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
Claim 1 is objected to because of the following informalities: Claim 1 recites “secondary framework” in lines 12-13 which should read “second framework” for consistency purposes. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 7-8, 10-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saffari (US 2018/0168832 A1) in view of Beach et al. (US 2009/0036976 A1).
Regarding claim 1, Saffari discloses an implantable prosthesis (stent 400; Fig. 21), comprising: a first framework (helical ring 440a) circumscribing in a first helical path about a longitudinal axis proximate a first end (end 410) to proximate a second end (end 402) of the implantable prosthesis (as 440a and 440b are alternating helical rings forming a double helix; [0076]-[0077]; Fig. 21), the first framework (440a) including a plurality of struts (struts making up zig-zag pattern of 440a) disposed in a first sinusoidal pattern (zig-zag) along the first helical path with a primary apex portion (apexes 422) connected for every pair of struts of the first framework (Fig. 21); a second framework (helical ring 440b) spaced from the first framework (via connecting struts 444), the second framework (440b) circumscribing a second helical path about the longitudinal axis proximate the first end to proximate the second end (Fig. 21), the second framework including a plurality of struts (struts making up zig-zag pattern of 440b) disposed in a second sinusoidal pattern (zing-zag) along the second helical path with a secondary apex portion (apexes 422) connected to a pair of struts for every pair of struts of the second framework (Fig. 21); a plurality of connectors (connecting struts 444), each connector is connected to proximate a primary apex portion of the first framework and to proximate a secondary valley portion of the secondary framework (Fig. 21); and wherein the first framework (440a) has a first starting location generally diametrically opposed to a second starting location of the second framework (440b) with reference to the longitudinal axis (see annotated Fig. 21 below; as Fig. 21 is a flat view of the stent 400 [0074]; thus, the second (middle) starting location is diametrically opposed to the first (end) starting location when the stent is in its cylindrical form).
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Saffari fails to disclose each connector is connected to proximate a primary apex portion of the first framework and to proximate a secondary apex portion of the secondary framework.
However, Beach teaches an implantable prosthesis (stent 200; Fig. 9; while stent 200 is being used, stent 200 shown in Fig. 9 has similar structure to stent 500; therefore, reference is made to stent 500 for like parts; [0027]; Fig. 1) with a first framework (helical strut band 502) circumscribing a first helical path (helical path of 502; Fig. 1) about a longitudinal axis (centerline through stent 500) proximate the first end to proximate the second end (Fig. 1), the first framework (502) including a plurality of struts (strut elements 503) disposed in a first pattern (zig-zag pattern; Fig. 9) along the first helical path with a primary apex portion connected for every pair of struts (Fig. 9); and a plurality of connectors (elements 507), each connector is connected to proximate a primary apex portion of the first framework and to proximate an apex portion of an adjacent primary apex portion of the adjacent band of helical struts (Fig. 9). Beach teaches the stent (200) comprising structure in which each apex of one framework or hoop (single band of 502) is connected to adjacent apexes of the adjacent framework or hoops (adjacent band of 502; Fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Saffari such that the connectors extend between each primary apex portion of the first framework to proximate each secondary apex portion of the second framework (adjacent band) as taught by Beach in order to provide more stability to the stent and improve pressure distribution along the length of the main body.
Regarding claim 2, modified Saffari discloses each primary apex portion is connected via the respective connector to each secondary apex portion circumferentially offset to such primary apex portion so that the respective connector defines an angle with respect to the longitudinal axis (Fig. 9 of Beach).
Regarding claim 3, modified Saffari discloses each primary apex portion is connected via the respective connector to each secondary apex portion circumferentially offset to such primary apex portion by one secondary apex portion so that the respective connector defines an angle with respect to the longitudinal axis (Fig. 9 of Beach).
Regarding claim 7, modified Saffari discloses each of the plurality of connectors comprises a linear member (Fig. 9 of Beach).
Regarding claim 8, modified Saffari discloses wherein adjacent connectors are disposed in a generally parallel configuration.
Regarding claim 10, modified Saffari discloses the implantable prosthesis includes a first length when crimped or compressed to have a smaller outer diameter and a second length of no less than about 80% of the first length when the implantable prosthesis is uncompressed to expand to a larger outer diameter.
Applicant’s specification states that when the prosthesis is in an uncompressed configuration, its length from the first end to the second end along the longitudinal axis is at least 80% of the length of the prosthesis in its compressed or crimped configuration. In order to achieve this, Applicant recites “This reduction in the foreshortening characteristic for a "fully connected" implantable prosthesis (i.e., a stent in which all vertices of one framework (or hoop) are connected to adjacent vertices of the adjacent frameworks or hoops) is believed to be the first of its kind to resolve this long standing problem that has been prevalent in this field.” ([0040]). Thus, a stent comprising structure in which all vertices of one framework or hoop are connected to adjacent vertices of the adjacent framework or hoops would achieve the desired claimed function. Beach teaches the stent (200) comprising structure in which all vertices of one framework or hoop (single band of 502) are connected to adjacent vertices of the adjacent framework or hoops (adjacent band of 502; Fig. 1). Thus, the stent of modified Saffari would achieve the desired claimed function such that when the prosthesis is in an uncompressed configuration, its length from the first end to the second end along the longitudinal axis is at least 80% of the length of the prosthesis in its compressed or crimped configuration.
Regarding claim 11, Saffari modified discloses the invention as claimed above, and Saffari further discloses the first framework (440a) defines a first helical angle (angle of box around 440a in Fig. 21 relative to the longitudinal axis of 400) with respect to the longitudinal axis and the second framework (440b) defines a second helical angle (angle of box around 440b in Fig. 21 relative to the longitudinal axis of 400) with respect to the longitudinal axis when the implantable prosthesis is in an uncompressed configuration (Fig. 21).
Regarding claim 12, modified Saffari discloses wherein one or more connector portions of the plurality of connectors define a third helical angle (angle of connectors of Beach relative to the longitudinal axis; see triangles of Fig. 9) with respect to the longitudinal axis when the implantable prosthesis is in the uncompressed configuration.
Regarding claim 13, Saffari modified discloses wherein the first helical angle is generally equal to the second helical angle (Fig. 21).
Regarding claim 14, modified Saffari discloses wherein the third helical angle is different from the first helical angle or the second helical angle (as the connectors of Beach extend from an apex of one framework to a second offset apex of the adjacent framework, creating an angle smaller relative to the longitudinal axis than that of the framework; Fig. 9 of Beach).
Regarding claim 15, modified Saffari discloses the first framework defines a first helical angle with respect to the longitudinal axis and the second framework defines a second helical angle with respect to the longitudinal axis when the implantable prosthesis is in an uncompressed configuration, wherein one or more connector portions of the plurality of connectors define a third helical angle with respect to the longitudinal axis when the implantable prosthesis is in the uncompressed configuration, wherein the third helical angle is less than either of the first helical angle or the second helical angle (see annotated Fig. 9 of Beach).
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Regarding claims 16-19, modified Saffari fails to explicitly disclose wherein the first helical angle is about 65 degrees with respect to the longitudinal axis, the second helical angle is about 65 degrees with respect to the longitudinal axis, and the third helical angle is about 30 degrees with respect to the longitudinal axis, wherein the third helical angle is about half of one of the first and second helical angles.
However, when viewing annotated Fig. 9 of Beach above, it appears the first and second helical angles are approximately about 65 degrees with respect to the longitudinal axis and that the third angle is approximately about 30 degrees with respect to the longitudinal axis, which is about half of one of the first and second helical angles.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to cause the first, second, and third helical angles of modified Saffari to be about 65 degrees, 65 degrees, and 30 degrees, respectively since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the implantable prosthesis of Saffari would not operate differently with the claimed angles since the stent would function appropriately having the claimed angles. Further, Applicant places no criticality on the range claimed, indicating simply “the helical angle may be configured to be generally equal to the second helical angle and the third helical angle can be configured to have a different magnitude from the first helical angle or the second helical angle” (specification para. [0037]).
Regarding claim 20, modified Saffari discloses the implantable prosthesis includes a first length and a smaller outer diameter when the implantable prosthesis is in a compressed configuration and a second length of no less than about 90% of the first length when the implantable prosthesis is in the uncompressed configuration.
Applicant’s specification states that when the prosthesis is in an uncompressed configuration, its length from the first end to the second end along the longitudinal axis is at least 90% of the length of the prosthesis in its compressed or crimped configuration. In order to achieve this, Applicant recites “This reduction in the foreshortening characteristic for a "fully connected" implantable prosthesis (i.e., a stent in which all vertices of one framework (or hoop) are connected to adjacent vertices of the adjacent frameworks or hoops) is believed to be the first of its kind to resolve this long standing problem that has been prevalent in this field.” ([0040]). Thus, a stent comprising structure in which all vertices of one framework or hoop are connected to adjacent vertices of the adjacent framework or hoops would achieve the desired claimed function. Beach teaches the stent (200) comprising structure in which all vertices of one framework or hoop (single band of 502) are connected to adjacent vertices of the adjacent framework or hoops (adjacent band of 502; Fig. 1). Thus, the stent of modified Saffari would achieve the desired claimed function such that when the prosthesis is in an uncompressed configuration, its length from the first end to the second end along the longitudinal axis is at least 90% of the length of the prosthesis in its compressed or crimped configuration.
Regarding claims 22-23, modified Saffari discloses the invention as claimed above, and Saffari further discloses wherein the implantable prosthesis comprises a biocompatible metal including alloys of metal or wherein the implantable prosthesis comprises a biocompatible polymer (as the stent 100 may be formed from a suitable biocompatible material such as a biocompatible alloy, a biocompatible metal, or a biocompatible polymer [0047] and the only difference between the stent 100 and the stent 400 is the alternating helical rings; [0076]).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saffari (US 2018/0168832 A1) in view of Beach et al. (US 2009/0036976 A1), as applied to claim 19 above, and further in view of Kang et al. (US 2016/0106560 A1).
Regarding claim 24, modified Saffari discloses wherein the implantable prosthesis can be made from a biocompatible metal or polymer (as the stent 100 of Saffari may be formed from a suitable biocompatible material such as a biocompatible alloy, a biocompatible metal, or a biocompatible polymer [0047] and the only difference between the stent 100 and the stent 400 is the alternating helical rings; [0076]) but fails to explicitly disclose wherein the implantable prosthesis comprises a combination of biocompatible metal and polymer.
However, Kang teaches an implantable prosthesis comprising a combination of biocompatible metal and polymer (as the stent may be metal and include a polymer carrier; [0036], [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable prosthesis of modified Saffari to be a combination of biocompatible metal and polymer as taught by Kang since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 25, modified Saffari fails to disclose wherein the implantable prosthesis comprises a drug coating disposed on surfaces of the implantable prosthesis.
However, Kang teaches an implantable prosthesis (stent) that may be coated with therapeutic agents, including drugs that have been used in the field of drug-eluting stents ([0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable prosthesis of modified Saffari to include a drug coating as taught by Kang in order to provide therapeutic agents to the treatment site, improving the healing process.
Conclusion
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/SARAH A LONG/Primary Examiner, Art Unit 3771