DETAILED ACTION
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
The Applicant argues that Burkett fails to disclose a grip portion that is made from a material that is heat shrinkable and further argues that Burkett fails to disclose where the cutouts are formed within the polymer tube prior to being applied to the core wire.
The Examiner disagrees and respectfully submits that Burkett discloses where the material of the grip portion is heat shrinkable (col. 6, lines 51-54) (also see col. 3, lines 46-58, the grip portion, e.g., coating 76, is explicitly described as capable of being reduced in size upon the application of heat). Furthermore, it is noted that PTFE, a material choice disclosed by Burkett (col. 9, lines 46-61), is a known material that can be heat shrunk.
Furthermore, the prior art of Burkett discloses the same structure as claimed: a core wire with a polymer tube attached thereto having cutouts through the sidewall forming a grip pattern. The Applicant’s specification acknowledges at paragraph [0050] that the cutouts may be formed either before or after the polymer tube is applied to the core wire, treating both as equivalent embodiments. Because the present claims are apparatus claims, any process limitation reciting how the cutouts are formed is non-limiting. Per MPEP 2113 “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
The prior art of Burkett and the claimed invention result in structurally identical products, e.g., a polymer tube with cutouts disposed on a guidewire core. The Applicant has provided no evidence of a structural distinction. The claims are therefore anticipated regardless of when the cutouts were formed relative to the assembly.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6,18-20, 22-26, and 28-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8613712 B1 to Burkett et al. (hereinafter, Burkett).
Regarding Claims 1-7 and 18-30, Burkett discloses a guidewire (guidewire 66, FIG. 7, col. 6, lines 25-54), comprising inter alia:
an elongate core wire (wire core 68) including a distal end, a proximal end (indicated in annotated Fig. 7, below), and a longitudinal axis extending along a length of the core wire from the distal end to the proximal end (indicated by dotted line in annotated FIG. 7, below), the core wire including a distal portion extending proximally from the distal end and a proximal portion extending distally from the proximal end (indicated in annotated Fig. 7, below), the distal portion including a distal profile and the proximal portion including a proximal profile (col. 6, lines 36-39 “…straight profile or tapered profile of the wire core 68), the distal profile being smaller than the proximal profile (note that the wire core 68 tapers from the proximal end to distal end along the proximal portion and distal portions, the distal portion becoming a smaller profile as compared to the proximal portion); and
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a grip portion (coating 76) disposed at least partially along the proximal portion of the core wire profile (col. 6, lines 36-39 “…the coating 76 generally follows the straight profile or tapered profile of the wire core 68), the grip portion includes a heat shrinkable (col. 6, lines 51-54) (also see col. 3, lines 46-58, the grip portion, e.g., coating 76, is explicitly described as capable of being reduced in size upon the application of heat) polymer tube applied to the core wire (col. 9, lines 18-28 “…coating … is polyurethane polymer, although, any polymer that meets design requirements can be used… as shown in FIG. 7…”), the polymer tube including a sidewall extending between first and second ends of the polymer tube (col. 6, lines 39-41 “…a thickness of the coating that is generally uniform…”), a plurality of cutouts (divots 78) at least partially through the sidewall of the polymer tube (col. 6, lines 41-44 “… the depths of the divots may … to a through hole exposing the wire core surface…”), and at least one bridging section between individual cutouts of the plurality of cutouts (as indicated by the boxed portions in annotated FIG. 7, below, the continuous rings around the polymer tube located between each of the sections), the plurality of cutouts disposed within the sidewall of the polymer tube forming a cut pattern of the grip portion, the grip portion configured to provide tactile feel to a user of the guidewire (the divots 78 in the coating 76 are form a pattern and are capable of providing tactile feel to a user of the guidewire, because the divot holes would have been capable of being felt in relation to the smooth outer surface of the coating 76);
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wherein each of the plurality of cutouts extends entirely through the sidewall of the polymer tube (col. 6, lines 41-44 “… the depths of the divots may … to a through hole exposing the wire core surface…”);
wherein the polymer tube includes a heat shrinkable polymer tube (col. 9, lines 18-28 “…coating … is polyurethane polymer, although, any polymer that meets design requirements can be used… as shown in FIG. 7…”) (col. 3, lines 40-42 “…heating and extruding a polymer through a die to adhere to at least a portion of the elongated core to create a polymer coating…”);
wherein the plurality of cutouts includes laser cut cutouts through the sidewall of the polymer tube (col. 3, lines 46-49 “…localized heating of the polymer coating to create the surface texture … may originate from a laser…”);
wherein the bridging section forms a continuous ring around the polymer tube configured to maintain a shape of the polymer tube (as indicated by the boxed portions in annotated FIG. 7, above, the continuous rings around the polymer tube located between each of the sections);
wherein the grip portion includes at least one bridging section between individual cutouts of the plurality of cutouts, the bridging section forming a continuous ring around the polymer tube configured to maintain a shape of the polymer tube (as indicated by the boxed portions in annotated FIG. 7, above, the continuous rings around the polymer tube located between each of the sections); and
a coating disposed over an outer surface of the polymer tube of the grip portion (col. 9, lines 46-61 “..one or more layers…”).
Burkett discloses the claimed invention except for expressly disclosing where the at least one cutout is formed within the polymer tube prior to the polymer tube being applied to the core wire. However, the prior art of Burkett discloses the same structure as claimed: a core wire with a polymer tube attached thereto having cutouts through the sidewall forming a grip pattern. The Applicant’s specification acknowledges at paragraph [0050] that the cutouts may be formed either before or after the polymer tube is applied to the core wire, treating both as equivalent embodiments. Because the present claims are apparatus claims, any process limitation reciting how the cutouts are formed is non-limiting. Per MPEP 2113 “The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.”
The prior art of Burkett and the claimed invention result in structurally identical products, e.g., a polymer tube with cutouts disposed on a guidewire core. The Applicant has provided no evidence of a structural distinction. The claims are therefore anticipated regardless of when the cutouts were formed relative to the assembly.
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.
Claim(s) 7, 21 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkett in view of US 20070249964 A1 to Richardson et al. (hereinafter, Richardson).
Burkett discloses the claimed invention except for expressly disclosing where the polymer tube is at least partially formed from Estane material. However, Richardson teaches a guidewire having a core member coated with a polymer layer (paragraph [0103]). Richardson teaches that the polymer layer may be a Estane material (paragraph [0129] “polyurethane thermoplastic”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the polymer tube of Burkett to the be Estane material of Richardson, as Richardson teaches in paragraph [0129] that a polyurethane thermoplastic would be a “suitable polymer” for covering a core member.
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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791