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 Status
Applicant’s Remarks and Amendments filed 04 March 2026 have been entered. Claims 1, 3-4, 6-8, 10-17, and 23 are pending.
Response to Arguments
Applicant’s arguments, see remarks, filed 4 March 2026, with respect to claim 7 have been fully considered and are persuasive. The objection of 7 has been withdrawn.
Applicant’s arguments, see remarks, filed 4 March 2026, with respect to claims 7-8 and 10-17 have been fully considered and are persuasive. The 112(b) rejection of claims 7-8 and 10-17 has been withdrawn.
Applicant’s arguments with respect to claims 1 and 7 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Gomez et al. (US Pat. No. 6656220 B1), “Gomez”.
Regarding claim 1, Lenker teaches a covered stent (Fig. 5, stent graft 90), comprising: a frame (Fig. 5, frame rings 72) comprising a midbody (Fig. 5, middle portion of stent graft 90 (i.e., non-flared section)) and flare zones (Fig. 5, end portions of stent graft 90 are flared); and a cover coupled to the frame (Fig. 5, expandible liner 92), wherein the cover comprises an electrospun polytetrafluoroethylene (PTFE) material (Fig. 5, liner 92 comprises PTFE (col. 10, lines 1-3)), wherein the frame (Fig. 5, frame rings 72) and the cover are configured to promote biocompatibility of the stent (PTFE liners are biocompatible (col. 14, lines 12-14)), and wherein the end of the flare zone is configured to be a-traumatic to healthy tissue of the vessel wall (sealing elements disposed at the ends of the prosthesis provides an atraumatic seal between the prosthesis and the body lumen (col. 6, lines 63-67)), but fails to teach wherein an end of the flare zone comprises an alternating pattern of long arms and short arms about a circumference of ends of the frame, wherein the alternating pattern is configured to distribute an outwardly directed force along a length of a vessel wall.
Gomez teaches an expandable stent comprising an alternating pattern of long arms and short arms about a circumference of ends the frame (Fig. 6B, the length of second struts 68 are shorter and arc shorter than the length of first struts 66 and alternate along the cylindrical rings (cols. 7-8, lines 47-37)), wherein the alternating pattern is configured to distribute an outwardly directed force along a length of a vessel wall (stent design provides uniform expansion capabilities and high radial strength (col. 8, lines 2-5)). Gomez discloses that this particular stent design provides uniform expansion capabilities, high radial strength, flexibility, and sufficient wall coverage to support the vessel (col. 8, lines 2-5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent pattern taught by Gomez with the covered stent taught by Lenker in order to provide sufficient support to the vessel in which the stent is implanted.
Regarding claim 3, Lenker further discloses wherein the flare zone (Fig. 5, end portions of stent graft 90 are flared) is configured to engage with healthy tissue of a blood vessel and minimize trauma to the healthy tissue (the prosthesis anchors securely to a healthy vessel wall and requires proper fitting (col. 1, lines 58-62)).
Regarding claim 4, Lenker further discloses wherein the first apex to apex length (Fig. 5C, diamond element 104 within middle portion of stent graft 90) ranges from 2.0 mm to 30.0 mm (Figs. 1A-H, struts range from 1-5 millimeters in length (col. 6, lines 8-10)), and wherein the second apex to apex length (Fig. 5C, diamond element 104 within flared portion of stent graft 90) ranges from 2.1 mm to 30.1 mm (Figs. 1A-H, struts range from 1-5 millimeters in length (col. 6, lines 8-10)).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Gomez et al. (US Pat. No. 6656220 B1), “Gomez”, and further in view of White et al. (US Pat. No. 6685736 B1), “White”.
Regarding claim 6, Lenker teaches the cover (Fig. 5, expandible liner 92), but Lenker in view of Gomez fails to teach a scallop shaped end, wherein the scallop shaped end is configured to reduce infolding of tissue of a vessel wall when an outside diameter of the stent is greater than an inside diameter of a vessel.
White teaches a scallop shaped end (Fig. 7, crimped tube 16), wherein the scallop shaped end is configured to reduce infolding of tissue of a vessel wall when an outside diameter of the stent is greater than an inside diameter of a vessel (tube 16 diameter is slightly larger than the diameter of the vessel location and the crimped ends serve to restrain the graft 10 against the vessel (col. 6, lines 3-13)).
White discloses that the scalloped edges of the graft serve to prevent a potential occlusion of the arterial lumen (col. 2, lines 60-65). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the edges of stent taught by Lenker to be scalloped to limit the chances of a blockage occurring in the vessel by the device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, and Anneaux et al. (US 2011/0031656 A1), “Anneaux”, and further in view of Hanson (US Pat. No. 8721711 B2), “Hanson”.
Regarding claim 7, Lenker teaches a covered stent (Fig. 5, stent graft 90), comprising: a frame (Fig. 5, frame rings 72); and a cover coupled to the frame (Fig. 5, expandible liner 92) comprising PTFE material (Fig. 5, liner 92 comprises PTFE (col. 10, lines 1-3)), but fails to teach wherein the cover comprises electrospun PTFE material, wherein an inner layer and an outer layer of the cover are each configured to be cell permeable, wherein an average percent porosity of the inner layer is between 30% to 80%, and wherein an average percent porosity of the outer layer is between 0% and 25%, and wherein the average percent porosity of the outer layer is less than the average percent porosity of the inner layer.
Bebb teaches an inner layer (Fig. 2D, inner graft 21) and an outer layer (Fig. 2D, outer graft 20) of the cover are each configured to be cell permeable (grafts are made of ePTFE that is porous and readily colonized by living cells in order to become a permanent part of the body [0003]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb fails to teach wherein an average percent porosity of the inner layer is between 30% to 80%, and wherein an average percent porosity of the outer layer is between 0% and 25%, and wherein the average percent porosity of the outer layer is less than the average percent porosity of the inner layer.
Anneaux teaches a multilayered electrospun composite wherein an average percent porosity of the inner layer is between 30% to 80% (Fig. 1, composite construction leads to porosity ranging from 20% to 90% which varies from layer to layer [0025]), and wherein an average percent porosity of the outer layer is between 0% and 25% (Fig. 1, composite construction leads to porosity ranging from 20% to 90% which varies from layer to layer [0025]). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of “about 1-5%” while the claim was limited to “more than 5%.” The court held that “about 1-5%” allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I. However, Lenker in view of Bebb and Anneaux fails to teach wherein the average percent porosity of the outer layer is less than the average percent porosity of the inner layer.
Hanson teaches devices for delivering substances into a blood vessel wherein the average percent porosity of the outer layer is less than the average percent porosity of the inner layer (an inner later has an average pore size that allows for easy passage of liquids and an overlaid layer has a much smaller average pore size that does not easily allow liquids to pass through (col. 5, par. 2)). Hanson discloses that the outer layer pores may be sized to restrict movement of liquid and drugs contained therein except for in response to a specific pressure application (col. 5, par. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the layers taught by Bebb with the average porosities taught by Hanson in order to better control the substances able to pass through the stent covering.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, Anneaux et al. (US 2011/0031656 A1), “Anneaux”, and Hanson (US Pat. No. 8721711 B2), “Hanson” and further in view of To et al. (US 2010/0119578 A1), “To”.
Regarding claim 8, Lenker fails to teach the limitations of claim 8. Bebb teaches wherein the inner layer (Fig. 2D, inner graft 21) is configured to promote attachment of a coating of epithelial cells (grafts are made of ePTFE that is porous and readily colonized by living cells (of the blood vessel, i.e., endothelial cells) in order to become a permanent part of the body [0003]), and an outer layer (Fig. 2D, outer graft 20). Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb, Anneaux, and Hanson fails to teach wherein a coating is configured to prevent thrombosis within a lumen of the stent, and wherein the outer layer is configured to permit healing of tissue adjacent the stent.
To teaches a coating (abstract) is configured to prevent thrombosis within a lumen of the stent (reduces the risk of thrombosis [0064]), and wherein the outer layer is configured to permit healing of tissue adjacent the stent (stent becomes buried within healthy tissue when natural endothelial cell layer has developed [0064]). To discloses that regrowth of the luminal tissue stops increasing once the stent is buried within the regrowth in order to avoid reclosure [0064]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Lenker in view of Bebb and Anneaux with the teachings of To in order to create a stent with a coating that promotes regrowth of tissue for faster recovery of the patient.
Claims 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, Anneaux et al. (US 2011/0031656 A1), “Anneaux”, and Hanson (US Pat. No. 8721711 B2), “Hanson” and further in view of Sanders (US Pat. No. 7947069 B2), “Sanders”.
Regarding claim 10, Lenker fails to teach the limitations of claim 10. Bebb teaches an inner layer (Fig. 2D, inner graft 21) and an outer layer (Fig. 2D, outer graft 20), but fails to disclose the average pore size of the layers each range from 1 micron to 12 microns. Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb and Anneaux and Hanson fails to teach that average pore size of the layers each range from 1 micron to 12 microns.
Sanders discloses a fibrous medical device teaches an average pore size that ranges from 1 micron to 12 microns (Fig. 6, pores 32 range from 10 micrometers to 120 micrometers (col. 5, lines 8-11). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the graft layers taught by Lenker in view of Bebb to range in pore size from 1 to 12 microns in order to promote biocompatibility.
Regarding claim 11, Lenker fails to teach the limitations of claim 11. Bebb teaches an inner layer (Fig. 2D, inner graft 21) and an outer layer (Fig. 2D, outer graft 20). Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb and Anneaux and Hanson fails to teach wherein a thickness of the inner and outer layers each range from 20 micrometers to 100 micrometers.
Sanders teaches a thickness of a layer ranges from 20 micrometers to 100 micrometers (Figs. 7A-C, thickness of layer 20 is not less than 5 micrometers (col. 5, lines 27-29)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the thickness of the device taught by Lenker in view of Bebb’s layers to range from 20 to 100 micrometers in order to promote biocompatibility of the device.
Regarding claim 12, Lenker fails to teach the limitations of claim 12. Bebb teaches the inner layer (Fig. 2D, inner graft 21) and the outer layer (Fig. 2D, outer graft 20). Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb and Anneaux and Hanson fails to teach that the layers comprise a plurality of fibers, and wherein an average diameter of the plurality of fibers ranges from 50 nanometers to 3 micrometers.
Sanders teaches layers that comprise a plurality of fibers (Fig. 6, fibers 22), and wherein an average diameter of the plurality of fibers ranges from 50 nanometers to 3 micrometers (Fig. 6, fibers 22 have a maximum diameter of at least 5 microns col. 2, lines 1-5)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the layers taught by Lenker in view of Bebb to include fibers ranging from 50 nanometers to 3 micrometers in order to promote permeability and biocompatibility.
Regarding claim 14, Lenker fails to teach the limitations of claim 14. Bebb teaches an inner layer (Fig. 2D, inner graft 21) and an outer layer (Fig. 2D, outer graft 20). Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb and Anneaux and Hanson fails to teach an average fibrous capsule thickness of less than 35 micrometers.
Sanders teaches an average fibrous capsule thickness of less than 35 micrometers (Figs. 11-13, capsule thickness averages less than 35 micrometers when comprising various materials (col. 11, lines 10-19)). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the layers taught by Lenker in view of Babb to include fibers with an average capsule thickness of less than 35 micrometers in order to promote biocompatibility.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, Anneaux et al. (US 2011/0031656 A1), “Anneaux”, and Hanson (US Pat. No. 8721711 B2), “Hanson” and further in view of Dubson et al. (US 2005/0137675 A1), “Dubson”.
Regarding claim 13, Lenker fails to teach the limitations of claim 13. Bebb teaches the inner layer (Fig. 2D, inner graft 21) and the outer layer (Fig. 2D, outer graft 20). Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. Lenker in view of Bebb fails to teach that the layers are each configured to allow an average cell penetration depth of greater than 98% of a thickness of the layer. However, Lenker in view of Bebb and Anneaux and Hanson fail to teach that the layers are each configured to allow an average cell penetration depth of greater than 98% of a thickness of the layer.
Dubson teaches a vascular prosthesis comprising layers that are each configured to allow an average cell penetration depth of greater than 98% of a thickness of the layer (vascular prosthesis disclosed includes features of tissue ingrowth and cell endothelization over at least 90% [0114]). Dubson discloses that cell endothelization promotes long term healing of the prosthesis [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft layers taught by Lenker to comprise the cell penetration capabilities taught by Dubson in order to promote a fast and long-term healing process.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, Anneaux et al. (US 2011/0031656 A1), “Anneaux”, and Hanson (US Pat. No. 8721711 B2), “Hanson” and further in view of Gertner (US 2006/0015138 A1), “Gertner”.
Regarding claim 15, Lenker fails to teach the limitations of claim 15. Bebb teaches an inner layer (Fig. 2D, inner graft 21), and an outer layer (Fig. 2D, outer graft 20). Bebb discloses that PTFE is extremely biocompatible and causes little to no immunogenic reaction when implanted [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the frame of stent taught by Lenker with the graft layers taught by Bebb to promote biocompatibility of the device. However, Lenker in view of Bebb and Anneaux and Hanson fails to teach a cover that is configured to filter blood, wherein the inner layer and the outer layer are configured to permit transmural migration of blood plasma and to prevent transmural migration of red blood cells.
Gertner teaches a filtering medical device that teaches a cover (Fig. 1B, filtering device 100) that is configured to filter blood (Fig. 1B, device 100 allows passage of fluid (i.e., blood) [0099]), wherein the inner layer (Fig. 1B, first surface 110) and the outer layer (Fig. 1B, second surface 112) are configured to permit transmural migration of blood plasma and to prevent transmural migration of red blood cells (Fig. 1B, filtering device 100 can retain or divert emboli and comprises pores sized to allow a certain blood product (i.e., plasma or red blood cells) [0077]).
Gertner discloses that the filtering device is able to be part of a stent [0027]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Lenker in view of Bebb with the teachings of Gertner in order to provide a filtering layer of the device that would divert emboli from the lumen of the vessel and prevent blockages.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, Anneaux et al. (US 2011/0031656 A1), “Anneaux”, Hanson (US Pat. No. 8721711 B2), “Hanson” and Gertner (US 2006/0015138 A1), “Gertner” and further in view of Dubson et al. (US 2005/0137675 A1), “Dubson”.
Regarding claim 16, Lenker in view of Bebb, Anneaux, Hanson and Gertner fails to teach wherein a middle layer is configured to prevent transmural migration of cells, and wherein the middle layer is configured to prevent restenosis of a vessel.
Dubson teaches a vascular prosthesis comprising a middle layer that is configured to prevent transmural migration of cells (Fig. 1d, adhesion sublayers 18 are impervious [0105]), and wherein the middle layer is configured to prevent restenosis of a vessel (Fig. 1d, first layer 12 ensures antithrombogenic properties and efficient endothelization [0097]). Dubson discloses that cell endothelization promotes long term healing of the prosthesis [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft layers taught by Lenker with the middle layer taught by Dubson in order to promote a fast and long-term healing process.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Bebb et al. (US 2009/0030499 A1), “Bebb”, Anneaux et al. (US 2011/0031656 A1), “Anneaux”, Hanson (US Pat. No. 8721711 B2), “Hanson” and Gertner (US 2006/0015138 A1), “Gertner”, Eller et al. (WO 2012/103501 A1), “Eller”, and further in view of Holloway et al. (US 2003/0114917 A1), “Holloway”.
Regarding claim 17, Lenker in view of Bebb, Anneaux, Hanson and Gertner fails to teach wherein the middle layer is configured to prevent transmural fluid migration, and wherein the middle layer is configured to contain a fluid within the stent.
Dubson teaches a vascular prosthesis wherein the middle layer is configured to prevent transmural fluid migration (Fig. 1d, adhesion sublayers 18 are impervious [0105]). Dubson discloses that the adhesion sublayers serve to adhere the various layers of the prosthesis to one another [0105]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the graft taught by Lenker with the middle layer taught by Dubson in order to promote a fast and long-term healing process. However, Lenker in view of Bebb, Anneaux, Gertner, and Dubson fails to teach that the middle layer is configured to contain a fluid within the stent.
Holloway teaches a layered stent-graft that teaches layers (Fig. 3, outer and sub layers 12, 30, 34, 36) that are configured to contain a fluid within the stent (Fig. 3, substances can be contained within outer layer 12 and outer layer 12 is made from any sub layer 30, 34, 36 with varying porosities [0034]). Holloway discloses that a plurality of sub layers having different porosities is useful when encouraging cell ingrowth [0034]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the teachings of Webb in view of Bebb and ___ with the teachings of Holloway in order to create a stent having a middle layer containing a fluid in order to promote cell ingrowth.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Lenker et. al (US Pat. No. 6176875 B1), “Lenker” in view of Gomez et al. (US Pat. No. 6656220 B1), “Gomez” and Chin et al. (US 2011/0224715 A1), “Chin”, and further in view of Nagl et al. (US 2012/0191176 A1), “Nagl”.
Regarding claim 23, Lenker teaches wherein the midbody (Fig. 5, middle portion of stent graft 90 (i.e., non-flared section)) comprises a first apex to apex length (Fig. 11A, independent ring frames 72 supporting a conventional liner 162 comprise and apex length), wherein the flare zones (Fig. 5, end portions of stent graft 90 are flared) comprises a second apex to apex length (Fig. 11A, axial end 164 of conventional liner 162 attaches a braided cuff 168 comprising apex lengths), but Lenker in view of Gomez fails to teach wherein the first apex to apex length is less than the second apex to apex length, and wherein a resistance to radial compression of the midbody is greater than a resistance to radial compression of the flare zone.
Chin teaches a vascular filter device wherein the first apex to apex length is less than the second apex to apex length (Figs. 3A-B, lengths of apexes of malleable portion 205 are shorter than lengths of apexes of tubular portions 202, 202’). Chin discloses that the device is self-expanding [0011]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the apex lengths taught by Lenker to reflect the apex lengths taught by Chin in order to simplify device placement. However, Lenker in view of Gomez and Chin fails to teach wherein a resistance to radial compression of the midbody is greater than a resistance to radial compression of the flare zone.
Nagl teaches a medical implant wherein a resistance to radial compression of the midbody is greater than a resistance to radial compression of the flare zone (Fig. 11, radial force in edge areas 20, 21 are less than the radial force in the central area of mesh structure 12 [0072]]). Nagl discloses that the radial forces of the mesh can be adjusted depending on their use which reduces the risk of side effects such as stenosis [0072]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent midbody taught by Lenker in view of Gomez and Chin to reflect the radial resistance features taught by Nagl in order to prevent further injury.
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.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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