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, with respect to Sirhan teaching the claimed axial force value in Newtons, have been fully considered and are persuasive. However, the Applicant’s remaining arguments regarding the optimization of the axial and the radial forces have been considered, but they are not persuasive. The applicant has not provided any evidence to support the assertion that one of ordinary skill in the art would not modify the axial force of the primary reference to have the claimed value. Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Sirhan teaches that it is well known in the art that the structural features of a stent are modified or controlled in order to provide the stent with the desired mechanical characteristics needed to best suit the implantation site (paras. 0050-0060, 0074, 0112-0114, 0193-0199, 0253-0256). Grandfield also recites using different methods of stent construction to modify the values of the axial force in order to provide the stent with the desired mechanical characteristics (para. 0157). It is maintained that it would be obvious to one having ordinary skill in the art to modify the stent to have the optimal radial force and axial force values needed to achieve the desired results and suit the implantation site.
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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grandfield et al. (Pub. No.: US 2017/0303944 A1; hereinafter “Grandfield”) in view of Sirhan et al. (Pub. No. US 2017/0290686 A1; hereinafter “Sirhan”).
Grandfield teaches the following regarding claim 1: a stent formed in a tubular shape by braiding one or more wire rods (e.g., Figs. 1B, 13B-13C, 50), wherein when a radial force (N/mm) is denoted as RF (paras. 0113, 0220) and an axial force (N) is denoted as AF (para. 0157), the RF ranges from 0.02 N/mm to 0.04 N/mm (paras. 0113, 0220).
Regarding claims 1 and 3, Grandfield teaches the limitations of the claimed invention, as described above. However, it is silent as to the value of the stent’s axial force, and it does not explicitly recite a RF/AF, which is a value obtained by dividing the RF by the AF, being 0.14 mm-1 or more. Sirhan teaches that it is well known in the art that the structural features of a stent are modified or controlled in order to provide the stent with the desired mechanical characteristics needed to best suit the implantation site (paras. 0050-0060, 0074, 0112-0114, 0193-0199, 0253-0256). 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 radial force and axial force needed to achieve the desired results and suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the radial force and the axial force, would have been obvious at the time of applicant's invention in view of the teachings of Grandfield and Sirhan. 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.
Regarding claim 2, Grandfield teaches a shortening of the stent (paras. 0146-0147). However, it does not specify the percentage of shortening that has occurred. 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 final stent length needed to achieve the desired results and suit the implantation site. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the shortening percentage, would have been obvious at the time of applicant's invention in view of the teachings of Grandfield and Sirhan. 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.
Grandfield teaches the following regarding claim 4: the stent according to claim 1 made of a structure formed of the wire rod (e.g., Figs. 1B, 13B-13C, 48A-50), the structure including, along an axial direction, a plurality of circumferential units (strut cells) in which a plurality of meshes is arrayed along a circumferential direction (Figs. 1B, 13B-13C, 48A-50) and including a bent part (e.g., 495, 860, bends in the struts) of one of adjacent circumferential units is coupled to a bent part or a wire rod intersecting part of the other of adjacent circumferential units (Figs. 48A-50).
Regarding claims 5 and 7, Grandfield teaches that the wire rod forming the structure has a diameter of from 0.1 mm to 0.5 mm (paras. 0281). However, it does not specify the number of coupling points per unit area of the bent part of the one of adjacent circumferential units and the bent part or the wire rod intersecting part of the other of adjacent circumferential units. 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 number of coupling points of the stent elements needed to achieve the desired results and provide the stent with the appropriate mechanical strength and density. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the number of coupling points of the stent elements, would have been obvious at the time of applicant's invention in view of the teachings of Grandfield and Sirhan. 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.
Grandfield teaches the following regarding claim 6: the stent according to claim 1 made of: a first mesh structure (struts of element 480) formed of a first wire rod (Figs. 47A-50), the first mesh structure including, along an axial direction, a plurality of circumferential units (e.g., cells formed by struts) in which a plurality of meshes is arrayed along a circumferential direction (Figs. 47A-50); and a second mesh structure (495) formed of a second wire rod (Fig. 50), the second mesh structure including, along the axial direction, a plurality of circumferential units (cells formed by 495) in which a plurality of meshes is arrayed along the circumferential direction and braided with the first mesh structure (Fig. 50), wherein in the first mesh structure, a bent part (bent portions of struts) of one of adjacent circumferential units is coupled to a bent part or a wire rod intersecting part of the other of adjacent circumferential units (Figs. 47A-50), and in the second mesh structure, a bent part (distal-most bent portion of element 495) of one of adjacent circumferential units is coupled to none of a bent part and a wire rod intersecting part of the other of adjacent circumferential units (Fig. 50).
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 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
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