DETAILED ACTION
The following Office Action is in response to the Request for Continued Examination filed on February 3, 2026. Claims 1-20 are currently pending.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 3, 2026 has been entered.
Response to Arguments
Concerning the “Claim Rejections – 35 USC 102” section on page 5 of the Applicant’s Response filed on February 3, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
Concerning the “Claim Rejections – 35 USC 103” section on pages 5-6 of the Applicant’s Response filed on February 3, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the new ground(s) of rejection.
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 1-7 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 1 recites the limitation of “the lumen in the shaft”, wherein the claim previously recites “a lumen”. It is indefinite as to whether “the lumen in the shaft” is the same as said lumen, and it cannot be determined whether the “a lumen” must specifically be in the shaft or if it may be any lumen. For the purposes of compact prosecution, the limitation of “a lumen” will be interpreted as “a lumen in the shaft”. Claims 2-7 are further rejected for being dependent on an indefinite claim.
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.
Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardert (US 2007/0073329) in view of Cummins et al. (US 2019/0350567, hereinafter Cummins).
Concerning claims 1 and 6, the Hardert prior art reference teaches a scoring balloon catheter (Figures 1-8; 10), comprising: a shaft having a proximal end section and a distal end section (Figure 1; 16); an inflatable balloon mounted on the distal end section of the shaft (Figure 1; 12); and at least one scoring wire partially located within the shaft proximal of the inflatable balloon (Figure 2; 14), and including a tip adapted for translating in a longitudinal direction to position a portion of the at least one scoring wire alongside the balloon ([¶ 0062]), but it does not specifically teach the tip being an atraumatic tip comprising a generally spherical bead, the atraumatic tip being oversized relative to a distal opening of a lumen in the shaft and adapted to prevent the at least one scoring wire from entering the distal opening of the lumen in the shaft.
However, the Cummins reference teaches a scoring wire (Figure 4; 1), therein being in the same field of endeavor as the Hardert reference, the scoring wire including a shaft having a proximal section and a distal section (Figure 4; 2), and the scoring wire partially located within the shaft and including an atraumatic tip comprising a generally spherical bead (Figure 4; 15), the atraumatic tip adapted to translate in a longitudinal direction relative to the shaft, and wherein the atraumatic tip is oversized relative to a distal opening of a lumen in the shaft and adapted to prevent the scoring wire from entering the distal opening of the lumen in the shaft ([¶ 0284]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tip of the at least one scoring wire of the Hardert reference be an atraumatic tip comprising a generally spherical bead, the atraumatic tip being oversized relative to a distal opening of a lumen in the shaft and adapted to prevent the at least one scoring wire from entering the distal opening of the lumen in the shaft as in the Cummins reference to prevent the scoring wire from snagging a vessel wall and reduce the risk of the tip causing penetration to the wall when it is deployed and withdrawn, while also allowing the tip to rest within a distal opening of the shaft in the deliver configuration (Cummins; [¶ 0284]).
Concerning claim 2, the combination of the Hardert and Cummins references as discussed above teaches the scoring balloon catheter of claim 1, wherein the Hardert reference further teaches a plurality of scoring wires (Figure 5; 14), wherein each scoring wire may include an atraumatic tip (Figure 5; 52) adapted for translating in a longitudinal direction.
Concerning claim 3, the combination of the Hardert and Cummins references as discussed above teaches the scoring balloon catheter of claim 1, wherein the Hardert reference further teaches an actuator for advancing and retracting the at least one scoring wire (Figure 1; 58).
Concerning claim 4, the combination of the Hardert and Cummins references as discussed above teaches the scoring balloon catheter of claim 1, wherein the Hardert reference further teaches a hub connected to the proximal end section of the shaft (Figure 1; 22), and wherein the actuator is connected to the hub (Figure 1; 58).
Concerning claim 7, the combination of the Hardert and Cummins references as discussed above teaches the scoring balloon catheter of claim 1, wherein the Hardert reference further teaches the atraumatic tip of the at least one scoring wire being located proximal of the balloon in a home position (Figure 6; distal ends of the scoring wires are within the shaft when in the home position, wherein the connector, and thus the atraumatic tips, would need to be outside of the shaft but still proximal of the balloon in the embodiment including the connector).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardert (US 2007/0073329) in view of Cummins et al. (US 2019/0350567, hereinafter Cummins) as applied to claims 1-4 and 6-7 above, and further in view of Longo et al. (US 2018/0000619, hereinafter Longo).
Concerning claim 5, but does not specifically teach the actuator comprising a thumb wheel rotatably mounted to the hub.
However, the Longo reference teaches a balloon catheter device (Figure 1; 10) including a shaft (Figure 1A; 12) having a proximal end section (Figure 1A; 6) and a distal end section (Figure 1A; 4) which may include an inflatable balloon mounted on the distal end section of the shaft and a hub connected to the proximal end section of the shaft (Figure 1; 24), wherein the hub may include an actuator in the form of a thumbwheel (Figure 23; 3220) to manipulate wires within the catheter ([¶ 0210]), wherein the Longo reference states that a thumbwheel is an obvious alternative to a slide ([¶ 0210]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the actuator of the Hardert and Cummins combination be a thumbwheel rotatably mounted to the hub as opposed to a slide given the Longo reference teaches that a thumbwheel is an obvious variant of a slide for an actuator structure for a balloon catheter hub (Longo; [¶ 0210]).
Claim(s) 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardert (US 2007/0073329) in view of Longo et al. (US 2018/0000619, hereinafter Longo).
Concerning claims 8 and 13, the Hardert prior art reference teaches a scoring balloon catheter (Figures 1-8; 10), comprising: a shaft having a proximal end section and a distal end section (Figure 1; 16); a hub connected to the proximal end section of the shaft (Figure 1; 22); an inflatable balloon mounted on the distal end section of the shaft (Figure 1; 12); and at least one scoring wire (Figure 2; 14); an actuator connected to the hub for advancing and retracting the at least one scoring wire in a longitudinal direction (Figure 1; actuator 58 connected to hub 22 via shaft 66), the actuator in the form of a slide, such that a portion thereof extends alongside the inflatable balloon ([¶ 0063]), but it does not specifically teach the actuator rotatably mounted on the hub.
However, the Longo reference teaches a balloon catheter device (Figure 1; 10) including a shaft (Figure 1A; 12) having a proximal end section (Figure 1A; 6) and a distal end section (Figure 1A; 4) which may include an inflatable balloon mounted on the distal end section of the shaft and a hub connected to the proximal end section of the shaft (Figure 1; 24), wherein the hub may include an actuator in the form of a thumbwheel (Figure 23; 3220) to manipulate wires within the catheter ([¶ 0210]), wherein the Longo reference states that a thumbwheel is an obvious alternative to a slide ([¶ 0210]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the actuator of the Hardert reference be a thumbwheel rotatably mounted to the hub as opposed to a slide given the Longo reference teaches that a thumbwheel is an obvious variant of a slide for an actuator structure for a balloon catheter hub (Longo; [¶ 0210]).
Concerning claim 9, the combination of the Hardert and Longo references as discussed above teaches the scoring balloon catheter of claim 8, wherein the Hardert reference further teaches that the at least one scoring wire may include an atraumatic tip (Figure 5; distal ends 52 of wires 14 may be connected via a connector 72 therein forming bends at the distal ends 52 that are atraumatic) adapted for translating in a longitudinal direction ([¶ 0065]).
Concerning claims 10 and 11, the combination of the Hardert and Longo references as discussed above teaches the scoring balloon catheter of claim 8, wherein the Hardert reference further teaches a plurality of scoring wires (Figure 5; 14), each scoring wire including an atraumatic tip (Figure 5; 52) adapted for translating in a longitudinal direction.
Concerning claim 12, he combination of the Hardert and Longo references as discussed above teaches the scoring balloon catheter of claim 8, wherein the Hardert reference further teaches the actuator being adapted for simultaneously advancing and retracting the plurality of scoring wires ([¶ 0063]).
Claim(s) 14-16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardert (US 2007/0073329) in view of Parikh et al. (US 2023/0173231, hereinafter Parikh).
Concerning claims 14-16 and 19-20, the Hardert prior art reference teaches a scoring balloon catheter (Figures 1-8; 10), comprising: a shaft having a proximal end section and a distal end section (Figure 1; 16); an inflatable balloon mounted on the distal end section of the shaft (Figure 1; 12); and a hub connected to a proximal end section of the shaft (Figure 1; 22), a plurality of scoring wires (Figure 2; 14); and an actuator for advancing and retracting the plurality of scoring wires in a longitudinal direction (Figure 1; 58), the actuator being in the form of a slide, such that a portion thereof extends alongside the inflatable balloon in an inflated position, wherein the actuator is adapted for simultaneously advancing and retracting the plurality of scoring wires ([¶ 0063]), but does not specifically teach the actuator being a rotary actuator, wherein the rotatory actuator is adapted to engage a rack, and wherein the rack is connected to a proximal end of the at least one scoring wire.
However, the Parikh reference teaches a catheter (Figure 21A; 2100) including a variety of actuators for advancing a wire within a lumen of the catheter, therein being in the same field of endeavor as the Hardert reference, wherein the Parikh reference teaches the catheter including a shaft having a proximal end section and a distal end section (Figure 21A; 2150), a wire (Figure 11A; 1104), and a rotary actuator (Figure 11A; 1102), wherein the rotary actuator is adapted to engage a rack (Figure 11A; 1134) for advancing and retracting the wire in a longitudinal direction, and wherein the rack is connected to a proximal end of the wire (Figure 11A; 1134), and further including a hub connected to the proximal end section of the shaft (Figure 21A; 2106) and wherein the rotary actuator is supported by the hub (Figure 11A; 1106), and wherein the rotary actuator comprises a thumb wheel rotatably mounted to the hub (Figure 11C; 1132).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the actuator of the Hardert reference be a rotary actuator adapted to engage a rack, and wherein the rack is connected to a proximal end of the at least one scoring wire as in the Parikh reference as opposed to the slider actuator taught in Hardert given the Parikh reference teaches that the rotary actuator and rack structure is an obvious variant of a slider actuator structure for advancing a wire within a catheter lumen (Parikh; [¶ 0064, 0072-0073).
Claim(s) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardert (US 2007/0073329) in view of Parikh et al. (US 2023/0173231, hereinafter Parikh) as applied to claims 14-16 and 19-20 above, and further in view of Cummins et al. (US 2019/0350567, hereinafter Cummins).
Concerning claims 17 and 18, the combination of the Hardert and Parikh references as discussed above teaches the scoring balloon catheter of claim 14, but does not specifically teach the tip being an atraumatic tip comprising a generally spherical bead.
However, the Cummins reference teaches a scoring wire (Figure 4; 1), therein being in the same field of endeavor as the Hardert reference, the scoring wire including a shaft having a proximal section and a distal section (Figure 4; 2), and the scoring wire partially located within the shaft and including an atraumatic tip comprising a generally spherical bead (Figure 4; 15), the atraumatic tip adapted to translate in a longitudinal direction relative to the shaft.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tip of the at least one scoring wire of the Hardert reference be an atraumatic tip comprising a generally spherical bead as in the Cummins reference to prevent the scoring wire from snagging a vessel wall and reduce the risk of the tip causing penetration to the wall when it is deployed and withdrawn (Cummins; [¶ 0284]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN T TON/Examiner, Art Unit 3771 3/20/2026