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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 March 2026 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 23 March 2026 have been entered. Claims 1-8, 10, 12-15, 18, and 20-21 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-8, 10, and 12 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 10-13 of remarks, filed 23 March 2026, with respect to the rejection(s) of claim(s) 13-15, 18, and 21 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found prior art reference.
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 1-7, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Berez et al. (2020/0360162), “Berez” in view of Eller et al. (US 2014/0067047 A1), “Eller”.
Regarding claim 1, Berez teaches a method of deploying a stent (“relates to methods and apparatus for luminal stenting” [0002]), comprising: actuating a stent deployment device (Fig. 52) comprising an outer sheath (Fig. 52, catheter 1), wherein the outer sheath is retracted (Fig. 52-53 exhibit catheter 1 retracting) relative to a stent (occluding device 100); deploying (Fig. 52) a first portion of the stent (Fig. 49, distal end 102 of the occluding device 100) from the stent deployment device, wherein the first portion comprises a plurality of rows of coils (Fig. 49, occluding device 100 is comprised of helical structures (i.e., coils) [0209]) such that the plurality of rows of coils of the first portion engage with a vessel wall (Fig. 50, distal end 103 of occluding device 100 expands within vasculature at a desired location [0289]); deploying (Fig. 52) a second portion of the stent (Fig. 49, proximal end 107 of the occluding device 100) from the stent deployment device, wherein the second portion comprises a plurality of rows of coils (Fig. 49, occluding device 100 is comprised of helical structures (i.e., coils)); and applying a distally directed force to each row of the plurality of rows of coils of the second portion of the stent while the second portion is deployed (Fig. 52, after distal section of stent is expanded, the middle section of the stent may be adjusted to a different porosity that other portions of the stent, and after expanding, the proximal section of the stent is expanded [0029]), such that the second portion of the stent is axially compressed (Figs. 56-57, axially compressive force is applied distally to a portion of the stent [0274]) by nesting of the plurality of rows of coils of the second portion (Figs. 11B-G, the lattice structure 63 of occluding device 60 is non-uniform across its length (i.e., the coils are “nesting” in denser lattice structure regions) [0199]), wherein an outer surface of the outer sheath (Fig. 52, catheter 1) comprises a lubricious coating (Fig. 45, introducer sheath 4 or catheter 1 are lined with a hydrophilic coating [0248]), but fails to teach wherein the stent is a single wire helical stent, and nesting apexes of one row of coils of the plurality of rows of coils of the second portion into apexes of an adjacent row of coils of the plurality of rows of coils of the second portion, and wherein the first portion comprises between two and ten equidistance rows. Examiner notes that occluding device 100 mentioned prior to claim 3 of Berez can have a lattice density between about 20% and about 30% and therefore is represented by occluding device 60 and Figs. 11A and D [0199].
Eller teaches a stent wherein the stent is a single wire helical stent (Fig. 1, stent 100 consists of wire 110 [0028]), wherein the first portion comprises between two and ten equidistance rows (Fig. 1, distal end of stent stopping at diameter D1 comprises approximately 7 rows of apexes of helical coils), and nesting apexes of one row of coils of the plurality of rows of coils of the second portion into apexes of an adjacent row of coils of the plurality of rows of coils of the second portion (Fig. 4, stent 100 comprises adjacent coils that are “nested” within each other [0036]). Eller discloses that nested stents create relatively higher strains in the scaffolding structure and are relatively stiff compared to non-nested stents with similar parameters [0036]. 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 Eller with the stent deployment device taught by Berez in order to provide a stent with greater mechanical strength which holds open the vasculature.
Regarding claim 2, Berez teaches wherein, when deployed (Fig. 52), each row of the plurality of rows of coils of the first portion (Fig. 49, distal end 102 of the occluding device 100) of the stent (occluding device 100) is spaced equidistance from an adjacent row (Fig. 52, shows equidistant helical (i.e., coiled) structures of the stent). Examiner notes that the “first portion” of the stent is synonymous with the “landing portion” of the stent and the “second portion” of the stent is synonymous with the “stacked portion”.
Regarding claim 3, Berez teaches wherein, when deployed (Fig. 52), a distance between each row of the plurality of rows of coils of the second portion of the stent (Figs. 11B and D, occluding device 60) is less than the distance between each row of the plurality of rows of coils of the first portion (Figs. 11B and D, higher lattice densities 63a on either portion of occluding device 60). Examiner notes that occluding device 100 mentioned prior to claim 3 can have a lattice density between about 20% and about 30% and therefore is represented by occluding device 60 and Figs. 11A and D [0199]. Examiner further notes that the “first portion” of the stent is synonymous with the “landing portion” of the stent and the “second portion” of the stent is synonymous with the “stacked portion”.
Regarding claim 4, Berez teaches wherein, when deployed (Fig. 52), at least one row of the plurality of rows of coils of the second portion (Figs. 11B and D, lattice densities 63 and occluding device 60) overlaps an adjacent row (Figs. 11B and D, occluding device 60 shows overlapping rows). Examiner notes that occluding device 100 mentioned prior to claim 3 can have a lattice density between about 20% and about 30% and therefore is represented by occluding device 60 and Figs. 11A and D [0199].
Regarding claim 5, Berez teaches wherein deploying (Fig. 52) the second portion of the stent (Fig. 49, proximal end 107 of occluding device 100) comprises constraining movement of the outer sheath (Figs. 52-53, occluding device 100 is constrained by catheter 1) relative to the stent (Figs. 52-53, catheter 1 moves relative to occluding device 100).
Regarding claim 6, Berez teaches wherein the outer sheath (Fig. 52, catheter 1) comprises a stiffness (catheter 1 is made from thermoplastic [0248]) configured to apply the distally directed force (Fig. 54, pressure (i.e., force) is applied distally to pass occluding device 100 out of catheter 1) to each row of the plurality of rows of coils of the second portion of the stent (Fig. 49, proximal end 107 of occluding device 100), wherein the stent is axially compressed (Fig. 54, occluding device expands or retracts due to applied force).
Regarding claim 7, Berez teaches wherein the outer sheath (Fig. 52, catheter 1) comprises a material having a durometer ranging from between 72 and 100 on the Shore D scale (Fig. 52, device can include introducer sheath 4 or catheter 1 made from thermoplastic, PEEK [0248]). Examiner notes that thermoplastic PEEK is categorized with a durometer on the Shore D scale within the claimed range.
Regarding claim 10, Berez teaches wherein the lubricious coating is any one of polyvinylpyrrolidone, polyvinylpyrrolidone and polyurethane blend, hyaluronic acid, silicone oil, parylene, and any combination thereof (Fig. 45, hydrophilic coating is PVP [0248]).
Regarding claim 12, Berez teaches wherein the stent deployment device is in direct contact with the wall of a body lumen (Fig. 53, arms 104 are in contact with vessel wall) at the point wherein the stent deployment device enters the body lumen (Fig. 53, arms 104 are in contact with the vessel wall where stent is released). Examiner notes that “body lumen” is synonymous with the “vessel” or “vessel wall”.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Berez et al. (2020/0360162), “Berez” in view of Eller et al. (US 2014/0067047 A1), “Eller”, and further in view of Mower et al. (US 2018/0085240 A1), “Mower”.
Regarding claim 8, Berez teaches wherein the stent (Fig. 52, occluding device 100) deployment device comprises a pliant member (Fig. 50, guidewire 41 bends), wherein the pliant member configured to engage the stent (occluding device 100 is engaged with guidewire 41) when constrained by the outer sheath (Fig. 52, bendable guidewire 41 is enclosed within catheter 1 [0250]), but Berez in view of Eller fails to teach wherein the stent is configured to imprint on the pliant member when constrained.
Mower teaches members for deploying vascular prostheses wherein the stent is configured to imprint on the pliant member when constrained (loaded stent imprints within a portion of the pliant member 290 [0117]). Mower discloses that imprinting of a stent around a pliant member supports the rows of coils of the stent [0120]. 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 teachings of Berez in view of Eller with those of Mower in order to better support the stent during deployment.
Claims 13-15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Berez et al. (2020/0360162), “Berez” in view of Mower et al. (US 2018/0085240 A1), “Mower”, and further in view of Heanue et al. (US 2016/0120677 A1), “Heanue”.
Regarding claim 13, Berez teaches a method of treating a vascular lesion (disclosure relates to methods and devices for treating aneurysms [0007]), comprising: positioning a stent adjacent the vascular lesion (Fig. 52, occluding device 100 is adjacent aneurysm A), wherein the stent is constrained by an outer sheath of a stent deployment device (Fig. 52, occluding device 100 is constrained by catheter 1); actuating the stent deployment device, wherein the outer sheath is retracted relative to a stent (Figs. 52-53 exhibit catheter 1 retracting); partially deploying the stent adjacent the vascular lesion (Fig. 57 depicts the partial deployment of occluding device 100 [0104]) comprising a landing portion (Fig. 49, distal end 102 of the occluding device 100) and a stacked portion (Fig. 49, proximal end 107 of the occluding device 100); engaging the landing portion of the stent against a vessel wall (Fig. 50, distal end 102 of occluding device 100 expands within vasculature at desired location [0289]), wherein the landing portion (Fig. 49, distal end 102 of the occluding device 100) and the stacked portion (Fig. 49, proximal end 107 of the occluding device 100) are non-constrained by the outer sheath (Fig. 50, distal and proximal ends 102, 107 of occluding device 100 are passed outside of catheter 1 [0290]) and the landing portion (Fig. 49, distal end 102 of the occluding device 100) and the stacked portion (Fig. 49, proximal end 107 of the occluding device 100) comprise a plurality of rows of coils (Fig. 49, occluding device 100 is comprised of helical structures (i.e., coils)), and wherein the stacked portion (Fig. 49, proximal end 107 of the occluding device 100) of the stent is deployed but not yet engaged with the vessel wall (Fig. 50, proximal end 107 of occluding device 100 may be advanced to pass outside the catheter and expands in response to pressure [0290]); applying a distally directed force to at least one row of the plurality of rows of coils of the stacked portion of the stent while the stacked portion is deployed (Fig. 52, after distal section of stent is expanded, the middle section of the stent may be adjusted to a different porosity that other portions of the stent, and after expanding, the proximal section of the stent is expanded [0029]), wherein the stent is axially compressed by stacking the stacked portion of the plurality of rows of coils of the stacked portion (Figs. 56-57, axially compressive force is applied distally to a portion of the stent [0274]); engaging the stacked portion of the stent (Fig. 49, proximal end 107 of occluding device 100) against the vessel wall (Fig. 52, occluding device 100 is against vessel wall) after the stacked portion is axially compressed (Fig. 49, when distal end 1032 of occluding device is positioned outside catheter 1 the proximal end 107 will begin to expand to contact the vasculature walls [0289]) and applying a radial outwardly directed force to the vessel wall by the stent (Fig. 53, fully expanded occluding device 100 applies outward pressure to vessel wall), wherein the stent deployment device (Fig. 52, occluding device 100 is constrained by catheter 1) comprises a pliant member (Fig. 50, guidewire 41 bends), wherein the pliant member (Fig. 50, guidewire 41 bends) configured to engage the stent when constrained by the outer sheath (Fig. 49, guidewire 41 interacts with occluding device 100 during positioning and delivery [0282]), wherein deploying the stacked portion of the stent comprises constraining movement of the outer sheath relative to the stent (Fig. 54, user applies a pressure or motion force at a proximal end for positioning the occluding device [0217, 0222, 0268]), but fails to teach wherein the stent is configured to imprint on the pliant member when constrained, and wherein constraining movement of the outer sheath comprises: actuating the stent deployment device with a user’s first hand; and pinching the outer sheath with fingers of the user’s second hand to constrain the outer sheath from moving relative to the landing portion.
Mower teaches members for deploying vascular prostheses wherein the stent is configured to imprint on the pliant member when constrained (loaded stent imprints within a portion of the pliant member 290 [0117]). Mower discloses that imprinting of a stent around a pliant member supports the rows of coils of the stent [0120]. 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 teachings of Berez with those of Mower in order to better support the stent during deployment. However, Berez in view of Mower fails to teach wherein constraining movement of the outer sheath comprises: actuating the stent deployment device with a user’s first hand; and pinching the outer sheath with fingers of the user’s second hand to constrain the outer sheath from moving relative to the landing portion.
Heanue teaches a pin & pull stent delivery system wherein constraining movement of the outer sheath comprises: actuating the stent deployment device with a user’s first hand; and pinching the outer sheath with fingers of the user’s second hand to constrain the outer sheath from moving relative to the landing portion (deployment of a stent comprises navigating the system to the treatment location and holding the inner shaft against the location with one hand and the outer sheath is pulled proximally by the user’s other hand [0014]). Heanue discloses that the pinning action fixes the location of the inner shaft at the point of implantation in the patient’s lumen [0014]. 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 method taught by Heanue with the delivery system taught by Berez in view of Mower in order to more accurately place the stent during delivery.
Regarding claim 14, Berez teaches wherein, when deployed (Fig. 52), each row of the plurality of rows of coils of the first portion (Fig. 49, distal end 102 of the occluding device 100) of the stent (occluding device 100) is spaced equidistance from an adjacent row (Fig. 52, shows equidistant helical (i.e., coiled) structures of the stent). Examiner notes that the “first portion” of the stent is synonymous with the “landing portion” of the stent and the “second portion” of the stent is synonymous with the “stacked portion”.
Regarding claim 15, Berez teaches wherein, when deployed (Fig. 52), a distance between each row of the plurality of rows of coils of the second portion of the stent (Figs. 11B and D, occluding device 60) is less than the distance between each row of the plurality of rows of coils of the first portion (Figs. 11B and D, higher lattice densities 63a on either portion of occluding device 60). Examiner notes that occluding device 100 mentioned prior to claim 3 can have a lattice density between about 20% and about 30% and therefore is represented by occluding device 60 and Figs. 11A and D [0199]. Examiner further notes that the “first portion” of the stent is synonymous with the “landing portion” of the stent and the “second portion” of the stent is synonymous with the “stacked portion”.
Regarding claim 18, Berez teaches wherein the outer sheath comprises a stiffness (catheter 1 is made from thermoplastic [0248]) configured to translate the distally directed force from a proximal portion of the stent deployment device (Fig. 54, catheter 1 is subject to pressure (i.e., force) to deliver occluding device 100) to each row of the plurality of rows of coils of the stacked portion of the stent (Fig. 54, occluding device 100 has helical structures (i.e., coils) where force is applied to be delivered).
Regarding claim 20, Berez teaches wherein the stent deployment device is in direct contact with the wall of a body lumen (Fig. 53, arms 104 are in contact with vessel wall) at the point wherein the stent deployment device enters the body lumen (Fig. 53, arms 104 are in contact with the vessel wall where stent is released). Examiner notes that “body lumen” is synonymous with the “vessel” or “vessel wall”.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Berez et al. (2020/0360162), “Berez” in view of Eller et al. (US 2014/0067047 A1), “Eller”, and further in view of Heanue et al. (US 2016/0120677 A1), “Heanue”.
Regarding claim 21, Berez teaches constraining movement of the outer sheath relative to the stent (Fig. 54, user applies a pressure or motion force at a proximal end for positioning the occluding device [0217, 0222, 0268]), but Berez in view of Eller fails to teach wherein constraining movement of the outer sheath comprises: actuating the stent deployment device with a user's first hand; and pinching the outer sheath with fingers of the user's second hand to constrain the outer sheath from moving relative to the first portion of the stent.
Heanue teaches a pin & pull stent delivery system wherein constraining movement of the outer sheath comprises: actuating the stent deployment device with a user’s first hand; and pinching the outer sheath with fingers of the user’s second hand to constrain the outer sheath from moving relative to the landing portion (deployment of a stent comprises navigating the system to the treatment location and holding the inner shaft against the location with one hand and the outer sheath is pulled proximally by the user’s other hand [0014]). Heanue discloses that the pinning action fixes the location of the inner shaft at the point of implantation in the patient’s lumen [0014]. 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 method taught by Heanue with the delivery system taught by Berez in view of Mower in order to more accurately place the stent during delivery.
Conclusion
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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