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 .
Claim Objections
Claims 1, 4, and 19 are objected to because of the following informalities:
Claim 1, line 6: “the disks” should read --the plurality of disks--
Claim 4, lines 1-2: “the plurality of disks and plurality of ribbons” should read –the plurality of disks and the plurality of longitudinally extending ribbons--
Claim 19, lines 4-5: “one or more preferred bending planes” should read --the one or more preferred bending planes--
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.
Claims 1, 4-6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Heidner (US 20090177119) (previously cited) in view of Jacobsen (US 6579246).
Regarding claim 1, Heidner teaches an intravascular device (Figs. 18); comprising a core wire (17b) extending between a proximal end (18b) and a distal end (20b), at least a distal section of the core wire being microfabricated so as to include: a plurality of disks (See annotated Fig. 18 below; spaced apart from one another along a length of the distal section (Paragraph [0058]; Paragraph [0068] Fig. 18 shows a plurality of slots 30b formed in the outer surface of core wire 17b (including proximal section 18b and distal section 20b) at articulating section 24b); and a plurality of longitudinally extending ribbons (See annotated Fig. 18 below) interposed between the disks, each ribbon extending between and connecting a pair of adjacent disks. (Paragraph [0058]; See annotated Fig. 18 below)
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However, Heidner does not teach “wherein a rotational offset is applied to successive ribbons or ribbon sets along a helical section of the core wire so that each successive ribbon or ribbon set within the helical section has a different rotational placement than its preceding ribbon or ribbon set, wherein the rotational offset is different than 90 degrees and forms a helical pattern along the helical length of the section of the core wire.”
Jacobsen, in a related field of endeavor, teaches a guidewire system comprising a core wire (Figs. 23-24) wherein a rotational offset is applied to successive ribbons or ribbon sets along a helical section of the core wire so that each successive ribbon or ribbon set within the helical section has a different rotational placement than its preceding ribbon or ribbon set, wherein the rotational offset is different than 90 degrees and forms a helical pattern along the helical length of the section of the core wire. (Col. 16, lines 45-65 the cut distribution of the beams are defined by a helical pattern).
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner to provide “wherein a rotational offset is applied to successive ribbons or ribbon sets along a helical section of the core wire so that each successive ribbon or ribbon set within the helical section has a different rotational placement than its preceding ribbon or ribbon set, wherein the rotational offset is different than 90 degrees and forms a helical pattern along the helical length of the section of the core wire” as taught by Jacobsen. Doing so provides a core wire with good bending and torque transmission characteristics. (Col. 16, lines 66-67).
Regarding claim 4, Heidner teaches wherein the plurality of disks and plurality of ribbons are arranged to form one or more preferred bending planes in the distal section of the core wire. (Paragraph [0068] the articulating section may include other structure to provide the desired increase in lateral flexibility. For example, the articulating section may include cuts, slots, or grooves defined in the outer surface of the core wire or shaft, or other such structure; See also Figs. 17-18).
Regarding claim 5, Heidner teaches wherein the distal section of the core wire includes a first portion (hinge portion 1116) and a second portion (distal portion 1114) that is distal of the first portion, wherein the first portion is configured to provide a first preferred bending plane, and the second portion is configured to provide a second preferred bending plane different from the first preferred bending plane. (See Fig. 20, 20A; Paragraph [0094]).
Regarding claim 6, Heidner teaches wherein the first and second preferred bending planes are substantially orthogonal to one another. (Paragraph [0094]).
Regarding claim 17, Heidner teaches a tube (Fig. 1, tubular shaft 18, 20); at least a portion of the core wire (17b) extending within the tube. (See Fig. 18)
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Heidner in view of Jacobsen, further in view of Douk (FR 2850285) (previously cited).
Regarding claim 2, Heidner as modified does not teach “wherein the microfabricated distal section of the core wire has a length of at least about 0.5 cm up to about 35 cm”.
Douk, in a related field of endeavor, teaches a guide wire apparatus (Fig. 13) wherein the microfabricated distal section (391) of the core wire has a length of at least about 0.5 cm up to about 35 cm. (Page 14, line 1 of Machine Translation, length of the distal segment 391 of the core wire can be between about 15 and 25 cm).
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner as modified to provide “wherein the microfabricated distal section of the core wire has a length of at least about 0.5 cm up to about 35 cm” as taught by Douk. Doing so provides a length of the distal section of the core wire that is suitable to be used in coronary arteries. (Page 13, last two lines of Machine Translation).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Heidner in view of Jacobsen, further in view of Crittenden (US 4917088) (previously cited).
Regarding claim 3, Heidner as modified does not teach “wherein the distal section of the core wire has an outer diameter of about 0.003 inches to about 0.010 inches”.
Crittenden, in a related field of endeavor, teaches a probe-like catheter comprising a core wire (44) wherein the distal section of the core wire has an outer diameter of about 0.003 inches to about 0.010 inches. (Col. 4, lines 8-10, the wire 44 is preferably 0.008 inches diameter).
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner as modified to provide “wherein the distal section of the core wire has an outer diameter of about 0.003 inches to about 0.010 inches” as taught by Crittenden. Doing so provides a design consideration known in the art that may optimize the utility of the device.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Heidner in view of Jacobsen, further in view of Ressemann (US 20070185415) (previously cited).
Regarding claim 7, Heidner as modified does not teach “wherein at least one ribbon is disposed such that it has a rotational offset relative to another ribbon”.
Ressemann, in a related field of endeavor, teaches a steerable guide wire device (Figure 10B) comprising a core wire (64) wherein at least one ribbon is disposed such that it has a rotational offset relative to another ribbon. (Paragraph [0068]; See Fig. 10B slotted segments 64a are rotationally offset relative to each other).
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner as modified to provide “wherein at least one ribbon is disposed such that it has a rotational offset relative to another ribbon” as taught by Ressemann. Doing so improves the torquability of the device. (Paragraph [0013]).
Regarding claim 8, Heidner as modified does not teach “wherein the rotational offset is applied to successive ribbons or ribbon sets along a length of the distal section of the core wire so that each successive ribbon or ribbon set has a different rotational placement than its preceding ribbon or ribbon set”.
Ressemann illustrates a steerable guide wire device (Figure 10B) comprising a core wire (64) wherein the rotational offset is applied to successive ribbons or ribbon sets along a length of the distal section of the core wire so that each successive ribbon or ribbon set has a different rotational placement than its preceding ribbon or ribbon set. (Paragraph [0068]; See Fig. 10B slotted segments 64a are rotationally offset relative to each other and are successive along the length of the distal section of the core wire).
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner as modified to provide “wherein the rotational offset is applied to successive ribbons or ribbon sets along a length of the distal section of the core wire so that each successive ribbon or ribbon set has a different rotational placement than its preceding ribbon or ribbon set” as taught by Ressemann. Doing so improves the torquability of the device. (Paragraph [0013]).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Heidner in view of Jacobsen, further in view of Davis (WO 2004012804) (previously cited).
Regarding claim 18, Heidner as modified does not teach “wherein the tube has an inner diameter, and wherein a ratio of an outer diameter or size of the distal section of the core wire to the inner diameter of the tube is greater than about 0.375”.
Davis teaches wherein the tube has an inner diameter, and wherein a ratio of an outer diameter or size of the distal section of the core wire to the inner diameter of the tube is greater than about 0.375. (Fig. 26 is a side, cross-sectional, partial view of a tubular catheter medical device 604 comprising lumen 608 which may be disposed an electrically conductive wire 612; the diameter of the lumen 608 may be .009 inches, and the diameter of the wire 612 and sheath 616 may be .006 inches.) Hence, the ratio between the outer diameter or size of the distal section of the core wire (.006 inches) to the inner diameter (.009 inches) of the tube is greater than about 0.375.
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner as modified to provide “wherein the tube has an inner diameter, and wherein a ratio of an outer diameter or size of the distal section of the core wire to the inner diameter of the tube is greater than about 0.375” as taught by Davis. Doing so provides a design consideration known in the art that may optimize the utility of the device.
Regarding claim 19, Heidner as modified does not teach “wherein the tube is microfabricated and has a plurality of circumferentially extending rings and axially extending beams arranged to provide the one or more preferred bending planes to the tube”.
Davis teaches wherein the tube (365) is microfabricated and has a plurality of circumferentially extending rings (364) and axially extending beams (segments 376) arranged to provide the one or more preferred bending planes to the tube (See Figs. 21B-22), and wherein the core wire is positioned so that one or more preferred bending planes of the tube are aligned with one or more substantially similar bending planes of the core wire. (See Fig. 21A; Page 31, lines 5-11 In the exemplary embodiment illustrated, slot 354 is formed on the top of the medical device 350, slot 358 is formed on the bottom, slot 362 is formed on the near side of the medical device, and slot 366 is formed on the far side. Thus, each slot may be rotated, for example, by 180 degrees or 90 degrees, and offset from the preceding slot. The slots may be formed to provide preferential bending (flex) in one plane, or may be formed randomly or in some pattern to allow bending (flex) equally, non-preferentially, in all planes.)
As a result, it would have been obvious to of ordinary skill in the art before the effective filing date to have modified Heidner as modified to provide “wherein the tube is microfabricated and has a plurality of circumferentially extending rings and axially extending beams arranged to provide one or more preferred bending planes to the tube” as taught by Davis. Doing so optimizes the machined tube for maximum torque transmission. (Page 23, lines 15-16).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 10/13/2025, with respect to the rejections of claims 1-5 and 17-19 have been fully considered. However, upon further consideration, a new ground of rejection is made under 103. In the new ground of rejection, Jacobsen is relied upon.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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