DETAILED ACTION
This action is pursuant to the claims filed on July 26, 2024. Claims 1-19 are pending. A first action on the merits of claims 1-19 is as follows.
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 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 of this title, 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 4-8, 10-13, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Baker (U.S. Pat. No. 6,113,598), and further in view of Gines (U.S. Pat. No. 6,033,399).
In regards to independent claim 1 & 6, Baker discloses an electrosurgical vessel sealing system (system in Fig. 9) including:
an electrosurgical generator (power controller and software 70, RF source, and Display in Fig. 9), comprising:
a power supply (RF source 60 in Fig. 9) configured for generating radiofrequency (RF) power having an output voltage, (col. 8, ln. 46-57: the RF current that flows to the electrodes 50A and 50B is a function of the voltage of the RF current), an output current (col. 8, ln. 46-57: “RF source or generator 60 is provided for delivering RF current to active bi-polar electrodes 50A and 50B”) and an output power (col. 3, ln. 37-38: “RF energy delivery [through first and second bi-polar electrodes] at very low power levels”);
control circuitry (power controller and software 70 in Fig. 9) configured to control delivery of the RF power to tissue being sealed by a tissue sealing device (bipolar instrument comprising jaw structures jaws 30A and 30B in Figs. 3A-3B) electrically connected to the generator (col. 11, ln. 55-col. 12: “Power controller 70 is adapted to control delivery of RF power in a bi-polar manner between paired electrodes 50A and 50B… The power controller 70, which typically includes microprocessor 160 together with appropriate software…”; col. 12, ln. 13-38: the power controller 70 uses feedback information such as impedance or temperature to terminate power delivery after the target vessel forms a biological glue or vessel sealing),
wherein the power is being delivered for a limited period of time, wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, wherein the limited period of time is no greater than 5 seconds (col. 10, ln. 26-36: “an elongate weld 125 is created where the proteins (including collagen) are denatured, then intermix, and then fuse together upon cooling to fuse the vessel walls together… the duration of RF delivery may range from about 1.0 seconds to about 30.0 seconds”), and
wherein the control circuitry is configured to hold the output power under 35 Watts (col. 10, ln. 15-25: “RF current ranging in power from 0.50 to 30 Watts for sealing lumens in organs”).
However, Baker fails to disclose that the power is a non-pulsing radiofrequency (RF) power.
Gines teaches a control circuitry (controller 12 in Fig. 1) configured to control delivery of RF power via a power supply (R.F. output Stage 13 in Fig. 1). Gines explains that electrical engineers will recognize that output power from an electrosurgical generator can be adjusted in several ways, one of which is the amplitude of the output power, changing the duty cycle or the crest factor (col. 6, ln. 40-49) and specifically, Gines teaches that the control circuitry can continuously apply power in a non-pulsing manner (standard electrosurgical output power shown in Fig. 2a) or adaptively by applying power in a cyclical or pulsing manner (adaptive output power as shown in Fig. 3a, col. 8, ln. 43-60). Given that Baker discloses that the power for sealing is between 0.50 to 30 Watts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to apply a continuous, non-pulsed, output power or adaptive, pulsed output power that oscillates to a low output power from a high output power as taught by Gines, as providing a relatively low output power (e.g. 0.50 to 30 Watts), whether delivered continuously or in a cyclic manner, provides a complete vessel seal and prevent electrical sparks or arcs, from passing through the tissue and burning small holes in a newly sealed or welded tissue (col. 7, ln. 5-22).
In regards to claim 2, Baker/Gines combination further discloses wherein the tissue is a portion of a blood vessel (col. 4, ln. 59-61: “The apparatus and methods of the present invention may be used to seal or weld blood vessels in a number of different procedures”).
In regard to claims 4-5, in view of the combination as set forth above, Gines further teaches that during the non-pulsing low power delivery (about 35 Watts of less between 1.75 sec and 3.75 sec in Fig. 2a and between 1.5 sec and 3.75 sec in Fig. 3a), the output current is between 0 and 2.5 Amperes RMS (see Figs. 2c and 3c) and the output voltage is between 0 to 120 Volts RMS (see Figs. 2d and 3d). Given that Baker teaches a low power delivery, and Gines illustrates that during low power delivery, the output current and voltage operate within the ranges recited in the current claim, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have claimed the teachings of Gines to arrive at the claimed output current and output voltage ranges since it is known in the art that during non-pulsing low power delivery (less than 35 Watts) that the output current is between 0 and 2.5 Amperes RMS (see Figs. 2c and 3c) and the output voltage is between 0 to 120 Volts RMS as exemplified by Gines.
In regards to independent claims 7, 11-12 and 15, Baker discloses Baker discloses an electrosurgical vessel sealing system (system in Fig. 9) including:
an electrosurgical generator (power controller and software 70, RF source, and Display in Fig. 9), comprising:
a power supply (RF source 60 in Fig. 9) configured for generating radiofrequency (RF) power having an output voltage, (col. 8, ln. 46-57: the RF current that flows to the electrodes 50A and 50B is a function of the voltage of the RF current), an output current (col. 8, ln. 46-57: “RF source or generator 60 is provided for delivering RF current to active bi-polar electrodes 50A and 50B”) and an output power (col. 3, ln. 37-38: “RF energy delivery [through first and second bi-polar electrodes] at very low power levels”);
control circuitry (power controller and software 70 in Fig. 9) configured to control delivery of the RF power to tissue being sealed by a tissue sealing device (bipolar instrument comprising jaw structures jaws 30A and 30B in Fig. 3A-3B) electrically connected to the generator (col. 11, ln. 55-col. 12: “Power controller 70 is adapted to control delivery of RF power in a bi-polar manner between paired electrodes 50A and 50B… The power controller 70, which typically includes microprocessor 160 together with appropriate software…”; col. 12, ln. 13-38: the power controller 70 uses feedback information such as impedance or temperature to terminate power delivery after the target vessel forms a biological glue pr vessel sealing),
wherein the power is being delivered for a limited period of time, wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, wherein the limited period of time is no greater than 5 seconds (col. 10, ln. 26-36: “an elongate weld 125 is created where the proteins (including collagen) are denatured, then intermix, and then fuse together upon cooling to fuse the vessel walls together… the duration of RF delivery may range from about 1.0 seconds to about 30.0 seconds”), and
wherein the control circuitry is configured to hold the output power under 35 Watts (col. 10, ln. 15-25: “RF current ranging in power from 0.50 to 30 Watts for sealing lumens in organs”).
However, Baker fails to disclose that the power is a non-pulsing radiofrequency (RF) power and to limit the output current to float up to no more than 2 Amperes RMS throughout the limited period of time or to limit the output voltage to float up to no more than 100 Volts RMS throughout the limited period of time.
Gines teaches a control circuitry (controller 12 in Fig. 1) configured to control delivery of RF power via a power supply (R.F. output Stage 13 in Fig. 1). Gines explains that electrical engineers will recognize that output power from an electrosurgical generator can be adjusted in several ways, one of which is the amplitude of the output power, changing the duty cycle or the crest factor (col. 6, ln. 40-49) and specifically, the control circuitry can continuously apply power in a non-pulsing manner (standard electrosurgical output power is shown in Fig. 2a) or adaptively by applying power in a cyclical or pulsing manner (adaptive output power as shown in Fig. 3a, col. 8, ln. 43-60). Given that Baker discloses that the power for sealing is between 0.50 to 30 Watts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to apply a continuous, non-pulsed, output power or adaptive, pulsed output power that oscillates to a low output power from a high output power as taught by Gines, as providing a relatively low output power (e.g. 0.50 to 30 Watts), whether delivered continuously or in a cyclic manner, provides a complete vessel seal and prevent electrical sparks or arcs, from passing through the tissue and burning small holes in a newly sealed or welded tissue (col. 7, ln. 5-22).
Furthermore, Gines further teaches that during the non-pulsing low power delivery (about 35 Watts of less between 1.75 sec and 3.75 sec in Fig. 2a and between 1.5 sec and 3.75 sec in Fig. 3a), the output current is between 0 and 2.5 Amperes RMS (see Figs. 2c and 3c) and the output voltage is between 0 to 120 Volts RMS (see Figs. 2d and 3d). Given that Baker teaches a low power delivery, and Gines illustrates that during low power delivery, the output current and voltage operate within the ranges recited in the current claim, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have claimed the teachings of Gines to arrive at the claimed invention since it is known in the art that during non-pulsing low power delivery (less than 35 Watts) that the output current is between 0 and 2.5 Amperes RMS (see Figs. 2c and 3c) and the output voltage is between 0 to 120 Volts RMS as exemplified by Gines and limiting the output current and output voltage to provide the desired output power involves routine skilled in the art.
In regard to claims 8 and 13, see the rejection of claim 2 above.
In regard to claims 17-19, in view of the combination in claim 1, 7 or 12, Gines further teaches a power control system that substantially reduces the power delivered to the vessel being sealed by 60%-80% (e.g. 100 watts to 20 watts) when tissue desiccation is determined. Gines further explains that determining an optimal point of desiccation using a threshold impedance is known in the art such that when the impedance of the tissue reaches the threshold impedance, power is adjusted by either termination or reduction (col. 2, ln. 1-8). Given that Baker teaches measuring impedance and terminating based upon a predetermined impedance threshold, it would have been obvious to modify the control circuitry of Baker/Gines combination and further configuring the circuitry to hold the RF power at a first power output level and substantially reducing the power delivered to the vessel being sealed by 80% prior to termination based upon an impedance threshold associated with tissue desiccation, as doing so ensures that a successful seal is achieved (col. 3, ln. 5-40; col. 8, ln. 18-29).
Claims 3, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Baker and Gines, and further in view of McClurken et al. (hereinafter ‘McClurken’, U.S. PGPub. No. 2005/0010212).
In regard to claims 3, 9 and 14, Baker/Gines combination discloses the invention substantially as claimed in claim 1, 7 or 12 and discussed above. Baker/Gines combination further discloses wherein the tissue sealing device comprises a conductive sealing surface (bipolar electrodes 50A, 50B and 55A, 55B are disposed along jaws 30A and 30B in Fig. 3A-3B, respectively).
However, Baker/Gines combination is silent as to the control circuitry configured to deliver the non-pulsing RF power to the tissue being sealed at a current density that is not greater than 0.1 Amperes root mean square (RMS) per square millimeter of the sealing surface.
McClurken teaches a current density in tissue of 0.027 amps per square millimeter for an area of 0.075 centimeter square and 0.06 amps per square millimeter for an area of 0.3 centimeter square ([0193]) to substantially limit thermal conduction heating to tissue within the end effectors of the device so as to prevent desiccation and charring the tissue ([0016],[0021]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified Baker/Gines combination to incorporate the teachings of McClurken and reduce the current density in tissue since having a low current density is advantageous for preventing damage to the tissue, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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 1-2, 3-8, 10-13, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 10, 12, 14 and 15 of U.S. Patent No. 9,144,455. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2, 3-8, 10-13, and 15-16 under examination are anticipated by claims 1 and 4. Every limitation in the application under examination claims is recited in the conflicting reference patent claims. Specifically, independent claims 1, 7 and 10 are addressed below.
Instant Application
Patent ‘455
Claim 1. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the limited period of time is no greater than 5 seconds, and
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time.
Claim 1. A surgical system for fusing a passageway of a fluid-carrying vessel with a diameter up to 5 millimeters, the system comprising:
an electrosurgical generator capable of delivering electrosurgical power;
a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer electrosurgical power from the electrosurgical generator to a pair of end effectors disposed at a distal end of the surgical instrument, wherein the end effectors are adapted to close the passageway of the vessel by clamping a portion of the vessel between the end effectors; and
a power control circuit for controlling the delivery of radio frequency energy to the vessel through the end effectors; wherein the surgical system is configured to: deliver radio frequency energy at a non-pulsing power to a portion of the vessel for a period of time, wherein the period of time is measured from the beginning of the radio frequency energy delivery and continues through a fusing of the portion of the vessel, the non-pulsing power having no less than 7 Watts and no more than 35 Watts, an output current between 0.2 and 1.75 Amperes RMS, and an output voltage between 5 and 135 Volts RMS throughout the period of time, the non-pulsing power further causing the portion of the vessel to reach a temperature of at least 140 degrees Celsius and begin to desiccate within the period of time; monitor an impedance of the portion of the vessel being fused during the period of time; limit the flow of non-pulsing power when the impedance of the portion of the vessel being fused reaches a set impedance threshold within the period of time; and terminate the flow of non-pulsing power when the impedance of the portion of the vessel being fused reaches a predetermined level.
Claim 4. The surgical system of claim 1, wherein the period of time is 3 seconds or less.
Claim 7. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time, and to limit the output current to no more than 2 Amperes root mean square (RMS), respectively, throughout the limited period of time.
Claim 1. A surgical system for fusing a passageway of a fluid-carrying vessel with a diameter up to 5 millimeters, the system comprising:
an electrosurgical generator capable of delivering electrosurgical power; a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer electrosurgical power from the electrosurgical generator to a pair of end effectors disposed at a distal end of the surgical instrument, wherein the end effectors are adapted to close the passageway of the vessel by clamping a portion of the vessel between the end effectors; and
a power control circuit for controlling the delivery of radio frequency energy to the vessel through the end effectors; wherein the surgical system is configured to: deliver radio frequency energy at a non-pulsing power to a portion of the vessel for a period of time, wherein the period of time is measured from the beginning of the radio frequency energy delivery and continues through a fusing of the portion of the vessel, the non-pulsing power having no less than 7 Watts and no more than 35 Watts, an output current between 0.2 and 1.75 Amperes RMS, and an output voltage between 5 and 135 Volts RMS throughout the period of time, the non-pulsing power further causing the portion of the vessel to reach a temperature of at least 140 degrees Celsius and begin to desiccate within the period of time; monitor an impedance of the portion of the vessel being fused during the period of time; limit the flow of non-pulsing power when the impedance of the portion of the vessel being fused reaches a set impedance threshold within the period of time; and terminate the flow of non-pulsing power when the impedance of the portion of the vessel being fused reaches a predetermined level.
Claim 12. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time, and to limit the output voltage to no more than 100 Volts root mean square (RMS), respectively, throughout the limited period of time.
Claim 1. A surgical system for fusing a passageway of a fluid-carrying vessel with a diameter up to 5 millimeters, the system comprising:
an electrosurgical generator capable of delivering electrosurgical power; a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer electrosurgical power from the electrosurgical generator to a pair of end effectors disposed at a distal end of the surgical instrument, wherein the end effectors are adapted to close the passageway of the vessel by clamping a portion of the vessel between the end effectors; and
a power control circuit for controlling the delivery of radio frequency energy to the vessel through the end effectors; wherein the surgical system is configured to: deliver radio frequency energy at a non-pulsing power to a portion of the vessel for a period of time, wherein the period of time is measured from the beginning of the radio frequency energy delivery and continues through a fusing of the portion of the vessel, the non-pulsing power having no less than 7 Watts and no more than 35 Watts, an output current between 0.2 and 1.75 Amperes RMS, and an output voltage between 5 and 135 Volts RMS throughout the period of time, the non-pulsing power further causing the portion of the vessel to reach a temperature of at least 140 degrees Celsius and begin to desiccate within the period of time; monitor an impedance of the portion of the vessel being fused during the period of time; limit the flow of non-pulsing power when the impedance of the portion of the vessel being fused reaches a set impedance threshold within the period of time; and terminate the flow of non-pulsing power when the impedance of the portion of the vessel being fused reaches a predetermined level.
Claims 2 and 4-6 are anticipated by claim 1.
Claims 8 and 10-11 are anticipated by claim 1.
Claims 13 and 15-16 are anticipated by claim 1.
Claims 3, 9 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 or 4 of U.S. Patent No. 9,144,455 and further in view of McClurken.
In regard to claims 3, 9 and 14, Patent ‘455 claims the invention substantially as claim 1.
Patent ‘455 further claims the tissue sealing device comprising a contacting surface (see claim 5).
However, Patent’ 455 does not claim the current density as claimed.
McClurken teaches a current density in tissue of 0.027 amps per square millimeter for an area of 0.075 centimeter square and 0.06 amps per square millimeter for an area of 0.3 centimeter square ([0193]) to substantially limit thermal conduction heating to tissue within the end effectors of the device so as to prevent desiccation and charring the tissue ([0016],[0021]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the conductive surface of Patent ‘455 and incorporate the current density as taught by McClurken to reduce the current density in tissue since having a low current density is advantageous for preventing damage to the tissue, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 or 4 of U.S. Patent No. 9,144,455 and further in view of Gines.
In regard to claim 17-19, Patent ‘455 claims the invention substantially as claim 1 or claim 4/1. However, Patent’ 455 does not claim the control circuitry configured to provide the first and second maximum power based upon an impedance threshold.
Gines further teaches a power control system that substantially reduces the power delivered to the vessel being sealed by 60%-80% (e.g. 100 watts to 20 watts) when tissue desiccation is determined. Gines further explains that determining an optimal point of desiccation using a threshold impedance is known in the art and when the impedance of the tissue reaches the threshold impedance, power is adjusted by either termination or reduction (col. 2, ln. 1-8). It would have been obvious to modify the control circuitry of Patent ‘064 and further configuring the circuitry to hold the RF power at a first power output level and substantially reducing the power delivered to the vessel being sealed by 80% prior to termination based upon an impedance threshold associated with tissue desiccation, as doing so ensures that a successful seal is achieved (col. 3, ln. 5-40; col. 8, ln. 18-29).
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 8, and 10 of U.S. Patent No. 9,265,561. Claims 1-16 under examination are anticipated by claim 1, 8 and 10. Every limitation in the application under examination claims is recited in the conflicting reference patent claims. Independent claims 1, 7 and 12 are addressed below.
Instant Application
Patent ‘561
Claim 1. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the limited period of time is no greater than 5 seconds, and
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time.
Claim 1. A surgical system for fusing tissue, the system comprising:
an electrosurgical generator capable of delivering electrosurgical power;
a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer the electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument; and
a power control circuit for controlling the delivery of radio frequency energy to the tissue in contact with the distal end of the surgical instrument; wherein the surgical system is configured to:
deliver the radio frequency energy at a non-pulsing power to the tissue for a period of time of 3 seconds or less, the non-pulsing power having no less than 7 Watts and no more than 35 Watts, the non-pulsing power further causing the tissue to begin to desiccate and to fuse within the period of time.
Claim 7. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time, and to limit the output current to no more than 2 Amperes root mean square (RMS), respectively, throughout the limited period of time.
Claim 1. A surgical system for fusing tissue, the system comprising:
an electrosurgical generator capable of delivering electrosurgical power;
a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer the electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument; and
a power control circuit for controlling the delivery of radio frequency energy to the tissue in contact with the distal end of the surgical instrument; wherein the surgical system is configured to:
deliver the radio frequency energy at a non-pulsing power to the tissue for a period of time of 3 seconds or less, the non-pulsing power having no less than 7 Watts and no more than 35 Watts, the non-pulsing power further causing the tissue to begin to desiccate and to fuse within the period of time.
Claim 8. The surgical system of claim 1, wherein the non-pulsing power has an output current of-between 0.75 and 1.00 Amperes RMS.
Claim 12. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time, and to limit the output voltage to no more than 100 Volts root mean square (RMS), respectively, throughout the limited period of time.
Claim 1. A surgical system for fusing tissue, the system comprising:
an electrosurgical generator capable of delivering electrosurgical power;
a surgical instrument electrically connected to the electrosurgical generator and adapted to transfer the electrosurgical power from the electrosurgical generator to a distal end of the surgical instrument; and
a power control circuit for controlling the delivery of radio frequency energy to the tissue in contact with the distal end of the surgical instrument; wherein the surgical system is configured to:
deliver the radio frequency energy at a non-pulsing power to the tissue for a period of time of 3 seconds or less, the non-pulsing power having no less than 7 Watts and no more than 35 Watts, the non-pulsing power further causing the tissue to begin to desiccate and to fuse within the period of time.
Claim 10. The surgical system of claim 1, wherein the non-pulsing power has an output voltage of between 70 and 90 Volts RMS.
Claims 2, 8 and 13 are anticipated by claim 1.
Claim 3, 9 and 14 are anticipated by claim 1.
Claim 4 and 10 are anticipated by claim 8.
Claim 5 is anticipated by claim 10.
Claim 6, 11 and 15 are anticipated by claim 1.
Claims 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 or 1 of U.S. Patent No. 9,265,561 and further in view of Gines.
In regard to claims 17-19, Patent ‘561 claims the invention substantially as claimed in claim 1, claim 8/1 and claim 10/1, respectively.
However, Patent ‘561 does not claim the control circuitry configured to provide the first and second maximum power based upon an impedance threshold.
Gines further teaches a power control system that substantially reduces the power delivered to the vessel being sealed by 60%-80% (e.g. 100 watts to 20 watts) when tissue desiccation is determined. Gines further explains that determining an optimal point of desiccation using a threshold impedance is known in the art and when the impedance of the tissue reaches the threshold impedance, power is adjusted by either termination or reduction (col. 2, ln. 1-8). It would have been obvious to modify the control circuitry of Patent ‘064 and further configuring the circuitry to hold the RF power at a first power output level and substantially reducing the power delivered to the vessel being sealed by 80% prior to termination based upon an impedance threshold associated with tissue desiccation, as doing so ensures that a successful seal is achieved (col. 3, ln. 5-40; col. 8, ln. 18-29).
Claims 1-5, 7-10, and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 20 of U.S. Patent No. 10,166,064. Claims 1-5, 7-10, and 12-14 under examination are anticipated by claims 15 and 20. Every limitation in the application under examination claims is recited in the conflicting reference patent claims. Independent claims 1, 7 and 12 are addressed below.
Instant Application
Patent ‘064
Claim 1. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the limited period of time is no greater than 5 seconds, and
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time.
Claim 15. A power control system for delivering radio frequency energy to a surgical instrument, the power control system comprising:
a power supply for delivering an output voltage and an output current to a distal end of the surgical instrument,
wherein the distal end of the surgical instrument has a pair of end effectors;
a sensing circuit for detecting parameters indicative of an impedance of a tissue portion being fused; and a power sequencing module for automatically sequencing an electrosurgical power delivered to the surgical instrument;
wherein the power sequencing module is adapted to: apply non-pulsing power to the tissue portion disposed between the pair of end effectors for a period of time of 3 seconds or less, wherein the period of time is measured from beginning application of the application of the non-pulsing power through the beginning of a desiccation of the tissue portion and through a drying out and the fusing of the tissue portion, and wherein the output current is held under 2 Amperes RMS, and- the output voltage is held under 100 Volts RMS, and the output current applies a current density of 0.1 Amperes per square millimeter or less to the tissue portion being fused.
Claim 20. The power control system of claim 15, wherein the power sequencing module is further adapted to: hold the non-pulsing power to 35 Watts or less.
Claim 7. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time, and to limit the output current to no more than 2 Amperes root mean square (RMS), respectively, throughout the limited period of time.
Claim 15. A power control system for delivering radio frequency energy to a surgical instrument, the power control system comprising:
a power supply for delivering an output voltage and an output current to a distal end of the surgical instrument,
wherein the distal end of the surgical instrument has a pair of end effectors;
a sensing circuit for detecting parameters indicative of an impedance of a tissue portion being fused; and a power sequencing module for automatically sequencing an electrosurgical power delivered to the surgical instrument;
wherein the power sequencing module is adapted to: apply non-pulsing power to the tissue portion disposed between the pair of end effectors for a period of time of 3 seconds or less, wherein the period of time is measured from beginning application of the application of the non-pulsing power through the beginning of a desiccation of the tissue portion and through a drying out and the fusing of the tissue portion, and wherein the output current is held under 2 Amperes RMS, and- the output voltage is held under 100 Volts RMS, and the output current applies a current density of 0.1 Amperes per square millimeter or less to the tissue portion being fused.
Claim 20. The power control system of claim 15, wherein the power sequencing module is further adapted to: hold the non-pulsing power to 35 Watts or less.
Claim 12. An electrosurgical generator, comprising:
a power supply configured for generating non-pulsing radiofrequency (RF) power having an output voltage, and an output current and an output power; and
control circuitry configured to control delivery of the non-pulsing RF power to tissue being sealed by a tissue sealing device electrically connected to the generator, the non-pulsing RF power being delivered for a limited period of time,
wherein the limited period of time begins upon delivery of the non-pulsing RF power to the tissue, and ends upon fusing of the tissue, and ends upon fusing of the tissue,
wherein the control circuitry is configured to hold the output power under 35 Watts throughout the limited period of time, and to limit the output voltage to no more than 100 Volts root mean square (RMS), respectively, throughout the limited period of time.
Claim 15. A power control system for delivering radio frequency energy to a surgical instrument, the power control system comprising:
a power supply for delivering an output voltage and an output current to a distal end of the surgical instrument,
wherein the distal end of the surgical instrument has a pair of end effectors;
a sensing circuit for detecting parameters indicative of an impedance of a tissue portion being fused; and a power sequencing module for automatically sequencing an electrosurgical power delivered to the surgical instrument;
wherein the power sequencing module is adapted to: apply non-pulsing power to the tissue portion disposed between the pair of end effectors for a period of time of 3 seconds or less, wherein the period of time is measured from beginning application of the application of the non-pulsing power through the beginning of a desiccation of the tissue portion and through a drying out and the fusing of the tissue portion, and wherein the output current is held under 2 Amperes RMS, and- the output voltage is held under 100 Volts RMS, and the output current applies a current density of 0.1 Amperes per square millimeter or less to the tissue portion being fused.
Claim 20. The power control system of claim 15, wherein the power sequencing module is further adapted to: hold the non-pulsing power to 35 Watts or less.
Claims 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20/15 of U.S. Patent No. 10,166,064, and further in view of Gines.
Gines further teaches a power control system that substantially reduces the power delivered to the vessel being sealed by 60%-80% (e.g. 100 watts to 20 watts) when tissue desiccation is determined. Gines further explains that determining an optimal point of desiccation based upon a threshold impedance is known in the art such that when the impedance of the tissue reaches the threshold impedance, power is adjusted by either termination or reduction (col. 2, ln. 1-8). Given that Baker teaches measuring impedance and terminating based upon a predetermined impedance threshold, it would have been obvious to modify the control circuitry of Baker/Gines combination and further configuring the circuitry to hold the RF power at a first power output level and substantially reducing the power delivered to the vessel being sealed by 80% prior to termination based upon an impedance threshold associated with tissue desiccation, as doing so ensures that a successful seal is achieved (col. 3, ln. 5-40; col. 8, ln. 18-29).
Claims 1-5, 7-10, 12-14 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 of U.S. Patent No. 11,988,260.
Independent claims 1, 7 and 10 of the reference patent includes all the limitations of claim 1 of the instant application, except for “wherein the control circuitry is configured to hold the output power under 35 Watts, throughout the limited period of time.”
However, claim 1 further recites that the control circuitry is configured to hold the output current under 2 Amperes root mean square (RMS) and to hold the output voltage under 100 Voltas RMS, respectively, through the limited period of time.
Baker discloses providing a low power of 35 Watts or less to provide a successful weld col. 12, ln. 13-38: the power controller 70 uses feedback information such as impedance or temperature to terminate power delivery after the target vessel forms a biological glue pr vessel sealing). Taken together, various output power is possible, one of which is 35 Watts or less if the power factor is less than 0.175 by incorporating various circuits to provide for the power factor. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide an output power under 35 Watts via incorporating circuitry providing a power factor of 0.175 or less as this would allow for reasonably low non-pulsing power of 35 Watts or less for successful welding of blood vessel.
Claim 2 of the reference patent recites the same limitations as claims 2, 8, and 13 of the instant application.
Claim 3 of the reference patent recites the same limitations as claims 3, 9 and 14 of the instant application.
Claim 1 of the reference patent recites the same limitations as claims 4-5, 10, and 16 of the instant application.
Claim 5 of the reference patent recites the same limitations as claim 17-19.
Conclusion
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 12/26/2025