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 .
Response to Amendment
Claims 1-5 are pending in the application. Claims 1-5 have been amended. Claims 1-5 are rejected.
Drawings
The drawings were received on December 3, 2025. These drawings are acceptable.
Specification
The substitute specification paragraph filed December 3, 2025 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: it is unclear where in the specification, the amended paragraph should be placed. The proposed amendment lists the paragraph as {0001}. Based on the language of the originally filed specification, it appears the amended paragraph has similar language to that of paragraph {0040}. Because it is unclear where the amended paragraph belongs in the specification, it will not be entered. It is noted that the proposed amendments otherwise appear to be acceptable.
Examiner’s Note
Examiner has cited particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited An et al (US Pat. No. 5,545,211) in view of Birdsall et al (US PG Pub 2008/0319534).
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Regarding claim 1, An teaches a tubular stent (See Fig. 3) formed of at least one wire (8), the tubular stent comprising:
a proximal end; a distal end; and an intermediate part interposed between the proximal end and the distal end (See annotated Fig. 3) wherein:
the intermediate part includes a woven1 plurality of annular windings (each sinusoidal ring) extending in a circumferential direction around a longitudinal axis of the tubular stent and arranged in a direction along the longitudinal axis (See Fig. 3);
the intermediate part includes a mesh pattern (See Fig. 3) with multiple rhombic2 meshes (note the diamond (rhombic) shapes formed by the interlinked wire windings) arranged in the circumferential direction and a longitudinal direction (note the intermediate portion of the stent has diamonds extending both around the circumference and along the longitudinal axis) wherein an intersection is located at each of the four apexes of each rhombic mesh (note each point of each diamond shape is an intersection of wire windings) (See Col. 2, line 62 – Col. 3, line 12);
each of the plurality of windings has a zig-zag shape (See Fig. 1E) with hill-shaped sections (peaks 1, 12, 22, 32, 42, 53, 62, 72, 82) and valley-shaped sections (1, 11, 21, 31, 41, 51, 61, 67 ,81, 91) alternately arranged in the circumferential direction (See Figs. 1E and 2), each of the hill-shaped sections being a part of each of the plurality of annular windings bent toward the proximal end, each of the valley-shaped sections being a part of each of the plurality annular windings bent toward the distal end (See annotated Fig. 3; Col. 2, lines 55-60),
all the hill-shaped sections (1, 12, 22…82, 92) and all the valley-shaped sections (1, 11, 21 …81, 91) form intersections (cross-linked/hooked) (See Col. 2, line 62 – Col. 3, line 12), the hill-shaped sections of one of the plurality of annular windings and the valley-shaped sections of another one of the plurality of annular windings adjacent to the one of the plurality of annular windings respectively overlapping each other at the intersections in a radial direction of the tubular stent (See Fig. 3),
wherein the intersections are helically (spirally) arranged around the longitudinal axis (See Col. 3, line 1-19);
An does not explicitly teach distances in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections of a first winding of the plurality of annular windings are different from each other in a circumferential direction of the tubular stent, the hill-shaped sections and the valley-shaped sections of the first winding forming at least one of the proximal end and the distal end. An does teach the zig-zag portions may have alternating heights (See Col. 2, lines 46-55)
Birdsall teaches an analogous tubular stent (See Fig. 1) formed of at least one wire (See paragraphs [0026], [0035]-[0037]) with a proximal end (16), a distal end (14) and an intermediate part (12) in between where the intermediate part has a plurality of annular zig-zag shaped windings (18) in a circumferential direction forming hills (peaks) and valleys (troughs). Birdsall also teaches for the proximal and distal end windings (end rings 14 and 16) the distances in the direction of the longitudinal axis between the hill-shaped sections and the valley shaped sections of a first winding are different from each other (See Figs. 1, 4, and 5; paragraphs [0029]-[0030]) (note struts 36 gradually decrease in length between the longest strut 36a and the shortest strut 36b in Fig. 4) in a circumferential direction of the tubular stent. Birdsall teaches the decreasing strut heights creates a taper with an angle which is substantially the same as the pitch angle of the helix defined by the central portion. This results in the outer surfaces of the end crowns which define each end of the tubular stent to be substantially perpendicular to the longitudinal axis in the same manner as traditional stents. (See paragraphs [0029]-[0030]). Additionally, this arrangement provides improved mechanical properties and allows the stent to expand and contract more uniformly (See paragraph [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the helical tubular stent as taught by An to incorporate the teachings of Birdsall such that the proximal or distal end winding of the stent has decreasing heights between the hill-shaped sections (peaks) and valley-shaped sections (troughs) so that the ends can be perpendicular to the longitudinal axis in a similar manner to tradition stents so as to provide improved mechanical properties and more uniform expansion and contraction.
Regarding claim 2, modified An further teaches the distances in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections of the first winding are gradually changed in the circumferential direction of the stent. (See Birdsall Figs. 1, 4, and 5; paragraphs [0029]-[0030])
Regarding claim 3, modified An further teaches a distance in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections of a second winding of the plurality of windings is different from a distance in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections of the first winding, the second winding being adjacent to the first winding. An as modified above to include the gradually decreasing strut heights of Birdsall would also result in the inwardly adjacent ring having a different strut height (distance) from the end ring.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited An et al (US Pat. No. 5,545,211) in view of Birdsall et al (US PG Pub 2008/0319534) as applied to claim 1 above, and further in view of Boyle et al (US Pat. No. 5,591,198).
Regarding claim 4, modified An teaches the tubular stent of claim 1 as set forth above but does not explicitly teach a distance in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections (strut height) of a second winding of the plurality of windings is larger than a distance in the direction of the longitudinal axis between the hill- shaped sections and the valley-shaped sections of the first winding (terminal end ring), the second winding being adjacent to the first winding.
Boyle teaches an analogous tubular stent featuring a proximal end, a distal end and an intermediate portion with a plurality of zig-zag windings. Boyle further teaches the amplitude (height) of the windings at the terminal ends of the tubular stent (25/30) are smaller than the heights of the windings in the intermediate section of the tubular stent (15). Specifically, Boyle teaches the next to last stent winding has a larger height (longitudinal distance) than the terminal ring (See Figs. 1-3; Col. 3, lines 56 through Col. 4 line 4). Boyle teaches having the terminal rings have a smaller tighter wave form provides greater radial (hoop) strength at the proximal and distal ends while also making it easier to visualize the ends of the stents under fluoroscopy.
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Boyle into the tubular stent of modified An such that the intermediate ring directly adjacent the terminal ring of the stent has a larger height since it’s known that having the terminal rings have a smaller height increases radial strength and makes the stent easier to visualize through fluoroscopy thus leading to more efficient (quick) placement and better outcomes for the patient.
Additionally, neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of a second winding having a larger longitudinal distance between the hill and valley shaped sections than the adjacent first winding. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See also MPEP §2144.04(IV)(A).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited An et al (US Pat. No. 5,545,211) in view of Birdsall et al (US PG Pub 2008/0319534) as applied to claim 1 above, and further in view of Burpee et al (US Pat. No. 7,803,180).
Regarding claim 5, modified An teaches the tubular stent of claim 1 as set forth above but does not explicitly teach a distance in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections of a second winding of the plurality of windings is smaller than a distance in the direction of the longitudinal axis between the hill-shaped sections and the valley-shaped sections of the first winding, the second winding being adjacent to the first winding.
Burpee teaches an analogous helical tubular stent where the end rings have longer strut lengths than the intermediate struts (See Fig. 13), or in other words, the lengths of the struts in the intermediate portion are smaller than the lengths of the struts at the terminal end (301). Burpee teaches having longer strut lengths at the terminal ends provides better anchoring of the stent and provide an area for adjacent stents to overlap, but not impede the flexibility of the helical portion. (See Col. 9, line 45 through Col. 10, line 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Burpee into the tubular stent as taught by modified An since it’s known that having the terminal rings of a stent have larger strut lengths (heights) than the intermediate portion allows for better anchoring of the stent in the desired deployment location.
Additionally, neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of a second winding having a smaller longitudinal distance between the hill and valley shaped sections than the adjacent first winding. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, F.2d 459, 105 USPQ 237 (CCPA 1955). Additionally, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See also MPEP §2144.04(IV)(A).
Response to Arguments
Applicant's arguments filed December 3, 2025 have been fully considered but they are not persuasive.
Applicant argues that “neither An nor Birdsall teaches or suggests a stent structure with a woven plurality of annular windings as presently claimed”. This is unpersuasive. As clearly seen in Figs. 1-3 of An and described in Col. 2, lines 47-68, the stent as disclosed by An is formed from “a wire zig-zag configuration” where “the upper bends of such turn are cross-linked with the corresponding lower bends of the next turn” resulting the “the wire having a plurality of spiral bends formed into a cylindrical elastic body as show in Fig. 3”. The stent is thus “woven” since the peaks and valleys of adjacent zig-zags are interconnected (cross-linked) with a plurality (more than one) of annular (ring shaped) windings (bends in wire) as required by the claim. It is noted that An teaches this concept entirely and Birdsall is not relied upon for this teaching.
Applicant next argues Birdsall “discusses forming the stent by laser cutting or chemical etching” which is not “weaving windings together”. Firstly, it is noted that Birdsall is not relied upon for the teaching of “woven”. Secondly, Birdsall does in fact teach the stent may be formed either by a wire or by cutting. (See paragraph [0026], [0035]-[0037]). It is generally understood in the stent art that “wire formed stents” are woven stents.
Applicant next argues An does not explicitly teach the intermediate part is a woven plurality of annular windings. In support of this assertion, applicant states that An’s disclosure “uses vague terminology” such as “hooked with each other like a chain link fence or net”. Firstly, it is quite clear to both those of ordinary skill in the art as well as the average lay person what a chain link fence looks like, and that a chain link fence is formed of wires woven together. Secondly, the determination of the level of ordinary skill in the art is not an inquiry into the thoughts of a specific inventor, but rather the relevant art as a whole at the time of invention. (See MPEP §2141.03). It is clear that the stent as taught by An meets the claimed limitation of “a woven plurality of annular windings”.
Applicant’s second argument is that neither An nor Birdsall teaches the intermediate part includes a mesh pattern with multiple rhombic meshes arranged in the circumferential and longitudinal directions where an intersection is located at each of the four apexes of each rhombic mesh. This is also unpersuasive. As noted above, MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “rhombic” is defined by Merriam-Webster as “having the form of a rhombus”. “Rhombus” is generally understood to be diamond or kite-shaped. As clearly seen in Figs. 2-3 of An, the intermediate section of the stent is formed from the zig-zag wires which in turn form a mesh comprised of a multitude of rhombic meshes (diamond shapes) in both the circumferential and axial (longitudinal) directions. Furthermore, each of the apexes (corners) of each diamond shape is an intersection with an adjacent wire winding. (See annotated Fig. 3 above)
Lastly, applicant argues that Birdsall cannot be relied upon for teaching varying strut heights at the end windings because Birdsall teaches the stent may be laser-cut. This is unpersuasive. As noted above, Birdsall repeatedly states the stent may be formed by a variety of means include a wire formed stent as well as cut-tubes. Birdsall also states “Different combinations of wires and cut tubes and sheets of materials may be used. The illustrated embodiments is not intended to be limiting in any way.” (See paragraph [0035]). However, the determination of the level of ordinary skill in the art is not an inquiry into the thoughts of a specific inventor, but rather the relevant art as a whole at the time of invention. (See MPEP §2141.03).
In response to applicant's argument that Birdsall is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Birdsall is clearly analogous art since it is in the field of inventor’s endeavor, namely stents. Additionally, Birdsall is reasonably pertinent to the problem with which the inventor was concerned which is “stents, stent delivery systems, and stent manufacturing methods” per applicant’s specification.
In response to applicant’s argument that the references are non-combinable, MPEP§ 2145 III states: “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). See also In re Sneed, 710 F.2d 1544, 1550, 218 USPQ 385, 389 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973) (“Combining the teachings of references does not involve an ability to combine their specific structures.”).
Inherent in the combination of references is the understanding that one skilled in the art would know and understand a suitable way to combine the teachings so as to make an appropriately sized and proportioned device with the desired characteristics from each of the references. Further KSR International Co. v. Teleflex, Inc. 82 USPQ2d 1385, 1396-1397 (2007) (as recited in the MPEP §2141.03(I)) states “a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton”. And further states “in many cases, a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary references. For the reasons set forth above, this is unpersuasive.
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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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “woven” is understood to be the past participle of “weave” which is defined by Merriam-Webster as “to form by lacing together strands of material”. Cambridge Dictionary defines “weave” as “ to twist long objects together or to make something by doing this”. The stent as disclosed by An clearly meets the broadest reasonable definition of “woven”. An teaches the “upper bends… are cross-linked with the corresponding lower bends of the next turn” (See Col. 2, lines 62-65) and further uses the term “weaves” in Col. 3, line 31. Both the Figures, particularly Fig. 3, and the written disclosure of An clearly show a “woven” wire stent.
2 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “rhombic” is defined by Merriam-Webster as “having the form of a rhombus”. “Rhombus” is generally understood to be diamond or kite-shaped. As clearly seen in Figs. 2-3 of An, the zig-zag wires form a mesh comprised of diamond shapes.