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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/2/2025 is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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(s) 1, 3, 6, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quigley (Pub. No.: US 2007/0208421 A1).
Quigley discloses the following regarding claim 1: a method of making a highly flexible stent graft (paras. 0056-0073), the method comprising: providing a stent graft (10) having a first and a second longitudinal end (Fig. 5) and a lumen (central opening of element 10) extending longitudinally therethrough (Figs. 5, 15), the stent graft comprising a base stent (24), the base stent having a first covering material (32) provided on the inside of the base stent so as to line the lumen (Figs. 2-4, 15) and a second covering material (16, 18) provided on the outside of the base stent (Figs. 2-4, 15), locally ablating the second covering material without puncturing the first covering material to thereby increase the flexibility of the stent graft (paras. 0056-0060), wherein the local ablation optionally occurs by means of applying heat to the second covering material (paras. 0056-0060).
Quigley discloses the following regarding claim 3: the method according to claim 1, wherein the second covering material is ablated so as to be locally thinned without locally uncovering the base stent (Figs. 6-7; para. 0060).
Quigley discloses the following regarding claim 6: the method according to claim 1, wherein the heat is applied by means of a laser (para. 0060).
Quigley discloses the following regarding claim 7: the method according to claim 6, wherein the laser is applied so as to graze the stent graft (para. 0060).
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) 2, 4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quigley in view of Weber (Pub. No.: US 2002/0065553 A1).
Regarding claim 2, Quigley discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the second covering material being ablated so as to locally uncover the base stent. Weber teaches that it is well known in the art that a stent with coatings is ablated to a depth that will expose the base stent (paras. 0021-0023, 0027-0028), as would be needed to provide the stent with the desired physical and mechanical properties needed for its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the depth of the ablation of the device Quigley to expose a base stent, as taught by Weber, in order to provide the stent with the desired physical and mechanical properties needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Regarding claims 4 and 5, Quigley discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the thickness of the second covering material prior to ablation and the relative amount of the coating that is ablated. Weber teaches that it is well known in the art that a stent with a coating to be ablated has a covering material with a thickness within the range of 0.02 to 0.15 mm; and that the covering material is locally thinned by at least 50% of the maximum thickness of the covering material (paras. 0032, 0053-0057), in order to properly control the dimensions of the coating on the stent and to provide the device with the desired physical and mechanical properties. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the covering material of the device Quigley to comprise the claimed thickness before and after ablation, as taught by Weber, in order to properly control the dimensions of the coating on the stent and to provide the device with the desired physical and mechanical properties. Such a modification would be made with a reasonable expectation of success.
In addition, it has been held that the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal covering material thicknesses and the ablation depths needed to achieve the desired results and provide the stent graft device with the desired physical properties. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the covering material thicknesses and the ablation depths, would have been obvious at the time of applicant's invention in view of the teachings of Quigley and Weber. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quigley in view of Harrington et al. (Pub. No.: US 2011/0307050 A1; hereinafter “Harrington”).
Quigley discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the angle at which the ablation laser is applied to the stent graft. Harrington teaches that it is well known in the art that the angle and orientation of the ablation laser system relative to the medical device it is cutting can be modified (Figs. 2-3; paras. 0032-0037), in order to provide the stent with the desired fabricated pattern. It would have been obvious to one having ordinary skill in the art to modify the laser angle of Quigley, according to the teachings of Harrington, for the purpose of providing the stent with the desired fabricated pattern to control its dimensions and mechanical properties. Such a modification would be made with a reasonable expectation of success.
In addition, it has been held that the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal angles of the ablation laser needed to achieve the desired results and provide the stent graft device with the desired physical properties. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the ablation laser angles, would have been obvious at the time of applicant's invention in view of the teachings of Quigley and Harrington. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quigley in view of Ho et al. (WO 2011/008897 A2; hereinafter “Ho”).
Quigley discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the second covering material being ablated so as to cut a helical pattern into the second covering material, with the helix extending along the axial direction of the stent graft. Ho teaches that it is well known in the art that the covering material on a stent is ablated to have a variety of different shapes and patterns, including a helical pattern extending along the length of the device (pgs. 1-2), as would be needed to provide the device with the desired physical and mechanical properties needed for its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the ablation pattern of the device Quigley to comprise a helix, as taught by Ho, in order to provide the device with the desired physical and mechanical properties needed for its implantation site. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774