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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/27/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 2/27/2026.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Bruszewski. Now, based on amendments to the claim language, claim 1 is now rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Bruszewski and Kolehmainen.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-6, and 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al., US 20190059994, herein referred to as “Shin”, in view of Bruszewski et al., US 20090234348, herein referred to as “Bruszewski”, further in view of Kolehmainen et al., US 5997487, herein referred to as “Kolehmainen”.
Regarding claim 1, Shin discloses a thermopuncture stent implantation device (Figure 3: stent delivery system 100), comprising: a proximal end (Figure 3: connector portion 200) and a distal end (Figure 3: electrocautery tip 300), the distal end of a front handle (Figures 3 and 12: first handle portion 470) is provided with an outer tube (Figure 12: external tube 450), the outer tube extends from the proximal end to the distal end (Figures 3-4 and 12: external tube 450 extends from the proximal end to the distal end of the device), an insulating middle tube is provided in the outer tube (Figure 12: first internal tube 410 and [0122]: “the first internal tube 410 is provided as an insulating coating agent”), the insulating middle tube extends from the proximal end to the distal end (Figures 3, 12, and 15: first internal tube 410 extends from the proximal end to the distal end of the device), a conductive part is provided at a radial center of the insulating middle tube (Figure 12: conductive wire 120b and [0122]-[0124]), the conductive part extends from the proximal end to the distal end ([0122] and Figures 12 and 15), a terminal of the proximal end of the conductive part can be connected to an external power source (Figures 3-4: external current source 110 and [0087]); a boosting tube (Figures 3-4 and 12: movable bar 490) is provided between the proximal end of the outer tube and the insulating middle tube (Figure 12: movable bar 490 is between external tube 450 and first internal tube 410 and [0135]), the distal end of the boosting tube and the proximal end of the insulating middle tube are connected with each other (Figure 12: tube connection portion 492 and [0133]), the insulating middle tube is located between the conductive part and the boosting tube (Figure 12: conductive wire 120b is within first internal tube 410 and movable bar 490 surrounds the exterior of a proximal portion of first internal tube 410) and insulates the conductive part from the boosting tube (Figure 4: conductive wire 120b is insulated from movable bar 490 and [0122]); the distal end of the conductive part is provided with an insulating part (Figure 15: tip insulator 320), a conductive head is distributed on the insulating part (Figure 15: electrode body 310 and first and second electrode bodies 313 and 315), and the conductive head is connected with the conductive part to achieve a conductive function ([0100]), and the conductive part also has a function of supporting a stent (Figure 15: stent 150); when the stent is compressed, it is located in a space between the distal end of the conductive part and the outer tube (Figure 15: stent 150 is located in the space between the distal end of external tube 450 and first internal tube 410 and [0136]), the front handle is connected to the proximal end of outer tube (Figure 12: first handle portion 470 is connected to the proximal end of external tube 450), and is moved backwards along the boosting tube, to drive the outer tube to move backwards to release the stent ([0200] and [0206]); and the conductive part is a hollow tubular conductive part (Figure 12: conductive wire 120b is looped around the inner circumference of first internal tube 410 and thus is both hollow and tubular in structure and [0122] and [0124]). Shin does not explicitly disclose a thermopuncture stent implantation device wherein the conductive part is provided at a radial center of an entire length of the insulating middle tube, the conductive part is a hollow metal conductive tube; the conductive part is configured to implement liquid injection, and liquid passes through a tube cavity of the conductive part to reach the conductive head; or a device wherein the terminal of the proximal end of the conductive part is directly connected with a Luer connector to implement liquid injection.
However, Bruszewski teaches a thermopuncture stent implantation device (Figures 6 and 8) wherein the conductive part (Figure 8: RF electrode 841) is provided at a radial center of an entire length of the insulating middle tube (Figure 8: RF electrode 841 is at a radial center of an entire length of inner insulator 847), is a hollow metal conductive tube (Figure 8 and [0073]-[0074]), and is configured to implement liquid injection ([0073]), and liquid passes through a tube cavity of the conductive part to reach the conductive head ([0073]: “RF electrode 841 has an inner circumferential edge surface with a diameter 873 so that as shown by the arrows in FIG. 8 saline can flow unimpeded through the lumens in each of center liner 843, inner insulator 847, and RF electrode 841.”; saline reaches convex exterior edge surface 841A, which corresponds to the conductive head).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the thermopuncture stent implantation device of Shin so that the conductive part is a hollow metal conductive tube and is configured to implement liquid injection, and liquid passes through a tube cavity of the conductive part to reach the conductive head as taught by Bruszewski to flush all of the coagulum out and then unblock flow through stent graft (Bruszewski [0051]).
However, Kolehmainen teaches a device (Figure 1) wherein the terminal of the proximal end of the conductive part (Figure 3: proximal core wire end 58 of core wire 56) is directly connected with a Luer connector (Figure3: proximal Luer connector housing 20 and Col. 7, lines 45-49) to implement liquid injection (Col. 6, lines 30-50).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the thermopuncture stent implantation device of Shin so that it includes a Luer connector to implement liquid injection as taught by Kolehmainen so that drugs or agents can be infused to a target site (Kolehmainen Col. 2, lines 25-30).
Regarding claim 2, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein there is a gap between the insulating part and the conductive part (Figure 15: there is a gap between tip insulating member 320 and first and second electrode bodies 313 and 315), the conductive head is provided at a terminal of the distal end of the implantation device (Figure 15: electrode body 310 is at a terminal of the distal end of the device), one end of the conductive head extends from the distal end to the proximal end to enter the gap between the insulating part and the conductive part (Figure 15: electrode body 310 and first and second electrode bodies 313 and 315 enters the gap between tip insulating member 320), and thus is connected with the conductive part to achieve the conductive function [0118], the other end of the conductive head is covered on an outer surface of the insulating part (Figure 15: electrode body 310 is on an outer surface of tip insulating member 320).
Regarding claim 5, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein the conductive part is a conductive wire (Figure 12: conductive wire 120b).
Regarding claim 6, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein the conductive part is a nickel-titanium wire (Figure 12: conductive wire 120b and [0151]).
Regarding claim 8, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein the conductive part is a stainless steel material (Figure 12: conductive wire 120b and [0151]).
Regarding claim 9, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein the outer tube comprises a proximal outer tube (Figure 12: first grip body 471) and a distal outer tube (Figure 12: external tube 450), the proximal outer tube and the distal outer tube are connected in a taper (Figure 12: first grip body 471 tapers to external tube 450).
Regarding claim 10, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein the boosting tube (Figure 12: movable bar 490) extends towards the proximal end and is connected with a rear handle (Figures 3-4: movable bar connects to second handle portion 480), and a positioning part is provided between the front handle and the rear handle (Figures 3-4: bar insulation body is between first handle portion 470 and second handle portion 480).
Regarding claim 11, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein an outer surface of the conductive part (Figure 12: conductive wire 120b) at a distance from the conductive head is covered with a resistance part (Figure 15: stent support block 131 and [0137]).
Regarding claim 12, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 3, and Shin further discloses a device wherein the conductive head comprises two or four conductive wires (Figure 15: first and second electrode lines 123 and 125), and the two or four conductive wires are evenly distributed within grooves on an outer surface of the insulating part (Figure 15: first and second electrode bodies 313 and 315 are within grooves formed by tip insulating member 320).
Regarding claim 13, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein the other end of the conductive head (Figure 15: electrode body 310) close to an outer side is completely covered on an outer surface of the insulating part (Figure 15: electrode body 310 is covered on an outer surface of tip insulating member 320), and when cutting with the conductive head, a cut surface of a wound is a circular surface ([0151]).
Regarding claim 14, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein an outer surface of the conductive part (Figure 12: conductive wire 120b) is covered with a riveting tube (Figure 15: external insulating body 380), one end of the conductive head extends from the distal end to the proximal end to enter a gap between the insulating part and the conductive part (Figure 15: tip electrode body 310 enters a gap between first and second electrode lines 123 and 125 and tip insulator 320), and is connected with the conductive part through the riveting tube to implement a conductive function ([0093]).
Regarding claim 15, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein a material of the insulating part is ceramic ([0108]).
Regarding claim 16, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 1, and Shin further discloses a device wherein a rear handle (Figure 3: second handle portion 480) is provided at the proximal end of the thermopuncture stent implantation device, a conductive base (Figure 4: first and second connector bodies 221 and 223) is provided at a proximal end of the rear handle (Figure 4), and the proximal end of the insulating middle tube extends to the conductive base (Figure 4: proximal end of first inner tube 410 extends to first and second connector bodies 221 and 223).
Regarding claim 17, Shin in view of Bruszewski and Kolehmainen discloses the thermopuncture stent implantation device according to claim 16, and Shin further discloses a device wherein there is a conductive plug within the conductive base (Figure 4 and [0086]: “the first connector body 221 itself of the first connection connector 221 can be connected to a first electrode line 123 by a method of welding bonding, knotting bonding, etc.”), and the terminal of the proximal end of the conductive part extends to the conductive base and is directly connected to the conductive plug (Figure 4: first and second electrode lines 123 and 125 and first and second connector bodies 221 and 223 and [0086]).
Conclusion
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
/N.W.R./Examiner, Art Unit 3794
