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 § 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) 1-3, 5-8, and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al (US 20180338847 A1) “Holzer”.
Regarding Claim 1, the first embodiment of Holzer teaches a method for producing a living body indwelling object (par. [0002]), comprising:
disposing a porous structure (porous structure 104, par. [0137], Fig. 1) having a large number of penetrating voids (apertures 110, par. [0148], Fig. 1) and a porous structure fixing material (par. [0199], polymer coating the supporting element) on a stent (support element 102, par. [0136], Fig. 1), the stent extending in an axial direction and configured to be inflatable in a radial direction (central axis 106, par. [0136], Fig. 1), but does not disclose fixing the porous structure to the stent by melting the porous structure fixing material. However, another embodiment of Holzer discloses fixing the porous structure to the stent by melting the porous structure fixing material (par. [0199]). 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 Holzer to include fixing the porous structure to the stent by melting the porous structure fixing material, as taught by another embodiment of Holzer, in order for the stent assembly to effectively deliver the necessary treatment to tissues (par. [0030]).
Regarding Claim 2, the main embodiment of Holzer further teaches the method for producing a living body indwelling object according to claim 1, wherein the porous structure includes a mesh having a knitted stitch structure, and the porous structure fixing material includes a mesh fixing material (pars. [0023], [0148], and [0149]).
Regarding Claim 3, the main embodiment of Holzer does not disclose disposing the porous structure on a surface of the porous structure fixing material. However, another embodiment of Holzer discloses disposing the porous structure on a surface of the porous structure fixing material after the porous structure fixing material is disposed on the stent (par. [0199]). 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 Holzer to include disposing the porous structure on a surface of the porous structure fixing material, as taught by another embodiment of Holzer, in order for the stent assembly to effectively deliver the necessary treatment to tissues (par. [0030]).
Regarding Claim 5, the main embodiment of Holzer does not disclose embedding the porous structure in the porous structure fixing material. However, another embodiment of Holzer teaches embedding the porous structure in the porous structure fixing material (par. [0187] and [0226]). 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 Holzer to include embedding the porous structure in the porous structure fixing material, as taught by another embodiment of Holzer, in order for the stent assembly to effectively deliver the necessary treatment to tissues (par. [0030]).
Regarding Claim 6, the main embodiment of Holzer does not disclose the porous structure fixing material formed a polymer and a wax. However, another embodiment of Holzer teaches the porous structure fixing material is formed of a material selected from a group consisting of a polymer and a wax (par. [0199]). 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 Holzer to include disclose the porous structure fixing material formed a polymer and a wax, as taught by another embodiment of Holzer, in order to have a material with the appropriate structure to prevent blood from passing through the device to prevent further expansion of the aneurysm (par. [0026]).
Regarding Claim 7, the main embodiment of Holzer does not disclose the porous structure fixing material with a melting point lower than a melting point of a material constituting the porous structure. However, another embodiment of Holzer teaches a material constituting the porous structure fixing material has a melting point lower than a melting point of a material constituting the porous structure (pars. [0192] and [0199], fixing material melting point may be at or below porous structure melting point). 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 Holzer to include the porous structure fixing material with a melting point lower than a melting point of a material constituting the porous structure, as taught by another embodiment of Holzer, in order for the stent assembly to effectively deliver the necessary treatment to tissues (par. [0030]).
Regarding Claim 8, the main embodiment of Holzer does not disclose disposing the porous structure fixing material on a part of the stent. However, another embodiment of Holzer teaches disposing the porous structure fixing material on a part of the stent (par. [0199]). 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 Holzer to include disposing the porous structure fixing material on a part of the stent, as taught by another embodiment of Holzer, in order for the stent assembly to effectively deliver the necessary treatment to tissues (par. [0030]).
Regarding Claim 10, the main embodiment of Holzer does not disclose a drug coating layer and an exposed portion disposed with the fixing material. However, another embodiment of Holzer teaches a drug coating layer coated with a drug and an exposed portion not coated with the drug are formed on an outer surface of the stent (par. [0030]), and the method further comprises:
disposing the porous structure fixing material on the exposed portion not coated with the drug formed on the outer surface of the stent (par. [0199], fixing material is disposed on entire stent, including exposed portion). 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 Holzer to include a drug coating layer and an exposed portion disposed with the fixing material, as taught by another embodiment of Holzer, in order for the stent assembly to effectively deliver the necessary treatment to tissues (par. [0030]).
Regarding Claim 11, the main embodiment of Holzer does not disclose forming the porous structure by jersey knitting. However, another embodiment of Holzer teaches the method for producing a living body indwelling object according to claim 1, further comprising: forming the porous structure by jersey knitting (Fig. 6b). 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 Holzer to include forming the porous structure by jersey knitting, as taught by another embodiment of Holzer, in order to assist in controlling blood flow (par. [0027]).
Regarding Claim 12, the main embodiment of Holzer teaches a method for producing a living body indwelling object for fixing a porous structure (porous structure 104, par. [0137], Fig. 1) having a large number of penetrating voids (apertures 110, par. [0148], Fig. 1) to a stent (support element 102, par. [0136], Fig. 1) extending in an axial direction and formed to be capable of inflating in a radial direction (central axis 106, par. [0136], Fig. 1), the method comprising:
and melting the porous structure fixing material to fix the porous structure to the stent (par. [0199]), but does not teach a pressing body for the porous structures on the stent.
However, another embodiment of Holzer teaches pressing a porous structure fixing material and the porous structure disposed on the stent toward the stent by a pressing body (funnel 1304, par. [0190], Fig. 13). 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 Holzer to include a pressing body for the porous structures on the stent, as taught by another embodiment of Holzer, in order to secure the device components and ensure the size is appropriate for certain procedures (pars. [0030] and [0190]).
Regarding Claim 13, the main embodiment of Holzer further teaches the method for producing a living body indwelling object according to claim 12, wherein
the porous structure includes a mesh having a knitted stitch structure, and the porous structure fixing material includes a mesh fixing material (pars. [0023], [0148], and [0149]).
Regarding Claim 14, the main embodiment of Holzer does not disclose melting the porous structure fixing material using a laser, a light beam, heat, and/or ultrasounds. However, another embodiment of Holzer teaches the method for producing a living body indwelling object according to claim 12, wherein
melting the porous structure fixing material by a method selected from a group consisting of a laser, a light beam, heat, and ultrasounds (pars. [0199] and [0202]). 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 Holzer to include melting the porous structure fixing material using a laser, a light beam, heat, and/or ultrasounds, as taught by another embodiment of Holzer, in order to effectively secure the device components (par. [0199]).
Regarding Claim 15, the main embodiment of Holzer does not disclose the pressing body having a laser light transmission property. However, another embodiment of Holzer teaches the method for producing a living body indwelling object according to claim 12, wherein
the pressing body has a laser light transmission property (pars. [0190] and [0202]), and the method further comprises:
irradiating the porous structure fixing material is irradiated with laser light via the pressing body (pars. [0190] and [0202]). 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 Holzer to include the pressing body having a laser light transmission property, as taught by another embodiment of Holzer, in order to effectively secure the device components (par. [0199]).
Regarding Claim 16, the main embodiment of Holzer does not disclose pressing the stents on the porous structures. However, another embodiment of Holzer teaches the method for producing a living body indwelling object according to claim 12, further comprising:
pressing the stent on which the porous structure fixing material and the porous structure are disposed with the pressing body that is heated (pars. [0190] and [0202]). 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 Holzer to pressing the stents on the porous structures, as taught by another embodiment of Holzer, in order to effectively secure the device components (par. [0199]).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al (US 20180338847 A1) “Holzer” in further view of Bjork (US 20090157173 A1) “Bjork”.
Regarding Claim 4, Holzer does not teach disposing the porous structure fixing material to form a gently bumped shape in a cross-sectional view. However, Bjork, in the same field of art, teaches a drug eluting stent (Abstract), comprising:
disposing the porous structure fixing material (bioactive layer 13, par. [0141], Figs. 2 and 3) to form a gently bumped shape in a cross-sectional view (Fig. 3). 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 Holzer to include disposing the porous structure fixing material to form a gently bumped shape in a cross-sectional view, as taught by Bjork, in order to have variable geometry and deposition of bioactive material within the device (Bjork, par. [0146]).
Claim(s) 9 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer et al (US 20180338847 A1) “Holzer” in further view of von Oepen et al (US 20130190856 A1) “von Oepen”.
Regarding Claim 9, Holzer does not teach a plurality of linear rings that connect through link portions. However, von Oepen, in the same field of art, teaches a stent attached to a porous biocompatible material (Abtract), wherein
the stent includes a plurality of linear rings (web patterns 5 and 6, par. [0088], Fig. 2) that forms a cylindrical outer periphery having gaps and a plurality of link portions (connection elements 7 and 8, par. [0089], Fig. 2) that connect the plurality of rings through the gaps, and the method further comprises:
disposing the porous structure fixing material on at least one of the plurality of link portions (pars. [0160] and [0161]). 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 Holzer to include a plurality of linear rings that connect through link portions, as taught by von Oepen, in order to have varied position, distribution density, and thickness of these pluralities of connection elements that allows for device adjustments (von Oepen, par. [0089]).
Regarding Claim 17, Holzer teaches a stent (support element 102, par. [0136], See Annotated Fig. 1, below) extending in an axial direction and configured to be inflatable in a radial direction (central axis 106, par. [0136], See Annotated Fig. 1, below), but does not disclose a plurality of wavy rings with connecting link portions. However, von Oepen, in the same field of art, teaches a stent attached to a porous biocompatible material (Abtract), the stent comprising:
a plurality of wavy rings (web patterns 5 and 6, par. [0088], Fig. 2) that forms a cylindrical outer periphery having gaps, and a plurality of link portions (connection elements 7 and 8, par. [0089], Fig. 2) that connect the plurality of wavy rings through the gaps;
and a porous structure fixed on at least one of the plurality of link portions (pars. [0160] and [0161]). 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 Holzer to include a plurality of wavy rings that connect through link portions, as taught by von Oepen, in order to have varied position, distribution density, and thickness of these pluralities of connection elements that allows for device adjustments (von Oepen, par. [0089]).
Regarding Claim 18, the main embodiment of Holzer does not disclose the porous structure fixing material formed a polymer and a wax. However, another embodiment of Holzer teaches the stent according to claim 17, wherein the porous structure is melted onto the stent with a porous structure fixing material, the porous structure fixing material selected from a group consisting of a polymer and a wax (par. [0199]). 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 Holzer to include disclose the porous structure fixing material formed a polymer and a wax, as taught by another embodiment of Holzer, in order to have a material with the appropriate structure to prevent blood from passing through the device to prevent further expansion of the aneurysm (par. [0026]).
Regarding Claim 19, the main embodiment of Holzer further teaches the stent according to claim 17, wherein each of the plurality of the wavy rings includes first strut portions formed of a straight line or a curved line, second strut portions formed of a straight line or a curved line, and curved portions formed between the first strut portions and the second strut portions (See Annotated Fig. 1, below).
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Regarding Claim 20, the main embodiment of Holzer further teaches the stent according to claim 17, wherein the porous structure includes a mesh having a knitted stitch structure, and the porous structure fixing material includes a mesh fixing material (pars. [0023], [0148], and [0149]).
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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