DETAILED ACTION
The following Office Action is in response to the Amendment filed on June 22, 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 .
Response to Amendment
Concerning the “Claim Rejections – 35 USC 112” section on page 6 of the Applicant’s Response filed on June 22, 2026, the amendment to claim 1 to address the issue of indefiniteness has obviated the necessity of the rejection of the claims under 35 U.S.C. §112(b). Therefore, the rejection of the claims under 35 U.S.C. §112(b) are withdrawn.
Response to Arguments
Concerning the “Claim Rejections – 35 USC 103” section, with regards to the arguments against the rejections of claim 1 and its dependent claims on pages 6-8 of the Applicant’s Response filed on June 22, 2026, the applicant’s arguments have been fully considered, but they are moot in view of the rejections under 35 U.S.C. §112(a) for introducing new matter.
With regards to the arguments against the rejections of claims 5 and 8-13 on pages 8-10 of the Applicant’s Response filed on June 2, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the combination of the Hardert, Cummins, and Longo references is improper because the Longo reference does not teach or suggest the claimed actuator in the claimed scoring balloon catheter architecture, and further argues that the Office does not provide an articulated, technically coherent reason why a person would have re-engineered Hardert’s sliding ring arrangement into a thumb wheel rotatably mounted to the hub for longitudinally translating scoring wires. However, the examiner asserts that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, the Longo reference clearly lists a slide and thumbwheel as two known actuators for a deployment mechanism, therein defining them as two obvious alternatives to one another. Although the Longo reference may teach a different deployment mechanism in moving a sheath as opposed to wires, the particulars of Longo do not need to be bodily incorporated into the combination. Rather, the Longo reference has merely been utilized to show that the combined teachings show that a thumbwheel and a slide are obvious alternatives. Another way of articulating the idea of these obvious alternatives is as a simple substitution of one known actuator for a deployment mechanism (the slide of Hardert) for another known actuator for deployment (the thumbwheel as in Longo), which would yield the predictable result of operating in the same manner with a different actuator mechanism, which is described in MPEP §2143 as sufficient rationale to show a prima facie case of obviousness. Although the applicant argues that the modification is not a mere substitution, the applicant again assumes bodily incorporation of the entire structure of the Longo reference. However, a person having ordinary skill in the art would recognize that a thumbwheel may easily be substituted for a slide as an actuator given they are obvious alternatives widely known in the art as identified in Longo. Therefore, the rejections of claims 8 and 10-13 under 35 U.S.C. §103 stand.
With regards to the arguments against the rejections of claims 9 and 11 on page 10 of the Applicant’s Response filed on June 2, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant further argues that the Hardert reference does not teach the limitation of an atraumatic tip, arguing that the annular connector and distal wire ends is not a tip and is not described as atraumatic. However, the examiner asserts that the connector of the Hardert reference forms curved bends at each dilation wire, therein defining an atraumatic tip on each distal wire end. The bends are smooth as opposed to pointed, which defines them as atraumatic, and they exist at the end of each dilation wire, therein defining them as tips, therein teaching the limitation of an atraumatic tip. Therefore, the rejection of claim 11 under 35 U.S.C. §103 stand.
With regards to the arguments against the rejections of claims 14-16 and 19-20 on pages 10-12 of the Applicant’s Response filed on June 2, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the rejection has not established that Parikh is analgous art for the claimed subject matter, arguing that the Parikh reference is not in the same field of endeavor as the claimed scoring and that the Office has not shown that Parikh’s guide-extension control-center mechanism is reasonably pertinent to the specific problem addressed by the claimed invention. However, the examiner asserts that the applicant has too narrowly interpreted the field of endeavor. The field of endeavor is “not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field” [MPEP 2141.01(a)]. In the instant case, both the Hardert reference and Parikh reference teach handles for deploying wires within a catheter system, or generally speaking, catheters as classified in A61M 25/00, therein being in the same field of endeavor. The applicant then argues that the Office has not provided the articulated reasoning with rational underpinning required for obviousness, arguing that merely characterizing Parikh’s rack and pinion as an “obvious variant” of Hardert’s sliding ring does not explain why a person of ordinary skill would have transplanted Parikh’s guide-extension advancement mechanism into Hardert’s scoring balloon catheter. However, as described above, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, the Parikh reference clearly lists a slider mechanism and rotary actuator as two known actuators for a deployment mechanism, therein defining them as two obvious alternatives to one another, with Figures 7A-D showing a slider mechanism, and Figures 11A-D showing an equivalent rack and pinion rotary mechaniusm. Another way of articulating the idea of obvious alternatives is as a simple substitution of one known actuator for a deployment mechanism (the slide of Hardert) for another known actuator for deployment (the rotary actuator as in Parikh), which would yield the predictable result of operating in the same manner with a different actuator mechanism, which is described in MPEP §2143 as sufficient rationale to show a prima facie case of obviousness. A person having ordinary skill in the art would recognize that a rotary actuator may easily be substituted for a slide as an actuator given they are obvious alternatives widely known in the art as described as two equivalent structural embodiments in Parikh. Therefore, the rejections of claims 14-16 and 19-20 under 35 U.S.C. §103 stand.
With regards to the arguments against the rejections of claims 17 and 18 on pages 12-13 of the Applicant’s Response filed on June 2, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that Cummins is not analogous to a scoring balloon catheter, arguing that Cummins is instead directed to a vein-denuding device. However, the field of endeavor is “not limited to the specific point of novelty, the narrowest possible conception of the field, or the particular focus within a given field” [MPEP 2141.01(a)]. In the instant case, both the Hardert reference and Cummins reference teach scoring wires for scraping or abrading tissue, therein teaching a shared field of endeavor. However, due to the newly added limitations to claim 17, a new ground(s) of rejection has been made for claims 17 and 18 for introducing new matter as described in the Office Action below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7, 9, and 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 9, and 17 recite the newly added limitation of “wherein the atraumatic tip is positioned to abut the distal opening as a distal-travel stop such that when the at least one scoring wire is advanced to position the portion of the at least one scoring wire alongside the balloon, the atraumatic tip remains proximal of the proximal end of the inflatable balloon”. The limitation claims that “when the scoring wire is advanced” “the atraumatic tip remains proximal of the proximal end of the inflatable balloon”. However, this is not taught in the Specification. Figure 4 of the Drawings shows the scoring wire in an advanced position, wherein the atraumatic tip 30a is clearly distal to the proximal end of the inflatable balloon. The scoring wire is instead proximal of the proximal end of the inflatable balloon when the scoring wire is in a retracted configuration as seen in Figure 3, not when it is advanced to position a portion of the scoring wire alongside the balloon as seen in Figure 4. Advancement of the scoring wire from an abutting position of the atraumatic tip with the distal opening will position the atraumatic tip at the proximal end of the balloon, as opposed to proximal to the proximal end of the balloon, and when a portion of the scoring wire advances to be alongside the balloon, the atraumatic tip will no longer be proximal of or at a proximal end of the balloon, but distal of the proximal end of the balloon. Additionally, it is noted that the Specification does not discuss any abutment or define any feature as a distal travel stop. Although the Specification does explain that the scoring wire may exit from openings located adjacent to a proximal end 15a of the balloon 12, and that the atraumatic tip is oversized to prevent the wire 30 from entering the distal opening (Specification; Page 6, Lines 15-23), this does not describe a travel stop associated with distal motion or advancement of the scoring wire, only proximal motion or retraction of the scoring wire, therein failing to convey to one skilled in the art that the inventor had possession of the claimed invention at the time the application was filed.
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) 8 and 10-13 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 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, 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 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).
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 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.
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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.
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/MARTIN T TON/Examiner, Art Unit 3771 9/22/2026
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