient. Henderson teaches the advantage of a fluid flow rate of about 0.5 cc per hour to about 10 cc per hour (paragraph [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a target flow rate of 5 ml of CSF per hour to 15 ml of CSF per hour in order to fit the particular procedure being done since this claimed dimension of the flow rate is non-critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see paragraphs 0094-0095 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding Claim 14, Glenn teaches the endovascular CSF shunt of claim 4. Glenn further teaches the method (paragraph [0012]) comprising:
navigating a delivery catheter through the patient's venous system to a target location in the venous sinus with the endovascular CSF shunt disposed in a lumen of the delivery catheter, the shunt anchor constrained in the collapsed delivery configuration (paragraph [0059]);
accessing the ISAS with a distal portion of the delivery catheter (paragraph [0039]);
advancing the shunt anchor through a distal end opening of the delivery catheter into the ISAS (paragraph [0039])
The combination of Glenn and Henderson further teaches observing the radiopaque maker in the distal portion (Henderson, paragraph [0061]) of the anchor (Glenn, 86, 88) move proximally toward the retaining element as the anchor self-expands from the collapsed delivery configuration to the expanded deployed configuration (Glenn, paragraph [0058])..
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glenn (US 20060224102 A) in view of Trescony (US 20080082036 A1).
Regarding Claim 5, Glenn teaches the endovascular CSF shunt of claim 2. Glenn fails to teach wherein the shunt body comprises a flexible unreinforced polyurethane-silicone blend or another polymer material. Trescony teaches a cerebrospinal fluid shunt wherein the shunt body comprises a flexible unreinforced polyurethane-silicone blend or another polymer material (claim 22). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify shunt of Glenn so that the shunt body comprises a flexible unreinforced polyurethane-silicone blend or another polymer material that the shunt may include a material that can absorb at least some of at least one occlusion resistant agent (motivated by paragraph [0024]).
Regarding Claim 6, Glenn in view of Trescony teaches the endovascular CSF shunt of claim 5. The combination further teaches wherein a proximal end of the CSF drainage lumen is fluidly sealed with a proximal plug (Glenn, 36)(Glenn, figure 6) of the flexible polyurethane-silicone blend or other polymer material (Trescony, paragraph [0024]).
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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781