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, 2, 6, 11, 16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stupecky (US PGPub 2007/0167973).
Regarding Claim 1, Stupecky teaches a catheter balloon (Figure 19-20D) comprising
a first layer (17; Figure 20D)(24; Figure 8A) and a second layer (19; Figure 20D) (22; Figure 8A) disposed adjacent to each other in a thickness direction of the balloon (Figure 20D),
the first layer (17) and the second layer (19) can being made of different materials (Paragraph 0024, 0091, 0107), and
a rupture strength (burst strength) of the first layer (17) and a rupture strength of the second layer (19) being the same (Paragraph 0024, 0107).
While Stupecky does not explicitly state that the first and second layer are formed of different materials, Stupecky does state “using substantially identical balloons for each layer of the multi-layer balloon makes each balloon layer have a substantially similar burst pressure, ensuring that they burst substantially simultaneously and reducing the possibility of sub-optimal inflation of any layer 20, 22, 24 of the multi-layer balloon. It will be apparent that balloons of different material may require different sizes and shapes to achieve this effect.” In Paragraph 0091. Furthermore Stupecky discloses ion Paragraph 0096, optimizing the radial stretch is more important to burst resistance than longitudinal stretch. See Paragraphs 0094-0097
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Stupecky such that the first and second layers are formed of different materials but the rupture strength be the same, given that rupture strength/burst strength is a result effective variable dependent on the preconditioning process during the formation (Paragraph 0093-0097), it would have been obvious to one of ordinary skill in the art to optimize the rupture strength of the balloon layer through routine experimentation in order to achieve a desirable flexural modulus for the dilator. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore the multilayer balloon with different materials having the same rupture strength recited in claim 1 is merely an obvious variant of the prior art.
Regarding Claim 2, Stupecky teaches the catheter balloon according to Claim 1, wherein the
second layer (16; Figure 20D) (22; Figure 8A) covers the first layer (17; Figure 20D) (24; Figure 8A), and
an elongation percentage of the first layer (17) (24) is larger than an elongation percentage of the second layer (16) (22) (Paragraph 0091 discloses that the inner most layer must stretch more than the other layers since it starts at a smaller diameter but stretches to match the outer most layer).
Regarding Claim 6, Stupecky teaches the catheter balloon according to Claim 1, further comprising
a third layer (15 Figure 20D) (20; Figure 8A) disposed adjacent to the second layer (16) (22; Figure 8A) and covering the second layer (16; Figure 20D)(22; Figure 8A),
wherein a rupture strength of the third layer is the same as the rupture strength of the first layer and the rupture strength of the second layer (Paragraph 0024, 0107).
Regarding Claim 11, Stupecky teaches a catheter balloon connected to a shaft portion and having an interior configured to receive a fluid to expand the catheter balloon (Figure 1), the catheter balloon comprising:
a distal end portion and a proximal end portion at opposite ends of the catheter balloon, the distal end of the catheter balloon being fixed to the shaft portion and the proximal end of the catheter balloon ballon being fixed to the shaft so that an interior of the catheter balloon forms a space configured to receive a fluid to expand the catheter balloon (Figure 1A; Paragraph 0078-0079);
a first layer made of a material and a second layer made of a material, the material from which the first layer is made being different from the material from which the second layer is made;
the second layer being positioned in covering relation to the first layer; the first layer possessing a rupture strength, the second layer possessing a rupture strength; and
the rupture strength of the first layer being the same as the rupture strength of the second layer.
a first layer (17; Figure 20D)(24; Figure 8A) made of a material and a second layer (19; Figure 20D) (22; Figure 8A) made of a material, the material from which the first later is made being different from the material from which the second layer is made (Paragraph 0024, 0091, 0107), and
the second layer (22) being positioned in covering relation to the first layer (23) (Figure 8A);
the first layer possessing a rupture strength, the second layer possessing a rupture strength (Paragraph 0029 and 0107);
the rupture strength (burst strength) of the first layer (17) being the same as the rupture strength of the second layer (19) (Paragraph 0024, 0107).
While Stupecky does not explicitly state that the first and second layer are formed of different materials, Stupecky does state “using substantially identical balloons for each layer of the multi-layer balloon makes each balloon layer have a substantially similar burst pressure, ensuring that they burst substantially simultaneously and reducing the possibility of sub-optimal inflation of any layer 20, 22, 24 of the multi-layer balloon. It will be apparent that balloons of different material may require different sizes and shapes to achieve this effect.” In Paragraph 0091. Furthermore Stupecky discloses ion Paragraph 0096, optimizing the radial stretch is more important to burst resistance than longitudinal stretch. See Paragraphs 0094-0097
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the teachings of Stupecky such that the first and second layers are formed of different materials but the rupture strength be the same, given that rupture strength/burst strength is a result effective variable dependent on the preconditioning process during the formation (Paragraph 0093-0097), it would have been obvious to one of ordinary skill in the art to optimize the rupture strength of the balloon layer through routine experimentation in order to achieve a desirable flexural modulus for the dilator. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore the multilayer balloon with different materials having the same rupture strength recited in claim 1 is merely an obvious variant of the prior art.
Regarding Claim 16, Stupecky teaches the catheter balloon connected to the shaft portion according to Claim 11, wherein the material forming the first layer has an elongation percentage and the material forming the second layer has an elongation percentage, the elongation percentage of the material forming the first layer being greater than the elongation percentage of the material forming the second layer (Paragraph 0091 discloses that the inner most layer must stretch more than the outer other layers since it starts at a smaller diameter but stretches to match the outer most layer).
Regarding Claim 18, Lin the catheter balloon connected to the shaft portion according to Claim 11, wherein the material forming the first layer has a tensile modulus of elasticity and the material forming the second layer has a tensile modulus of elasticity, the tensile modulus of elasticity of the material forming the first layer being greater than the tensile modulus of elasticity of the material forming the second layer.
Lin teaches in Paragraph 0091 that the inner most layer must stretch more than the outer other layers since it starts at a smaller diameter but stretches to match the outer most layer).
It would have been obvious to one of ordinary skill in the art to choose a material where the first layer has a tensile modulus of elasticity greater than the tensile modulus of elasticity of the second layer for the advantage that the first layer must stretch more than the second layer to reach the same expanded diameter. Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the materials of layers of the ballons using the materials as taught by Lin, 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 19, Stupecky teaches the catheter balloon connected to the shaft portion according to Claim 11, further comprising:
a third layer (15 Figure 20D) (20; Figure 8A) overing the second layer (16) (22; Figure 8A) and covering the second layer (16; Figure 20D)(22; Figure 8A),
the third layer having a rupture strength that is the same as the rupture strength of the first layer and the rupture strength of the second layer (Paragraph 0024, 0107).
Claim(s) 3-5, 10, 12-15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stupecky (US PGPub 2007/0167973) as applied to claim 1, 2, 6, 11 and 19 above, and further in view of Lin (US PGPub 2015/0290434).
Regarding Claim 3, Stupecky teaches the catheter balloon according to Claim 2, but fails to disclose wherein hardness of the first layer is smaller than hardness of the second layer.
Lin teaches a multilayered balloon wherein the hardness of the first layer (inner most layer; 32) is smaller than a hardness of the second layer (31; middle later; Figure 3; Paragraph 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the layers of Stupecky to have the layer hardness taught by Lin, for the advantage of the presence of the lower durometer material inner layer provides increased softness and more flexibility and thus a better ability to track than a balloon formed of 100% of the highest durometer material. The presence of the lower durometer inner layer also provides better refolding after inflation (Paragraph 0050; Lin)
Regarding Claim 4, the combination of references disclosed above teaches the catheter balloon according to Claim 3, wherein Lin teaches a tensile modulus of elasticity of the first layer is smaller than a tensile modulus of elasticity of the second layer (Paragraph 0058 of Lin discloses that the second layer (middle layer) has a tensile modulus than the first layer (outermost) and third layer (inner most).
It would have been obvious to one of ordinary skill in the art to modify the prior art to include the teachings of Lin for the advantage of providing increased rupture pressure, decreased compliance, and/or to reduce axial growth of the balloon (Paragraph 0058; Lin)
Regarding Claim 5, Stupecky teaches the catheter balloon according to Claim 1, wherein the second layer is a polyamide (Paragraph 0125) but fails to disclose:
the first layer is any one of a polyamide elastomer, a polyurethane, and a polyurethane elastomer,
Lin teaches a multilayers balloon wherein the second layer is a polyamide (nylon) and the first layer (inner layer/third layer) is formed of a PEBA material (Paragraph 0057-0058).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the materials of layers of the ballons using the materials as taught by Lin, 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 10, the combination of references disclosed above teaches the catheter balloon according to Claim 6, wherein Lin teaches
the first layer is a polyamide elastomer (PEBA; Paragraph 0057-0058),
the second layer is a polyamide (Nylon; Paragraph 0058), and
the third layer is a polyamide elastomer (PEBA, Paragraph 0057-0058).
Regarding Claim 12, Stupecky teaches the catheter balloon connected to the shaft portion according to Claim 11, but fails to disclose wherein the material forming the first layer is a polyamide elastomer, a polyurethane or a polyurethane elastomer, and the material forming the second layer is a polyamide.
Lin teaches a multilayers balloon wherein the material forming the first layer (inside layer) is a polyamide elastomer, a polyurethane or a polyurethane elastomer (PEBA; Paragraph 0057-0058), and the material forming the second layer is a polyamide (nylon; Paragraph 0058).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the materials of layers of the ballons using the materials as taught by Lin, 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 13, the combination of references disclosed above teaches the catheter balloon connected to the shaft portion according to Claim 12, wherein Stupecky teaches the material forming the first layer has an elongation percentage and the material forming the second layer has an elongation percentage, the elongation percentage of the material forming the first layer being greater than the elongation percentage of the material forming the second layer (Paragraph 0091 discloses that the inner most layer must stretch more than the outer other layers since it starts at a smaller diameter but stretches to match the outer most layer).
Regarding Claim 14, teaches the catheter balloon connected to the shaft portion according to Claim 12, wherein the material forming the first layer has a hardness and the material forming the second layer has a hardness, the hardness of the material forming the first layer (inner most layer 32) being less than the hardness of the material forming the second layer (31; middle later; Figure 3; Paragraph 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the layers of Stupecky to have the layer hardness taught by Lin, for the advantage of the presence of the lower durometer material inner layer provides increased softness and more flexibility and thus a better ability to track than a balloon formed of 100% of the highest durometer material. The presence of the lower durometer inner layer also provides better refolding after inflation (Paragraph 0050; Lin)
Regarding Claim 15, the combination of references disclosed above teaches the catheter balloon connected to the shaft portion according to Claim 12, wherein Lin teaches the material forming the first layer has a tensile modulus of elasticity and the material forming the second layer has a tensile modulus of elasticity, the tensile modulus of elasticity of the material forming the first layer being greater than the tensile modulus of elasticity of the material forming the second layer. (Paragraph 0058 of Lin discloses that the second layer (middle layer) has a tensile modulus than the first layer (outermost) and third layer (inner most).
It would have been obvious to one of ordinary skill in the art to modify the prior art to include the teachings of Lin for the advantage of providing increased rupture pressure, decreased compliance, and/or to reduce axial growth of the balloon (Paragraph 0058; Lin)
Regarding Claim 17, teaches the catheter balloon connected to the shaft portion according to Claim 11, wherein the material forming the first layer has a hardness and the material forming the second layer has a hardness, the hardness of the material forming the first layer (inner most layer 32) being less than the hardness of the material forming the second layer (31; middle later; Figure 3; Paragraph 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the layers of Stupecky to have the layer hardness taught by Lin, for the advantage of the presence of the lower durometer material inner layer provides increased softness and more flexibility and thus a better ability to track than a balloon formed of 100% of the highest durometer material. The presence of the lower durometer inner layer also provides better refolding after inflation (Paragraph 0050; Lin)
Claim(s) 7-9 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stupecky (US PGPub 2007/0167973) and Lin (US PGPub 2015/0290434) as applied to claim 7 above, and further in view of Radisch (US PGPub 2005/0261721)
Regarding Claim 7, the combination of references disclosed above teaches the catheter balloon according to Claim 6, but fails to disclose wherein
an elongation percentage of the first layer and an elongation percentage of the third layer are the same, and
the elongation percentage of the first layer and the elongation percentage of the third layer are larger than an elongation percentage of the second layer.
Radisch discloses a multilayered balloon catheter having an inner and outer layer (first and second later) and a intermediate (third layer), wherein the inner and outer layers are formed on the same polymeric material (Paragraph 0044) and the third (intermediate layer) is formed of a another material (Paragraph 0044) wherein the third layer is sandwiched between the first and second layers (Paragraph 0033).
It would have been obvious to one of ordinary skill in the art to modify the combination of references such that the first and second layers are formed of the same materials taught by Lin, such that the elongation percent of the first and third layers are the same and the elongation percent of the intermediate layer would be smaller than the first and second layers 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 8, the combination of references disclosed above teaches the catheter balloon according to Claim 7, but fails to disclose wherein
a hardness of the first layer and hardness of the third layer are the same, and
the hardness of the first layer and the hardness of the third layer are smaller than hardness of the second layer.
Radisch discloses a multilayered balloon catheter having an inner and outer layer (first and second later) and an intermediate (third layer), wherein the inner and outer layers are formed on the same polymeric material (Paragraph 0044) and the third (intermediate layer) is formed of a another material (Paragraph 0044) wherein the third layer is sandwiched between the first and second layers (Paragraph 0033).
It would have been obvious to one of ordinary skill in the art to modify the combination of references such that the first and second layers are formed of the same materials taught by Lin, such that the hardness of the first and third layers are the same and the hardness of the intermediate layer would be larger than the first and second layers 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 9, the combination of references disclosed above teaches the catheter balloon according to Claim 8, but fails to disclose wherein
a tensile modulus of elasticity of the first layer and a tensile modulus of elasticity of the third layer are the same, and
the tensile modulus of elasticity of the first layer and the tensile modulus of elasticity of the third layer are smaller than a tensile modulus of elasticity of the second layer.
Radisch discloses a multilayered balloon catheter having an inner and outer layer (first and second later) and an intermediate (third layer), wherein the inner and outer layers are formed on the same polymeric material (Paragraph 0044) and the third (intermediate layer) is formed of a another material (Paragraph 0044) wherein the third layer is sandwiched between the first and second layers (Paragraph 0033).
It would have been obvious to one of ordinary skill in the art to modify the combination of references such that the first and second layers are formed of the same materials taught by Lin, such that the tensile modulus of elasticity of the first and third layers are the same and the tensile modulus of elasticity of the intermediate layer would be larger than the first and second layers 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Regarding Claim 20, the combination of references disclosed above teaches the catheter balloon connected to the shaft portion according to Claim 19, wherein but fails to disclose the third layer is made of a material having an elongation percentage and a hardness, the elongation percentage of the material forming the third layer being the same as the elongation percentage of the material forming the first layer, the hardness of the material forming the third layer being the same as the hardness of the material forming the first layer.
Radisch discloses a multilayered balloon catheter having an inner and outer layer (first and second later) and an intermediate (third layer), wherein the inner and outer layers are formed on the same polymeric material (Paragraph 0044) and the third (intermediate layer) is formed of a another material (Paragraph 0044) wherein the third layer is sandwiched between the first and second layers (Paragraph 0033).
It would have been obvious to one of ordinary skill in the art to modify the combination of references such that the first and second layers are formed of the same materials taught by Lin, such that the elongation percentage and a hardness of the first and third layers are the same 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, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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