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 filed 5/8/26 have been fully considered but they are not persuasive.
Applicant argues Wilson does not disclose a one-piece filament. Applicant argues Wilson discloses a shape memory polymer SMP 811, but does not disclose the SMP being slender or a filament.
Wilson et al. discloses an embolization device comprising a one-piece filament comprising a plurality of notches at least partially contributing to the shape of the embolization device in a deployed state. Examiner notes a one piece-filament may be considered only the element 811, as it is a single continuous piece of material or foam and forms a slender elongated body. A filament may be defined as: “a slender or threadlike structure or part” – The American heritage dictionary. Wilson et al. discloses the filament element 811 being a monolithic SMP (formed of a single piece of foam) having a compressed outer diameter of about .33 mm (paragraph 0101). Therefore, Wilson et al. discloses can be considered a slender structure – or considered a filament. Further, the claim does not require the body consisting of a one-piece filament, therefore still allows for another element to be coupled within, while the filament itself, or the foam component, is one-piece. Lippert further teaches various notch patterns depending on the shape desired.
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) 1-8, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. US 2021/0137527 in view of Lippert 2014/0257363.
Regarding claims 1, 2, and 11, Wilson et al. discloses an embolization device (for example, figures 2F, 8A, Examiner notes the filament may be a shorter version shown in figure 8A, or a longer version similar to device shown in figure 2F) to occlude a cavity within the body (for example, figure 3D, shown within an aneurysm or cavity, for example, device 800 to fill an aneurysm, paragraph 0040) comprising: a one-piece filament 811 (for example, figure 2F, 8A; paragraph 0038, portion 811 or the monolithic foam element formed of a single piece of foam, may be considered “one-piece filament” as it is a continuous material and forms a slender elongated body; a filament may be defined as: “a slender or threadlike structure or part” – The American heritage dictionary; Examiner further notes the claim does not require the body consisting of a one-piece filament, therefore still allows for another element to be coupled within, while the filament itself is one-piece) having a longitudinal axis extending therein (axis within center of portion 811); a plurality of notches (paragraph 0041, joints 821, 822, 823, joints may include slits broadly used to include for example, an aperture, cut, slice, compression, notch, cleft, breach, cleavage, fissure, and/or split) distributed in a pattern on the filament (figure 8A-8B), the pattern comprising angles of the notches at an oblique angle with respect to the longitudinal axis of the one-piece filament (figure 8B, notches are at an angle relative in the curved configuration), the pattern at least partially contributing to the shape of the embolization device in a deployed state by selectively biasing the embolization device to assume a shape (paragraph 0027, 0042; slits or notches allow for flexibility of the body, the filament or expandable polymer foam may comprise a shape memory polymer to be transitioned to the activated or expanded configuration), the pre-defined shape being based on the configuration of the cavity in which the embolization device is deployed (paragraph 0040, body 811 configured to fill partially or fully a void such as an aneurysm).
Wilson et al. fails to disclose a plurality of notches distributed in a non-uniform pattern.
Lippert teaches an embolic device (for example, figures 1, 3A-5B), a plurality of notches distributed in a non-uniform pattern (paragraph 0059, 0062, pattern may be repeated or different patterns may be used along different portions of the embolic device), the non-uniform pattern comprising angles of the notches at an oblique angle with respect to the longitudinal axis (paragraph 0060, embolic device may comprise varied cutting angle of the blade forming the notches, for example, figure 17B), the pattern at least partially contributing to the shape of the embolization device in a deployed state by selectively biasing the embolization device to assume a pre-defined shape (paragraph 0062, patterns that create coils that form a particular shape), the pre-defined shape being based on the configuration of the cavity in which the embolization device is deployed (paragraph 0057, cutting pattern may be used to control and alter the orientation of bending of the embolic device and/or the deployed state to facilitate occlusion of the aneurysm), wherein the non-uniform pattern comprises a non-uniform pattern of spacing, angle, orientation, depth, and/or shape of the plurality of notches to create an embolic device with the desired shape (paragraph 0060, 0071, 0073, size of the notches or angles of the notches or spacing may vary, the device folds based upon the cutting pattern, size and shape of the notches).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Wilson et al. with a plurality a plurality of notches in a non-uniform pattern, as taught by Lippert, in order to provide an embolic member having a pattern at least partially contributing to the shape of the embolization device in a deployed state by selectively biasing the embolization device to assume a pre-defined shape as required for occlusion.
Regarding claim 3, Wilson et al. discloses in combination wherein at least some of the plurality of notches extends in a direction different than the direction in which the longitudinal axis extends (figures 8A, 8B, portions 821, 822 and 823 show cuts perpendicular to or angled with respect to the longitudinal axis).
Regarding claim 4, Wilson et al. discloses wherein the cavity within the body is an aneurysm and the pre-defined shape is based on the configuration of the aneurysm in which the embolization device is deployed (paragraph 0040, body 811 configured to fill partially or fully a void such as an aneurysm).
Regarding claim 5, Wilson et al. discloses wherein the one-piece filament 811 comprises a plurality of segments having varying diameters (figure 8B, diameters about notches are different diameter than the segments without notches; additionally, the depth of the cut may be varied, paragraph 0041; for example, may extend 50, 100, 150, 200, 250, 300 degrees, thereby forming various diameter sections; additionally the filament or foam element may be cylindrical, ellipsoidal, spherical, diamond or other shape, various shapes will result in various diameters, paragraph 0057).
Regarding claim 6, Wilson et al. discloses the one-piece filament having a varying diameter, as discussed above, but fails to explicitly disclose the one-piece filament has a non-uniform pattern of the plurality of segments having varying diameters.
Lippert discloses an embolic device comprising a non- uniform pattern of the plurality of segments having varying diameters to allow for adequate flexibility, strength, and shape retention (for example, figure 3E, diameters about fenestrations 346, 350; depth of the cut may be varied, the fenestrations or notches may be random, paragraphs 0036, 0060, 0066, 0069).
Therefore, it would have been obvious to one having ordinary skill in the art to provide the one-piece filament having a non-uniform pattern of the plurality of segments having varying diameters, as taught by Lippert, in order to allow for adequate flexibility, strength, and shape retention of the embolic device.
Regarding claim 7, Wilson et al. discloses wherein some of the plurality of segments are offset or eccentric relative to the longitudinal axis of the one-piece filament (figure 8B, joints 821 and 823 are offset forming a V-shape slot relative to the longitudinal axis along 810).
Regarding claim 8, Wilson et al. discloses wherein the one-piece filament comprises a shape memory material (paragraph 0027; the filament or foam may comprise a shape memory polymer in some embodiments).
Regarding claim 10, Wilson et al. discloses wherein the cavity within the body is an aneurysm and the pre-defined shape is a complex fill shape (paragraph 0040, 60, body 811 configured to fill partially or fully a void such as an aneurysm, the device may result in a complex 3D shape).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. US 2021/0137527 in view of Lippert 2014/0257363 as discussed above and further in view of Wallace et al. US 2002/0087077.
Regarding claim 9, Wilson et al. discloses the embolization device essentially as claimed as discussed above, but fails to disclose wherein the filament comprises magnetic dipoles on opposing sides thereof to facilitate self-organization of the embolization device in the cavity within the body.
Wallace et al. discloses an embolization device 205 deployed within an aneurysm 107 (figure 2) comprising magnetic dipoles on opposing sides thereof to facilitate self-organization of the embolization device in the cavity within the body (paragraph 0031, 0037, one or more magnetic segments 200 internally attract, forming a convoluted, three-dimensional configuration attached to an element shaped to retain or secure the apparatus within the aneurysm).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wilson et al. with magnetic dipoles, as taught by Wallace et al. to internally attract and facilitate self-organization of the embolization device in the cavity within the body and secure the embolization apparatus within the aneurysm by forming a convoluted, three-dimensional configuration.
Conclusion
THIS ACTION IS MADE FINAL. 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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