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 .
Response to Amendments
The amendment filed August 14, 2026 in response to the Office Action of June 1, 2026 has been acknowledged and entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “wherein the tapered region comprises a plurality of tapers” in lines 1-2.
However, claim 1 already recites that the tapered region comprises a plurality of tapers in lines 6-7, 10-11 (i.e., a middle tapered region and a distal tapered region with a flattened region between the two tapered regions). Clarification regarding what further limitation claim 6 provides to the claimed invention is requested.
Claim 25 recites “wherein the tapered region comprises a plurality of tapers” in lines 1-2. However, claim 21 already recites that the tapered region comprises a plurality of tapers in lines 6-7, 10-11 (i.e., a middle tapered region and a distal tapered region with a flattened region between the two tapered regions). Clarification regarding what further limitation claim 25 provides to the claimed invention is requested.
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, 8-9, 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) (previously cited).
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).
However, Kurth does not explicitly teach “a tapered region, wherein the tapered region comprises a middle tapered region and a distal tapered region distal to the middle tapered region, the middle tapered region and the distal tapered region reducing a cross-section of the elongate member from a large cross-section to a small cross-section; a plurality of flattened regions comprising a proximal flattened region positioned at a transition region between the middle tapered region and the distal tapered region, and one or more distal flattened regions positioned at discrete locations along the elongate member distal to the transition region; and one or more unflattened regions separating adjacent flattened regions of the plurality of flattened regions, the one or more unflattened regions including an unflattened region positioned between the proximal flattened region and a proximal-most distal flattened region of the one or more distal flattened regions; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending the proximal flattened region and the one or more distal flattened regions.”
Mawatari, in a related field of endeavor, teaches a guide wire (Fig. 4) comprising a tapered region, wherein the tapered region comprises a middle tapered region (14A2) and a distal tapered region (13A2) distal to the middle tapered region (14A2), the middle tapered region and the distal tapered region reducing a cross-section of the elongate member from a large cross-section to a small cross-section (See Fig. 4); a plurality of flattened regions (13A1, 14A1, 16A1) comprising a proximal flattened region (14A1) positioned at a transition region between the middle tapered region (14A2) and the distal tapered region (13A2), and one or more distal flattened regions (13A1) positioned at discrete locations along the elongate member distal to the transition region (See Fig. 4); and one or more unflattened regions (113B2) separating adjacent flattened regions of the plurality of flattened regions, the one or more unflattened regions including an unflattened region (113B2) positioned between the proximal flattened region (14A1) and a proximal-most distal flattened region (13A1) of the one or more distal flattened regions; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending the proximal flattened region (14A1) and the one or more distal flattened regions (13A1). (Page 6, lines 23-25).
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 tapered region, wherein the tapered region comprises a middle tapered region and a distal tapered region distal to the middle tapered region, the middle tapered region and the distal tapered region reducing a cross-section of the elongate member from a large cross-section to a small cross-section; a plurality of flattened regions comprising a proximal flattened region positioned at a transition region between the middle tapered region and the distal tapered region, and one or more distal flattened regions positioned at discrete locations along the elongate member distal to the transition region; and one or more unflattened regions separating adjacent flattened regions of the plurality of flattened regions, the one or more unflattened regions including an unflattened region positioned between the proximal flattened region and a proximal-most distal flattened region of the one or more distal flattened regions; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending the proximal flattened region and the one or more distal flattened regions” as taught by Mawatari. Doing provides a guidewire with superior torque transmission properties with improved flexibility such that it can navigate complex, highly curved pathways, such that the guidewire is not affected by occlusions. (Abstract; Page 2, lines 3-10).
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 8, Kurth teaches wherein a distal-most distal flattened region (226) of the one or more distal flattened regions extends from the distal tip and ends proximal to the distal curved portion (228a). (See Fig. 10).
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).
However, Kurth does not specifically teach “a tapered region comprising a middle tapered region and a distal tapered region distal to the middle tapered region, the middle tapered region and the distal tapered region reducing a cross-section of the elongate member from a large cross-section to a small cross-section; a plurality of flattened regions comprising a proximal flattened region positioned at a transition region between the middle tapered region and the distal tapered region, and one or more distal flattened regions positioned at discrete locations along the elongate member distal to the transition region, each of the plurality of flattened regions having a cross-section including a width greater than a height; and one or more unflattened regions separating adjacent flattened regions of the plurality of flattened regions, the one or more unflattened regions including an unflattened region positioned between the proximal flattened region and a proximal-most distal flattened region of the one or more distal flattened regions; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending the proximal flattened region and the one or more distal flattened regions.”
Mawatari, as previously discussed, teaches a guide wire (Fig. 4) comprising a tapered region, comprising a middle tapered region (14A2) and a distal tapered region (13A2) distal to the middle tapered region (14A2), the middle tapered region and the distal tapered region reducing a cross-section of the elongate member from a large cross-section to a small cross-section (See Fig. 4); a plurality of flattened regions (13A1, 14A1, 16A1) comprising a proximal flattened region (14A1) positioned at a transition region between the middle tapered region (14A2) and the distal tapered region (13A2), and one or more distal flattened regions (13A1) positioned at discrete locations along the elongate member distal to the transition region (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); and one or more unflattened regions (113B2) separating adjacent flattened regions of the plurality of flattened regions, the one or more unflattened regions including an unflattened region (113B2) positioned between the proximal flattened region (14A1) and a proximal-most distal flattened region (13A1) of the one or more distal flattened regions; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending the proximal flattened region (14A1) and the one or more distal flattened regions (13A1). (Page 6, lines 23-25).
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 tapered region comprising a middle tapered region and a distal tapered region distal to the middle tapered region, the middle tapered region and the distal tapered region reducing a cross-section of the elongate member from a large cross-section to a small cross-section; a plurality of flattened regions comprising a proximal flattened region positioned at a transition region between the middle tapered region and the distal tapered region, and one or more distal flattened regions positioned at discrete locations along the elongate member distal to the transition region, each of the plurality of flattened regions having a cross-section including a width greater than a height; and one or more unflattened regions separating adjacent flattened regions of the plurality of flattened regions, the one or more unflattened regions including an unflattened region positioned between the proximal flattened region and a proximal-most distal flattened region of the one or more distal flattened regions; whereby, when a force is exerted onto the guidewire, the guidewire undergoes bending the proximal flattened region and the one or more distal flattened regions” as taught by Mawatari. Doing provides a guidewire with superior torque transmission properties such that the guidewire is not affected by the hardness of the lesion. (Abstract; Page 6, lines 25-27).
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 one or more distal flattened regions comprises a single distal flattened region (226). (See Fig. 10).
Regarding claim 27, Kurth teaches wherein the single distal flattened region (226) extends from the distal tip and ends proximal to the distal curved portion (228a). (See Fig. 10).
Regarding claim 28, Kurth teaches wherein the curved distal portion is J-shaped. (Paragraph [0098]).
Claim 6 is 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 further 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 further 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).
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 8/14/2026, with respect to the rejections of claims 1-6, 8-11, and 21-29 have been fully considered. However, upon further consideration, a new ground of rejection is made in view of Mawatari.
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 Om A. Patel whose telephone number is (571)272-6331. The examiner can normally be reached Monday - Friday 8 a.m. - 5 p.m..
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/OM PATEL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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