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 of Invention I: a stent defined in claims 1-8 in the reply filed on 7/3/26 is acknowledged. It is also noted Applicant elected Specie B: Fig. 9b a catheter type, but the catheter was not the elected invention. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim.
Drawings
The drawings were received on 6/24/24. These drawings are acceptable.
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.
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) 1,8 are rejected under 35 U.S.C. 103 as being unpatentable over Tongji Hospital (CN 115486962) in view of Venkateswara (WO 00/28922). Fig. 9 shows an open cell intracranial stent comprising: a plurality of rings arranged sequentially in a longitudinal direction, each ring comprising a plurality of cells arranged adjacently to each other in a transverse direction generally perpendicular to the longitudinal direction, each cell comprising a pair of struts 111, each strut in the cell having a first end and an opposing second end, the first ends of the pair of struts joined at a first peak, the second end of each of the pair of struts joined to a second end of one of the pair of struts in a separate, adjacent, one of the plurality of cells in the ring to form a pair of peaks opposing the first peaks, such that the struts and peaks in the ring form a generally sinusoidal configuration, each of the plurality of rings being joined to another one of the plurality of rings at a nodal connection, each of the pair of struts in each one of the plurality of cells in each ring having a uniform strut length dimension; and wherein the stent has a pair of opposing ends and the plurality of rings includes a first ring at one of the opposing ends, a second ring, a third ring, a fourth ring, a fifth ring, and a sixth ring at the other of the opposing ends. However, CN ‘962 did not disclose the uniform strut length dimension of the second ring cells having a relative value of 0.9 times the uniform strut length dimension of the cells of the first ring, the third ring cells having a relative value of 0.85 times the uniform strut length dimension of the cells of the first ring, the fourth ring cells having a relative value of 0.85 times the uniform strut length dimension of the cells of the first ring, the fifth ring cells having a relative value of 1.15 times the uniform strut length dimension of the cells of the first ring, and the sixth ring cells having a relative value of 1.25 times the uniform strut length dimension of the cells of the first ring. Venkateswara teaches (Figs. 1,3) a stent 12 with a plurality of rings to define stent cells arranged with each cell having a pair of struts with the adjacent rings connected. Venkateswara further teaches (page 6, lines 13-15) the strut length dimensions of the cells for adjacent rings can be different or a ratio of the end ring value. Venkateswara further teaches (page 7, lines 17-25) any combination of varied length for struts can be arranged for unit cells of the stent. Thus, it would have been obvious to one of ordinary skill in the art per the teaching of Venkateswara to modify length along a stent axis and optimize values such as selecting strut length dimension of the second ring cells to be a relative value of 0.9 times the uniform strut length dimension of the cells of the first ring, the third ring cells having a relative value of 0.85 times the uniform strut length dimension of the cells of the first ring, the fourth ring cells having a relative value of 0.85 times the uniform strut length dimension of the cells of the first ring, the fifth ring cells having a relative value of 1.15 times the uniform strut length dimension of the cells of the first ring, and the sixth ring cells having a relative value of 1.25 times the uniform strut length dimension of the cells of the first ring in the stent of CN ‘962 so that the desired radial strength, longitudinal flexibility or coverage differentiation can be provided, see Venkateswara page 8, lines 2,3. With respect to claim 8, Tongji discloses a stent configuration can be conical shape when expanded, para. 1. However, it is also noted that Venkateswara teaches (Figs. 3,4) that a stent when expanded has a conical shape. Thus, it would have been obvious to one of ordinary skill in the art to select a shape to match the vessel anatomy such as using a conical shape when expanded per the teaching of Venkateswara with the stent of CN ‘962 so that it can be in engagement with a tapered vessel.
Claim(s) 2,3 are rejected under 35 U.S.C. 103 as being unpatentable over Tongji Hospital (CN 115486962) in view of Venkateswara (WO 00/28922) as applied to claim 1 above, and further in view of Owens et al. (9770349). Tongji Hospital in view of Venkateswara is explained supra. However, Tongji Hospital as modified by Venkateswara did not disclose each of the struts is coated with a layer comprising a mixture of nanoparticles of an anti-thrombotic medication and a bioabsorbable polymer.
Owens et al. teach that a stent be provided with a coating comprising a mixture of nanoparticles of an anti-thrombotic medication and a bioabsorbable polymer. See citations from col. 82, lines 6,7 (claim 1) recites “a stent for insertion into a body, the stent comprising a metal stent having a dealloyed porous surface” also citation “wherein the porous surface is a nanoporous surface” see col. 82, line 13 (claim 2) and also see
Col. 82, lines 21,22 (claim 5) reciting “wherein the stent further comprises a biodegradable coating bonded to the porous surface” and also see col. 82, lines 30-49 (claims 8,9) with the recitation of “wherein the nanoporous surface contains at least one therapeutic agent….selected from a group consisting of….tirofiban” and further see col. 19, lines 10-36 with the citation “the stent may optionally further comprise a polymeric coating bonded to at least a portion of the outer surface of the porous layer….the polymeric coating comprises a material selected from a group consisting ….of a polyanhydride..” therefore it would have been obvious to one of ordinary skill in the art before the priority date to provide the stent of Tongji as modified with Venkateswara per the teaching of Owens et al. with a coating layer comprising a mixture of nanoparticles of an anti-thrombotic medication and a bioabsorbable polymer so that each of the struts would be coated with a layer comprising a mixture of nanoparticles of an anti- thrombotic medication and a bioabsorbable polymer. The motivation would be to prevent blood clots and reduce the risk of long-term complications. Regarding Claim 3, modified Tongji discloses the stent of claim 2. Tongji fails to explicitly disclose wherein the anti-thrombotic medication is Tirofiban and the bioabsorbable polymer is polyanhydride. However, Owens is in the field of stents (abstract) and teaches wherein the anti-thrombotic medication is Tirofiban and the bioabsorbable polymer is polyanhydride ("A stent for insertion into a body, the stent comprising a metal stent having a dealloyed porous surface", Claim 1, Col. 82 Lns. 6-7. "wherein the porous surface is a nanoporous surface", Claim 2, Col. 82 Ln. 13. "wherein the stent further comprises a biodegradable coating bonded to the porous surface", Claim 5, Col. 82 Lns. 21-22. "wherein the nanoporous surface contains at least one therapeutic agent selected from a group consisting of: tirofiban", Claims 8-9, Col. 82 Lns. 30-49. "The stent may optionally further comprise a polymeric coating bonded to at least a portion of the outer surface of the porous layer the polymeric coating comprises a material selected from a group consisting of: polyanhydrides", Col. 19 Lns. 10-36). It would have been obvious to one of ordinary skill in the art before the priority date to modify the stent of Tongji to include wherein the anti-thrombotic medication is Tirofiban and the bioabsorbable polymer is polyanhydride as taught by Owens. The motivation would be to enhance safety, effectiveness, and long-term outcomes of the stent.
Claim(s) 4,5 are rejected under 35 U.S.C. 103 as being unpatentable over Tongji Hospital (CN 115486962) in view of Venkateswara (WO 00/28922) as applied to claim 1 above, and further in view of Dehnad et al. (20040088038). Tongji Hospital in view of Venkateswara is explained supra. However, Tongji Hospital as modified by Venkateswara did not disclose the stent defines a plurality of microholes, the microholes filled with a radiopaque substance. Regarding claim 4, Dehnad provides a teaching in the same field of endeavor, stents (see abstract) with incorporated microholes of which are filled with a radiopaque substance. Dehnad also shows (Fig. 5) an enlarged view of the microcellular porous metal stent 10 shown in Fig. 4. Dehnad further teach (paragraph 31) that the microholes 30 has disposed therein the radiopaque material 26 that is metallic of which forms a porous fill material. It would have been obvious to one of ordinary skill in the art before the priority date to provide the stent of Tongji as modified with Venkateswara with a plurality of microholes that can be filled with a radiopaque material as taught by Dehnad to improve the visibility under imaging and real-time guidance. With respect to claim 5, as mentioned already Dehnad teaches the use of the radiopaque material in a microhole, but further teaches (paragraph 31) the metal can be tantalum. It would have been obvious to select a known radiopaque material such as tantalum as taught by Dehnad to use in the microholes incorporated in the stent of Tongji as modified with Venkateswara such that the appropriate visibility marker is provided, since such a modification only involves routine skill in the art. Selection of materials is a result dependent variable based on the imaging modality.
Claim(s) 6,7 are rejected under 35 U.S.C. 103 as being unpatentable over Tongji Hospital (CN 115486962) in view of Venkateswara (WO 00/28922) as applied to claim 1 above, and further in view of Boismier (20160067070). Tongji Hospital in view of Venkateswara is explained supra. Regarding claim 6, Tongji Hospital as modified by Venkateswara did not disclose the struts have a thickness from about 40 microns to about 60 microns. It is noted that Venkateswara teach (page 7, lines 17-25) that the strut thickness can be optimized to particular dimensions to achieve a desired functional effect. Boismier teaches (paragraph 29) the dimensions for strut thickness can be provided to be from about 40 microns to about 60 microns. Please note MPEP 2144.05 states that when there is some overlapping values for ranges, a prima facie case of obviousness exists where the claimed ranges or amounts overlap. Thus, it would have been obvious to one of ordinary skill in the art to select a strut thickness for the stent to be within the range from about 40 microns to about 60 microns as taught by Boismier for the stent struts of Tongji Hospital as modified with Venkateswara since finding the optimal thickness for a stent strut is a result effective variable and only involves routine skill in the art. Regarding claim 7, Tongji Hospital as modified by Venkateswara did not disclose a width at the first peak and a width at each of the second peaks is less than a width of the struts. It is noted that Venkateswara teach (page 7, lines 17-25) that the width can be optimized to particular dimensions to achieve a desired functional effect of a stent. Boismier teaches (paragraph 32 and claim 12) a width at the first peak and a width at each of the second peaks is less than a width of the struts. Please note MPEP 2144.05 states that when there is some overlapping values for ranges, a prima facie case of obviousness exists where the claimed ranges or amounts overlap. Thus, it would have been obvious to one of ordinary skill in the art to select a width at the first peak and a width at each of the second peaks is less than a width of the struts as taught by Boismier for the stent struts of Tongji Hospital as modified with Venkateswara since finding the optimal width for a stent peak is a result effective variable and only involves routine skill in the art in that one of ordinary skill will select the appropriate flexibility that can be a result of the peak widths being less than the strut widths.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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