DETAILED ACTION
Applicant's preliminary amendments and remarks, filed 11/6/23, are fully acknowledged by the Examiner. Currently, claims 1-20 are pending with claims 21-54 canceled, and claim 1 amended. The following is a complete response to the 11/6/23 communication.
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 .
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.
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) 1-2, 7-10, 13-14, 16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry (US 2003/0195511).
Regarding claim 1, Barry teaches an electrosurgical access catheter for assisting a physician perform an ancillary surgical procedure on a region of interest (ROI) in a lung of a patient (par. [0039]), the catheter comprising: a tubular shaped elongate shaft (par. [0030] shaft 92), the shaft comprising a proximal section (proximal region within the catheter), a flexible distal section and a distal end (distal region exposed from the distal end of the catheter); a ring-shaped active electrode located at the distal end (electrode 98 as a ring shape at the distal end as in at least Fig. 3); a passageway extending from the proximal section to the distal end (92 with a lumen from the proximal to distal end as in at least Fig. 4), and through the ring-shaped active electrode (98 with a lumen therethrough as in Fig. 4); and an electrical conductor extending from the proximal section to the distal section (connection between 89 and electrode 98), and in electrical contact with the active electrode (connection from electrode 98 through 89 and the generator as in par. [0034]); wherein the proximal section of the elongate shaft is detachably coupled to an electrosurgical controller such that the ring-shaped active electrode is operable with the electrosurgical controller (98 operable via actuation of 86 as in at least par. [0030]-[0032]) and a dispersive electrode (ground electrode 84) to electrosurgically make a circular-shaped incision through an airway wall (par. [0008]), as the ring-shaped active electrode is advanced through the airway wall (Fig. 6, par. [0039]).
Barry is not explicit regarding the proximal section of the elongate shaft being detachably coupled to an electrosurgical controller.It would have been obvious to one of ordinary skill in the art to have a detachable and attachable cable for the electrosurgical controller and the elongate shaft, especially given that foot pedals as the controller 86 are known to have attachable and detachable connections.
Regarding claim 2, Barry teaches wherein the dispersive electrode is a pad affixed to the skin of the patient (ground electrode 84 as pad attached to skin).
Regarding claim 7, Barry teaches the active electrode comprises a blunt distal edge (98 not sharp as in at least Fig. 4).
Regarding claim 8, Barry teaches wherein the ring- shaped active electrode comprises a wall defining a tubular lumen and having an inner diameter of at least 2 mm (par. [0029 nodules of 3 cm diameter, with the electrode 98 to cut around nodules as in par. [0035], such that the diameter of the electrode must be larger than the nodule diameter).
Regarding claim 9, Barry is silent wherein the incision has a diameter less than 3 mm. However, Barry teaches the surgeon may select an inside diameter may vary, and may be smaller than the nodule (par. [0035)).
It would have been obvious to one of ordinary skill in the art to make the diameter a size that may be smaller than 3mm according to the nodule diameter and the procedure to be performed.
Regarding claim 10, Barry teaches wherein the active electrode is operable to cut tissue when a sinusoidal voltage waveform from the electrosurgical controller is applied at a frequency between 300kHz and 500kHz (radiofrequency as in par. [0032)).
Regarding claim 13, Barry teaches wherein the electrical conductor is a stylet (Fig. 4).
Regarding claim 14, Barry teaches an electrosurgical access catheter for assisting a physician perform an ancillary surgical procedure on a region of interest (ROI) in a lung of a patient (par. [0039]), the catheter comprising:
a tubular shaped elongate shaft (par. [0030] shaft 92), the shaft comprising a proximal section (section at a proximal portion of the shaft), a flexible distal section and a distal end (distal region exposed from the distal end of the catheter);
an active electrode located at the distal end (electrode 98 at the distal end), the active electrode comprising a die-shaped body, and an opening extending therethrough (92 with a lumen from the proximal to distal end as in at least Fig. 4);
a passageway extending from the proximal section to the distal end, and through the active electrode (92 with a lumen from the proximal to distal end as in at least Fig. 4, and through 98); and
an electrical conductor extending from the proximal section to the distal section, and in electrical contact with the active electrode (connection between 89 and electrode 98):
wherein the proximal section of the elongate shaft is detachably coupled to an electrosurgical controller such that the active electrode is operable with the electrosurgical controller (98 operable via actuation of 86 as in at least par. [0030]-[0032]) and a dispersive electrode (84) to electrosurgically make an incision through an airway wall corresponding to the shape of the die shaped body as the active electrode is advanced through the airway wall (Fig. 6, par. [0039]).Barry is not explicit regarding the proximal section of the elongate shaft being detachably coupled to an electrosurgical controller.It would have been obvious to one of ordinary skill in the art to have a detachable and attachable cable for the electrosurgical controller and the elongate shaft, especially given that foot pedals as the controller 86 are known to have attachable and detachable connections.
Regarding claim 16, Barry teaches wherein the active electrode has a cross sectional shape of an annulus (Fig. 4).
Regarding claim 19, Barry teaches the active electrode comprises a blunt distal edge (98 not sharp as in at least Fig. 4).
Regarding claim 20, Barry teaches an electrosurgical guide assembly for assisting a physician perform an ancillary surgical procedure on a region of interest (ROI) in a lung of a patient (par. [0039]) comprising:
an elongate guide member (par. [0030] shaft 92), the guide member comprising a proximal section (proximal region within the catheter), an intermediate section (between proximal and distal section), and a distal section (distal region exposed from the distal end of the catheter), and an active electrode located in the distal section (electrode 98):
an electrical conductor extending from the proximal section to the distal section of the guide member (connection between 89 and electrode 98), and in electrical contact with the active electrode (connection from electrode 98 through 89 and the generator as in par. [0034]);
an elongate flexible access sheath coaxially advanceable over the elongate guide member (89); and wherein the proximal section of the elongate guide member is detachably coupled to an electrosurgical controller (98 operable via actuation of 86 as in at least par. [0030]-[0032]) such that the active electrode is operable with the electrosurgical controller and a dispersive electrode (84) to electrosurgically make an incision through an airway wall as the active electrode is activated and advanced through the airway wall (Fig. 6, par. [0039]).
Claim(s) 3-4 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of Ormsby (US 2007/0066972).
Regarding claim 3, Barry teaches wherein the shaft comprises an outer polymer layer.However, Ormsby teaches layers of polymer material at the catheter as in at least par. [0009] and [0026].It would have been obvious to one of ordinary skill in the art to modify Barry with the layer of polymer on the shaft as in Ormsby, as a known material that is bio-compatible with the body (par. [0026].
Regarding claim 4, Barry is silent regarding wherein the electrical conductor is a braid coaxially arranged and extending from the proximal section to the distal end of the shaft.However, Ormsby teaches an electrical conductor as a braided wire 260 coaxial with the shaft from the proximal to distal direction (fig. 3a and par. [0029]).
It would have been obvious to one of ordinary skill in the art to modify the electrical conductor of Barry to be a braided wire construction as in Ormsby, to provide a desired level of strength (par. [0027]).
Regarding claim 11, Barry is silent wherein the electrical conductor has a flexibility effecting form selected from the group consisting of variable braid pitch, transition from braid to a coil, and variable thickness.However, Ormsby teaches an electrical conductor as a braided wire having a coil transition from the proximal to distal direction (fig. 3a and pars. [0028]-[0029] with 255 and 120).It would have been obvious to one of ordinary skill in the art to modify Barry with the flexibility of Ormsby, to preferentially vary flexibility along the shaft.
Regarding claim 12, Barry is silent wherein the electrical conductor is axially movable and separable from the shaft.However, Ormsby teaches an electrical conductor as a braided wire 260 coaxial with the shaft from the proximal to distal direction (fig. 3a and par. [0029]).It would have been obvious to one of ordinary skill in the art to modify Barry with the electrical conductor of Ormsby.
Claim(s) 5 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of Swanson (US 2005/0119653).
Regarding claim 5, Barry is silent regarding wherein the active electrode has a length less than or equal to 1 mm.
Swanson teaches an ablation catheter system comprising an electrode with a length of less than 1 mm (114 with a 0.5 mm length as in par. [0133]).
It would have been obvious to one of ordinary skill in the art to modify Barry with the length of the electrodes of Swanson as a known electrode length capable of treating tissue.
Regarding claim 17, Barry is silent regarding wherein the active electrode has a length less than or equal to 1 mm.
Swanson teaches an ablation catheter system comprising an electrode with a length of less than 1 mm (114 with a 0.5 mm length as in par. [0133]).
It would have been obvious to one of ordinary skill in the art to modify Barry with the length of the electrodes of Swanson as a known electrode length capable of treating tissue.
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of Mauch (US 2012/0197246).
Regarding claim 6, Barry is silent wherein the active electrode is made of a material visible under fluoroscopy.
Mauch teaches an electrode made with material visible under fluoroscopy (140 viewable under fluoroscopy as they are radiopaque as in par. [0042]).
It would have been obvious to one of ordinary skill in the art to make the electrode of Barry radiopaque as in Mauch, to allow for viewing during a procedure.
Regarding claim 18, Barry is silent wherein the active electrode is made of a material visible under fluoroscopy.
Mauch teaches an electrode made with material visible under fluoroscopy (140 viewable under fluoroscopy as they are radiopaque as in par. [0042]).
It would have been obvious to one of ordinary skill in the art to make the electrode of Barry radiopaque as in Mauch, to allow for viewing during a procedure.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of Eggers (US 5,843,019).
Regarding claim 15, Barry is silent regarding the electrode having a C-ring profile.
However, Eggers teaches electrodes having a c-shape for directional treatment (col. 21, lines 4- 7).
It would have been obvious to one of ordinary skill in the art to modify Barry with the electrode shape of Eggers to allow for a directional treatment shape, allowing for more control.
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 1, 7-8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,832,877. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '877 patent anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim 1 is taught by patented claim 6.
Claim 7 is taught by patented claim 8.
Claim 8 is taught by patented claim 5.
Claim 14 is taught by patented claim 1.
Conclusion
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794