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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 02, 2026 has been entered.
Response to Amendment
2. Applicant's amendments, filed January 02, 2026 are respectfully acknowledged and have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed January 02, 2026 and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 10, 15, and 19 are amended.
Claims 1-20 are pending.
Claim Rejections - 35 USC § 112
The amendments to Claim 19 addressing 35 U.S.C. 112(b) issues are respectfully acknowledged, and the corresponding rejection of Claim 19 is withdrawn.
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 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Martin et al. (U.S. Patent Application 20200030583 A1, hereinafter “Martin”) in view of Keach et al. (U.S. Patent Application 20170119365 A1, hereinafter “Keach”).
Regarding Claim 1 (Currently Amended), Martin teaches a guidewire (par 0071 Fig 2A guidewire 100) comprising:
an elongated core with a proximal end, a distal end (paras 0014,0018,0038 Fig 2A elongated core/body 102 of guidewire extending between a proximal portion and a distal portion), and a length extending along a longitudinal axis therebetween (par 0077 Fig 12A the guidewire body 102 extends longitudinally); and
a three-dimensional atraumatic tip disposed at the distal end of the elongated core (par 0087 Figs 5A,B guidewire 100 comprises a compliant member 104 including a three-dimensional [par 0092] atraumatic tip 108 at the distal end of the elongated core [par 0076])
wherein the three-dimensional atraumatic tip is permanently affixed to the elongated core and is incapable of detachment from the elongated core during use (par 0072 Fig 2B a portion of the elements forming the compliant structure 104 continuously extend along a section 106 of the guidewire body; the parts may be fixed by welding, glue, soldering, crimping, etc. paras 0080,0081), wherein
the three-dimensional atraumatic tip is configured to collapse toward the elongated core be axially ssible so as to absorb axial ssion when an axial force such as encountered in the advancement of endovascular devices [over the compliant structure 104]), and wherein
the three-dimensional atraumatic tip is dimensioned and configured to avoid exerting sustained radial force sufficient to occlude a lumen or cavity (par 0086 Fig 5B the compliant structure’s compressibility maximizes the atraumatic interaction if it were to be inadvertently advanced into the vessel wall; par 0015 Fig 5B compliant structure 104 and atraumatic tip 108 are made to be fluid permeable to allow fluid flow therethrough).
However, Martin appears not to expressly teach
the three-dimensional atraumatic tip is configured to collapse toward the elongated core during withdrawal without engaging or anchoring to surrounding tissue.
Keach teaches a similar guidewire wherein
the three-dimensional atraumatic tip is configured to collapse toward the elongated core during withdrawal without engaging or anchoring to surrounding tissue
(par 0031 Fig 6 the guidewire, following deployment, deforms with the application of a retraction force F; par 0032 the needle is reintroduced through the fenestration and the guidewire 20 is retracted/withdrawn into the delivery device and back to the collapsed [toward the elongated core] configuration).
Martin and Keach are analogous art as they each pertain to guidewires with atraumatic tips. It would have been obvious to a person of ordinary skill in the art to modify the guidewire with atraumatic tip of Martin with the inclusion of the configuration to collapse toward the elongated core during withdrawal of Keach. The motivation would have been in order to allow the guidewire to be removed in a small diameter form (Keach par 0031).
Regarding Claim 2 (Original), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip comprises a spherical shaped coil of wire (Martin par 0092 Fig 6A the tip portion 108 can comprise a spherical profile 142).
Regarding Claim 3 (Previously Presented), Martin as modified teaches the guidewire of claim 2, wherein
the spherical shaped coil of wire has a diameter at least two times the thickness of the elongated core (Martin par 0073 Fig 6A the structure 104/tip portion 108 can comprise a spherical profile 142 diameter of 1-4 mm, which is greater than 2x the elongated core diameter of 0.016” = 0.41mm).
Regarding Claim 4 (Original), Martin as modified teaches the guidewire of claim 2, wherein
the spherical shaped coil of wire has a thickness and a diameter at least four times the thickness of the elongated core (Martin par 0073 Fig 6A the structure 104/tip portion 108 can comprise a spherical profile 142 diameter of 4 mm, which is greater than 4x the elongated core diameter of 0.016” = 0.41mm).
Regarding Claim 5 (Original), Martin as modified teaches the guidewire of claim 2, wherein
the spherical shaped coil of wire has a thickness and a diameter at least ten times the thickness of the elongated core (Martin par 0073 Fig 6A the structure 104/tip portion 108 can comprise a spherical profile 142 diameter of 4 mm, which is greater than 10x the minimum taught elongated core diameter of 0.010” = 0.25mm).
Regarding Claim 6 (Original), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip comprises an oblong shaped coil of wire (Martin par 0075 Fig 6A the tip portion 108 can comprise an egg- or football-shape).
Regarding Claim 7 (Original), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip comprises an umbrella shaped coil of wire (Martin par 0092 Fig 6D teaches a conical [partially closed umbrella] shape formed of coil turns that diverge radially outward from the elongated core; other umbrella-shaped guidewire tips are known, see e.g. Sperry 20170196577 A1).
Regarding Claim 8 (Original), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip comprises a three-dimensional coil of wire (Martin par 0092 Fig 6A the tip portion 108 can comprise a spherical coil of wire 142).
Regarding Claim 9 (Original), Martin as modified teaches the guidewire of claim 2, further comprising
a sheath, at least one of the elongated core and the atraumatic tip disposed within the sheath prior to deployment (Martin par 0093 teaches use of a standard guidewire with atraumatic tip; par 0071 guidewire 100 may be positioned within a catheter/sheath that would apply a constraining force on the compliant structure 104; when advanced from the distal end of the catheter/sheath, the compliant structure 104 assumes its expanded profile).
Regarding Claim 10 (Currently Amended), Martin teaches a method of a guidewire (par 0087 Fig 5A method of using a guidewire 100 deployed through a microcatheter 12), the method comprising:
providing the guidewire (par 0089 a physician provides a guidewire),
the guidewire comprising
an elongated core with a proximal end, a distal end (paras 0014,0018,0038 Fig 2A elongated core/body 102 of guidewire extending between a proximal portion and a distal portion), and a length extending along a longitudinal axis therebetween (par 0077 Fig 12A the guidewire body 102 extends longitudinally) and
a three-dimensional atraumatic tip disposed at the distal end of the elongated core (par 0087 Figs 5A,B guidewire 100 comprises a compliant member 104 including a three-dimensional [par 0092] atraumatic tip 108 at the distal end of the elongated core [par 0076]), the three-dimensional atraumatic tip being permanently affixed to the elongated core and incapable of detachment therefrom during use (par 0072 Fig 2B a portion of the elements forming the compliant structure 104 continuously extend along a section 106 of the guidewire body; the parts may be fixed by welding, glue, soldering, crimping, etc. paras 0080,0081),
at least one of the elongated core and the atraumatic tip disposed within a sheath prior to deployment of the elongated core and the atraumatic tip (par 0093 Fig 5A teaches use of a standard guidewire with atraumatic tip; par 0071 guidewire 100 may be positioned within a catheter/sheath that would apply a constraining force on the compliant structure 104; when advanced from the distal end of the catheter/sheath, the compliant structure 104 assumes its expanded profile); and
deploying the elongated core and the atraumatic tip (par 0071 Fig 5A advancing the core and tip such that the tip is advanced from the distal end of the catheter/sheath and the compliant structure 104 assumes its expanded profile),
wherein deploying comprises advancing the guidewire through vasculature for atraumatic navigation (par 0019 Fig 5A advancing the catheter/sheath with guidewire, and then the guidewire from the sheath, through vasculature for atraumatic navigation) and subsequently withdrawing the guidewire from the vasculature (par 0093 Fig 5A teaches use of a standard guidewire with atraumatic tip; par 0012 teaches withdrawal of the standard guidewire [with atraumatic tip]), wherein
the three-dimensional atraumatic tip is not detached, implanted, or left within the body (par 0072 Fig 2B a portion of the elements forming the compliant structure 104 continuously extend along a section 106 of the guidewire body; the parts may be fixed by welding, glue, soldering, crimping, etc. paras 0080,0081; Martin discusses at par 0093 Fig 5A use of a standard guidewire with atraumatic tip, and par 0012 teaches standard guidewire usage including withdrawal of the standard guidewire [and its non-detachable atraumatic tip]), and wherein
the three-dimensional atraumatic tip is configured to collapse toward the elongated core within the delivery device or sheath (par 0086 Fig 5A the atraumatic tip 108 of the compliant structure 104, or the entire compliant structure 104 may be configured to be axially ssible so as to absorb axial ssion when an axial force such as encountered in the advancement of endovascular devices [over the compliant structure 104]) without exerting sustained radial force sufficient to occlude a lumen or cavity (par 0086 Fig 5B the compliant structure’s compressibility maximizes the atraumatic interaction if it were to be inadvertently advanced into the vessel wall; par 0015 Fig 5B compliant structure 104 and atraumatic tip 108 are made to be fluid permeable to allow fluid flow therethrough).
However, Martin appears not to expressly teach
the three-dimensional atraumatic tip is configured to collapse toward the elongated core during withdrawal without engaging or anchoring to surrounding tissue.
Keach teaches a similar guidewire wherein
the three-dimensional atraumatic tip is configured to collapse toward the elongated core during withdrawal without engaging or anchoring to surrounding tissue
(par 0031 Fig 6 the guidewire, following deployment, deforms with the application of a retraction force F; par 0032 the needle is reintroduced through the fenestration and the guidewire 20 is retracted/withdrawn into the delivery device and back to the collapsed [toward the elongated core] configuration).
Martin and Keach are analogous art as they each pertain to methods of guidewires with atraumatic tips. It would have been obvious to a person of ordinary skill in the art to modify the method of Martin with the inclusion of the configuration to collapse toward the elongated core during withdrawal of Keach. The motivation would have been in order to allow the guidewire to be removed in a small diameter form (Keach par 0031).
Regarding Claim 11 (Original), Martin as modified teaches the method of claim 10, wherein
the three-dimensional atraumatic tip comprises a spherical shaped coil of wire (Martin par 0092 Fig 6A the tip portion 108 can comprise a spherical profile 142).
Regarding Claim 12 (Original), Martin as modified teaches the method of claim 10, wherein
the three-dimensional atraumatic tip comprises an oblong shaped coil of wire (Martin par 0075 Fig 6A the tip portion 108 can comprise an egg- or football-shape).
Regarding Claim 13 (Original), Martin as modified teaches the method of claim 10, wherein
the three-dimensional atraumatic tip comprises an umbrella shaped coil of wire (Martin par 0092 Fig 6D teaches a conical [partially closed umbrella] shape formed of coil turns that diverge radially outward from the elongated core; other umbrella-shaped guidewire tips are known, see e.g. Sperry 20170196577 A1).
Regarding Claim 14 (Original), Martin as modified teaches the method of claim 10, further comprising
retracting the elongated core and the atraumatic tip (Martin discusses at par 0093 Fig 5A use of a standard guidewire with atraumatic tip, and par 0012 teaches standard guidewire usage including withdrawal of the standard guidewire [and its non-detachable atraumatic tip]).
Regarding Claim 15 (Currently Amended), Martin teaches a 3-D protective structure comprising:
a three-dimensional atraumatic structure (par 0087 Figs 5A,B compliant member 104 including a three-dimensional [par 0092] atraumatic tip 108),
the three-dimensional atraumatic structure configured to be attached to a medical device at a distal end of the medical device to protect a patient from having the medical device cause trauma to a structure within the body of the patient (par 0087 Figs 5A,B medical device comprising guidewire 100 comprises an attached compliant member 104 including a three-dimensional [par 0092] atraumatic tip 108 at the distal end of the elongated core of the medical device/guidewire [par 0076]; par 0086 compressibility allows the compliant structure to maximize the atraumatic interaction if it were to be inadvertently advanced into the vessel wall),
wherein the three-dimensional atraumatic structure is permanently affixed to the medical device and incapable of detachment therefrom during use (par 0072 Fig 2B a portion of the elements forming the compliant structure 104 continuously extend along a section 106 of the guidewire body; the parts may be fixed by welding, glue, soldering, crimping, etc. paras 0080,0081), wherein
the three-dimensional atraumatic structure is not an implantable medical device and is configured to be removed from the body together with the medical device after completion of a procedure (par 0072 Fig 2B a portion of the elements forming the compliant structure 104 continuously extend along a section 106 of the guidewire body; the parts may be fixed by welding, glue, soldering, crimping, etc. paras 0080,0081; Martin discusses at par 0093 Fig 5A use of a standard guidewire with atraumatic tip, and par 0012 teaches standard guidewire usage including withdrawal of the standard guidewire [and its non-detachable atraumatic tip]), and wherein
the three-dimensional atraumatic structure is configured to collapse or deform within the delivery device or sheath (par 0086 Fig 5A the atraumatic tip 108 of the compliant structure 104, or the entire compliant structure 104 may be configured to be axially ssible so as to absorb axial ssion when an axial force such as encountered in the advancement of endovascular devices [over the compliant structure 104]) without exerting sustained radial force sufficient to occlude a lumen or cavity (par 0086 Fig 5B the compliant structure’s compressibility maximizes the atraumatic interaction if it were to be inadvertently advanced into the vessel wall; par 0015 Fig 5B compliant structure 104 and atraumatic tip 108 are made to be fluid permeable to allow fluid flow therethrough).
However, Martin appears not to expressly teach
the three-dimensional atraumatic tip is configured to collapse or deform during withdrawal.
Keach teaches a similar guidewire wherein
the three-dimensional atraumatic tip is configured to collapse or deform during withdrawal (par 0031 Fig 6 the guidewire, following deployment, deforms with the application of a retraction force F; par 0032 the needle is reintroduced through the fenestration and the guidewire 20 is retracted/withdrawn into the delivery device and back to the collapsed [toward the elongated core] configuration).
Martin and Keach are analogous art as they each pertain to guidewires with atraumatic tips. It would have been obvious to a person of ordinary skill in the art to modify the guidewire with atraumatic tip of Martin with the inclusion of the configuration to collapse toward the elongated core during withdrawal of Keach. The motivation would have been in order to allow the guidewire to be removed in a small diameter form (Keach par 0031).
Regarding Claim 16 (Previously Presented), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip is formed as an umbrella-shaped coil having coil turns that diverge radially outward from the elongated core (Martin par 0092 Fig 6D teaches a conical [partially closed umbrella] shape formed of coil turns that diverge radially outward from the elongated core).
Regarding Claim 17 (Previously Presented), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip is compressed within a delivery sheath and configured to self-expand to a spherical configuration upon release from the sheath (par 0093 Fig 5A teaches use of a standard guidewire with atraumatic tip; par 0071 guidewire 100 may be positioned within a catheter/sheath that would apply a constraining force on the compliant structure 104; when advanced from the distal end of the catheter/sheath, the compliant structure 104 assumes its expanded profile; par 0092 Fig 6A the tip portion 108 can comprise a spherical profile 142).
Regarding Claim 18 (Previously Presented), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip is constructed from a superelastic nickel-titanium alloy coil configured to repeatedly deform during advancement and recover its pre-biased three-dimensional shape (Martin par 0082 Fig 2A wires of the compliant structure 104 [comprising the three-dimensional atraumatic tip] or the body 102 may comprise a shape memory or superelastic alloy [par 0085 Nitinol nickel-titanium alloy] to impart predetermined shapes or resiliency to the device).
Regarding Claim 19 (Currently Amended), Martin as modified teaches the guidewire of claim 2, wherein
the three-dimensional atraumatic tip includes at least one radiopaque marker disposed on the coil of wire to facilitate fluoroscopic visualization during positioning (Martin par 0083 the compliant structure 104 or the guidewire body 102 may include a number of radiopaque wires [to serve as markers] or improved visibility under fluoroscopic imaging).
Regarding Claim 20 (Previously Presented), Martin as modified teaches the guidewire of claim 1, wherein
the three-dimensional atraumatic tip has a diameter at least four times greater than the diameter of the elongated core when in its expanded configuration (Martin par 0073 Fig 6A the structure 104/tip portion 108 can comprise a spherical profile 142 diameter of 4 mm, which is greater than 4x the elongated core diameter of 0.016” = 0.41mm).
Response to Arguments
Applicant's arguments filed January 02, 2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to claims 1, 10, and 15 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.
As such, the rejections of independent Claims 1, 10, and 15 are maintained, as are those of claims dependent on Claims 1, 10, and 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK EDWARDS whose telephone number is (571)270-7731. The examiner can normally be reached on Mon-Fri 9a-5p EST.
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/MARK EDWARDS/Primary Examiner, Art Unit 2624