DETAILED ACTION
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.
Claim Objections
Claim 7 is objected to because of the following informalities: line 6 should be amended to -the first portion of the wire extending from the second portion of the wire towards the proximal-. 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 9, 11, 14 and 17 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 9:
The claim is unclear because of the limitations “a substantially flat wire” and “substantially all of the inner layer of the flat wire in the distal portion” in lines 1 and 5 respectively. The term “substantially” raises a question of how flat the wire should be and how much of the inner layer should be coiled around the inner layer. For the sake of the examination, the office has assumed that the flat wire should be at least partially flat and that the flat wire should at least be partially coiled all around the inner layer. However, the applicant should amend the claims to clarify.
Regarding claim 11:
The claim recites the limitation "the stiffener tip" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14:
The claim limitations “a distal portion” and “a proximal portion” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a distal portion” and “a proximal portion” in lines 2 and 3 respectively of claim 12 (on which this claim depends) which raises a question of if two of each distal portion and proximal portion are required by the claim 14 or only one. For the sake of examination, the office has assumed that only one proximal and distal portion are required by the claim. However, the applicant should amend the claim to clarify.
The limitation “the distal portion” and “the proximal portion” in lines 4-5 are unclear. These limitations are unclear because multiple distal and proximal portions have been established in claim 14 and 12 raising a question of which one is being referred to. For the sake of examination, the office has assumed that all recitations of the distal portion and the proximal portion refer to the same distal and proximal portions. However, the applicant should amend the claim to clarify.
Regarding claim 17:
The claim limitation “a braided and/or coiled wire frame” in line 1 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a braided and/or coiled wire frame” in line 2 of claim 12 (on which this claim depends) which raises a question of if two braided and/or coiled wire frames are required by the claim 17 or only one. For the sake of examination, the office has assumed that only one braided and/or coiled wire frame is required by the claim.
The claim limitations “a sheath shaft” and “a proximal portion” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a sheath shaft” and “a proximal portion” in lines 2 and 3 respectively of claim 12 (on which this claim depends) which raises a question of if two of each sheath shaft and proximal portion are required by the claim 17 or only one. For the sake of examination, the office has assumed that only one proximal portion and sheath shaft are required by the claim. However, the applicant should amend the claim to clarify.
The limitation “the proximal portion” in line 3 are unclear. The limitation is unclear because multiple proximal portions have been established in claim 17 and 12 raising a question of which one is being referred to. For the sake of examination, the office has assumed that all recitations of the proximal portion refer to the same proximal portions. However, the applicant should amend the claim to clarify.
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 1-3, 6-7, 10, 12-15 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2004033015 A1 to Hewitt et al. (Hewitt).
Hewitt discloses:
Regarding claim 1:
An introducer sheath (figures 1-6) comprising:
a shaft (400) forming a lumen (¶0030) and comprising:
a braided or coiled wire frame (20) having a distal portion (see distal portion A in figure 1 below) and a proximal portion (see proximal portion B in figure 1 below), wherein a wire (¶0040) is disposed more densely in the distal portion (A in figure 1 below) than the proximal portion (B in figure 1 below) of the wire frame (20) (see the density of the wire 20 and how it is more closely/densely wound near distal portion A then at proximal portion B),
a jacket (30) encompassing the wire frame (20) (as shown in figure 3d), and
a liner (10) forming an inner wall (as shown in figure 3d), the liner (10) encompassed by the wire frame (20) (as shown in figure 3d).
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Figure 1 - figure 6 of Hewitt, annotated by the examiner
Regarding claim 2:
The sheath of claim 1, wherein the wire frame (20) includes a coiled wire frame (20; see figures 1-2 and 6) and the distal portion (A in figure 1 above) of the coiled wire frame (20) includes a first portion (see the first portion C (wire strand C) in figure 1 above) of coiled wire extending a length (as shown in figure 1 above) of the distal portion (A in figure 1 above) and a second portion (see the first portion D (wire strand D) in figure 1 above) of coiled wire extending the length (as shown in figure 1 above) of the distal portion (A in figure 1 above) such that the second portion of coiled wire overlaps the first portion of coiled wire (as shown in figure 1 above) and the wire of the distal portion (A in figure 1 above) is more densely disposed (as shown in figure 1 above) than the proximal portion (B in figure 1 above) of the wire frame (20).
Regarding claim 3:
The sheath of claim 1, wherein the wire frame (20) includes a braided wire frame (20, see figure 6), wherein the distal portion (A in figure 1 above) of the braided wire frame (20) has more picks/inch than the proximal portion (B in figure 1 above) of the braided wire frame (20) such that the wire of the distal portion (A in figure 1 above) is more densely disposed than the proximal portion (B in figure 1 above) of the wire frame (20)(see figure 1 above and figure 6 which shows the braiding of the wire 20 is tighter/denser near distal portion A then near proximal portion B).
Regarding claim 6:
The sheath of claim 1, wherein the wire frame (20) includes a coiled wire frame (20; as shown in figure 6) comprising:
the proximal portion (B in figure 1 above) having a first portion (portion G of wire in figure 1 above) of a wire (wire of 20) coiled at a first pitch (see the pitch of wire at portion G near portion B); and
the distal portion (A in figure 1 above) having a second portion (see the second portion C in figure 1 above) of the wire coiled at a second pitch (pitch of wire near portion C near portion A) that is tighter than the first pitch (pitch near portion C is tighter than the pitch near portion G in figure 1 above), a third portion of the wire coiled at a third pitch (pitch of the wire near the third portion E in figure 1 above) over at least some of the second portion (C and E form the second portion of the wire) of the wire, and a fourth portion (portion of the wire F in figure 1 above) of the wire coiled at a fourth pitch tighter than the first pitch (pitch at the fourth portion F is greater than the pitch at the first portion G), the first portion of the wire extending from the fourth portion (first portion G extends from the fourth portion F as shown in figure 1 above) of the wire towards the proximal portion (B in figure 1 above).
Regarding claim 7:
The sheath of claim 1, wherein the wire frame (20) includes a coiled wire frame (20) comprising:
the proximal portion (B in figure 1 above) having a first portion of a wire coiled at a first pitch (see the first portion of wire G in figure 1 above coiled at the first pitch); and
the distal portion (A in figure 1 above) having a second portion of the wire coiled at a second pitch (see the second portion C in figure 1 above with a second pitch) that is tighter than the first pitch (pitch of C is greater than the pitch of C) and coiled over a segment of the wire (one of the wire strands that extends of portion G and C overlaps with other strands of wire frame 20 which all wrap around the liner 10) coiled around the liner (10), the first portion of the wire extending from second portion of the wire (first portion G extends from portion C toward the proximal portion B as shown in figure 1 above) towards the proximal portion (B in figure 1 above).
Regarding claim 10:
The sheath of claim 1, further comprising a hub (40) forming a chamber (chamber within 42) and comprising:
a side port (port at 44) in fluid communication with the chamber (chamber within 42), and
an introducer bore (bore within 43) with a seal to maintain hemostasis of the introducer sheath while allowing a medical instrument to be introduced through the introducer bore (bore within 43) into the chamber (chamber within 42) (¶0030 indicated a medical instrument is introduced into the chamber within 43 into the sheath 400),
wherein the shaft (400) is coupled to the hub (40) at a proximal end (see the proximal end 41 in figure 3) of the shaft (400), the lumen (¶0030) of the shaft (400) being in fluid communication with the chamber (chamber within 42) of the hub (40) (as shown in figure 3).
Regarding claim 12:
A method of manufacturing an introducer sheath (see figures 1-6), the method comprising:
forming a braided and/or coiled wire frame (20; ¶0029) of a sheath shaft (400) having a distal portion (A in figure 1 above) and a proximal portion (B in figure 1 above), wire (¶0037) being disposed more densely (see how the density becomes greater at A then at B as shown in figure 1 above) in the distal portion (A in figure 1 above) than in the proximal portion (B in figure 1 above);
reflowing a liner (10) to an interior surface (¶0034 indicated it is coated over the wire) of the wire frame (20);
reflowing a jacket (30) to an exterior surface (heat fusing as described in ¶0045 and ¶0056) of the wire frame (20); and
securing a hub (40) to the proximal portion (B in figure 1 above) of the wire frame (20), the hub (40) having a chamber (chamber within 42) in fluid communication with a hollowing conduit (see the conduit within 10 as shown in figure 3d) formed from reflowing the liner (10) and the jacket (30) to the wire frame (20)(as shown in figure 2d), a side port (port at 44) in fluid communication with the chamber (chamber within 42), and an introducer bore (bore within 43) with a seal to maintain hemostasis of the introducer sheath (400) while allowing a medical instrument to be introduced through the introducer bore (bore within 43) into the chamber (chamber within 42) (¶0030 indicated a medical instrument is introduced into the chamber within 43 into the sheath 400).
Regarding claim 13:
The method of claim 12, wherein forming a braided or coiled wire frame (20) includes forming a coiled wire frame (20) by winding the wire (strand of wire frame 20) on a spring winder (see the wound coil wire frame 20) from the proximal portion (B in figure 1 above) to the distal portion (A in figure 1 above) and then winding the wire (other strand of the wire frame 20 overlaps other strands of wire frame 20 at the distal portion A) over the distal portion (A in figure 1 above) again such that the wire is disposed more densely (plurality of overlapping strands of wire frame 20 are more densely arranged near distal portion A as shown in figure 1 above) in the distal portion (A in figure 1 above) than in the proximal portion (B in figure 1 above).
Regarding claim 14:
The method of claim 12, wherein forming a braided or coiled wire frame (20) having a distal portion (A in figure 1 above) and a proximal portion (B in figure 1 above) includes braiding metal wires at a first picks/inch (see the picks/inch/pitch of wire braiding 20 near proximal portion B) to form the proximal portion (B in figure 1 above) of the wire frame (20) and braiding the metal wires at a second picks/inch (see the picks/inch/pitch of wire braiding 20 near distal portion A) that is greater than the first picks/inch to form the distal portion (A in figure 1 above) having the wire disposed more densely than in the proximal portion (B in figure 1 above)(density of wires in wire frame 20 greater near the distal portion A than the proximal portion B as shown in figure 1 above).
Regarding claim 15:
The method of claim 12, further comprising adjoining a tip (50 or 10) to a distal end (end of 400 as shown in figure 2) at of the distal portion (A in figure 1 above) of the wire frame (20).
Regarding claim 17:
The method of claim 12, wherein forming a braided and/or coiled wire frame (20) of a sheath shaft (400) having a distal portion (A in figure 1 above) and a proximal portion (B in figure 1 above) includes:
braiding wires (see braided wire of wire frame 20 as shown in figure 1 above near portion B) to form at least the proximal portion (B in figure 1 above) of the wire frame (20); and
coiling wire (wire frame 20 consists of wires coiled over other wires as shown in figure 6) over at least some of the braided wires to form (as shown in figure 1 above) the distal portion (A in figure 1 above) having the wire of the wire frame (20) disposed more densely (wires/coils of 20 disposed more densely near portion A then near portion B as shown in figure 1 above) than the proximal portion (B in figure 1 above).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004033015 A1 to Hewitt et al. (Hewitt) as applied to claim 1 above, and further in view of US 20040236367 A1 to Brown et al. (Brown).
Regarding claim 4:
Hewitt fails to disclose:
The sheath of claim 1, further comprising a safety line extending longitudinally through the wire frame and secured to the proximal portion and the distal portion.
Brown teaches:
A catheter (figures 1-5) that includes a distal and proximal portion (see the ends of the catheter as shown in figure 5) with a safety line (14) which holds the ends of the catheter in case of failure of the catheter (¶0029).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hewitt to further include a safety tether/line between the proximal and distal portions as taught by Brown in order to hold the catheter together in the case of failure (Brown, ¶0029).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: claims 18-20 is/are allowed primarily because the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Furthermore, the prior art of record does not teach “removing at least some of the wire coiled on the liner between the distal region and the proximal region” as within the context of the claimed invention as disclosed and within the context of the other limitations present in claim 18.
Therefore, the prior art of record cannot anticipate Applicant' s claimed invention by a single reference nor render Applicant' s claimed invention obvious by the combination of more than one reference.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 9 and 11 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 5, 8 and 16 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20140214006-A1
HIROSHIGE
See the braided wire (26)
US-20140180329-A1
Krahbichler
See the wire 12
US-20160000443-A1
LILBURN
See the braided wire (104)
US-20060030835-A1
Sherman
See the wire 38
US-20180310957-A1
Cise
See the braided wire (234a)
US-20090287182-A1
Bishop
See the braided wire (612)
US-5454795-A
Samson
See the wire 204
US-7905877-B1
Jimenez
See the wire 28
US-20080262472-A1
Lunn
See the braided wire (350)
US-20050131387-A1
Pursley
See the wire 20
JP-2006051080-A
MURATA
See the wire 10
WO-2018163401-A1
HORI
See the wire 30a
WO-2007124500-A1
JACOBS
See the wire 104a
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783