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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/16/2025 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 Line 16 reading “to send signals” should read --to send the signals--. Appropriate correction is required.
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); an RF loop electrode (46) carried at a distal end of a cutting sleeve (42) extending through a bore in the elongated introducer member to the handle (28) (Ciccone ¶ 0067-0068, 0071; Figs. 4-5); 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) configured to rotate the cutting sleeve (42) (Ciccone ¶ 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 cutting sleeve (42) 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 signals to a controller; and wherein the second motor is powered by an electrical source and comprises a second encoder motor configured to send the 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 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 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 signals to a controller; and wherein the second motor is powered by an electrical source and comprises a second encoder motor configured to send the 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 with respect to Claims 1-6, 8-15 and 31 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.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783