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 Objections
Claim 26 is objected to because of the following informalities: “wherein the each of the plurality of stiffening elements” should be changed to “wherein each of the plurality of stiffening elements”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 21-24, 26-29, 31-35 and 37-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hewitt et al. US 2016/0249934.
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)).
Regarding claim 22, 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 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 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 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).
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).
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) 25, 30, 36, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hewitt et al. US 2016/0249934.
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 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.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771