DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 & 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 16/209759, 14/848116, PCT/US2015/031452, 61/994185, 61/994192, 16/994215 & 61/994415 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Application Nos. 16/209759, 14/848116, PCT/US2015/031452, 61/994185, 61/994192, 16/994215 & 61/994415 fail to provide adequate support for “an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument to the first and second electrodes and not the conductive post”.
Accordingly, the claims are given the priority date of 5/18/15.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a second electrode facing the first electrode” on the second jaw (none of Figs. 23, 25, 34-35 nor 38-40 show this feature with the claimed conductive post) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The Examiner notes amendments to the specification would also be needed if a new reference numeral is included.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph to include respective patent numbers.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the same conductive material” to -a same conductive material- in ll. 7-8. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: indent ll. 12 such that the “conductive post” falls under the “electrosurgical instrument”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: delete “and conductive material” in ll. 16-17. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “supply RF energy” to -supply the RF energy- in ll. 21. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “an RF amplifier” to -a RF amplifier- in ll. 21. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “an RF sense circuitry” to -RF sense circuitry- in ll. 21. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “arranged to" to -configured to- in ll. 1 & 3 (twice). Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “the supply of RF energy” to -the supplied RF energy- in ll. 4. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “Sense” to -sense- in ll. 1. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “measures” to -is configured to measure- in ll. 1. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “generates” to -is configured to generate- in ll. 2. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “arranged to" to -configured to- in ll. 4. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: amend “RF sense” to -RF sense circuitry- in ll. 4-5. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “real and imaginary voltage” to -the real and imaginary voltage- in ll. 1-2. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “the supplied RF waveform” to -the supplied RF energy- in ll. 2. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “calculates” to -is configured to calculate- in ll. 1. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “means” to -mean-. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: amend “is made of a conductive material that is the same as the conductive material” to -is made of the same conductive material- in ll. 1-2. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “moves” to -is configured to move- in ll. 3. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “initiates the supply of RF energy” to -initiate supply of the RF energy- in ll. 3-4. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: amend “RF energy” to -the RF energy- in ll. 1. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: amend “that causes the generator to supply RF energy” to -configured to cause the electrosurgical generator to supply the RF energy- in ll. 2. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “logs the usage” to -is configured to log usage- in ll. 1. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: amend “the instrument and the generator” to -the electrosurgical instrument and the electrosurgical generator- in ll. 1-2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument to the first and second electrodes and not the conductive post”. It is unclear how the RF energy is not supplied to the conductive post when current travels through the tissue between the electrodes and is thus indirectly supplied to the conductive post. It is suggested to amend claim 1 to: -an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument to the first and second electrodes, the electrosurgical generator configured to not directly supply the RF energy to the conductive post-. The claim will be interpreted in this manner.
Claims 2-20 depend from claim 1 and are thus also rejected.
Claim 4 recites the limitation “an identified voltage”; however, claim 1 recites the limitation “real and imaginary voltage and current components of the supplied RF waveform”. It is unclear if the “an identified voltage” is the same as or different from the “…voltage…components” of claim 1. For purposes of examination, “an identified voltage” will be interpreted as either.
Claims 5-20 depend from claim 4 as are thus also rejected.
Claim 5 recites the limitation “voltage and current of the supplied RF energy”; however, claim 1 recites the limitation “real and imaginary voltage and current components of the supplied RF waveform”. It is unclear if the “voltage and current” of claim 5 is the same as or different from the “…voltage and current components” of claim 1. For purposes of examination, “voltage and current” of claim 5 will be interpreted as either.
Claim 5 recites the limitation “DC signals representing voltage, current, power, and phase of the measured voltage and current”. It is unclear how the measured “voltage” and “current” can be represented by “voltage and “current” and how the “voltage” and “current” represented by the DC signals is different from the “measured voltage and current”. For purposes of examination, the “DC signals” will be interpreted as representing the “ the measured voltage and the measured current”.
Claim 5 recites the limitation “voltage, current,…and phase of the measured voltage and current” in ll. 1 & 6; however, claim 1, upon which the claim depends, recites the limitation “real and imaginary voltage and current components of the supplied RF waveform” and claim 2, upon which the claim depends, recites the limitation “the RF sense circuitry is arrange to determine a phase angle of the supplied RF energy” . It is unclear if the “voltage, current,…and phase of the measured voltage and current” of claim 5 is the same as or different from the “…voltage and current components” of claim 1 or the “phase angle” of claim 2. For purposes of examination, “voltage, current,…and phase” of claim 5 will be interpreted as being the same as the those of claims 1 & 2. The Examiner notes also that claim 2 recites “phase angle” while claim 5 recites “phase” and one will need to be amended accordingly.
Claims 6-20 depend from claim 5 and are thus also rejected.
Claim 10 recites the limitation “where manipulation of the actuator moves the first and second jaws, initiates the supply of RF energy or translational movement of the blade” which is grammatically unclear. Does the actuator perform all three functions? Or does the actuator perform just one of the functions. For purposes of examination, the claim will be interpreted as the latter.
Claims 11-20 depend from claim 10 and are thus also rejected.
Claim Interpretation
Claim 1 recites the limitation “an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument to the first and second electrodes and not the conductive post. The Examiner notes that this limitation is interpreted as the generator being configured to supply the RF energy to the electrode(s) via a direct connection to the generator and configured not to supply the RF energy to the conductive post(s) via direct connection (i.e., no direct connection between the post(s) and the generator exists but energy still is configured to be supplied indirectly via a jaw electrode and tissue).
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784) and Falkenstein et al. (2009/0248007).
The Examiner notes that the claims fail to receive priority to the provisional application(s) and thus, the filing date of Corbett et al. (12/8/2014) falls before the filing date of the earliest received priority date of the current application (5/18/2015).
Concerning claim 1, as illustrated in at least Figs. 1 & 4A, Corbett et al. disclose an electrosurgical system (Fig. 1) comprising:
an electrosurgical instrument arranged to grasp and fuse tissue using radio frequency (RF) energy (surgical instrument 2 having grasping end effector 10 that includes electrodes 92, 94 configured to pass RF energy through tissue; [0025-0026]), the electrosurgical instrument comprises:
a first jaw having a first electrode (first jaw 22a includes electrode 94; [0026]);
a second jaw coupled to the first jaw and having a second electrode facing the first electrode (second jaw 22B includes electrode 92; [0026]), the first and second electrodes arranged to conduct the RF energy between the first and second electrodes (electrodes 92, 94 can be configured to pass energy through tissue positioned between the electrodes 92, 94; [0026]);
an elongate shaft having a proximal end and a distal end and a longitudinal axis extending from the proximal end to the distal end (shaft assembly 12; [0025]), the first and second jaws being pivotably coupled to the distal end of the elongate shaft (first jaw 22a can be pivotably coupled to the second jaw 22b at the distal end of shaft assembly 12; [0026]); and
a conductive post incorporated into the second jaw and extending from the second jaw towards the first jaw, the conductive post being stationary, and having an upper portion extending past an upper surface of the second electrode and a lower portion encased in an insulated material in the second jaw (one or more stationary protrusions or projections 50 comprised of electrically conductive material extends from non-conductive layer 46 of jaw 22B through aperture 44 of electrically conductive layer 42 of electrode 92; [0031-0032]), the insulated material separating the conductive post from the second electrode and conductive material in the second jaw (non-conductive layer 46 partially encloses or insulates the conductive portion 50 from electrode 92 and a minimum gap between the electrode 94 and the electrically conductive layer 42 of the electrode 92 is maintained; [0050-0052], [0055]); and
an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument to the first and second electrodes and not the conductive post (an energy button 18 is configured to deliver energy to the at least one electrode 92 from a power source. In certain instances, when the energy button 18 is depressed, a circuit is completed allowing delivery of energy to the electrode 92, and, in so much as Applicant shows, where electrical current may pass between electrodes 94, 92 and indirectly to electrically conductive protrusion or projection 50 through tissue, where projection 50 is not directly connected to conductive portions 94, 99, 92, 101 of jaws 22a,b; [0027], [0029], [0037], [0052]).
Corbett et al. fail to specifically disclose the first and second electrodes being made of the same conductive material and the conductive post being made of the same conductive material as the first and second electrodes. However, Davison et al. disclose an electrosurgical instrument (100) having a conductive post (322) extending from a second jaw (320B) to a first jaw (320A) and insulated from a first jaw electrode (324), where the conductive post (322) may be made from the same material as other parts of the end effector (310), thereby easing manufacturing ([0082][0101]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. such that the first and second electrodes are made of the same conductive material and the conductive post are made of the same conductive material as the first and second electrodes in order to provide the benefit of an ease in manufacturing as taught by Davison et al. ([0101]) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Corbett et al. in view of Davison et al. fail to disclose specifics of the electrosurgical generator, and specifically wherein the electrosurgical generator comprises: an RF amplifier to supply RF energy through the electrosurgical instrument; and an RF sense circuitry arranged to receive a supplied RF waveform from the supplied RF energy through the electrosurgical instrument, the RF sense circuitry comprising a synchronous detector arranged to calculate real and imaginary voltage and current components of the supplied RF waveform using synchronization signals. However, Falkenstein et al. disclose an electrosurgical system (2) comprising an electrosurgical instrument (40) and an electrosurgical generator (12) comprising an RF amplifier (633) to supply RF energy through the electrosurgical instrument (40); and an RF sense circuitry (544-547) arranged to receive a supplied RF waveform (ESU output) from the supplied RF energy through the electrosurgical instrument (40), the RF sense circuitry comprising a synchronous detector (547) arranged to calculate real and imaginary voltage and current components of the supplied RF waveform using synchronization signals, the RF sense circuitry (544-547) is arranged to determine a phase angle of the supplied RF energy from the calculated real and imaginary voltage and current components and further comprising a controller (543) arranged to signal the RF amplifier(633) to terminate the supply of RF energy when the determined phase angle is less than a predefined phase value (endpoint). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al. such that the electrosurgical generator comprises: an RF amplifier to supply RF energy through the electrosurgical instrument; and an RF sense circuitry arranged to receive a supplied RF waveform from the supplied RF energy through the electrosurgical instrument, the RF sense circuitry arranged to calculate real and imaginary voltage and current components of the supplied RF waveform in order to provide the benefit of determining the treatment endpoint as taught by Falkenstein et al. (Abstract; [0182], [0189], [0200-0201], [0245]; Fig. 9 & 32)
Concerning claim 2, Falkenstein et al. further disclose the RF sense circuitry (544-547) is arranged to determine a phase angle of the supplied RF energy from the calculated real and imaginary voltage and current components and further comprising a controller (543) arranged to signal the RF amplifier (633) to terminate the supply of RF energy when the determined phase angle is less than a predefined phase value (endpoint) (Abstract; [0182], [0189], [0200-0201], [0245]; Fig. 9 & 32)
Concerning claim 8, Corbett et al. disclose the electrosurgical instrument (2) further comprises a blade (cutting member (not shown) movable along the longitudinal axis from a proximal position to a distal position and back to the proximal position, the blade disposed within an outer periphery of the second jaw (22B) and the second jaw (22B) includes a channel (40) through which the blade traverses there through ([0026]; Fig. 4).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784) and Falkenstein et al. (2009/0248007), as applied to claim 8, in further view of Buysse et al. (5,827,271).
Concerning claim 3, Corbett et al. in view of Davison et al. and Falkenstein et al. fail to disclose the predefined phase value is a negative value. However, Buysse et al. disclose an electrosurgical system comprising an electrosurgical generator (11) comprising RF sense circuitry configured to sense a phase angle between current and voltage, where power is terminated to an electrosurgical instrument (12) when the output current leads the output voltage by an angle greater than approximately fifty degrees, or the phase angle is -50°. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al., and Falkenstein et al. such that the predefined phase value is a negative value in order to provide the benefit of avoiding tissue charring as taught by Buysse (Col. 2, ll. 38-51, Col. 7, ll. 9-16, Col. 8, ll. 66-5)
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784), Falkenstein et al. (2009/0248007) and Buysse et al. (5,827,271), as applied to claim 3, in further view of Heckel (2013/0197874).
Concerning claim 4, Corbett et al. in view of Davison et al., Falkenstein and Buysse et al. fail to disclose the controller configured to compare an identified voltage to a predetermined voltage value to determine the predefined phase value. However, Heckel discloses sensing an identified voltage on a test load and comparing it to a predetermined voltage to determine a predefined phase value. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al., Falkenstein and Buysse et al. such that the controller is configured to compare an identified voltage to a predetermined voltage value to determine the predefined phase value in order to provide the benefit of determining actual power applied to tissue as taught by Heckel ([0009-0010], [0042]).
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784), Falkenstein et al. (2009/0248007), Buysse et al. (5,827,271) and Heckel (2013/0197874), as applied to claim 4, in further view of Frangineas et al. (2008/0058782).
Concerning claim 5, Falkenstein et al. disclose the RF Sense circuitry measures voltage and current of the supplied RF energy from the RF amplifier and generates DC signals representing voltage, current, power, and phase of the measured voltage and current ([0183]). Corbett et al. in view of Davison et al., Falkenstein et al., Buysse et al. and Heckel fail to disclose the controller further comprises a RF smoother arranged to remove noise from the generated DC signals from the RF sense and extrapolate from the generated DC signals smooth modulated DC signals representative of the voltage, current, power, and phase of the supplied RF energy. However, Frangineas et al. teach that DC filtering can also be used to improve the signal to noise ratio of a detected signal. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al., Falkenstein, Buysse and Heckel to further comprise a RF smoother arranged to remove noise from the generated DC signals from the RF sense and extrapolate from the generated DC signals smooth modulated DC signals representative of the voltage, current, power, and phase of the supplied RF energy in order to provide the benefit of improving the signal to noise ratio of the detected signals as taught by Frangineas et al. ([0127])
Claim 6 is rejected upon the same rationale as applied to claims 1-2.
Concerning claim 7, Falkenstein et al. further disclose the RF sense circuitry configured to calculate a root means square (RMS) voltage, RMS current, apparent power and phase using calculated real and imaginary voltage and current components ([0190]).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784) and Falkenstein et al. (2009/0248007), as applied to claim 8, in further view of Manzo et al. (2012/0215220).
Concerning claim 9, Corbett et al. disclose the blade is made of a conductive material and an entire surface of the first jaw (22A) facing the second jaw (22B) is smooth and flat having no indentations or pockets ([0026]; Fig. 4-4A). Corbett et al. fail to disclose the blade conductive material is the same as the conductive material of the conductive post. However, Manzo et al. disclose an electrosurgical instrument (100) where electrodes (21a,b) on jaws (7a,b) are made of the same material as a cutting blade (19) ([0080], [0093]). Further, Davison et al. teaches forming conductive elements of an electrosurgical instrument from the same material as other parts to ease manufacturing ([0101]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al. and Falkenstein et al. such that the blade conductive material is the same as the conductive material of the conductive post in order to provide the benefit of an ease in manufacturing as taught by Davison et al. ([0101]) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Concerning claim 10, Corbett et al. disclose the electrosurgical instrument (2) further comprises an actuator (8 and/or 16) disposed on the proximal end of the elongate shaft (12) and arranged to be user accessible where manipulation of the actuator (8 and/or 16) moves the first and second jaws (22a,b), initiates the supply of RF energy or translational movement of the blade (not shown) ([0028]; Fig. 1).
Concerning claim 11, Corbett et al. disclose the electrosurgical generator is arranged to supply RF energy only to the first and second electrodes (92, 94) and not directly to the conductive post and blade ([0026-0027], [0029], [0037], [0052]).
Concerning claim 12, Corbett et al. disclose the electrosurgical instrument further comprises a switch (18) that causes the generator to supply RF energy ([0027]; Fig. 1).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784), Falkenstein et al. (2009/0248007) and Manzo et al. (2012/0215220), as applied to claim 12, in further view of Swayze et al. (2002/0081871) and Bek et al. (2011/0098698).
Concerning claim 13, Corbett et al. in view of Davison et al., Falkenstein et al. and Manzo et al. fail to disclose the controller of the generator configured to log usage of both the instrument and the generator. However, Swayze et al. teach some energy generators carry computers to monitor usage of the generators and teaches that it can be advantageous for energy delivery devices associated with computerized energy generators to carry a memory device to record information about the usage of the energy delivery device ([0004]). Further, Bek et al. disclose a system comprising a controller (52) of a generator (38) that logs usage of an electrosurgical instrument (26) to prevent unpredictable future performance. ([0003], [0057-0059], [0070-0078], [0082], [0093]). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al., Falkenstein et al. and Manzo et al. such that the controller of the generator is configured to log usage of the generator and instrument as taught by Swayze et al. in order to provide the benefit of preventing unpredictable future device performance as taught by Bek et al.
Claim(s) 14-17 & 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784), Falkenstein et al. (2009/0248007), Manzo et al. (2012/0215220), Swayze et al. (2002/0081871) and Bek et al. (2011/0098698), as applied to claim 13, in further view of Twomey et al. (2013/0185922).
Concerning claim 14, Corbett et al. disclose the conductive post (50) is affixed to the second jaw (22B) ([0055-0056]; Fig. 8-10). Corbett et al. in view of Davison et al., Falkenstein et al., Manzo et al., Swayze et al. and Bek et al. fail to specifically disclose the conductive post affixed to the second jaw by an over-molding. However, Twomey et al. disclose an electrosurgical instrument (10) comprising a conductive element (112/122) that is affixed to a second jaw (118/124) by over-molding. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al., Falkenstein et al., Manzo et al., Swayze et al. and Bek et al. such that the conductive post is affixed to the second jaw by an over-molding in order to provide the benefit of shaping the elements to a desired configuration as taught by Twomey et al. ([0038], [0040])
Concerning claim 15, Corbett et al. disclose the conductive post (50) is arranged to contact the first electrode (94) ([0037], [0052]; Fig. 8-10).
Concerning claim 16, Corbett et al. disclose the conductive post (50) has a flat upper atraumatic surface (53) ([0056]; Fig. 8-10).
Concerning claim 17, Corbett et al. disclose the conductive post (50) is disposed adjacent to the channel (40) of the second jaw (22B) ([0026], [0056-0057]; Fig. 8-10).
Concerning claim 19, Corbett et al. disclose the conductive post (50) includes a plurality of conductive posts (50) ([0031]; Fig. 8-10). Corbett et al. fail to disclose the plurality of conductive posts having varying heights and the plurality of conductive posts includes a distal most conductive post having a height greater than a height of a proximal most conductive post. However, Manzo et al. further discloses a plurality of posts (22b, 26b) having varying heights, including a distalmost post (22b) having a height greater than a height of a proximal most post (26b). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. such that the plurality of conductive posts have varying heights and the plurality of conductive posts includes a distal most conductive post having a height greater than a height of a proximal most conductive post in order to provide the benefit of promoting a uniform gap g across the length of the electrode surfaces while also permitting the electrode surfaces to come sufficiently close along their entire length to ensure effective gripping and sealing of tissue as taught by Manzo et al. ([0082-0083]; Fig. 4 & 16)
20. Concerning claim 20, Corbett et al. disclose the plurality of conductive posts (50) are disposed adjacent to the channel (40) of the second jaw (22B) (Fig. 8-10).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (2016/0157927) in view of Davison et al. (2012/0083784), Falkenstein et al. (2009/0248007), Manzo et al. (2012/0215220), Swayze et al. (2002/0081871), Bek et al. (2011/0098698) and Twomey et al. (2013/0185922), as applied to claim 16, in further view of Brandt et al. (2015/0223868).
Concerning claim 18, Corbett et al. in view of Davison et al., Falkenstein et al., Manzo et al., Swayze et al., Bek et al. and Twomey et al. fail to disclose a temperature sensor disposed within the second jaw and proximate the conductive post. However, Brandt et al. disclose an electrosurgical instrument (10) comprising jaws (110, 120) and a temperature sensor (161-165) disposed within a jaw (110). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Corbett et al. in view of Davison et al., Falkenstein et al., Manzo et al., Swayze et al., Bek et al. and Twomey et al. to further comprise a temperature sensor disposed within the second jaw in order to provide the benefit of a temperature-sensing device that is readily integrated into the manufacturing process and provides feedback information for controlling operating parameters of the generator as taught by Brandt et al. ([0012], [0064-0066]; Fig. 1& 5-6) The modified invention in view of the teachings of Brandt et al. teach the temperature sensor disposed proximate the conductive post.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 10,149,713. Although the claims at issue are not identical, they are not patentably distinct from each other because they both disclose an electrosurgical system (An electrosurgical system) comprising: an electrosurgical instrument arranged to grasp and fuse tissue using radio frequency (RF) energy (an electrosurgical instrument arranged to grasp and fuse tissue using radio frequency (RF) energy), the electrosurgical instrument comprises: a first jaw having a first electrode (a first jaw having a first electrode); a second jaw coupled to the first jaw and having a second electrode facing the first electrode (a second jaw coupled to the first jaw and having a second electrode facing the first electrode), the first and second electrodes arranged to conduct the RF energy between the first and second electrodes and the first and second electrodes being made of the same conductive material (the first and second electrodes arranged to conduct the supplied RF energy between the first and second electrodes and the first and second electrodes being made of the same conductive material); an elongate shaft having a proximal end and a distal end and a longitudinal axis extending from the proximal end to the distal end, the first and second jaws being pivotably coupled to the distal end of the elongate shaft (an elongate shaft having a proximal end and a distal end and a longitudinal axis extending from the proximal end to the distal end, the first and second jaws being pivotably coupled to the distal end of the elongate shaft); and a conductive post incorporated into the second jaw and extending from the second jaw towards the first jaw, the conductive post being stationary, made of the same conductive material as the first and second electrodes (a conductive post incorporated into the second jaw and extending from the second jaw towards the first jaw, the conductive post being stationary and made of the same conductive material as the first and second electrodes) and having an upper portion extending past an upper surface of the second electrode and a lower portion encased in an insulated material in the second jaw, the insulated material separating the conductive post from the second electrode and conductive material in the second jaw (an upper portion extending from an upper surface of the second jaw and a lower portion encased in an insulated material in the second jaw, the insulated material separating the conductive post from conductive material in the second jaw and the conductive post being not connectable to conductive material extending from the elongate shaft); and an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument to the first and second electrodes (an electrosurgical generator connectable to the electrosurgical instrument and configured to supply the RF energy through the electrosurgical instrument) and not the conductive post (the electrosurgical generator is configured to supply RF energy only to the first and second electrodes and not to the conductive post), the electrosurgical generator comprising: an RF amplifier to supply RF energy through the electrosurgical instrument (an RF amplifier to supply RF energy through the electrosurgical instrument); and an RF sense circuitry arranged to receive a supplied RF waveform from the supplied RF energy through the electrosurgical instrument (an RF sense circuitry arranged to receive a supplied RF waveform from the supplied RF energy through the electrosurgical instrument), the RF sense circuitry comprising a synchronous detector arranged to calculate real and imaginary voltage and current components of the supplied RF waveform (a synchronous detector arranged to calculate real and imaginary voltage and current components of the supplied RF waveform). Claim 2 of the application is anticipated by claim 10 of the patent. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mihori et al. (2009/0048595) teach detecting when a phase changes zero to the negative side, a cauterization process is finished switched over to a desiccation process, whereupon a constant-power application mode is replaced by an intermittent-power application mode ([0069]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794