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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the limitation of “a distal end of the elongate shaft” was also recited in claim 1 (“an elongate shaft extending… to a distal end”). This causes at least grammatical confusion as to whether there is one or instead more distal end to the elongate shaft. The examiner will interpret claim 10 as referring to the originally recited distal end of claim 1.
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).
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).
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.
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(s) 1-5, 8, 11 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 8,057,430 to Grovender et al. (Grovender).
Regarding claim 1, Grovender teaches a rapid exchange catheter (10) including an elongate shaft (14) extending from a proximal end (at 12) to a distal end (at 16), a catheter hub (12), a guidewire port (proximal end of guidewire lumen 74), a core wire (105) including a distal end region (see e.g. Fig. 5) secured to the elongate shaft distal of the guidewire port.
Regarding claim 2, Grovender teaches securement without adhesive (see col. 10, ln. 57+).
Regarding claim 3, Grovender teaches reflowing (see col. 11, ln. 4-13, “a temperature greater than the melting temperatures of each of the outer tubular member and the inner tubular member 72).
Regarding claims 4 and 11, Grovender teaches a distal inner shaft (72) disposed within a distal outer shaft (70) with a proximal shaft (30, 100) surrounding a proximal end of the distal outer shaft and adjacent to a proximal end of the distal inner shaft (72), with the core wire disposed between an outer diameter of the distal inner shaft and the inner diameter of the distal outer shaft (see Fig. 5).
Regarding claim 5, 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).
Regarding claim 8, Grovender teaches a crescent shaped lumen (76) extending proximal and distal of the guidewire port.
Regarding claim 14, Grovender teaches the crescent shaped inflation lumen (74) and a guidewire lumen (72) with oppositely spaced centroids (Fig. 4B).
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) 9-10 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grovender.
Regarding claim 9, Grovender teaches the limitation of claim 8 as discussed above. Grovender does not teach the centroid positions claimed. However, it has been held that the mere rearrangement of parts in a fashion which does not modify operation of the device having them is not a patentable distinction (see MPEP 2144.04 VI. C). As the examiner is unaware of any substantive difference in operation allowed by the centroid positions claimed the invention of claim 9 is held to be obvious.
Regarding claim 10, Grovender teaches an inflation lumen (74).
Regarding claims 15 and 16, Grovender teaches the limitations of claim 14 as discussed above. Grovender does not teach the centroid positions claimed. However, it has been held that the mere rearrangement of parts in a fashion which does not modify operation of the device having them is not a patentable distinction (see MPEP 2144.04 VI. C). As the examiner is unaware of any substantive difference in operation allowed by the centroid positions claimed the invention of claim 15 is held to be obvious
Conclusion
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 1 February 2026