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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/15/2026 has been entered.
Response to Arguments
Applicant’s arguments, see remarks and amendments, filed 6/15/2026, with respect to the rejection(s) of claim(s) 48, 84, 86, 87, 92 and 95 under 35 USC 102a1 over Kampa have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Babrowicz (US 5837335 A) as applied below.
However, Babrowicz discloses a heat-shrinkable, biaxially-oriented, multilayer film with a cooling step in between, and thus makes obvious heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer.
See column, lines, disclosing:
Film No. 1 was produced in accordance with a process schematically illustrated in FIG. 2. In the process illustrated in FIG. 2, solid polymer beads (not illustrated) are fed to a plurality of extruders 28 (for simplicity, only one extruder is illustrated). Inside extruders 28, the polymer beads are forwarded, melted, and degassed, following which the resulting bubble-free melt is forwarded into die head 30, and extruded through an annular die, resulting in tubing 32 which is preferably about 24 mils thick.
After cooling or quenching by water spray from cooling ring 34, tubing 32 is collapsed by pinch rolls 36, and is thereafter fed through irradiation vault 38 surrounded by shielding 40, where tubing 32 is irradiated with high energy electrons (i.e., ionizing radiation) from iron core transformer accelerator 42. Tubing 32 is guided through irradiation vault 38 on rolls 44. Preferably, tubing 32 is irradiated to a level of from about 3 to 8 MR.
After irradiation, irradiated tubing 46 is directed through pinch rolls 48, following which irradiated tubing 46 is slightly inflated, resulting in trapped bubble 50. However, at trapped bubble 50, the tubing is not significantly drawn longitudinally, as the surface speed of nip rolls 52 are about the same speed as nip rolls 48. Furthermore, irradiated tubing 46 is inflated only enough to provide a substantially circular tubing without significant transverse orientation, i.e., without stretching.
Slightly inflated, irradiated tubing 50 is passed through vacuum chamber 54, and thereafter forwarded through coating die 56. Second tubular film 58 is melt extruded from coating die 56 and coated onto slightly inflated, irradiated tube 50, to form two-ply tubular film 60. Second tubular film 58 preferably comprises an O.sub.2 barrier layer, which does not pass through the ionizing radiation. Further details of the above-described coating step are generally as set forth in U.S. Pat. No. 4,278,738, to BRAX et al., which is hereby incorporated by reference thereto, in its entirety.
After irradiation and coating, two-ply tubing film 60 is wound up onto windup roll 62. Thereafter, windup roll 62 is removed and installed as unwind roll 64, on a second stage in the process of making the tubing film as ultimately desired. Two-ply tubular film 60, from unwind roll 64, is unwound and passed over guide roll 66, after which two-ply tubular film 60 passes into hot water bath tank 68 containing hot water 70. The now collapsed, irradiated, coated tubular film 60 is submersed in hot water 70 (having a temperature of about 185.degree. F.) for a retention time of at least about 30 seconds, i.e., for a time period in order to bring the film up to the desired temperature for biaxial orientation. Thereafter, irradiated tubular film 60 is directed through nip rolls 72, and bubble 74 is blown, thereby transversely stretching tubular film 60. Furthermore, while being blown, i.e., transversely stretched, nip rolls 76 draw tubular film 60 in the longitudinal direction, as nip rolls 76 have a surface speed higher than the surface speed of nip rolls 72. As a result of the transverse stretching and longitudinal drawing, irradiated, coated biaxially-oriented blown tubing film 78 is produced, this blown tubing preferably having been both stretched in a ratio of from about 1:1.5-1:6, and drawn in a ratio of from about 1:1.5-1:6. More preferably, the stretching and drawing are each performed a ratio of from about 1:2-1:4. The result is a biaxial orientation of from about 1:2.25-1:36, more preferably, 1:4-1:16. While bubble 74 is maintained between pinch rolls 72 and 76, blown tubing 78 is collapsed by rolls 80, and thereafter conveyed through pinch rolls 76 and across guide roll 82, and then rolled onto wind-up roll 84. Idler roll 86 assures a good wind-up.
See Figure 2, below:
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer by using intermediate cooling steps as disclosed by Babrowicz in order to achieve a biaxially stretch heat shrunk tube or film.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 48, 84, 86, 87, 92 and 95-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kampa (US 20080251966 A1) in view of Babrowicz (US 5837335 A).
As to claim 48, Kampa discloses a method of manufacturing a peel-away sheath assembly (see the abstract, disclosing “a tubular body for a catheter, sheath or lead”) for insertion of a blood pump (see paragraph 0112, disclosing “In use, a puncture is made with a thin walled needle through the skin and into a blood vessel.”), the peel-away sheath assembly comprising a peel-away sheath body and a peel-away sheath hub, the method comprising:
coating a mandrel with a first layer of a first material (paragraph 0079, disclosing “As indicated in FIGS. 4 and 10, the pre-extruded core 20 is pulled over a core rod or mandrel 90 and tightened down [block 210].”);
heat-shrinking the first layer (see paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”) following the coating of the mandrel with the first layer (paragraph 0082 occurs after paragraph 0079, and therefore the order reads on the claim);
coating the heat-shrunk first layer with a second layer of a second material (paragraph 0079, “As illustrated in FIG. 5, where a reinforcement layer 55 is utilized, the reinforcement layer (i.e., a cylindrical wire braid) 55 is pulled or woven over the outer circumferential surface 65 of the core 20 and tightened down [block 220]”, and see paragraph 0080, disclosing “As shown in FIGS. 6 and 11, the entirety of the aforementioned components is then encased within the outer polymer layer 60 [block 230].”), and an outermost third layer of a third material (see paragraph 0081, disclosing “s depicted in FIGS. 7 and 12, a heat-shrinkable tube or layer 95 is snuggly placed over the outer polymer layer 60 [block 240].”) wherein the second layer is a reinforcing layer (“a cylindrical wire braid”); and
heat-shrinking the first, second, and third layers materials to form a peel-away sheath body (see paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”).
See Figures 3-8 below, and Figures 9-12, 14-15 below:
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Kampa, however, does not disclose heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer.
However, Babrowicz discloses a heat-shrinkable, biaxially-oriented, multilayer film with a cooling step in between, and thus makes obvious heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer.
See column, lines, disclosing:
Film No. 1 was produced in accordance with a process schematically illustrated in FIG. 2. In the process illustrated in FIG. 2, solid polymer beads (not illustrated) are fed to a plurality of extruders 28 (for simplicity, only one extruder is illustrated). Inside extruders 28, the polymer beads are forwarded, melted, and degassed, following which the resulting bubble-free melt is forwarded into die head 30, and extruded through an annular die, resulting in tubing 32 which is preferably about 24 mils thick.
After cooling or quenching by water spray from cooling ring 34, tubing 32 is collapsed by pinch rolls 36, and is thereafter fed through irradiation vault 38 surrounded by shielding 40, where tubing 32 is irradiated with high energy electrons (i.e., ionizing radiation) from iron core transformer accelerator 42. Tubing 32 is guided through irradiation vault 38 on rolls 44. Preferably, tubing 32 is irradiated to a level of from about 3 to 8 MR.
After irradiation, irradiated tubing 46 is directed through pinch rolls 48, following which irradiated tubing 46 is slightly inflated, resulting in trapped bubble 50. However, at trapped bubble 50, the tubing is not significantly drawn longitudinally, as the surface speed of nip rolls 52 are about the same speed as nip rolls 48. Furthermore, irradiated tubing 46 is inflated only enough to provide a substantially circular tubing without significant transverse orientation, i.e., without stretching.
Slightly inflated, irradiated tubing 50 is passed through vacuum chamber 54, and thereafter forwarded through coating die 56. Second tubular film 58 is melt extruded from coating die 56 and coated onto slightly inflated, irradiated tube 50, to form two-ply tubular film 60. Second tubular film 58 preferably comprises an O.sub.2 barrier layer, which does not pass through the ionizing radiation. Further details of the above-described coating step are generally as set forth in U.S. Pat. No. 4,278,738, to BRAX et al., which is hereby incorporated by reference thereto, in its entirety.
After irradiation and coating, two-ply tubing film 60 is wound up onto windup roll 62. Thereafter, windup roll 62 is removed and installed as unwind roll 64, on a second stage in the process of making the tubing film as ultimately desired. Two-ply tubular film 60, from unwind roll 64, is unwound and passed over guide roll 66, after which two-ply tubular film 60 passes into hot water bath tank 68 containing hot water 70. The now collapsed, irradiated, coated tubular film 60 is submersed in hot water 70 (having a temperature of about 185.degree. F.) for a retention time of at least about 30 seconds, i.e., for a time period in order to bring the film up to the desired temperature for biaxial orientation. Thereafter, irradiated tubular film 60 is directed through nip rolls 72, and bubble 74 is blown, thereby transversely stretching tubular film 60. Furthermore, while being blown, i.e., transversely stretched, nip rolls 76 draw tubular film 60 in the longitudinal direction, as nip rolls 76 have a surface speed higher than the surface speed of nip rolls 72. As a result of the transverse stretching and longitudinal drawing, irradiated, coated biaxially-oriented blown tubing film 78 is produced, this blown tubing preferably having been both stretched in a ratio of from about 1:1.5-1:6, and drawn in a ratio of from about 1:1.5-1:6. More preferably, the stretching and drawing are each performed a ratio of from about 1:2-1:4. The result is a biaxial orientation of from about 1:2.25-1:36, more preferably, 1:4-1:16. While bubble 74 is maintained between pinch rolls 72 and 76, blown tubing 78 is collapsed by rolls 80, and thereafter conveyed through pinch rolls 76 and across guide roll 82, and then rolled onto wind-up roll 84. Idler roll 86 assures a good wind-up.
See Figure 2, below:
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer by using intermediate cooling steps as disclosed by Babrowicz in order to achieve a biaxially stretch heat shrunk tube or film.
As to claim 84, Kampa discloses wherein the first material is a thermoplastic (see paragraph 0083, disclosing “the core 20 is extruded from PTFE”).
As to claim 85, Kampa discloses wherein the thermoplastic includes PEBAX. See paragraph 0013, disclosing “In one embodiment, the polymer layer is formed from a thermoplastic polymer (e.g., polyether block amide ("PEBAX"), nylon, polyurethane, etc. In another embodiment, the polymer layer is formed form a thermoset polymer (e.g., silicone, etc.).”
As to claim 86, Kampa discloses wherein the thermoplastic includes TPU. See paragraph 0013, disclosing “In one embodiment, the polymer layer is formed from a thermoplastic polymer (e.g., polyether block amide ("PEBAX"), nylon, polyurethane, etc. In another embodiment, the polymer layer is formed form a thermoset polymer (e.g., silicone, etc.).”
As to claim 87, Kampa discloses wherein heat-shrinking the first layer includes coating the first layer with a heat shrink and heating the first layer and the heat shrink. See paragraph 0081, disclosing “As depicted in FIGS. 7 and 12, a heat-shrinkable tube or layer 95 is snuggly placed over the outer polymer layer 60 [block 240].” See paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”
As to claim 92, Kampa discloses a method for manufacturing a peel-away sheath assembly see the abstract, disclosing “a tubular body for a catheter, sheath or lead”) for insertion of a blood pump (see paragraph 0112, disclosing “In use, a puncture is made with a thin walled needle through the skin and into a blood vessel.”), the peel-away sheath assembly comprising a peel-away sheath body and a peel-away sheath hub, the method comprising:
coating a mandrel with a first layer of a first material (paragraph 0079, disclosing “As indicated in FIGS. 4 and 10, the pre-extruded core 20 is pulled over a core rod or mandrel 90 and tightened down [block 210].”);
heat-shrinking the first layer (see paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”);
coating the mandrel a second layer of a second material (paragraph 0079, “As illustrated in FIG. 5, where a reinforcement layer 55 is utilized, the reinforcement layer (i.e., a cylindrical wire braid) 55 is pulled or woven over the outer circumferential surface 65 of the core 20 and tightened down [block 220]”, and see paragraph 0080, disclosing “As shown in FIGS. 6 and 11, the entirety of the aforementioned components is then encased within the outer polymer layer 60 [block 230].”), wherein the mandrel is already coated with the first material (see Figures 3-15), wherein the second layer is a reinforcing layer (“a cylindrical wire braid”);
heat-shrinking the second layer while the second layer is disposed on the first layer and the mandrel (see paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”);
coating the mandrel with a third layer of a third mater (see paragraph 0081, disclosing “s depicted in FIGS. 7 and 12, a heat-shrinkable tube or layer 95 is snuggly placed over the outer polymer layer 60 [block 240].”); and
heat-shrinking the third layer while the third layer is disposed on the second layer, the first layer, and the mandrel to form a peel-away sheath body (see paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”).
See Figures 3-8 below, and Figures 9-12, 14-15 below:
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Kampa, however, does not disclose heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer.
However, Babrowicz discloses a heat-shrinkable, biaxially-oriented, multilayer film with a cooling step in between, and thus makes obvious heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer.
See column, lines, disclosing:
Film No. 1 was produced in accordance with a process schematically illustrated in FIG. 2. In the process illustrated in FIG. 2, solid polymer beads (not illustrated) are fed to a plurality of extruders 28 (for simplicity, only one extruder is illustrated). Inside extruders 28, the polymer beads are forwarded, melted, and degassed, following which the resulting bubble-free melt is forwarded into die head 30, and extruded through an annular die, resulting in tubing 32 which is preferably about 24 mils thick.
After cooling or quenching by water spray from cooling ring 34, tubing 32 is collapsed by pinch rolls 36, and is thereafter fed through irradiation vault 38 surrounded by shielding 40, where tubing 32 is irradiated with high energy electrons (i.e., ionizing radiation) from iron core transformer accelerator 42. Tubing 32 is guided through irradiation vault 38 on rolls 44. Preferably, tubing 32 is irradiated to a level of from about 3 to 8 MR.
After irradiation, irradiated tubing 46 is directed through pinch rolls 48, following which irradiated tubing 46 is slightly inflated, resulting in trapped bubble 50. However, at trapped bubble 50, the tubing is not significantly drawn longitudinally, as the surface speed of nip rolls 52 are about the same speed as nip rolls 48. Furthermore, irradiated tubing 46 is inflated only enough to provide a substantially circular tubing without significant transverse orientation, i.e., without stretching.
Slightly inflated, irradiated tubing 50 is passed through vacuum chamber 54, and thereafter forwarded through coating die 56. Second tubular film 58 is melt extruded from coating die 56 and coated onto slightly inflated, irradiated tube 50, to form two-ply tubular film 60. Second tubular film 58 preferably comprises an O.sub.2 barrier layer, which does not pass through the ionizing radiation. Further details of the above-described coating step are generally as set forth in U.S. Pat. No. 4,278,738, to BRAX et al., which is hereby incorporated by reference thereto, in its entirety.
After irradiation and coating, two-ply tubing film 60 is wound up onto windup roll 62. Thereafter, windup roll 62 is removed and installed as unwind roll 64, on a second stage in the process of making the tubing film as ultimately desired. Two-ply tubular film 60, from unwind roll 64, is unwound and passed over guide roll 66, after which two-ply tubular film 60 passes into hot water bath tank 68 containing hot water 70. The now collapsed, irradiated, coated tubular film 60 is submersed in hot water 70 (having a temperature of about 185.degree. F.) for a retention time of at least about 30 seconds, i.e., for a time period in order to bring the film up to the desired temperature for biaxial orientation. Thereafter, irradiated tubular film 60 is directed through nip rolls 72, and bubble 74 is blown, thereby transversely stretching tubular film 60. Furthermore, while being blown, i.e., transversely stretched, nip rolls 76 draw tubular film 60 in the longitudinal direction, as nip rolls 76 have a surface speed higher than the surface speed of nip rolls 72. As a result of the transverse stretching and longitudinal drawing, irradiated, coated biaxially-oriented blown tubing film 78 is produced, this blown tubing preferably having been both stretched in a ratio of from about 1:1.5-1:6, and drawn in a ratio of from about 1:1.5-1:6. More preferably, the stretching and drawing are each performed a ratio of from about 1:2-1:4. The result is a biaxial orientation of from about 1:2.25-1:36, more preferably, 1:4-1:16. While bubble 74 is maintained between pinch rolls 72 and 76, blown tubing 78 is collapsed by rolls 80, and thereafter conveyed through pinch rolls 76 and across guide roll 82, and then rolled onto wind-up roll 84. Idler roll 86 assures a good wind-up.
See Figure 2, below:
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized heat-shrinking the first layer following the coating of the mandrel with the first layer resulting in a heat-shrunk first layer, and then heat-shrinking the heat-shrunk first layer, the second layer, and the outermost third layer by using intermediate cooling steps as disclosed by Babrowicz in order to achieve a biaxially stretch heat shrunk tube or film.
As to claim 95, Kampa discloses wherein the steps of heat-shrinking the first layer, heat-shrinking the second layer, and heat-shrinking the third layer are performed simultaneously (see paragraph 0082, disclosing “The assemblies depicted in FIGS. 7 and 12 are subjected to the aforementioned temperature conditions to bring about the reflow process [block 250].”).
As to claim 96, Kampa does not discloses wherein the step of heat-shrinking the second layer is performed following the step of heat-shrinking the first layer.
However, Changes in Sequence is very often obvious. MPEP 2144.04 IV C. In this case, Kampa discloses simultaneously heat shrinking the first, second and third layers. In any event, it would have been an obvious change in sequence wherein the step of heat-shrinking the second layer is performed following the step of heat-shrinking the first layer.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the step of heat-shrinking the second layer is performed following the step of heat-shrinking the first layer as an obvious change in sequence.
As to claim 97, Kampa does not discloses wherein the steps of heat-shrinking the second layer and heat- shrinking the third layer are performed simultaneously.
However, Changes in Sequence is very often obvious. MPEP 2144.04 IV C. In this case, Kampa discloses simultaneously heat shrinking the first, second and third layers. In any event, it would have been an obvious change in sequence wherein the steps of heat-shrinking the second layer and heat- shrinking the third layer are performed simultaneously.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the steps of heat-shrinking the second layer and heat- shrinking the third layer are performed simultaneously as an obvious change in sequence.
Claim(s) 49, 83, 93, and 94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kampa (US 20080251966 A1) in view of Babrowicz (US 5837335 A) as applied to claims 48, 84, 86, 87, 92 and 95-97 above, and further in view of Hastings (US 20100268196 A1) and LeeFlang (US 9937319 B1).
As to claim 49, Kampa does not disclose wherein: the mandrel possesses a raised protrusion that is configured to leave at least one inner diameter notch in the heat-shrunk peel-away sheath body, wherein the at least one inner diameter notches extends from an innermost surface of the first layer, through the second layer, and terminates before or within the third layer.
However, Hastings discloses wherein: the mandrel (“mandrel 54”) possesses a raised protrusion that is configured to leave at least an one inner diameter notch (“protruding geometry 56”) in the heat-shrunk peel-away sheath body.
See paragraph 0032, disclosing:
[0032] As shown in FIG. 6, which is a cross section of the tubular body halves 12a', 12b', the braid-reinforced tubular body halves 12a', 12b' are assembled onto a reflow mandrel 54 [block 110 of FIG. 4]. The mandrel 54 may include protruding geometry 56 to form score lines. A shrink tube 58 formed of FEP or other shrink tube material may be pulled or otherwise provided about the outer circumferential surface of the braid-reinforced layer 44 provided by the tubular body halves 12a', 12b' [block 115 of FIG. 4]. When tubular body halves 12a', 12b' and heat shrink tube 58 are assembled on the mandrel 54 as indicated in FIG. 6, gaps 60 may exist between the strip edges 52a', 52a'' and 52b', 52b''. The assembly depicted in FIG. 6 may be subjected to a reflow process [block 120 of FIG. 4]. In other words, the assembly depicted in FIG. 6 is subjected to bonding conditions (e.g., reflow, laser bonding, thermoforming, etc.) that cause the strip edges 52a', 52a'' and 52b', 52b'' to flow into the gaps 60, filling the gaps 60 and forming the stress concentration lines 26', 26'' that join the tubular body halves 12a', 12b' into a braid-reinforced tubular body 12 that is similar to that of FIG. 1-3, less the outer layer 46. The protruding geometry 56 of the mandrel 54 forms the score lines 36 in the interior surface 32 in the vicinity of the stress concentrations 26', 26''. Once the reflow process is completed, the material forming the shrink tube 58 may be removed from about the completed tubular body 12. The completed peelable braid-reinforced tubular body 12 that is similar to that of FIGS. 1-3, less the outer layer 46, may be removed from the mandrel 54 [block 125 of FIG. 4]. The approximately one inch long non-slit portion 50 discussed above with respect to FIG. 5 (i.e., the portion 50 of the braid-reinforced tubular body 12' not slit in [block 105 of FIG. 4]) may be cut from the completed peelable braid-reinforced tubular body 12 [block 130 of FIG. 4].
See marked up Figure 6 below:
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Additionally, LeeFlang discloses and makes obvious wherein the at least an one inner diameter notches extends from an innermost surface of the first layer, through the second layer, and terminates before or within the third layer.
See column 6, lines 52-61 and column 13, lines 35-52, disclosing:
Optionally, the hub 30 may also include one or more actuators, such as sliders, buttons, switches, and the like, e.g., for activating and/or manipulating any components (also not shown) on the distal end 14 or otherwise operating the apparatus 10, e.g., for steering the distal end 14, as described elsewhere herein. In addition or alternatively, the hub 30 may include one or more features, e.g., a notch 34 and/or a weakened region 36 aligned with the seam 50, for facilitating slitting the apparatus 10 during use, as described elsewhere herein.
…
In particular, with additional reference to FIG. 1, a slitting device, such as any of the slitter devices described elsewhere herein (not shown), may be aligned with the seam 50 and used to cut through the sidewall of the tubular member 10 from the proximal end 12 towards the distal end 14. If the tubular member 10 includes a hub 30, the hub 30 may include one or more features aligned with the seam 50 to facilitate the user slitting along the seam 50 rather at another location around the circumference of the tubular member 10. For example, as shown in FIG. 1, the hub 30 may include a notch 34 or other feature that may identify the circumferential location of the seam 50 where the slitting device is to be advanced. In addition or alternatively, the hub 30 may include a thin walled or otherwise weakened region 36 aligned with the seam 50 and/or notch 34 such that, when the slitting device is used to cut through the hub 30, the weakened region 36 may guide the slitting device through the hub 30 towards the seam 50.
See also marked up Figures 1 and 2A-C, below:
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein: the mandrel possesses a raised protrusion that is configured to leave at least an one inner diameter notch in the heat-shrunk peel-away sheath body, wherein the at least an one inner diameter notches extends from an innermost surface of the first layer, through the second layer, and terminates before or within the third layer as suggested by Hastings and LeeFlang in order to form score lines and create the weakened region that may guide the slitting device.
As to claim 83, Kampa does not disclose wherein the at least one inner diameter notch defines at least one peel-away line.
However, Hastings and LeeFlang disclose and make obvious wherein the at least one inner diameter notch defines at least one peel-away line. Hastings discloses in paragraph 0032 that “ The mandrel 54 may include protruding geometry 56 to form score lines.” Similarly, LeeFlang discloses in column 13 that “the weakened region 36 may guide the slitting device through the hub 30 towards the seam 50”.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the at least one inner diameter notch defines at least one peel-away line as suggested by Hastings and LeeFlang in order to form score lines and create the weakened region that may guide the slitting device.
As to claim 93, Kampa does not disclose wherein: the mandrel possesses a raised protrusion that is configured to leave at least one inner diameter notch in the peel-away sheath body, wherein the at least one inner diameter notch extends from an innermost surface of the first layer, through the second layer, and terminates before or within the third layer.
However, Hastings wherein: the mandrel (“mandrel 54”) possesses a raised protrusion that is configured to leave at least one inner diameter notch (“protruding geometry 56”) in the peel-away sheath body.
See paragraph 0032, disclosing:
[0032] As shown in FIG. 6, which is a cross section of the tubular body halves 12a', 12b', the braid-reinforced tubular body halves 12a', 12b' are assembled onto a reflow mandrel 54 [block 110 of FIG. 4]. The mandrel 54 may include protruding geometry 56 to form score lines. A shrink tube 58 formed of FEP or other shrink tube material may be pulled or otherwise provided about the outer circumferential surface of the braid-reinforced layer 44 provided by the tubular body halves 12a', 12b' [block 115 of FIG. 4]. When tubular body halves 12a', 12b' and heat shrink tube 58 are assembled on the mandrel 54 as indicated in FIG. 6, gaps 60 may exist between the strip edges 52a', 52a'' and 52b', 52b''. The assembly depicted in FIG. 6 may be subjected to a reflow process [block 120 of FIG. 4]. In other words, the assembly depicted in FIG. 6 is subjected to bonding conditions (e.g., reflow, laser bonding, thermoforming, etc.) that cause the strip edges 52a', 52a'' and 52b', 52b'' to flow into the gaps 60, filling the gaps 60 and forming the stress concentration lines 26', 26'' that join the tubular body halves 12a', 12b' into a braid-reinforced tubular body 12 that is similar to that of FIG. 1-3, less the outer layer 46. The protruding geometry 56 of the mandrel 54 forms the score lines 36 in the interior surface 32 in the vicinity of the stress concentrations 26', 26''. Once the reflow process is completed, the material forming the shrink tube 58 may be removed from about the completed tubular body 12. The completed peelable braid-reinforced tubular body 12 that is similar to that of FIGS. 1-3, less the outer layer 46, may be removed from the mandrel 54 [block 125 of FIG. 4]. The approximately one inch long non-slit portion 50 discussed above with respect to FIG. 5 (i.e., the portion 50 of the braid-reinforced tubular body 12' not slit in [block 105 of FIG. 4]) may be cut from the completed peelable braid-reinforced tubular body 12 [block 130 of FIG. 4].
See marked up Figure 6 below:
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Additionally, LeeFlang discloses and makes obvious wherein the at least one inner diameter notch extends from an innermost surface of the first layer, through the second layer, and terminates before or within the third layer.
See column 6, lines 52-61 and column 13, lines 35-52, disclosing:
Optionally, the hub 30 may also include one or more actuators, such as sliders, buttons, switches, and the like, e.g., for activating and/or manipulating any components (also not shown) on the distal end 14 or otherwise operating the apparatus 10, e.g., for steering the distal end 14, as described elsewhere herein. In addition or alternatively, the hub 30 may include one or more features, e.g., a notch 34 and/or a weakened region 36 aligned with the seam 50, for facilitating slitting the apparatus 10 during use, as described elsewhere herein.
…
In particular, with additional reference to FIG. 1, a slitting device, such as any of the slitter devices described elsewhere herein (not shown), may be aligned with the seam 50 and used to cut through the sidewall of the tubular member 10 from the proximal end 12 towards the distal end 14. If the tubular member 10 includes a hub 30, the hub 30 may include one or more features aligned with the seam 50 to facilitate the user slitting along the seam 50 rather at another location around the circumference of the tubular member 10. For example, as shown in FIG. 1, the hub 30 may include a notch 34 or other feature that may identify the circumferential location of the seam 50 where the slitting device is to be advanced. In addition or alternatively, the hub 30 may include a thin walled or otherwise weakened region 36 aligned with the seam 50 and/or notch 34 such that, when the slitting device is used to cut through the hub 30, the weakened region 36 may guide the slitting device through the hub 30 towards the seam 50.
See also marked up Figures 1 and 2A-C, below:
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein: the mandrel possesses a raised protrusion that is configured to leave at least one inner diameter notch in the peel-away sheath body, wherein the at least one inner diameter notch extends from an innermost surface of the first layer, through the second layer, and terminates before or within the third layer as suggested by Hastings and LeeFlang in order to form score lines and create the weakened region that may guide the slitting device.
As to claim 94, Kampa does not disclose wherein the at least one inner diameter notch defines at least one peel-away line.
However, Hastings and LeeFlang disclose and make obvious wherein the at least one inner diameter notch defines at least one peel-away line. Hastings discloses in paragraph 0032 that “ The mandrel 54 may include protruding geometry 56 to form score lines.” Similarly, LeeFlang discloses in column 13 that “the weakened region 36 may guide the slitting device through the hub 30 towards the seam 50”.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the at least one inner diameter notch defines at least one peel-away line as suggested by Hastings and LeeFlang in order to form score lines and create the weakened region that may guide the slitting device.
Claim(s) 86 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Kampa (US 20080251966 A1) in view of Babrowicz (US 5837335 A)) as applied to claims 48, 84, 86, 87, 92 and 95-97 above, and further in view of Zhou (US 20160296332 A1).
As to claim 86, Kampa has been interpreted as disclosing wherein the thermoplastic includes TPU. See paragraph 0013, disclosing “In one embodiment, the polymer layer is formed from a thermoplastic polymer (e.g., polyether block amide ("PEBAX"), nylon, polyurethane, etc. In another embodiment, the polymer layer is formed form a thermoset polymer (e.g., silicone, etc.).”
In any event, Zhou also discloses or makes obvious wherein the thermoplastic includes TPU. See paragraph 0065, disclosing
[0065] Referring again to FIG. 3, the mixed, expandable layer 24 is constructed of a mixture of alternating full-thickness portions, including soft portions 46 and hard portions 48. The soft portions 46 are constructed of elastomer material—such as materials similar to the outer layer 20—that provide elasticity to the expandable layer 24. The hard portions 48 are constructed of a relatively stiff material and thus provide some columnar stability for advancing the sheath 3 against resistance of a body lumen. The number and spacing of the portions 46, 48 can be adjusted per application. Greater amounts or dimensions of stiff portions 48 can be included for more stiffness. Greater number or dimensions of soft/elastomeric portions 46 can be included for improved expandability and flexibility. TECOFLEX, an aliphatic polyether polyurethane, is one material that can be used for the stiff portions 48.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the thermoplastic includes polyurethane as suggested by Zhou in order to provide the stiff portions.
Claim(s) 88 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kampa (US 20080251966 A1) in view of Babrowicz (US 5837335 A) as applied to claims 48, 84, 86, 87, 92 and 95-97 above, and further in view of Heisel (US 20170296777 A1)
As to claim 88, Kampa does not disclose wherein the heat shrink is a polytetrafluoroethylene (PTFE) heat shrink.
However, Heisel discloses wherein the heat shrink is a polytetrafluoroethylene (PTFE) heat shrink. See paragraph 0050-51 and 0077, disclosing:
[0050] FIG. 6 displays a cross-section of catheter assembly/introducer assembly 200 having two flat wires 30 and braided wired assembly 50 encompassed by outer layer 60 before lamination of the materials by heating. In one embodiment, a layer of heat shrink 70 is placed over the top of outer layer 60 as depicted in FIG. 6. Heat shrink 70 may be, for example, a fluoropolymer or polyolefin material.
[0051] FIG. 7 depicts introducer assembly 200 after a lamination process. Catheter assembly 200 may be laminated by heating catheter assembly 200 until the material comprising outer layer 60 flows and redistributes around the circumference thereof as depicted in FIG. 7. Heat shrink 70 has a higher melting temperature than outer layer 60; and during the melt process, heat shrink 70 retains its tubular shape and forces the liquefied outer layer 60 material into braided wire assembly 50 (if present) and into contact with tubes 40 and inner liner 20. Introducer assembly 200 may then be cooled. In FIG. 7, mandrel 10 is still in place.
…
[0077] The outer sheath 1206 may be constructed of an extruded PEBAX or PTFE tubing. The melt-processing polymer of the outer sheath 1206 occupies a plurality of voids of the wire mesh in the torque transfer layer. The outer sheath 1206 may also be made of other melt processing polymers, including, without limitation, etched PTFE, polyether block amides, nylon and other thermoplastic elastomers, at varying durometers. The outer sheath 1206 may also comprise more than one layer, including, for example, two or more tubes of a melt processing polymer. Alternatively, as shown in FIG. 15, the outer sheath 306 may be comprised of varying segments 322, 324, 326, 328, 330 differing in hardness and/or material along the length of the introducer 300 and being reflow bonded together. This may be accomplished by layering or by placing annular rings of differing materials along the length of the introducer 300. Varying the sheath composition in this manner provides the additional benefit of adjusting flexibility, torqueability, and pushability at various points along the introducer 300.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the heat shrink is a polytetrafluoroethylene (PTFE) heat shrink in order to enable melt processing.
Claim(s) 89-91 and 98-100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kampa (US 20080251966 A1) in view of Babrowicz (US 5837335 A) as applied to claims 48, 84, 86, 87, 92 and 95-97 above, and further in view of Weber (US 20050182387 A1).
As to claim 89, Kampa does not disclose wherein the third layer is configured with a mold during heat-shrinking, wherein the mold is configured to leave at least one outer diameter notch in the peel-away sheath body.
However, Webler discloses and makes obvious wherein the third layer is configured with a mold during heat-shrinking, wherein the mold is configured to leave at least one outer diameter notch in the peel-away sheath body. See paragraph 0035-0036, disclosing:
[0035] In some configurations of the catheter shaft 200, the braid 206 may be impregnated with a miscible material that is molded into a smooth outer surface of the shaft 200 suitable for medical use. In other configurations, an outer member, or jacket, may be provided to ensure a smooth shaft outer surface. In FIG. 2, an outer jacket 210 is shown surrounding the braid 206. The outer jacket 210 may be formed from a smooth, abrasion resistant polymer. The outer jacket 210 may be formed of the same materials used to impregnate the braid 206. The outer jacket 210 can be formed of a clear or translucent material if it is desired that the braid gap 208 be made visible to the end user. The outer jacket 210 may include one or more peel-away features 212 that are co-located with the braid gap(s) 208. It will be appreciated that the peel-away feature 212 may be provided as an indicator of location of the underlying braid gap 208, as well as providing a pre-stress for ease of separating the outer jacket 210. In the latter case, the peel-away feature 212 need not be formed adjacent to the braid gap 208, assuming it is acceptable to remove the outer jacket 210 separately from the braid 206.
[0036] The peel-away feature 212 may include a pre-stress line (e.g., notch) that eases removal of the outer jacket 210. A similar pre-stress line may be included in the inner liner 202. In other arrangements, the peel-away feature 212 may be a molded-in feature of the outer jacket 210, such as a different color material and/or an embedded fiber or wire. An embedded fiber or wire may be installed such that the pulling/removal of the fiber creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action. An alternate peel-away feature 212A is shown in FIG. 3, which shows a cross-section of the shaft section 200 of FIG. 2 according to embodiments of the present invention. The alternate peel-away feature in FIG. 3 includes a different color material embedded in the outer jacket 210.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the third layer is configured with a mold during heat-shrinking, wherein the mold is configured to leave at least one outer diameter notch in the peel-away sheath body as suggested by Webler disclosing the peel-away feature 212 may be a molded-in feature of the outer jacket 210 in order to creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action.
As to claim 90, Kampa does not disclose wherein the at least one outer diameter notch extends from an outermost of the third layer, through the second layer, and terminates before or within the first layer.
However, Webler discloses and makes obvious wherein the at least one outer diameter notch extends from an outermost of the third layer, through the second layer, and terminates before or within the first layer. See paragraph 0035-0036, disclosing:
[0035] In some configurations of the catheter shaft 200, the braid 206 may be impregnated with a miscible material that is molded into a smooth outer surface of the shaft 200 suitable for medical use. In other configurations, an outer member, or jacket, may be provided to ensure a smooth shaft outer surface. In FIG. 2, an outer jacket 210 is shown surrounding the braid 206. The outer jacket 210 may be formed from a smooth, abrasion resistant polymer. The outer jacket 210 may be formed of the same materials used to impregnate the braid 206. The outer jacket 210 can be formed of a clear or translucent material if it is desired that the braid gap 208 be made visible to the end user. The outer jacket 210 may include one or more peel-away features 212 that are co-located with the braid gap(s) 208. It will be appreciated that the peel-away feature 212 may be provided as an indicator of location of the underlying braid gap 208, as well as providing a pre-stress for ease of separating the outer jacket 210. In the latter case, the peel-away feature 212 need not be formed adjacent to the braid gap 208, assuming it is acceptable to remove the outer jacket 210 separately from the braid 206.
[0036] The peel-away feature 212 may include a pre-stress line (e.g., notch) that eases removal of the outer jacket 210. A similar pre-stress line may be included in the inner liner 202. In other arrangements, the peel-away feature 212 may be a molded-in feature of the outer jacket 210, such as a different color material and/or an embedded fiber or wire. An embedded fiber or wire may be installed such that the pulling/removal of the fiber creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action. An alternate peel-away feature 212A is shown in FIG. 3, which shows a cross-section of the shaft section 200 of FIG. 2 according to embodiments of the present invention. The alternate peel-away feature in FIG. 3 includes a different color material embedded in the outer jacket 210.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the at least one outer diameter notch extends from an outermost of the third layer, through the second layer, and terminates before or within the first layer as suggested by Webler disclosing the peel-away feature 212 may be a molded-in feature of the outer jacket 210 in order to creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action.
As to claim 91, Kampa does not disclose wherein the at least one outer diameter notch defines at least one peel-away line.
However, Webler discloses wherein the at least one outer diameter notch defines at least one peel- away line. See paragraph 0035-0036, disclosing:
[0035] In some configurations of the catheter shaft 200, the braid 206 may be impregnated with a miscible material that is molded into a smooth outer surface of the shaft 200 suitable for medical use. In other configurations, an outer member, or jacket, may be provided to ensure a smooth shaft outer surface. In FIG. 2, an outer jacket 210 is shown surrounding the braid 206. The outer jacket 210 may be formed from a smooth, abrasion resistant polymer. The outer jacket 210 may be formed of the same materials used to impregnate the braid 206. The outer jacket 210 can be formed of a clear or translucent material if it is desired that the braid gap 208 be made visible to the end user. The outer jacket 210 may include one or more peel-away features 212 that are co-located with the braid gap(s) 208. It will be appreciated that the peel-away feature 212 may be provided as an indicator of location of the underlying braid gap 208, as well as providing a pre-stress for ease of separating the outer jacket 210. In the latter case, the peel-away feature 212 need not be formed adjacent to the braid gap 208, assuming it is acceptable to remove the outer jacket 210 separately from the braid 206.
[0036] The peel-away feature 212 may include a pre-stress line (e.g., notch) that eases removal of the outer jacket 210. A similar pre-stress line may be included in the inner liner 202. In other arrangements, the peel-away feature 212 may be a molded-in feature of the outer jacket 210, such as a different color material and/or an embedded fiber or wire. An embedded fiber or wire may be installed such that the pulling/removal of the fiber creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action. An alternate peel-away feature 212A is shown in FIG. 3, which shows a cross-section of the shaft section 200 of FIG. 2 according to embodiments of the present invention. The alternate peel-away feature in FIG. 3 includes a different color material embedded in the outer jacket 210.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the at least one outer diameter notch defines at least one peel- away line as suggested by Webler disclosing the peel-away feature 212 may be a molded-in feature of the outer jacket 210 in order to creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action.
As to claim 98, Kampa does not disclose wherein the third layer is configured with a mold during heat-shrinking, wherein the mold is configured to leave at least one outer diameter notch in the peel-away sheath body.
However, Webler discloses and makes obvious wherein the third layer is configured with a mold during heat-shrinking, wherein the mold is configured to leave at least one outer diameter notch in the peel-away sheath body. See paragraph 0035-0036, disclosing:
[0035] In some configurations of the catheter shaft 200, the braid 206 may be impregnated with a miscible material that is molded into a smooth outer surface of the shaft 200 suitable for medical use. In other configurations, an outer member, or jacket, may be provided to ensure a smooth shaft outer surface. In FIG. 2, an outer jacket 210 is shown surrounding the braid 206. The outer jacket 210 may be formed from a smooth, abrasion resistant polymer. The outer jacket 210 may be formed of the same materials used to impregnate the braid 206. The outer jacket 210 can be formed of a clear or translucent material if it is desired that the braid gap 208 be made visible to the end user. The outer jacket 210 may include one or more peel-away features 212 that are co-located with the braid gap(s) 208. It will be appreciated that the peel-away feature 212 may be provided as an indicator of location of the underlying braid gap 208, as well as providing a pre-stress for ease of separating the outer jacket 210. In the latter case, the peel-away feature 212 need not be formed adjacent to the braid gap 208, assuming it is acceptable to remove the outer jacket 210 separately from the braid 206.
[0036] The peel-away feature 212 may include a pre-stress line (e.g., notch) that eases removal of the outer jacket 210. A similar pre-stress line may be included in the inner liner 202. In other arrangements, the peel-away feature 212 may be a molded-in feature of the outer jacket 210, such as a different color material and/or an embedded fiber or wire. An embedded fiber or wire may be installed such that the pulling/removal of the fiber creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action. An alternate peel-away feature 212A is shown in FIG. 3, which shows a cross-section of the shaft section 200 of FIG. 2 according to embodiments of the present invention. The alternate peel-away feature in FIG. 3 includes a different color material embedded in the outer jacket 210.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the third layer is configured with a mold during heat-shrinking, wherein the mold is configured to leave at least one outer diameter notch in the peel-away sheath body as suggested by Webler disclosing the peel-away feature 212 may be a molded-in feature of the outer jacket 210 in order to creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action.
As to claim 99, Kampa does not disclose wherein the at least one outer diameter notch extends from an outermost of the third layer, through the second layer, and terminates before or within the first layer.
However, Webler discloses and makes obvious wherein the at least one outer diameter notch extends from an outermost of the third layer, through the second layer, and terminates before or within the first layer. See paragraph 0035-0036, disclosing:
[0035] In some configurations of the catheter shaft 200, the braid 206 may be impregnated with a miscible material that is molded into a smooth outer surface of the shaft 200 suitable for medical use. In other configurations, an outer member, or jacket, may be provided to ensure a smooth shaft outer surface. In FIG. 2, an outer jacket 210 is shown surrounding the braid 206. The outer jacket 210 may be formed from a smooth, abrasion resistant polymer. The outer jacket 210 may be formed of the same materials used to impregnate the braid 206. The outer jacket 210 can be formed of a clear or translucent material if it is desired that the braid gap 208 be made visible to the end user. The outer jacket 210 may include one or more peel-away features 212 that are co-located with the braid gap(s) 208. It will be appreciated that the peel-away feature 212 may be provided as an indicator of location of the underlying braid gap 208, as well as providing a pre-stress for ease of separating the outer jacket 210. In the latter case, the peel-away feature 212 need not be formed adjacent to the braid gap 208, assuming it is acceptable to remove the outer jacket 210 separately from the braid 206.
[0036] The peel-away feature 212 may include a pre-stress line (e.g., notch) that eases removal of the outer jacket 210. A similar pre-stress line may be included in the inner liner 202. In other arrangements, the peel-away feature 212 may be a molded-in feature of the outer jacket 210, such as a different color material and/or an embedded fiber or wire. An embedded fiber or wire may be installed such that the pulling/removal of the fiber creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action. An alternate peel-away feature 212A is shown in FIG. 3, which shows a cross-section of the shaft section 200 of FIG. 2 according to embodiments of the present invention. The alternate peel-away feature in FIG. 3 includes a different color material embedded in the outer jacket 210.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the at least one outer diameter notch extends from an outermost of the third layer, through the second layer, and terminates before or within the first layer as suggested by Webler disclosing the peel-away feature 212 may be a molded-in feature of the outer jacket 210 in order to creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action.
As to claim 100, Kampa does not disclose wherein the at least one outer diameter notch defines at least one peel-away line.
However, Webler discloses wherein the at least one outer diameter notch defines at least one peel- away line. See paragraph 0035-0036, disclosing:
[0035] In some configurations of the catheter shaft 200, the braid 206 may be impregnated with a miscible material that is molded into a smooth outer surface of the shaft 200 suitable for medical use. In other configurations, an outer member, or jacket, may be provided to ensure a smooth shaft outer surface. In FIG. 2, an outer jacket 210 is shown surrounding the braid 206. The outer jacket 210 may be formed from a smooth, abrasion resistant polymer. The outer jacket 210 may be formed of the same materials used to impregnate the braid 206. The outer jacket 210 can be formed of a clear or translucent material if it is desired that the braid gap 208 be made visible to the end user. The outer jacket 210 may include one or more peel-away features 212 that are co-located with the braid gap(s) 208. It will be appreciated that the peel-away feature 212 may be provided as an indicator of location of the underlying braid gap 208, as well as providing a pre-stress for ease of separating the outer jacket 210. In the latter case, the peel-away feature 212 need not be formed adjacent to the braid gap 208, assuming it is acceptable to remove the outer jacket 210 separately from the braid 206.
[0036] The peel-away feature 212 may include a pre-stress line (e.g., notch) that eases removal of the outer jacket 210. A similar pre-stress line may be included in the inner liner 202. In other arrangements, the peel-away feature 212 may be a molded-in feature of the outer jacket 210, such as a different color material and/or an embedded fiber or wire. An embedded fiber or wire may be installed such that the pulling/removal of the fiber creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action. An alternate peel-away feature 212A is shown in FIG. 3, which shows a cross-section of the shaft section 200 of FIG. 2 according to embodiments of the present invention. The alternate peel-away feature in FIG. 3 includes a different color material embedded in the outer jacket 210.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the filing of the invention to have utilized wherein the at least one outer diameter notch defines at least one peel- away line as suggested by Webler disclosing the peel-away feature 212 may be a molded-in feature of the outer jacket 210 in order to creates the pre-stress line or a deeper notch or gap and thus facilitates the peel-away action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE R KOCH whose telephone number is (571) 272-5807. The examiner can also be reached by E-mail at george.koch@uspto.gov if the applicant grants written authorization for e-mails. Authorization can be granted by filling out the USPTO Automated Interview Request (AIR) Form.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PHILIP C TUCKER can be reached at (571)272-1095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE R KOCH/Primary Examiner, Art Unit 1745
GRK
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