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 .
Applicant’s amendments and remarks filed on 02/06/2026 have been fully considered.
Claims 1-13 and 15 are pending for examination. Claim 14 is cancelled.
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.
Claims 1-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Young (GB 2516718 – applicant cited) in view of LaBelle et al. (USPGPUB 2019/0054277). In regard to claims 1 and 15, Young discloses a method of inserting a catheter into a patient during a medical procedure, (Figs. 1-9 and associated descriptions; vein/ artery, page 15 lines 17-33) comprising: (a) inserting at least one of a needle and a mini-catheter into a blood vessel of a patient (needle or short catheter, page 1 lines 8-11, page 3 lines 31-33 and page 10 lines 1-11; vein/ artery, page 15 lines 17-33); (b) inserting, into the at least one of the needle and the mini-catheter (Fig. 3 and associated descriptions), a guidewire (element 100, Figs. 1-5 and 8-9 and associated descriptions) having (1) a patient-side portion having a first diameter (section 1, Figs. 1-5 and 8-9 and associated descriptions), (2) a doctor-side portion (section 5, Figs. 1-5 and 8-9 and associated descriptions), and (3) an intermediary portion interposed between the patient-side portion and the doctor-side portion (section 3, Figs. 1-5 and 8-9 and associated descriptions), wherein the intermediary potion is S-shaped (Figs. 1, 3, 8B, and 9 and associated descriptions; page 3 lines 18-22; it is noted that the shapes including S-shaped portion(s)) and has an intermediary diameter greater than an inner diameter of the at least one of the needle and the mini-catheter and greater than the first diameter of the patient-side portion (Figs. 1, 3 and 8-9 and associated descriptions); and (c) advancing the patient-side portion of the guidewire in the at least one of the needle and the mini-catheter and into the blood vessel of the patient by pushing axially on the doctor-side portion such that the intermediary portion does not advance into the at least one of the needle and the mini-catheter during the medical procedure (Figs. 3-5 and associated descriptions; “The guidewire 100 is inserted into the patient until the mid-section 3 abuts the needle 11, for example a proximal end of the needle 1 1. The shape or morphology of the mid-section 3 in its original shape or first configuration is configured to inhibit further insertion of the guidewire 100 into the patient, by forming an elbow and/or a change of direction between the first section 1 and the mid-section 3”, page 10 lines 1-11).
Young does not specifically disclose the guidewire is constructed of at least one inner wire surrounded by a coil external to the at least one wire and the at least one inner wire comprises a ribbon wire and a core wire.
LaBelle teaches a guidewire having atraumatic tip (Fig. 2 and associated descriptions) and the guidewire is constructed of at least one inner wire (core wire 24 and a safety ribbon wire, Fig. 2 and associated descriptions; [0005]) surrounded by a coil external to the at least one wire (coil 26, Fig. 2 and associated descriptions; [0005]) and the at least one inner wire comprises a ribbon wire and a core wire (core wire 24 and a safety ribbon wire, Fig. 2 and associated descriptions; [0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the configuration of the atraumatic tip of the guidewire (Young) with the configuration of the atraumatic tip as taught by LaBelle to yield predictable results, since both guidewires are alternative equivalent guidewires utilized for blood vessel related procedures (see both Young and LaBelle). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
In regard to claim 2, Young as modified by LaBelle discloses (d) removing the at least one of the needle and the mini-catheter from the blood vessel of the patient while leaving the guidewire in place by temporarily reducing the diameter of the intermediary portion while the at least one of the needle and the mini-catheter passes over the intermediary portion (Figs. 3-5 and associated descriptions; “The needle 11 is removed by sliding it along the guidewire 100 and over the mid-section 3, for example after having straightened the mid-section 3”, page 10 lines 1-11).
In regard to claim 3, Young as modified by LaBelle discloses temporarily reducing the intermediary diameter of the intermediary portion in step (d) comprises pulling a portion of the guidewire (“after having straightened the mid-section 3”, page 10 lines 1-11; example of the straighten configuration/ the arrow indicated near 500, Fig. 5 and associated descriptions; applying a force, page 5 lines 21 –33; page 10 line 26 – page 11 line 7 of Young).
In regard to claim 4, Young as modified by LaBelle discloses temporarily reducing the intermediary diameter of the intermediary portion in step (d) comprises pushing a portion of the guidewire (“after having straightened the mid-section 3”, page 10 lines 1-11; example of the straighten configuration/ the arrow indicated near 550, Fig. 5 and associated descriptions; applying a force, page 5 lines 21 –33; page 10 line 26 – page 11 line 7 of Young).
In regard to claim 5, Young as modified by LaBelle discloses temporarily reducing the intermediary diameter of the intermediary portion in step (d) comprises twisting a portion of the guidewire (“if the mid-section 3 comprises a kink, straightening the mid-section 3 may comprise "unkinking" the mid-section 3 of the guidewire 100”, page 11 lines 6-7; “the mid-section 3 may be configured to form any one of a helix, a spiral, a curve, a bend, a kink, a coil or any other shape or morphology as shown in Figs. 8A to 8c. It will be understood that the term "kink" may include an axial twist of the guidewire 100, page 12 lines 30-33 of Young).
In regard to claim 6, Young as modified by LaBelle discloses (e) advancing a catheter along the doctor-side portion of the guidewire (element 9, Figs. 4-5 and associated descriptions of Young); (f) temporarily reducing the diameter of the intermediary portion while the catheter passes over the intermediary portion (element 9, Figs. 4-5 and associated descriptions of Young); and (g) inserting a leading tip of the catheter into the blood vessel after temporarily reducing the intermediary diameter of the intermediary portion (Fig. 5 and associated descriptions; “catheter 9 which is to be inserted into the patient”, page 10 lines 18-19; “the operator can slide the catheter 9 over the mid-section 3 of the guidewire 100 and into the patient”, page 10 lines 33-34; vein/ artery, page 15 lines 17-33 of Young).
In regard to claim 7, Young as modified by LaBelle discloses temporarily reducing the intermediary diameter of the intermediary portion in step (f) comprises pulling a portion of the guidewire (example of the straighten configuration/ the arrow indicated near 500, Fig. 5 and associated descriptions; applying a force, page 5 lines 21 –33; page 10 line 26 – page 11 line 7 of Young).
In regard to claim 8, Young as modified by LaBelle discloses temporarily reducing the intermediary diameter of the intermediary portion in step (f) comprises pushing a portion of the guidewire example of the straighten configuration/ the arrow indicated near 550, Fig. 5 and associated descriptions; applying a force, page 5 lines 21 –33; page 10 line 26 – page 11 line 7 of Young).
In regard to claim 9, Young as modified by LaBelle discloses temporarily reducing the intermediary diameter of the 9 intermediary portion in step (f) comprises twisting a portion of the guidewire (“if the mid-section 3 comprises a kink, straightening the mid-section 3 may comprise "unkinking" the mid-section 3 of the guidewire 100”, page 11 lines 6-7; “the mid-section 3 may be configured to form any one of a helix, a spiral, a curve, a bend, a kink, a coil or any other shape or morphology as shown in Figs. 8A to 8c. It will be understood that the term "kink" may include an axial twist of the guidewire 100, page 12 lines 30-33 of Young).
In regard to claim 10, Young as modified by LaBelle discloses removing the guidewire from the catheter (inherent step(s); “The catheter 9 may be any tube that is suitable for the transfer of fluids and/or gasses into and/or out of a patient. For example, the catheter 9 may be a venous catheter, an arterial catheter…, page 16 lines 28-30; or after all the procedures, all the components are removed from the patient of Young).
In regard to claim 11, Young as modified by LaBelle discloses the at least one of the needle and the mini-catheter is a needle (element 11, Fig. 3 and associated descriptions; needle or short catheter, page 1 lines 8-11, page 3 lines 31-33 and page 10 lines 1-11 of Young).
In regard to claim 12, Young as modified by LaBelle discloses the at least one of the needle and the mini-catheter is a mini-catheter (element 11, Fig. 3 and associated descriptions; needle or short catheter, page 1 lines 8-11, page 3 lines 31-33 and page 10 lines 1-11 of Young).
In regard to claim 13, Young as modified by LaBelle discloses the intermediary portion is located between the patient-side portion and the doctor-side portion such that the patient-side portion is more than 50% linger than the doctor-side portion have (Fig. 9 and associated descriptions of Young).
Response to Arguments
Applicant’s arguments, see pages 6-7 of Remarks, filed on 02/06/2026, with respect to claims 1-14 have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1-14 has been withdrawn.
In regard to the DP rejection, the filed TD has been approved on 02/06/2026 and therefore the DP rejection has been withdrawn.
Applicant’s amendment and argument with respect to claim 1 filed on 02/06/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fugoso (USPN 5497782) teaches a guidewire (Figs. 1-4) comprises a doctor-side, intermediary, and patient-side portions (Fig. 2) and the intermediary portion includes a plurality of S-shaped sections (element 30, Fig. 2) and the patient-site portion includes at least one wires (elements 24-26, Fig. 1) surrounded by a coil (element 18, Fig. 1). Fojtik (USPGPUB 2011/0282338) teaches a device comprises S-shaped section(s) in the intermediary portion (Fig. 2; [0038]).
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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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791