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 Objections
Claims 2-10, 12-15, and 17-20 are objected to because of the following informalities: There appears to be a repeated typographical error regarding claim dependencies.
For example, claim 2 reads “The stent of claim 16” in line 1. This line should instead read “The stent of claim 1”.
Appropriate correction of claims 2-10, 12-15, and 17-20 is required. For examining purposes, the examiner will examine “claim 16” as claim 1, “claim 17” as claim 2, “claim 18” as claim 3, “claim 26” as claim 11, and “claim 31” as claim 16.
Claim 20 is objected to because of the following informality: There appears to be a typographical error in the phrase “wherein the first retention member, the second retention member, the first retention member, or the fourth retention member” in lines 1-2. These lines should instead read “wherein the first retention member, the second retention member, the third retention member, or the fourth retention member”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eller (US 20220023026 A1), herein referred to as Eller.
Regarding claim 1, Eller discloses a stent (100), comprising: an elongate body (fig. 1b illustrates an elongate body 102) configured to expand between a first constrained configuration and a second unconstrained configuration, the elongate body in the second unconstrained configuration including a first end (110), a second end (112), and a cylindrical saddle region extending therebetween (104), wherein: the first end (110) comprises a first retention member (122a) and a second retention member (120a), and the second end (112) comprises a third retention member (120b) and a fourth retention member (122b).
The limitation “…configured to expand between a first constrained configuration and a second unconstrained configuration…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements. Eller discloses an unelongated and unstretched state in Fig. 1A-B [0021] and loading the stent into a catheter by radial compression at [0044]. Therefore, the stent is considered capable of expanding between a first constrained configuration and a second unconstrained configuration.
Regarding claim 2, Eller discloses the invention as claimed as discussed above with respect to claim 1. Eller further discloses that the second retention member (120a) comprises a substantially cylindrical first radially outward surface, the third retention (120b) member comprises a substantially cylindrical second radially outward surface, or both (fig. 1b illustrates a second 120a and third retention 120b member with a radially outward surface).
Regarding claim 3, Eller discloses the invention as claimed as discussed above with respect to claim 2. Eller further discloses that the second retention member (120a) comprises a first axially inner face joined to the first radially outward surface at a first corner (fig. 1b illustrates a first axially inner face 124a joined to a first radially outward surface 128a at a first corner/peak 126a), wherein the third retention member comprises a second axially inner face joined to the second radially outward surface at a second corner, or both (fig. 1b illustrates a first axially inner face 124b joined to a first radially outward surface 128b at a first corner/peak 126b).
Regarding claim 4, Eller discloses the invention as claimed as discussed above with respect to claim 3. Eller further discloses that the first axially inner face comprises a curved profile, wherein the second axially inner face comprises a curved profile, or both (fig. 1b discloses both a first axially inner face 124a and a second axially inner face 124b with curved profiles).
Regarding claim 6, Eller discloses the invention as claimed as discussed above with respect to claim 1. Eller discloses a first (122a) and fourth (122b) retention member. However, the limitation “…configured to interface with tissue along an entire first longitudinal length thereof…” and “… configured to interface with tissue along an entire second longitudinal length thereof…” are functional limitations that are not given full patentable weight. The prior art is not required to explicitly disclose these functions, but merely have the capability of performing in the recited manner in order to meet the claim requirements. Since it is widely known in the art that the structure of bodily lumens differs widely due to different locations in the body and specific patient anatomy, the retention members are considered to be capable of engaging, or contacting, tissue along any portion of the outer surface.
Regarding claim 8, Eller discloses the invention as claimed as discussed above with respect to claim 1. Eller discloses a first (122a), second (120a), third (120b), and fourth retention member (122b). However, the limitation “…retention members configured to atraumatically interface with tissue about a radially outwardmost circumference of the respective retention member…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements. It is widely known the structure of stent retention members differ widely due to a variety retention member surfaces, contours, and shapes utilized to prevent tissue damage at the implantation site, and that structure of bodily lumens differ widely due to different locations in the body and specific patient anatomy. Therefore, the retention members are considered to be capable of engaging, or contacting tissue atraumatically about a radially outwardmost circumference of the respective retention members.
Regarding claim 9, Eller discloses the invention as claimed as discussed above with respect to claim 1. Eller further discloses that the stent is formed from at least one braided or woven filament comprising a different pitch density, angle, or pattern at the first retention member, the second retention member, the cylindrical saddle region, the third retention member, or the fourth retention member, or any combination thereof, in the second configuration (paragraphs 0028-0031 disclose a stent 100 elongated body 102 may comprise braided or woven wire arranged in a particular braid pattern having a pitch (axial distance between crossing strands) and a braid angle that can be constant over a given region of the body and also vary over other regions). Figures 1A and 1B clearly illustrates the braid angle and pitch being different in the retention members (126) than that in the saddle region (104).
Claims 1-3, 5-8, 11 and 12are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Folan (US 20200170776 A1), herein referred to as Folan.
Regarding claim 1, Folan discloses a stent (300), comprising: an elongate body (fig. 7b illustrates an elongate tubular body) configured to expand between a first constrained configuration and a second unconstrained configuration (paragraph 0055 discloses an expandable stent), the elongate body in the second unconstrained configuration including a first end (312), a second end (314), and a cylindrical saddle region (316) extending therebetween (fig. 7b), wherein: the first end (312) comprises a first retention member (320) and a second retention member (340), and the second (314) end comprises a third retention member (345) and a fourth retention member (322).
Regarding claim 2, Folan discloses the invention as claimed as discussed above with respect to claim 1. Folan further discloses that the second retention member (340) comprises a substantially cylindrical first radially outward surface, the third retention member (345) comprises a substantially cylindrical second radially outward surface, or both (paragraph 0051 discloses a second and third retention member with cylindrical outward surfaces).
Regarding claim 3, Folan discloses the invention as claimed as discussed above with respect to claim 2. Folan further discloses that the second retention member comprises a first axially inner face joined to the first radially outward surface at a first corner (see annotated fig. 7b), wherein the third retention member comprises a second axially inner face joined to the second radially outward surface at a second corner (see annotated fig. 7b), or both (fig. 7b illustrates retention members 340/345 with an inner face joined to a radially outward surface at a corner).
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Regarding claim 5, Folan discloses the invention as claimed as discussed above with respect to claim 3. Folan further discloses that the first corner comprises an interior angle of 90 degrees or less, wherein the second corner comprises an interior angle of 90 degrees or less, or both (paragraph 0051 discloses and annotated fig. 7b below illustrates retention members 320, 340, 345, and 322 perpendicular to a longitudinal axis).
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Regarding claim 6, Folan discloses the invention as claimed as discussed above with respect to claim 1. Folan discloses a first (320) and fourth (322) retention member. However, the limitation “…configured to interface with tissue along an entire first longitudinal length thereof…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements. Since it is widely known in the art that the structure of bodily lumens differs widely due to different locations in the body and specific patient anatomy, the retention members are considered to be capable of engaging, or contacting, tissue along any portion of the outer surface.
Regarding claim 7, Folan discloses the invention as claimed as discussed above with respect to claim 1. Folan further discloses that the first end (312) comprises a first cylindrical portion (311) extending between the first retention member (320) and the second retention member (340), wherein the second end (314) comprises a second cylindrical portion (313) extending between the third retention member (345) and the fourth retention member (322), or both (fig. 7b illustrates a cylindrical portion 311/313 between both pairs of retention members at each end).
Regarding claim 8, Folan discloses the invention as claimed as discussed above with respect to claim 1. Folan discloses a first (320), second (340), third (345), and fourth retention member (322). However, the limitation “…retention members configured to atraumatically interface with tissue about a radially outwardmost circumference of the respective retention member…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements. It is widely known in the art that the structure of retention members differs widely due to a variety retention member surfaces, contours, and shapes, and that structures of bodily lumens differ widely due to different locations in the body and specific patient anatomy, Therefore, the retention members are considered to be capable of engaging, or contacting tissue atraumatically about a radially outwardmost circumference of the respective retention members.
Regarding claim 11, Folan discloses a medical device (300), comprising: an elongate body defining a lumen extending therethrough (fig. 7b illustrates an elongate tubular body), the elongate body configured to transition between a first configuration and a second configuration (paragraph 0055 discloses an expandable stent); wherein, in the second configuration, the elongate body comprises at least four retention features (fig. 7b illustrates an elongate body with at least four retention members 320, 322, 340, and 345), the at least four retention features comprising at least second and third retention members each comprising an interior angle of 90 angles or less (fig. 7b annotated above), and wherein, in the second configuration, the elongate body comprises a cylindrical region extending between the second and third retention members (fig. 7b illustrates a cylindrical region 330 extending between the second 340 and third 345 retention members), between the first and second retention members (fig. 7b illustrates cylindrical region 311 extending between the first 320 and second 340 retention members) or between the third and fourth retention members (fig. 7b illustrates cylindrical region 313 extending between the third 345 and fourth 322 retention members), or any combination thereof.
However, the limitation “…configured to interface with tissue, and wherein at least the first and fourth retention members are configured to atraumatically interface with tissue…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements. Since it is widely known the structure of stent retention members differ widely due to a variety retention member surfaces, contours, and shapes utilized to prevent tissue damage at the implantation site, the retention members are considered to be capable of engaging, or contacting tissue atraumatically.
Regarding claim 12, Folan discloses the invention as claimed as discussed above with respect to claim 11. Folan discloses a first (320), second (340), third (345), and fourth retention member (322). However, the limitation “… retention members are each configured to atraumatically interface with tissue about a radially outwardmost circumference of the respective retention member…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements. It is widely known the structure of retention members differs widely due to a variety retention member surfaces, contours, and shapes, and that the structures of bodily lumens differ widely due to different locations in the body and specific patient anatomy. Therefore, the retention members are considered to be capable of engaging, or contacting, tissue along any portion of the outer surface.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Eller (US 20220023026 A1), herein referred to as Eller.
Regarding claim 10, Eller discloses the invention as claimed as discussed above with respect to claim 1. Eller teaches an alternate embodiment (200) wherein the elongate body comprises at least a partial cover (Fig. 3 illustrates an elongate body 200 comprising a partial cover 250. Paragraph 0043 also teaches that parts of the stent 200 may be partially uncovered).
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 stent (100) of Eller to include an elongate body comprising at least a partial cover as taught by an alternate embodiment (200) in order to facilitate the passage of particles or fluid through the interior and at the same time having uncovered portions to secure the stent and allow for tissue ingrowth (Eller Paragraphs 0042-0043).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Folan et al. (US 20200170776 A1), in view of Eller et al. (US 20220023026 A1), herein referred to as Eller.
Regarding claim 13, Folan discloses the invention as claimed as discussed above with respect to claim 11. Folan fails to disclose that the first retention member comprises an asymmetrical cross section in an orthogonal plane to a longitudinal axis extending through the lumen of the body, the second retention member comprises an asymmetrical cross section in an orthogonal plane to the longitudinal axis, or both.
Eller also discloses a medical device (100), comprising: an elongate body (fig. 1b illustrates an elongate body 102) defining a lumen extending therethrough (paragraph 0037 discloses a hollow cylindrical body/lumen 102). Eller further discloses that the elongate body (102) comprises at least four retention features (fig. 1b), the at least four retention features (120a, 120b, 122a, and 122b) comprising at least second and third retention members each comprising a shoulder (fig. 1b illustrates at least four retention features comprising at least a second 120a and third 120b retention members each comprising a shoulder 124a/124b). Eller further discloses that the elongate body (102) comprises a cylindrical region extending between the second and third retention members (fig. 1a illustrates a cylindrical region 104 extending between the second 120a and third 120b retention members). Eller teaches that the first retention member (122a) comprises an asymmetrical cross section in an orthogonal plane to a longitudinal axis extending through the lumen of the body (fig. 1b annotated below), the second (120a) retention member comprises an asymmetrical cross section in an orthogonal plane to the longitudinal axis (fig. 1b annotated below), or both (fig. 1b illustrates and paragraph 0037 discloses retention members with asymmetric profiles in an orthogonal plane to a longitudinal axis 140 ).
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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 stent of Folan to include a first and second retention member comprising asymmetrical cross sections in an orthogonal plane to a longitudinal axis extending through the lumen of the body as taught by Eller in order to facilitate greater retention of the stent in the body lumen (Eller paragraph 0037).
Regarding claim 14, Folan discloses the invention as claimed as discussed above with respect to claim 11. Folan fails to disclose that the elongate body is formed from at least one braided or woven filament comprising a different pitch density, angle, or pattern at the first retention member, the second retention member, the cylindrical saddle region, the third retention member, or the fourth retention member, or any combination thereof, in the second configuration.
Eller further teaches that the elongate body (102) is formed from at least one braided or woven filament comprising a different pitch density, angle, or pattern at the first retention member (122a), the second retention member (120a), the cylindrical saddle region (104), the third retention member (120b), or the fourth retention member (122b), or any combination thereof, in the second configuration (paragraphs 0028-0031 disclose a stent 100 elongated body 102 may comprise braided or woven wire arranged in a particular braid pattern having a pitch (axial distance between crossing strands) and a braid angle that can be constant over a given region of the body and also vary over other regions).
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 stent of Folan to include a stent formed from at least one braided or woven filament comprising a different pitch density, angle, or pattern at the first retention member, the second retention member, the cylindrical saddle region, the third retention member, or the fourth retention member, or any combination thereof, in the second configuration, as taught by Eller, in order to provide certain shape and strength characteristics (Eller paragraph 0028).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Folan (US 20200170776 A1), herein referred to as Folan.
Regarding claim 15, Folan discloses the invention as claimed as discussed above with respect to claim 11. Folan further discloses an alternate embodiment (400) where the elongate body comprises at least a partial cover (0022 discloses and fig. 8 illustrates a stent 400 comprising a covering 450 on its surface).
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 stent (300) of Folan to include an elongate body comprising at least a partial cover, as taught by an alternate embodiment (400), in order to prevent tissue in-growth and fluid leakage into the inter-vessel cavity (paragraph 0059).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eller et al. (US 20220023026 A1) in view of Rafiee et al. (US 20090192601 A1), herein referred to as Rafiee.
Regarding claim 16, as discussed above with reference claim 1, Eller discloses a stent having all the claimed features. While Eller generically discloses the stent is loaded on a catheter in a narrowed, or compressed state [0044], Eller fails to disclose structural features of the catheter.
Rafiee discloses a delivery catheter (fig. 6) for a stent comprising an inner member (114), and an outer sheath (126) slidably disposed about the inner member (114), and a stent (500) disposed between the inner member and the outer sheath in a first configuration (paragraph 0014 discloses and fig. 6 illustrates a slidable sheath enclosing a stent and inner member 114), the stent (500) configured to transition between the first configuration and a second configuration when deployed from between the inner member and outer sheath (fig. 8 illustrates a stent 500 disposed between an inner member 114 and outer sheath 126 transitioning from a first or collapsed configuration to an expanded or second configuration in between an inner member 14 and outer sheath 16). Rafiee also discloses retention members (fig. 10) on both distal and proximal ends (510) of a stent (500) used to secure the stent inside of a tubular organ. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the delivery catheter taught by Raifee with the Eller stent, as the modification merely provides a known stent delivery catheter to achieve delivery of the Eller stent in a compressed profile.
Regarding claim 17, Eller discloses a first (122a) and fourth (122b) retention member. The limitation “…retention members are each configured to atraumatically interface with tissue about a radially outwardmost circumference of the respective retention member…” is a functional limitation that is not given full patentable weight. The prior art is not required to explicitly disclose this function, but merely have the capability of performing in the recited manner in order to meet the claim requirements.
It is widely known the structure of stent retention members differ widely due to a variety retention member surfaces, contours, and shapes utilized to prevent tissue damage at the implantation site, and that the structure of bodily lumens differs widely due to different locations in the body and specific patient anatomy. Therefore, the retention members are considered to be capable of engaging, or contacting, tissue along any portion of the outer surface.
Regarding claim 18, Eller discloses that the stent is formed from at least one braided or woven filament comprising a different pitch density, angle, or pattern at the first retention member, the second retention member, the cylindrical saddle region, the third retention member, or the fourth retention member, or any combination thereof, in the second configuration (paragraphs 0028-0031 disclose a stent 100 elongated body 102 may comprise braided or woven wire arranged in a particular braid pattern having a pitch (axial distance between crossing strands) and a braid angle that can be constant over a given region of the body and also vary over other regions).
Regarding claim 19, modified Eller disclose the invention as claimed as discussed above with respect to claim 16. The embodiment of Fig 1 does not include a partial cover, but Eller teaches an alternate embodiment (200) wherein the elongate body comprises at least a partial cover (Fig. 3 illustrates an elongate body 200 comprising a partial cover 250. Paragraph 0043 also teaches that parts of the stent 200 may be partially uncovered).
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 stent Eller to include a partial cover, as taught by Eller’s alternate embodiment (200), in order to facilitate the passage of particles or fluid through the interior and at the same time having uncovered portions to secure the stent and allow for tissue ingrowth (Eller Paragraphs 0042-0043).
Regarding claim 20, Eller further teaches that the first retention member (122a), the second retention member (120a), the third retention member (120b), or the fourth retention member (122b), any combination thereof, comprises an asymmetrical cross section in an orthogonal plane to a longitudinal axis extending through a lumen of the stent (fig. 1b, annotated above with reference to claim 13, illustrates and paragraph 0037 discloses retention members with asymmetric profiles in an orthogonal plane to a longitudinal axis 140).
Conclusion
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/A.G.B/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774