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 1/27/2026 have been fully considered but they are not persuasive. Applicant asserts that the device of Ferrera ‘617 is comprised of several wires welded together to form the device shown in fig. 24, noting col. 16, ll. 39-44 of Ferrera ‘617, and therefore fails to disclose a vaso-occlusive device comprising a single wire that forms the pyramidal portion that includes a plurality of distal coils wound from the single wire as claimed. However, with respect to the embodiment shown in fig. 24, Ferrera ‘617 also states, in col. 16, ll. 44-51, “Alternatively, the hexahedral coil configuration can be formed as a continuous primary wind of the coil by winding the central coil body, and forming the radiating arms by a double winding of the radiating conical coil arms, first up from the center and then back down, with each of the radiating conical coil arms being wound in turn about the central spherical [sic] at the appropriate location.” Thus, Ferrera ‘617 discloses an embodiment of the vaso-occlusive device shown in fig. 24 that comprises a single wire.
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera et al. (US 6,616,617; “Ferrera ‘617”) in view of Fererra et al. (US 6,171,326; “Ferrera ‘326”).
Ferrera ‘617 discloses a vaso-occlusive device (fig. 24) comprising a single wire (col. 16, ll. 45-61) having a primary configuration in a constrained condition, wherein the single wire forms a secondary configuration in a relaxed, unconstrained condition (col. 6, ll. 52-57; col. 16, ll. 52-63), the secondary configuration comprising a pyramidal portion (noting device in fig. 24 may be a tetrahedron as per col. 15, ll. 25-41) comprising a plurality of distal coils (each radiating arm) wound from the single wire (col. 16, ll. 45-61), each distal coil comprising a winding forming a closed loop (noting structure may comprise a single wire that is wound up and then back down to form distal coil arms and central coil body; col. 16, ll. 45-50) of greater than 360 degrees, wherein the winding has a perimeter which tapers outwardly from an interior of the pyramidal portion at an angle (as understood in view of figs. 23, 24, noting shape can be a tetrahedron; this is consistent with the specification of the instant application, which describes a widening in the outward direction as an outward “taper”), and a transition segment of the wire between each distal coil and connecting each distal coil to an adjacent distal coil, the plurality of distal coils arranged in a pyramidal shape such that each coil lies in a different lateral face of the pyramidal shape (as understood in view of the placement of the distal coils on each respective face of the polyhedral shape of fig. 24, it would have been obvious to place each distal coil on a respective face of the tetrahedron), each of the distal coils comprising from 12/3 turns to 2 turns (note: term “comprising” allows for additional turns), and the distal coils overlapping in a transition from one distal coil to an adjacent distal coil (i.e., two adjacent coils share the same transition segment that extends over the central body to connect adjacent distal coils, consistent with specification of instant application).
Fererra ‘617 does not expressly disclose the exact angle at which the perimeter of the windings of each distal coil tapers. However, it would have been obvious to one of ordinary skill in the art to have dimensioned the taper of the distal coil windings of the device of Ferrera ‘617 to have an angle between 5 to 15 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the prior art device of Fererra ‘617 includes tapered soft arms that extend to fill the vessel in three dimensions, thus allowing the occlusive device to accommodate the shape of the vessel, and therefore would not perform differently than a device with the claimed dimensions.
Ferrera ‘617 also fails to expressly disclose a body portion proximal of the pyramidal portion comprising a coil formed from the wire and extending proximally from the pyramidal portion.
Ferrera ‘326 discloses another vaso-occlusive device having a polyhedral portion (8; fig. 2, noting distal portion can be cubical as understood in view of cubical mandrel of fig. 14) as well as a body portion (9 or 9’; fig. 2) comprising a coil formed of the same wire as the polyhedral portion and extending proximally from the polyhedral portion. Ferrera ‘326 discloses that the body portion fills and reinforces the distal 3-D shaped portion when the device is implanted at the site in the vasculature to be treated (col. 6, ll. 33-47). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Ferrera ‘617 to include a body portion as claimed in view of Ferrera ‘326 in order to fill and reinforce the distal pyramidal portion when the device is implanted at the intended site in the vasculature.
Regarding claim 2, the pyramidal shape is a tetrahedron, and thus forms a pyramid shape having 3 lateral faces (col. 15, ll. 29-38).
Regarding claim 3, Ferrera ‘617 discloses that the polyhedral portion may form a symmetric pentahedron (col. 15, ll. 29-39). Since there are only 2 convex, symmetric pentahedral shapes, one of which is the quadrilateral pyramid shape having 4 lateral (triangular) faces and a square base, it would have been considered obvious to one of ordinary skill in the art construct the portion comprising the plurality of distal coils in either one of the two convex symmetric pentahedral shapes as they both lead to the predictable result of an occlusive device forming a pentahedral shape having 5 faces from which coils extend, and one skilled in the art would have had a reasonable expectation of success when employing either of the two pentahedral shapes. It is further noted that applicant does not disclose any problem solved, purpose served, or advantage gained by the use of a quadrilateral pyramid shape over any other pentahedral shape and thus the selection of this particular pentahedral shape is considered a mere design choice.
Regarding claim 4, Ferrera ‘617 discloses that the pyramidal shape is a tetrahedron, which is a polyhedral shape forming a polygonal base (triangle) having n number of sides (3 sides) and n number of lateral faces (3 faces) connecting to an apex.
Regarding claim 5, the primary configuration comprises an elongate helical coil (i.e., the coil forming the occlusive device), noting that the term “elongate” does not require that the helical coil is substantially linear in the primary configuration.
Regarding claim 6, the wire is formed from a shape memory material and the secondary configuration is set by winding the wire on a mandrel and heat treating the wire wound on the mandrel (col. 16, ll. 51-63).
Regarding claims 7 and 8, the vaso-occlusive device is configured to treat an aneurysm having a diameter to be treated. Because the device of Ferrera is capable of being deployed within an aneurysm having a diameter such that each of the distal coils has an average outer diameter of between 10 to 90 percent, or 55 to 85 percent, of the diameter of the aneurysm, it meets this recitation of intended use. In other words, the claim does not appear to limit the diameter of the distal coils because the diameter of the aneurysm to which they are being compared is not limited to any particular dimension, or range of dimensions. Note also that claims 7 and 8 are drawn to an apparatus, not its method of use, and thus the prior art must only be capable of being disposed in an aneurysm that results in the claimed relationship between the diameter of the aneurysm and the diameter of the distal coils.
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.
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KSH 3/2/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771