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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 1-2 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. WO 2013/177068 A1 in view of McIntyre et al. U.S. Patent 7,862,552 B2.
Regarding Claim 1, Lee et al. discloses a controllable operation-free take-out ureteral stent 54 (abstract and page 5, lines 3-12) as seen in Figure 5, comprising: a ureteral stent 54, a traction wire 52, a discharged body 56, and a degradable fixture 58 (page 2, lines 12-26), wherein the discharged body 56 is fixed on a first end of the traction wire, and the degradable fixture 58 fixes the discharged body on a second end of the traction wire (the traction wire 52 is coiled and wrapped around the fixture 58, thus allowing the coupling of the discharged body 56 to be fixed to the second end) and is arranged adjacent to an end of the ureteral stent 54 within a limited period of time (Fig. 5); the ureteral stent comprises a nondegradable base layer (formed from polyurethane, see page 16, lines 10-16). Lee et al. does not expressly disclose a degradable coating and wherein the nondegradable base layer and the degradable coating are sequentially arranged from an inside to an outside. McIntyre et al. teaches a ureteral stent in the same field of endeavor comprising a substrate/base layer formed from polyurethane (column 6, lines 40-54) and coating layer provided onto the underlying uterine device body (column 5, lines 54-67 and column 6, lines 1-62 and column 8, lines 18-24), the coating layer formed of a degradable polymer (column 6, lines 34-67, column 7, lines 29-41 and column 8, lines 60-67 and column 9, lines 10-16) such as polylactic acid, polyglycolic acid, polylactic-glycolic acid copolymer, polydioxanone, chitosan, alginates (column 10, lines 4-30) for the purpose of having a biocompatible polymer that is suitable for an implantable medical device and degrades to control release at least one therapeutic agents for treating a uterine condition (column 5, lines 4-30). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s ureteral stent to further include a biodegradable coating onto of the base/substrate of the stent as taught by McIntyre et al. for the purpose of having a biocompatible polymer that is suitable for an implantable medical device and degrades to control release at least one therapeutic agent for treating a uterine condition.
Regarding Claim 2, Lee et al. discloses wherein the nondegradable base layer is made of polyurethane or silica gel (formed from polyurethane, see page 16, lines 10-16). However, Lee et al. does not expressly disclose wherein the coating layer is made of a degradable material selected from polylactic acid, polyglycolic acid, polylactic-glycolic acid copolymer, chitosan, alginate-based material, polyhydroxyalkanoate, and polydioxanone. McIntyre et al. teaches a ureteral stent in the same field of endeavor comprising a substrate/base layer formed from polyurethane (column 6, lines 40-54) and coating layer provided onto the underlying uterine device body (column 5, lines 54-67 and column 6, lines 1-62 and column 8, lines 18-24), the coating layer formed of a degradable polymer (column 6, lines 34-67, column 7, lines 29-41 and column 8, lines 60-67 and column 9, lines 10-16) such as polylactic acid, polyglycolic acid, polylactic-glycolic acid copolymer, polydioxanone, chitosan, alginates (column 10, lines 4-30) for the purpose of having a biocompatible polymer that is suitable for an implantable medical device and degrades to control release at least one therapeutic agents for treating a uterine condition (column 5, lines 4-30). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s ureteral stent to further include a biodegradable coating formed from polydioxanone or polylactic acid, poly glycolic acid onto of the base/substrate of the stent as taught by McIntyre et al. for the purpose of having a biocompatible polymer that is suitable for an implantable medical device and degrades to control release at least one therapeutic agent for treating a uterine condition.
Regarding Claim 8, Lee et al. discloses wherein the degradable fixture is one or more of a degradable wire, the degradable wire is a binary copolymer formed by a polymerization of glycolide and lactide, terpolymers or alginate polymers formed by a polymerization of glycolide, lactide, and caprolactone (page 16, lines 17-30).
Regarding Claim 9, Lee et al. discloses wherein a length of the traction wire is longer than a length of a human urethra (as seen in Figure 10, wherein Lee discloses the retrieval string is long to extend outside the patient’s urethra, see page 7, lines 20-26), the traction wire is a non-absorbent and nondegradable wire (page 5, lines 13-24), and some points on a line segment of the traction wire are simultaneously fixed by a degradable wire to be folded (see plurality of folds/undulations wrapped around the degradable structure 58, see Figure 5 in the form of a single “wire”).
Regarding Claim 10, Lee et al. discloses wherein a surface of the discharged body 56 is smooth (as seen in Figure 5, the outer surface has no ridges or textured surface, just smooth area), a density of the discharged body is higher than a density of water (page 8, lines 11-16, the discharged body 56 is formed from a metal having a density greater than 1.0 g/ml wherein it is known in the medical art, the density of water is about 1.0 g/ml); the traction wire 52 is embedded into the discharged body and the degradable wire 58 passes through a hole (see Figure 5). However, in the embodiment used in the rejection above, Figure 5 does not expressly disclose the discharged body has a plurality of through holes, wherein the degradable wire and traction wire are configured to pass through the plurality of through holes to bind the discharged body, and a largest through hole of the plurality of through holes has a hole size allowing a loach guide wire or a zebra guide wire to pass through. In an alternative embodiment as seen in Figures 3A-3D, Lee teaches a discharged body in the same field of endeavor, wherein the discharged body 30, 31 includes a plurality of through holes for allowing the traction wire to be attached to the discharged device (page 6, lines 25-34). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s discharged body to further include a plurality of through holes as taught in Figures 3A-3D for securing the traction wire to be attached to the discharged device (page 6, lines 25-34). Although, Lee et al. does not expressly disclose the plurality of through holes have varying sizes. It would have been an obvious matter of design choice to modify Lee’s plurality of through holes to have varying sizes, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Also, Lee discloses the traction wire can be different shapes (see Figure 12), therefore, it would have been obvious to vary the size of the through holes to allow for the passage of the different sizes of traction wires or additional wires, including guide wires to aid in the surgery/placement of the ureteral stent.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. WO2013/177068 A1 in view of McIntyre et al. U.S. Patent 7,862,552 B2 and further in view of Ruane et al. WO 2008/042228 A3.
Regarding Claim 3, Lee et al. as modified by McIntyre does not expressly disclose wherein a hydrophilic coating is arranged between the nondegradable base layer and the degradable coating, and the hydrophilic coating is made of one of polyacrylamide, polyvinylpyrrolidone, polyoxyethylene, hydrogel, and sodium hyaluronate. Ruane teaches a ureteral stent in the same field of endeavor (abstract), the stent having a surface formed from polyurethane (paragraphs [0075], [0080]) and a primer layer added to the surface of the ureteral stent before the deposition of the biodegradable coating (paragraphs [0013], [0093]), the primer layer is formed from a hydrophilic coating, polyvinylpyrrolidone (paragraph [0093]) for the purpose of promoting adhesion of further coating layers to the stent surface (paragraph [0092]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Lee’s ureteral stent to further include a hydrophilic coating in the form of polyvinylpyrrolidone arranged between the base layer and the degradable coating as taught by Ruane for the purpose of promoting adhesion of further coating layers to the stent surface.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. WO 2017/180386 A1 in view of Lyu CN 212166306 U and further in view of Ruane et al. WO 2008/042228 A3.
Regarding Claim 1, Koh et al. discloses a controllable operation-free take-out ureteral stent 16 (abstract and page 1, lines 17-23 and page 2, lines 28-32) as seen in Figures 1A-2, comprising: a ureteral stent 16, a traction wire 18, a discharged body 20, wherein the discharged body 20 is fixed on a first end of the traction wire 18 (page 4, lines 21-27 and page 5, lines 15-31 and as seen in Figure 2); the ureteral stent comprises a base layer (Koh discloses the stent is made from polymers, see page 4, lines 5-6) as described in the disclosed patent 9,445,884 Barron the ureteral stent can be formed from the polymer polyurethane, see page 8, lines 15-31) and a coating comprising a biocompatible polymer (page 5, lines 4-6). Koh et al. does not expressly disclose a degradable fixture and the degradable fixture fixes the discharged body on a second end of the traction wire and is arranged adjacent to an end of the ureteral stent within a limited period of time. Lyu teaches a ureteral stent in the same field of endeavor, the stent having a traction wire 2 and a degradable fixture 3 in the form of an adhesive that bonds a second end of the traction wire to the ureteral stent forming a plurality of folds along the traction wire, wherein the degradation of the degradable fixture 3 allows the folds to be unfolded to release the traction wire (paragraphs [0009-0011]) for the purpose of allowing the folds of the traction wire to be lengthened and allow the second end of the traction wire to be discharged from the urethral opening of the patient and allow the patient to draw the stent out of the body (paragraphs [0010-011]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s ureteral stent to further include a degradable fixture in the form of an adhesive that couples the second end of a traction wire to the ureteral stent (Koh discloses the traction wire includes a discharged body on the second end of the traction wire, therefore using this teaching would place the discharged body adjacent to an end of the ureteral stent for a limited period of time until the degradable fixture is absorbed) as taught by Lyu for the purpose of allowing the folds of the traction wire to be lengthened and allow the second end of the traction wire to be discharged from the urethral opening of the patient and allow the patient to draw the stent out of the body. In addition, Koh et al. does not expressly disclose a degradable coating and wherein the nondegradable base layer and the degradable coating are sequentially arranged from an inside to an outside. Ruane teaches a ureteral stent in the same field of endeavor (abstract), the stent having a surface formed from polyurethane (paragraphs [0075-0076], [0080] and [0107]) and a primer layer added to the surface of the ureteral stent before the deposition of the biodegradable coating (paragraphs [0013], [0093] and [0098]), the biodegradable coating is formed from PLGA, PLA (paragraph [0013]) for the purpose of having a biocompatible material that would further aid in the rate of release of therapeutic agents upon implantation of the ureteral stent (paragraphs [0012] and [0035]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s coating layer to be formed on top of the base layer and formed from a degradable material selected from PLA as taught by Ruane et al. for the purpose of having a biocompatible material that would further aid in the rate of release of therapeutic agents upon implantation of the ureteral stent.
Regarding Claim 2, Koh et al. does not expressly disclose wherein the coating layer is made of a degradable material selected from polylactic acid, polyglycolic acid, polylactic-glycolic acid copolymer, chitosan, alginate-based material, polyhydroxyalkanoate, and polydioxanone. Ruane teaches a ureteral stent in the same field of endeavor (abstract), the stent having a surface formed from polyurethane (paragraphs [0075], [0080]) and a primer layer added to the surface of the ureteral stent before the deposition of the biodegradable coating (referred to as the carrier layer, paragraphs [0013], [0093]), the primer layer is formed from a hydrophilic coating, polyvinylpyrrolidone (paragraph [0093]) and the biodegradable coating is formed from PLGA, PLA for the purpose of having a biocompatible material that would further aid in the rate of release of therapeutic agents upon implantation of the ureteral stent (paragraphs [0012] and [0035]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s coating layer to be formed from a degradable material selected from PLA as taught by Ruane et al. for the purpose of having a biocompatible material that would further aid in the rate of release of therapeutic agents upon implantation of the ureteral stent.
Regarding Claim 3, Koh et al. does not expressly disclose wherein a hydrophilic coating is arranged between the nondegradable base layer and the degradable coating, and the hydrophilic coating is made of one of polyacrylamide, polyvinylpyrrolidone, polyoxyethylene, hydrogel, and sodium hyaluronate. Ruane teaches a ureteral stent in the same field of endeavor (abstract), the stent having a surface formed from polyurethane (paragraphs [0075], [0080]) and a primer layer added to the surface of the ureteral stent before the deposition of the biodegradable coating (paragraphs [0013], [0093]), the primer layer is formed from a hydrophilic coating, polyvinylpyrrolidone (paragraph [0093]) for the purpose of promoting adhesion of further coating layers to the stent surface (paragraph [0092]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s ureteral stent to further include a hydrophilic coating in the form of polyvinylpyrrolidone arranged between the base layer and the degradable coating as taught by Ruane for the purpose of promoting adhesion of further coating layers to the stent surface.
Regarding Claim 4, Koh et al. discloses wherein the ureteral stent comprises a stent body and a forward J-shaped tube (as seen in Figures 1A-2 and page 2, lines 5-6), wherein the stent body is tubular and a first end of the stent body far from the discharged body is connected to the forward J-shaped tube; a drainage channel 15 runs through between the stent body and the forward J-shaped tube (as seen in Figure 1B), the drainage channel 15 is located in the nondegradable base layer and runs through a front and a back (as seen in Figure 1B and page 4, lines 5-20), and a plurality of drainage holes 17 communicating with an outside and the drainage channel 15 are respectively arranged on the stent body and the forward J-shaped tube (page 4, lines 5-20).
Regarding Claim 5, Koh et al. discloses wherein a second end of the stent body adjacent to the discharged body 20 is further provided with a bladder retaining structure 13 (page 2, lines 20-23), wherein the bladder retaining structure 13 is an inverted J-shaped tube (as seen in Figure 2, page 4, lines 5-20), and a ring size of the inverted J-shaped tube is smaller than a ring size of the forward J-shaped tube.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. WO 2017/180386 A1 in view of LV CN 212166306 U and further in view of Ruane et al. WO 2008/042228 A3 and further in view of Yan et al. CN 109745612 A.
Regarding Claim 6, Koh et al. does not expressly disclose wherein the other end of the bladder retaining structure is connected to an end of an anti-reflux water-retaining soft sleeve, and a length of the anti-reflux water-retaining soft sleeve is greater than or equal to twice a width of the bladder retaining structure. Yan et al. teaches a ureteral stent in the same field of endeavor comprising a ureteral stent body 6 having a bladder retention section 3 which is connected to anti-reflux water retaining soft sleeve 4, the sleeve 4 has a length greater than a width of the bladder retaining structure (as seen in Figure 1) for the purpose of preventing the reflux of urine in the urinary bladder to the renal pelvis and prevent renal damage and prevent the ureter stent from falling off the bladder (abstract). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s ureteral stent to further include an anti-reflux water-retaining soft sleeve connected to a bladder retaining structure as taught by Yan et al. for the purpose of preventing the reflux of urine in the urinary bladder to the renal pelvis and prevent renal damage and prevent the ureter stent from falling off the bladder.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koh et al. WO 2017/180386 A1 in view of LV CN 212166306 U and further in view of Ruane et al. WO 2008/042228 A3 and further in view of Balbierz et al. U.S. Patent 5,599,291.
Regarding Claim 7, Koh et al. discloses a J-shaped tube having a bladder retaining structure 13 (as seen in Figures 1A-2). However, Koh et al. does not expressly disclose wherein a plurality of marking scales for a length measurement are arranged outside the stent body, and a hardness of the forward J-shaped tube, the stent body and the bladder retaining structure gradually becomes softer, and diameters of the forward J-shaped tube and the stent body gradually become smaller. Balbierz et al. teaches a ureteral stent in the same field of endeavor comprising a J-shaped tube having a first end portion and a second end portion, wherein the first end forms the kidney end having a stiff material for better retention and a second end, a bladder end having a softer material to provide more comfort for the patient, wherein the ureteral stent has an initial diameter and is formulated with a polymer capable of hydrating such that the stent softens or expands to different degree of strength at different locations and after hydration the final ureteral diameter decreases to a smaller diameter (page 3, lines 1-25 and page 4, lines 10-20). In addition, the ureteral stent 110 includes a plurality of markings 44 along the length of the stent 110 so as to render the stent visible during x-ray or fluoroscopic examination so that confirmation that the stent has been correctly position within the ureter can be obtained (page 11, lines 45-67). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s ureteral stent to further include a plurality of markings along the length of the stent so as to confirm the placement of the stent and allow the visualization of the stent during x-ray and fluoroscopic imaging. Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Koh’s ureteral stent to further have an initial outer diameter and is formulated with a polymer capable of hydrating such that the stent softens or expands to different degree of strength at different locations and after hydration the final ureteral diameter decreases to a smaller diameter.
Conclusion
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774