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 1 December 2025 have been entered. Claims 1-24 are cancelled. Claims 25-44 are new and pending.
Response to Arguments
Applicant’s arguments, see remarks, filed 1 December 2025, with respect to the specification have been fully considered and are persuasive. The objections to the specification have been withdrawn.
Applicant’s arguments, see remarks, filed 1 December 2025, with respect to the drawings have been fully considered and are persuasive. The objections to the drawings have been withdrawn.
Applicant’s arguments, see remarks, filed 1 December 2025, with respect to claims 1-24 have been fully considered and are persuasive. The 112(b) rejections of claims 1-24 have been withdrawn.
Applicant’s arguments, see 1 December 2025, filed 1 December 2025, with respect to claims 1-24 have been fully considered and are persuasive. The rejections under U.S.C. 102 and 103 of claims 1-14 have been withdrawn.
Claim Objections
Claim 31 is objected to because of the following informality: claim 31 states, “characterized by comprising…” The claim should have one transitional word, either characterized or comprising.
Claim 38 is objected to because of the following informalities: claim 38 states “staggered by one phase means” when only “staggered by one phase” should be in quotation marks. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: claim 40 states “a plurality groups of assemblies” in line 2 when it should state “a plurality of groups of assemblies”. Further, claim 40 does not have a punctuation mark at the end of the claim. Appropriate correction is required.
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 35 and 41 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 35 recites the limitation "the hardness ratio" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the length ratio" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the longitudinal center axis" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 31 and 38 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Xiao et al. (CN 108186176 A), “Xiao”.
Regarding claim 31, Xiao teaches
a stent delivery system, characterized by comprising a stent (Fig. 15b, stent 200) and
a stent delivery device (Fig. 1, delivery system 100),
wherein the stent delivery device (Fig. 1, delivery system 100) comprises a sheath core tube (Fig. 15a, inner sheath core tube 83),
an outer sheath tube (Fig. 15a, outer sheath tube 82) and
an assembly (Fig. 15a, one of hooking units 91, 92, 93),
wherein the outer sheath tube is slidably surrounded over the sheath core tube in an axial direction (Fig. 15b, outer sheath tube 82 is axially moved relative to the inner sheath core tube 83), and
an accommodating cavity for accommodating a stent is formed between the inner wall of the outer sheath tube and the outer wall of the sheath core tube (Fig. 15b, stent 200 is released when outer sheath tube 82 is axially moved relative to inner sheath core tube 83);
the assembly (Fig. 15a, one of hooking units 91, 92, 93) has a fixed end (Fig. 15a, hooking members 911, 921, 931) and
a free end opposite to the fixed end (Fig, 15a, deformation portions 9111, 9211, 9311);
the fixed end is connected to the sheath core tube (Fig. 15a, hooking units 91, 92, 93 are disposed above outer surface of inner sheath core tube 83); and
when the stent is radially pressed against the sheath core tube (Fig. 15b, stent 200 is fixed on the inner sheath core tube 83), and
the stent is accommodated in the accommodating cavity (Fig. 15b, stent 200 is released when outer sheath tube 82 is axially moved relative to inner sheath core tube 83),
the free end of each of the plurality of assemblies is hooked to the stent (Fig. 15a, hooking units 91, 92, 93 ensure stent 200 is fixed on the inner sheath core tube 83).
Regarding claim 38, Xiao teaches
wherein the stent delivery device (Fig. 1, delivery system 100) comprises a plurality of assemblies (Fig. 15a, hooking units 91, 92, 93),
each of the plurality of assemblies only comprises on protrusion (Fig. 12, hooking units 91, 92, 93 comprise less than 12 hooking members (i.e., one single hooking member comprising a deformation portion)), and
the orientations of the protrusions are different (Fig. 15a, deformation portions 9111, 9211, and 9311 extend from hooking units 91, 92, and 93 in different directions from different locations circumferentially), and
the plurality of assemblies are arranged on the sheath core tube according to a rule of being staggered by one phase (Fig. 12b, deformation portions extending from hooking units are placed evenly around the circumference of the hooking units), wherein being "staggered by one phase means" that along a cross section of the sheath core tube, the protrusions of the plurality of assemblies are circumferentially distributed, and the circumferential space of any two adjacent protrusions is equal, but fails to teach wherein each of the plurality of assemblies only comprises one protrusion.
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 25-26, 28, 30 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Alonso et al. (US 2019/0314177 A1), “Alonso”.
Regarding claim 25, Xiao teaches a stent delivery device (Fig. 1, delivery system 100), comprising a sheath core tube (Fig. 15b, inner sheath core tube 83), an outer sheath tube (Fig. 15b, outer sheath tube 82) that is slidably surrounded over the sheath core tube in an axial direction (Fig. 15b, outer sheath tube 82 is axially moved relative to the inner sheath core tube 83), and an accommodating cavity (cavity between outer sheath tube 82 and inner sheath core tube 83) for accommodating a stent is formed between the inner wall of the outer sheath tube and the outer wall of the sheath core tube (Fig. 15b, stent 200 is released when outer sheath tube 82 is axially moved relative to inner sheath core tube 83); further including: a plurality of assemblies (Fig. 15a, hooking units 91, 92, 93) that are arranged on the sheath core tube at intervals in the axial direction (Fig. 15a, hooking units 91, 92, 93 are spaced apart along inner sheath core tube 83), with each of the plurality of assemblies having a fixed end that is connected to the sheath core tube (Fig. 15a, hooking units 91, 92, 93 are disposed above outer surface of inner sheath core tube 83), and a free end opposite to the fixed end (Fig, 15a, deformation portions 9111, 9211, 9311); and when the stent (Fig. 15b, stent 200) is radially pressed against the sheath core tube (Fig. 15b, stent 200 is fixed on the inner sheath core tube 83), the stent is limited by the hooking of the free end of each of the plurality of assemblies to the stent (Fig. 15a, hooking units 91, 92, 93 ensure stent 200 is fixed on the inner sheath core tube 83), but fails to teach a plurality of connecting members, with each pair of adjacent assemblies connected by at least one connecting member.
Alonso teaches a medical delivery device comprising a plurality of connecting members (Fig. 2, spacers 225), with each pair of adjacent assemblies connected by at least one connecting member (Fig. 2, stent engagement members 223 are separated by spacers 225 and are both coupled to the core member 202 so that proximal coupling assembly 220 rotates about core member 202 [0341]). Alonso discloses that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 assemblies taught by Xiao with the connecting members taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent.
Regarding claim 26, Xiao teaches the plurality of assemblies (Fig. 15a, hooking units 91, 92, 93), but fails to teach wherein the plurality of assemblies and the plurality of connecting members form an assembled component that is directly mounted on the sheath core tube.
Alonso teaches a medical delivery device wherein the plurality of assemblies and the plurality of connecting members form an assembled component that is directly mounted on the sheath core tube (Fig. 2, stent engagement members 223 are separated by spacers 225 and are both coupled to the core member 202 so that proximal coupling assembly 220 rotates about core member 202 [0341]). Alonso discloses that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 assemblies taught by Xiao with the connecting members taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent.
Regarding claim 28, Xiao teaches wherein each assembly (Fig. 15a, hooking units 91, 92, 93) comprises a base (Fig. 15a, hooking units 91, 92, 93 include fixing portions connected to inner sheath core tube 83) and a protrusion fixedly connected to the base (Fig, 15a, deformation portions 9111, 9211, 9311 extend from fixing portions); the base is connected to the sheath core tube (Fig. 15a, hooking units 91, 92, 93 are disposed above outer surface of inner sheath core tube 83), and the base has an inner cavity (Fig. 11, hooking units 91, 92, 93 comprise open center), and the base is provided on and surrounds the sheath core tube through the inner cavity (Fig. 10a, hooking units 91, 92, 93 engage with inner sheath core tube 83 via middle opening (from tube-like shape)); and the protrusion extends in a radial direction from the base (Fig. 15a, deformation portions 9111, 9211, 9311 comprise an angle ranging from 0 to 180 degrees extending from sheath core tube 83), but fails to teach wherein two ends of each connecting member are respectively connected to the bases of two adjacent assemblies.
Alonso teaches a medical delivery device wherein two ends of each connecting member are respectively connected to the bases of two adjacent assemblies (Fig. 2, ends of spacers 225 engage with stent engagement members 223). Alonso discloses that the number of stent engagement members and spacers can vary [0325] and further that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 assemblies taught by Xiao with the connecting members taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent.
Regarding claim 30, Xiao teaches wherein the sheath core tube (Fig. 15b, inner sheath core tube 83) has an outer diameter of d3 (Fig. 2b, outer sheath tube 12 is movably sleeved outside inner sheath tube 13 (similar to outer sheath tube 82 and inner sheath tube 83)) and the base (Fig. 11, hooking units 91, 92, 93) has an outer diameter of d4 (Fig. 4c, diameter D of formed by the connecting line of the free end of each deformation portion 222 ranges from 3 to 50 mm), the ratio of an axial length of the base to an axial length of the protrusion is 1:1-1:25 (Fig. 4b, length L1 of deformation portion 222 ranges from 3 to 50 mm), but fails to teach d3 and d4 satisfy this relationship: (d3+0.2 mm)≤d4≤(d3+4 mm).
Alonso teaches a medical delivery device wherein d3 (Fig. 4B, coil 230 can have a radially outermost diameter (OD) [0357]) and d4 (Fig. 3A, radially outermost diameter of the stent engagement members 223 [0357]) satisfy this relationship: d3+0.2 mm ≤ d4 ≤ d3+4 mm (Fig. 3B, coil 230 has a radially outermost diameter (OD) that is smaller than a radially outermost diameter of the stent engagement members 223 so that coil 230 doesn’t contact stent 205 during operation of the delivery system 200 [0357). Alonso discloses that the radially outermost diameter OD of the coil 230 can be between about 0.008″-0.02″, or between about 0.016″-0.018″, or between about 0.0165″-0.017″ [0357]. 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 sheath core tube and base taught by Xiao to reflect the outer diameters taught by Alonso in order to optimize the efficiency of the delivery tool.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Alonso et al. (US 2019/0314177 A1), “Alonso” and further in view of Keating et al. (US 2019/0029850 A1), “Keating”.
Regarding claim 27, Xiao fails to teach the limitations of claim 27. However, Alonso teaches a medical delivery device comprising the plurality of connecting members (Fig. 2, spacers 225). Alonso discloses that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 assemblies taught by Xiao with the connecting members taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent. However, Xiao in view of Alonso fails to teach the connecting members are flat rods or arc-shaped rods.
Keating teaches a stent mandrel comprising flat rods or arc-shaped rods (Fig. 5, tapered segment 24 comprises tapered surfaces 26 between apertures 27 that are narrow and curved [0051]). Keating discloses that the tapered surfaces may not be tapered [0051] and that the relative dimensions of the anti-migration features may be a function of the ultimate end-use of the knitted stent [0063]. 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 connecting members taught by Alonso to reflect the non-tapered shape of the rods taught by Keating in order to create a delivery system best suited for a particular delivery region.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Alonso et al. (US 2019/0314177 A1), “Alonso” and further in view of Dwyer et al. (US 2017/0216068 A1), “Dwyer”.
Regarding claim 29, Xiao teaches wherein the base is an arc-shaped housing (Fig. 11, hooking units 91, 92, 93 comprise tube-like shape), but Xiao in view of Alonso fails to teach the base does not completely wrap the sheath core tube in the circumferential direction.
Dwyer teaches an expandable vascular retention barrier wherein the base does not completely wrap the sheath core tube in the circumferential direction (Fig. 4B, shaft 48 comprises cut-outs 54). Dwyer discloses that the arm, cut-outs, and shaft are sized to be covered by the sheath and further that the arms will not interfere with the stent deployment or radial expansion [0058-0059]. 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 base taught by Xiao to reflect the shape of the base taught by Dwyer in order to increase the ease of stent deployment.
Claims 32, 34, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Xiao et al. (US 2019/0015227 A1), “Xiao 227” and further in view of Alonso et al. (US 2019/0314177 A1), “Alonso”.
Regarding claim 32, Xiao teaches wherein the stent is a bare stent (Fig. 15b, stent 200 comprises a metal skeleton structure made of nitinol); the stent delivery device (Fig. 1, delivery system 100) comprises a plurality of assemblies (Fig. 15a, hooking units 91, 92, 93), the outer sheath tube has an inner diameter of d1 (Fig. 2b, outer sheath tube 12 is movably sleeved outside inner sheath tube 13 (similar to outer sheath tube 82 and inner sheath tube 83)), the stent comprises a supporting framework (Fig. 15b, stent 200 comprises a metal skeleton structure), but fails to teach each of the plurality of assemblies has a height of h1; the supporting framework is formed by weaving a metal wire or is formed by cutting a metal tube; the metal wire has a wire diameter of d2 or the supporting framework has a wall thickness of d2; and wherein d1, h1, and d2 satisfy this relationship: (0.4xd1-2xd2)≤h1≤(0.85xd1), and d1 and h1 satisfy this relationship: (0.45xd1-0.5 mm) ≤h1≤(0.55xd1+0.55 mm).
Xiao 227 teaches a stent wherein the supporting framework (Fig. 4A, first radial supporting structure 211 of first tubular body 21) is formed by weaving a metal wire or is formed by cutting a metal tube (Fig. 4A, first radial supporting structure 211 is formed by weaving a metal wire or may be formed by cutting a metal tube [0066]); the wire diameter of the metal wire or the wall thickness of the supporting framework is d2 (wire diameter of a metal rod forming the waveform 0.05 mm to 0.4 mm [0091]), but Xiao in view of Xiao 227 fails to teach the height of the assembly is h1 and d1, h1, and d2 satisfy this relationship: 0.4xd1-2xd2≤h1≤0.85xd1.
Alonso teaches a medical delivery device comprising d1 (Fig. 1, inner diameter of catheter 101 [0369]) and h1 (Fig. 5A, stent engagement members 223 comprise radial diameter D [0357]) satisfy this relationship: (0.4xd1-2xd2)≤h1≤(0.85xd1) (Fig. 2, stent engagement members 223 comprise features that include varying diameters to accommodate different stent sidewall thicknesses which vary on wire size and further, the stent contained in the catheter will vary based on wire size [0314]). Alonso discloses that different pad diameters accommodate different stent sizes within a desired range [0314]. 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 wire diameter and covered film thickness taught by Xiao 227 with the diameter of the outer sheath tube and height of the assembly and its adaptable sizing taught by Alonso in order to optimize the efficiency of the delivery tool.
Regarding claim 34, Xiao teaches wherein the outer sheath tube has an inner diameter of d1 (Fig. 2b, outer sheath tube 12 is movably sleeved outside inner sheath tube 13 (similar to outer sheath tube 82 and inner sheath tube 83)); the stent delivery device comprises a plurality of assemblies (Fig. 15a, hooking units 91, 92, 93); the stent comprises a supporting framework (Fig. 15b, stent 200 comprises a metal skeleton), but fails to teach each of the plurality of assemblies has a height of h1, and a covered film wrapping the supporting framework; the supporting framework is formed by weaving a metal wire or is formed by cutting a metal tube; the metal wire has a wire diameter of d2 or the supporting framework has a wall thickness of d2; the covered film has a thickness t; and d1, h1, d2, and to satisfy this relationship: ((0.35xd1)-(2xd2)-t)≤h1≤(0.85xd1).
Xiao 227 teaches a stent comprising a covered film wrapping the supporting framework (Fig. 4A, first overlay film 212); the supporting framework (Fig. 4A, first radial supporting structure 211 of first tubular body 21) is formed by weaving a metal wire or is formed by cutting a metal tube (Fig. 4A, first radial supporting structure 211 is formed by weaving a metal wire or may be formed by cutting a metal tube [0066]); the wire diameter of the metal wire or the wall thickness of the supporting framework is d2 (wire diameter of a metal rod forming the waveform 0.05 mm to 0.4 mm [0091]); the thickness of the covered film is t (Fig. 4A, film 212 inherently comprises a thickness). However, Xiao in view of Xiao 227 fails to teach this relationship: ((0.35xd1)-(2xd2)-t)≤h1≤(0.85xd1).
Alonso teaches a medical delivery device comprising the inner diameter of the outer sheath tube is d1 (Fig. 1, inner diameter of catheter 101 [0369]) and the height of the assembly is h1 (Fig. 5A, stent engagement members 223 comprise radial diameter D [0357]), satisfy this relationship: ((0.35xd1)-(2xd2)-t)≤h1≤(0.85xd1) (Fig. 2, stent engagement members 223 comprise features that include varying diameters to accommodate different stent sidewall thicknesses which vary on wire size and further, the stent contained in the catheter will vary based on wire size [0314]). Alonso discloses that different pad diameters accommodate different stent sizes within a desired range [0314]. 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 wire diameter and covered film thickness taught by Xiao 227 with the diameter of the outer sheath tube and height of the assembly and its adaptable sizing taught by Alonso in order to optimize the efficiency of the delivery tool.
Regarding claim 41, Xiao teaches wherein the stent delivery device (Fig. 1, delivery system 100) but Xiao in view of Xiao 227 fails to teach a plurality groups of assemblies, each group of assemblies comprises two assemblies; in the plurality of groups of assemblies, some of them are inclined towards the distal end of the stent delivery device, some of them are inclined towards the proximal end of the stent delivery device, and some of them are perpendicular to the longitudinal center axis of the sheath core tube, and the assemblies inclined towards the distal end are located at the distal end; the assemblies inclined towards the proximal end are located at the proximal end; and the assemblies perpendicular to the longitudinal center axis of the sheath core tube are located in the middle.
Alonso teaches a medical delivery device comprising a plurality groups of assemblies (Fig. 3A, the number of stent engagement members 223 can vary to be up to six or more [0325]), each group of assemblies comprises two assemblies (Fig. 3A, one group comprises both stent engagement members 223a-b and can be duplicated up to six or more engagement members (i.e., three groups of two engagement members)); in the plurality of groups of assemblies, some of them are inclined towards the distal end of the stent delivery device, some of them are inclined towards the proximal end of the stent delivery device (Fig. 2, stent engagement members 223 and spacers spread out to be nearer either proximal region 204 or distal region 206), and some of them are perpendicular to the longitudinal center axis of the sheath core tube (Fig. 3A, stent engagement members 223 are perpendicular to longitudinal axis of core member 103 unless tilted [0334]), and the assemblies inclined towards the distal end are located at the distal end; the assemblies inclined towards the proximal end are located at the proximal end (Fig. 3A, stent engagement members 223 may be tilted along the core member 103 [0334]); and the assemblies perpendicular to the longitudinal center axis of the sheath core tube are located in the middle (Fig. 3A, stent engagement members may be orthogonal to longitudinal axis of core member 103 and there may be up to 3 or more groups of engagement members (i.e., one group in the middle of the three)). Alonso discloses that the number of stent engagement members and spacers can vary [0325] and further that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 delivery device taught by Xiao with the groups of assemblies taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent.
Claims 33 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Alonso et al. (US 2019/0314177 A1), “Alonso”.
Regarding claim 33, Xiao teaches wherein the stent delivery device (Fig. 1, delivery system 100) comprises a plurality of assemblies (Fig. 15a, hooking units 91, 92, 93), but fails to teach each pair of adjacent assemblies connected by at least one connecting member.
Alonso teaches a medical delivery device comprising a plurality of connecting members (Fig. 2, spacers 225), with each pair of adjacent assemblies connected by at least one connecting member (Fig. 2, stent engagement members 223 are separated by spacers 225 and are both coupled to the core member 202 so that proximal coupling assembly 220 rotates about core member 202 [0341]). Alonso discloses that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 assemblies taught by Xiao with the connecting members taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent.
Regarding claim 40, Xiao teaches wherein the stent delivery device (Fig. 1, delivery system 100), but fails to teach a plurality groups of assemblies, each group of assemblies comprises two assemblies, in the plurality of groups of assemblies, some of them are inclined towards the distal end of the stent delivery device, and some of them are inclined towards the proximal end of the stent delivery device, the plurality of groups of assemblies inclined towards the distal end are closer to the distal end of the stent delivery device than the plurality of groups of assemblies inclined towards the proximal end; the plurality of groups of assemblies inclined towards the distal end and the plurality of groups of assemblies inclined towards the proximal end are disposed at unequal intervals.
Alonso teaches a medical delivery device comprising a plurality groups of assemblies (Fig. 3A, the number of stent engagement members 223 can vary to be up to six or more [0325]), each group of assemblies comprises two assemblies (Fig. 3A, stent engagement members 223a-b (one group) may be duplicated to comprise three groups (six stent engagement members) [0325]), in the plurality of groups of assemblies, some of them are inclined towards the distal end of the stent delivery device, and some of them are inclined towards the proximal end of the stent delivery device (Fig. 2, stent engagement members 223 and spacers spread out to be nearer either proximal region 204 or distal region 206), the plurality of groups of assemblies inclined towards the distal end are closer to the distal end of the stent delivery device than the plurality of groups of assemblies inclined towards the proximal end (Fig. 2, stent engagement members 223 and spacers spread out to be nearer either proximal region 204 or distal region 206); the plurality of groups of assemblies inclined towards the distal end and the plurality of groups of assemblies inclined towards the proximal end are disposed at unequal intervals (Fig. 16, the plurality of hooking units 90 may be distributed unevenly along the axial direction of the inner sheath core tube 83). Alonso discloses that the number of stent engagement members and spacers can vary [0325] and further that the addition of spacers and other elements, and their shapes and orientations, increase contact area and pushability and column strength of the overall system [0355]. 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 delivery device taught by Xiao with the groups of assemblies taught by Alonso in order to increase the column strength of the delivery device and avoid device rupture during delivery of the stent.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Rosenman et al. (US 2006/0135961 A1), “Rosenman”.
Regarding claim 35, Xiao teaches wherein the assembly (Fig. 15a, one of hooking units 91, 92, 93) comprises a rigid part (Fig. 4a, fixing portion 221) and a flexible part (Fig, 4a deformation portion 222 bends relative to fixing portion 221), and the rigid part is the fixed end that is fixedly connected to the sheath core tube (Fig. 15a, hooking units 91, 92, 93 are disposed above outer surface of inner sheath core tube 83), one end of the flexible part is connected to the end of the rigid part away from the sheath core tube (Fig. 15a, deformation portions 9111, 9211, 9311 extends from hooking units 91, 92, 93), and the other end is the free end (Fig, 15a, deformation portions 9111, 9211, 9311), and the length ratio of the rigid part to the flexible part is 1:5-5:1 (Fig. 4b, length L1 of deformation portion 222 ranges from 3-50 mm and length L2 of fixing portion 221 ranges from 2-10 mm), but fails to teach the hardness ratio of the rigid part to the flexible part is 0.3-0.9.
Rosenman teaches a deflectable guide catheter wherein the hardness ratio of the rigid part (Fig. 9d, segment 50) to the flexible part (Fig. 9d, segment 5) is 0.3-0.9 (Fig. 9d, segment 50 comprises a hardness of 50D and segment 5 comprises a hardness of 35D [0050]). Rosenman discloses that the guide is able to execute very tight turns in order to direct the device throughout tortuous vasculature [0047]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a hardness ratio of the rigid part to the flexible part of 0.3-0.9, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the hardness ratio, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Xiao et al. (US 2019/0015227 A1), “Xiao 227” and further in view of Keating et al. (US 2019/0029850 A1), “Keating”.
Regarding claim 36, Xiao teaches wherein the stent delivery device (Fig. 1, delivery system 100) comprises a plurality of assemblies (Fig. 15a, hooking units 91, 92, 93), the supporting framework (Fig. 15b, stent 200 comprises a metal skeleton), but fails to teach and each of the plurality of assemblies has a cross-sectional area of S1; and a plurality of waveform ring structures containing wave crests and wave valleys; the wave crest or wave valley has a radius of R1; and S1 and R1 satisfy this relationship: (0.05xR1xR1xπ)≤S1≤(R1xR1xπ).
Xiao 227 teaches a stent wherein the supporting framework (Fig. 4A, first radial supporting structure 211 of first tubular body 21) comprises a plurality of waveform ring structures containing wave crests and wave valleys (Fig. 4A, first radial supporting structure 211 includes multiple turns of waveform ring-like objects [0066]) wherein the radius of the wave crest or wave valley is R1 (Fig. 18, maximum width m1 of any waveform is less than or equal to D/8, D/10, D/12, D/13, or D/14 [0014]). However, Xiao in view of Xiao 227 fails to teach the cross-sectional area of the assembly is S1 and S1 and R1 satisfy this relationship: (0.05xR1xR1xπ)≤S1≤(R1xR1xπ).
Keating teaches a stent mandrel wherein the cross-sectional area of the assembly is S1 (Fig. 9, anti-migration feature forming pin 18 including pin body 60 and base 44 which may have an enlarged cross-section relative to the pin body 60 [0058]) and R1 (Fig. 12A, stent 70 comprises anchor pints 80 forming loops being roughly equal in shape and dimension [0061]) satisfy this relationship: (0.05xR1xR1xπ)≤S1≤(R1xR1xπ) (Fig. 10, a larger diameter knitted stent 70 may have larger anti-migration features 78 while a smaller diameter knitted stent 70 may have smaller anti-migration features 78 [0063]). Keating discloses that the relative dimensions of the anti-migration features may be a function of the ultimate end-use of the knitted stent [0063]. 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 framework taught by Xiao with the waveform structures taught by Xiao 227 and the sizing taught by Keating in order to create a delivery system best suited for a particular delivery region.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Xiao et al. (US 2019/0015227 A1), “Xiao 227” and further in view of Spindler (US 2018/0303597 A1), “Spindler”.
Regarding claim 37, Xiao teaches wherein the stent comprises a supporting framework (Fig. 15b, stent 200 comprises a metal skeleton) but fails to teach a covered film wrapping the supporting framework; and the covered film has an elongation that is greater than or equal to 95% and less than or equal to 300%; and the covered film has a breaking strength which satisfies this relationship: 0.5 N/mm≤ breaking strength≤ 15.0 N/mm.
Xiao 227 teaches a stent comprising a covered film wrapping the supporting framework (Fig. 4A, first overlay film 212 surrounding first radial supporting structure 211 of first tubular body 21); and the elongation of the covered film is greater than or equal to 95% and less than or equal to 300% (Fig. 4A, first and second tubular bodies 21, 22 comprise first overlay film 212 and second graft 222 (i.e., covering films)). Xiao discloses that this stent has an enhanced surgical effect and increases the healing success rate [0004]. 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 delivery device taught by Xiao with the covered stent taught by Xiao 227 in order to increase healing rates. However, Xiao in view of Xiao 227 fails to teach the covered film has a breaking strength which satisfies this relationship: 0.5 N/mm≤ breaking strength≤ 15.0 N/mm.
Spindler teaches a reinforced graft prosthesis wherein the covered film has a breaking strength which satisfies this relationship: 0.5 N/mm≤ breaking strength≤ 15.0 N/mm (Fig. 14, graft material variants comprise breaking points at over 3N or 3.5N [0054]). Spindler discloses that these grafts can resist high loads and have extension capabilities of at least 50% with a margin before rupture [0054]. 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 Xiao in view of Xiao 227 with the covered film taught by Spindler in order to provide an implant unaffected by high loads.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Xiao et al. (US 2019/0015227 A1), “Xiao 227” and Alonso et al. (US 2019/0314177 A1), “Alonso”, and further in view of Dwyer et al. (US 2017/0216068 A1), “Dwyer”.
Regarding claim 39, Xiao teaches wherein the stent comprises a supporting framework (Fig. 15b, stent 200 comprises a metal skeleton) but fails to teach a covered film wrapping the supporting framework; the thickness of the covered film is t; the height of the assembly is h1; and t and h1 satisfy this relationship: 0.010≤t/h1≤0.500; wherein in a natural state, the stent has an outer diameter of D1; the outer sheath tube has an inner diameter of d1; and D1 and d1 satisfy this relationship: 40%≤(D1-d1)/D1≤85%.
Xiao 227 teaches a stent comprising a covered film wrapping the supporting framework (Fig. 4A, first overlay film 212 surrounding first radial supporting structure 211 of first tubular body 21), the thickness of the covered film is t (Fig. 4A, film 212 inherently comprises a thickness), but Xiao in view of Xiao 227 fails to teach the height of the assembly is h1; and t and h1 satisfy this relationship: 0.010 ≤t/h1≤0.500.
Alonso teaches a medical delivery device wherein D1 (Fig. 2, stent 105 collapses along its length until it assumes an outer diameter corresponding to the inner diameter of catheter 101 [0335]) and d1 (Fig. 1, inner diameter of catheter 101 [0369]) satisfy this relationship: 40%≤(D1-d1)/D1≤85% (Fig. 3B, when stent 205 is compressed its outer diameter is equal to the inner diameter of the catheter [0369]). 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 and sheath tube taught by Xiao with the sizing taught by Alonso in order to optimize the efficiency of the device.
Dwyer teaches a radially expandable endoluminal stent wherein t and h1 satisfy this relationship: 0.010 ≤t/h1≤0.500 (Fig. 9, film 64 may vary in size and density dependent upon various factors associated with the stent delivery [0068] (i.e., stent cover thickness may change depending on delivery aspects)). Dwyer discloses that the film may be formed from any biocompatible and flexible material [0069]. 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 Xiao, and the framework taught by Xiao 227, and the height h1 taught by Alonso, with the adaptable film taught by Dwyer in order to create a more biocompatible implant.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Xiao et al. (US 2019/0015227 A1).
Regarding claim 42, Xiao teaches the free ends (Fig, 15a, deformation portions 9111, 9211, 9311) of the plurality of assemblies (Fig. 15a, hooking units 91, 92, 93); furthermore, when the outer sheath tube bends (Fig. 15b, outer sheath tube 82 is made of an elastic material (i.e., bendable)), but fails to explicitly teach the plurality of assemblies are all located on the same side of a longitudinal center axis of the sheath core tube, or that the free ends of the plurality of assemblies all point to a greater curvature side of the outer sheath tube.
However, Xiao further teaches wherein the plurality of assemblies are all located on the same side of a longitudinal center axis of the sheath core tube, or that the free ends of the plurality of assemblies all point to a greater curvature side of the outer sheath tube (the number and position of the hooking units adapt to the skeleton structure of the lumen stent [0128]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to rearrange the hooking units to only project from one side of the sheath core tube in order to better adapt to the structure of the stent being implanted.
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. (CN 108186176 A), “Xiao” in view of Xiao et al. (US 2019/0015227 A1) in view of Xiao et al. (US 2019/0015227 A1), “Xiao 227”.
Regarding claim 43, Xiao teaches the stent comprises a supporting framework (Fig. 15b, stent 200 comprises a metal skeleton), but fails to teach a covered film wrapping the supporting framework, the covered film includes an inner-layer film and an outer-layer film, with the inner-layer film having a barrel-shaped one-piece structure, and the inner-layer film is wrapped by the supporting framework in a circumferential direction to form a circumferentially closed tube cavity structure; and wherein the supporting framework has metal wires that are connected to form mutually hooked intersections, the outer-layer film has a strip-type structure and is wound on the metal wires and the outer surface of the inner-layer film, and the metal wires located on the mutually hooked intersections are uncovered by the outer-layer film.
Xiao 227 teaches a stent comprising a covered film wrapping the supporting framework (Fig. 4A, first overlay film 212 surrounding first radial supporting structure 211 of first tubular body 21), the covered film includes an inner-layer film (Fig. 26, inner graft 210) and an outer-layer film (Fig. 26, outer graft 219), with the inner-layer film having a barrel-shaped one-piece structure (Fig. 26, inner graft 210 is barrel-shaped [0124]), and the inner-layer film is wrapped by the supporting framework in a circumferential direction to form a circumferentially closed tube cavity structure (Fig. 29, wave loops 218 are wrapped around inner graft 210 and are externally wrapped by outer graft 219 [0124-0125]); and wherein the supporting framework has metal wires that are connected to form mutually hooked intersections (Fig. 17, supporting structure 221 comprises grids 2224 [0105]), the outer-layer film has a strip-type structure (Fig. 26, outer graft 219 forms a strip) and is wound on the metal wires and the outer surface of the inner-layer film (Fig. 26, outer graft 216 is annular and surrounds inner graft 210 [0124]), and the metal wires located on the mutually hooked intersections are uncovered by the outer-layer film (Fig. 29, wave crests of wave loops 218 are exposed outside outer graft 219 [0124-0126]). Xiao discloses that this stent has an enhanced surgical effect and increases the healing success rate [0004]. 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 delivery device taught by Xiao with the covered stent taught by Xiao 227 in order to increase healing rates.
Regarding claim 44, Xiao teaches wherein the stent comprises a supporting framework (Fig. 15b, stent 200 comprises a metal skeleton), but fails to teach a covered film wrapping the supporting framework, the covered film includes an inner-layer film and an outer-layer film, with the inner-layer film having a barrel-shaped one-piece structure, and the inner-layer film is wrapped by the supporting framework in a circumferential direction to form a circumferentially closed tube cavity structure; and wherein the supporting framework has metal wires that are connected to form mutually hooked intersections, the outer-layer film has a strip-type structure and is wound on the metal wires and the outer surface of the inner-layer film, and the outer-layer film is spirally wound on the metal wire and the outer surface of the inner-layer film to prevent the mutually hooked intersections from being covered.
Xiao 227 teaches a stent comprising a covered film wrapping the supporting framework (Fig. 4A, first overlay film 212 surrounding first radial supporting structure 211 of first tubular body 21), the covered film includes an inner-layer film (Fig. 26, inner graft 210) and an outer-layer film (Fig. 26, outer graft 219), with the inner-layer film having a barrel-shaped one-piece structure (Fig. 26, inner graft 210 is barrel-shaped [0124]), and the inner-layer film is wrapped by the supporting framework in a circumferential direction to form a circumferentially closed tube cavity structure (Fig. 29, wave loops 218 are wrapped around inner graft 210 and are externally wrapped by outer graft 219 [0124-0125]); and wherein the supporting framework has metal wires that are connected to form mutually hooked intersections (Fig. 29, wave crests of wave loops 218 are exposed outside outer graft 219 [0124-0126]), the outer-layer film has a strip-type structure (Fig. 26, outer graft 219 forms a strip) and is wound on the metal wires and the outer surface of the inner-layer film (Fig. 26, outer graft 216 is annular and surrounds inner graft 210 [0124]), and the outer-layer film is spirally wound on the metal wire and the outer surface of the inner-layer film to prevent the mutually hooked intersections from being covered (Fig. 26, outer graft 216 is annular and surrounds inner graft 210 [0124] and wave crests of wave loops 218 are exposed outside outer graft 219 [0124-0126]). Xiao discloses that this stent has an enhanced surgical effect and increases the healing success rate [0004]. 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 delivery device taught by Xiao with the covered stent taught by Xiao 227 in order to increase healing rates.
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.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799