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 2/23/26 have been fully considered but they are not persuasive. In response to applicant's argument that Shin did not disclose the outer body or stent is balloon-expandable, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, it must be noted balloons provide controllable means of delivering or inflating a balloon to expand a stent, thus the outer body or stent of Lin is fully capable of being balloon-expandable. Further in addressing Applicant’s arguments, see page 1 of remarks (pg 6 of response), filed 2/23/26, with respect to the rejection(s) of claim(s) 1,4,6-8,14 under 35 U.S.C. 102 (a)(1) over Li have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the teaching of Chun WO ‘410 to address the use of self-expanding material with a stent as this was the only argument against Li. In addition to the Applicant’s arguments that Haindl also did not disclose the feature of “the inner body is self-expanding” see page 2 of remarks (pg 7 of response), filed 2/23/26, with respect to the rejection(s) of claim(s) 1-3,10,14,16 under 35 U.S.C. 102 (a)(1) over Haindl have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the teaching of Chun WO ‘410 to address the use of self-expanding material with a stent as this was the only argument against Haindl. Regarding the comments against Neuss, the Applicant argues the new limitation of “the inner body is self-expanding and the outer body is balloon-expandable” is not met by the reference. The examiner notes that the reference discloses an outer stent body can be biodegradable and an inner stent body can be of self-expandable material. In addressing the functional recitation, the examiner uses Austin in combination with Neuss as presented below.
Applicant did not submit an argument pointing out disagreements with the examiner’s contentions with respect to dependent claims 9,13,17,19 against the teaching references. Since Applicant did not explain how the claims avoid the teaching references or distinguish from them, these rejected claims are rejected with the same teachings and new references addressing the new limitation.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6-8, 10, 11, 15, 18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Shin et al. (EP 2085050) or, in the alternative, under 35 U.S.C. 103 as obvious over Austin et al. (6945994). Fig. 15 shows a stent (45) for transluminal implantation into hollow organs, paragraph 6. Fig. 2 shows the stent comprising an at least substantially tubular body 15 that extends along a longitudinal direction and that can be converted from a compressed state having a first cross-sectional diameter into an expanded state having an enlarged second cross-sectional diameter, paragraph 36. In addition it can be seen (Fig. 15) the tubular body comprises an inner body (15) and an outer body (23), with the outer body surrounding the inner body at least regionally, with the outer body completely running around at least one section of the inner body,
and the outer body being formed from a bioresorbable material or comprises a bioresorbable material, paragraph 44. With respect to the limitation of “the inner body is self-expanding and the outer body is balloon-expandable” it must be noted these are properties or functional limitations of the elements, thus only need to possess such capabilities. Shin et al. does disclose the inner body is self-expanding as the material is superelastic inherently possesses such capability, paragraph 19. Additionally, the stent of Shin is fully capable of being deployed with a balloon catheter and therefore the outer body is “balloon-expandable” since it is expandable device. However, in the alternative Shin et al. is silent as to any properties of the inner and outer bodies, such that the inner body is self-expanding and the outer body is balloon-expandable. Austin et al. teach (col. 11, lines 41-63) that a stent device can be constructed with components having the properties of both self-expandable and balloon-expandable. It would have been obvious to one of ordinary skill in the art to utilize both self-expandable and balloon-expandable properties in a stent as taught by Austin et al. and provide the inner body is self-expanding and the outer body is balloon-expandable for the stent of Shin et al. in order to give the surgeon controlled deployment force via the use of the balloon expandable body and also provide self-expanding properties to use with body temperature known in the art. With respect to claims 6,7 it can be seen (Fig. 15) the inner body comprises a plurality of cells with bordering elements 11 formed by the inner body 10 and form a convex polygon having a diamond shape and have the same shape. Further regarding claim 8, it can be seen (Fig. 15) the outer body has cells that lie congruently on one another or are arranged offset from one another. With respect to claim 10, it can be seen (Fig. 15) that the inner body outer surface engages or presses the inner surface of the outer body upon expansion. Regarding claims 11,18 Shin et al. disclose (Figs. 5-7) fastening means 100 on inner stent body or the inner body can have fastening means 200 that are projections. Regarding claim 15, Shin et al. disclose (paragraph 6) the stent is capable of being placed in a hollow organ such as one of a blood vessel, ureters, esophagi, the colon, the duodenum, the airways and the biliary tract.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,4, 6-8, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Li (EP 3257481) in view of Chun et al. (WO 2016/077410). Li shows (Fig. 1) a stent (10) for transluminal implantation into hollow organs, the stent comprising an at least substantially tubular body that extends along a longitudinal direction and that can be converted from a compressed state having a first cross-sectional diameter into an expanded state having an enlarged second cross- sectional diameter, wherein the tubular body comprises an inner body (10) and an outer body (10), with the outer body (10) surrounding the inner body (10) at least regionally, with the outer body (10) completely running around at least one section of the inner body (10), and the outer body (10) being formed from a bioresorbable material, paragraph 11. It is noted Li does disclose (paragraph 5) that the outer body is balloon expandable. However, Li did not explicitly disclose that the inner body is self-expandable. Li disclosed the stent inner and outer body structures can include magnesium. Chun et al. teach (paragraph 73) that a stent can include self-expandable material incorporated with the stent framework which includes magnesium. It would have been obvious to one of ordinary skill in the art to incorporate self-expanding material with the framework of magnesium as taught by Chun et al. in the stent device of Li such that it improves the properties of the stent body, see paragraphs 25, 75. With respect to claim 4, it can be seen (Fig. 1) that the inner and outer bodies are independent stents. Regarding claim 14, Li discloses (paragraph 5) the inner body includes a balloon disposed therein., see Fig. 1 showing balloon 30. With respect to claims 6-8, it can be seen (Fig. 1) the inner body 10 comprises a plurality of cells with bordering elements formed by the inner body 10 and form a convex polygon having a diamond shape and have the same shape, in addition the outer body 10 comprises a plurality of cells with bordering elements formed by the outer body 10 and form a convex polygon having a diamond shape and have the same shape along with lying congruently on the cells of the inner stent body.
Claim(s) 1-3,10, 14,16,20 are rejected under 35 U.S.C. 103 as being unpatentable over Haindl (DE 10223399) in view of Chun et al. (WO 2016/077410). Haindl shows (Fig. 3) a stent for transluminal implantation into hollow organs, the stent comprising an at least substantially tubular body that extends along a longitudinal direction and that can be converted from a compressed state having a first cross-sectional diameter into an expanded state having an enlarged second cross-sectional diameter, wherein the tubular body comprises an inner body (10) and an outer body (12), with the outer body (12) surrounding the inner body (10) at least regionally, with the outer body (12) completely running around at least one section of the inner body (10), and the outer body (12) being formed from a bioresorbable material, page 3 of translation. However, Haindl did not explicitly disclose that the inner body is self-expandable. Haindl did disclose (page 3 of translation) the stent inner body structure is made of a plastic. Chun et al. teach (paragraph 73) that a stent can include self-expandable material incorporated with the stent framework which includes a plastic (paragraph 63). It would have been obvious to one of ordinary skill in the art to incorporate self-expanding material with the plastic framework as taught by Chun et al. in the stent device of Haindl such that it improves the properties of the stent body, see paragraphs 25, 75. With respect to claims 2,3,16,20 see Fig. 3 of Haindl showing the inner body is a plurality of annular sections (10) or separate elements and are held by the outer body (12). Regarding claim 14 Haindl disclose (page 3 of translation) the inner and outer body can be balloon expandable. With respect to claim 10, Haindl discloses (page 3 of translation) the inner body is to press against the outer body in the expanded state since it encloses the inner body elements.
Claim(s) 1,4, 6-8, 10-12,14,15 are rejected under 35 U.S.C. 103 as being unpatentable over Neuss (WO 2019/175330) in view of Austin et al. (6945994). Neuss shows (Fig. 2) a stent 2 for transluminal implantation into hollow organs, the stent comprising an at least substantially tubular body that extends along a longitudinal direction and that can be converted from a compressed state having a first cross-sectional diameter into an expanded state having an enlarged second cross-sectional diameter. Fig. 1 shows the tubular body comprises an inner body 2 and an outer body 3, with the outer body 3 surrounding the inner body 2 at least regionally, with the outer body 3 completely running around at least one section of the inner body 2. Neuss discloses the outer body being formed from a bioresorbable material, page 6 of translation, claim 9. It is noted (claims 3,5 of Neuss) the inner body is self-expanding, but is silent the outer body is balloon-expandable. Austin et al. teach (col. 11, lines 41-63) that a stent device can be constructed with components having the properties of both self-expandable and balloon-expandable. It would have been obvious to one of ordinary skill in the art to utilize both self-expandable and balloon-expandable properties in a stent as taught by Austin et al. and provide the outer body as balloon-expandable in the stent of Neuss in order to give the surgeon controlled deployment force via the use of the balloon expandable body as combined with self-expanding properties of the inner body the stent structure is assured of being open and affixed against a vessel wall using both mechanisms of expansion. With respect to claim 4, it can be seen (Fig. 1) that the inner and outer bodies are independent stents since they are separated by the membranes. Regarding claim 6, it can be seen (Fig. 2) that the inner body has a plurality of cells defined by the stent ring segments considered as bordering elements. Regarding claim 10, Fig. 1 shows how the inner body presses against the outer body in the expanded state as they are assembled together. With respect to claim 11, Neuss discloses (page 4 of translation) the inner body and/or the outer body has fastening means to fasten the respective other body. Regarding claim 12, Neuss disclose both the inner and outer bodies are surrounded by a stent graft 4,5 respectively. With respect to claim 14, Neuss discloses (page 3 of translation) that a balloon is used with the stent.
Claim(s) 9,17 are rejected under 35 U.S.C. 103 as being unpatentable over Li (EP 3257481) in view of Chun et al. (WO 2016/077410) as applied to claim 1 above, and further in view of Berglung et al. (2011/0264186). Li as modified with Chun et al. is explained supra. However, Li in view of Chun et al. did not explicitly disclose the outer body with rails that extend along the longitudinal direction. Berglung et al. teach (Fig. 11) a stent 1100 for transluminal implantation with a tubular body comprising an inner body (110) and an outer body (106A,B), with the outer body (106A,B) including rails 1150 that extend along the longitudinal direction. Berglung et al. further disclose (paragraph 46) the rails can be bioresorbable. It would have been obvious to one of ordinary skill in the art to alternatively incorporate rails with the outer body as taught by Berglung et al. in the stent of Li as modified with Chun et al. such that it can provide a less constrictive central section in the circumferential radius of the stent to allow for more outward expansion against the vessel. Regarding claim 17, it can be seen (Fig. 11) Berglung teaches the rails on the outer surface of the outer body..
Claim(s) 13,19 are rejected under 35 U.S.C. 103 as being unpatentable over Li (EP 3257481) in view of Chun et al. (WO 2016/077410) as applied to claim 1 above, and further in view of Hoffmann et al. (WO 2008/092435). Li as modified with Chun et al. is explained supra. However, Li in view of Chun et al. did not explicitly disclose the bioresorbable material comprises zinc with a mass between 90 to 99.5% and silver with a mass between 0.05 to 10%. Hoffmann et al. teach (page 9 of translation) that a stent material that degrades can be formed from zinc with a mass between 90 to 99.5% and (page 10 of translation) silver with a mass between 0.05 to 10%. It would have been obvious to one of ordinary skill in the art to provide a stent layer that degrades with a bioresorbable material comprising zinc with a mass between 90 to 99.5% and silver with a mass between 0.05 to 10% as taught by Hoffmann et al. for the stent of Li as modified by Chun et al. such that the appropriate degradation rate or time of presence is provided for the structural device as optimization of the materials only involves routine skill in the art. Regarding claim 19, Hoffmann et al. teach that the combination of materials of zinc and silver is an option only based on the scope of the disclosure of Hoffman, see pages 9,10 of translation.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799