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 Arguments
Applicant’s arguments with respect to claim(s) 1-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1-5, 7-14, 16-22 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Wijay et al. (WO 89/02763) hereinafter Wijay.
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Regarding claim 1, Wijay teaches:
A catheter comprising: a tube-shaped member (26) having a distalmost end and a proximal most end at opposite ends of the tube-shaped member, the tube-shaped member also having a lumen (lumen 22) passing through the tube-shaped member and communicating with both a first open end of the tube-shaped member located at the distalmost end of the tube-shaped member and a second open end of the tube-shaped member at the proximal most end of the tube-shaped member;
The tube-shaped member including a distalmost end portion (T, Figure 1), the distalmost end portion of the tube-shaped member having an axial extent (area where the outward and inward protrusion extends) extending in an axial direction from a distal end of the distalmost end portion to a proximal end of the distalmost end portion,
the distal end of the distalmost end portion being at the distalmost end of the tube-shaped member;
the tube-shaped member further including an extension portion (Annotated Fig. 1) having a distalmost end that is immediately proximal (the extension portion distal end is next to the distal most end of the tube) of the distalmost end portion of the tube- shaped member, the extension portion having an inner surface and an outer surface;
an entirety of the axial extent of the distalmost end portion (T) including an outwardly protruding portion and an inwardly protruding portion (See Annotated Figure 1);
the outwardly protruding portion and the inwardly protruding portion having a same length along the axial direction (See Annotated Figure 1);
an entirety of the axial extent of the outwardly protruding portion protruding radially outwardly relative to the outer surface of the extension portion (See Annotated Figure 1);
and an entirety of the axial extent of the inwardly protruding portion protruding radially inwardly relative to the inner surface of the extension portion (see Figure 1)
Regarding claim 2, Wijay teaches the tube-shaped member comprises: a tube having a distal end and a proximal end; a distal end tip fixed to the distal end of the tube (see Figure 1); and a hub (106, Figure 11) fixed to the proximal end of the tube.
Regarding claim Claim 3, Wijay teaches the tube- shaped member comprises:
a tube having a distal end and a proximal end (26, Fig. 1); and a distal end tip fixed to the distal end of the tube, the distalmost end portion (T) of the tube-shaped member having the an outer diameter greater than the an outer diameter of the distalmost end of the extension portion (see Figure 1) that is immediately proximal of the distalmost end portion of the tube-shaped member, the distalmost end portion of the tube-shaped member having an inner diameter smaller than the an inner diameter of the distalmost end of the extension portion that is immediately proximal of the distalmost end portion of the tube-shaped member (see Figure 1).
Regarding claim 4, Wijay teaches the distalmost end portion (T, Figure 1) of the tube-shaped member having the outer diameter greater than the outer diameter of the distalmost end of the extension portion immediately adjacent portion of the tubeshaped member has a radially outwardly facing outer peripheral surface and an axially facing distal end surface that faces away from the extension portion, the radially outwardly facing outer peripheral surface of the distalmost end portion of the tube-shaped member and the axially facing distal end surface of the distalmost end portion of the tube-shaped member intersecting one another at a rounded corner (see figure 1).
Regarding claim 5, Wijay teaches a distal portion of the tube-shaped member is curved (the tube is curved, See Figure 1).
Regarding claim 7, Wijay teaches a catheter comprising:
a tube-shaped member (26) having a distalmost end and a proximal most end at opposite ends of the tube-shaped member, the tube-shaped member also having a lumen (22) passing through the tube-shaped member and communicating with both a first open end of the tube-shaped member located at the distalmost end of the tube-shaped member and a second open end of the tube-shaped member at the proximal most end of the tube-shaped member; the tube-shaped member including a distalmost end portion (portion 34 to area pointed by 46 of T), the distalmost end portion of the tube-shaped member having an axial extent extending in an axial direction from a distal end of the distalmost end portion to a proximal end of the distalmost end portion, the distal end of the distalmost end portion being at the distalmost end of the tube-shaped member; the tube-shaped member further including an extension portion (Extension portion, in annotated Figure 1) that is immediately adjacent to and on a proximal side of the distalmost end portion, the extension portion having an outer surface and an inner surface; the distalmost end portion including an outwardly protruding portion and an inwardly protruding portion; the outwardly protruding portion and the inwardly protruding portion having a same length along the axial direction (see annotated Figure 1);
the outwardly protruding portion protruding radially outwardly relative to the outer surface of the extension portion; the inwardly protruding portion protruding radially inwardly relative to the inner surface of the extension portion (see annotated Figure 1);
and an entirety of the distalmost end portion of the tube-shaped member that is on a distal side of a most distal end of the extension portion having a maximum outer diameter greater than an outer diameter of the most distal end of the extension portion (see Figure 1).
Regarding claim 8, Wijay teaches the tube- shaped member comprises: a tube (26)_having a distal end and a proximal end; a distal end tip fixed to the distal end of the tube; and a hub (106) fixed to the proximal end of the tube.
Regarding claim 9, Wijay teaches the distalmost end portion and the extension portion together constitute the distal end tip that is fixed to the distal end of the tube (Figure 1).
Regarding claim 10, Wijay teaches the distalmost end portion of the tube-shaped member and the extension portion of the tube-shaped member are made of the same material (nylon, at different hardness “Typically, by example and not by way of limitation, the tip T can be in the range of 50 -90A hardness as measured by the Shore method and can be made from a material such as nylon. The inner body member I, by example and not by way of limitation, can be made of a stiffer grade of nylon such as approximately 140 on the Rockwell scale. Page 14, lines 16-25).
Regarding claim 11, Wijay teaches wherein the entirety of the axial extent of the distalmost end entirety of the axial extent of the distalmost end portion of the tube-shaped member includes the inwardly protruding portion that protrudes radially inwardly relative to the inner surface of the extension portion (see annotated Figure 1).
Regarding claim 12, Wijay teaches the tube-shaped member (26) comprises: a tube (26) having a distal end and a proximal end; and a distal end tip fixed to the distal end of the tube, the distalmost end portion of the tube-shaped member that includes the protruding portion being a part of the distal end tip (See annotated Figure 1).
Regarding claim 13, Wijay teaches wherein the distalmost end portion of the tube-shaped member having the outwardly protruding portion (see annotated figure 1) has a radially outwardly facing outer peripheral surface and an axially facing distal end surface that faces away from the extension portion, the radially outwardly facing outer peripheral surface of the distalmost end portion of the tube-shaped member (outer distal end of tube 26) and the axially facing distal end surface (surface of T contacting 26) of the distalmost end portion of the tube-shaped member intersecting one another at a rounded corner (see Figure 1).
Regarding claim 14, Wijay teaches a distal portion of the tube-shaped member is curved (tube 16 is curved).
Regarding claim 16 Wijay teaches A catheter having a hollow shape, the catheter comprising: an outward protruding portion provided at a distalmost end portion and protruding outward in a radial direction (see annotated figure 1); and an inward protruding portion provided at the distalmost end portion and protruding inward in the radial direction ((see annotated figure 1) an extension portion (see annotated figure 1) having a most distal end, the extension portion having an outer surface and an inner surface;
a distalmost end portion having an axial extent extending in an axial direction from a most distal end of the distalmost end portion to a most proximal end of the distalmost end portion, the distalmost end portion being distal of the extension portion such that the most distal end of the extension portion is immediately proximal of the most proximal end of the distalmost end portion (see Figure 1);
the distalmost end portion and the extension portion together constituting a distal end tip of the catheter, the distal end tip having a central axis; (see Figure 1);
an outward protruding portion (see annotated figure 1) provided at the distalmost end portion and protruding outwardly in a radial direction relative to the outer surface of the extension portion; an inward protruding portion provided at the distalmost end portion and protruding inwardly in the radial direction relative to the inner surface of the extension portion (see annotated figure 1);
the outward protruding portion and the inward protruding portion having the same length along the axial direction (see annotated figure 1); and
an entirety of the axial extent of the distalmost end portion, from the most distal end of the distalmost end portion to the most proximal end of the distalmost end portion, being symmetrical about a plane extending in the axial direction and containing the central axis of the distal end tip of the catheter (the outer and inner protruding portions are symmetrical about a plane extending and containing the central axis, See figure 1).
Regarding claim 17, Wijay teaches wherein the catheter is an elongated tube-shaped member that includes a tube having a distal end, the distal end tip being connected to the distal end of the tube (see Figure 1).
Regarding claim 18, Wijay teaches a distal end portion of the outward protruding portion has a rounded shape (the distal end of T is rounded).
Regarding claim 19, Wijay teaches a distal end portion of the inward protruding portion has a rounded shape (the distal end of T is rounded).
Regarding claim 20, Wijay teaches the catheter satisfies a relational expression of D1 > D2, d1< d2, and T1>T2 (see Figure 1)
D1 is a maximum outer diameter of the distalmost end portion (outer diameter of T),
d1 is a minimum inner diameter of the distalmost end portion,
T1 is a maximum thickness of the distalmost end portion,
D2 is an outer diameter of a proximal portion (outer diameter of the extension portion) provided on a proximal end side with respect to the distalmost end portion,
d2 is an inner diameter of the proximal portion, and
T2 is a thickness of the proximal portion
Regarding claim 21, Wijay teaches the catheter satisfies a relational expression of D1>D2, and d1<d2, wherein
D1 is an outer diameter of the distalmost end portion of the tube-shaped member (outer diameter of T is larger than the outer diameter of the extension portion, see figure 1),
d1 is an inner diameter of the distalmost end portion of the tube-shaped member (the inner diameter of T, is smaller than the inner diameter of the extension portion see annotated figure 1),
D2 is an outer diameter of the extension portion of the tube-shaped member and d2 is an inner diameter of the extension portion of the tube-shaped member (see annotated Figure 1).
Regarding claim 22, Wijay teaches the catheter satisfies the following relationships: D1>D2, and d1<d2, wherein D1 is a maximum outer diameter of the distalmost end portion of the tube-shaped member (outer diameter of T), d1 is a minimum inner diameter of the distalmost end portion of the tube-shaped member (inner diameter of T), D2 is an outer diameter of the extension portion of the tube-shaped member, and d2 is an inner diameter of the extension portion of the tube-shaped member (See annotated Figure 1) .
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) 6 and 15 s/are rejected under 35 U.S.C. 103 as being unpatentable over Wijay in view of AAzam et al. (WO 95/15780) hereinafter Aazam.
Regarding claim 6, Wijay teaches D1>D2, and T1>T2, where
D1 is an outer diameter of the distalmost end portion,
D2 is an outer diameter of a portion of the tube-shaped member that is the immediately proximal of the extension portion of the tube-shaped member,
T1 is a maximum thickness of the distalmost end portion,
And T2 is a thickness of the portion of the tube-shaped member that is immediately proximal of the extension portion of the tube-shaped member.
But fails to explicitly disclose d1<d2 where
d1 is the inner diameter of the distalmost end portion, and
d2 is the an inner diameter of the portion of the tube-shaped member that is immediately proximal of the extension portion of the tube-shaped member.
AAzam r teaches a distalmost end portion (30), with an inner diameter (diameter, at the distalmost end of 30) that is smaller than the inner diameter of a tube shaped portion 52. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a smaller inner diameter in the distalmost end portion of Wijay as taught by AAZAM, for flow control.
Regarding claim 15, Wijay teaches D1>D2, and T1>T2, where
D1 is an outer diameter of the distalmost end portion,
D2 Is an outer diameter of the tube shaped member immediately adjacent the proximal end of the extension portion,
T1 is a maximum thickness of the distalmost end portion,
T2 is a thickness of the tube-shaped member immediately adjacent most proximal end of the extension portion.
But fails to explicitly disclose d1<d2 where
d1 is the inner diameter of the distalmost end portion, and
d2 is an inner diameter of the tube shaped member immediately adjacent most proximal end of the extension portion.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a smaller inner diameter in the distalmost end portion of Wijay as taught by AAZAM, for flow control.
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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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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