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.
Response to Amendment
Acknowledgement is made to the claims received 12/08/2025.
Acknowledgement is made to the newly added claims 5-10.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1-10 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardeski (US 20040116848 A1).
Regarding claim 1, Gardeski teaches a medical introducer sheath (Fig. 1-4; catheter body 12) having a steerable distal end portion (Fig. 1-4; distal segment 54) and a proximal end portion (Fig. 1-4; proximal segment 50) for being fixed with a hub (Fig. 1-4; valve 80) having a side port (Fig. 1-4; side port 84), the introducer sheath comprising:
an inner sheath (Fig. 1-4; delivery lumen liner 44) elongated from the distal end portion to the proximal end portion and opened on the distal end portion and the proximal end portion ([0041]), the inner sheath defining a main lumen (Fig. 1-4; delivery lumen 24) in fluid communication with the side port ([0070]); and
an outer sheath (Fig. 1-4; outer sheath segments 40, 42, [0042] discusses the outer sheath as being comprised of outer sheath segments 40 and 42) running along an outer face of the inner sheath and defining one or more sub-lumens ([0041]), each sub-lumen being elongated from the distal end portion and terminating at any position anterior to a proximal end of the inner sheath ([0041]), the outer sheath covering the inner sheath throughout from the distal end portion to the proximal end portion and, at least at the proximal end portion, being in gas-tightly contact with or being formed in a unitary body with the inner sheath ([0061]).
Regarding claim 2, Gardeski teaches the introducer sheath of claim 1, further comprising: sub-sheaths embedded in the outer sheath and respectively defining the sub-lumens ([0041]).
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gardeski (US 20040116848 A1).
Regarding claim 3, Gardeski teaches the introducer sheath of claim 1, further comprising:
a wire (Fig. 1-4; deflection mechanism 30, [0044]) fixed to the distal end portion and respectively passing through the sub-lumens, wherein the outer sheath includes an opening (Fig. 1-4; opening 32) anterior to the proximal end portion and respectively in communication with the sub-lumens, and the wires are respectively led through the openings out of the outer sheath ([0041]).
While Gardeski does not explicitly teach the wire and opening as being plural “wires” and “openings, there is no evidence that more than wire and opening makes a meaningful difference to the function of the device compared to the currently taught wire and opening and it has been held that a duplication of parts is an obvious modification (MPEP 2144.04(VI)(B)).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gardeski (US 20040116848 A1) in view of Uihlein (US 20090187163 A1).
Regarding claim 4, The introducer sheath of claim 1, further comprising: a braid embedded in the outer sheath and elongated along the inner sheath ([0062]).
However, Gardeski fails to teach the braid as terminating at any place anterior to the proximal end portion.
Uihlein teaches an elongated element, referred to as a guide wire unit for positioning a medical catheter within the body having a controlled stiffness at different sections of the guide wire (Abstract).
Uihlein further teaches the proximal section as not containing a braided portion so as to provide the proximal most section with being able to provide a connection for the device ([0033], [0034], [0050]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the proximal portion of a portion of a catheter as not having a braided portion as is taught by Uihlein into the elongate medical sheath of Gardeski to produce the predictable result of the proximal portion providing a proximal connection, as is taught by Uihlein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gardeski (US 20040116848 A1) in view of Webster ‘590 (US 5772590 A).
Regarding claim 5, Gardeski teaches the introducer sheath of claim 1
However, Gardeski fails to teach the introducer sheath wherein each sub-lumen includes a gas-tightly sealed end closed by the outer sheath.
Webster ‘590 teaches a catheter having a puller wire which is attached at a distal position and a proximal position (Abstract).
Webster ‘590 further teaches the puller wire as being covered by a tube which is sealed at both distal and proximal ends so as to prevent fluids from infiltrating the puller wire (Col. 9, Lines 15-30)
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the tube which the puller wire is located within as being sealed and closed by an end of the sheath, as is taught by Webster ‘590, into the lumen containing a deflection wire as is taught by Wilkowske, to produce the predictable result of preventing fluids from infiltrating the puller wire, as is taught by Webster ‘590, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gardeski (US 20040116848 A1) in view of Webster ‘974 (US 6198974 B1).
Regarding claim 6, Gardeski teaches the introducer sheath of claim 1.
However, Gardeski fails to teach the introducer sheath further comprising: one or more fillers closing the sub-lumens at the position anterior to the proximal end of the inner sheath.
Gardeski further teaches the sub-lumens ending at the position anterior to the proximal end of the inner sheath (Fig. 1; deflection lumen 26 end at opening 32).
Webster ‘974 teaches a catheter comprising a pair of puller wires, surrounded by plastic sheaths (Fig. 11; sheath 44) which result in deflection of the tip section (Abstract). The catheter further comprising an inner elongated element which extends to the proximal end of the device (Fig. 8; wire 116) and the puller wires extending to a position distal to a proximal most position of inner elongated element (Fig. 8; puller wires 34).
Webster ‘974 further teaches proximal end of the puller wire as being positioned within a piston having a threaded axial hold that receives a threaded set screw, the screw having an axial bore for passage of the proximal end of the puller wire (Col. 9, Lines 30-50). This position of the attachment mechanism of the puller wire to the enclosed lumen surrounding said puller wire is provided so as to provide adjustable movement of the puller wire (Col. 10, Lines 1-30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the attachment of the puller wire to the proximal portion of the enclosed lumen surrounding said wire by an intermediate filled element, such as the threaded screw set, as is taught by Webster ‘974, into the moveable deflection wires located within a lumen as is taught by Gardeski, to produce the predictable result of adjustable movement of the puller wire, as is taught by Webster ‘974, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkowske (US 8273285 B2) in view of Cise (US 20180310957 A1) and Webster ‘590 (US 5772590 A).
Regarding claim 7, Wilkowske teaches a medical introducer sheath (Fig. 1; steerable catheter sheath 10) having a steerable distal end portion (Fig. 1; distal end 18) and a proximal end portion for being fixed with a hub (Fig. 1; actuator handle 14), the introducer sheath comprising:
an inner sheath (Fig. 1-3; inner layer 50) elongated from the distal end portion to the proximal end portion and opened on the distal end portion and the proximal end portion (Col. 3, Lines 60-65), the inner sheath defining a main lumen (Fig. 1-3; central lumen 48);
an outer sheath (Fig. 1-3; outer sheath 56) running along an outer face of the inner sheath and covering the inner sheath throughout from the distal end portion to the proximal end portion (Col. 4, Lines 5-15); and
one or more sub-sheaths (Fig. 2; wire lumens 54) embedded in the outer sheath and elongated along the inner sheath from the distal end portion toward the proximal end portion (Col. 3, Lines 54-62), each sub-sheath defining a sub-lumen (Col. 4, Lines 1-12).
However, Wilkowske is silent upon the hub as having a side port and the main lumen being in fluid communication with said side port.
Cise teaches an introducer sheath having a sheath shaft and lumen, a hub, and port for introducing medical instruments or fluids ([0034]- [0035]).
Cise further teaches the port which is in fluid communication with the sheath shaft lumen for introducing medical instruments or fluids as being a side port ([0035]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the side port for introducing medical instruments or fluids into the sheath shaft lumen, as is taught by Cise, into the steerable sheath having a central lumen for delivering medical fluids or equipment as is taught by Wilkowske, to produce the predictable result of introducing medical instruments or fluids into a lumen of a sheath shaft, as is taught by Cise, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Further, Wilkowske fails to specifically teach the proximal end portion of the outer sheath being in gas-tightly contact with or being formed in a unitary body with the inner sheath.
While Wilkowske does not specifically teach the proximal end portion as being formed in a unitary body with the inner sheath, Applicant has not disclosed that these components being integral produces an unexpected result and it has been held that integration of parts is an obvious modification (MPEP 2144.04(V)(B)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided any functional elements, such as the inner and outer sheaths, of the steerable catheter sheath of Wilkowske to be integral components as long as each functional element retains its ability to function in a desired and/or predictable manner.
Wilkowske further fails to teach the wire lumens as including an end gas-tightly sealed and closed by the outer sheath.
Webster ‘590 teaches a catheter having a puller wire which is attached at a distal position and a proximal position (Abstract).
Webster ‘590 further teaches the puller wire as being covered by a tube which is sealed at both distal and proximal ends so as to prevent fluids from infiltrating the puller wire (Col. 9, Lines 15-30)
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the tube which the puller wire is located within as being sealed and closed by an end of the sheath, as is taught by Webster ‘590, into the lumen containing a deflection wire as is taught by Wilkowske, to produce the predictable result of preventing fluids from infiltrating the puller wire, as is taught by Webster ‘590, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Regarding claim 8, Wilkowske teaches the introducer sheath of claim 7, further comprising:
wires (Fig. 1-3; deflection wires 40) fixed to the distal end portion (Fig. 1; pull ring 42) and respectively passing through the sub-lumens (Fig. 1-3; deflection wires 40 are shown as passing through wire lumens 54),
wherein the outer sheath includes openings (Fig. 1; windows 46) anterior to the proximal end portion (Fig. 1; shows the proximal end of the flexible body of the sheath as extending into and through the actuation handle with the windows being positioned distal to the shown proximal end of the sheath) and respectively in communication with the sub-lumens, and the wires are respectively led through the openings out of the outer sheath (Fig. 1; the wires 40 are shown as exiting the body 12 and therefore the wire lumens 54 via windows 46).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Wilkowske (US 8273285 B2) in view of Cise (US 20180310957 A1) and Webster ‘590 (US 5772590 A) further in view of Uihlein (US 20090187163 A1).
Regarding claim 9, Wilkowske teaches the introducer sheath of claim 7, further comprising:
a braid embedded in the outer sheath (Fig. 2-3; wire brad 52 is shown as being embedded within the outer layer 56) and elongated along the inner sheath (Col. 5, Lines 4-5).
However, Wilkowske fails to teach the braid as terminating at any place anterior to the proximal end portion.
Uihlein teaches an elongated element, referred to as a guide wire unit for positioning a medical catheter within the body having a controlled stiffness at different sections of the guide wire (Abstract).
Uihlein further teaches the proximal section as not containing a braided portion so as to provide the proximal most section with being able to provide a connection for the device ([0033], [0034], [0050]).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the proximal portion of a portion of a catheter as not having a braided portion as is taught by Uihlein into the elongate medical sheath of Wilkowske to produce the predictable result of the proximal portion providing a proximal connection, as is taught by Uihlein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wilkowske (US 8273285 B2) in view of Cise (US 20180310957 A1) and Webster ‘590 (US 5772590 A) further in view of Webster ‘974 (US 6198974 B1).
Regarding claim 10, Wilkowske as modified teaches the introducer sheath of claim 7.
In accordance with the above rejection of claim 7, Wilkowske as currently modified by Webster ‘590 teaches the sub-sheaths as being closed at the position anterior to the proximal end of the inner sheath (Fig. 1).
However, Wilkowske as currently modified fails to teach the introducer sheath further comprising: one or more fillers closing the sub-sheaths.
Wilkowske further teaches the sub-sheaths as being wire lumens containing deflection wires (Fig. 1-3).
Webster ‘974 teaches a catheter comprising a pair of puller wires, surrounded by plastic sheaths (Fig. 11; sheath 44) which result in deflection of the tip section (Abstract). The catheter further comprising an inner elongated element which extends to the proximal end of the device (Fig. 8; wire 116) and the puller wires extending to a position distal to a proximal most position of inner elongated element (Fig. 8; puller wires 34).
Webster ‘974 further teaches proximal end of the puller wire as being positioned within a piston having a threaded axial hold that receives a threaded set screw, the screw having an axial bore for passage of the proximal end of the puller wire (Col. 9, Lines 30-50). This position of the attachment mechanism of the puller wire to the enclosed lumen surrounding said puller wire is provided so as to provide adjustable movement of the puller wire (Col. 10, Lines 1-30).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the attachment of the puller wire to the proximal portion of the enclosed lumen surrounding said wire by an intermediate filled element, such as the threaded screw set, as is taught by Webster ‘974, into the moveable deflection wires located within a lumen as is taught by Wilkowske, to produce the predictable result of adjustable movement of the puller wire, as is taught by Webster ‘974, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Response to Arguments
Applicant’s argument’s that Gardeski does not teach the deflection lumen as terminating at any position anterior to the proximal end of the delivery lumen are currently unpersuasive. Specifically, as Fig. 1 shows the delivery lumen 24 and the deflection lumen 26 by dashed lines, where the dashed lines which show the delivery lumen as extending to the proximal end of the catheter body and the dashed lines which show the deflection lumen extending to the point of the proximal end opening 32 and do not extend proximally past this point.
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 extension fee 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 date of this final action.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794