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 .
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 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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, (in cl.1 and 17) the sheath “sealing a slot thereunder but for a sheath opening in the sheath to the needle slot” must be shown or the feature(s) canceled from the claim(s). Currently, Figs 1-2 and 4-9 show at least two sheath openings to the needle slot including at the tip of the sheath (which is formed as a hollow cylinder with an open end) and at 160,168. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims are objected to because of the following informalities:
Cl.4 “pleat through holes” is believed to be in error for --pleat through-holes--
Cl.15: “the distal portion of the catheter” is believed to be in error for --the distal end portion of the catheter--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 10, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding Claims 4, 10, and 20, the recitation(s) of “a proximal direction” is unclear because a proximal direction is already recited in claims 1 and 17, thus it is unclear whether this is the same direction or a new direction.
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, 9, 11, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ribelin WO2016187063A1 in view of Kurth US20090187147A1.
Regarding claim 1, Ribelin teaches a rapidly insertable central catheter ("RICC") insertion assembly (Fig 15A shows a catheter assembly; the descriptors “rapidly insertable central” and RICC are not terms of art and provide only an intended use of the assembly), comprising:
a RICC (catheter 42 with 220, 220A);
an introducer needle (incl. 216, 226, 214) including a needle hub (214) over a proximal portion of a needle shaft (forming 216) having a longitudinal needle slot (226);
a coupler (210) coupling the RICC and the introducer needle together (Fig 15A), the coupler including:
a coupler housing (212); and
a valve module (incl. 56; [0105,135] refers to a needle safety component 56 from the embodiments of Figs 1A-14F that can be added to this embodiment) disposed in the coupler housing (in all these embodiments the module is disposed within an outer housing of a coupler between the catheter and the needle, e.g.146, 112), the needle shaft passing through an introducer-needle passageway (incl. 74, internal space of 54, passage through 58 and 80) defined by a valve-module housing (54) of the module (Figs 10A-C) such that the valve module forms a seal over the needle shaft in a ready-to-deploy state of the RICC insertion assembly (74 seals over 16 in the ready to deploy state and seals closed to contain blood flash back after needle withdrawal; Figs 6B and 7B and [0109]),
the valve module including a needle-stick-injury ("NSI") protection mechanism (56) configured to capture a distal needle tip of the needle shaft (Figs 10A-B) within the valve module when the introducer needle is withdrawn from the coupler in a proximal direction (Figs 8-9, 10A-C, 22).
Ribelin does not teach a composite shaft, the composite shaft including a sheath over the needle shaft sealing the needle slot thereunder but for a sheath opening in the sheath to the needle slot, the composite shaft passing through the introducer-needle passageway such that the valve module forms a seal over the sheath opening in the ready-to-deploy state of the RICC insertion assembly.
However, Kurth teaches forming the introducer needle (16) of a catheter introducing device (Fig 5) as a composite shaft (Figs 4 and 6-7), the composite shaft including a sheath (22) over the needle shaft (18) sealing the needle slot (20) thereunder but for a sheath opening in the sheath to the needle slot (just as Applicant’s sheath actually has at least two openings: one at the needle tip for communication with the blood vessel and one at the proximal end for receiving the guidewire/catheter and passing blood away from the patient; Kurth teaches the sheath having at least two openings: one at the needle tip for communication with the blood vessel and one at the proximal end for receiving the guidewire/catheter and passing blood away from the patient), the composite shaft passing through an introducer-needle passageway of a coupler module (24) coupling the needle and the rest of the catheter (Figs 5, 8-11) such that the coupler module forms a seal over the sheath opening in the ready-to-deploy state of the RICC insertion assembly (sealing over sheath provides blood passage away from patient without leaking or allowing air to enter the patient’s blood vessel); [0053, 56]). The composite shaft of Kurth is compatible with the needs and apparatus of Ribelin (by being splittable longitudinally to release guidewire from the slotted needle) while providing the advantages of leak prevention and mitigating air entrance into the body ([0053, 56]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slotted needle of the catheter device of Ribelin to use a composite shaft as taught by Kurth, in order to prevent leaks and air entry ([0053,56]).
Regarding claim 17, Ribelin teaches an introducer needle subassembly (Fig 15A) comprising:
an introducer needle (incl. 216, 226, 214) including a needle hub (214) over a proximal portion of a needle shaft (forming 216) having a longitudinal needle slot (226);
a coupler (210) coupled to the introducer needle (Fig 15A), the coupler including:
a coupler housing (212); and
a valve module (incl. 56; [0105,135] refers to a needle safety component 56 from the embodiments of Figs 1A-14F that can be added to this embodiment) disposed in the coupler housing (in all these embodiments the module is disposed within an outer housing of a coupler between the catheter and the needle, e.g.146, 112), the needle shaft passing through an introducer-needle passageway (incl. 74, internal space of 54, passage through 58 and 80) defined by a valve-module housing (54) of the module (Figs 10A-C) such that the valve module forms a seal over the needle shaft in a ready-to-deploy state of the introducer needle subassembly (74 seals over 16 in the ready to deploy state and seals closed to contain blood flash back after needle withdrawal; Figs 6B and 7B and [0109]),
the valve module including a needle-stick-injury ("NSI") protection mechanism (56) configured to capture a distal needle tip of the needle shaft (Figs 10A-B) within the valve module when the introducer needle is withdrawn from the coupler in a proximal direction (Figs 8-9, 10A-C, 22).
Ribelin does not teach a composite shaft, the composite shaft including a sheath over the needle shaft sealing the needle slot thereunder but for a sheath opening in the sheath to the needle slot, the composite shaft passing through the introducer-needle passageway such that the valve module forms a seal over the sheath opening in the ready-to-deploy state.
However, Kurth teaches forming the introducer needle (16) of a catheter introducing device (Fig 5) as a composite shaft (Figs 4 and 6-7), the composite shaft including a sheath (22) over the needle shaft (18) sealing the needle slot (20) thereunder but for a sheath opening in the sheath to the needle slot (just as Applicant’s sheath actually has at least two openings: one at the needle tip for communication with the blood vessel and one at the proximal end for receiving the guidewire/catheter and passing blood away from the patient; Kurth teaches the sheath having at least two openings: one at the needle tip for communication with the blood vessel and one at the proximal end for receiving the guidewire/catheter and passing blood away from the patient), the composite shaft passing through an introducer-needle passageway of a coupler module (24) coupling the needle and the rest of the catheter (Figs 5, 8-11) such that the coupler module forms a seal over the sheath opening in the ready-to-deploy state of the RICC insertion assembly (sealing over sheath provides blood passage away from patient without leaking or allowing air to enter the patient’s blood vessel); [0053, 56]). The composite shaft of Kurth is compatible with the needs and apparatus of Ribelin (by being splittable longitudinally to release guidewire from the slotted needle) while providing the advantages of leak prevention and mitigating air entrance into the body ([0053, 56]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slotted needle of the catheter device of Ribelin to use a composite shaft as taught by Kurth, in order to prevent leaks and air entry ([0053,56]).
Regarding claim 9, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin further teaches an access guidewire (220) including a distal portion (222A) having a distal end (tip of 222A in Fig 16), the distal portion of the access guidewire passing through a guidewire passageway defined by the valve-module housing of the valve module (when valve-module includes inner portions of 212A and 212B, forming 270), a continuation of the guidewire passageway defined an introducer-needle lumen (in 216 per Figs 17A-18) of the introducer needle such that the distal end of the access guidewire is disposed just proximal of the needle tip of the needle shaft in the ready-to-deploy state of the RICC insertion assembly (Figs 18-20A).
Ribelin in view of Kurth as discussed so far, does not teach the continuation of the guidewire passageway further defined by an elastomeric gasket of the valve module and the sheath opening in the sheath.
However, Kurth further teaches modifying the needle and catheter coupler module (24) to include at least two ports, one (40) for a syringe and the other (32, 38) for the catheter such that the coupler comprises a passageway (through 32, 38) for the access guidewire (12) of the catheter, a continuation of the guidewire passageway defined by an elastomeric gasket (36) of the coupler, the sheath opening in the sheath (in order for guidewire to pass into the sheath per Fig 2), and an introducer-needle lumen (in 18) per Fig 2) of the introducer needle such that the distal end of the access guidewire is disposed just proximal of the needle tip of the needle shaft in the ready-to-deploy state of the catheter insertion assembly ([0056-57]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve-module of Ribelin to include the port, elastomer, and sheatopening as taught by Kurth, in order to prevent leaks and air entry ([0053,56]).
Regarding claim 11, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin further teaches the RICC includes: a catheter tube (42) including a catheter-tube portion of a primary lumen of the RICC (44 being hollow; Fig 16);
a single-piece catheter tip (extending to 220 and optionally including 220B) coupled to a distal end portion of the catheter tube (Figs 15B-16);
a catheter hub (46) coupled to a proximal portion of the catheter tube (Fig 15B); and
one or more extension legs (extending proximally from 46), each extension leg of the one-or-more extension legs coupled to the catheter hub by a distal portion thereof (Fig 15B).
Regarding claim 16, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth as discussed so far, does not teach a syringe fluidly coupled to the needle hub of the introducer needle in at least the ready-to-deploy state of the RICC insertion assembly.
However, Kurth further teaches modifying the coupler module of the catheter assembly to have two ports, one (32, 38) for guidewire and catheter insertion and the other (40) for fluidly coupling a syringe to the needle hub of the introducer needle in at least the ready-to-deploy state of the catheter insertion assembly ([0056]) in order to enable blood aspiration in the same procedure as catheter insertion ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ribelin in view of Kurth to further include a second syringe port in communication with the needle hub as taught by Kurth in order to facilitate blood aspiration in the same procedure as catheter insertion ([0056]).
Claims 2-4 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ribelin in view of Kurth, and in further view of Howell US20050251092A1 (hereinafter Howell2005).
Regarding claims 2 and 18, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth does not teach the NSI protection mechanism includes a tether having a proximal portion coupled to the needle hub and a distal portion coupled to the valve-module housing.
However, Howell2005 teaches adding a tether (44) to an NSI protection mechanism (inc. 41, 49) to further prevent needle sticks by accidental withdrawal of the needle tip (31) in the proximal direction out of the NSI protection mechanism (41, 49; [0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI protection mechanism of RIbelin in view of Kurth to further include the tether as taught by Howell2005, in order to provide further safeguards against accidental needle sticks ([0014]).
Regarding claims 3 and 19, Ribelin in view of Kurth and Howell2005 teaches all the limitations of the claimed invention as discussed above (including the valve module). Ribelin in view of Kurth and Howell2005 as discussed so far, does not teach the tether has a fixed tether length configured to prevent the needle tip of the needle shaft from escaping the valve module when the introducer needle is withdrawn from the coupler in the proximal direction or thereafter.
However, Howell2005 further teaches the tether has a fixed tether length configured to prevent the needle tip of the needle shaft from escaping when the introducer needle is withdrawn from the coupler in the proximal direction or thereafter (Fig 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI protection mechanism of RIbelin in view of Kurth and Howell2005 to further include the tether as taught by Howell2005, in order to provide further safeguards against accidental needle sticks ([0014]).
Regarding claims 4 and 20, Ribelin in view of Kurth and Howell teaches all the limitations of the claimed invention as discussed above (including the composite shaft). Ribelin in view of Kurth and Howell as discussed so far, does not teach the tether includes a plurality of pleats and a plurality of pleat through holes through the pleats, the composite shaft disposed in the pleat through holes such that the pleats unfold over the composite shaft when the introducer needle is withdrawn from the coupler in a proximal direction.
However, Howell2005 further teaches the tether includes a plurality of pleats (Fig 5) and a plurality of pleat through-holes (45) through the pleats, the needle shaft disposed in the pleat through holes (Fig 5) such that the pleats unfold over the needle shaft when the introducer needle is withdrawn from the coupler in a proximal direction (Figs 3-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI protection mechanism of RIbelin in view of Kurth and Howell2005 to further include the tether as taught by Howell2005, in order to provide further safeguards against accidental needle sticks ([0014]).
Claims 5-8 and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ribelin in view of Kurth, and in further view of Fu CN114870208A.
Regarding claims 5 and 21, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin further teaches the NSI protection mechanism includes a spring (80) loaded in a spring cavity (of 58 and 54; Figs 10A-C) along a portion of the introducer-needle passageway (Figs 10A-C), the spring configured to unload into the introducer-needle passageway when the introducer needle is withdrawn from the coupler in the proximal direction and the needle tip of the needle shaft passes the spring (Figs 6B, 7B, 10A-C). Ribelin describes the spring as “binding” the needle in the valve module. It appears that at least a portion of the spring does move to at least partially “block” a space that was previously held by the needle, thus reading on the claim.
However, in case Applicant believes the teachings are not clear, Fu teaches a similar spring-based NSI protection mechanism that both binds the needle tip inside the valve module and unloads into the introducer-needle passageway (Figs 14-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI spring of Ribelin (in view of Kurth) with the NSI spring of Fu, because it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the spring needle retention mechanism of Ribelin (in view of Kurth) with the spring needle retention mechanism of Fu provided the same predictable result of needle retention and accident prevention (Fu [0081, 82]; Ribelin [0105, 112]).
Regarding claims 6 and 22, Ribelin in view of Kurth and Fu teaches all the limitations of the claimed invention as discussed above (including the spring being in the valve-module housing). Ribelin in view of Kurth and Fu as discussed so far, does not teach the spring is a flat spring including an end tab configured to extend across the introducer-needle passageway into a tab receiver of the valve-module housing opposite the spring cavity at the time the needle tip of the needle shaft passes the spring, thereby preventing the needle tip of the needle shaft from escaping the valve module if the introducer needle is advanced into the coupler in a distal direction.
However, Fu further teaches the spring is a flat spring (Figs 12-16) including an end tab (any of 48, 46, 45) configured to extend across the introducer-needle passageway (Figs 12-16) into a tab receiver (portion of 41 providing space for 45, 46, 48 in the position of Fig 15) of the housing opposite the spring cavity (portion of 41 providing space for 45, 46, 48 in the position of Figs 12, 14) at the time the needle tip of the needle shaft passes the spring (Figs 14-15), thereby preventing the needle tip of the needle shaft from escaping the module if the introducer needle is advanced into the coupler in a distal direction (Fig 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI spring of Ribelin (in view of Kurth and Fu) with the NSI spring of Fu, because it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the spring needle retention mechanism of Ribelin (in view of Kurth and Fu) with the spring needle retention mechanism of Fu provided the same predictable result of needle retention and accident prevention (Fu [0081, 82]; Ribelin [0105, 112]).
Regarding claims 7 and 23, Ribelin in view of Kurth and Fu teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth and Fu as discussed so far, does not teach the end tab of the spring provides a primary tip shield, and a fulcrum of the spring provides a secondary tip shield if the needle tip of the needle shaft is forcibly advanced into the coupler in the distal direction past the end tab.
However, Fu further teaches the end tab of the spring provides a primary tip shield (incl. 45; Fig 15), and a fulcrum (b/w 46 and 48; or b/w 45 and 44; or b/w 44 and 43) of the spring provides a secondary tip shield (at 46, 48) if the needle tip of the needle shaft is forcibly advanced into the coupler in the distal direction past the end tab (Fig 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI spring of Ribelin (in view of Kurth and Fu) with the NSI spring of Fu, because it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the spring needle retention mechanism of Ribelin (in view of Kurth and Fu) with the spring needle retention mechanism of Fu provided the same predictable result of needle retention and accident prevention (Fu [0081, 82]; Ribelin [0105, 112]).
Regarding claims 8 and 24, Ribelin in view of Kurth and Fu teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth and Fu as discussed so far, does not teach the fulcrum of the spring is between a free arm of the spring including the end tab and a fixed arm of the spring fixed to the valve-module housing in the spring cavity.
However, Fu further teaches the fulcrum (b/w 45 and 44 or b/w 44 and 43) of the spring (provides the secondary tip shield by facilitating the geometries of two of 45, 46, 48 to act as the primary and secondary tip shields, respectively) is between a free arm of the spring (incl. at least 45, 46, 48) including the end tab and a fixed arm (43) of the spring fixed to the module housing in the spring cavity (Fig 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the NSI spring of Ribelin (in view of Kurth and Fu) with the NSI spring of Fu, because it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, substituting the spring needle retention mechanism of Ribelin (in view of Kurth and Fu) with the spring needle retention mechanism of Fu provided the same predictable result of needle retention and accident prevention (Fu [0081, 82]; Ribelin [0105, 112]).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ribelin in view of Kurth, and in further view of Walker US5261887A.
Regarding claim 10, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin further teaches that when the introducer needle is withdrawn from the coupler in a proximal direction, the needle slot allows the access guidewire to escape from the introducer-needle lumen of the introducer needle (Figs 18-24).
Ribelin in view of Kurth as discussed so far, does not teach the valve module includes a blade extending into the sheath opening of the sheath from the valve-module housing to which the blade is fixed, the blade configured to cut the sheath along the needle slot when the introducer needle is withdrawn from the coupler in a proximal direction, thereby allowing the access guidewire to escape from the introducer-needle lumen of the introducer needle.
However, Kurth further teaches the sheath being slittable from the coupler module to the tip/distal end of the sheath along the needle slot to allow the access guidewire to escape from the introducer-needle lumen of the introducer needle (Figs 2, 4, and 7; [0060]). Kurth teaches the guidewire itself being used to split the sheath ([0060]).
And Walker teaches a blade (52) can be fixed to catheter coupler module housing (10, Fig 2) and extend into a sheath opening (of 12) to cut a sheath (12) longitudinally along an inner structure (14) while the inner structure is withdrawn from the coupler module in a proximal direction (Figs 1-2, col.8 ll.36-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter assembly of Ribelin in view of Kurth to use the slittable sheath and sheath slitter blade of Kurth and Walker (respectively) in order to prevent leaks and air entry via the needle (Kurth [0053, 56]) and in order to more safely and precisely split the sheath compared to tearing by pulling (Walker, col.1 ll.13-15, col.4 ll.16-24). Note, although Walker is slitting a catheter over a guidewire rather than a sheath over a needle, Walker is considered analogous art because it is drawn to the medical art of medical catheter devices and because it is solving the same problem of slitting a discardable sheath structure around an inner structure.
Claims 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ribelin in view of Kurth, and in further view of Howell US20210361915A1 (hereinafter Howell2021).
Regarding claim 12, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth does not teach the catheter tip is of a first polymeric material and the catheter tube is of a second, softer polymeric material.
However, Howell teaches a catheter tip (116) is of a first polymeric material and a catheter tube (118) is of a second, softer polymeric material ([0052-55]) in order to provide sufficient strength to prevent buckling during insertion and advancement, while still being flexible enough for patient comfort and reducing vessel irritation ([0052-55]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Ribelin in view of Kurth to use the materials taught by Howell2021 in order to provide sufficient strength to prevent buckling during insertion and advancement, while still being flexible enough for patient comfort and mitigating vessel irritation ([0052-55]). Furthermore, MPEP2144.07 provides that the selection of a known material (the polymers taught by Howell2021) based on its suitability for its intended use (for the same catheter structures taught in Howell2021 and RIbelin) supported a prima facie obviousness determination.
Regarding claim 13, Ribelin in view of Kurth and Howell2021 teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth and Howell2021 also teaches the first polymeric material is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when a distal portion of the RICC is advanced into a blood-vessel lumen of a patient, the first polymeric material also being sufficiently pliable to prevent trauma to the blood-vessel lumen when the distal portion of the RICC is advanced farther into the blood-vessel lumen.
That is, Howell2021 teaches the first polymeric material is sufficiently stiff to prevent the catheter tip from collapsing, buckling, or otherwise appreciably deforming when a distal portion of the RICC is advanced into a blood-vessel lumen of a patient, the first polymeric material also being sufficiently pliable to prevent trauma to the blood-vessel lumen when the distal portion of the RICC is advanced farther into the blood-vessel lumen ([0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Ribelin in view of Kurth to use the materials taught by Howell2021 in order to provide sufficient strength to prevent buckling during insertion and advancement, while still being flexible enough for patient comfort and mitigating vessel irritation ([0052-55]). Furthermore, MPEP2144.07 provides that the selection of a known material (the polymers taught by Howell2021) based on its suitability for its intended use (for the same catheter structures taught in Howell2021 and RIbelin) supported a prima facie obviousness determination.
Regarding claim 14, Ribelin in view of Kurth teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth does not teach the RICC includes a set of three lumens including the primary lumen, a secondary lumen, and a tertiary lumen formed of fluidly connected portions of at least three catheter-tube lumens, three catheter-hub lumens, and three extension-leg lumens, the secondary and tertiary lumens terminating in the distal end portion of the catheter tube by at least some infill of melted polymeric material of the first polymeric material.
However, Howell2021 teaches an RICC (catheter 102) including a set of three lumens (incl. 122/124, 126, and 128) including the primary lumen (incl. 122/124), a secondary lumen (one of 126 or 128), and a tertiary lumen (other of 126 or 128) formed of fluidly connected portions of at least three catheter-tube lumens (Figs 5-8), three catheter-hub lumens (in 108; [0058]), and three extension-leg lumens (110; Fig 2), the secondary and tertiary lumens terminating in the distal end portion of the catheter tube by at least some infill of melted polymeric material of the first polymeric material ([0051] includes melting at least some of the first polymeric material at the terminal/distal end of the secondary and tertiary lumens for bonding sections 116 and 118 and the transition 120; Figs 5-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Ribelin in view of Kurth to be triluminal as taught by Howell2021 because Howell2021 further teaches triluminal and monoluminal catheters as substitutional equivalents ([0061]).
Regarding claim 15, Ribelin in view of Kurth and Howell2021 teaches all the limitations of the claimed invention as discussed above. Ribelin in view of Kurth and Howell2021 as discussed so far, does not teach the primary lumen has a primary-lumen aperture (130) in a distal end of the catheter tip (Fig 5), the secondary lumen has a secondary-lumen aperture in a side of the distal portion of the catheter tube, and the tertiary lumen has a tertiary-lumen aperture in the side of the distal end portion of the catheter tube but proximal of the secondary-lumen aperture.
However, Howell2021 further teaches the primary lumen has a primary-lumen aperture (130) in a distal end (112) of the catheter tip (Fig 5), the secondary lumen (126) has a secondary-lumen aperture (132) in a side of the distal portion of the catheter tube (Fig 5), and the tertiary lumen (128) has a tertiary-lumen aperture (134) in the side of the distal end portion of the catheter tube but proximal of the secondary-lumen aperture (Fig 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Ribelin in view of Kurth and Howell2021 to have the triluminal arrangement as taught by Howell2021 because Howell2021 further teaches triluminal and monoluminal catheters as substitutional equivalents ([0061]).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741