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 Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, and 11-13 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kang (WO 2019099080 A1) "Kang".
Regarding Claim 1, Kang teaches a stent (stent 30, par. [44], Fig. 1) comprising: a tubular body (tubular body 34, par. [44], Fig. 1) having a longitudinal axis (direction of extension of end flanges 50 and 54, par [45], See Annotated Fig. 2, below), a midbody (portion of tubular body 34 between first end 38 and second end 42, par. [44], See Annotated Fig. 2, below) extending between a first end (first end 38, par. [44], See Annotated Fig. 2, below) and a second end (second end 42, par. [44], See Annotated Fig. 2, below), and a helical thread (helical spiral 46, par. [44], Fig. 1) circumferentially arranged on an outer surface of the midbody, wherein the helical thread comprises a plurality of turns and an interthread space (See Annotated Fig. 2, below).
Regarding Claim 2, Kang teaches the stent of claim 1, wherein the interthread space has a constant length (pars. [63] and [64], See Annotated Fig. 2, below).
Regarding Claim 3, Kang teaches the stent of claim 1, wherein the interthread space has a length that varies (pars. [13] and [57]).
Regarding Claim 6, Kang teaches the stent of claim 1, wherein the interthread space has a length of from about 2 mm to about 20 mm (par. [13]).
Regarding Claim 7, Kang teaches the stent of claim 1, wherein the interthread space defines an interior space of the midbody having a cylindrical profile and having a profile diameter (See Annotated Fig. 2, below), and wherein the helical thread protrudes radially from the cylindrical profile (par. [44], Fig. 1) at a thread height that is from about 0.5 mm to about 5 mm, from about 1 mm to about 4 mm, or from about 2 mm to about 3 mm (par. [57]).
Regarding Claim 8, Kang teaches the stent of claim 1, wherein the helical thread has a cross-sectional profile shape selected from a circle, an ellipse, or a triangle (par. [67], Fig. 4, helices forming acute, right, and obtuse angles against stent body, which creates circular/elliptical, square, and triangular cross-sectional profiles for the helical thread).
Regarding Claim 11, Kang teaches the stent of claim 1, wherein the helical thread extends onto at least one of the first end and second end (par. [44], Fig. 1).
Regarding Claim 12, Kang teaches the stent of claim 1, wherein at least one of the first end and second end is a flange having a diameter greater than a diameter of the midbody (first end flange 50, par. [45], Fig. 1).
Regarding Claim 13, Kang teaches the stent of claim 12, further comprising one to three additional flanges situated between the end and the midbody (second end flange 54, par. [45], Fig. 1).
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Claim(s) 17 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gill et al (US 20130325141 A1) "Gill".
Regarding Claim 17, Gill teaches a stent assembly (stent 100, par. [0041], Fig. 1), comprising: a stent (cover 130 and valve 150, par. [0041], Fig. 1) comprising a midbody (proximal zone alpha, transition zone beta, valve zone gamma, par. [0048], Fig. 1) extending between a first end (proximal end 102, par. [0041], Fig. 1) and a second end (distal end 104, par. [0041], Fig. 1), and a tubular sleeve (scaffolding structure 110, par. [0041], Fig. 1) surrounding a length of the midbody and comprising a helical thread (strut arms 514, helical pattern 544, par. [0138], Figs. 5A-D) circumferentially arranged on an outer surface of the sleeve.
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.
Claim(s) 4, 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (WO 2019099080 A1) "Kang" in view of Milbocker et al (WO 2018126238 A1) "Milbocker".
Regarding Claim 4, Kang does not disclose the tubular body comprising a mesh structure. However, Milbocker, in the same field of art, teaches an esophageal stent (stent body 200, par. [0060], Fig. 2A) with a tubular body (stent body 202, par. [0060], Fig. 2A), wherein the tubular body (stent body 202, par. [0060], Fig. 2A) comprises a mesh structure (mesh segments 210, par. [0060]). 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 structure disclosed by Kang to include a tubular body comprising a mesh structure, as taught by Milbocker, in order to provide flexibility to the stent, which prevents pressure that damages the esophageal wall (Milbocker, pars. [0005] and [0060]).
Regarding Claim 14, Kang does not disclose a textured surface over the tubular body. However, Milbocker, in the same field of art, teaches an esophageal stent (stent body 200, par. [0060], Fig. 2A) with a tubular body (stent body 202, par. [0060], Fig. 2A), further comprising a textured surface (surface texture 222, par. [0062], Fig. 2B) disposed over the entirety of the tubular body or a designated portion thereof (par. [0062], Fig. 2B, covers part of tubular body of stent body 200). 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 structure disclosed by Kang to include a textured surface over the tubular body, as taught by Milbocker, in order to prevent stent migration (Milbocker, par. [0014]).
Regarding Claim 15, Kang does not disclose a textured surface that is micropatterned. However, Milbocker, in the same field of art, teaches an esophageal stent (stent body 200, par. [0060], Fig. 2A) with a tubular body (stent body 202, par. [0060], Fig. 2A), wherein the textured surface is a micropatterned surface (pars. [0024] and [0030]). 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 structure disclosed by Kang to include a textured surface that is micropatterned, as taught by Milbocker, in order to prevent stent migration and provide a non-mechanical bonding surface (Milbocker, pars. [0014] and [0024]).
Regarding Claim 16, Kang does not disclose a textured surface covering either the helical thread or interthread space. However, Milbocker, in the same field of art, teaches an esophageal stent (stent body 200, par. [0060], Fig. 2A) with a tubular body (stent body 202, par. [0060], Fig. 2A), wherein the designated portion thereof is selected from the helical thread and the interthread space (par. [0069], Fig. 3, surface texture layer 322 forms a helical pattern and serves as the helical thread because it is not integrally formed with the elastomeric membrane 304 or stent body 300). 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 structure disclosed by Kang to include a textured surface covering either the helical thread or interthread space, as taught by Milbocker, in order to provide various anti-migration structures (Milbocker, pars. [0014] and [0070]).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kang (WO 2019099080 A1) "Kang" in view of Gill et al (US 20130325141 A1) "Gill".
Regarding Claim 5, Kang does not disclose a cover coupled to the tubular body. However, Gill, in the same field of art, teaches an esophageal stent (stent 100, par. [0041], Fig. 1) with a tubular body (scaffolding structure 110, par. [0041], Fig. 1), further comprising a cover (cover 130, par. [0107], may have second outer layer) coupled to the tubular body (scaffolding structure 110, par. [0041], Fig. 1). 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 structure disclosed by Kang to include a cover coupled to the tubular body, as taught by Gill, in order to reduce friction on the outer layer of the stent (Gill, par. [0107]).
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (WO 2019099080 A1) "Kang".
Regarding Claim 9, the first embodiment of Kang does not teach a helical thread cross-section profile shaped as an isosceles triangle. However, another embodiment of Kang teaches the stent of claim 8, wherein the cross-sectional profile shape is an isosceles triangle (par. [67], Fig. 4, when both sides of helix form obtuse angle from stent body, isosceles triangle may be formed). 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 structure disclosed by the first embodiment of Kang to include a helical thread cross-section profile shaped as an isosceles triangle, as taught by another embodiment of Kang, in order to have a lower stress configuration based on the angle creating the isosceles triangle, which would therefore provide the lowest risk for the stent to be broken due to external forces (par. [67]).
Regarding Claim 10, the first embodiment of Kang does not teach a helical thread cross section shaped as an isosceles triangle wherein a face of the isosceles triangle is oriented at an angle of from about 10 degrees to about 35 degrees from perpendicular to the longitudinal axis. However, another embodiment of Kang teaches the stent of claim 9, wherein a face of the isosceles triangle is oriented at an angle of 45 degrees from perpendicular to the longitudinal axis (par. [67], Fig. 4, this specific angle was only used for experimentation, any angle obtuse from the body of the stent (angle greater than zero degrees starting from perpendicular to the longitudinal axis) will create a similar isosceles triangle appearance). 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 modify the ranges of Kang since it has been held that “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”, see MPEP 2144..
Claim(s) 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gill et al (US 20130325141 A1) "Gill".
Regarding Claim 18, the first embodiment of Gill does not teach a sleeve to allow movement of the stent relative to the sleeve. However, another embodiment of Gill teaches the stent assembly of claim 17, wherein the sleeve is configured to allow movement of the stent relative to the sleeve (par. [0119], stent can be moved by engaging the sutures 135 on the sleeve (scaffolding structure 110)). 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 structure disclosed by the first embodiment of Gill to include a sleeve to allow movement of the stent relative to the sleeve, as taught by another embodiment of Gill, in order for the practitioner to more easily reposition or remove the stent from the body lumen without adversely affecting other components or anatomy (par. [0119]).
Regarding Claim 19, the first embodiment of Gill does not teach a sleeve fixedly secured to the stent. However, another embodiment of Gill teaches the stent assembly of claim 17, wherein the sleeve is fixedly secured to the stent (par. [0047], suture 154 may secure valve 150 to scaffolding structure 110). 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 structure disclosed by the first embodiment of Gill to include a sleeve fixedly secured to the stent, as taught by another embodiment of Gill, in order for the sleeve to reliably envelop the stent and allow for portions of the stent to decrease in diameter in response to axial forces and thus reduce incidences of infoldings (Abstract).
Regarding Claim 20, the first embodiment of Gill does not teach a stent with a cover and a portion of a sleeve not including a cover. However, another embodiment of Gill teaches the stent assembly of claim 17, wherein the stent includes a cover (cover 130, par. [0107], may have second outer layer) and at least a portion of the sleeve does not include a cover (par. [0158]). 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 structure disclosed by the first embodiment of Gill to include a stent with a cover and a portion of a sleeve not including a cover, as taught by another embodiment of Gill, in order to reduce friction along the desired areas of the outside diameter (par. [0107]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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