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 .
Election/Restrictions
Applicant’s election without traverse of group II claims, claim 11-21, in the reply filed on 08/24/2026 is acknowledged.
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 (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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160120602 to Ransbury et al. (hereinafter “Ransbury”) in view of US 20240099773 to Schabert.
Regarding claim 11. Ransbury discloses a method for treating a lesion of a body lumen (abstract, para 0009, etc.), comprising: advancing a shock wave catheter through the body lumen without use of a guidewire such that at least one shock wave emitter enclosed within an enclosure of the shock wave catheter is disposed proximate to the lesion of the body lumen (para 0009 “advancing a distal tip of an ablation catheter to a tissue in need of ablation”, para 0042, “The catheter body 142 may be made of a biocompatible material, and may be sufficiently flexible to enable steering and advancement of the catheter 140 to a site of ablation” – hence, not using a guidewire); and generating at least one shock wave by the at least one shock wave emitter to treat the lesion (para 0023, 0042 “RF generator”).
Ransbury, provides a method for delivering ablation energy to the tissue but fails to disclose “treating the lesion” (para 0003-0004, fig. 2, para 0031). It would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify the disclosure of Ransbury with the teachings of Schabert to provide the predictable result of treating the lesion formed.
Regarding claim 12. Ransbury as modified by Schabert renders obvious the method of claim 11, wherein the shock wave catheter comprises a core wire extending within the shock wave catheter and coupled to a distal portion of the shock wave catheter and to a switch at a proximal end of the shock wave catheter (para 0035, 0047 “wire” “control”/”workstation 120”), and the method comprises engaging the switch to control deflection of the distal portion of the shock wave catheter (para 0035).
Regarding claim 13. Ransbury as modified by Schabert renders obvious the method of claim 11, comprising, prior to generating the at least one shock wave, filling the enclosure with a conductive fluid (para 0033, 0051 “saline into the catheter”).
Regarding claim 14. Ransbury as modified by Schabert renders obvious the method of claim 11, wherein generating the at least one shock wave by the at least one shock wave emitter comprises generating one or more energy pulses by a pulse generator electrically coupled to the at least one shock wave emitter (Schabert, figs 1 and 2), the one or more energy pulses causing the at least one shock wave emitter to generate the at least one shock wave (Schabert, figs 1 and 2, para 0033).
Regarding claim 15. Ransbury as modified by Schabert renders obvious the method of claim 14, wherein generating the one or more energy pulses by the pulse generator comprises generating a series of energy pulses that cause the at least one shock wave emitter to generate a series of shock waves in accordance with a frequency between 1 Hz and 5 Hz (such values are considered to be an obvious design choice. The skilled artisian is expected to experiment with frequency and to best treat a given patient; see US 20220280765 to Tabriliran et al and/or CA3204915A1 to Phan et al. as an exemplary evidence).
Regarding claim 16. The method of claim 14, wherein generating the one or more energy pulses by the pulse generator comprises generating one or more voltage pulses that cause the at least one shock wave emitter to generate the at least one shock wave, wherein the one or more voltage pulses comprises a voltage between 0.5 kV and 10.0 kV (such values are considered to be an obvious design choice. The skilled artisian is expected to experiment with voltage and to best treat a given patient; see US 20220280765 to Tabriliran et al and/or CA3204915A1 to Phan et al. as an exemplary evidence).
Regarding claim 17. Ransbury as modified by Schabert renders obvious the method of claim 14, wherein generating the one or more energy pulses by the pulse generator comprises generating one or more laser pulses that cause the at least one shock wave emitter to generate the at least one shock wave (Schabert, para 0003-0004, 0030 “using an optical energy source”).
Regarding claim 18. Ransbury as modified by Schabert renders obvious the method of claim 11, comprising using the shock wave catheter as a guidewire for a balloon catheter device (such is considered to be intended use, not a structural limitation. One could use the device for any purpose as desired).
Regarding claim 19. Ransbury as modified by Schabert renders obvious the method of claim 11, wherein an outer diameter of the shock wave catheter is between 0.25-1 mm (such dimensions are considered to be an obvious design choice. See In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.).
Regarding claim 20. Ransbury as modified by Schabert renders obvious the method of claim 11, wherein an internal volume of the enclosure is less than 1.5 cm3 (such dimensions are considered to be an obvious design choice. See In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.).
Regarding claim 21. Ransbury as modified by Schabert renders obvious the method of claim 11, wherein at least a portion of the shock wave catheter comprises a coil, a plurality of slits, a braided portion, or a combination thereof (Schabert, para 0035, “grooves” which are considered to be an obvious variant of slits).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,178,458. Although the claims at issue are not identical, they are not patentably distinct from each other. See details below.
11. A method for treating a lesion of a body lumen, comprising: advancing a shock wave catheter through the body lumen without use of a guidewire such that at least one shock wave emitter enclosed within an enclosure of the shock wave catheter is disposed proximate to the lesion of the body lumen; and generating at least one shock wave by the at least one shock wave emitter to treat the lesion.
1. A shock wave catheter for treating a lesion of a body lumen, the shock wave catheter comprising: an elongate tube;at least one shock wave emitter disposed distal to the elongate tube and configured to generate at least one shock wave; []
12. The method of claim 11, wherein the shock wave catheter comprises a core wire extending within the shock wave catheter and coupled to a distal portion of the shock wave catheter and to a switch at a proximal end of the shock wave catheter, and the method comprises engaging the switch to control deflection of the distal portion of the shock wave catheter.
18. The system of claim 15, wherein the system comprises a switch coupled to the core wire to control the deflection of the distal portion of the shock wave catheter.
13. The method of claim 11, comprising, prior to generating the at least one shock wave, filling the enclosure with a conductive fluid.
10. The shock wave catheter of claim 1, comprising a first fluid lumen
14. The method of claim 11, wherein generating the at least one shock wave by the at least one shock wave emitter comprises generating one or more energy pulses by a pulse generator electrically coupled to the at least one shock wave emitter, the one or more energy pulses causing the at least one shock wave emitter to generate the at least one shock wave.
1 generate at least one shock wave;[]
15. The method of claim 14, wherein generating the one or more energy pulses by the pulse generator comprises generating a series of energy pulses that cause the at least one shock wave emitter to generate a series of shock waves in accordance with a frequency between 1 Hz and 5 Hz.
16. The system of claim 15, wherein the pulse generator is configured to generate the energy pulses with a frequency between 1 Hz and 5 Hz and a voltage between 0.5 kV and 10.0 kV.
16. The method of claim 14, wherein generating the one or more energy pulses by the pulse generator comprises generating one or more voltage pulses that cause the at least one shock wave emitter to generate the at least one shock wave, wherein the one or more voltage pulses comprises a voltage between 0.5 kV and 10.0 kV.
16. The system of claim 15, wherein the pulse generator is configured to generate the energy pulses with a frequency between 1 Hz and 5 Hz and a voltage between 0.5 kV and 10.0 kV.
17. The method of claim 14, wherein generating the one or more energy pulses by the pulse generator comprises generating one or more laser pulses that cause the at least one shock wave emitter to generate the at least one shock wave.
17. The system of claim 15, wherein the pulse generator is configured to generate one or more laser pulses to cause the at least one shock wave emitter to generate the at least one shock wave.
18. The method of claim 11, comprising using the shock wave catheter as a guidewire for a balloon catheter device.
19. The method of claim 11, wherein an outer diameter of the shock wave catheter is between 0.25-1 mm.
12. The shock wave catheter of claim 1, wherein an outer diameter of the shock wave catheter is between 0.25-1 mm.
20. The method of claim 11, wherein an internal volume of the enclosure is less than 1.5 cm3.
4. The shock wave catheter of claim 1, wherein an internal volume of the enclosure is less than 1.5 cm3.
21. The method of claim 11, wherein at least a portion of the shock wave catheter comprises a coil, a plurality of slits, a braided portion, or a combination thereof.
2. The shock wave catheter of claim 1, wherein at least a portion of the elongate tube comprises a coil or a plurality of slits.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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/SANA SAHAND/Examiner, Art Unit 3796
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