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 .
Claim Status
Applicant’s Remarks and Amendments filed 26 December 2025 have been entered. Claims 7-20, 25-28, and 30-32 are cancelled. Claim 35 is new. Claims 1-6, 21-24, 29, and 33-35 are pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 29, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Callister (US 2018/0256378 A1), “Callister” in view of Ferrera et al. (US 2011/0160763 A1), “Ferrera”.
Regarding claim 1, Callister teaches an implantable device comprising: a tubular member (Fig. 4, stent 100) defining a longitudinal axis (Fig. 4, dashed line through length of stent 100) and a lumen (Fig. 4, stent 100 comprises lumen diameters [0033]), the tubular member configured to be disposed within venous sinuses (Fig. 1, exemplary stenting zone being the sigmoid sinus of the venous sinus system [0005]) having: a plurality of interconnected filaments defining a plurality of openings (Fig. 3, strut members 112 of strut segments 110 which are coupled together by longitudinal connection members 118 [0026]) therebetween; a distal end portion having a first cross-sectional dimension (Fig. 4, distal end 104 comprises lumen diameter D2); and a proximal end portion having a second cross-sectional dimension larger than the first cross-sectional dimension (Fig. 4, proximal end 102 comprises lumen diameter D1 which is greater than lumen diameter D2 [0033]) and configured to have a circular or oval cross-sectional shape (Fig. 4, stent 100 comprises a cylindrical shape which is conically shaped [0033]), but fails to teach a distal end portion configured to have a triangular cross-sectional shape.
Ferrera teaches devices for treatment of ischemic stroke comprising a distal end portion configured to have a triangular cross-sectional shape (Fig. 32C, expandable scaffold 3210C comprises a triangular configuration). Ferrera discloses that the expandable scaffold may comprise various profiles, shapes and geometries intended for a desired clinical effect [0262]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the distal end portion taught by Callister to reflect the triangular shape taught by Ferrera in order to better fit non-circular vasculature.
Regarding claim 2, Callister teaches wherein the second cross-sectional dimension is from 10 mm to 14 mm (Fig. 4, lumen diameter D1 may be 0.3937 inches (10 mm) [0033]) and the first cross-sectional dimension is from 4 mm to 8 mm (Fig. 4, lumen diameter D2 may be 0.2756 inches (7 mm) [0033])
Regarding claim 3, Callister teaches wherein the second cross-sectional dimension (Fig. 9, proximal end diameter D2) is larger than the first cross-sectional dimension (Fig. 9, distal end diameter D3) by a factor from 2 to 3 (Fig. 9, diameter increases of proximal and distal ends 902, 904 may be different (i.e., one end may be larger/smaller than the other) and D2 may be about 5 mm greater than D1 while D3 may be about 3 mm greater than D1 [0150]).
Regarding claim 29, Callister teaches an implantable device comprising: a tubular member (Fig. 4, stent 100) defining a longitudinal axis (Fig. 4, dashed line through length of stent 100) and a lumen (Fig. 4, stent 100 comprises lumen diameters [0033]), the tubular member configured to be disposed within venous sinuses (Fig. 1, exemplary stenting zone being the sigmoid sinus of the venous sinus system [0005]) and having: a plurality of interconnected filaments defining a plurality of openings therebetween (Fig. 3, strut members 112 of strut segments 110 which are coupled together by longitudinal connection members 118 [0026]); a distal end portion (Fig. 4, distal end 104); and a proximal end portion (Fig. 4, proximal end 102) opposite the distal end portion and configured to have a circular or oval cross-sectional shape (Fig. 4, stent 100 comprises a cylindrical shape which is conically shaped [0033]), but fails to teach a distal end portion configured to have a triangular cross-sectional shape.
Ferrera teaches devices for treatment of ischemic stroke comprising a distal end portion configured to have a triangular cross-sectional shape (Fig. 32C, expandable scaffold 3210C comprises a triangular configuration). Ferrera discloses that the expandable scaffold may comprise various profiles, shapes and geometries intended for a desired clinical effect [0262]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the distal end portion taught by Callister to reflect the triangular shape taught by Ferrera in order to better fit non-circular vasculature.
Regarding claim 33, Callister teaches wherein the distal end portion has a distal cross-sectional dimension (Fig. 4, distal end 104 comprises lumen diameter D2), and the proximal end portion has a proximal cross-sectional dimension (Fig. 4, proximal end 102 comprises lumen diameter D1), and wherein the implantable device further comprises: an intermediate portion having an intermediate cross-sectional dimension smaller than at least one of the distal cross-sectional dimension or the proximal cross-sectional dimension (stent 100 may have a mix of straight and conical portions therebetween the distal and proximal ends [0033]).
Regarding claim 34, Callister teaches wherein the distal end portion has a distal cross-sectional dimension (Fig. 4, distal end 104 comprises lumen diameter D2), and the proximal end portion has a proximal cross-sectional dimension (Fig. 4, proximal end 102 comprises lumen diameter D1), and wherein the implantable device further comprises: an intermediate portion having an intermediate cross-sectional dimension smaller than both the distal cross-sectional dimension and the proximal cross-sectional dimension (stent 100 may have a mix of straight and conical portions therebetween the distal and proximal ends [0033]), but fails to teach the tubular member has an hour-glass shape.
Ferrera teaches devices for treatment of ischemic stroke wherein the tubular member has an hour-glass shape (Fig. 32B, expandable scaffold 3210B comprises an hourglass shape [0262]). Ferrera discloses that the expandable scaffold may comprise various profiles, shapes and geometries intended for a desired clinical effect [0262]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the intermediate portion taught by Callister to reflect the hourglass shape taught by Ferrera in order to better fit vasculature with changing diameters.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Callister (US 2018/0256378 A1), “Callister” in view of Ferrera et al. (US 2011/0160763 A1), “Ferrera”, and further in view of Chanduszko et al. (US 2009/0105747 A1), “Chanduszko”.
Regarding claim 4, Callister in view of Ferrera fails to teach the limitations of claim 4. Chanduszko teaches an implantable medical device comprising an attachment member (Fig. 2, filtering element 50) including a plurality of attachment filaments (Fig. 2, filaments 52) and a hook coupled to the plurality of attachment filaments (Fig. 2, hub 54 with a hook-like design [0026]). Chanduszko discloses that the hook may be more elastic than other parts of the device to allow for straightening in response to withdrawal forces so as to avoid injury to the vessel wall [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Callister with the attachment member taught by Chanduszko in order to facilitate removal of the member without harming the patient’s vasculature.
Regarding claim 6, Callister teaches wherein the tubular member is formed from a non-biodegradable material (Fig. 2, stent 100 may be made of nitinol [0029]), but Callister in view of Ferrera fails to teach the attachment member is formed from a biodegradable material.
Chanduszko teaches an implantable medical device wherein the attachment member is formed from a biodegradable material (Fig. 2, filaments 52 of filtering element 50 are formed of bio-resorbable material [0026]). Chanduszko discloses that the filter is placed to intercept clots and prevent them from further entering a patient’s vasculature and organs [0002]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tubular member taught by Callister with the attachment member taught by Chanduszko in order to capture blood clots in the venous sinuses and prevent further injury to the vasculature.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Callister (US 2018/0256378 A1), “Callister” in view of Ferrera et al. (US 2011/0160763 A1), “Ferrera”, Chanduszko et al. (US 2009/0105747 A1), “Chanduszko”, and further in view of Cartledge et al. (US 2012/0239133 A1), “Cartledge”.
Regarding claim 5, Callister teaches the tubular member (Fig. 4, stent 100) and the longitudinal axis (Fig. 4, dashed line through length of stent 100), but fails to teach wherein rotation of the attachment member about the longitudinal axis in a first direction expands the tubular member and a rotation of the attachment member about the longitudinal axis in a second direction, opposite the first direction, constrains the tubular member.
Chanduszko teaches an implantable medical device comprising an attachment member (Fig. 2, filtering element 50). Chanduszko discloses that the filter is placed to intercept clots and prevent them from further entering a patient’s vasculature and organs [0002]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tubular member taught by Callister with the attachment member taught by Chanduszko in order to capture blood clots in the venous sinuses and prevent further injury to the vasculature. However, Callister in view of Chanduszko fails to teach wherein rotation of the attachment member about the longitudinal axis in a first direction expands the tubular member and a rotation of the attachment member about the longitudinal axis in a second direction, opposite the first direction, constrains the tubular member.
Cartledge teaches a deployable endograft system wherein rotation of the attachment
member about the longitudinal axis in a first direction expands the tubular member (Figs. 14A-
B, control system 2400 comprising torque wire 2410 rotates to bring points 2420 and 2430
together to expand lattice structure 2100 [0104]) and rotation of the attachment member
about the longitudinal axis in a second direction, opposite the first direction, constrains the
tubular member (Figs. 14A-B, control system 2400 comprising torque wire 2410 rotates to
distance points 2420 and 2430 away from each other to contract lattice structure 2100
[0104]). Cartledge discloses that the expansion and contraction of the stent is actively controlled by the user [0104]. Therefore, it would have been obvious to one of ordinary skill in
the art before the filing date of the claimed invention to combine the attachment member
taught by Chanduszko with the control system taught by Cartledge and the tubular member taught by Callister in order to provide an implant that is adjustable in real time by the user.
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Callister (US 2018/0256378 A1), “Callister” in view of Ferrera et al. (US 2011/0160763 A1), “Ferrera”, and further in view of You et al. (US 2016/0375175 A1), “You”.
Regarding claim 21, Callister teaches the tubular member (Fig. 4, stent 100), but Callister in view of Ferrera fails to teach wherein when the tubular member is compressed to 30% of a nominal state, a radial pressure of the tubular member is from 20 mmHg to 50 mmHg.
You teaches scaffolds used for treatment of sinusitis wherein when the tubular member is compressed to 30% of a nominal state, a radial pressure of the tubular member is from 20 mmHg to 50 mmHg (scaffolds comprise a “chronic outward force” (COF) which is the force the scaffold applies against a static abutting surface (i.e., vessel wall) ranging from 10 to 100 mmHg [0187]). You discloses that the scaffolds comprise a relatively low COF to avoid applying injurious forces against walls of bodily lumens [0187]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tubular member taught by Callister with the radial pressure features taught by You in order to avoid injury to the venous sinuses.
Regarding claim 22, Callister teaches the tubular member (Fig. 4, stent 100), but Callister in view of Ferrera fails to teach wherein in a nominal state, a radial pressure of the tubular member is from 10 mmHg to 30 mmHg.
You teaches scaffolds used for treatment of sinusitis wherein in a nominal state, a radial pressure of the tubular member is from 10 mmHg to 30 mmHg (scaffolds comprise a “chronic outward force” (COF) which is the force the scaffold applies against a static abutting surface (i.e., vessel wall) ranging from 10 to 100 mmHg [0187]). You discloses that the scaffolds comprise a relatively low COF to avoid applying injurious forces against walls of bodily lumens [0187]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tubular member taught by Callister with the radial pressure features taught by You in order to avoid injury to the venous sinuses.
Regarding claim 23, Callister teaches the tubular member (Fig. 4, stent 100), but Callister in view of Ferrera fails to teach wherein when the tubular member is fully compressed, the radial pressure of the tubular member is from 30 mmHg to 200 mmHg.
You teaches scaffolds used for treatment of sinusitis wherein when the tubular member is fully compressed, the radial pressure of the tubular member is from 30 mmHg to 200 mmHg (scaffolds comprise a “chronic outward force” (COF) which is the force the scaffold applies against a static abutting surface (i.e., vessel wall) ranging from 10 to 100 mmHg [0187]). You discloses that the scaffolds comprise a relatively low COF to avoid applying injurious forces against walls of bodily lumens [0187]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tubular member taught by Callister with the radial pressure features taught by You in order to avoid injury to the venous sinuses.
Regarding claim 24, Callister teaches the tubular member (Fig. 4, stent 100), but Callister in view of Ferrera fails to teach wherein when fully compressed, the radial pressure of the tubular member is from 40 mmHg to 60 mmHg.
You teaches scaffolds used for treatment of sinusitis wherein when fully compressed, the radial pressure of the tubular member is from 40 mmHg to 60 mmHg (scaffolds comprise a “chronic outward force” (COF) which is the force the scaffold applies against a static abutting surface (i.e., vessel wall) ranging from 10 to 100 mmHg [0187]). You discloses that the scaffolds comprise a relatively low COF to avoid applying injurious forces against walls of bodily lumens [0187]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the tubular member taught by Callister with the radial pressure features taught by You in order to avoid injury to the venous sinuses.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Callister (US 2018/0256378 A1), “Callister” in view of Ferrera et al. (US 2011/0160763 A1), “Ferrera”, and further in view of Sirhan et al. (US 2020/0253757 A1), “Sirhan”.
Regarding claim 35, Callister teaches further comprising an intermediate portion (Fig. 4, region of stent 100 between ends 102, 104) between the distal end portion (Fig. 4, distal end 104) and the proximal end portion (Fig. 4, proximal end 102), but Callister in view of Ferrera fails to teach wherein a cross-sectional shape of the intermediate portion is increasingly triangular in a distal direction toward the distal end portion.
Sirhan teaches a stent prosthesis wherein a cross-sectional shape of the intermediate portion is increasingly triangular in a distal direction toward the distal end portion (stent may change shape after expansion to fit a change in the body lumen, including shape changes within the annulus (i.e., from circular to triangular), and may change dynamically [0383]). Sirhan discloses that the stent’s ability to dynamically change shape minimizes the risk of a mismatched fit between the blood vessel and stent and instead allows for an improved fit between the two [0383]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the distal end taught by Callister to comprise an increasingly triangular cross-section in order to better fit within the vessel it was positioned.
Conclusion
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/G.G.R./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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