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 .
Claim Objections
Claim(s) 2, 18, 23, 82 is/are objected to because of the following informalities:
Within claim 2, line 3: “the short crest” should be replaced with --the two short crests-- (to maintain consistent claim terminology).
Within claim 18, line 1: “the W-shaped crests” should be replaced with --the at least two W-shaped crests-- (to maintain consistent claim terminology).
Within claim 23, line 1: “the W-shaped crests” should be replaced with --the at least two W-shaped crests-- (to maintain consistent claim terminology).
Within claim 82, line 2: polyline is misspelled as polyene.
Appropriate correction is required.
Applicant is advised that should claim(s) 34-35, 63-65 be found allowable, claim(s) 42-43, 76-78 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 5-13, 16-18, 20-65, 70-78, 83-91 is/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 5 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 12-13, which depend from claim 11, inherit all the problems associated with claim 11.
Claim 16 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear, and therefore indefinite, if the offset (within claim 16, line 1) is linking back to the offset from claim 1, line 15. Claim(s) 17-18, which depend from claim 16, inherit all the problems associated with claim 16.
Within claim 17, line 1: Applicant claims, “the inner arc and the outer arc”; it is unclear, and therefore indefinite, which inner and outer arcs are being referred to – the arcs from claim(s) 15-17 OR the arc from claim 1. Claim 18, which depends from claim 17, inherits all the problems associated with claim 17.
Claim 21 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear, and therefore indefinite, if the offset (within claim 20, line 1) is linking back to the offset from claim 1, line 15. Claim(s) 21-23, which depend from claim 21, inherit all the problems associated with claim 21.
Within claim 22, line 1: Applicant claims, “the inner arc and the outer arc”; it is unclear, and therefore indefinite, which inner and outer arcs are being referred to – the arcs from claim(s) 20-217 OR the arc from claim 1. Claim 23, which depends from claim 22, inherits all the problems associated with claim 22.
Within claim 24, lines 10-11: Applicant states the rings have six crests; additionally, within claim 24, lines 19-21: Applicant claims, “each Y-shaped member […] forming a non-uniform crest width”; due to the “crest width” language associated with the Y-shaped member it is unclear, and therefore indefinite, if the Y-shaped member is part of the six crests OR an additional structure to the six crests. Claim(s) 25-44, which depend from claim 24, inherit all the problems associated with claim 24.
Claim 28 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 34 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear, and therefore indefinite, if the offset is linking back to the offset of the four long crest (within claim 24, lines 16-18) OR the offset of the Y-shaped member (within claim 24, lines 19-21). Claim(s) 12-13, which depend from claim 11, inherit all the problems associated with claim 11.
Within claim 35, line 1: Applicant claims, “the inner arc and the outer arc”; it is unclear, and therefore indefinite, which inner and outer arcs are being referred to – the arcs from the four long crests (in claim 24, line 16) OR the arcs from the Y-shaped members (in claim 24, line 19).
Within claim 37, lines 1-2: Applicant claims, “each of the distal end ring and the plurality of body rings has at least two W-shaped crests”; it is unclear, and therefore indefinite, if the W-shaped member is part of the six crests (from claim 24, lines 10-11) OR an additional structure to the six crests (from claim 24, lines 10-11). Claim(s) 38-41, which depend from claim 37, inherit all the problems associated with claim 37.
Claim 39 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear, and therefore indefinite, if the offset is linking back to the offset of the four long crest (within claim 24, lines 16-18) OR the offset of the Y-shaped member (within claim 24, lines 19-21) OR the offset of the W-shaped crest (within claim 38, lines 2-3). Claim(s) 40-41, which depend from claim 39, inherit all the problems associated with claim 39.
Within claim 40, line 1: Applicant claims, “the inner arc and the outer arc”; it is unclear, and therefore indefinite, which inner and outer arcs are being referred to – the arcs from the four long crests (in claim 24, line 16) OR the arcs from the Y-shaped members (in claim 24, line 19) OR the arcs from the W-shaped crests (in claim 38, lines 1-2).
Within claim 45, lines 10-11: Applicant states the rings have six crests; additionally, within claim 45, lines 16-18: Applicant claims, “each W-shaped member […] forming a non-uniform crest width”; due to the “crest width” language associated with the W-shaped member it is unclear, and therefore indefinite, if the W-shaped member is part of the six crests OR an additional structure to the six crests. Claim(s) 46-65, 68-78, which depend from claim 45, inherit all the problems associated with claim 45.
Claim 50 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 51 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 52 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 53 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 54 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 55 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 58 recites the limitation "the W-shaped crests" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Within claim 59, lines 1-2: Applicant claims, “each of the distal end ring and the plurality of body rings has at least two W-shaped crests”; it is unclear, and therefore indefinite, if the W-shaped crests are the same as OR in addition to the W-shaped member (within claim 45, lines 14-15).
Claim 63 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear, and therefore indefinite, if the offset is linking back to the offset of the W-shaped member (within claim 45, lines 16-18) OR the offset of the two short crests (within claim 47, lines 1-3). Claim(s) 64-65, 68-78, which depend from claim 63, inherit all the problems associated with claim 63.
Within claim 64, line 1: Applicant claims, “the inner arc and the outer arc”; it is unclear, and therefore indefinite, which inner and outer arcs are being referred to – the arcs from the W-shaped member (within claim 45, lines 16-18) OR the arcs from the two short crests (within claim 47, lines 1-3). Claim(s) 65-65, 68-78, which depend from claim 64, inherit all the problems associated with claim 64.
Claim 65 recites the limitation "the three short crests" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim(s) 68-78, which depend from claim 65, inherit all the problems associated with claim 65.
Within claim 68, lines 1-2: Applicant claims, “the proximal end ring has six equal length U-shaped members”; it is unclear, and therefore indefinite, if these are the same as OR different from the six crests (within claim 45, lines 10-11).
Claim 70 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 71 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 72 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 73 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 74 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 83 recites the limitation "the variation in offset" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Within claim 84, line 1: Applicant claims, “a strut width of the plurality of crests”, it is unclear, and therefore indefinite, if this is the same as OR in addition to the strut width at an apex of the plurality of crests (within claim 80, line 2).
Claim 85 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 86 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 87 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 88 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 89 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 90 recites the limitation "the number of links" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 91 recites the limitation "the number of links" in line 1. 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.
Claim(s) 79-84 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Gregorich (US 2006/0224231 A1).
With respect to claim 79:
A stent (stent 20), as can be seen in figs. 1-2B (paragraph [0029]), comprising:
a tubular body having a distal end ring (band closest to the left side of the page in fig. 2A), a proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) therebetween;
the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) being aligned in an in-phase configuration, as can be seen in fig. 2A;
multiple connecting links (connectors 24) connect the distal end ring (band closest to the left side of the page in fig. 2A), the plurality of body rings (middlemost bands 22), and the proximal end ring (band closest to the right side of the page in fig. 2A) (paragraph [0031]);
each of the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and the plurality of body rings (middlemost bands 22) has a plurality of crests (curved portions 26) (paragraphs [0032]); and
the plurality of crests (curved portions 26) having an outer arc (outside curve of curved portions 26), as can be seen in fig. 2B, and an inner arc (inside curve of curved portions 26), a center point of the inner arc (inside curve of curved portions 26) being offset from a center point of the outer arc (outside curve of curved portions 26) in a direction away from the inner arc (inside curve of curved portions 26), thereby forming an increased non-uniform width on the plurality of crests (curved portions 26) (paragraph [0033]) (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], which result in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed).
With respect to claim 80:
Wherein the increased non-uniform width on the plurality of crests (curved portions 26) comprises an increased strut width at an apex of the plurality of crests (curved portions 26), as can be seen in fig. 2B.
With respect to claim 81:
Wherein at least some of the multiple connecting links (connectors 24) have a non-linear configuration (non-linearly/ bent) (paragraphs [0031, 0036]).
With respect to claim 82:
Wherein the inner arc (inside curve of curved portions 26) and the outer arc (outside curve of curved portions 26) have an arc configuration of a semi-circle arc (as can be seen in fig. 2B), or a polyline arc, or a 3-point arc.
With respect to claim 83:
Wherein the variation in offset between the center point of the inner arc (inside curve of curved portions 26) and the center point of the outer arc (outside curve of curved portions 26) is in a range from 2 µm to 100 µm (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], this “cone head” result in the offsets of the center points of the inner and outer arcs being equal to the difference in width created by the additional material, as discussed by Applicant in specifications paragraph [0079]; thus when Wbs is 30μm and Wbc/Wbs=1.25, then Wbc will be 37.5μm resulting in an offset of 7.5μm (numbers merely given as examples from the size ranges given within paragraphs [0034-0045])).
With respect to claim 84:
Wherein a strut width (Wbc) of the plurality crests (curved portions 26) is in a range from 40 µm to 250 µm (.03-.2mm) (paragraph [0035]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ta et al. (US 2021/0000625 A1) in view of Gregorich (US 2006/0224231 A1).
With respect to claim 1:
Ta et al. discloses the invention substantially as claimed. Specifically, Ta et al. discloses a stent (stent 10), as can be seen in figs. 14A-14B, comprising:
a tubular body (tubular body 20) having a distal end ring (distal end ring 264), a proximal end ring (proximal end ring 266), and a plurality of body rings (rings 268-298) therebetween (paragraphs [0056-0057]);
the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) being aligned in an in-phase configuration (paragraphs [0056-0057]);
the proximal end ring (proximal end ring 266) being connected to a first proximal body ring (body ring 298) by three links (three of the links 32), and the first proximal body ring (body ring 298) being connected to a second proximal body ring (body ring 296) by three links (three of the links 32) (paragraphs [0056-0057]);
the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) being connected by two links (links 32) (paragraphs [0056-0057]);
each of the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) has six crests (six of the valleys/ peaks oriented toward the top of the page in fig. 14A);
each of the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) has four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) and two short crests (two of the valleys/ peaks oriented toward the top of the page in fig. 14A which are aligned with the band of the links 32); and
the four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) having an outer arc (topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) and an inner arc (bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A). (Please note: “comprising” (in the preamble) is open ended and does not exclude additional unrecited elements (see MPEP 2111.03); as such, the stent (stent 10), as disclosed by Ta et al., does include additional structure to the structure within the claim – specifically additional crests (peaks/ valleys) and links (links 32) but is still considered to read on the current claims.)
However, Ta et al. does not disclose a center point of the inner arc (center point of bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A) being offset from a center point of the outer arc (center point of topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) in a direction away from the inner arc, thereby forming a non-uniform width on the four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A).
Gregorich teaches a stent (stent 20), as can be seen in figs. 1-2B (paragraph [0029]), comprising:
a tubular body having a distal end ring (band closest to the left side of the page in fig. 2A), a proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) therebetween;
each of the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and the plurality of body rings (middlemost bands 22) has a plurality of crests (curved portions 26) (paragraphs [0032]); and
the plurality of crests (curved portions 26) having an outer arc (outside curve of curved portions 26), as can be seen in fig. 2B, and an inner arc (inside curve of curved portions 26), a center point of the inner arc (inside curve of curved portions 26) being offset from a center point of the outer arc (outside curve of curved portions 26) in a direction away from the inner arc (inside curve of curved portions 26), thereby forming an increased non-uniform width on the plurality of crests (curved portions 26) (paragraph [0033]) (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], which result in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed). The increased non-uniform width on the plurality of crests (additional material creating outer coneheads in the curved portions 26) results in plastic, instead of elastic deformation during expansion (thus resulting in less recoil) and enhances the flexibility of the overall stent (paragraph [0033]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make all the crests (valleys/ peaks oriented toward the top of the page in fig. 14A) of the stent (stent 10), as disclosed by Ta et al., with the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, in order to reduce the likelihood of elastic recoil after expansion/ implantation and to improve the overall flexibility of the stent (stent 10), as taught by Gregorich.
With respect to claim 24:
Ta et al. discloses the invention substantially as claimed. Specifically, Ta et al. discloses a stent (stent 10), as can be seen in figs. 14A-14B, comprising:
a tubular body (tubular body 20) having a distal end ring (distal end ring 264), a proximal end ring (proximal end ring 266), and a plurality of body rings (rings 268-298) therebetween (paragraphs [0056-0057]);
the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) being aligned in an in-phase configuration (paragraphs [0056-0057]);
the proximal end ring (proximal end ring 266) being connected to a first proximal body ring (body ring 298) by three links (three of the links 32), and the first proximal body ring (body ring 298) being connected to a second proximal body ring (body ring 296) by three links (three of the links 32) (paragraphs [0056-0057]);
the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) being connected by two links (links 32) (paragraphs [0056-0057]);
each of the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) has six crests (six of the valleys/ peaks oriented toward the top of the page in fig. 14A);
each of the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) has four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) and two short crests (two of the valleys/ peaks oriented toward the top of the page in fig. 14A which are aligned with the band of the links 32); and
each of the proximal end ring (proximal end ring 266) and the plurality of body (rings 268-294) rings has a Y-shaped member (valley/ peak oriented toward the bottom of the page in fig. 14A to which a link 32 is attached);
the four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) having an outer arc (topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) and an inner arc (bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A),
each Y-shaped member (valley/ peak oriented toward the bottom of the page in fig. 14A to which a link 32 is attached) has an outer arc (bottommost curve of peaks/ valleys connecting to a link 32 oriented toward the bottom of the page in fig. 14A) and an inner arc (top curve of peaks/ valleys oriented toward the bottom of the page in fig. 14A) (Please note: “comprising” (in the preamble) is open ended and does not exclude additional unrecited elements (see MPEP 2111.03); as such, the stent (stent 10), as disclosed by Ta et al., does include additional structure to the structure within the claim – specifically additional crests (peaks/ valleys) and links (links 32) but is still considered to read on the current claims.)
However, Ta et al. does not disclose the four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) nor the Y-shaped member (valley/ peak oriented toward the bottom of the page in fig. 14A to which a link 32 is attached) to have center point of the inner arcs (center point of bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A/ top curve of peaks/ valleys oriented toward the bottom of the page in fig. 14A) being offset from a center point of the outer arc (center point of topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A/ bottommost curve of peaks/ valleys connecting to a link 32 oriented toward the bottom of the page in fig. 14A) in a direction away from the inner arc, thereby forming a non-uniform width on the four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) nor the Y-shaped member (valley/ peak oriented toward the bottom of the page in fig. 14A to which a link 32 is attached).
Gregorich teaches a stent (stent 20), as can be seen in figs. 1-2B (paragraph [0029]), comprising:
a tubular body having a distal end ring (band closest to the left side of the page in fig. 2A), a proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) therebetween;
each of the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and the plurality of body rings (middlemost bands 22) has a plurality of crests (curved portions 26) (paragraphs [0032]); and
the plurality of crests (curved portions 26) having an outer arc (outside curve of curved portions 26), as can be seen in fig. 2B, and an inner arc (inside curve of curved portions 26), a center point of the inner arc (inside curve of curved portions 26) being offset from a center point of the outer arc (outside curve of curved portions 26) in a direction away from the inner arc (inside curve of curved portions 26), thereby forming an increased non-uniform width on the plurality of crests (curved portions 26) (paragraph [0033]) (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], which result in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed). The increased non-uniform width on the plurality of crests (additional material creating outer coneheads in the curved portions 26) results in plastic, instead of elastic deformation during expansion (thus resulting in less recoil) and enhances the flexibility of the overall stent (paragraph [0033]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make all the crests (valleys/ peaks oriented toward the top of the page in fig. 14A) and Y-shaped member (valley/ peak oriented toward the bottom of the page in fig. 14A to which a link 32 is attached) of the stent (stent 10), as disclosed by Ta et al., with the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, in order to reduce the likelihood of elastic recoil after expansion/ implantation and to improve the overall flexibility of the stent (stent 10), as taught by Gregorich.
With respect to claim 45:
Ta et al. discloses the invention substantially as claimed. Specifically, Ta et al. discloses a stent (stent 10), as can be seen in figs. 14A-14B, comprising:
a tubular body (tubular body 20) having a distal end ring (distal end ring 264), a proximal end ring (proximal end ring 266), and a plurality of body rings (rings 268-298) therebetween (paragraphs [0056-0057]);
the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) being aligned in an in-phase configuration (paragraphs [0056-0057]);
the proximal end ring (proximal end ring 266) being connected to a first proximal body ring (body ring 298) by three links (three of the links 32), and the first proximal body ring (body ring 298) being connected to a second proximal body ring (body ring 296) by three links (three of the links 32) (paragraphs [0056-0057]);
the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) being connected by two links (links 32) (paragraphs [0056-0057]);
each of the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) has six crests (six of the valleys/ peaks oriented toward the top of the page in fig. 14A);
each of the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-298) has four long crests (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) and two short crests (two of the valleys/ peaks oriented toward the top of the page in fig. 14A which are aligned with the band of the links 32); and
each of the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-298) have a W-shaped member (valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto); and
each W-shaped member (valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto) has an outer arc (bottommost curve of valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto) and an inner arc (top curve of valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto). (Please note: “comprising” (in the preamble) is open ended and does not exclude additional unrecited elements (see MPEP 2111.03); as such, the stent (stent 10), as disclosed by Ta et al., does include additional structure to the structure within the claim – specifically additional crests (peaks/ valleys) and links (links 32) but is still considered to read on the current claims.)
However, Ta et al. does not disclose a center point of the inner arc (top curve of valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto) being offset from a center point of the outer arc (bottommost curve of valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto) in a direction away from the inner arc, thereby forming a non-uniform crest width on the W-shaped member (valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto).
Gregorich teaches a stent (stent 20), as can be seen in figs. 1-2B (paragraph [0029]), comprising:
a tubular body having a distal end ring (band closest to the left side of the page in fig. 2A), a proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) therebetween;
each of the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and the plurality of body rings (middlemost bands 22) has a plurality of crests (curved portions 26) (paragraphs [0032]); and
the plurality of crests (curved portions 26) having an outer arc (outside curve of curved portions 26), as can be seen in fig. 2B, and an inner arc (inside curve of curved portions 26), a center point of the inner arc (inside curve of curved portions 26) being offset from a center point of the outer arc (outside curve of curved portions 26) in a direction away from the inner arc (inside curve of curved portions 26), thereby forming an increased non-uniform width on the plurality of crests (curved portions 26) (paragraph [0033]) (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], which result in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed). The increased non-uniform width on the plurality of crests (additional material creating outer coneheads in the curved portions 26) results in plastic, instead of elastic deformation during expansion (thus resulting in less recoil) and enhances the flexibility of the overall stent (paragraph [0033]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make all the crests (valleys/ peaks) including the W-shaped member (valleys/ peaks oriented toward the bottom of the page in fig. 14A which have a link 32 bisecting/ connecting thereto) of the stent (stent 10), as disclosed by Ta et al., with the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, in order to reduce the likelihood of elastic recoil after expansion/ implantation and to improve the overall flexibility of the stent (stent 10), as taught by Gregorich.
With respect to claim 66:
Ta et al. discloses the invention substantially as claimed. Specifically, Ta et al. discloses a stent (stent 10), as can be seen in figs. 14A-14B, comprising:
a tubular body (tubular body 20) having a distal end ring (distal end ring 264), a proximal end ring (proximal end ring 266), and a plurality of body rings (rings 268-298) therebetween (paragraphs [0056-0057]);
the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) being aligned in an in-phase configuration (paragraphs [0056-0057]);
the proximal end ring (proximal end ring 266) being connected to a first proximal body ring (body ring 298) by three links (three of the links 32), and the first proximal body ring (body ring 298) being connected to a second proximal body ring (body ring 296) by three links (three of the links 32) (paragraphs [0056-0057]);
the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) being connected by two links (links 32) (paragraphs [0056-0057]);
each of the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) has six U-shaped members (six of the valleys/ peaks oriented toward the top of the page in fig. 14A);
each of the distal end ring (distal end ring 264) and the plurality of body rings (rings 268-294) up to the second proximal body ring (body ring 296) has four long U-shaped members (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) and two short U-shaped members (two of the valleys/ peaks oriented toward the top of the page in fig. 14A which are aligned with the band of the links 32); and
the four long U-shaped members (four of the valleys/ peaks oriented toward the top of the page in fig. 14A) having an outer arc (topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) and an inner arc (bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A). (Please note: “comprising” (in the preamble) is open ended and does not exclude additional unrecited elements (see MPEP 2111.03); as such, the stent (stent 10), as disclosed by Ta et al., does include additional structure to the structure within the claim – specifically additional crests (peaks/ valleys) and links (links 32) but is still considered to read on the current claims.)
However, Ta et al. does not disclose a center point of the inner arc (center point of bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A) being offset from a center point of the outer arc (center point of topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) in a direction away from the inner arc, thereby forming a non-uniform width on the four long U-shaped members (four of the valleys/ peaks oriented toward the top of the page in fig. 14A).
Gregorich teaches a stent (stent 20), as can be seen in figs. 1-2B (paragraph [0029]), comprising:
a tubular body having a distal end ring (band closest to the left side of the page in fig. 2A), a proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) therebetween;
each of the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and the plurality of body rings (middlemost bands 22) has a plurality of crests (curved portions 26) (paragraphs [0032]); and
the plurality of crests (curved portions 26) having an outer arc (outside curve of curved portions 26), as can be seen in fig. 2B, and an inner arc (inside curve of curved portions 26), a center point of the inner arc (inside curve of curved portions 26) being offset from a center point of the outer arc (outside curve of curved portions 26) in a direction away from the inner arc (inside curve of curved portions 26), thereby forming an increased non-uniform width on the plurality of crests (curved portions 26) (paragraph [0033]) (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], which result in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed). The increased non-uniform width on the plurality of crests (additional material creating outer coneheads in the curved portions 26) results in plastic, instead of elastic deformation during expansion (thus resulting in less recoil) and enhances the flexibility of the overall stent (paragraph [0033]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make all the U-shaped members (valleys/ peaks oriented toward the top of the page in fig. 14A) of the stent (stent 10), as disclosed by Ta et al., with the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, in order to reduce the likelihood of elastic recoil after expansion/ implantation and to improve the overall flexibility of the stent (stent 10), as taught by Gregorich.
With respect to claim 79:
Ta et al. discloses the invention substantially as claimed. Specifically, Ta et al. discloses a stent (stent 10), as can be seen in figs. 14A-14B, comprising:
a tubular body (tubular body 20) having a distal end ring (distal end ring 264), a proximal end ring (proximal end ring 266), and a plurality of body rings (rings 268-298) therebetween (paragraphs [0056-0057]);
the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) being aligned in an in-phase configuration (paragraphs [0056-0057]);
multiple connecting links (links 32) connect the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) (paragraphs [0056-0057]);
each of the distal end ring (distal end ring 264), the proximal end ring (proximal end ring 266), and the plurality of body rings (rings 268-298) has a plurality of crests (valleys/ peaks oriented toward the top of the page in fig. 14A); and
the plurality of crests (valleys/ peaks oriented toward the top of the page in fig. 14A) having an outer arc (topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) and an inner arc (bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A).
However, Ta et al. does not disclose a center point of the inner arc (center point of bottom curve of peaks/ valleys oriented toward the top of the page in fig. 14A) being offset from a center point of the outer arc (center point of topmost curve of peaks/ valleys oriented toward the top of the page in fig. 14A) in a direction away from the inner arc, thereby forming a non-uniform width on the plurality of crests (valleys/ peaks oriented toward the top of the page in fig. 14A).
Gregorich teaches a stent (stent 20), as can be seen in figs. 1-2B (paragraph [0029]), comprising:
a tubular body having a distal end ring (band closest to the left side of the page in fig. 2A), a proximal end ring (band closest to the right side of the page in fig. 2A), and a plurality of body rings (middlemost bands 22) therebetween;
each of the distal end ring (band closest to the left side of the page in fig. 2A), the proximal end ring (band closest to the right side of the page in fig. 2A), and the plurality of body rings (middlemost bands 22) has a plurality of crests (curved portions 26) (paragraphs [0032]); and
the plurality of crests (curved portions 26) having an outer arc (outside curve of curved portions 26), as can be seen in fig. 2B, and an inner arc (inside curve of curved portions 26), a center point of the inner arc (inside curve of curved portions 26) being offset from a center point of the outer arc (outside curve of curved portions 26) in a direction away from the inner arc (inside curve of curved portions 26), thereby forming an increased non-uniform width on the plurality of crests (curved portions 26) (paragraph [0033]) (as can be seen in fig. 2B, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], which result in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed). The increased non-uniform width on the plurality of crests (additional material creating outer coneheads in the curved portions 26) results in plastic, instead of elastic deformation during expansion (thus resulting in less recoil) and enhances the flexibility of the overall stent (paragraph [0033]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make all the plurality of crests (valleys/ peaks oriented toward the top of the page in fig. 14A), as disclosed by Ta et al., with the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, in order to reduce the likelihood of elastic recoil after expansion/ implantation and to improve the overall flexibility of the stent (stent 10), as taught by Gregorich.
With respect to claim(s) 2, 25, 47, 67:
Wherein the two short crests (two of the valleys/ peaks oriented toward the top of the page in fig. 14A which are aligned with the band of the links 32) having an outer arc and an inner arc, a center point of the inner arc being offset from a center point of the outer arc in a direction away from the inner arc, thereby forming a non-uniform width on the short crests. (Please note: in making the aforementioned combination of Ta et al. and Gregorich, as discussed above, Examiner is adding the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, to ALL of the different crests/ U-shaped members (valleys/ peaks) of the stent (stent 10), as disclosed by Ta et al., which is inclusive of the two short crests (two of the valleys/ peaks oriented toward the top of the page in fig. 14A which are aligned with the band of the links 32).)
With respect to claim(s) 3, 26, 48, 68:
Wherein the proximal end ring (proximal end ring 266) has six equal length crests/ U-shaped members (valleys/ peaks oriented toward the top of the page in fig. 14A), as can be seen in fig. 14A.
With respect to claim(s) 4, 27, 49, 69:
Wherein the six equal length crests/ U-shaped members (valleys/ peaks oriented toward the top of the page in fig. 14A) on the proximal end ring (proximal end ring 266) have an outer arc and an inner arc, a center point of the inner arc being offset from a center point of the outer arc in a direction away from the inner arc, thereby forming a non-uniform width on the six equal length crests. (Please note: in making the aforementioned combination of Ta et al. and Gregorich, as discussed above, Examiner is adding the additional material creating outer coneheads in the curved portions (26) (thus resulting in the non-uniform width of the curved portions 26 and the center points of the inner and outer arcs being offset in same manner as claimed), as taught by Gregorich, to ALL of the different crests/ U-shaped members (valleys/ peaks) of the stent (stent 10), as disclosed by Ta et al., which is inclusive of the six equal length crests/ U-shaped members (valleys/ peaks oriented toward the top of the page in fig. 14A) on the proximal end ring (proximal end ring 266).)
With respect to claim(s) 5-10, 28-33, 50-55, 70-75, 85-91:
Ta et al. as modified by Gregorich does not disclose the specific links (links 32) connecting the rings to have a pattern of 2-2-2-2-2-2-2-2-2-2-3-3 (or 2-2-2-2-2-2-2-2-2-3-3; or 2-2-2-2-2-2-2-2-3-3; or 2-2-2-2-2-2-2-3-3; or 2-2-2-2-2-2-3-3; or 2-2-2-2-2-3-3) moving from the distal end ring (distal end ring 264) toward the proximal end ring (proximal end ring 266).
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to lengthen or shorten the stent (by adding or removing rings and the links 32 used to connect thereto) thus creating the number of rings to have the pattern as claimed, as disclosed by Ta et al. as modified by Gregorich, in order to create a stent of a desired length (particularly within the range of 8-45 mm, as disclosed by Ta et al. paragraph [0061]). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to reduce the number of links (links 32), between the three proximal most end rings, as disclosed by Ta et al. as modified by Gregorich, to three links for stents of smaller diameter with only six peaks (as disclosed by Ta et al. paragraph [0061]).
With respect to claim(s) 11, 16, 21, 34, 39, 42, 56, 60, 63, 76, 82:
In making the combination of Ta et al. as modified by Gregorich (as discussed above with respect to claim(s) 1, 24, 45, 66, 79) the center point of the inner arc will be offset from the center point or the outer arc for all the crests/ U-shaped members (due to the addition of the additional material/ outer coneheads, as taught by Gregorich). Additionally, Ta et al. is silent concerning the specific dimensions of the struts going into the crests/ U-shaped members and the crests/ U-shaped members. However, Gregorich teaches dimensions for both (Gregorich paragraphs [0034-0035]).
It would have been further obvious to one having ordinary skill in the art to use the dimensions for both the struts going into the crests/ U-shaped members and the crests/ U-shaped members, as taught by Gregorich, for the corresponding structures, as disclosed by Ta et al., as the two structures are used for the same purpose and therefore should have the same/ similar dimensions (both are balloon expandable stents made for the same materials positioned within the vascular system). The aforementioned combination will result in an offset in a range from 2 µm to 100 µm (as can be seen in fig. 2B of Gregorich, the outside curves of the curved portions 26 have additional material creating outer coneheads, as discussed by Applicant in specifications paragraph [0079], this “cone head” result in the offsets of the center points of the inner and outer arcs being equal to the difference in width created by the additional material, as discussed by Applicant in specifications paragraph [0079]; thus when Wbs is 30μm and Wbc/Wbs=1.25, then Wbc will be 37.5μm resulting in an offset of 7.5μm (numbers merely given as examples from the size ranges given within paragraphs [0034-0045])).
With respect to claim(s) 12, 17, 22, 35, 40, 43, 57, 61, 64, 77:
Wherein the inner arc and the outer arc, as disclosed by Ta et al. as modified by Gregorich, have an arc configuration of a semi-circle arc, or a polyline arc, or a 3-point arc (as can be seen in fig. 14A of Ta et al. and fig. 2A of Gregorich).
With respect to claim(s) 13, 18, 23, 36, 41, 44, 58, 62, 65, 78, 84:
Wherein a crest width of the all the crests is in a range from 40 µm to 250 µm (as discussed above with respect to claim(s) 11, 16, 21, 34, 39, 42, 56, 60, 63, 76, 82) all the crest widths will be Wbc which is 0.03-0.20mm Gregorich paragraph [0035]).
With respect to claim(s) 14, 37, 59:
Wherein each of the distal end ring and plurality of body rings has at least two W-shaped crests (see W-shaped crest member analysis for claim 45).
With respect to claim(s) 15, 38:
Wherein the at least two W-shaped crests have an outer arc and an inner arc, a center point of the inner are being offset from a center point of the outer arc in a direction away from the inner arc, thereby forming a non-uniform width on the at least two W-shaped crests (see W-shaped crest analysis for claim 45).
With respect to claim(s) 19:
Wherein each of the proximal end ring and the plurality of body rings have at least two Y-shaped crests (see Y-shaped member analysis for claim 24).
With respect to claim(s) 20:
Wherein the at least two Y-shaped crests have an outer are and an inner arc, a center point of the inner arc being offset from a center point of the outer arc in a direction away from the inner arc, thereby forming a non-uniform width on the at least two Y-shaped crests (see Y-shaped member analysis for claim 24).
With respect to claim(s) 46:
wherein: the four long crests having an outer arc and an inner arc, a center point of the inner arc being offset from a center point of the outer arc in a direction away from the inner arc, thereby forming a non-uniform width on the four long crests (see four long crests analysis for claim 1).
With respect to claim 80:
Wherein the increased non-uniform width on the plurality of crests (valleys/ peaks oriented toward the top of the page in fig. 14A with additional material), as disclosed by Ta et al. as modified by Gregorich, comprises an increased strut width at an apex of the plurality of crests.
With respect to claim 81:
Wherein at least some of the multiple connecting links (links 32), as disclosed by Ta et al., have a non-linear configuration, as can be seen in fig. 14A.
With respect to claim 82:
Wherein the inner arc (inside curve of curved portions 26) and the outer arc (outside curve of curved portions 26), as disclosed by Ta et al., have an arc configuration of a semi-circle arc, or a polyene arc, or a 3-point arc.
Conclusion
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
Prosecution Insights