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 § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laudenslager (US 20150105714), cited previously.
Regarding claim 1, Laudenslager discloses a single optical fiber or optical fiber bundle 82, 90 (Fig. 10, section 0103, This output optical window again may include a high NA optical fiber or a silica rod coated with a low index amorphous fluoropolymer coating) configured for insertion through a lesion 116 in a blood vessel 118 (Fig. 28-30, section 0135, Pulsed UV laser energy may be used for treating blockages 116 in coronary and peripheral arteries 119 for both de nova and restenosed lesions), the single optical fiber or optical fiber bundle 82, 90 having a proximal end 24 and a distal end 34 and being couplable to an associated laser generator 10 at the proximal end 24, (Figs. 1-3, section 0073-0074, A liquid core ablation catheter 22 has a laser coupler 24 which is disposed at a proximal end 30 of the ablation catheter 22 and which is coupled to the output coupler 20 of the laser source. The laser system 8 may also include an aiming diode for applications where locating the distal tip 34 of liquid core ablation catheter 22); wherein the single optical fiber or optical fiber bundle 82, 90 has a diameter of 1.5 mm or less (section 0103, the output optical window may have an outer diameter or transverse dimension of about 0.5 mm to about 1.5 mm, more specifically, about 0.8 mm to about 1.2 mm).
Regarding claim 2, Laudenslager discloses the single optical fiber or optical fiber bundle 82, 90 is a single optical fiber 82, 90 (Fig. 10, section 0103, This output optical window again may include a high NA optical fiber or a silica rod coated with a low index amorphous fluoropolymer coating).
Regarding claim 3, Laudenslager discloses the single optical fiber 82, 90 has an optical output end 82 comprising a square tip or a beveled tip (Fig. 10).
Regarding claim 4, Laudenslager discloses the single optical fiber comprises: a glass core layer; a cladding layer surrounding the glass core layer; and a polyimide buffer layer surrounding the cladding layer (section 0102, the input optical window may include a silica core silica clad window, but it may also include an optically polished silica rod that is radially surrounded by an air interface. The input optical window of the ablation catheter may also include a silica rod. The input optical window of the ablation catheter may also include a silica rod that has a low index amorphous fluoropolymer coating).
Regarding claim 5, Laudenslager discloses the single optical fiber 82, 90 comprises a hydrophilic coating 91 (section 0102, 0103, The input optical window 80 of the ablation catheter may also include a silica rod that has a low index amorphous fluoropolymer coating. This output optical window again may include a high NA optical fiber or a silica rod 90 coated with a low index amorphous fluoropolymer coating).
Regarding claim 6, Laudenslager discloses the single optical fiber or optical fiber bundle 82, 90 is an optical fiber bundle that does not have an internal lumen (Fig, 10, shows the optical fiber 82 with no lumen).
Regarding claim 7, Laudenslager discloses a support catheter 26 insertable into the blood vessel 118 and having a central lumen 28 sized to pass the single optical fiber or optical fiber bundle 82, 90, (Fig. 10, 26, 28-30, section 0108, The support catheter 26 may then be advanced distally over the ablation catheter 22 and through the lumen 122 created by the active ablation catheter).
Regarding claim 8, Laudenslager discloses a vascular lesion crossing device 56, 56’ and a vascular therapy device 350, 352 which is different from the single optical fiber or optical fiber bundle of the vascular lesion crossing device and is configured to treat the lesion in the blood vessel (Fig. 35, 64, section 0134, 0148, a combination of laser ablation and drug eluting balloon (DEB) therapy may be more effective for treatment yielding long term patency of a lumen of an AV fistula and/or vessels adjacent to the AV fistula. Once the blockage has been completely traversed, the AV fistula and adjacent vessels, for example, AVG or vein, may be further treated by treating the neolumen created by the laser ablation process with a drug eluting balloon catheter).
Regarding claim 9, Laudenslager discloses inserting an optical fiber or fiber bundle 82, 90 through a blood vessel to position an end of the optical fiber or fiber bundle at a lesion 116 in the blood vessel 118 (Fig. 10, section 0108, the ablation catheter 22 crosses the lesion), the optical fiber or fiber bundle 82, 90 having a proximal end 24 and a distal end 34 (Figs. 1-3, section 0073-0074, A liquid core ablation catheter 22 has a laser coupler 24 which is disposed at a proximal end 30 of the ablation catheter 22 and which is coupled to the output coupler 20 of the laser source. The laser system 8 may also include an aiming diode for applications where locating the distal tip 34 of liquid core ablation catheter 22); energizing, with a laser generator 10, the optical fiber or fiber bundle to form an opening in the lesion 116 at least in part by laser ablation using light from the laser generator that passes through the optical fiber or fiber bundle (Fig. 28-30, section 0135, Pulsed UV laser energy may be used for treating blockages 116 in coronary and peripheral arteries for both de nova and restenosed lesions), wherein the proximal end 24 of the optical fiber or fiber bundle 82, 90 is coupled to the laser generator 10 (Figs. 1-3, section 0073-0074, A liquid core ablation catheter 22 has a laser coupler 24 which is disposed at a proximal end 30 of the ablation catheter 22 and which is coupled to the output coupler 20 of the laser source. The laser system 8 may also include an aiming diode for applications where locating the distal tip 34 of liquid core ablation catheter 22); inserting a vascular therapy device 350 which is different from the optical fiber or fiber bundle through the blood vessel to position the vascular therapy device at the lesion in the blood vessel (Fig. 64, section 0148, Once the blockage has been completely traversed, the AV fistula and adjacent vessels, for example, AVG or vein, may be further treated by treating the neolumen created by the laser ablation process with a drug eluting balloon catheter); and performing a therapy on the lesion in the blood vessel using the vascular therapy device (section 0149, The balloon is also configured to elute materials such as drugs into tissue of the blockage that surrounds the balloon during inflation).
Regarding claim 10, Laudenslager discloses after forming the opening in the lesion (Fig. 59- 60, 63, section 0142, guiding with a support catheter 26', 322 or the like, the distal tip 34 of the laser ablation catheter 22 may be extended by a distance of up to about 5 mm from the distal end 324 of the support catheter ), retracting the optical fiber or fiber bundle from the blood vessel, and inserting a guidewire through the blood vessel and through the opening in the lesion (Fig. 64, section 0108, 0148, The support catheter may then be retracted as shown in. Other devices, such as a balloon or a stent, may then be deployed over this guidewire to achieve the necessary opening diameter in the vessel for adequate blood flow. Once the blockage has been completely traversed, the AV fistula and adjacent vessels, for example, AVG or vein, may be further treated by treating the neolumen created by the laser ablation process with a drug eluting balloon catheter); wherein the vascular therapy device is inserted through the blood vessel along the guidewire (Fig. 64).
Regarding claim 11, Laudenslager discloses the inserting of the optical fiber or fiber bundle 82, 90 includes: inserting a support catheter 26 through the blood vessel 118 and positioning an opening of the support catheter at the lesion 116 (Fig. 30, section 0108, the ablation catheter crosses the lesion); and wherein the optical fiber or fiber bundle is inserted through a central lumen of the support catheter (section 0073, The ablation catheter is disposed within an inner lumen of a support catheter which may be used to guide or support the ablation catheter within a body lumen of a patient).
Regarding claim 12, Laudenslager discloses removing the support catheter 26 from the blood vessel (Fig. 32, 34, section 0108, The support catheter 26 may then be retracted. Other devices, such as a balloon or a stent, may then be deployed over this guidewire to achieve the necessary opening diameter in the vessel for adequate blood flow); and inserting, with the guidewire 56, the vascular therapy device to perform the therapeutic therapy on the lesion (Fig. 64, section 0148, Once the blockage has been completely traversed, the AV fistula and adjacent vessels, for example, AVG or vein, may be further treated by treating the neolumen created by the laser ablation process with a drug eluting balloon catheter).
Regarding claim 13, Laudenslager discloses the therapy comprises one or more of a cutting operation (section 0082, a straight support catheter with a means to angle or otherwise transversely deflect the tip in one or more directions or axes, as shown in FIG. 62, can be used to deflect the tip from a straight configuration to an angled deflected configuration having an angle 59 of up to a 45 degree angle for proper positioning of the ablation catheter cutting tip), a laser ablating operation (Section 0083, during emission of ablation energy suitable for tissue ablation from the distal end of the liquid core ablation catheter 22. This nutation of the ablation energy emitting surface of the liquid core ablation catheter 22 may produce a band or annulus of ablation or tissue removal), or a remodeling operation (Figs. 64-66, , the combination of treating soft spongy blockages with laser ablation and debulking in combination with subsequent treatment by DEB 352 is believed to yield good long term patency results).
Regarding claim 14, Laudenslager discloses the energizing comprises: energizing the at least one optical fiber with a laser having a wavelength ranging from 308 nm to 355 nm (Section 0147, pulsed ultraviolet laser ablation energy from a XeCl excimer laser at a nominal output wavelength of about 308 nm and a repetition rate of less than about 100 Hz may be directed into an input end of the liquid core ablation catheter).
Regarding claim 15, Laudenslager discloses an optical fiber 82, 90 configured for insertion through a lesion 116 in a blood vessel 118, (Fig. 10, section 0108, the ablation catheter 22 crosses the lesion), the optical fiber 82m, 90 having a proximal end 24 and a distal end 34 (Figs. 1-3, section 0073-0074, A liquid core ablation catheter 22 has a laser coupler 24 which is disposed at a proximal end 30 of the ablation catheter 22 and which is coupled to the output coupler 20 of the laser source. The laser system 8 may also include an aiming diode for applications where locating the distal tip 34 of liquid core ablation catheter 22), the proximal end 24 being couplable to an associated laser generator 10 (Fig. 1, section 0073, A liquid core ablation catheter 22 has a laser coupler 24 which is disposed at a proximal end 30 of the ablation catheter 22 and which is coupled to the output coupler 20 of the laser source); and a support catheter 26 insertable into the blood vessel 119 and having a central lumen 28 sized to pass the optical fiber 82, 90 (Fig. 28-30, section 0073, The ablation catheter is disposed within an inner lumen of a support catheter which may be used to guide or support the ablation catheter within a body lumen of a patient).
Regarding claim 16, Laudenslager discloses the optical fiber 82, 90 has a diameter of 1.5 mm or less (section 0103, the output optical window may have an outer diameter or transverse dimension of about 0.5 mm to about 1.5 mm, more specifically, about 0.8 mm to about 1.2 mm).
Regarding claim 17, Laudenslager discloses the optical fiber 82, 90 has an optical output end 82 comprising a square tip or a beveled tip (Fig. 10).
Regarding claim 18, Laudenslager discloses the optical fiber 80, 92 comprises: a glass core layer; a cladding layer surrounding the glass core layer; and a polyimide buffer layer 91 surrounding the cladding layer (section 0102, the input optical window may include a silica core silica clad window, but it may also include an optically polished silica rod that is radially surrounded by an air interface. The input optical window of the ablation catheter may also include a silica rod. The input optical window of the ablation catheter may also include a silica rod that has a low index amorphous fluoropolymer coating).
Regarding claim 19, Laudenslager discloses the optical fiber 80, 92 comprises a hydrophilic coating 91(section 0102, The input optical window of the ablation catheter may also include a silica rod that has a low index amorphous fluoropolymer coating).
Regarding claim 20, Laudenslager discloses a vascular lesion crossing device (Fig. 64); and a vascular therapy device 350 which is different from the single optical fiber or optical fiber bundle 80, 92 (Fig. 64, section 0148, Once the blockage has been completely traversed, the AV fistula and adjacent vessels, for example, AVG or vein, may be further treated by treating the neolumen created by the laser ablation process with a drug eluting balloon catheter) and is configured to treat the lesion in the blood vessel (section 0149, The balloon is also configured to elute materials such as drugs into tissue of the blockage that surrounds the balloon during inflation).
Response to Arguments
Applicant's arguments filed 2/18/2026 have been fully considered but they are not persuasive. Examiner finds that Laudenslager discloses the single optical fiber or optical fiber bundle 82, 90 having a proximal end 24 and a distal end 34 and being couplable to an associated laser generator 10 at the proximal end 24, (Figs. 1-3, section 0073-0074, A liquid core ablation catheter 22 has a laser coupler 24 which is disposed at a proximal end 30 of the ablation catheter 22 and which is coupled to the output coupler 20 of the laser source. The laser system 8 may also include an aiming diode for applications where locating the distal tip 34 of liquid core ablation catheter 22);
Conclusion
THIS ACTION IS MADE FINAL. 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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796