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 .
Response to Amendment
This office action is responsive to the amendment filed on 03/02/2026. As directed by the amendment: claims 1-6, 9, 13, 15, and 21-23 have been amended, claim 20 has been cancelled, and claim 24 has been added. Thus, claims 1-19 and 21-24 are presently pending in this application, with no claims being withdrawn from consideration. Notes for rejections/objections overcome. The 112(f) interpretation is maintained.
Response to Arguments
Applicant’s arguments, see p.9-10 of “Remarks”, filed 03/02/2026, with respect to the 112(b) rejections of claims 1-6 have been fully considered and are persuasive. The 112(b) rejections of 12/02/2025 have been withdrawn.
Applicant's arguments see p.13 of “Remarks”, filed 03/02/2026, with respect to the 103 rejection of claim 1 has been fully considered but they are not persuasive. In response to the applicant’s argument that Kurth fails to disclose or teach “an access guidewire including: […] a distal end disposed in the introducer needle through the sheath opening of the sheath body, the sheath opening having a width commensurate with diameter of the access guidewire”, the examiner respectfully disagrees. The applicant argues that the slit of Kurth has a width that can vary anywhere from a narrowest width w1 of the slit to an arbitrarily wider width w2 of the slit as annotated on p.13 of “Remarks”, and thus the slit does not have a width defined as commensurate with a diameter of the access guidewire. Examiner notes that this limitation is rejected under 112(a) as new matter and 112(b) as indefinite as discussed below, but for examination purposes this limitation is interpreted using the Merriam Webster definition of the term “commensurate” as corresponding in size, extent, amount, or degree, and thus the sheath opening is interpreted as having a width that corresponds in size or extent to the diameter of the access guidewire. Kurth discloses the distal end 12 of guidewire 8 is disposed in the introducer needle and will extend through the slit 20 once removed, and the slit in sheath body 20 has a width that corresponds to the size or extent of the diameter of the guidewire 8 allowing the guidewire 8 to contact the slit (see para. 0049 and 0053). Therefore, the 103 rejection of claim 1 is maintained.
Applicant's arguments see p.14 of “Remarks”, filed 03/02/2026, with respect to the 103 rejection of claim 13 has been fully considered but they are not persuasive. In response to the applicant’s argument that Kurth fails to disclose or teach an access guidewire having a proximal end coupled to an extension arm of the coupler, the examiner respectfully disagrees. The applicant argues “Kurth neither discloses nor shows the proximal portion 10 of the guidewire 8 coupled to the bifurcation 32 of the slotted hub 24”. This argument is not persuasive because para. 0056 of Kurth states “the guidewire 8 may be introduced through the bifurcation port 32 and through the hemostatic membrane 36 while the syringe stays attached to a straight Luer fitting 40.” Thus, the proximal end 10 of the guidewire 8 would be coupled to the bifurcation 32 of the slotted hub 24 and thus discloses the claim limitation. The rejection of claim 13 is maintained.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Regarding “a sheath-splitting means” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (means), (ii) it is coupled with functional language (sheath-splitting), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Para. 0010 discloses “the sheath-splitting means is a blade, the access guidewire, the catheter tip, or a combination thereof,” and para. 0102 discloses “a number of sheath-splitting means such as the stationary or moveable blade 191 or 192, the access guidewire 106, or the catheter tip 126 and associated manners for splitting the sheath body 142 away from the access guidewire 106 subsequent to establishing a needle tract to a blood-vessel lumen by way of a percutaneous puncture with the introducer needle 104.” Therefore, the sheath-splitting means is being interpreted as a blade, access guidewire, catheter tip, or equivalent structure associated with splitting a sheath body.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation “the sheath opening having a width commensurate with a diameter of the access guidewire” in lines 19-20 is new matter. The specification discloses in para. 0078 “the sheath opening 162 has a width approximately commensurate with a width of the needle slot 148 which, in turn, is sized in accordance with the diameter of the access guidewire 106.” This limitation provides support only for a sheath opening approximately commensurate with the needle slot not the diameter of the access guidewire. The specification nor the drawing provide support for this limitation. Thus, it is new matter.
Regarding claim 24, the limitation “the sheath opening having a width commensurate with a diameter of the access guidewire” in lines 8-9 is new matter for the above discussed reasons.
Regarding claims 2-11, these claims are rejected due to a rejected base claim.
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 1-12 and 24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “the sheath opening having a width commensurate with a diameter of the access guidewire” in lines 19-20 renders the claim indefinite because it is unclear. The examiner is unable to ascertain the scope of the term “commensurate” within the claim limitation. It is unclear whether this limitation should be interpreted as the sheath opening having a width equal to the diameter of the access guidewire, a width proportional to the diameter of the access guidewire, or a width somehow related to the diameter of the guidewire. Fig. 9 does appear to illustrate the needle opening 162 and needle slot 148 but fails to illustrate the access guidewire. Examiner is interpreting this limitation using the Merriam Webster definition of the term “commensurate” as corresponding in size, extent, amount, or degree, and thus the sheath opening is interpreted as having a width that corresponds in size or extent to the diameter of the access guidewire.
Claim 24 recites the limitation "the proximal portion of the needle shaft" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 24, the phrase “the sheath opening having a width commensurate with a diameter of the access guidewire” in lines 8-9 renders the claim indefinite because it is unclear for the above discussed reasons.
Regarding claims 2-11, these claims are rejected due to their dependency upon a rejected base claim.
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. 48
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 6-7, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth et al. (U.S Patent Pub. No. 20090187147 A1, “Kurth”) in view of Kurrus et al. (U.S Patent Pub. No. 20140221831 A1, “Kurrus”) in view of Bierman et al. (U.S Patent Pub. No. 20140276432 A1, “Bierman”).
Regarding claim 1, Kurth discloses the limitations of (Claim 1) a rapidly insertable central catheter ("RICC") insertion assembly (16 in Fig. 4-5A and 10-11 and 7 and para. 0043-0044 – insertion assembly 16 uses an introducer needle to puncture an endovascular cavity, disposed a guidewire therein, and allow for introduction of a catheter and thus is capable of being used with a RICC), comprising:
an introducer needle (18, 22 in Fig. 4) including:
a needle shaft (18) including a longitudinal needle slot (20) extending from a proximal portion of the needle shaft (18) through a distal needle tip (26) of the needle shaft (18, see Fig. 4 and para. 0053 – slot 20 is formed longitudinally through the needle shaft 18 and distal tip 26), and
a sheath body (22 in Fig. 4) over the needle shaft (18) sealing the needle slot (20) thereunder except for a portion of the needle slot (20) under a sheath opening (slit of 20) in a proximal portion of the sheath body (22, see para. 0053 – sheath 22 is placed over needle shaft 18 and slot 20 to seal it thereunder except for a slit provided in the proximal portion of the sheath 22 which is unsealed to allow the guidewire 8 to contact the sheath 22 to initiate the splitting);
a coupler (24 in Fig. 10-11) coupling the introducer needle (18, 22) with a later disposed catheter (see para. 0056 – examiner is interpreting the insertion assembly described in Fig. 4-5A having the bifurcated hub 24 of Fig. 10-11 which couples the needle shaft 18 and sheath body 22 to a later introduced catheter as described in para. 0043), the coupler (24 in Fig. 10-11) including:
a coupler housing (housing of 24 in Fig. 10-11);
and a valve module disposed in the coupler housing (24 in Fig. 10-11, see Fig. 11 and para. 0056 – hemostatic membrane 36 is placed in the coupler 24 such that the interior cavity of the coupler 24 is being interpreted as the valve module);
an access guidewire (8 in Fig. 1) including:
a proximal end (10 in Fig. 1) coupled to an extension arm (32 in Fig. 11) of the coupler (24, see para. 0056 – proximal portion 10 of guidewire 8 couples to port 32 of coupler 24);
and a distal end (12 in Fig. 1) disposed in the introducer needle (18, 22) through the sheath opening (slit of 20) of the sheath body (20), the sheath opening (slit of 20) having a width commensurate with a diameter of the access guidewire (8, examiner notes this limitation is being interpreted in light of the 112(b) rejection above using the Merriam Webster definition of the term “commensurate” as corresponding in size, extent, amount, or degree, and thus the sheath opening is interpreted as having a width that corresponds in size or extent to the diameter of the access guidewire, see para. 0049 and 0053 – distal end 12 of guidewire 8 is disposed in the introducer needle and will extend through the slit 20 once removed, the slit in sheath body 20 has a width that corresponds to the size or extent of the diameter of the guidewire 8 allowing the guidewire 8 to contact the slit);
and a sheath-splitting means for splitting the sheath body (22) away from the access guidewire (8) subsequent to a percutaneous puncture with the introducer needle (18, 22, examiner notes the sheath-splitting means is being interpreted under 112(f) as a blade, access guidewire, catheter tip, combination thereof, or an equivalent structure for splitting the sheath body away from the access guidewire, see para. 0049, 0053, and 0054-0056 – introducer needle 18 and 22 are used to puncture vessel 14 and subsequently the guidewire 8 acts as the sheath-splitting means by tearing the sheath body 22 away from guidewire 8 for its removal, examiner notes the coupler 24 of Fig. 10-11 is disclosed as having wings 26a-26b which assist in opening the slot 23 in the coupler 24 in conjunction with the guidewire 8 splitting the sheath 22 when the coupler 24 is withdrawn) and, the splitting by the sheath-splitting means initiated by withdrawing the sheath body (22) by a pair of finger tab (26a, 26b) extending from a sheath hub (34 in Fig. 10-11) around the proximal portion of the sheath body (22, see Fig. 5 and 11 and para. 0053 and 0054-0056 – needle shaft 18 is molded to coupler 24 thus movement of coupler 24 coincides with movement of sheath body 22, withdrawal of coupler 24 and thus sheath body 22 using wings 26a and 26b extending from sheath hub 34 seen in Fig. 10 would initiated the guidewire 8 splitting the sheath 22, examiner notes the embodiment of Fig. 10-11 builds upon the mechanism of Fig. 5 wherein the wings 26a and 26b would still be used to withdraw the sheath body 22 as well as be squeezed to open the slot 23 as discussed in para. 0056).
While Kurth discloses that a catheter may be inserted into the vessel over the guidewire after percutaneous puncture with the assembly (see para. 0043), Kurth fails to explicitly disclose the assembly comprising the coupler coupling a catheter and the introducer needle together. Kurth further fails to disclose the valve module sealing the proximal portions of the needle shaft and the sheath body therein.
Kurrus discloses an introducer sheath assembly (50 in Fig. 3 and 5B) and explicitly teaches the introducer sheath assembly (50) comprising a coupler (60) coupling the introducer (52, 54) with a central venous catheter (20, see Fig. 5B and para. 0034 and 0036-0037 – catheter 20 may be a central venous catheter that is capable of being configured to be rapidly inserted such that it is interpreted as a rapidly insertable central catheter).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion assembly taught by Kurth to incorporate a central venous catheter coupled to the coupler as taught by Kurrus. Kurrus discloses that the introducer sheath assembly provides the vascular access and is coupled to a catheter assembly allowing a less-traumatic catheterization process that significantly reduces the number of steps and time associated with gaining percutaneous access to a body vessel for treatment (see 0010).
Bierman discloses a vascular access device (20 in Fig. 1A) comprising a coupler (42B in Fig. 4G) and an introducer needle (22, 40B) including a needle shaft (22) and a sheath body (40B in Fig. 4G), where Bierman teaches (Claim 1) a valve module sealing the proximal portions of the needle shaft (22) and the sheath body (40B) therein (see Fig. 1A, 4G and para. 0067-0068 – valve element 240 is disposed in the coupler 42B such that the interior cavity 241 of the coupler 42B is interpreted as the valve module, proximal portion of sheath body 40B is disposed inside the interior cavity 241 of the coupler 42B as seen in Fig. 4G and the needle shaft 22 extends through the sheath body 40B such that the interior cavity 241 seals the proximal portions of both the needle shaft 22 and sheath body 40B).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle shaft and sheath body taught by modified Kurth to extend into the coupler and be sealed by the interior cavity therein as taught by Bierman. In modification, the needle shaft (18) and the sheath body (22) would be molded to the coupler (24) such that they are molded to the interior of the coupler (24) to seal their respective proximal portions therein as taught by Bierman by known methods to yield predictable results. One of ordinary skill in the art would have recognized that modifying an introducer needle molded to the outside of the hub to be instead molded to an interior hub would yield results that are predictable, and such a combination would provide a better sealed structure and prevent leaking that could occur when an introducer needle is molded to the outside of the hub.
Regarding claim 6, modified Kurth discloses the RICC insertion assembly of claim 1, as discussed above. In modified Kurth, Kurth discloses (Claim 6) wherein the splitting the sheath-splitting means is continued after initiation by pulling the access guidewire (8) distally against a side of the sheath body (22, see Fig. 5 and para. 0053 and 0062 – the sheath-splitting of sheath body 22 is capable of being configured to continue splitting by pulling the guidewire 8 distally away from the coupler 24 such that the guidewire 8 tears the side of the sheath body 22).
Regarding claim 7, modified Kurth discloses the RICC insertion assembly of claim 1, as discussed above. In modified Kurth, Kurth discloses (Claim 7) wherein the sheath-splitting means is the access guidewire (8, see para. 0053).
Regarding claim 12, modified Kurth discloses the RICC insertion assembly of claim 1, as discussed above. In modified Kurth, Kurth discloses (Claim 12) wherein the coupler housing (housing of 24) includes a longitudinal coupler-housing slot (23 in Fig. 10) configured to allow the access guidewire (8) to escape from the coupler housing (housing of 24) when the sheath body (22) is split away from the access guidewire (8, see para. 0053 – coupler 24 comprises a longitudinal slot 23 for allowing the guidewire 8 to be removed when sheath body 22 is split).
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Kurrus in view of Bierman as applied to claim above, in further view of Bierman et al. (U.S Patent Pub. No. 20110009827 A1, “Bierman 2”).
Regarding claim 10, modified Kurth discloses the RICC insertion assembly of claim 1, as discussed above.
However, modified Kurth fails to disclose (Claim 10) wherein the proximal and distal ends of the access guidewire enforce a loop in the access guidewire, over which loop the RICC is disposed in a ready-to-deploy state of the RICC insertion assembly.
Bierman 2 discloses a vascular access device (20’ in Fig. 19), wherein Bierman 2 teaches the limitations (Claim 10) wherein the proximal and distal ends of the access guidewire (44’) enforce a loop in the access guidewire (44’, see Fig. 19 and para. 0160).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidewire taught by modified Kurth to enforce a loop with the catheter disposed thereover as taught by Bierman 2 as Bierman 2 teaches the guidewire being fixed at its proximal end to the coupler secures the guidewire in a preloaded position preventing excessive incidental distal movement of the guidewire until it has been disengaged from the coupler and ready for insertion (see para. 0160). In modified Kurth, Kurrus discloses the central venous catheter (20) that is disposed over the guidewire (104, see Fig. 5B) such that the assembly of Kurth comprises a central venous catheter disposed over the guidewire (8). In combination, the guidewire (8) of Kurth is modified to enforce a loop as taught by Bierman 2, and the catheter would be disposed thereover in its ready to deploy state.
Regarding claim 11, modified Kurth discloses the RICC insertion assembly of claim 10, as discussed above. In modified Kurth, Kurth discloses (Claim 11) further comprising: a syringe fluidly coupled to the introducer needle (18, 22) in the ready-to-deploy state of the RICC insertion assembly (16, see para. 0056 – coupler 24 and thus sheath body 22 and needle shaft 18 may be connected to a syringe), the sheath body (22) sealing the needle slot (20) of the needle shaft (18) thereunder outside of the valve module (see Fig. 5 and para. 0053 - sheath 22 seals the slot 20 of the needle shaft 18 distally outside the interior cavity of the coupler 24 interpreted as the valve module), the valve module sealing around the access guidewire (8) enabling the syringe to aspirate blood (see Fig. 11 and para. 0056 – the interior cavity of coupler 24 comprising the hemostatic membrane 36 is interpreted as the valve module wherein the membrane 36 seals around guidewire 8 allowing for blood aspiration by the connected syringe).
In modified Kurth, Bierman discloses the valve module sealing a proximal portion of the sheath body (40B, see Fig. 4G and para. 0067).
In combination, the proximal portions of needle shaft (18) and sheath body (22) would be molded to an interior of the coupler (24) such that their proximal portions are sealed within an interior cavity of the coupler (24) interpreted as the valve module. Thus, the sheath opening (slit of 22) at the proximal portion of the sheath body (22) would be sealed within the interior cavity of the coupler (24).
Claim(s) 13, 19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Kurrus.
Regarding claim 13, Kurth discloses (Claim 13) a method for inserting a rapidly insertable central catheter ("RICC") into a blood-vessel lumen of a patient (see Fig. 2-3 for reference, see Fig. 4-5a and 10-11 for insertion assembly, para. 0043-0044 – insertion assembly 16 uses an introducer needle to puncture an endovascular cavity, dispose a guidewire therein, and allow for introduction of a catheter and thus is capable of being used for inserting a RICC), comprising: obtaining a RICC insertion assembly (16 in Fig. 4-5a and 10-11), an introducer needle (18, 22 in Fig. 4) including a sheath body (22) over a needle shaft (18, see Fig. 4 and para. 0053), and an access guidewire (8 in Fig. 1, see para. 0053), a coupler (24 in Fig. 5 and 10-11, see para. 0056 – examiner is interpreting the insertion assembly described in Fig. 4-5A having the bifurcated hub 24 of Fig. 10-11 which couples the needle shaft 18 and sheath body 22 to a later introduced catheter as described in para. 0043), a proximal end (10 in Fig. 1) coupled to an extension arm (32 in Fig. 11) of the coupler (24 in Fig. 11) and a distal end (12 in Fig. 1) of the access guidewire (8) disposed in the introducer needle (18, 22) by way of a valve module of the coupler (24, see para. 0053 and 0056 – guidewire 8 has distal portion 10 disposed within needle shaft 18 by way of an interior cavity of the coupler 24 having a hemostatic membrane 36 forming a valve module and proximal portion coupled to side port 32 of coupler 24); establishing a needle tract from an area of skin to the blood-vessel lumen with the introducer needle (18, 22, see 0049 and 0062); advancing the distal end (12) of the access guidewire (8) from its initial location in the needle shaft (18) just proximal of a needle tip (26) of the needle shaft (18) into the blood- vessel lumen (see para. 0049 – distal portion 10 of guidewire 8 is inserted into needle shaft 18 such that it is advanced from a location just proximal of needle tip 26 and into the blood vessel lumen); and splitting the sheath body (22) away from the access guidewire (8, see para. 0053 and 0062 – sheath body 22 is split away from guidewire 8), thereby allowing the access guidewire (8) to escape from the sheath body (22) and remain in the needle tract (see para. 0058 and 0062), the splitting of the sheath body (22) initiated by withdrawing the sheath body (22) by a pair of finger tab (26a, 26b) extending from a sheath hub (34 in Fig. 10-11) around a proximal portion of the sheath body (22, see Fig. 5 and 11 and para. 0053 and 0054-0056 – needle shaft 18 is molded to coupler 24 thus movement of coupler 24 coincides with movement of sheath body 22, withdrawal of coupler 24 and thus sheath body 22 using wings 26a and 26b extending from sheath hub 34 seen in Fig. 10 would initiated the guidewire 8 splitting the sheath 22, examiner notes the embodiment of Fig. 10-11 builds upon the mechanism of Fig. 5 wherein the wings 26a and 26b would still be used to withdraw the sheath body 22 as well as be squeezed to open the slot 23 as discussed in para. 0056).
While Kurth discloses that a catheter may be inserted into the vessel over the guidewire after percutaneous puncture with the assembly (see para. 0043), Kurth fails to explicitly disclose the assembly comprising the coupler coupling a catheter and the introducer needle together, and the method comprising advancing the catheter tip of the RICC over the access guidewire and into the blood-vessel lumen, thereby inserting the RICC into the blood-vessel lumen.
Kurrus discloses an introducer sheath assembly (50 in Fig. 3 and 5B) and explicitly teaches the introducer sheath assembly (50) comprising a coupler (60) coupling the introducer (52, 54) with a central venous catheter (20, see Fig. 5B and para. 0034 and 0036-0037 catheter 20 may be a central venous catheter that is capable of being configured to be rapidly inserted such that it is interpreted as a rapidly insertable central catheter), wherein after the guidewire (104) has been introduced through the introducer needle (52, 54), the catheter tip (tip of 20) of the catheter (20) is advanced over the access guidewire (104) and into the blood-vessel lumen (see Fig. 5B and para. 0036-0037), thereby inserting the catheter (20) into the blood-vessel lumen.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion assembly and method of insertion taught by Kurth to incorporate a central venous catheter coupled to the coupler wherein after the guidewire has been introduced through the introducer needle, advancing the catheter tip of the catheter over the access guidewire and into the blood-vessel lumen as taught by Kurrus. Kurrus discloses that the introducer sheath assembly provides the vascular access and is coupled to a catheter assembly allowing a less-traumatic catheterization process that significantly reduces the number of steps and time associated with gaining percutaneous access to a body vessel for treatment (see 0010).
Regarding claim 19, modified Kurth discloses method of claim 13, as discussed above. In modified Kurth, Kurth discloses (Claim 19) wherein the splitting of the sheath body (22) away from the access guidewire (8) is continued after initiation by pulling the access guidewire (8) distally toward the patient and against a side of the sheath body (22, see Fig. 5 and para. 0053 and 0062 – the sheath-splitting of sheath body 22 is continued after initiation by continuing to pull the guidewire 8 distally and coupler 24 away from the guidewire such that the guidewire 8 is pulled against a side of the sheath body 22).
Regarding claim 24. Modified Kurth discloses the method of claim 13, as discussed above. In modified Kurth, Kurth discloses (Claim 24) wherein:
the needle shaft (18 in Fig. 4) includes a longitudinal needle slot (20 in Fig. 4) extending from the proximal portion of the needle shaft (18) through the needle tip (26) of the needle shaft (18, see Fig. 4 and para. 0053 – slot 20 is formed longitudinally through the needle shaft 18 and distal tip 26),
the sheath body (22 in Fig. 4) over the needle shaft (18) seals the needle slot (20) thereunder except for a portion of the needle slot (20) under a sheath opening (slit of 20) in the proximal portion of the sheath body (22, see para. 0053 – sheath 22 is placed over needle shaft 18 and slot 20 to seal it thereunder except for a slit provided in the proximal portion of the sheath 22 which is unsealed to allow the guidewire 8 to contact the sheath 22 to initiate the splitting); and
the distal end (12 in Fig. 1) of the access guidewire (8) is disposed in the introducer needle (18, 22) through the sheath opening (slit of 20) of the sheath body (20), the sheath opening (slit of 20) having a width commensurate with a diameter of the access guidewire (8, examiner notes this limitation is being interpreted in light of the 112(b) rejection above using the Merriam Webster definition of the term “commensurate” as corresponding in size, extent, amount, or degree, and thus the sheath opening is interpreted as having a width that corresponds in size or extent to the diameter of the access guidewire, see para. 0049 and 0053 – distal end 12 of guidewire 8 is disposed in the introducer needle and will extend through the slit 20 once removed, the slit in sheath body 20 has a width that corresponds to the size or extent of the diameter of the guidewire 8 allowing the guidewire 8 to contact the slit).
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Kurrus as applied to claim 13 above, in further view of Hawkins et al. (U.S Patent Pub. No. 20060135973 A1, “Hawkins”).
Regarding claim 23, modified Kurth discloses the method of claim 13, as discussed above.
In modified Kurth, Kurrus discloses the method of inserting the catheter (20) over the guidewire (104) and into the vessel (see para. 0037), but modified Kurth fails to disclose (Claim 23) further comprising withdrawing the access guidewire leaving a catheter tube of the RICC in place in the blood-vessel lumen.
Hawkins discloses an apparatus for providing percutaneous access to a vessel of a patient over a guidewire (see Abstract), wherein Hawkins provides a description of the well-known Seldinger technique comprising gaining access to vasculature through a percutaneous puncture using an introducer needle, introducing a guidewire through the needle and into the vasculature, withdrawing the needle leaving the guidewire in place, advancing a catheter over the guidewire, and once the catheter is in place removing the guidewire (see para. 0006).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for inserting a catheter into a blood-vessel lumen as taught by modified Kurth to remove the guidewire once the catheter is in place in the blood-vessel lumen as taught by Hawkins according to known methods to yield predictable results. As discussed above, Hawkins teaches that the Seldinger technique including the step of removing the guidewire after placement of the catheter is a known technique that in combination with modified Kurth would yield predictable results (see para. 0006).
Allowable Subject Matter
Claims 2-5 and 8-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 14-18 and 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Kurth, Roeder et al. (U.S Patent Pub. No. 20140188211 A1, “Roeder”), Lowe et al. (U.S Patent Pub. No. 20020123755 A1, “Lowe”), and Kraus et al. (U.S Patent No. 5290241, “Kraus”).
Regarding claim 2 and with respect to the 103 rejection of claim 1 above, in modified Kurth, Kurth fails to disclose the limitations of claim 2 as the coupler (24) is molded to the introducer needle (18, 22) and thus the any movement of the coupler (24) is also movement of the introducer needle (18, 22). There is no motivation to modify the coupler (24) to be moved relative to the introducer needle (18, 22) or vice versa as this would render the coupler (24) inoperable for splitting the sheath body (22) when it is pulled so the guidewire (8) can tear the sheath body (22, see para. 0053 and 0062). The limitations of claim 14, dependent upon the method claim 13, are indicated as allowable subject matter for the same reasons as claim 2 as discussed above. Claim 15 is indicated as allowable subject matter for being dependent upon claim 14.
Regarding claim 3 and with respect to the 103 rejection of claim 1 above, in modified Kurth, Kurth fails to disclose the limitations of claim 3 as the coupler (24) is molded to the introducer needle (18, 22) and thus the introducer needle (18,22) cannot be withdrawn from the coupler (24). There is no motivation to modify the coupler (24) to be moved relative to the introducer needle (18, 22) or vice versa as this would render the coupler (24) inoperable for splitting the sheath body (22) when it is pulled so the guidewire (8) can tear the sheath body (22, see para. 0053 and 0062). The limitations of claim 16, dependent upon the method claim 13, are indicated as allowable subject matter for the same reasons as claim 3 as discussed above.
Regarding claim 4 and with respect to the 103 rejection of claim 1 above, in modified Kurth, Kurth fails to disclose the limitations of claim 4 with the sheath body being withdrawn from the coupler. There is no motivation to modify Kurth to disclose the limitations of claim 4 for the above discussed reasons with respect to claim 3. The limitations of claim 17, dependent upon the method claim 13, are indicated as allowable subject matter for the same reasons as claim 3 as discussed above.
Regarding claim 5 and with respect to the 103 rejection of claim 1 above, in modified Kurth, Kurth fails to disclose the limitations of claim 5. Kurth discloses that the catheter can be inserted into the vessel over the guidewire after the introducer needle (18, 22) and coupler (24) are withdrawn. Therefore, there is no motivation to modify Kurth to have the sheath body (22) continue splitting by pushing the catheter tip into the sheath body (22) as the sheath body (22) of Kurth would already be removed before insertion of the catheter. The limitations of claim 18, dependent upon the method claim 13, are indicated as allowable subject matter for the same reasons as claim 5 as discussed above.
Roeder discloses an insertion assembly (100 in Fig. 1-2) for inserting an endoluminal prosthesis (200) comprising a pusher catheter (120) having a guidewire (106) disposed therein (see Fig. 1 and Fig. 8), a sheath body (130) disposed over the pusher catheter (120, see Fig. 1), and a coupler (160, 103) having a valve module (160) disposed therein. After insertion of the assembly (100) into a vessel puncture done by a separate introducer, the sheath body (130) may be withdrawn from the valve module (160) causing a blade (180 in Fig. 5) to split the sheath body (130) as its withdrawn (see para. 0051-0052). However, Roeder fails to disclose an introducer needle and cannot be modified to have the needle shaft as claimed as the guidewire (106) of Roeder is disposed within a pusher catheter (120) for pushing the prosthesis (200) and modifying the pusher catheter (120) to be a needle shaft would render the pusher catheter (120) inoperable for its intended use. Regarding claim 8, modified Kurth could not be modified with the blade teachings of Roeder as the introducer needle (18, 22) of Kurth are molded to the coupler (24) while the pusher catheter (120) and sheath body (130) extend through the valve module (160) of the coupler (160, 103) of Roeder. Kurth would be rendered inoperable if the introducer needle (18, 22) was modified to extend through the coupler (24) to be able to be withdrawn through the coupler (24) for splitting upon a blade as Kurth requires that the coupler (24) and introducer needle (18, 22) be molded together for splitting of the sheath body (22) by the guidewire (8, see para. 0053). Claim 9 is indicated as allowable subject matter due to its dependency upon claim 8. The limitations of claims 20-22, dependent upon the method claim 13, are indicated as allowable subject matter for the same reasons as claim 8 as discussed above.
Lowe discloses an embolic protection filter delivery sheath (10 in Fig. 1) comprising a splitable sheath (12), a guidewire (20), and a coupler (28). The coupler (28) comprising a blade (30) affixed within the coupler housing such that withdrawing of the sheath (12) by pull tab (40) fixed to the distal end of the sheath (12) retracts the sheath (12) over the blade (30) to split the sheath (12) and thus allow for removal of the guidewire (20, see para. 0016 and 0019). However, Lowe fails to disclose a catheter, an introducer needle comprising a needle shaft, or a valve module. There is no motivation to modify Lowe to have the structures of an introducer and catheter insertion assembly as this would require significant modification to the delivery sheath structures of Lowe which are designed to be introducer after an introducer and used only for delivery of the embolic protection filter.
Kraus discloses a coupler (11 in Fig. 3) for an angiography catheter, wherein the coupler (11) comprises a blade (25 in Fig. 2) disposed therein which can be manually moved using a finger pad (29 in Fig. 2) to split a catheter tubing so a guidewire (52) can be removed (see abstract). However, Kraus fails to disclose an introducer needle comprising a needle shaft and sheath body or a valve module. There is no motivation to modify Lowe to have the structures of an introducer and catheter insertion assembly as this would require significant modification to the adapter’s structure which is designed to be introduced after an introducer.
Therefore, there is no reference that discloses or teaches the limitations of claims 2-5, 8-9, 14-18, and 20-22.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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