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 Arguments
Applicant’s arguments, filed 6/30/2026, with respect to the previous rejections have been considered but are moot because the new ground of rejections do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Duerig et al (6,190,406). Evidenced by Shobayashi (2016/0015541).
Duerig et al teaches a stent comprising:
a first strut 52a that is arranged along a cylindrical surface and forms a wave shape having an amplitude direction that is an axial direction of the cylindrical surface (see included figure 4);
a second strut 52b that is arranged along the cylindrical surface, that forms a wave shape having an amplitude direction that is the axial direction, and that is adjacent to the first strut in the axial direction;
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a first extension portion (see depicted extension and column 6, lines 8-39) that is formed on a first crest and extends along a first bisector (depicted), bisecting the first crest, from both sides with respect to the first bisector toward the second strut, the first crest being at least one of a plurality of crests in the first strut protruding toward the second strut (see at least figure 4);
a second extension portion (self-evident) that is formed on a second crest (self-evident) and extends along a second bisector (self-evident), bisecting the second crest, from both sides with respect to the second bisector toward the first strut,
the second crest being displaced in a circumferential direction with respect to the first crest among a plurality of crests in the second strut protruding toward the first strut side (see depictions above and at least figure 4); and
a bridge portion (depicted) extending from the first extension portion to the second extension portion; see figure 4,
wherein the bridge portion is arranged at intervals in the circumferential direction and provided only on some of the plurality of crests (see figure 4).
If first extension portions and second extensions portions of Duerig et al are not inherently taught, the examiner provides Shobayashi as evidence that extension portions are known in the art as depicted below.
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It would have been obvious to one skilled in the art to have added an extension portion to the at least the first and second crests to reduce the strain occurring at the crests (apices).
Claim 2, under anticipation: Duerig et al teaches the stent is laser cutting the from a tube. Duerig makes no suggestion throughout the entire document that the thickness of the bridge portions are not equal to and do not have a uniform thickness with one of the first extension portion or the second extension portion. Therefore, it is inherent that the thickness of the bridge portion is equal to and uniform in thickness with one of the first extension portion or the second extension portion due to the constant thickness of the tube the stent is cut from.
Under obviousness, Duerig et al (or Duerig et al evidenced by Shobayashi) teach the stent can be manufactured by laser-machining a tube of super elastic alloy. It would have been obvious to one having ordinary skill in the art to have manufactured the thickness of the bridge portion to have been equal to or uniform in thickness with one of the first extension portion or the second extension portion for the ease of manufacturing said stent from a constant thickness of the tube.
Claim 3, as depicted, the extension portions have an elliptical shape (same as applicant’s shape) whose major axes is the bisectors (depicted).
Claim 4, the stent configuration is the similar/same as applicant’s figures and, therefore, inherently fulfills the claim language.
Claim 5, Duerig et al teaches Nitinol which is shape memory.
Claim 6, under obviousness only, Shobayashi teaches a coating layer on a surface of the stent; see at least par. 0132. It would have been obvious to have used with the stent of Duerig et al such that the stent may be coated with the drug.
Claim 8, stent according to claim 6, wherein the coating layer comprises a drug-eluting coating layer; see at least par. 0132.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Duerig et al (6,190,406) or Duerig et al evidenced by Shobayashi (2016/0015541), and, further in view of Armstrong et al (12,232,987).
Duerig et al (6,190,406) or Duerig et al evidenced by Shobayashi teach a stent as described above, however, fail to teach a coating layer comprises a ceramic layer. Armstrong et al also teaches a stent which can comprise various coatings including a ceramic layer. See 17:65-18:24, specifically 18:4.
It would have been obvious to one having ordinary skill in the art to have used a coating layer comprising a ceramic layer as taught by Armstrong et al on the stent of to improve the biocompatibility of the stent and reduce the risk of foreign body reactions and immune responses.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Duerig et al (6,190,406) or Duerig et al evidenced by Shobayashi (2016/0015541), and, further in view of Weber (2010/0087910).
Duerig et al (6,190,406) or Duerig et al evidenced by Shobayashi teach a stent as described above, however, fails to teach wherein a thickness of each of the first strut and the second strut is in a range of from 0.6 times a minimum width B of each of the first strut and the second strut in a direction along the cylindrical surface, to the minimum width B.
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It is the examiner’s understanding that the thickness T is in a range from 0.6 times a minimum width B to minimum width B. Therefore, the T can equal B.
Weber also teaches a stent wherein the struts have a minimum thickness of 100 nanometers and a maximum width of 250 nanometers which falls within applicant’s claimed range.
It would have been obvious to one having ordinary skill in the art to made the thickness as a function of the width of the first strut and second strut of according to the teachings of Weber to adjust flexibility.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774
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