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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) in the reply filed on 08/27/2026 is acknowledged.
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.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 7-8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Keith et al. (US 5, 888, 436) in view of D1 (EP 2367671 B1) and in further view of Murata (US 2009/0240235 A1).
Regarding claims 1 - 3, Keith et al. teach a sheath (“a method for manufacturing novel composite microtubing with variable stiffness” see abstract; Figs. 1-9), the method comprising:
providing liner (Fig. 1 item 13; see col 3 lines 1-20) having a metal wire disposed therein (Fig 1 item 29-a wire mandrel 29 is supplied from wire mandrel supply 11; col 2 lines 55-65); unrolling at least a portion of the liner from a wire mandrel supply (11) (see col 2 lines 55-65); coiling a reinforcing wire on at least the portion of the liner to form (1) a plurality of coiled wire frames (Fig 1);
and securing a jacket over at least some of the plurality of coiled wire frames and the interim portion of the reinforcing wire coiled on the portion of the liner to form a continuous shaft having the plurality of coiled wire frames (Fig 1 item 22-anotehr resin bath which is a jacket over some of the plurality of coiled wire frames, see Figs. 1-9); and cutting the shaft at desired locations (see claim 1, claim 11).
However, D1 fails to explicitly teach using a first spool for supplying materials (liner) rolled… thereon as claimed.
In the same field of endeavor, pertaining to producing reinforced tubing for medical application, D1 teaches the tubular members can be formed by a continuous process via using spool, as contrasted from the individualized prior art batch process typically used to form the sheaths described above. The inventive method for forming the sheaths is considerably less labor intensive than the prior art methods described herein, resulting in a sheath that can be formed at lower cost when compared to conventional sheaths. In addition, the inventive method utilizes inner and outer layer components that are amenable to the formation of a very reliable bond therebetween (see Figs. 3-4 shows one coating process suitable for use in forming the reinforced tubular member, extruding the inner liner onto mandrel, and then again for coating the outer jacket onto the inner liner following winding of the coil over the liner, item 101-unspooling device comprises a mandrel that is wound onto a conventional spool; The term “mandrel” is used to describe a wire or core that is initially wound around the spool, and that is thereafter unwound to form an inner core in the coating (extrusion process); Fig. 3-4 item 110 spooling device comprises coated mandrel wound onto a spool, 205-coiling mechanism 205, spooling device 206).
It would have been obvious to one ordinary skilled in the art at the time of the Applicant’s invention was made to have modified the batch process as taught by Keith et al. with a continuous process using spool as taught by D1, for the benefit of producing sheath having lower profile when compared to sheaths formed by conventional process.
However, both Keith et al. and D1 fails to teach a plurality of coiled wire frames each having a proximal portion and a distal portion having the reinforcing wire coiled more densely than the proximal portion, and (2) an interim portion of the reinforcing wire coiled between the distal portion of a first wire frame of the plurality of wire frames and a proximal portion of a second wire frame of the plurality of wire frames adjacent to the first wire frame such that the distal portion of the first wire frame is spaced from the proximal portion of the second wire frame.
In the same field of endeavor, pertaining to forming catheter tube, Murata teaches a plurality of coiled wire frames each having a proximal portion and a distal portion having the reinforcing wire coiled more densely than the proximal portion, and (2) an interim portion of the reinforcing wire coiled between the distal portion of a first wire frame of the plurality of wire frames and a proximal portion of a second wire frame of the plurality of wire frames adjacent to the first wire frame such that the distal portion of the first wire frame is spaced from the proximal portion of the second wire frame (see Fig. 4-5 different sections at 5, 51; [0005],[0022],[0024][0108]).
It would have been obvious to one ordinary skilled in the art at the time of the Applicant’s invention was made to modify the process of producing catheter tube as taught by Keith et al. and D1, with having rigidity/flexible balance via varying the braiding, as taught by Murata, for the benefit of producing improved tube with desired flexibility during use (see [0040]). Additionally, Keith et al. also provides suggestions for varying the stiffness across the catheter tube (see Fig. 1 item 18-braider; see col 3 lines 40-65 discloses braiding to form predetermined pattern and thickness of metal ribbon).
As for claim 7, Keith et al. further teaches comprising removing the metal wire from the liner after securing the jacket over the plurality of coiled wire frames and the interim portion of the reinforcing wire coiled on the portion of the liner (col 5 lines 1-15).
As for claim 8, Keith et al. further teaches comprising annealing a segment of the reinforcing wire (Fig. 1 item 23), however, fails to teach such that the segment is between two unannealed regions of the reinforcing wire as claimed. However, since Keith et al. discloses controlling stiffness of the microtubing in different sections (see col 4 lines 30-50), having two unannealed regions would have been obvious to one ordinary skilled in the art for providing similar functional benefit of controlling stiffness rigidity in different sections of the microtubing.
As for claim 13, Keith et al. further teaches wherein annealing (Fig 1 item 23; col 4 lines 30-50), thus the segment of the reinforcing wire reduces the hardness in view of Murata and/or spring constant by at least about 10% in coils of the wire frame that include the segment of reinforcing wire that is annealed relative to the hardness and/or spring constant of coils of the wire frame that include the two unannealed regions would have been obvious.
Allowable Subject Matter
Claims 5 – 6 and 9-12 are objected to because of the following informalities: The closest prior art D1 (EP 2367671 B1), D2 (US 2005-0131387 A1), D3 (US 7905877 B1), D4 (KR 10-2007-0043791), D5 (US 6152912) fail to teach wherein removing at least a portion of the reinforcing wire from the first sheath proximate to the distal portion of the second coiled wire frame includes laser cutting the wire frame about 0.5 mm to about 2 mm from a terminating end of the first sheath; wherein providing of a first spool having a liner rolled thereon includes: providing a silver plated copper wire; disposing the liner on the silver plated copper wire such that the liner has the silver plated copper wire disposed therein; and rolling the liner having the silver plated copper wire disposed therein around the first spool; further comprising unrolling the reinforcing wire from a spool prior to annealing the segment of the reinforcing wire.
Appropriate correction is required.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 7,037,865 B1; US 5,851,464 are pertaining to metal with sheathing for producing reinforced composite hose.
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NAHIDA SULTANA
Primary Examiner
Art Unit 1743
/NAHIDA SULTANA/Primary Examiner, Art Unit 1743