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 Amendment
The Amendment filed 06/10/2026 has been entered. Claims 1, 3-9, 11-17, and 19-20 remain pending in the application. Claims 2, 10, and 18 have been cancelled.
Response to Arguments
Applicant’s arguments, see pgs. 6-12, filed 06/10/2026, with respect to the rejection of claim 1, 3-5, 7, and 17 under 35 U.S.C. 102 (a)(1) and rejections of claims 2, 6, 8-10, 11-16, 18-20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn and new grounds of rejection have been set forth below.
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.
Claims 1, 7-9, 13-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller et al. (US 20160135941 A1), in view of Aguirre et al. (US 20110118765 A1) and Peredo et al. (US 20020173843 A1).
Regarding claim 1, Binmoeller discloses an implantable stent (100; ¶ 0025), comprising: an elongate body extending from a distal region to a proximal region (see fig. 2b), the elongate body including one or more filaments that are woven together to form the elongate body (¶ 0036), the elongate body defining an outer stent surface and an inner stent surface (¶ 0003 discloses lumen stents, i.e. an elongate body defining an outer stent surface and inner stent surface), and wherein the distal region or the proximal region includes a flared end, the inner stent surface extending into the flared end (fig. 3 illustrates a stent with a distal flared end). Binmoeller fails to disclose one or more visual indicators positioned relative to the inner stent surface such that the one or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent; wherein the distal region or the proximal region includes a flared end, the inner stent surface extending into the flared end, and the one or more visual indicators are positioned relative to the inner stent surface within the flared end.
Aguirre also discloses an implantable stent (100). Aguirre teaches that a plurality of visual indicators/markers can be placed on the stent where visualization is desired (¶ 0024, e.g., one or more visual indicators positioned relative to the inner stent surface), and further that the one or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent (¶ 0024 discloses markers with endoscopically visual colors).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller to include that to one or more visual indicators positioned relative to the inner stent surface such that the one or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent, as taught by Aguirre, in order to allow a physician to understand the orientation of the stent or a location on the stent (¶ 0024). Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller to include the one or more visual indicators positioned relative to the inner stent surface within the flared end as the visual indicators/markers of Aguirre may be placed on the stent where visualization is desired such as the flared end (¶ 0024).
Binmoeller in view of Aguirre fails to disclose that the one or more visual indicators include two or more visual indicators with at least two visual indicators being different visible colors. Peredo also discloses an implantable device (160) having visual indicators. Peredo teaches two or more visual indicators with at least two visual indicators being different visible colors (¶ 0052 discloses markers with different colors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre to include that the one or more visual indicators include two or more visual indicators with at least two visual indicators being different visible colors, as taught by Peredo, in order to visually distinguish markers from one another (Peredo - ¶ 0052) thereby allowing a physician to distinguish different portions of the stent.
Regarding claim 7, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 1. Aguirre further discloses that at least one of the two or more visual indicators comprise a radiopaque material (¶ 0052).
Regarding claim 8, Binmoeller discloses an implantable medical device (100) adapted to be deployed endoscopically (¶ 0005/¶ 0021), the implantable medical device comprising: an elongate body extending from a distal region to a proximal region (see fig. 3), at least one of the distal region and the proximal region including a flared region defining an inner flared surface (fig. 3 illustrates a stent with a distal flared end). Binmoeller fails to disclose that two or more visual indicators are secured relative to the inner flared surface, each of the two or more visual indicators positioned to be visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable medical device and in direct line of sight of the stent; wherein each of the two or more visual indicators comprise a color different from a color of any other of the two or more visual indicators.
Aguirre also teaches an implantable medical device (100). Aguirre teaches that a plurality of visual indicators/markers can be placed on the stent where visualization is desired (¶ 0024, e.g., two or more visual indicators positioned relative to the inner stent surface), and further that the two or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent (¶ 0024 discloses markers with endoscopically visual colors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller to include that to one or more visual indicators positioned relative to the inner stent surface such that the one or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent, as taught by Aguirre, in order to allow a physician to understand the orientation of the stent or a location on the stent (¶ 0024). Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller to include the one or more visual indicators positioned relative to the inner flared surface as the visual indicators/markers of Aguirre may be placed on the stent where visualization is desired such as the flared end (¶ 0024).
Binmoeller in view of Aguirre fails to disclose that each of the two or more visual indicators comprise a color different from a color of any other of the two or more visual indicators. Peredo also discloses an implantable medical device (160) having visual indicators. Peredo teaches two or more visual indicators include two or more visual indicators with at least two visual indicators being different visible colors (¶ 0052 discloses markers with different colors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre to include that that each of the two or more visual indicators comprise a color different from a color of any other of the two or more visual indicators, as taught by Peredo, in order to visually distinguish markers from one another (Peredo - ¶ 0052) thereby allowing a physician to distinguish different portions of the stent.
Regarding claim 9, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 8. Peredo further discloses that each of the two or more visual indicators are visually distinguishable from others of the two or more visual indicators (Peredo - ¶ 0052).
Regarding claim 13, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 8. Aguirre further discloses that at least some of the two or more visual indicators comprise objects that are secured relative to the inner stent surface as Aguirre discloses that endoscopically visual colors may be used in stent (¶ 0024).
Regarding claim 14, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 8. Binmoeller further discloses an implantable medical device comprising a polymeric coating over at least part of the elongate body (¶ 0041).
Regarding claim 16, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 8. Aguirre further discloses that at least one of the two or more visual indicators comprise a radiopaque material (¶ 0052).
Claims 3-5, 11-12, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller et al. (US 20160135941 A1), in view of Aguirre et al. (US 20110118765 A1), Peredo et al. (US 20020173843 A1), and Chau (US 9980818 B2).
Regarding claim 3, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 1. Aguirre discloses that markers can be placed on stent where visualization is desired (¶ 0024, e.g., the inner surface flared ends of a stent), and Peredo discloses visual indicators in which each of the two or more visual indicators are visually distinguishable from the other position indicators (¶ 0052). Binmoeller in view of Aguirre and Peredo fails to disclose that the two or more visual indicators are circumferentially equidistantly spaced apart.
Chau also discloses an implantable stent (fig. 25b). Chau teaches that two or more visual indicators are circumferentially equidistantly spaced apart (see 190 in fig. 25b; also see col. 23 lines 1-3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre and Peredo to arrange the visual indicators circumferentially equidistantly spaced apart, as taught by Chau, in order to provide a physician reference markings to ensure the proper orientation of a stent (col. 23 lines 8-10), especially since these markings can comprise a color different from the rest of a stent, i.e. visually distinguishable indicators/markers (Chau - col. 23 lines 10-12).
Regarding claim 4, Binmoeller in view of Aguirre, Peredo, and Chau discloses the invention as claimed as discussed with respect to claim 3. Aguirre further discloses that at least some of the two or more visual indicators comprise objects that are placed/secured relative to the inner stent surface as Aguirre discloses that endoscopically visual colors may be used in stent (¶ 0024).
Regarding claim 5, Binmoeller in view of Aguirre, Peredo, and Chau discloses the invention as claimed as discussed with respect to claim 3. Binmoeller further discloses that the stent comprises a polymeric coating over at least part of the elongate body (¶ 0041).
Regarding claim 11, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 8. Aguirre discloses that markers can be placed on stent where visualization is desired (¶ 0024), e.g. the inner surface flared ends of a stent. Binmoeller in view of Aguirre and Peredo fails to disclose an implantable medical device comprising three visual indicators that are equidistantly spaced.
Chau also discloses an implantable medical device (fig. 25b). Chau teaches three visual indicators that are equidistantly spaced apart on the inner flared surface (see fig. 25b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre and Peredo to arrange the visual indicators circumferentially equidistantly spaced apart, as taught by Chau, in order to provide a physician reference markings to ensure the proper orientation of a stent (col. 23 lines 8-10), especially since these markings can comprise a color different from the rest of a stent, i.e. visually distinguishable indicators/markers (Chau - col. 23 lines 10-12).
Regarding claim 12, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 8. Aguirre discloses that markers can be placed on stent where visualization is desired (¶ 0024), e.g. the inner surface flared ends of a stent. Binmoeller in view of Aguirre and Peredo fails to disclose an implantable medical device comprising four visual indicators that are equidistantly spaced.
Chau also discloses an implantable medical device (fig. 25a). Chau teaches three visual indicators that are equidistantly spaced apart on the inner flared surface (see fig. 25a). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre and Peredo to arrange the visual indicators circumferentially equidistantly spaced apart, as taught by Chau, in order to provide a physician reference markings to ensure the proper orientation of a stent (col. 23 lines 8-10), especially since these markings can comprise a color different from the rest of a stent, i.e. visually distinguishable indicators/markers (Chau - col. 23 lines 10-12).
Regarding claim 17, Binmoeller discloses an implantable stent (100; ¶ 0025), comprising: an elongate body extending from a distal region to a proximal region (see fig. 2b), the elongate body including one or more filaments that are woven together to form the elongate body (¶ 0036), the elongate body moveable between a collapsed configuration for delivery and an expanded configuration for deployment (¶ 0043), the elongate body including a constant diameter main segment and a flared end segment (see fig. 3), the flared end segment including an inner flared surface and an outer flared surface (¶ 0003 discloses lumen stents, i.e. an elongate body defining an outer stent surface and inner stent surface; see fig. 3). Binmoeller fails to disclose a plurality of visual indicators that are secured relative to the inner flared surface such that each of the plurality of visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent.
Aguirre also discloses an implantable stent (100). Aguirre teaches that a plurality of visual indicators/markers can be placed/secured on stent where visualization is desired (¶ 0024, e.g., one or more visual indicators positioned relative to the inner stent surface), and further that the one or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent (¶ 0024 discloses markers with endoscopically visual colors); and the one or more visual indicators are positioned relative to the inner stent surface within the flared end as the visual indicators/markers of Aguirre may be placed on the stent where visualization is desired such as the flared end (¶ 0024). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller to include that to one or more visual indicators positioned relative to the inner stent surface such that the one or more visual indicators are visible by an endoscopic visualization tool of an endoscope with the visualization tool positioned within or proximate the implantable stent and in direct line of sight of the stent, as taught by Aguirre, in order to allow a physician to understand the orientation of the stent or a location on the stent (¶ 0024). Further, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller to include the one or more visual indicators positioned relative to the inner flared surface as the visual indicators/markers of Aguirre may be placed on the stent where visualization is desired such as the flared end (¶ 0024).
Binmoeller in view of Aguirre fails to disclose that the plurality of visual indicators comprises three visual indicators that are equidistantly spaced apart on the inner stent surface. Chau also discloses an implantable medical device (fig. 25b). Chau teaches three visual indicators that are equidistantly spaced apart on the inner flared surface (see fig. 25b). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre and Peredo to arrange the visual indicators circumferentially equidistantly spaced apart, as taught by Chau, in order to provide a physician reference markings to ensure the proper orientation of a stent (col. 23 lines 8-10), especially since these markings can comprise a color different from the rest of a stent, i.e. visually distinguishable indicators/markers (Chau - col. 23 lines 10-12).
Binmoeller in view of Aguirre and Chau fails to disclose that each of the three visual indicators has a unique color relative to the other two visual indicators. Peredo also discloses an implantable medical device (160). Peredo teaches a plurality, e.g. two visual indicators having a unique color relative to another visual indicator (¶ 0052 discloses markers with different colors). Although Peredo does not teach three visual indicators each having a unique color relative to the other two visual indicators it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre to include three or more visual indicators comprise a color different from a color of any other of the two or more visual indicators, as Peredo teaches that each color corresponds to a position on the medical device, i.e. the more positions a physician/surgeon wishes to denote on a medical device, the more visually distinguishable indicators that will be necessary to visually distinguish different portions of a medical device/stent (Peredo - ¶ 0052).
Regarding claim 19, Binmoeller in view of Aguirre, Chau, and Peredo discloses the invention as claimed as discussed with respect to claim 17. Peredo teaches a plurality, e.g. two visual indicators having a unique color relative to another visual indicator (¶ 0052 discloses markers with different colors). As previously discussed, although Peredo does not teach three visual indicators each having a unique color relative to the other two visual indicators it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable stent of Binmoeller in view of Aguirre to include four visual indicators that are equidistantly spaced apart on the inner stent surface, each of the four visual indicators has a unique color relative to the other three visual indicators, as Peredo teaches that each color corresponds to a position on the medical device, i.e. the more positions a physician/surgeon wishes to denote on a medical device, the more visually distinguishable indicators that will be necessary to visually distinguish different portions of a medical device/stent (Peredo - ¶ 0052).
Claims 6, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller et al. (US 20160135941 A1), in view of Aguirre et al. (US 20110118765 A1), Peredo et al. (US 20020173843 A1), and Chau (US 9980818 B2), as applied to claim 5, 8, and 17 above, in further view of Hossainy (US 20150305943 A1).
Regarding claim 6, Binmoeller in view of Aguirre, Peredo, and Chau discloses the invention as claimed as discussed with respect to claim 5. Binmoeller in view of Aguirre, Peredo, and Chau fails to disclose that at least some of the two or more visual indicators comprise color changes introduced into the polymeric coating.
Hossainy also teaches an implantable stent (10). Hossainy further teaches wherein at least some of the two or more visual indicators (figure 6, 106) comprise color changes introduced into the polymeric coating (paragraph 0077 and figure 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the visual indicators of Binmoeller, in view of Binmoeller, Aguirre, Peredo, and Chau, to provide two or more visual indicators comprising color changes introduced into the polymeric coating as taught by Hossainy in order to indicate to a physician the position of a stent (Hossainy ¶ 0075).
Regarding claim 15, Binmoeller in view of Aguirre and Peredo discloses the invention as claimed as discussed with respect to claim 14. Binmoeller in view of Aguirre, Peredo, and Chau fails to disclose that at least some of the two or more visual indicators comprise color changes introduced into the polymeric coating.
Hossainy also teaches an implantable medical device (10). Hossainy further teaches wherein at least some of the two or more visual indicators (figure 6, 106) comprise color changes introduced into the polymeric coating (paragraph 0077 and figure 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the visual indicators of Binmoeller, in view of Binmoeller, Aguirre, Peredo, and Chau, to provide two or more visual indicators comprising color changes introduced into the polymeric coating, as taught by Hossainy, in order to indicate to a physician, the position of a stent (Hossainy ¶ 0075).
Regarding claim 20, Binmoeller in view of Aguirre, Chau, and Peredo discloses the invention as claimed as discussed with respect to claim 17. Binmoeller further discloses a stent comprising a polymeric coating over at least part of the elongate body (¶ 0041). Binmoeller in view of Aguirre, Chau, and Peredo fails to disclose that at least some of the plurality of visual indicators comprise a pigment added to a portion of a polymeric coating disposed over the elongate body.
Hossainy also teaches an implantable medical device (10). Hossainy further teaches wherein at least some of the two or more visual indicators (figure 6, 106) comprise color changes introduced into a polymeric coating (paragraph 0077 and figure 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the visual indicators of Binmoeller, in view of Binmoeller, Aguirre, Peredo, and Chau, to provide that at least some of the plurality of visual indicators comprise a pigment added to a portion the polymeric coating of Binmoeller, as taught by Hossainy, in order to indicate to a physician the position of a stent (Hossainy ¶ 0075).
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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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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