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 § 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.
Claim(s) 1-2, 6-7, 11-12 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2002/0177841 to Moloney et al. (Moloney hereinafter).
Regarding claim 1, Moloney teaches a rapid exchange catheter (110) comprising an elongate shaft (114, 116) extending from a proximal end (120) to a distal end (126, 134, see e.g. Figs. 17-23, paragraph 47), a catheter hub (124), a guidewire port (122), a core wire (144) extending past the guidewire port (see e.g. Fig. 17) and a distal end region secured to the elongate shaft distal of the guidewire port (see e.g. paragraph 57). Moloney further teaches a guidewire lumen (130) and an inflation lumen (128) arranged such that the centroid of the distal end region of the core wire (144) is laterally offset from the axis of a longitudinally extending plane (as illustrated in Fig. 20) passing through a centroid of the guidewire lumen (130) and a centroid of the inflation lumen (128).
Regarding claim 2, Moloney teaches that the core wire may be secured using heat lamination, i.e. without any adhesive (paragraph 67).
Regarding claim 6, Moloney teaches a distal outer shaft (116) having a lumen (128), a distal inner shaft (132) and a proximal shaft (112) extending proximal of the distal outer shaft and the distal inner shaft (see Fig. 17), wherein the core wire (144) extends through a lumen of the proximal shaft (see Fig. 18) such that a distal end region of the core wire is secured directly between an outer surface of the distal inner shaft (132) and an inner surface of the distal outer shaft (see Fig. 21).
Regarding claim 7, Moloney teaches that the distal end region of the core wire is embedded between the distal inner shaft (132) and the distal outer shaft (see Figs. 19-20).
Regarding claim 11, Moloney teaches a rapid exchange catheter, comprising an elongate shaft (112, 114, 116), a port joint (118), the shaft including a proximal shaft (112), a distal inner shaft (132), and a distal outer shaft (116) secured to proximal end (at 122) of the distal inner shaft (132) at the port joint (118), wherein a lumen (130) of the distal inner shaft opens to a guidewire port (122), and a core wire (144) extending distally past the port joint (Fig. 19). Moloney further teaches a guidewire lumen (130) and an inflation lumen (128) arranged such that the centroid of the distal end region of the core wire (144) is laterally offset from the axis of a longitudinally extending plane (as illustrated in Fig. 20) passing through a centroid of the guidewire lumen (130) and a centroid of the inflation lumen (128) and that all three are spaced from a central axis.
Regarding claim 12, wherein the core wire is secured to the elongate shaft at the port joint by heat lamination (paragraph 67), i.e. without any adhesive.
Regarding claim 17, Moloney teaches a manufacturing method including forming an assembly by disposing a distal inner shaft (132) within a distal outer shaft (116), disposing a distal end region of a proximal shaft (112) around a proximal end region of the distal outer shaft with a proximal end region (at 122) of the distal inner shaft extending adjacent to the distal end region of the proximal shaft, inserting a first mandrel (150) through a lumen of the distal inner shaft (see Fig. 18, paragraph 66), inserting a second mandrel (152) between the outer diameter of the distal inner shaft and the inner diameter of the distal outer shaft, as illustrated in Fig. 18. Moloney further states that Fig. 18 illustrates the catheter (110) “prior to the heat lamination process that bonds the components of exchange joint 118), which means that the application of heat and pressure called for in heat lamination occurs after the disposing and inserting steps discussed above. Moloney further teaches a guidewire lumen (130) and an inflation lumen (128) arranged such that the centroid of the distal end region of the core wire (144) is laterally offset from the axis of a longitudinally extending plane (as illustrated in Fig. 20) passing through a centroid of the guidewire lumen (130) and a centroid of the inflation lumen (128).
Regarding claim 18, Moloney teaches that the distal end region of the proximal shaft (112) includes an enlarged profile (see hatched area of Fig. 20) including a tab that extends along the OD of the distal inner shaft.
Regarding claim 19, Moloney teaches that the core wire extends proximally of the guidewire port.
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) 3-4, 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moloney in view of U.S. Patent 10,668,258 to Calhoun et al. (Calhoun).
Regarding claim 3, Moloney teaches the limitations of claim 1 as discussed above, and further teaches that known methods may be used to form the rapid exchange port (paragraph 70, “other suitable bonding techniques”). Moloney does not teach reflowing one or more components around the core wire. Calhoun teaches another catheter generally, and particularly teaches that reflowing around a wire is a suitable bonding method for securing a wire to an element of a catheter (see col. 23, ln. 48-50). As such, Moloney teaches a catheter identical in structure to the claimed invention which differs therefrom only by the method of manufacture including a step of reflowing. Calhoun teaches that the technique is known in the catheter wire art and generally treat the technique as conventional. As such, one of ordinary skill in the art would have had an expectation that reflowing could be used in the manufacture of the catheter of Moloney and such a substitution of bonding steps would have the predictable result of a functional rapid exchange catheter system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to perform such substitution as the simple substitution of one bonding step for another.
Regarding claim 4, Moloney teaches a distal inner shaft (132) and a distal outer shaft (116) as illustrated in Figs. 17-23, the core wire being disposed between the outer diameter of the inner shaft and the inner diameter of the outer shaft (see Fig. 20).
Regarding claim 13, Moloney teaches the limitations of claim 11 as discussed above, and further teaches that known methods may be used to form the rapid exchange port (paragraph 70, “other suitable bonding techniques”). Moloney does not teach reflowing one or more components around the core wire. Calhoun teaches another catheter generally, and particularly teaches that reflowing around a wire is a suitable bonding method for securing a wire to an element of a catheter (see col. 23, ln. 48-50). As such, Moloney teaches a catheter identical in structure to the claimed invention which differs therefrom only by the method of manufacture including a step of reflowing. Calhoun teaches that the technique is known in the catheter wire art and generally treat the technique as conventional. As such, one of ordinary skill in the art would have had an expectation that reflowing could be used in the manufacture of the catheter of Moloney and such a substitution of bonding steps would have the predictable result of a functional rapid exchange catheter system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to perform such substitution as the simple substitution of one bonding step for another.
Regarding claim 20, Moloney teaches the limitations of claim 17 as discussed above, and further teaches that known methods may be used to form the rapid exchange port (paragraph 70, “other suitable bonding techniques”). Moloney does not teach reflowing one or more components around the core wire. Calhoun teaches another catheter generally, and particularly teaches that reflowing around a wire is a suitable bonding method for securing a wire to an element of a catheter (see col. 23, ln. 48-50). As such, Moloney teaches a catheter identical in structure to the claimed invention which differs therefrom only by the method of manufacture including a step of reflowing. Calhoun teaches that the technique is known in the catheter wire art and generally treat the technique as conventional. As such, one of ordinary skill in the art would have had an expectation that reflowing could be used in the manufacture of the catheter of Moloney and such a substitution of bonding steps would have the predictable result of a functional rapid exchange catheter system. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to perform such substitution as the simple substitution of one bonding step for another.
Claim(s) 5, 8, 10-11 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moloney in view of U.S. Patent 8,057,430 to Grovender et al. (Grovender).
Regarding claim 5, Moloney teaches the catheter of claim 1 as discussed above, but does not teach a mandrel. Grovender teaches a port mandrel (92) and a crescent shaped mandrel (94) inserted between the facing diameters of the distal inner and outer shafts (see Fig. 4B). Grovender teaches that this mandrel helps maintain the shape of the catheter during manufacturing (see col. 10, ln. 36-45). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a mandrel as taught by Grovender in the catheter of Moloney in order to maintain its shape during manufacturing.
Regarding claims 8 and 14, Moloney teaches an inflation lumen, but does not teach a crescent shape thereof. Grovender teaches a crescent shaped inflation lumen (76) extending proximal and distal of the guidewire port. Grovender implicitly teaches that this shape improves inflation flow through areal management. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a crescent shape for the inflation lumen of Moloney in order to manage the area within the catheter. Alternatively, Grovender may be considered to teach an alternate shape for an inflation lumen within a catheter. Since Moloney teaches a catheter which differs from that of claim 8 only in the shape of the inflation lumen, it would have been obvious to use a crescent shape as taught by Grovender as the mere substitution of one known passage shape for another according to the known construction and operation methods evinced by the combined references.
Regarding claim 10, Moloney teaches a balloon (26).
Regarding claims 15-16, Moloney teaches that a centroid of the core wire is spaced away from the central axis, and an angle between the third direction and the first is acute (Fig. 20, first direction being vertical).
Response to Arguments
Applicant’s arguments, see page 7, filed 23 April 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and 103 have been fully considered and are partially persuasive. Therefore, some of the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Moloney in view of Grovender.
With respect to the argument that Moloney does not teach the claimed centroid positions, the examiner disagrees. While Moloney does not use the term centroid, each of the core wire, guidewire lumen and inflation lumen are positioned in their entirety as claimed. That is to say that whatever the centroid is within each element, it is placed as claimed. Accordingly, the examiner must conclude that the claimed positions are taught by Moloney and therefore do not constitute a patentable distinction over the prior art.
In view of the foregoing, the examiner maintains the 35 U.S.C. 102 rejection over Moloney and notes that the new grounds of rejection render the arguments against Grovender substantially moot.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 15 July 2026
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