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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/29/26 has been entered.
Response to Amendment
Claims 1-19 are pending in the application. Claims 1 and 11 have been amended.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12, and 13 of U.S. Patent No. 10,441,449 B1 in view of Jimenez et al. (US 2007/0168014 A1) (“Jimenez”).
Regarding claim 1, US 10,441,449 B1 discloses a delivery device having a housing (claim 2) comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft (claim 1); a timing belt having a plurality of belt teeth on a surface of the timing belt (claim 1); a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath (claim 1) with respect to the inner core and the outer support shaft; a barrel having barrel teeth corresponding to belt teeth (claim 1); a belt tensioner for maintaining tension of the belt with respect to the barrel (claim 1); and a thumbwheel coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (claim 1).
US 10,441,449 B1 fails to disclose a strain relief disposed at a distal end of the housing and all three of the concentric shafts extend through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing and three concentric shafts (122, 124, 128) of a catheter (104) extending through the strain relief (paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by US 10,441,449 B1 to include a strain relief disposed at a distal end of the housing and all three of the concentric shafts to extend through the strain relief, as taught by Jimenez. This modification would prevent sharp bends in the outer tubular member near the handle portion, reducing stress or strain that may otherwise be introduced on connection points between the handle portion and the outer tubular member (Jimenez, paragraph 0053).
Regarding claim 2, US 10,441,449 B1 as modified by Jimenez teaches a housing, wherein a portion of the thumbwheel is external to the housing, wherein the barrel is internal to the housing and the timing belt is internal to the housing (claim 2).
Regarding claim 11, US 10,441,449 B1 discloses a system for delivery of an intraluminal stent, comprising: a delivery device having a housing (claim 13) comprising: a catheter having three concentric shafts including: an inner core having the intraluminal stent thereon; an outer sheath over the intraluminal stent in an unexpanded state on the inner core therein, the outer sheath holding the intraluminal stent in an unexpanded state, the outer sheath translatable coaxially over the inner core and the intraluminal stent (claim 12); and an outer support shaft at least partially extending over the inner core and the outer sheath (claim 12); a timing belt having a plurality of belt teeth on a surface of the timing belt (claim 12); a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath with respect to the outer support shaft and the inner core to expose the intraluminal stent (claim 12); a barrel having barrel teeth corresponding to belt teeth (claim 12); a belt tensioner for maintaining tension of the belt with respect to the barrel (claim 12); and a thumbwheel coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (claim 12).
US 10,441,449 B1 fails to disclose a strain relief disposed at a distal end of the housing and all three concentric shafts of the catheter extending through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing and three concentric shafts (122, 124, 128) of a catheter (104) extending through the strain relief (paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by US 10,441,449 B1 to include a strain relief disposed at a distal end of the housing and all three of the concentric shafts to extend through the strain relief, as taught by Jimenez. This modification would prevent sharp bends in the outer tubular member near the handle portion, reducing stress or strain that may otherwise be introduced on connection points between the handle portion and the outer tubular member (Jimenez, paragraph 0053).
Regarding claim 12, US 10,441,449 B1 as modified by Jimenez teaches a housing, wherein a portion of the thumbwheel is external to the housing, wherein the barrel is internal to the housing and the timing belt is internal to the housing (claim 13).
Claims 1, 2, 11, and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 12, and 13 of U.S. Patent No. 10,987,239 B2 in view of Jimenez et al. (US 2007/0168014 A1) (“Jimenez”).
Regarding claim 1, US 10,987,239 B2 discloses a delivery device having a housing (claim 2) comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft (claim 1); a timing belt having a plurality of belt teeth on a surface of the timing belt (claim 1); a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath with respect to the inner core and the outer support shaft (claim 1); a barrel having barrel teeth corresponding to belt teeth (claim 1); a belt tensioner for maintaining tension of the belt with respect to the barrel (claim 1); and a thumbwheel coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (claim 1).
US 10,987,239 B2 fails to disclose a strain relief disposed at a distal end of the housing and all three concentric shafts of the catheter extending through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing and three concentric shafts (122, 124, 128) of a catheter (104) extending through the strain relief (paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by US 10,987,239 B2 to include a strain relief disposed at a distal end of the housing and all three of the concentric shafts to extend through the strain relief, as taught by Jimenez. This modification would prevent sharp bends in the outer tubular member near the handle portion, reducing stress or strain that may otherwise be introduced on connection points between the handle portion and the outer tubular member (Jimenez, paragraph 0053).
Regarding claim 2, US 10,987,239 B2 as modified by Jimenez teaches a housing, wherein a portion of the thumbwheel is external to the housing, wherein the barrel is internal to the housing and the timing belt is internal to the housing (claim 2).
Regarding claim 11, US 10,987,239 B2 discloses a system for delivery of an intraluminal stent, comprising: a delivery device having a housing (claim 13) comprising: a catheter having three concentric shafts including: an inner core having the intraluminal stent thereon; an outer sheath over the intraluminal stent in an unexpanded state on the inner core therein, the outer sheath holding the intraluminal stent in an unexpanded state, the outer sheath translatable coaxially over the inner core and the intraluminal stent (claim 12); and an outer support shaft at least partially extending over the inner core and the outer sheath (claim 12); a timing belt having a plurality of belt teeth on a surface of the timing belt (claim 12); a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath with respect to the outer support shaft and inner core to expose the intraluminal stent (claim 12); a barrel having barrel teeth corresponding to belt teeth (claim 12); a belt tensioner for maintaining tension of the belt with respect to the barrel (claim 12); and a thumbwheel coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (claim 12).
US 10,987,239 B2 fails to disclose a strain relief disposed at a distal end of the housing and all three concentric shaft of the catheter extending through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing and three concentric shafts (122, 124, 128) of a catheter (104) extending through the strain relief (paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by US 10,987,239 B2 to include a strain relief disposed at a distal end of the housing and all three of the concentric shafts to extend through the strain relief, as taught by Jimenez. This modification would prevent sharp bends in the outer tubular member near the handle portion, reducing stress or strain that may otherwise be introduced on connection points between the handle portion and the outer tubular member (Jimenez, paragraph 0053).
Regarding claim 12, US 10,987,239 B2 as modified by Jimenez teaches a housing, wherein a portion of the thumbwheel is external to the housing, wherein the barrel is internal to the housing and the timing belt is internal to the housing (claim 13).
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 13, and 17 of U.S. Patent No. 11,234,848 B2 in view of Jimenez et al. (US 2007/0168014 A1) (“Jimenez”).
Regarding claim 1, US 11,234,848 B2 discloses a delivery device comprising: a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft (claim 1); a timing belt having a plurality of belt teeth on a surface of the timing belt (claim 1); a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath with respect to the inner core and the outer support shaft (claim 1); a barrel having barrel teeth corresponding to belt teeth (claim 1); a belt tensioner for maintaining tension of the belt with respect to the barrel (claim 5); and a thumbwheel coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (claim 1).
US 11,234,848 B2 fails to disclose a housing and a strain relief disposed at a distal end of the housing and all three concentric shafts of the catheter extending through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing and three concentric shafts (122, 124, 128) of a catheter (104) extending through the strain relief (paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by US 11,234,848 B2 to include a housing and a strain relief disposed at a distal end of the housing and all three concentric shafts of the catheter to extend through the strain relief, as taught by Jimenez. This modification would prevent sharp bends in the outer tubular member near the handle portion, reducing stress or strain that may otherwise be introduced on connection points between the handle portion and the outer tubular member (Jimenez, paragraph 0053).
Regarding claim 11, US 11,234,848 B2 discloses a system for delivery of an intraluminal stent, comprising: a delivery device comprising: a catheter having three concentric shafts including: an inner core having the intraluminal stent thereon; an outer sheath over the intraluminal stent in an unexpanded state on the inner core therein, the outer sheath holding the intraluminal stent in an unexpanded state, the outer sheath translatable coaxially over the inner core and the intraluminal stent (claim 13); and an outer support shaft at least partially extending over the inner core and the outer sheath (claim 13); a timing belt having a plurality of belt teeth on a surface of the timing belt (claim 13); a timing belt link coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath with respect to the outer support shaft and the inner core to expose the intraluminal stent (claim 13); a barrel having barrel teeth corresponding to belt teeth (claim 13); a belt tensioner for maintaining tension of the belt with respect to the barrel (claim 17); and a thumbwheel coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (claim 13).
US 11,234,848 B2 fails to disclose the delivery device having a housing and a strain relief disposed at a distal end of the housing and all three concentric shafts of the catheter extending through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing and three concentric shafts (122, 124, 128) of a catheter (104) extending through the strain relief (paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by US 11,234,848 B2 to include a housing and a strain relief disposed at a distal end of the housing and all three concentric shafts of the catheter to extend through the strain relief, as taught by Jimenez. This modification would prevent sharp bends in the outer tubular member near the handle portion, reducing stress or strain that may otherwise be introduced on connection points between the handle portion and the outer tubular member (Jimenez, paragraph 0053).
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 1-6, 10-14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Shimoyama (US 2016/0135975 A1) in view of Jimenez et al. (US 2007/0168014 A1) (“Jimenez”).
Regarding claim 1, Shimoyama discloses (Figures 1-5) a delivery device (10) having a housing (18) comprising: a catheter having concentric shafts including an inner core (14), an outer sheath (16) over the inner core; a timing belt (66) having a plurality of belt teeth (67) on a surface of the timing belt; a timing belt link (54) coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath; a barrel (64a) having barrel teeth (65) corresponding to belt teeth (paragraph 0080); a belt tensioner (69a) for maintaining tension of the belt with respect to the barrel (paragraph 0082); and a thumbwheel (58) coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (paragraph 0081). Shimoyama fails to disclose a strain relief disposed at a distal end of the housing. Shimoyama fails to disclose a concentric outer support shaft. Shimoyama fails to disclose that movement of the timing belt link causes movement of the outer sheath with respect to the inner core and the outer support shaft. Shimoyama fails to disclose all three of the concentric shaft extend through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing, the delivery device comprising: a catheter (104) extending through the strain relief and having three concentric shafts (Figure 6) including an inner core (128), an outer sheath (124) over the inner core, and an outer support shaft (122) at least partially extending over the inner core and the outer sheath (Figure 2), wherein the outer support shaft (122) is fixed with respect to the proximal end of the delivery device (Figures 21 and 22; paragraphs 0093-0102); and a thumbwheel (106) coupled to the housing such that rotation of the thumbwheel causes movement of the outer sheath (124) with respect to the inner core and the outer support shaft (paragraph 0054). Jimenez teaches that the outer support shaft (122) extends along a portion of the length of the outer sheath (124) to reduce any unintended movement of the catheter (104) while the outer sheath (124) is being retracted (e.g. sideways or curling movement due to friction between the outer tubular sheath and the inner core; paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by Shimoyama to include a strain relief disposed at a distal end of the housing and to modify the catheter to include an outer support shaft at least partially extending over the inner core and the outer sheath, wherein all three concentric shafts extend through the strain relief, and wherein the outer support shaft is fixed with respect to the proximal end of the delivery device, as taught by Jimenez, such that movement of the timing belt link causes movement of the outer sheath with respect to the inner core and the outer support shaft. Modifying the catheter to include an outer support shaft would provide a structure that extends along a portion of the length of the outer sheath to reduce any unintended movement of the catheter while the outer sheath is being retracted (e.g. sideways or curling movement due to friction between the outer tubular sheath and the inner core; Jimenez, paragraph 0053). Modifying the delivery device to include a strain relief disposed at the distal end of the housing would prevent sharp bends in the outer sheath near the housing, reducing stress or strain that may otherwise be introduced on connection points between the housing and the outer sheath (Jimenez, paragraph 0053)
Regarding claim 2, Shimoyama as modified by Jimenez teaches (Shimoyama, Figure 1) a housing (18), wherein a portion of the thumbwheel (58) is external to the housing, wherein the barrel (64) is internal to the housing and the timing belt (66) is internal to the housing.
Regarding claim 3, Shimoyama as modified by Jimenez teaches the belt teeth (67) are on an outer surface of the timing belt (66). NOTE: teeth (67) are disclosed as being formed on an “inner circumferential portion” of the belt. However, the belt is disclosed as a solid (i.e., not hollow) member formed of resin material (Shimoyama, paragraph 0079). Since the belt is not hollow, the “inner circumferential portion” is being interpreted as an outer surface. The Examiner suggests further defining the belt.
Regarding claim 4, Shimoyama as modified by Jimenez teaches (Shimoyama, Figure 3) at least one pulley (64), the timing belt (66) extending around the at least one pulley such that the direction of rotation of the thumbwheel imparts a desired direction of translation of the outer sheath (Shimoyama, paragraphs 0092-0093).
Regarding claim 5, Shimoyama as modified by Jimenez teaches (Shimoyama, Figure 2) that the three concentric shafts comprise: the inner core (14) sized to receive a medical device (12) thereon; the outer sheath (16) sized to receive the medical device in an unexpanded state on the inner core therein and to hold the medical device, the outer sheath (16) translatable coaxially over the inner core (Shimoyama, paragraph 0064); and the outer support shaft at least partially extending over the inner core and the outer sheath (as modified by Jimenez above, Figures 1, 6, 21, 22 of Jimenez teaches the outer support shaft 122 at least partially extending over the inner core 128 and the outer sheath 124).
Regarding claim 6, Shimoyama as modified by Jimenez teaches that the inner core (14) is fixed with respect to a proximal end (18) of the delivery device (Shimoyama, paragraph 0057). Shimoyama as modified by Jimenez teaches that the outer support shaft is fixed with respect to a proximal end of the delivery device (as modified by Jimenez above).
Regarding claim 10, Shimoyama as modified by Jimenez teaches that the thumbwheel (58) is rotatable in a forward direction and a reverse direction such that the outer sheath translates in first direction when the thumbwheel is rotated in the forward direction and the outer sheath translates in a second direction when the thumbwheel is rotated in the reverse direction (Shimoyama, paragraphs 0092-0093).
Regarding claims 11 and 19, Shimoyama discloses (Figures 1-5) system for delivery of an intraluminal stent (12), comprising: a delivery device (10) having a housing (18) comprising: a catheter having concentric shafts including: an inner core (14) having the intraluminal stent (12) thereon, the inner core fixed with respect to a proximal end (18) of the delivery device (paragraph 0057); an outer sheath (16) over the intraluminal stent in an unexpanded state on the inner core therein, the outer sheath holding the intraluminal stent in an unexpanded state (Figure 2), the outer sheath translatable coaxially over the inner core and the intraluminal stent; a timing belt (66) having a plurality of belt teeth (67) on a surface of the timing belt; a timing belt link (54) coupled to the outer sheath such that movement of the timing belt link causes movement of the outer sheath to expose the intraluminal stent; a barrel (64a) having barrel teeth (65) corresponding to belt teeth; a belt tensioner (69a) for maintaining tension of the belt with respect to the barrel (paragraph 0082); and a thumbwheel (58) coupled to the barrel such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath (paragraph 0081). Shimoyama fails to disclose a strain relief disposed at a distal end of the housing. Shimoyama fails to discloses a concentric outer support shaft at least partially extending over the inner core and the outer sheath, wherein the outer support shaft is fixed with respect to the proximal end of the delivery device, such that movement of the timing belt link causes movement of the outer sheath with respect to the inner core and the outer support shaft. Shimoyama fails to disclose all three concentric shafts of the catheter extending through the strain relief.
In the same field of endeavor, Jimenez teaches (Figures 1-22) a system for delivery of an intraluminal stent (160), comprising a delivery device (100) having a housing (102) and a strain relief (120) disposed at a distal end of the housing (paragraph 0053), the delivery device comprising: a catheter (104) extending through the strain relief and having three concentric shafts (Figure 6) including an inner core (128) having the intraluminal stent (160) thereon (Figure 7, paragraph 0049), an outer sheath (124) over the intraluminal stent in an unexpanded state on the inner core therein (Figure 7), the outer sheath holding the intraluminal stent in an unexpanded state, the outer sheath translatable coaxially over the inner core and the intraluminal stent, and an outer support shaft (122) at least partially extending over the inner core and the outer sheath (Figures 1, 6, 21, 22), wherein the outer support shaft (122) and the inner core (128) are fixed with respect to the proximal end of the delivery device (paragraphs 0051 and 0093-0102); and a thumbwheel (106) coupled to the housing such that rotation of the thumbwheel causes movement of the outer sheath with respect to the inner core and the outer support shaft to expose the intraluminal stent (paragraph 0054). Jimenez teaches that the outer support shaft (122) extends along a portion of the length of the outer sheath (124) to reduce any unintended movement of the catheter (104) while the outer sheath (124) is being retracted (e.g. sideways or curling movement due to friction between the outer tubular sheath and the inner core; paragraph 0053).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device disclosed by Shimoyama to include a strain relief disposed at a distal end of the housing and to modify the catheter to include an outer support shaft at least partially extending over the inner core and the outer sheath, wherein all three concentric shafts extend through the strain relief, and wherein the outer support shaft is fixed with respect to the proximal end of the delivery device, as taught by Jimenez, such that movement of the timing belt link causes movement of the outer sheath with respect to the inner core and the outer support shaft to expose the intraluminal stent. Modifying the catheter to include an outer support shaft would provide a structure that extends along a portion of the length of the outer sheath to reduce any unintended movement of the catheter while the outer sheath is being retracted (e.g. sideways or curling movement due to friction between the outer tubular sheath and the inner core; Jimenez, paragraph 0053). Modifying the delivery device to include a strain relief disposed at the distal end of the housing would prevent sharp bends in the outer sheath near the housing, reducing stress or strain that may otherwise be introduced on connection points between the housing and the outer sheath (Jimenez, paragraph 0053)
Regarding claim 12, Shimoyama as modified by Jimenez teaches (Shimoyama, Figure 1) a housing (18), wherein a portion of the thumbwheel (58) is external to the housing, wherein the barrel (64) is internal to the housing and the timing belt (66) is internal to the housing.
Regarding claim 13, Shimoyama as modified by Jimenez teaches (Shimoyama. Figure 3) the belt teeth (67) are on an outer surface of the timing belt (66). NOTE: teeth (67) are disclosed as being formed on an “inner circumferential portion” of the belt. However, the belt is disclosed as a solid (i.e., not hollow) member formed of resin material (Shimoyama, paragraph 0079). Since the belt is not hollow, the “inner circumferential portion” is being interpreted as an outer surface. The Examiner suggests further defining the belt.
Regarding claim 14, Shimoyama as modified by Jimenez teaches (Shimoyama. Figure 3) at least one pulley (64), the timing belt (66) extending around the pulley such that the direction of rotation of the thumbwheel imparts a desired direction of translation of the outer sheath (Shimoyama, paragraphs 0092-0093).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Shimoyama (US 2016/0135975 A1) in view of Jimenez et al. (US 2007/0168014 A1) (“Jimenez”) as applied to claim 1 above, and further in view of Wu et al. (US 2005/0090890 A1) (“Wu”).
Regarding claims 7-9, Shimoyama as modified by Jimenez above teaches the invention substantially as claimed. However, the combined teaching fails to teach a stainless steel shaft bonded to an outer diameter of the inner core.
In the same field of endeavor, Wu teaches a delivery device with a stainless steel shaft bonded to an outer diameter of an inner core (paragraph 0046).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device taught by Shimoyama in view of Jimenez to comprise a stainless steel shaft bonded to an outer diameter of the inner core, as taught by Wu. This modification would provide a strong, but flexible, inner core in order to provide good trackability and pushability over a guide wire. This modification would provide an inner core with sufficient rigidity to prevent unwanted buckling or deformation, yet is flexible enough to track along the torturous anatomy to the target site (Wu, paragraph 0046).
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Shimoyama (US 2016/0135975 A1) in view of Jimenez et al. (US 2007/0168014 A1) (“Jimenez”) as applied to claim 11 above, and further in view of Wu et al. (US 2005/0090890 A1) (“Wu”).
Regarding claims 15-17, Shimoyama as modified by Jimenez above teaches the invention substantially as claimed. However, the combined teaching fails to teach a stainless steel shaft bonded to an outer diameter of the inner core.
In the same field of endeavor, Wu teaches a delivery device with a stainless steel shaft bonded to an outer diameter of an inner core (paragraph 0046).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device taught by Shimoyama in view of Jimenez to comprise a stainless steel shaft bonded to an outer diameter of the inner core, as taught by Wu. This modification would provide a strong, but flexible, inner core in order to provide good trackability and pushability over a guide wire. This modification would provide an inner core with sufficient rigidity to prevent unwanted buckling or deformation, yet is flexible enough to track along the torturous anatomy to the target site (Wu, paragraph 0046).
Regarding claim 18, Shimoyama as modified by Jimenez and Wu teaches that the thumbwheel (58) is rotatable in a forward direction and a reverse direction such that the outer sheath translates in first direction when the thumbwheel is rotated in the forward direction and the outer sheath translates in a second direction when the thumbwheel is rotated in the reverse direction (Shimoyama, paragraphs 0092-0093).
Response to Arguments
Applicant’s arguments with respect to claims 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Jimenez reference is newly cited to teach the new claim limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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