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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/27/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11 have been considered but are moot because the new ground of rejection over Jacobsen et al. US 5911717 in view of Lippert US 2014/0257363 as further discussed below.
Jacobsen et al. discloses an embolization device to occlude a cavity within the body consisting essentially of comprising: a one-piece filament or hypotube (wire 4, figure 1A) having a longitudinal axis extending therein (figure 3, longitudinal axis along center of wire); and a plurality of notches (cuts 36) distributed on the one-piece filament or hypotube (figures 1A, 3).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 4, 10, 16 and 18 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 1, 4, 10, 16 and 18 disclose the limitations “pre-defined shape being based on the configuration of the cavity in which the embolization device is deployed” or “the cavity within the body is an aneurysm”. This language is directed to the cavity within the body.
Examiner suggests including language wherein the pre-defined shape being configured to be based on the configuration of the cavity in which the embolization is deployed.
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) 1-7 and 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. US 5911717 in view of Lippert US 2014/0257363.
Regarding claims 1, 2, 11, 16, 17, Jacobsen et al. discloses an embolization device to occlude a cavity within the body consisting essentially of comprising: a one-piece filament or hypotube (wire 4, figure 1A) having a longitudinal axis extending therein (figure 3, longitudinal axis along center of wire); and a plurality of notches (cuts 36) distributed on the one-piece filament or hypotube (figures 1A, 3), 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 (column 2, lines 43-51; column 3, lines 47-48; appropriate spacing of the cuts to the desired flexibility and shape), the pre-defined shape being based on the configuration of the cavity in which the embolization device is deployed (column 1, lines 53-58; column 3, lines 19-20; wire shaped to occupy a certain volume or cavity when unconstrained; and expand and occupy the target location), and a bioactive substance included in or on the one-piece filament or hypotube wherein the bioactive substance comprises a peptide, a pro-thrombotic agent, an anti-thrombotic agent, a biologically active protein, a biologically active DNA, a biologically active RNA, or suitable combinations thereof (column 3, lines 55-57; thrombogenic fibers 44 attached).
Jacobsen et al. discloses providing cuts of varying notch spacing, width, or depth to achieve the desired flexibility and shape (column 2, lines 3-7), but fails to explicitly disclose the notches being distributed in a non-uniform pattern, wherein the non-uniform pattern on the one-piece filament or hypotube, comprising angles of the notches at an oblique angle with respect to the longitudinal axis X of the one-piece filament or hypotube.
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 before the effective filing date of the invention to modify Jacobsen 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, Jacobsen et al. discloses wherein at least some of the plurality of notches extends in a direction different than the direction in which the longitudinal axis extends (figures 1A, 3, notches are perpendicular to the longitudinal axis).
Regarding claim 4, Jacobsen 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 (column 1, lines 53-58; column 3, lines 19-20; wire shaped and configured to occupy a certain volume or cavity such as an aneurysm when unconstrained; and configured to expand and occupy the target location or aneurysm).
Regarding claim 5, Jacobsen et al. discloses wherein the one-piece filament or hypotube comprises a plurality of segments having varying diameters (diameters about notches are different diameter than the segments without notches, depth of cuts may be varied, column 2, lines 49, 50).
Regarding claim 6, Jacobsen et al. in combination discloses the one piece filament or hypotube having varying diameters as discussed above, but fails to explicitly disclose wherein the one-piece filament or hypotube has a non-uniform pattern of the plurality of segments having varying diameters.
Lippert teaches 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 before the effective filing date of the invention to modify Jacobsen et al. with 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, Jacobsen et al. Jacobsen et al. discloses the one piece filament or hypotube having varying diameters as discussed above, but fails to explicitly disclose wherein some of the plurality of segments are offset or eccentric relative to the longitudinal axis of the one-piece filament or hypotube.
Lippert teaches 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), the plurality of segments are offset or eccentric relative to the longitudinal axis of the one-piece filament or hypotube (may have various cut angles resulting in an offset notch from the longitudinal axis, the offset angles may be constant or change along one or more portions, paragraph 0035, 0060, 0069).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Jacobsen et al. with the one-piece filament having a non-uniform pattern of the plurality of segments having various cut angles, as taught by Lippert, in order to allow for adequate flexibility, strength, and shape retention of the embolic device.
Regarding claim 10, Jacobsen et al. discloses wherein the cavity within the body is an aneurysm and the pre-defined shape is a complex fill shape (column 1, lines 53-58; column 3, lines 19-20; wire shaped to occupy a certain volume or cavity when unconstrained; configured to expand and occupy the target location such as an aneurysm and configured to result in a complex fill shape to fill the aneurysm or cavity).
Regarding claim 12, Jacobsen et al. discloses wherein the one-piece filament or hypotube comprises variable stiffness and/or softness along the longitudinal axis (column 2, lines 51-53, varying the cuts will vary the flexibility or stiffness along the longitudinal axis of the wire or filament).
Regarding claim 13, Jacobsen et al. discloses the one piece filament or hypotube essentially as claimed above, but fails to disclose wherein the one-piece filament or hypotube is fabricated from a polymer mix including radiodense or radioactive materials, a polymer curable with an ultraviolet light in its final configuration, and/or a fluorescent luminescent material to improve visualization.
Lippert teaches an embolic device comprising a polymer mix including radiopaque dopants that may be added for visibility (paragraph 0041).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Jacobsen et al. with a polymer mix including radiodense or radioactive materials, a polymer curable with an ultraviolet light in its final configuration, and/or a fluorescent luminescent material, as taught by Lippert, to improve visibility.
Regarding claim 14, Jacobsen et al. discloses wherein the embolization device has a circular or polygonal cross-sectional shape (outside diameter of circular cross section of coil receiving radiopaque bands 40, column 2, lines 56-59).
Regarding claim 15, Jacobsen et al. in combination discloses wherein the non-uniform pattern of the plurality of notches is computationally derived. Examiner notes in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e non-uniform pattern of the plurality of notches, does not depend on its method of production, i.e. the notches being computationally derived. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985).
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. US 5911717 in view of Lippert US 2014/0257363 as discussed above and further in view of Wallace et al. US 2002/0087077.
Regarding claim 8, Jacobsen et al. discloses the embolization device essentially as claimed as discussed above, but fails to disclose wherein the one-piece filament or hypotube comprises a shape memory material.
Wallace et al. discloses an embolization device deployed within an aneurysm 107 (figure 2) the device having a pre-shaped memory so the device will automatically deploy into the convoluted, three dimensional configuration when advanced into the aneurysm (paragraph 0036).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Jacobsen et al. with a shape memory material, as taught by Wallace et al. to automatically deploy into the predetermined shape for occluding the aneurysm.
Regarding claim 9, Jacobsen et al. discloses the embolization device essentially as claimed as discussed above, but fails to disclose wherein the one-piece filament or hypotube comprises magnetic dipoles on opposing sides thereof or structural modules or cassettes to facilitate self-organization or self-adherence of the embolization device in the cavity within the body.
Wallace et al. discloses an embolization device deployed within an aneurysm 107 (figure 2), the device 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 Jacobsen 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.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobsen et al. US 5911717 in view of Lippert US 2014/0257363 as discussed above and further in view of Islak et al. US 2015/0327868.
Regarding claim 18 and 19, Jacobsen et al. discloses an embolization device to occlude a cavity within the body consisting essentially of comprising: a one-piece filament or hypotube (wire 4, figure 1A) having a longitudinal axis extending therein (figure 3, longitudinal axis along center of wire); and a plurality of notches (cuts 36) distributed on the one-piece filament or hypotube (figures 1A, 3), the non-uniform 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 (column 2, lines 43-51; column 3, lines 47-48; appropriate spacing of the cuts to the desired flexibility and shape), the pre-defined shape being based on the configuration of the cavity in which the embolization device is deployed (column 1, lines 53-58; column 3, lines 19-20; wire shaped to occupy a certain volume or cavity when unconstrained; and expand and occupy the target location), and a bioactive substance included in or on the one-piece filament or hypotube wherein the bioactive substance comprises a peptide, a pro-thrombotic agent, an anti-thrombotic agent, a biologically active protein, a biologically active DNA, a biologically active RNA, or suitable combinations thereof (column 3, lines 55-57; thrombogenic fibers 44 attached).
Jacobsen et al. discloses providing cuts of varying notch spacing, width, or depth to achieve the desired flexibility and shape (column 2, lines 3-7), but fails to explicitly disclose the notches being distributed in a non-uniform pattern, or having a fixed or variable conductive or thermally reactive detachment zone to allow for thermal detachment or dissociation of the one-piece filament or hypotube based on conductivity.
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 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).
Islak teaches an embolic device, the device having a fixed or variable conductive or thermally reactive detachment zone to allow for thermal detachment or dissociation of the one-piece filament or hypotube based on conductivity, wherein the fixed or variable detachment zone comprises a substrate sensitive or conductive to heat or light to allow selective detachment of the embolization device (paragraph 0067-0069, 0094, figures 15A-19C, claims 14-15; proximal end is detachable from the delivery assembly, mechanically, chemically, electrolytically or thermally, heat transferred to the gripper assembly 120 and opening jaws to hold or release the embolic member).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Jacobsen 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, and with a fixed or variable conductive or thermally reactive detachment zone to allow for thermal detachment or dissociation of the one-piece filament or hypotube based on conductivity, as taught by Islak, as it is known in the art to provide attachment zones based on thermal detachment for controlled delivery and placement into an aneurysm with the delivery assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
