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 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 1-10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Petersen et al. (US 20140052097; hereinafter “Petersen et al.”).
Regarding claim 1, Petersen et al. discloses an extension guide catheter (Fig. 4 guide extension catheter 14) for a guide catheter (Fig. 4 guide catheter 10), comprising: a tubular body (Fig. 4 distal sheath 26) with a lumen (Fig 4. lumen 28) extending in a longitudinal axis direction and having a proximal opening (see “Modified Fig. 4” below, proximal opening) and a distal opening (see “Modified Fig. 4” below, distal opening); and a linear member (Fig. 4 proximal member 16) fixed to the tubular body (26) and extending proximally beyond the proximal opening (see “Modified Fig. 4” below, proximal opening) of the tubular body (26). Peterson et al. does not explicitly show the extension guide catheter embodiment of Fig. 4 wherein annular or helical groove extending in a circumferential direction is formed in an inner surface of a distal end portion of the tubular body so that wall thickness of the tubular body is formed thin at a part where the groove is formed is thinner than that of the tubular body at a part where the groove is not formed, adjacent to the groove. However, Peterson et al. discloses other embodiments (not shown) wherein an annular or helical (p. 3-4, col 2-1, [0051], lines 21-25, helical slots or grooves) groove (p. 3-4, col 2-1, [0051], lines 21-25, slot 150) extending in a circumferential direction (p. 7, col 2, [0079], lines 1-11, circumferential distance) is formed in an inner surface (p. 7, col 2, [0079], lines 1-11, single slot 150 may be disposed at some or all of these locations) of a distal end portion (p. 7, col 2, [0079], lines 1-11, distal portion 148) of the tubular body (p. 7, col 1, [0075], lines 2-3, distal sheath 26) so that wall thickness of the tubular body (p. 7, col 1, [0075], lines 2-3, distal sheath 26) is formed thin at a part where the groove (p. 7, col 2, [0079], lines 1-11, slot 150) is formed is thinner than that of the tubular body (p. 7, col 1, [0075], lines 2-3, distal sheath 26) at a part where the groove (p. 7, col 2, [0079], lines 1-11, slot 150) is not formed, adjacent to the groove (p. 7, col 2, [0079], lines 1-11, slot 150) (see the varying wall thickness and thinness caused in parts as described in p. 8, col 1, [0079], lines 12-15, some embodiments of distal portion 148 include slots 150 that are equal in size in a first group and then unequally sized in an adjacent group). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the extension guide catheter embodiment of Fig. 4 combination with the teachings of the other embodiments (not shown) of Petersen et al. described in [0051] and [0075]-[0079] as Peterson et al. discloses in addition to variations in materials, various embodiments of arrangements and configurations are also contemplated for slots 150 (and/or other slots disclosed herein) in addition to what is described above (p. 7, col 1-2, [0077], lines, 1-4).
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Regarding claim 2, The modified device of Petersen et al. discloses an outer surface (see “Modified Fig. 8” below, outer surface) of the distal end portion (see “Modified Fig. 8” below, distal end portion 148) of the tubular body (see “Modified Fig. 8” below, distal sheath 26) is formed flat (see “Modified Fig. 8” below, formed flat) in a range in the longitudinal axis (see “Modified Fig. 8” below, longitudinal axis) direction where the groove (see “Modified Fig. 5” below, slot 150) is formed.
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Regarding claim 3, the modified device of Petersen et al. does not explicitly mention an outer surface of the distal end portion of the tubular body has an inclined part that is formed inclined toward a longitudinal axis of the tubular body toward a distal side. However, Petersen et al. discloses in an embodiment of Fig. 20 an outer surface of the distal end portion of the tubular body has an inclined part (Fig. 20 tip 526) that is formed inclined toward a longitudinal axis of the tubular body (Fig. 20 tubular member 554) toward a distal side (see Fig. 20 where tip 526 is on a distal side opposite to proximal portion 516). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. above with the teachings of the embodiment of Fig. 20 including the inclined part as Peterson et al. discloses a tip member 36 may be attached body portion 30, for example at a distal end of body portion 30. In some embodiments, tip member 36 may be a single layer of material. Alternatively, tip member 36 may include an outer layer 38 and an inner layer 40. In at least some embodiments, tip member 36 may be configured to be generally atraumatic and may include a relatively soft, high compliance material or structure, which may include a polymer or composite material. (p. 3, col 1, [0043], lines, 5-13). Accordingly, it would have been obvious to incorporate the inclined distal end of Fig. 20 into the modified device because Petersen et al. recognizes the desirability of an atraumatic high compliance structure of a tapered distal tip, and the inclined distal surface represents a characteristic of such a tip that predictably provides a smooth, tapered leading end for insertion.
Regarding claim 4, the modified device of Petersen et al. does not explicitly mention the distal end portion of the tubular body has a first section including a distal end of the tubular body and a second section located proximal to the first section, with respect to the longitudinal axis direction, and an outer surface of the distal end portion of the tubular body is formed parallel to the longitudinal axis direction in the second section, and is formed inclined toward a longitudinal axis of the tubular body toward a distal side in the first section. However, Petersen et al. discloses in an embodiment of Fig. 20 the distal end portion (see “First Modified Fig. 20” below, distal end portion) of the tubular body has a first section (see “First Modified Fig. 20” below, first section) including a distal end of the tubular body (see “First Modified Fig. 20” below, tubular member 554) and a second section (see “First Modified Fig. 20” below, second section) located proximal to the first section (see “First Modified Fig. 20” below, first section), with respect to the longitudinal axis direction, and an outer surface (see “First Modified Fig. 20” below, outer surface) of the distal end portion (see “First Modified Fig. 20” below, distal end portion) of the tubular body (see “First Modified Fig. 20” below, tubular member 554) is formed parallel to the longitudinal axis direction in the second section (see “First Modified Fig. 20” below, second section), and is formed inclined (see the tapering of tip 526 in “First Modified Fig. 20” below) toward a longitudinal axis of the tubular body toward a distal side in the first section (see “First Modified Fig. 20” below, first section). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. above with the teachings of the embodiment of Fig. 20 as Peterson et al. discloses Fig. 20 illustrates another example guide extension catheter 514 that may be similar in form and function to other guide extension catheters disclosed herein (p. 5, col 2, [0064], lines 1-3).
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Regarding claim 5, the modified device of Petersen et al. does not explicitly mention the distal end portion of the tubular body has a first section including a distal end of the tubular body and a second section located proximal to the first section, with respect to the longitudinal axis direction, and an outer surface of the distal end portion of the tubular body is formed inclined toward a longitudinal axis of the tubular body toward a distal side in the second section, and is formed inclined toward the longitudinal axis of the tubular body toward the distal side in the first section so that an angle between the outer surface and the longitudinal axis direction in the first section is greater than an angle between the outer surface and the longitudinal axis direction in the second section. However, Petersen et al. discloses in an embodiment of Fig. 20 the distal end portion (see “Second Modified Fig. 20” below, distal end portion) of the tubular body (see “Second Modified Fig. 20” below, tubular member 554) has a first section (see “Second Modified Fig. 20” below, first section) including a distal end of the tubular body and a second section (see “Second Modified Fig. 20” below, second section) located proximal to the first section (see “Second Modified Fig. 20” below, first section), with respect to the longitudinal axis direction, and an outer surface (see “Second Modified Fig. 20” below, outer surface) of the distal end portion (see “Second Modified Fig. 20” below, distal end portion) of the tubular body is formed inclined toward a longitudinal axis of the tubular body (see “Second Modified Fig. 20” below, tubular member 554) toward a distal side in the second section (see “Second Modified Fig. 20” below, second section), and is formed inclined toward the longitudinal axis of the tubular body (see “Second Modified Fig. 20” below, tubular member 554) toward the distal side in the first section (see “Second Modified Fig. 20” below, first section) so that an angle between the outer surface (see “Second Modified Fig. 20” below, outer surface) and the longitudinal axis direction in the first section (see “Second Modified Fig. 20” below, first section) is greater than an angle between the outer surface (see “Second Modified Fig. 20” below, outer surface) and the longitudinal axis direction in the second section (see “Second Modified Fig. 20” below, second section). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. above with the teachings of the embodiment of Fig. 20 as Peterson et al. discloses Fig. 20 illustrates another example guide extension catheter 514 that may be similar in form and function to other guide extension catheters disclosed herein (p. 5, col 2, [0064], lines 1-3).
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Regarding claim 6, the modified device of Peterson et al. discloses the angle (see “First Modified Fig. 20” above, angle) between the outer surface (see “First Modified Fig. 20” above, outer surface) and the longitudinal axial direction increases in a stepwise or continuously (see “First Modified Fig. 20” above, angle continuously increasing) toward the distal side in the first section (see “First Modified Fig. 20” below, first section).
Regarding claim 7, the modified device of Petersen et al. discloses the groove (p. 7, col 2, [0078], lines 1-3, slots 150) is formed in the second section (see p. 7, col 2, [0078], lines 1-3, slots 150 can be arranged along the length of, or about the circumference of, distal portion 148 to achieve desired properties).
Regarding claim 8, the modified device of Petersen et al. does not explicitly mention the tubular body has a high-rigidity portion that is composed of a material of higher rigidity than the distal end portion, which is located proximal to the distal end portion. However, the embodiments of Petersen et al. described in (p. 7, col 1, [0076], lines 1-12) disclose the tubular body (p. 7, col 1, [0076], line 1, sheath) has a high-rigidity portion (p. 7, col 1, [0076], lines 4-6, layer) that is composed of a material of higher rigidity (see p. 7, col 1, [0076], lines 1-12, gradual reduction of stiffness) than the distal end (p. 7, col 1, [0076], lines 4-6, distal end) portion, which is located proximal (p. 7, col 1, [0076], lines 4-6, proximal) to the distal end (p. 7, col 1, [0076], lines 4-6, distal end) portion. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. above with the teachings of the embodiments of Petersen et al. described in (p. 7, col 1, [0076], lines 1-12) as Peterson et al. discloses in addition to variations in materials, various embodiments of arrangements and configurations are also contemplated for slots 150 (and/or other slots disclosed herein) in addition to what is described above (p. 7, col 1-2, [0077], lines, 1-4).
Regarding claim 9, the modified device of Petersen et al. further modified by the embodiments of Petersen et al. described in (p. 7, col 1, [0076], lines 1-12) does not explicitly mention the distal end portion is composed of a resin layer, and the high-rigidity portion is composed of a resin and a helical, mesh or braided reinforcing member (the modified device of Petersen et al. further modified by the embodiments of Petersen et al. described in (p. 7, col 1, [0076], lines 1-12) only discloses the high-rigidity portion is composed of a helical, mesh or braided reinforcing member). However, the embodiments of Petersen et al. described in (p. 7, col 1, [0075], lines 1-28) disclose the distal end portion (p. 7, col 1, [0075], lines 1-10, portion of proximal member 16 and distal sheath 26) is composed of a resin (p. 7, col 1, [0075], lines 10-28, epoxy) layer (p. 7, col 1, [0075], lines 10-28, coating), and the high-rigidity portion (p. 7, col 1, [0076], lines 4-6, layer) is composed of a resin (p. 7, col 1, [0075], lines 10-28, epoxy) and a helical, mesh or braided reinforcing member (p. 3, col 1, [0042], lines 24-26, reinforcement member 32). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. further modified by the embodiments of Petersen et al. described in (p. 7, col 1, [0076], lines 1-12) above with the teachings of the embodiments of Petersen et al. described in (p. 7, col 1, [0075], lines 1-28) as Peterson et al. discloses in addition to variations in materials, various embodiments of arrangements and configurations are also contemplated for slots 150 (and/or other slots disclosed herein) in addition to what is described above (p. 7, col 1-2, [0077], lines, 1-4).
Regarding claim 10, the modified device of Petersen et al. discloses the distal end portion has an inner layer (Fig. 8 liner 34) and an outer layer (Fig. 8 outer layer 38), the inner layer (Fig. 8 liner 34) is composed of a material of higher rigidity than the outer layer (the sheath or covering that can be joined with the outer layer of the distal sheath can be composed of silicone which would be less rigid than the polytetrafluoroethylene composing the inner layer described in p. 3, col 1, [0043], lines 1-5. See the silicone sheath or covering composition described in p. 6-7, col 2-1, [0074], lines 1-42), and the groove (see p. 7, col 2, [0078], lines 1-3, slot 150) is formed at least in the inner layer (see p. 7, col 2, [0078], lines 1-3, slots 150 can be arranged along the length of, or about the circumference of, distal portion 148 to achieve desired properties).
Regarding claim 12, the modified device of Petersen et al. discloses the angle (see “Second Modified Fig. 20” above, angle) between the outer surface (see “Second Modified Fig. 20” above, outer surface) and the longitudinal axial direction increases in a stepwise or continuously (see “Second Modified Fig. 20” above, angle increasing continuously) toward the distal side in the first section (see “Second Modified Fig. 20” above, first section).
Regarding claim 13, the modified device of Petersen et al. discloses the groove (p. 7, col 2, [0078], lines 1-3, slots 150) is formed in the second section (see p. 7, col 2, [0078], lines 1-3, slots 150 can be arranged along the length of, or about the circumference of, distal portion 148 to achieve desired properties).
Regarding claim 14, the modified device of Petersen et al. does not explicitly mention the distal end portion is composed of a resin layer. However, the embodiments of Petersen et al. described in (p. 7, col 1, [0075], lines 1-28) disclose the distal end portion (p. 7, col 1, [0075], lines 1-10, portion of proximal member 16 and distal sheath 26) is composed of a resin (p. 7, col 1, [0075], lines 10-28, epoxy) layer (p. 7, col 1, [0075], lines 10-28, coating). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. above with the teachings of the embodiments of Petersen et al. described in (p. 7, col 1, [0075], lines 1-28) as Peterson et al. discloses in addition to variations in materials, various embodiments of arrangements and configurations are also contemplated for slots 150 (and/or other slots disclosed herein) in addition to what is described above (p. 7, col 1-2, [0077], lines, 1-4).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Petersen et al. (US 20140052097) in view of Anderson et al. (US 20140039461).
Regarding claim 11, the modified device of Petersen et al. does not explicitly mention length of the distal end portion in the longitudinal axial direction is 1 mm or longer and 10 mm or shorter. However, Anderson et al. discloses length of the distal end portion in the longitudinal axial direction is 1 mm or longer and 10 mm or shorter (see Anderson et al., p. 2, col 2, [0027], lines 1-4, the length of the distal sheath 102, in general, may be substantially less than the length of the guide catheter; however, the distal sheath 102 may be designed with any desired length according to a desired application). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified device of Peterson et al. above with the teachings of the lengths of the portions of the distal sheath of the extension guide catheter of Anderson et al. described in (p. 2, col 2, [0027], lines 1-4) as Peterson et al. discloses guide extension catheter 514 may have a length that is sufficiently long so that the therapeutic device may be passed along proximal portion 516 and out from the distal end 12 of guide catheter 10 (e.g., while a section of proximal portion 516 and/or tip 526 is positioned slightly further distally within the coronary artery CA (as described in p.5, col 2, [0064], lines 18-23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISSA J GHANNOUM whose telephone number is (571) 272-8591. The examiner can normally be reached Monday through Friday 8:30 AM to 5:00 PM.
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/ISSA JAMIL GHANNOUM/Examiner, Art Unit 3783
/KEVIN C SIRMONS/
Supervisory Patent Examiner, Art Unit 3783
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