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 § 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.
Claims 1-3, 5, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ciccone et al. (USPGPub 2018/0125567) in view of Hsu et al. (USPGPub 2019/0133676).
Re Claim 1, Ciccone teaches an electrosurgical device (10) (Ciccone Figs. 3-5), comprising: a handle (28) coupled to an elongated introducer member (12) extending about a central axis to a working end (68) (as seen in Ciccone Fig. 5), wherein the elongated introducer member (12) has an outer surface that defines an introducer envelope (as seen in Ciccone Fig. 5); a cutting sleeve (42) extending through a bore in the elongate introducer member (12) to the handle (28) (Ciccone Fig. 4; ¶ 0067); an RF loop electrode (46) at a distal end of the cutting sleeve (42) (Ciccone ¶ 0067-0068, 0071; Figs. 4-5); an electrode shaft (as seen in Ciccone Fig. 5; ¶ 0067 - connected at its proximal end to cable 20) extending through the cutting sleeve (42), wherein the RF loop electrode (46) is at a distal end of the electrode shaft (as can be seen in embodiment of Ciccone Fig. 2C); an actuator (32) in the handle (28) adapted for moving the RF loop electrode (46) between a first position within the introducer envelope (as seen in Ciccone Fig. 11) and at least one second position (Ciccone Fig. 5) radially outward from the introducer envelope (Ciccone ¶ 0074-0075); a first drive motor (30) in the handle (28) coupled to a proximal end of the electrode shaft and configured to rotate the electrode shaft (Ciccone Claim 4; ¶ 0068, 0072-0073, 0077-0085 - wherein motor is being interpreted broadly to mean anything that converts one form of energy into mechanical motion); a second motor drive (32) in the handle (28) configured for axial extension and retraction of the RF loop electrode (46) from a distal end of the bore of the elongated introducer member (12) (Ciccone ¶ 0068, 0103 - wherein motor is being interpreted broadly to mean anything that converts one form of energy into mechanical motion), and wherein the RF loop electrode (46) cuts a spiral path in a tissue upon actuation of the first motor drive (30) and the second motor drive (32) (Ciccone ¶ 0077-0085).
However, Ciccone fails to teach wherein the first motor is powered by an electrical source and comprises a first encoder motor configured to send a first plurality of signals to a controller; and wherein the second motor is powered by an electrical source and comprises a second encoder motor configured to send a second plurality of signals to the controller. Hsu teaches an electrosurgical device (400) comprising an RF electrode (425) and a handle (416) (Hsu Fig. 8), a first motor drive in the handle (416), wherein the first motor drive is powered by an electrical source and comprises a first encoder motor configured to send a first plurality of signals to a controller (Hsu ¶ 0081); a second motor drive in the handle (416), wherein the second motor drive is powered by the electrical source and comprises a second encoder motor configured to send a second plurality of signals to the controller (Hsu ¶ 0081-0088), the configuration for precision control of the RF electrode (Hsu ¶ 0081-0088). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the first motor and second motor of Hsu such that the first motor is powered by an electrical source and comprises a first encoder motor configured to send a first plurality of signals to a controller; and wherein the second motor is powered by an electrical source and comprises a second encoder motor configured to send a second plurality of signals to the controller, such a motor configuration as disclosed by Hsu for precision control of the RF electrode (Hsu ¶ 0081-0088).
Re Claim 2, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the spiral path includes at least one 360° rotation of the cutting sleeve (42) and RF loop electrode (46) (Ciccone ¶ 0068, 0072-0073, 0077-0085).
Re Claim 3, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the spiral path comprises from two to eight 360° rotations of the cutting sleeve (42) and RF loop electrode (46) (Ciccone ¶ 0068, 0072-0073, 0077-0085).
Re Claim 5, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the second motor driven (32) provides a fixed pitch of the spiral path (Ciccone ¶ 0068, 0072-0073, 0077-0085).
Re Claim 8, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the first motor drive (30) rotates the cutting sleeve (42) in a first rotational direction in the extension of the cutting sleeve (42) and an opposing rotational direction in the retraction of the cutting sleeve (42) (Ciccone ¶ 0068, 0072-0073, 0077-0085).
Re Claim 9, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone fails to teach wherein the motor-driven mechanism rotates the cutting sleeve in the same rotational direction in the extension of the cutting sleeve and in the retraction of the cutting sleeve. However, Ciccone does teach wherein the motor-driven mechanism (30) rotates the cutting sleeve (42) in a first rotational direction in the extension of the cutting sleeve (42) and an opposing rotational direction in the retraction of the cutting sleeve (42) (Ciccone ¶ 0068, 0072-0073, 0077-0085). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to have the motor-driven mechanism rotate the cutting sleeve in the same rotational direction in the extension of the cutting sleeve and in the retraction of the cutting sleeve, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Re Claim 10, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the actuator (32) is adapted to move the RF loop electrode to a plurality of selected positions radially outward from the introducer envelope (Ciccone ¶ 0072-0085).
Re Claim 11, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the actuator (32) in the handle is manually operated (Ciccone ¶ 0074-0075).
Re Claim 12, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone further teaches wherein the RF loop electrode (28) in the first position is retracted into the bore of the elongated introducer member (12) (Ciccone ¶ 0082; Fig. 11).
Claims 4 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ciccone et al. (USPGPub 2018/0125567) in view of Hsu et al. (USPGPub 2019/0133676) as applied to Claim 1 above, and further in view of Hsu et al. (USPGPub 2021/0059748), hereinafter Hsu'748.
Re Claim 4, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone fails to teach wherein the spiral path defines a stroke having an axial length that ranges from 5 mm to 20 mm. Hsu'748 teaches an electrosurgical device (100) (Hsu'748 Fig. 3; ¶ 0063), comprising: a handle (162) coupled to an elongated introducer member (550), wherein the elongated introducer member (550) has an outer surface that defines an introducer envelope (as seen in Hsu'748 Figs. 4A-6); an RF loop electrode (645) carried at a distal end of a cutting sleeve (610) extending through a bore in the elongated introducer member (550) to the handle (162) (Hsu'748 Fig. 1); and a motor-driven mechanism (622) in the handle (162) configured for extension and retraction of the cutting sleeve (42) in a spiral path from a distal end of the bore of the elongated introducer member (550) (Hsu'748 ¶ 0076), wherein the spiral path defines a stroke having an axial length that ranges from 4 mm to 10 mm (Hsu'748 ¶ 0079). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005) (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 4 mm to 10 mm (Hsu'748 ¶ 0079) substantially overlaps and thus anticipates the claimed range of 5 mm to 20 mm.
Re Claim 13, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone fails to teach wherein an outer diameter of the elongated introducer member is 5 mm or less. Hsu'748 teaches an electrosurgical device (100) (Hsu'748 Fig. 3; ¶ 0063), comprising: a handle (162) coupled to an elongated introducer member (550) (as seen in Hsu'748 Figs. 4A-6), an outer diameter of the elongated introducer member is from about 2 mm to 6 mm (Hsu'748 ¶ 0064, 0075). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 2 mm to 6 mm (Hsu'748 ¶ 0064, 0075) substantially overlaps and thus anticipates the claimed range of 5 mm or less.
Re Claim 14, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone fails to teach wherein an outer diameter of the elongated introducer member is from 2.5 mm to 10 mm. Hsu'748 teaches an electrosurgical device (100) (Hsu'748 Fig. 3; ¶ 0063), comprising: a handle (162) coupled to an elongated introducer member (550) (as seen in Hsu'748 Figs. 4A-6), an outer diameter of the elongated introducer member is from about 2 mm to 6 mm (Hsu'748 ¶ 0064, 0075). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. (anticipation found even where prior art range was not identical to claimed ranges)); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 2 mm to 6 mm (Hsu'748 ¶ 0064, 0075) substantially overlaps and thus anticipates the claimed range of 2.5 mm to 10 mm.
Re Claim 15, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone fails to teach wherein the RF loop electrode comprises a wire having a diameter 0.015" to 0.025". Hsu'748 teaches an electrosurgical device (100) (Hsu'748 Fig. 3; ¶ 0063), comprising: a handle (162) coupled to an elongated introducer member (550), wherein the elongated introducer member (550) has an outer surface that defines an introducer envelope (as seen in Hsu'748 Figs. 4A-6); an RF loop electrode (645) carried at a distal end of a cutting sleeve (610) extending through a bore in the elongated introducer member (550) to the handle (162) (Hsu'748 Fig. 1), wherein the RF loop electrode comprises a wire having a diameter of less than 0.020" (Hsu'748 ¶ 0099). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005) (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of less than 0.020" (Hsu'748 ¶ 0099) substantially overlaps and thus anticipates the claimed range of 0.015" to 0.025".
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ciccone et al. (USPGPub 2018/0125567) in view of Hsu et al. (USPGPub 2019/0133676) as applied to Claim 1 above, and further in view of Govari (USPGPub 2004/0254458).
Re Claim 6, Ciccone in view of Hsu teach all of the limitations of Claim 1. However, Ciccone in view of Hsu fail to teach wherein the motor-driven mechanism allows for selection of pitch of the spiral path. Govari teaches a system comprising a motor-driven mechanism (34, 77) calibrated via a computer (Govari ¶ 0016, 0028, 0073, 0117), said motor-driven mechanism (34, 77) adapted to position a catheter (20), wherein the motor-driven mechanism (34, 77) allows for selection of pitch of a spiral path (Govari ¶ 0016, 0028, 0073, 0117), wherein the motor- driven mechanism (34, 77) allows for precise placement of the catheter during a medical procedure (Govari ¶ 0014-0015). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the motor-driven mechanism of Ciccone in view of Hsu to allow for selection of pitch of the spiral path as disclosed by Govari wherein the system provided for in Govari allows for precise placement of the catheter during a medical procedure (Govari ¶ 0014-0015).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Ciccone et al. (USPGPub 2018/0125567) in view of Hsu et al. (USPGPub 2019/0133676) as applied to Claim 1 above, and further in view of Burbank et al. (USPGPub 2002/0193705).
Re Claim 31, Ciccone in view of Hsu teach all of the limitations of Claim 1. Ciccone in view of Hsu fail to teach wherein the cutting sleeve comprises a slot through which the RF loop electrode rotates out of. Burbank teaches an electrosurgical device (Hsu Fig. 1) comprising a sleeve (152), said sleeve (152) comprising a slot (162) through which an RF loop electrode (138) rotates out of (Burbank ¶ 0056; Figs. 9-10), the embodiment for shielding the RF loop electrode prior to and after lateral extension of the RF loop electrode (Burbank ¶ 0014, 0056; Figs. 9-10). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the cutting sleeve of Ciccone in view of Hsu to comprise a slot through which the RF loop electrode rotates out of as disclosed by Burbank for shielding the RF loop electrode prior to and after lateral extension of the RF loop electrode (Burbank ¶ 0014, 0056; Figs. 9-10).
Response to Arguments
Applicant’s arguments filed 04/15/2026 with respect to claim objection of Claim 1 have been fully considered and are persuasive. Due to clarifying amendments, objection to Claim 1 of the present case is hereinafter withdrawn.
Applicant's arguments filed 04/15/2026 have been fully considered but they are not persuasive. Near the top of Page 11 of the response, applicant argues Ciccone's inner sheath 42 is not a "cutting sleeve" in the claimed sense. However, applicant has not included any functional limitations that indicate the “cutting sleeve” performs any function other than having the RF loop electrode extend therethrough. Furthermore, the electrode shaft is an independent member from that of the inner sheath, regardless of it rotating with the inner sheath (Ciccone Fig. 5; ¶ 0067 - connected at its proximal end to cable 20; and as can be seen in embodiment of Fig. 2C). Although the motor in Ciccone rotates the cutting sleeve and electrode shaft together, it is coupled to a proximal end of the cutting sleeve and therefore, “coupled to a proximal end of the electrode shaft” where the cutting sleeve and electrode shaft are coupled to one another. Applicant is not claiming the electrode shaft rotates in relation to the cutting sleeve.
In the following paragraph of Page 8 of the response, applicant argues Ciccone failing to teach an electrode shaft extending through a cutting sleeve and that the loop 46 is coupled to a loop power cable that passes through the collar 58 and cone 54 and is mechanically connected to the trigger 32 for lateral extension and retraction. In the embodiment of Fig. 2C, the electrode shaft is referenced as element 530. The embodiment of Figs. 4-6 appears to have the exact same structure (as can be seen in Ciccone Fig. 5). Examiner is interpreting this electrode wire tube as the electrode shaft. In the last paragraph of Page 8 of the response, applicant argues the first motor in Hsu is configured to move electrode 425 in a lateral sweeping arc across tissue-receiving window 420, a windshield-wiper type oscillation within a ceramic housing 418. Examiner has interpreted this lateral sweep as rotational movement as it occurs about a central axis.
In the first full paragraph of Page 9 of the response, applicant argues the second motor in Hsu is configured to reciprocate the working end 415 and sleeve 428 axially relative to the handle, providing a retracting and extending stroke of the entire working end assembly during a tissue resection procedure. Applicant goes on to argue this axial reciprocation of the working end assembly is not the same as the claimed second motor drive configured for axial extension and retraction of the RF loop electrode from a distal end of the bore of the elongated introducer member. However, Hsu is only relied upon to teach “the second motor is powered by an electrical source and comprises a second encoder motor configured to send a second plurality of signals to the controller.” Primary reference Ciccone was relied upon to teach the second motor drive configured for axial extension and retraction of the RF loop electrode from a distal end of the bore of the elongated introducer member. In the second full paragraph of Page 9 of the response, applicant argues Hsu's control architecture is directed to coordinating RF energy delivery, negative pressure, and axial stroke timing, not to the independent encoder-based control of shaft rotation and loop extension with different signals as claimed. However, the configuration of Hsu comprises two separate motors for perfuming two separate functions and thus, must comprise independent encoder-based control of shaft rotation and loop extension with different signals. The above arguments are applicable to the remainder of applicant’s response.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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