DETAILED ACTION
Response to Amendment
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) 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pereira et al. (US 2017/0291013; hereafter Pereira).
In regard to claim 1, Pereira discloses a resin-coated wire (10), the resin-coated wire comprising: a wire (20); and a coating (i-34; see par. [0058]; ii-see “fluoropolymer coating” in par. [0051]; iii- see “hydrophobic coating” in par. [0065]) made of resin coating the wire, wherein the coating includes: a distal end coating formed of a first resin material and coating a first part that includes a distal end portion of the wire (see coating i discussed directly above- 34 includes the distal end portion); and a proximal end coating (see coatings ii) formed of a second resin material and coating a second part adjacent to a proximal end side of the first part of the wire (coil 30 is proximal to distal polymer tip 34; see at least Fig. 1), and wherein the distal end coating and the proximal end coating form a continuous longitudinal layer of resin directly on the wire (see Fig. 1; the coating on the wire 30 abuts the coating 34 in the same manner as the applicant’s coatings and therefore can be considered continuous), and the first resin material of the distal end coating has a higher affinity for water than the second resin material of the proximal end coating (coating i is made of hydrophilic polymer while coating ii is made of hydrophobic material; see par. [0051], [0058]).
In regard to claim 2, Pereira discloses wherein the wire is a rope wire formed by spirally winding a plurality of fine wires (see par. [0055]; 30 can be of a multi-filar configuration; such a configuration can be considered a rope).
In regard to claim 3, Pereira discloses wherein each of the plurality of fine wires is a stranded wire formed by spirally winding a plurality of strands (see par. [0055]; 30 can be of a multi-filar configuration).
In regard to claim 4, Pereira discloses, wherein the first resin material permeates a distal end part of the second part of the wire (see par. [0058]).
In regard to claim 5, Pereira discloses wherein a most distal end portion of the resin-coated wire has an approximate hemisphere shape forming a projection toward a distal end (see rounded end of 34 in Fig. 1 which is approximately hemisphere; see also embodiment in Fig. 3).
In regard to claim 6, Pereira discloses wherein the resin-coated wire includes: a most distal end portion (34); an intermediate portion (22) adjacent to a proximal end side of the most distal end portion and having a taper shape with an outer diameter reduced toward the distal end (portions of 24 can be included in the interpretation of “intermediate”; portions 24 tapers distally; see par. [0047]; see Fig. 1); and a proximal end portion (proximal portion of 22 including 26) adjacent to a proximal end side of the intermediate portion and having an approximately constant outer diameter (various portions of this area have a constant diameter; see Fig. 1).
In regard to claim 7, Pereira discloses wherein a part (the first part can be interpreted as including a thicker portion of 22) formed of the first part of the wire has higher rigidity than that of a part formed of the second part (the second part can be interpreted as a narrowed tapered portion of 26) of the wire (the thicker first part will have a higher rigidity than a narrowed portion).
In regard to claim 8, Pereira discloses wherein a most distal end portion of the resin-coated wire has an approximate hemisphere shape forming a projection toward a distal end (see rounded end of 34 in Fig. 1 which is approximately hemisphere; see also embodiment in Fig. 3).
In regard to claim 9, see the rejection of claim 6 as substantially similar subject matter is recited.
In regard to claim 10, see the rejection of claim 7 as substantially similar subject matter is recited.
In regard to claim 11, see the rejection of claim 4 as substantially similar subjected matter is recited.
In regard to claim 12, Pereira discloses wherein the first resin material is hydrophilic and the second resin material is hydrophobic (coating i is made of hydrophilic polymer while coatings ii is made of hydrophobic material; see par. [0051], [0058]).
In regard to claim 13, Pereira discloses wherein the first resin material is hydrophilic and the second resin material is hydrophobic (coating i is made of hydrophilic polymer while coatings ii is made of hydrophobic material; see par. [0051], [0058]).
In regard to claim 14, Pereira discloses wherein a most distal end portion (34) of the resin-coated wire has an approximate hemisphere shape forming a projection toward a distal end (see rounded end of 34 in Fig. 1 which is approximately hemisphere; see also embodiment in Fig. 3).
In regard to claim 15, Pereira discloses wherein the resin-coated wire includes: a most distal end portion (34); an intermediate portion (22) adjacent to a proximal end side of the most distal end portion and having a taper shape with an outer diameter reduced toward the distal end (portions of 24 can be included in the interpretation of “intermediate”; portions 24 tapers distally; see par. [0047]; see Fig. 1); and a proximal end portion (proximal portion of 22 including 26) adjacent to a proximal end side of the intermediate portion and having an approximately constant outer diameter (various portions of this area have a constant diameter; see Fig. 1).
In regard to claim 16, Pereira discloses wherein a part (the first part can be interpreted as including a thicker portion of 22) formed of the first part of the wire has higher rigidity than that of a part formed of the second part (the second part can be interpreted as a narrowed tapered portion of 26) of the wire (the thicker first part will have a higher rigidity than a narrowed portion).
In regard to claim 17, Pereira discloses wherein the first resin material is hydrophilic and the second resin material is hydrophobic (coating i is made of hydrophilic polymer while coatings ii is made of hydrophobic material; see par. [0051], [0058]).
In regard to claim 18, Pereira discloses a drug solution injection device comprising: the resin-coated wire according to claim 1 (see rejection of claim 1); and the catheter (see par. [0003]).
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(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Pereira in view of Rosenberg et al. (US 2009/0062602; hereafter Rosenberg).
In regard to claim 19, Pereira fails to disclose further comprising a controller configured to advance the resin-coated wire inside the catheter.
In a similar art, Rosenberg discloses a motor-driven controller in the form an instrument driver 3120, wherein the instrument driver is used to advance a guidewire, sheath, or catheter (see par. [0137]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pereira with the instrument driver of Rosenberg in order to provide a means for advancing the guidewire within the body.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Pereira in view of Noone et al. (US 5,916,178; hereafter Noone).
In regard to claim 20, Pereira discloses wherein the distal end coating (34) coats a tapered portion of the wire (see Fig. 1) and the proximal end coating (30) coats at least part of the tapered portion and a straight portion (28a; see Fig.1 and par. [0047]; each step has a straight portion) but Pereira fails to disclose wherein the distal end coating coats a welded portion because Pereira does not disclose a welded portion.
In a similar art, Noone discloses a guidewire (20) comprising a tip 40 welded to the distal end of the core wire 25. The tip 40 can be made of radiopaque materials such as epoxy loaded with tantalum so that the physician can visualize the distal portion under fluoroscopy. The welded blunt tip also reduces trauma to the blood vessel. The tip is positioned under a distal end coating (95).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pereira with the welded blunt tip as taught by Noone in order to provide an alternate means for radiopacity to the guidewire and reduce the risk of trauma to the patient. The blunt tip is also taught as being positioned under a distal end coating so there is a reasonable expectation of success in making the combination.
Response to Arguments
Applicant's arguments filed 6/17/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Pereira fails to disclose or suggest a coating directly on the wire, the examiner respectfully disagrees. The applicant argues (see page 8 of the Remarks) that the fluoropolymer coating does not contact the wire (20). This argument is not persuasive. Figure 1 and par. [0051] disclose that the coil wire (30) includes a coating and Figure 1 clearly shows the coil wire (30) placed directly on the wire (20). Par. [0058] also discloses that the polymer tip (34) can extend up to a position adjacent the shoulder 28a; meaning that the wire coil (30) is positioned directly on the wire (20) in the area of the shoulder (28a).
In response to the applicant’s argument that Pereira fails to disclose a continuous longitudinal resin layer directly on the wire, the examiner respectfully disagrees. The examiner directs the applicant’s attention concerning the “directly” limitation to the response above. The examiner maintains that coil wire (30) and its coating are directly on the wire (20) and thus form the proximal end coating which is continuous with the coating (34). The defined coatings are directly adjacent to each other and are at least partially made of resin and for that reason can be considered a continuous resin layer. The examiner notes that the term “continuous” is not specially defined in the specification and support for the phrase appears to come from the originally filed drawings. Pereira seems to show a substantially similar configuration as that disclosed by the applicant.
In response to the applicant’s argument that Periera does not disclose the required water affinity, the examiner respectfully disagrees. The coating on wire coil (30) is polytetrafluoroethylene which is highly hydrophobic and the coating (34) is hydrophilic (see par. [0058]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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