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 10/14/25, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 10111670 to Lorenzo et al.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 10, --is-- should be added between “the first section” and “stiffer”.
In line 13, --is-- should be added between “the first spring coefficient” and “2 to 20 times”.
Appropriate correction is required.
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, 5-12 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,111,670 to Lorenzo et al.
As to claim 1, Lorenzo et al. disclose, in figure 6, 7, 11, and 16a-17c and col. 5, line 29 to col. 6, line 44 and col. 8, line 4 to col. 9 line 15; an implant (e.g., 200) for vascular treatment, the implant comprising: a wire having a first section (e.g., 204) and a second section (e.g., 202), the first section and the second section each movable from a delivery state to a deployed state in response to removal of external pressure on the wire (as shown in fig. 17a-17c), the first section (framing coil 204, as shown in fig. 17a), in the deployed state, including at least one loop securable to a target anatomical location (e.g., the wall of an aneurysm) of a subject, the second section (202, which is within element 300, as shown in fig. 17b-17c), in the deployed state, having a nonlinear shape positionable to at least partially occupy an anatomical vessel with the first section secured to the target anatomical location.
Lorenzo et al. also disclose the first section 204 is stiffer than the second section 202, the first section of the wire having a first spring coefficient (i.e., stiffness), the second section of the wire having a second spring coefficient (i.e., stiffness), and the first spring coefficient is 20-30 times greater than the second spring coefficient (col. 6, lines 7-12). Lorenzo et al. fail to specifically disclose that the first spring coefficient is 2-20 times greater than the second spring coefficient. Instead, as mentioned above, Lorenzo et al. disclose a range value that overlaps with the claimed invention. Therefore, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have found it prima facie obvious to have selected the overlapping value as a predictable choice within the known range.
As to claims 5-7, 9-12 and 22, Lorenzo et al. disclose the implant of claim 1, and wherein the first section of the wire and the second section of the wire are coupled to one another at a coupling location (at 206, as shown in fig. 6-7); wherein the first section of the wire and the second section of the wire are collectively monolithic (as shown in fig. 6-7); wherein, in the absence of external pressure on the wire, the at least one loop comprises at least three loops (as shown in fig. 16b); wherein, in the deployed state of the wire, the second section of the wire is packable onto itself to at least partially occupy the anatomical vessel with the first section secured to the target anatomical location (as shown in fig. 17b-17c); wherein, in the deployed state of the wire, the second section of the wire has a predetermined three-dimensional shape (according to col. 6, lines 17-20); wherein at least one of the first section of the wire and the second section of the wire includes primary windings, the primary windings defining a longitudinal axis circumscribed by the primary windings (as shown in fig. 6-7); wherein the wire has a first length in the delivery state (as shown in fig. 6-7), the wire has a second length in the deployed state, and the first length is greater than the second length (as shown in fig. 16a-16b); and wherein the primary windings define a plurality of gaps therebetween (i.e., between coils, as shown in fig. 6-7).
As to claims 8 and 21, Lorenzo et al. disclose the invention substantially as claimed, but do not explicitly disclose that, wherein in the deployed state of the wire, the at least one loop of the first section of the wire has a maximum outer diameter of greater than about 2 mm and less than about 25 mm; or that, wherein, in the deployed state of the wire, the second section of the wire has a predetermined three-dimensional shape having a maximum outer dimension of greater than about 2 mm and less than about 25 mm. Nevertheless, Lorenzo et al. disclose, in col. 10, lines 24-35, that the wire can have different shapes and different diameters to form complex predetermined three-dimensional configurations or shapes once deployed from the catheter. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to configure the wire, so that in the deployed state of the wire, the at least one loop of the first section of the wire has a maximum outer diameter as desired; or that in the deployed state of the wire, the second section of the wire has a predetermined three-dimensional shape having a maximum outer dimension as desired; since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges (of maximum outer diameter) involves only routine skill in the art. In re Aller.
As to claim 23, Lorenzo et al. also disclose, in col. 5, lines 56-60; that “coil pitch” (including the axial dimension of a gap between coils) may be varied to effect a spring softness and stiffness as desired. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to configure the wire, so that in the deployed state, at least some of the plurality of gaps have an axial dimension as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges (of an axial dimension of a gap) involves only routine skill in the art. In re Aller.
Claims 2 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,111,670 to Lorenzo et al. in view of US 10,842,607 to Bowman et al.
Lorenzo et al. disclose the invention substantially as claimed, but do not explicitly disclose that the first section of the wire has a first spring coefficient of greater than about 10 N/in and less than about 20 N/in, and the second section of the wire has a second spring coefficient greater than about 1 N/in and less than about 100 N/in. Nevertheless, Bowman et al. teach, in col. 4, lines 12-14, that spring coefficients (k-value) may be affected by “wire diameter, primary wind diameter, shear modulus, and coil gap.” Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to configure the wire, so that the first and second spring coefficients are as desired; since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges (of spring coefficients) involves only routine skill in the art. In re Aller.
Also, Lorenzo et al. do not explicitly disclose that the primary windings of the first section of the wire have a first outer diameter, and the primary windings of the second section of the wire have a second outer diameter, wherein the first outer diameter is different from the second outer diameter. Bowman et al. teaches, in col. 4, lines 10-23; that the outer diameters of primary windings of a wire can be varied according to the flexibility and stiffness desired for sections of the wire. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to size the outer diameters of the first and second sections of the wire, so that they have values as desired, since it has been held that discovering an optimal value of a result effective variable (e.g., outer diameter of a primary winding of the first or second section) involves only routine skill in the art. In re Boesch.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 10,111,670 to Lorenzo et al. in view of US 5,766,160 Samson et al.
Lorenzo et al. disclose the invention substantially as claimed, wherein, according to col. 5, lines 35-55; the wire may be formed of platinum, tungsten, “other alloys,” or “other suitable biocompatible materials.” However, Lorenzo et al. do not explicitly disclose that at least one section of the first section of the wire or the second section of the wire includes tungsten and platinum. Samson et al. teach in col. 3, lines 59-67; that a wire may be formed of tungsten and platinum. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Samson et al., to modify the wire of Lorenzo et al., so that at least one section of the first section of the wire or the second section of the wire includes tungsten and platinum. Such a modification would make for a wire having a biocompatible, radiopaque alloy with a desired, tailored blend flexibility and stiffness.
Conclusion
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DARWIN P. EREZO
Supervisory Patent Examiner
Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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