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 .
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because it exceeds the 150-word limit. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 9, and 18 objected to because of the following informalities:
The claim recites “included angle between rods” but should recite “included angle between oblique rods”
Appropriate correction is required.
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.
Claim(s) 1, 9-10, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng (US 20150122687 A1) in view of Richter (US 7044963 B1) and Fleury (US 20150265437 A1).
Regarding claim 1, Zeng teaches an interventional valve stent (see annotated fig 4f), comprising: a valve stent defining a frame lumen (see annotated fig 4f), the valve stent including straight rods (see annotated fig 4f) connecting an upstream port and a downstream port (see annotated fig 4f), and oblique rods connected between the straight rods (see annotated fig 4f); an upstream section, a midstream section, and a downstream section being sequentially formed along a direction from the upstream port to the downstream port (see annotated fig 4f), when the valve stent expands from a compressed state (see fig 4e) to an expanded state (see fig 4f), wherein the straight rods being distributed in parallel in a column direction (see annotated fig 4f), and the oblique rods being distributed between the straight rods in multiple rows along a row direction perpendicular to the column direction (see annotated fig 4f); the oblique rods being connected in a V-shaped arrangement between two adjacent straight rods to form an included angle between rods (see annotated fig 4f).
Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein an expansion strain provided by the connecting rods located in the midstream section to a circumferential direction of the valve stent being greater than an expansion strain provided by the connecting rods located in the upstream section and/or the downstream section to the circumferential direction of the valve stent (structure is capable of this, see struts in non-end sections have reduced width making deformation possible, for example col 2, lines 23-47, see fig 2), to compensate for a rate difference between a rate of circumferential expansion of the midstream section, and a rate of circumferential expansion of the upstream section and/or a rate of circumferential expansion of the downstream section (structure is capable of this, for example see col 2, lines 23-47, see fig 2) and the connecting rods satisfying a requirement: from a middle of the valve stent to two ends of the valve stent (col 2 lines 8-10), rod widths, wall thicknesses, and included angles between rods of the connecting rods located in different rows all increase sequentially (col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase sequentially, for example see a sequential increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47). Additionally, combining prior art elements, such as known strut dimensions and shape, according to known methods to yield predictable results, such as fitting the target anatomy as desired requires only ordinary skill in the art (MPEP 2143).
Zeng in view of Richter does not specifically teach varying angles. Fleury teaches a stent with variable features (abstract) wherein included angles vary to change radial force(abstract).
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 device taught by Zeng in view of Richter by applying the teaching of varying angles resulting in varying radial forces, as taught by Fleury, in order to change the shape of the adjustable struts (Richter: col 1, lines 40-55) to successfully vary the properties, flexibility, and radial support of the struts (Richter: col 1, lines 40-55).
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Annotated figure 4f
Regarding claim 9 and 18, Zeng further teaches wherein the oblique rods are connected in a V-shaped arrangement between two adjacent straight rods to form an included angle between rods (see annotated fig 4f). Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein from a middle of the valve stent to two ends of the valve stent (col 2 lines 8-10), shapes between rods of the connecting rods located in different rows can increase sequentially (col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase sequentially, for example see a sequential increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47). Additionally, combining prior art elements, such as known strut dimensions and shape, according to known methods to yield predictable results, such as fitting the target anatomy as desired requires only ordinary skill in the art (MPEP 2143).
Zeng in view of Richter does not specifically teach varying angles. Fleury teaches a stent with variable features (abstract) wherein included angles vary to change radial force(abstract).
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 device taught by Zeng in view of Richter by applying the teaching of varying angles resulting in varying radial forces, as taught by Fleury, in order to change the shape of the adjustable struts (Richter: col 1, lines 40-55) to successfully vary the properties, flexibility, and radial support of the struts (Richter: col 1, lines 40-55).
Regarding claim 10 and 19, Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein from the middle of the valve stent to the two ends of the valve stent (col 2 lines 8-10), the shape between rods of the connecting rods located in different rows increase linearly or in stages in an order of rows (col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase linearly/ in stages, for example see a row increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
Zeng in view of Richter does not specifically teach varying angles. Fleury teaches a stent with variable features (abstract) wherein included angles vary to change radial force(abstract).
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 device taught by Zeng in view of Richter by applying the teaching of varying angles resulting in varying radial forces, as taught by Fleury, in order to change the shape of the adjustable struts (Richter: col 1, lines 40-55) to successfully vary the properties, flexibility, and radial support of the struts (Richter: col 1, lines 40-55).
Claim(s) 2-8 and 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng (US 20150122687 A1) in view of Richter (US 7044963 B1).
Regarding claim 2, Zeng teaches an interventional valve stent (see annotated fig 4f), comprising: a valve stent defining a frame lumen (see annotated fig 4f), the valve stent including straight rods (see annotated fig 4f) connecting an upstream port and a downstream port (see annotated fig 4f), and oblique rods connected between the straight rods (see annotated fig 4f); an upstream section, a midstream section, and a downstream section being sequentially formed along a direction from the upstream port to the downstream port (see annotated fig 4f), when the valve stent expands from a compressed state (see fig 4e) to an expanded state (see fig 4f).
Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein an expansion strain provided by the connecting rods located in the midstream section to a circumferential direction of the valve stent being greater than an expansion strain provided by the connecting rods located in the upstream section and/or the downstream section to the circumferential direction of the valve stent (structure is capable of this, see struts in non-end sections have reduced width making deformation possible, for example col 2, lines 23-47, see fig 2), to compensate for a rate difference between a rate of circumferential expansion of the midstream section, and a rate of circumferential expansion of the upstream section and/or a rate of circumferential expansion of the downstream section (structure is capable of this, for example see col 2, lines 23-47, see fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
Regarding claim 3 and 12, Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein during an expansion process of the valve stent, the rate of circumferential expansion of the midstream section is the same as the rate of circumferential expansion of the upstream section and/or the rate of circumferential expansion of the downstream section (structure is capable of this, col 2, lines 23-47).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
Regarding claim 4 and 13, Zeng further teaches wherein the straight rods being distributed in parallel in a column direction (see annotated fig 4f), and the oblique rods being distributed between the straight rods in multiple rows along a row direction perpendicular to the column direction (see annotated fig 4f).
Regarding claim 5 and 14, Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein from a middle of the valve stent to two ends of the valve stent (col 2 lines 8-10), rod widths of the connecting rods located in different rows increase sequentially (col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase sequentially, for example see a sequential increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47). .
Regarding claim 6 and 15, Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein from the middle of the valve stent to the two ends of the valve stent (col 2 lines 8-10), the rod widths of the connecting rods located in different rows increase linearly or in stages in an order of rows (col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase linearly/ in stages, for example see a row increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
Regarding claim 7 and 16, Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein from a middle of the valve stent to two ends of the valve stent (col 2 lines 8-10), wall thicknesses of the connecting rods located in different rows increase sequentially (col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase sequentially, for example see a sequential increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47). .
Regarding claim 8 and 17, Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein from the middle of the valve stent to the two ends of the valve stent (col 2 lines 8-10), the wall thicknesses of the connecting rods located in different rows increase linearly or in stages in an order of rows(col 1, lines 40-55, note that width -width-, thickness -wall thickness-, and shape - included angle contributes to shape- can be altered in any section of the stent, therefore can increase linearly/ in stages, for example see a row increase in fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
Regarding claim 11, Zeng teaches an artificial aortic valve, comprising: an interventional valve stent (see annotated fig 4f), and a valve leaflet (see annotated fig 4f) arranged in a frame lumen formed by the valve stent (see annotated fig 4f) wherein the interventional valve stent includes a valve stent defining a frame lumen (see annotated fig 4f), the valve stent including straight rods (see annotated fig 4f) connecting an upstream port and a downstream port (see annotated fig 4f), and oblique rods connected between the straight rods (see annotated fig 4f); an upstream section, a midstream section, and a downstream section being sequentially formed along a direction from the upstream port to the downstream port (see annotated fig 4f), when the valve stent expands from a compressed state (see fig 4e) to an expanded state (see fig 4f).
Zeng fails to teach the details of the connecting rods relationship with strain. Richter teaches a stent with variable features (abstract) wherein an expansion strain provided by the connecting rods located in the midstream section to a circumferential direction of the valve stent being greater than an expansion strain provided by the connecting rods located in the upstream section and/or the downstream section to the circumferential direction of the valve stent (structure is capable of this, see struts in non-end sections have reduced width making deformation possible, for example col 2, lines 23-47, see fig 2), to compensate for a rate difference between a rate of circumferential expansion of the midstream section, and a rate of circumferential expansion of the upstream section and/or a rate of circumferential expansion of the downstream section (structure is capable of this, for example see col 2, lines 23-47, see fig 2).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng (US 20150122687 A1) in view of Richter (US 7044963 B1) and Fleury (US 20150265437 A1) and in further view of Jang (WO 2004087015 A2).
Regarding claim 20, Zeng in view of Richter and Fleury does not exactly teach the specific values of changing strut width. Jang teaches an intravascular stent (abstract) with connecting struts with a width of 0.10 mm (pg. 26, lines 29-31). Richter teaches a stent with variable features (abstract) wherein a change of rod width between connecting rods in adjacent rows can be 40% or 50% although does not discuss the initial width (col 7, lines 3-5, 50% narrower than .10 mm is .05 mm, resulting in a .05 mm change which is between a .01-.10 mm change of width).
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 device taught by Zeng by including the variation in struts, as taught by Richter, in order to minimize flare, catching, and trauma (col 2, lines 23-47).
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 device taught by Zeng in view of Richter and Fleury, by applying the teachings of a base strut width, as taught by Jang, because it would be obvious to try choosing from a finite number of identified base strut widths with reasonable expectation of success (MPEP 2143). Additionally routine optimization only requires ordinary skill in the art (MPEP 2144.05).
Conclusion
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/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774