DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 12, 14, 19, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SATO et al. (US Patent Pub. No. 2016/0250442).
With regards to claim 1, Sato et al. discloses a catheter reinforcement layer (fig. 1 or fig.4 ), comprising a spring component (3 or 23) and at least one axial component (4 or 24), wherein each of the at least one axial component extends along the spring component from a proximal end to a distal end, and has at least one intersection with the spring component (see fig. 1 or 4), see para. [0032], [0034]-[0036], [0047], [0048].
Re. claims 3, 4, 5, 6, 7, 8, 12, Sato discloses the axial component has a filamentous structure shaped such as straight line; the axial component is arranged parallel to an axial direction of the spring component; the axial member has at least 1 intersection with the spring component; the axial component, from the proximal end to the distal end, is shaped as a straight line or spiral line attached to an inner surface or an outer surface of the spring component, the plurality of axial components are arranged symmetrically or asymmetrically along a circumference of the spring component at a predetermined position or are sequentially arranged at intervals along an axial direction of the spring component at a predetermined position, see fig. 1 or 4 and see para. [0036].
Re. claim 19, Sato et al. teaches a catheter, comprising an inner layer, a reinforcement layer and an outer layer that are sequentially arranged from inside to outside and are all in a shape of a tube, and wherein the reinforcement layer comprises the catheter reinforcement layer of claim 1, see para [0047].
Re. claim 22, Sato et al. teaches, the thickness of the inner layer is a polymeric material with a thickness of .0001-.002 inches (40 microns, see para [0048]).
Re. claims 2 and 14, para [0054], describes the axial component including radiopaque material and being made of either metal or non-metal member.
Claims 1-8, 12, 17, 19 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Keating et al. (US Patent Pub. No. 2021/0307766).
With regards to claim 1, Keating et al. discloses a catheter reinforcement layer (100, see fig. 2-5B, 7A-8C, 13A-13C, and 20A-20C), comprising a spring component (118) and at least one axial component (116), wherein each of the at least one axial component extends along the spring component from a proximal end to a distal end, and has at least one intersection with the spring component (when the axial component is attached to the spring component, see fig. 2-5B, 7A-8C, 13A-13C, and 20A-20C), see para. [0011], [0024], [0026], [0077]-[00119].
Re. claims 2, Keating et al. discloses the material including Nitinol, see para. 0078.
Re. claims 3, 4, 5, 6, 12, Keating et al., discloses the axial component has a filamentous structure shaped such as straight line; the axial component is arranged parallel to an axial direction of the spring component; the axial member has 1 intersection with the spring component; the axial component, from the proximal end to the distal end, is shaped as a straight line or spiral line attached to an inner surface or an outer surface of the spring component, see fig. 2-5B, 7A-8C, 13A-13C, and 20A-20C and para. [0011], [0024], [0026], [0077]-[00119].
Re. claims 7 and 8, Keating et al. discloses multiple axial components, see fig. 5B, and 20C and the plurality of axial components are sequentially arranged at intervals along an axial direction of the spring component at a predetermined position.
Re, claim 17, Keating et al. discloses the axial component and spring component are monolithically formed through laser machining, see para. [0011], [0090], [0132].
Re. claim 19, Keating et al. teaches a catheter, comprising an inner layer, a reinforcement layer and an outer layer that are sequentially arranged from inside to outside and are all in a shape of a tube, and wherein the reinforcement layer comprises the catheter reinforcement layer of claim 1, see para [0076], [0078], [0135].
Re. claim 20, Keating et al. teaches a plurality of catheter segments connected in series (the segments are separated by the non-rib sections, see fig. 13A, 13B, 20A, 20B, 20C), the axial component being arranged at a predetermined position; wherein the predetermined position is between a circumferential surface or a clearance of the spring component where joints of adjacent catheter segments are located (see fig. 13A, 13B, 20A, 20B, 20C); or the predetermined position is between a circumferential surface or a clearance of the spring component where a modulus value of a catheter segment is lower than a modulus value of an adjacent catheter segment at one or both sides; or the predetermined position is at a part of the inner or outer layer of the catheter with a smaller thickness, or between a circumferential surface or a clearance of the spring component where a flexibility of a catheter segment is higher; or the predetermined position is between a circumferential surface or a clearance of the spring component where a diameter of the catheter segment is smaller than a diameter of an adjacent catheter segment at one or both sides (see fig. 13A, 13B, 20A, 20B, 20C).
Claims 1-8, 12, 13, 17, 19, and 20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (US Patent No. 6,022,343).
With regards to claim 1, Johnson et al. discloses a catheter reinforcement layer (fig. 3), comprising a spring component (72) and at least one axial component (78a…78f), wherein each of the at least one axial component extends along the spring component from a proximal end to a distal end, and has at least one intersection with the spring component (see fig. 3).
With regards to claim 2, the reinforcement layer is steel (col. 4, ll. 8).
Re. claim 19, Johnson et al. teaches a catheter, comprising an inner layer (62), a reinforcement layer (70) and an outer layer (90) that are sequentially arranged from inside to outside and are all in a shape of a tube, and wherein the reinforcement layer comprises the catheter reinforcement layer of claim 1, see fig. 2-3 and para [0047].
Re. claims 3, 4, 5, 6, 12, Johnson et al., discloses the axial component has a filamentous structure shaped such as straight line; the axial component is arranged parallel to an axial direction of the spring component; the axial member has 1 intersection with the spring component; the axial component, from the proximal end to the distal end, is shaped as a straight line or spiral line attached to an inner surface or an outer surface of the spring component, see fig. 2-3.
Re. claims 7 and 8, Johnson et al. discloses multiple axial components, see fig. 2 and 3 and the plurality of axial components are sequentially arranged at intervals along an axial direction of the spring component at a predetermined position.
Re. claim 13, Johnson et al. discloses a plurality axial with an axial distance between two axial components adjacent in an axial direction of the spring component is in a range of 0.001- 0.1 inches (see col. 3, ll. 50 – col. 4, ll. 7).
Re, claim 17, Johnson et al. discloses the axial component and spring component are formed by laser cutting, see col. 5, ll. 10-14.
Re. claim 20, Johnson et al. teaches a plurality of catheter segments connected in series (the segments consists of 4 coils, see fig. 2, 3), the axial component being arranged at a predetermined position; wherein the predetermined position is between a circumferential surface or a clearance of the spring component where joints of adjacent catheter segments are located (see fig. 2 and 3); or the predetermined position is between a circumferential surface or a clearance of the spring component where a modulus value of a catheter segment is lower than a modulus value of an adjacent catheter segment at one or both sides; or the predetermined position is at a part of the inner or outer layer of the catheter with a smaller thickness, or between a circumferential surface or a clearance of the spring component where a flexibility of a catheter segment is higher; or the predetermined position is between a circumferential surface or a clearance of the spring component where a diameter of the catheter segment is smaller than a diameter of an adjacent catheter segment at one or both sides (see fig. 2, 3).
Claims 1-6, 12, and 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noriega et al. (US Patent Pub. No. 20050020974).
With regards to claim 1, Noriega et al. discloses a catheter reinforcement layer (12), comprising a spring component (elongated body 12 which includes 14/16/18) and at least one axial component (46/66), wherein each of the at least one axial component extends along the spring component from a proximal end to a distal end, and has at least one intersection with the spring component (coupled to the distal tip ref. 18 of the spring component, see para [0051]).
With regards to claim 2, the reinforcement layer is steel (col. 4, ll. 8).
Re. claim 19, Noriega et al. teaches a catheter, comprising an inner layer (40), a reinforcement layer (12) and an outer layer (42) that are sequentially arranged from inside to outside and are all in a shape of a tube, and wherein the reinforcement layer comprises the catheter reinforcement layer of claim 1, see fig. 3 and 14A and para [0047].
Re. claim 2, 15, and 16, Noriega et al. teaches the axial component (46) is steel, has a diameter between .003 inches and .007 inches and is in the form of a strip or solid or braided wire, see para. 0053.
Re. claims 3, 4, 5, 6, 12, Noriega et al. teaches the axial component has a filamentous structure shaped such as straight line; the axial component is arranged parallel to an axial direction of the spring component; the axial member has 1 intersection with the spring component; the axial component, from the proximal end to the distal end, is shaped as a straight line or spiral line attached to an inner surface or an outer surface of the spring component, see fig. 1, 12 and 14.
Re, claim 17, Noriega et al. discloses the axial component and spring component are bond through soldering, see para. [0053].
Re. claims 18 and 21, Noriega et al. teaches the axial component by part of a control wire system, see fig. 1, 12, and 14 and para [0054].
Re. claim 20, Noriega et al. teaches a plurality of catheter segments connected in series (ref. 14, 16, 18, see fig. 12 and 14) the axial component being arranged at a predetermined position; wherein the predetermined position is between a circumferential surface (axial component is position at/between the circumferential inner surface – see fig. 12 and 14).
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 9 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Keating et al. (US Patent Pub. No. 2021/0307766).
Re. claim 9, Keating et al. teaches the limitations of claim 1. Keaton et al. further discloses a plurality of axial components (117) are arranged spirally along an axial direction of the spring component (118) and the axial distances between the plurality of axial components are the same or different or circumferential angular distances between the plurality of axial components are the same or different (see fig. 7A-8C) but fails to explicitly state the axial distances between the axial components located at the proximal end is smaller than the axial distances of the axial components located at the distal end or the circumferential angular distances between the axial components located at the proximal end is smaller than the axial distances of the axial components located at the distal end.
Keating et al. further suggestions that varying the pitch between the ribs, 118, can vary the stiffness profile, therefore adjusting “the pitch between ribs 118 can be varied to further optimize the stiffness profile of the support tube 100.” Thus reducing the rib pitch and increasing the thickness of rib struts can each contribute towards adding stiffness to a given region of the tube, whereas increasing rib pitch and/or decreasing rib width can reduce the stiffness properties of a given section. See para [0091] of Keating et al.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the space between the ribs and the axial distance of the axial component in order to modify the stiffness profile of the catheter device as taught in fig. 8A-8C of Keaton et al., since this was taught and suggested by Keaton et al. (result effective variable in order to optimization the stiffness) in para [0091]. Furthermore, it would have been obvious to have the axial distances between the axial components located at the proximal end smaller than the axial distances of the axial components located at the distal end since this would allow for a stiffer proximal end and a more flexible distal end. (see Keaton et al., para. 0091). Lastly, Keaton teaches this arrangement in fig. 5B of having less space between the ribs in the proximal end which would create smaller space between the axial components since the ribs are closer together in the proximal end versus the distal end, thus creating the axial distance between the axial components located at the proximal end smaller than the axial distance of the axial components located at the distal end. Keaton et al. provides a TSM of the specific rib spacing and axial distance required in the claim. Therefore, it would have been obvious for one of ordinary skill in the art to modify the embodiment taught in figure 8A-8C of Keaton et al. such that the ribs spacing and axial distance in the spiral embodiment of Keaton et al. (fig. 7A-8C) will have axial distances between the axial components located at the proximal end smaller than the axial distances of the axial components located at the distal end because of the suggestions and teachings of Keaton et al. in para 0091 and fig. 5B with the embodiment taught in Fig. 8A-8C.
Conclusion
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Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, TC 3700