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 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 a radial force (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 stent’s axial force and does not explicitly recite a ratio (RF/AF) of the radial force (RF) to an axial force (AF) is 0.14 mm-1 or more. Sirhan teaches that it is well known in the art that the strength of stents is modified and stents can be provided with an axial force of about 0.033, which provides the claimed ratio (paras. 0027-0028, 0063-0070, 1413). This stent construction allows the user to provide the stent with the desired mechanical and structural characteristics needed to properly fit an implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the axial force of Grandfield, according to the teachings of Sirhan, as would be needed to provide the stent with the desired mechanical and structural characteristics needed to properly fit an implantation site. 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 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
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774