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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-40 have been considered but are moot because the new ground of rejection over Hewitt et al. US 2016/0249934 in view of Hyodoh et al. US 2003/0040771, as discussed below.
Hewitt et al. discloses wherein the plurality of stiffening elements comprise a plurality of DFT wires (paragraph 0294, filaments may made of nickel titanium with a core of platinum or platinum alloy, or may be drawn filled tubes (DFT) and supply strength, stiffness and radiopacity (paragraph 0294), but does not explicitly disclose wherein each of the plurality of stiffening elements has a helical shape.
Hyodoh et al. teaches an intravascular occluding device having an expandable shell 700, wherein the proximal portion includes at least one coil 714 stiffening element having a helical shape (figure 57C) to increase the thrombogenicity of the occluder (paragraph 0239). Examiner further notes that the helical coils of Hyodoh et al. are have the same structure and may also be filaments or wires, such as stainless steel or nitinol wires, that are manually wrapped around the segments and attached to the segments in any suitable fashion, such as formed helically around the shell. The coil pieces may be pre-formed hollow pieces of coil made from any suitable metal or alloy. The coils with lumens are wrapped around filaments of the occluding device and the coil segments 714 and may be made from stainless steel or nitinol (paragraph 239), similar to the present invention (as disclosed in paragraph 23, coils can be made of nitinol or stainless steel). The present invention additionally discloses that increasing the effective diameter of the filament by adding the coil wrapped around the filament would directly contribute to the stiffness based on the stiffness relationship to the diameter of the wire (present invention, paragraph 0023).
Therefore, it would have been obvious to one having ordinary skill in the art to wrap the stiffening element filaments or wires of Hewitt et al. in a helical fashion, as taught by Hyodoh et al. as known in the art to provide additional strength and thrombogenicity of the occluder by helically wrapping the shell with stiffening filaments or wires.
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) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewitt et al. US 2016/0249934 in view of Hyodoh et al. US 2003/0040771.
Regarding claim 21, Hewitt et al. discloses a device for treatment of a patient's cerebral aneurysm, comprising: a resilient self-expanding permeable shell (1200 or 1300, figures 55, 56) including a radially constrained elongated state configured for delivery within a catheter lumen (paragraph 0292, the mesh device 1200, 1300 may be radially constrained into a smaller diameter, and fit through a smaller microcatheter lumen), an expanded state with a longitudinally shortened configuration relative to the radially constrained state (once expanded from catheter to form shell, expands outward, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, figures 55, 56, paragraph 0247), and a plurality of elongate filaments that are woven together to form a mesh and define a cavity of the permeable shell (figures 55, 56, filaments 1005, paragraph 0294, 0297), wherein the permeable shell comprises a proximal (adjacent the aneurysm neck, 1208 or 1308, figures 55, 56), and a distal portion (1210 or 1310, figures 55, 56), and a plurality of stiffening elements associated with the proximal portion of the permeable shell (paragraph 0294, figures 57, 58, smaller and medium wires may be included to provide a higher density portion adjacent the neck of the aneurysm, or the proximal portion of the shell, the medium wires may supply strength, stiffness and radiopacity; Examiner notes the wires are wound throughout the shell, therefore, would also be considered to be associated with at least the proximal portion), wherein the plurality of stiffening elements comprise a plurality of DFT wires (paragraph 0294, filaments may be made from platinum or platinum alloy, or may be drawn filled tubes (DFT)), but fails to disclose each of the stiffening elements having a helical shape.
Hyodoh et al. teaches an intravascular occluding device having an expandable shell 700, wherein the proximal portion includes at least one coil 714 stiffening element having a helical shape (figure 57C) to increase the thrombogenicity of the occluder (paragraph 0239). Examiner further notes that the helical coils of Hyodoh et al. are have the same structure and may also be filaments or wires, such as stainless steel or nitinol wires, that are manually wrapped around the segments and attached to the segments in any suitable fashion, such as formed helically around the shell. The coil pieces may be pre-formed hollow pieces of coil made from any suitable metal or alloy. The coils with lumens are wrapped around filaments of the occluding device and the coil segments 714 and may be made from stainless steel or nitinol (paragraph 239), similar to the present invention (as disclosed in paragraph 23, coils can be made of nitinol or stainless steel). The present invention additionally discloses that increasing the effective diameter of the filament by adding the coil wrapped around the filament would directly contribute to the stiffness based on the stiffness relationship to the diameter of the wire (present invention, paragraph 0023).
Therefore, it would have been obvious to one having ordinary skill in the art to wrap the stiffening element filaments or wires of Hewitt et al. in a helical fashion, as taught by Hyodoh et al. as known in the art to provide additional strength and thrombogenicity of the occluder by helically wrapping the shell with stiffening filaments or wires.
Regarding claim 22, Hewitt et al. in combination discloses wherein the plurality of elongate filaments has a first thickness and the plurality of stiffening elements has a second thickness (paragraph 0294, elongate filaments may include larger diameter wires or smaller diameter wires, and the DFT filaments or stiffening elements may comprise a medium diameter).
Regarding claim 23, Hewitt et al. discloses wherein the second thickness is greater than the first thickness (paragraph 0294, elongate filaments may include smaller diameter wires around 0.0005 inches to 0.001 inches for the first thickness, and the DFT filaments or stiffening elements may comprise a medium diameter around 0.00075 inches and 0.00125 inches for the second thickness, the second thickness being greater).
Regarding claim 24, Hewitt et al. discloses wherein the second thickness is less than the first thickness (paragraph 0294, elongate filaments may include larger diameter wires around 0.001 inches to 0.002 inches for the first thickness, and the DFT filaments or stiffening elements may comprise a medium diameter around 0.00075 inches and 0.00125 inches for the second thickness, the second thickness being less).
Regarding claims 25 and 36, Hewitt et al. discloses wherein the plurality of elongate filaments has a first thickness and the stiffening elements have a second thickness (paragraph 0018), and the elongate filaments may have a mixture of nitinol wires and drawn filled tubes (paragraph 0018), the dimension of the elongate filaments may have a dimension about .0005 inches to .002 inches or alternatively between about .00075 to .00125 inches, but fails to explicitly disclose the second thickness is equal to the first thickness. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a second thickness is equal to a first thickness, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Examiner notes the dimension of both types of filaments may be within the ranges of about .0005 inches to .002 inches or alternatively between about .00075 to .00125 inches, and may be equal or different dimensions as required for the desired characteristics of the shell.
Regarding claim 26, Hewitt et al. discloses wherein the each of the plurality of stiffening elements is interwound in the mesh in the proximal portion the resilient permeable shell (figures 5, 7; paragraph 0294, filaments including DFT filaments are interwound within the mesh therefore, in at least the proximal portion).
Regarding claim 27, Hewitt et al. discloses the device essentially as claimed, wherein the plurality of stiffening elements are incorporated into at least about 40% to about 100% of the proximal portion of the permeable shell (paragraph 0010, 0238; shell includes at least 40% composite filaments relative to a total number of filaments, the composite filaments being the stiffening elements, such as the DFT wires). Examiner notes the stiffening elements are incorporated throughout the shell, therefore, would also be considered to be associated with at least the proximal portion.
Regarding claim 28, Hewitt et al. discloses wherein the proximal portion is about 1/3 to about 1/4 of a length of an expanded state of the permeable shell (Examiner notes that the proximal portion may be considered 1/3 to about 1/4 of a length of the expanded state of the permeable shell, as the proximal portion may be considered any proximal segment of the whole shell).
Regarding claim 29, Hewitt et al. discloses wherein the proximal portion extends from a proximal end of the permeable shell to about 40% or less of a total length of an expanded state of the permeable shell (Examiner notes that the proximal portion may be considered extends from a proximal end of the permeable shell to about 40% or less of a total length of an expanded state of the permeable shell, as the proximal portion may be considered any proximal segment of the whole shell).
Regarding claims 30 and 40, Hewitt et al. discloses the device essentially as claimed, but fails to disclose wherein the plurality of stiffening elements comprise a number of stiffening elements selected from the group consisting of between about 2 and about 10, about 3 and about 12, about 4 and about 8, about 5 and about 10, about 5 and about 15, about 2 and about 30, and about 2 and about 25.
However, Hewitt et al. discloses the stiffening element filaments may be included in variable percentages (in relation to the total number of filaments) to in order to achieve a specific stiffness characteristic.
Therefore, it would have been obvious to modify Hewitt et al. with a plurality of stiffening elements comprise a number of stiffening elements selected from the group consisting of between about 2 and about 10, about 3 and about 12, about 4 and about 8, about 5 and about 10, about 5 and about 15, about 2 and about 30, and about 2 and about 25, as taught by Hewitt et al. and known in the art to vary the number of stiffening elements within the shell to achieve a specific stiffness characteristic as desired.
Regarding claim 31, Hewitt et al. discloses wherein each of the plurality of stiffening elements are coated with a hydrogel (paragraph 0221, coating embodiments may be disposed on the filaments, active materials such as a hydrogel may be attached or otherwise incorporated into the shell).
Regarding claim 32, Hewitt et al. discloses a method of treating method for treating an aneurysm having an interior cavity and a neck (for example, aneurysm 160 shown in figure 18), comprising the steps of: advancing an implant (for example, 1200 or 1300, figures 55, 56) in a microcatheter to a region of interest in an artery (paragraph 0013, implant is constrained within a microcatheter to a region of interest within a cerebral artery), wherein the implant comprises a resilient self-expanding permeable shell including a radially constrained elongated state configured for delivery within a catheter lumen (paragraph 0010 and 0247), an expanded state with a longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments that are woven together to form a mesh and define a cavity of the permeable shell (once expanded from catheter to form shell, expands outward, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, figures 55, 56, paragraph 0247), wherein the permeable shell comprises a proximal portion (adjacent the aneurysm neck, 1208 or 1308, figures 55, 56), and a distal portion (1210 or 1310, figures 55, 56), and a plurality of stiffening elements associated with the proximal portion of the permeable shell (paragraph 0294, figures 57, 58, smaller and medium wires may be included to provide a higher density portion adjacent the neck of the aneurysm, or the proximal portion of the shell, the medium wires may supply strength, stiffness and radiopacity; Examiner notes the wires are wound throughout the shell, therefore, would also be considered to be associated with at least the proximal portion), wherein the plurality of stiffening elements comprise a plurality of DFT wires (paragraph 0294, filaments may be made from platinum or platinum alloy, or may be drawn filled tubes (DFT)), deploying the implant within the aneurysm (figures 24-26, implant shown after deployed into an aneurysm), wherein the permeable shell expands to the expanded state in the interior cavity of the aneurysm (figures 24-26); and withdrawing the microcatheter from the region of interest after deploying the implant (paragraph 0013, microcatheter is withdrawn from the region of interest after deploying the implant), but fails to explicitly disclose wherein each of the plurality of stiffening elements has a helical shape.
Hyodoh et al. teaches an intravascular occluding device having an expandable shell 700, wherein the proximal portion includes at least one coil 714 stiffening element having a helical shape (figure 57C) to increase the thrombogenicity of the occluder (paragraph 0239). Examiner further notes that the helical coils of Hyodoh et al. are have the same structure and may also be filaments or wires, such as stainless steel or nitinol wires, that are manually wrapped around the segments and attached to the segments in any suitable fashion, such as formed helically around the shell. The coil pieces may be pre-formed hollow pieces of coil made from any suitable metal or alloy. The coils with lumens are wrapped around filaments of the occluding device and the coil segments 714 and may be made from stainless steel or nitinol (paragraph 239), similar to the present invention (as disclosed in paragraph 23, coils can be made of nitinol or stainless steel). The present invention additionally discloses that increasing the effective diameter of the filament by adding the coil wrapped around the filament would directly contribute to the stiffness based on the stiffness relationship to the diameter of the wire (present invention, paragraph 0023).
Therefore, it would have been obvious to one having ordinary skill in the art to wrap the stiffening element filaments or wires of Hewitt et al. in a helical fashion, as taught by Hyodoh et al. as known in the art to provide additional strength and thrombogenicity of the occluder by helically wrapping the shell with stiffening filaments or wires.
Regarding claim 33, Hewitt et al. discloses wherein the plurality of elongate filaments has a first thickness and the plurality of stiffening elements has a second thickness (paragraph 0294, elongate filaments may include larger diameter wires or smaller diameter wires, and the DFT filaments or stiffening elements may comprise a medium diameter).
Regarding claim 34, Hewitt et al. discloses wherein the second thickness is greater than the first thickness (paragraph 0294, elongate filaments may include smaller diameter wires around 0.0005 inches to 0.001 inches for the first thickness, and the DFT filaments or stiffening elements may comprise a medium diameter around 0.00075 inches and 0.00125 inches for the second thickness, the second thickness being greater).
Regarding claim 35, Hewitt et al. discloses wherein the second thickness is less than the first thickness (paragraph 0294, elongate filaments may include larger diameter wires around 0.001 inches to 0.002 inches for the first thickness, and the DFT filaments or stiffening elements may comprise a medium diameter around 0.00075 inches and 0.00125 inches for the second thickness, the second thickness being less).
Regarding claim 37, Hewitt et al. discloses wherein the each of the plurality of stiffening elements is interwound in the mesh in the proximal portion the resilient permeable shell (figures 5, 7; paragraph 0294, filaments including DFT filaments are interwound within the mesh therefore, in at least the proximal portion).
Regarding claim 38, Hewitt et al. discloses the device essentially as claimed, wherein the plurality of stiffening elements are incorporated into at least about 40% to about 100% of the proximal portion of the permeable shell (paragraph 0010, 0238; shell includes at least 40% composite filaments relative to a total number of filaments, the composite filaments being the stiffening elements, such as the DFT wires). Examiner notes the stiffening elements are incorporated throughout the shell, therefore, would also be considered to be associated with at least the proximal portion.
Regarding claim 39, Hewitt et al. discloses wherein the proximal portion extends from a proximal end of the permeable shell to about 40% or less of a total length of an expanded state of the permeable shell (Examiner notes that the proximal portion may be considered extends from a proximal end of the permeable shell to about 40% or less of a total length of an expanded state of the permeable shell, as the proximal portion may be considered any proximal segment of the whole shell).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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