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 .
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 1-5, 9, 21-24, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth (US 20090105654) (cited by Applicant) (previously cited) in view of Mawatari (JP 2022181104).
Regarding claim 1, Kurth teaches a transeptal guidewire (Fig. 10, 220) comprising an elongate member (222) comprising: a proximal portion (Fig. 10); a distal portion, (Fig. 10), the distal portion comprising: a distal curved portion (228) ending in a distal tip (229); a tapered region, wherein the tapered region reduces a cross-section of the elongate member from a large cross-section to a small cross-section (Paragraph [0104]).
However, Kurth does not explicitly teach “a plurality of flattened regions positioned at discrete locations along the elongate member; and, wherein each of the plurality of flattened regions are separated from one another by an unflattened region; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending at the plurality of flattened regions.”
Mawatari, in a related field of endeavor, teaches a guide wire (Fig. 4) comprising a plurality of flattened regions (13A1, 14A1, 16A1) positioned at discrete locations along the elongate member (Page 2, last paragraph of Machine Translation); and, wherein each of the plurality of flattened regions are separated from one another by an unflattened region (113B2, 114B2) (Page 5, lines 10, 25); whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending at the plurality of flattened regions. (Page 6, lines 19-26 of Machine Translation).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth to provide “a plurality of flattened regions positioned at discrete locations along the elongate member; and, wherein each of the plurality of flattened regions are separated from one another by an unflattened region; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending at the plurality of flattened regions” as taught by Mawatari. Doing provides a guidewire with superior torque transmission properties. (Abstract).
Regarding claim 2, Kurth teaches wherein the elongate member is composed of nitinol. (Paragraph 0061]).
Regarding claim 3, Kurth teaches wherein the elongate member comprises a circular cross section. (Paragraph 0061]).
Regarding claim 4, Kurth teaches wherein a radiopaque coil (225) positioned along the distal portion. (Paragraph 0102]).
Regarding claim 5, Kurth teaches wherein the radiopaque coil is held in place by a coil stopper. (Paragraph [0104] radiopaque coil 225 is positioned adjacent the tapered transition and then held in place by crimping a portion of the end section 226 opposite the tapered transition.)
Regarding claim 9, Kurth teaches wherein the curved distal portion is J-shaped. (Paragraph [0098]).
Regarding claim 21, Kurth teaches a guidewire (Fig. 10, 220) comprising: an elongate member (222) comprising: a proximal portion (Fig. 10); a distal portion, (Fig. 10), the distal portion comprising: a distal curved portion (228) ending in a distal tip (229); a tapered region, wherein the tapered region reduces a cross-section of the elongate member from a large cross-section to a small cross-section (Paragraph [0104]).
However, Kurth does not specifically teach “a plurality of flattened regions positioned at discrete locations along the elongate member, each of the plurality of flattened regions having a cross-section including a width greater than a height and, wherein each of the plurality of flattened regions are separated from one another by an unflattened region; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending at the plurality of flattened regions.
Mawatari, as previously discussed, teaches a guide wire (Fig. 4) comprising a plurality of flattened regions (13A1, 14A1, 16A1) positioned at discrete locations along the elongate (See Fig. 4), each of the plurality of flattened regions having a cross-section including a width greater than a height (Page 2, last paragraph of Machine Translation flat region is formed into a flat plate shape by pressing a cylindrical portion having the same diameter as the outer diameter of the second region 14B), wherein each of the plurality of flattened regions are separated from one another by an unflattened region (113B2, 114B2) (Page 5, lines 10, 25); whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending at the plurality of flattened regions. (Page 6, lines 19-26 of Machine Translation).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth to provide “a plurality of flattened regions positioned at discrete locations along the elongate member; and, wherein each of the plurality of flattened regions are separated from one another by an unflattened region; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending at the plurality of flattened regions” as taught by Mawatari. Doing provides a guidewire with superior torque transmission properties. (Abstract).
Regarding claim 22, Kurth teaches wherein the elongate member is composed of nitinol. (Paragraph 0061]).
Regarding claim 23, Kurth teaches wherein a radiopaque coil (225) positioned along the distal portion. (Paragraph 0102]).
Regarding claim 24, Kurth teaches wherein the radiopaque coil is held in place by a coil stopper. (Paragraph [0104] radiopaque coil 225 is positioned adjacent the tapered transition and then held in place by crimping a portion of the end section 226 opposite the tapered transition.)
Regarding claim 26, Kurth teaches wherein the plurality of flattened regions comprises a proximal flattened region and a distal flattened region. (See annotated Fig. 10 above).
Regarding claim 27, Kurth teaches wherein the distal flattened region (See Figs. 7B, 10, 12) extends from the sharp distal tip (229) and ends proximal to the curved distal portion (228). (Paragraph [0116]).
Regarding claim 28, Kurth teaches wherein the curved distal portion is J-shaped. (Paragraph [0098]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Mawatari, further in view of Reynolds (JP 2006519062) (previously cited).
Regarding claim 6, Kurth as modified does not teach “wherein the tapered region comprises a plurality of tapers, wherein the plurality of tapers are separated by at least one intermediate portion of constant diameter.”
Reynolds teaches elongate medical device comprising a guidewire wherein the tapered region comprises a plurality of tapers, wherein the plurality of tapers are separated by at least one intermediate portion of constant diameter. (Page 4, lines 16-19).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth to provide ““wherein the tapered region comprises a plurality of tapers, wherein the plurality of tapers are separated by at least one intermediate portion of constant diameter” as taught by Reynolds. Doing so enables changes based on desired flexibility characteristics and gradual transitions in stiffness. (Page 4, lines 30-32).
Regarding claim 7, Kurth does not teach “wherein the plurality of flattened regions comprises a proximal flattened region and a distal flattened region.”
Mawatari teaches wherein the plurality of flattened regions comprises a proximal flattened region and a distal flattened region. (See Fig. 4).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth to provide “wherein the plurality of flattened regions comprises a proximal flattened region and a distal flattened region” as taught by Mawatari. Doing provides a guidewire with superior torque transmission properties. (Abstract).
Regarding claim 8, Kurth teaches wherein the distal flattened region (See Figs. 7B, 10, 12) extends from the sharp distal tip (229) and ends proximal to the curved distal portion (228). (Paragraph [0116]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Mawatari, further in view of Urbanski (WO 2018083599) (previously cited).
Regarding claim 10, Kurth as modified does not teach “wherein the curved distal portion is in a pigtail configuration.”
Urbanski, in a related field of endeavor, teaches a puncture device comprising a guidewire wherein the curved distal portion is in a pigtail configuration. (Paragraph [00153]).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth as modified to provide “wherein the curved distal portion is in a pigtail configuration” as taught by Urbanski. Doing so enables anchoring of the wire. (Paragraph [00153]).
Regarding claim 11, Kurth as modified does not teach “wherein the distal tip comprises an electrode configured to deliver energy to a target tissue.”
Urbanski teaches a puncture device comprising a guidewire wherein the distal tip comprises an electrode configured to deliver energy to a target tissue. (Paragraph [0076]).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth as modified to provide “wherein the distal tip comprises an electrode configured to deliver energy to a target tissue” as taught by Urbanski. Doing so delivers radiofrequency energy in order to puncture tissue. (Paragraph [0069]).
Claims 25 is rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Mawatari, further in view of Reynolds.
Regarding claim 25, Kurth as modified does not teach “wherein the tapered region comprises a plurality of tapers, wherein the plurality of tapers are separated by at least one intermediate portion of constant diameter.”
Reynolds teaches elongate medical device comprising a guidewire wherein the tapered region comprises a plurality of tapers, wherein the plurality of tapers are separated by at least one intermediate portion of constant diameter. (Page 4, lines 16-19).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth as modified to provide “wherein the tapered region comprises a plurality of tapers, wherein the plurality of tapers are separated by at least one intermediate portion of constant diameter” as taught by Reynolds. Doing so enables changes based on desired flexibility characteristics and gradual transitions in stiffness. (Page 4, lines 30-32).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Mawatari, further in view of Urbanski.
Regarding claim 29, Kurth as modified does not teach “wherein the distal tip comprises an electrode configured to deliver energy to a target tissue.”
Urbanski teaches a puncture device comprising a guidewire wherein the distal tip comprises an electrode configured to deliver energy to a target tissue. (Paragraph [0076]).
As a result, it would have been obvious to one ordinary skill in the art before the effective filing date to have modified Kurth as modified to provide “wherein the distal tip comprises an electrode configured to deliver energy to a target tissue” as taught by Urbanski. Doing so delivers radiofrequency energy in order to puncture tissue. (Paragraph [0069]).
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 3/27/2026, with respect to the rejections of claims 1-11 and 21-29 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Mawatari.
Conclusion
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/OM PATEL/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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