DETAILED ACTION
This action is in response to amendments received on 12/18/2025. Claims 12-31 were previously pending. Claims 12-13, 15-16, 18 and 20 have been amended, claims 19 and 21-31 have been canceled and new claims 32-43 added. A complete action on the merits of claims 12-18, 20 and 32-43 follows below.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 Objections
Claim 42 is objected to because of the following informalities: “the ultrasonic blade comprises is configured to” in claim 42 should be amended to remove “comprises”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 34 and 37-41 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Wiener (US Pub. No. 2009/0036913).
Regarding Claim 34, Wiener teaches an ultrasonic surgical system (Figs. 1-9), comprising:
a handpiece 50/252; a shaft 160 extending from the handpiece; a waveguide 181 extending through the shaft (Figs. 1-3 and [0066]); an end effector 180 extending from the shaft and operable to manipulate tissue ([0037]-[0041]), wherein the end effector includes an ultrasonic blade 180’/256’ extending from the waveguide and operable to receive ultrasonic vibrations ([0043]); a tissue state indicator to provide feedback indicative of a change in state of the tissue occurring ([0090] and [0099]); and a processor to adjust the ultrasonic vibrations to the ultrasonic blade based on the change in state of the tissue occurring ([0008], [0090]-[0091] and claims 6-7).
Regarding Claim 37, Wiener teaches wherein the end effector further comprises a clamp arm 190 movable relative to the ultrasonic blade from an open position to a closed position to capture the tissue therebetween ([0074] and Figs. 1-4).
Regarding Claim 38, Wiener teaches further comprising a closure actuator 222 configured to move the clamp arm 190 toward the closed position ([0079] and Figs. 1-2), wherein the closure actuator comprises a trigger and a trigger hook extending from the trigger, and wherein an aperture is defined between the trigger and the trigger hook (Figs. 2 and 5 and [0076] and [0079]).
Regarding Claim 39, Wiener teaches further comprising a power level indicator configured to provide audible feedback indicative of the ultrasonic vibrations ([0098] and [0103]).
Regarding Claim 40, Wiener teaches further comprising a generator 30 (Fig. 1) configured to provide the ultrasonic vibrations to the ultrasonic blade, wherein the handpiece and the generator form a unitary assembly when assembled ([0037]-[0038] and [0045]).
Regarding Claim 41, Wiener teaches further comprising a switch 34, wherein the generator is configured to provide the ultrasonic vibrations to the ultrasonic blade based on actuation of the switch ([0041]).
Claims 34-38 and 40-43 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Witt (US Patent No. 6,454,781).
Regarding Claim 34, Witt teaches an ultrasonic surgical system (Figs. 1a-8), comprising:
a handpiece 14;
a shaft 22 extending from the handpiece (Figs.1a-c & 8);
a waveguide extending through the shaft (Figs. 1a-c and Col. 1, ll. 36-42);
an end effector extending from the shaft and operable to manipulate tissue (Figs. 1a-1c), wherein the end effector includes an ultrasonic blade 20 extending from the waveguide and operable to receive ultrasonic vibrations (Col. 1, ll. 36-42 and Col. 4, ll. 37-54);
a tissue state indicator to provide feedback indicative of a change in state of the tissue occurring (Col. 11, ll. 46-Col. 13, ll. 10); and a processor to adjust the ultrasonic vibrations to the ultrasonic blade based on the change in state of the tissue occurring (Col. 3, ll. 21-27, Col. 11, ll. 37-Col. 12, ll. 27 and claims 15-19).
Regarding Claim 35, Witt teaches further comprising a sensor to sense an impedance of the tissue, wherein the tissue state indicator is operable to provide feedback indicative of the change in state of the tissue occurring based on the sensed impedance (Col. 11, ll. 37-Col. 13, ll. 10).
Regarding Claim 36, Witt teaches further comprising: a transducer 14 (Figs. 1a-1c) operable to provide the ultrasonic vibrations (Col. 4, ll. 37-54); and a sensor to sense an impedance of the transducer, wherein the tissue state indicator is operable to provide feedback indicative of the change in state of the tissue occurring based on the sensed impedance (Col. 11, ll. 37-Col. 13, ll. 10).
Regarding Claim 37, Witt teaches the end effector further comprises a clamp arm 24 movable relative to the ultrasonic blade from an open position to a closed position to capture tissue therebetween (Figs. 2-3, 8 and Col. 5, ll. 43-56).
Regarding Claim 38, Witt teaches further comprising a closure actuator 72 configured to move the clamp arm toward the closed position, wherein the closure actuator 72 comprises a trigger 76 and a trigger hook 80 extending from the trigger, and wherein an aperture 81 is defined between the trigger and the trigger hook (Fig. 2 and Col. 5, ll. 43-56).
Regarding Claim 40, Witt teaches further comprising a generator 302 (Figs. 8 and 12) configured to provide the ultrasonic vibrations to the ultrasonic blade (“power controller may include at least one electrical switch for selectively controlling the energy supplied to the instrument to coagulate tissue, or to cut tissue, depending on the electrical switch setting” Col. 3, ll. 1-7 and Col. 9, ll. 21-29), and wherein the handpiece and the generator form a unitary assembly when assembled (Figs. 8 and 12 shows the system including the clamp coagulator 12, generator 302 and the feedback control module 300 through plug connector 235, where in the assembled, plugged configuration the whole system is interpreted to be a unitary assembly; furthermore, Manwaring teaches containing the power generator 30 into a foot pedal 20 coupled to the handheld surgical tool 50 to thereby form a unitary assembly when assembled as seen in Fig. 2, where system 10 is considered to be a unitary assembly in the assembled configuration to make it portable).
Regarding Claim 41, Witt teaches further comprising a switch, wherein the generator is configured to provide the ultrasonic vibrations to the ultrasonic blade based on actuation of the switch (Col. 3, ll. 1-7).
Regarding Claim 42, Witt teaches an ultrasonic surgical system (Figs. 1a-12), comprising:
a handpiece 14;
a transducer arranged in the handpiece (Col. 4, ll. 37-54);
a waveguide extending from the transducer (Figs. 1a-2 and Col. 1, ll. 36-42); and
an ultrasonic blade 20 extending from the waveguide, wherein the ultrasonic blade comprises is configured to receive ultrasonic vibrations from the transducer via the waveguide to apply energy to tissue (Col. 1, ll. 36-42, Col. 4, ll. 37-54 and Col. 8, ll. 40-46);
a sensor to sense an impedance of the transducer or the tissue; and a tissue state indicator to provide feedback indicative of a change in tissue of the tissue occurring (Col. 11, ll. 37-Col. 13, ll. 10).
Regarding Claim 43, Witt teaches further comprising a processor to adjust the ultrasonic vibrations to the ultrasonic blade based on the change in state of the tissue occurring (Col. 3, ll. 21-27, Col. 11, ll. 37-Col. 12, ll. 27 and claims 15-19).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pre-AIA 35 U.S.C. 103(a) 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 12-18, 20, 32-33 and 39 are rejected under pre-AIA 35 U.S.C. 102(b) as being unpatentable over Witt (US Patent No. 6,454,781) in view of Manwaring (US Pub. No. 2010/0268205).
Regarding Claim 12, Witt teaches an ultrasonic surgical instrument (Figs. 1a-8), comprising:
a handpiece 14 comprising an output indicator that provides: a tissue state indicator (“The ultrasonic portion 152 of the circuit diagram illustrates an ultrasonic generator such as, for example, generator 302. The electrical impedance portion 154 of the circuit is the impedance sensing device, used to provide a high frequency sensing current I.sub.z that can be used to detect the presence, absence, and condition (impedance) of tissue being treated by ultrasonic blade 20” Col. 11, ll. 45-52);
a shaft 22 extending from the handpiece (Figs.1a-c & 8);
a waveguide extending through the shaft (Figs. 1a-c and Col. 1, ll. 36-42); and
an end effector extending from the shaft and operable to manipulate tissue (Figs. 1a-1c);
an ultrasonic blade 20 extending from the waveguide along a blade axis (Figs. 1a-8), wherein the ultrasonic blade comprises:
a proximal end configured to receive ultrasonic vibrations (Col. 1, ll. 36-42 and Col. 4, ll. 37-54); and
a distal end movable along the blade axis in accordance with the ultrasonic vibrations applied to the proximal end (Col. 8, ll. 40-46), and
wherein the tissue state indicator is operable to provide feedback indicative of a change in state of the tissue occurring (Col. 11, ll. 46-Col. 13, ll. 10);
however, Witt does not teach the handpiece comprising an output indicator that provides a power level indicator to provide a feedback indicative of a power level.
In the same field of invention, Manwaring teaches “a series of lights 52 could be used to indicate power level” in [0085] thereby providing a visual feedback indicative of a power level.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date filing date of the current invention to add a series of lights indicative of the power level to the handpiece of Witt in order to allow the user to visually track the power level during use; however, does not teach a tissue state indicator and wherein the tissue state indicator is operable to provide feedback indicative of a change in state of the tissue occurring.
Regarding Claim 13, Witt teaches wherein the end effector further comprises a clamp arm 24 movable relative to the ultrasonic blade 20 from an open position to a closed position to capture tissue therebetween (Figs. 2-3, 8 and Col. 5, ll. 43-56).
Regarding Claim 14, Witt teaches further comprising a closure actuator 72 configured to move the clamp arm toward the closed position, wherein the closure actuator 72 comprises a trigger 76 and a trigger hook 80 extending from the trigger, and wherein an aperture 81 is defined between the trigger 76 and the trigger hook 80 (Fig. 2 and Col. 5, ll. 43-56).
Regarding Claim 15, Witt in view of Manwaring teaches wherein the power level indicator is configured to provide audible feedback indicative of the ultrasonic vibrations (Manwaring teaches the use of a visual feedback indicative of a power level on the handpiece, but not audible. Witt teaches “feedback signal may, for example, provide a visual audible or tactile signal to a user, and/or may provide instructions to a control unit to automatically alter the energy supply to the tissue” Col. 2, ll. 63-67 and Col. 9, ll. 21-29, in light of the teachings of Wiener (US Patent No. 6,679,899) stating “the amount of longitudinal movement will vary proportionately with the amount of driving power (current) applied, as adjustably selected by the user … cutting efficiency of the blade, as well as the degree of hemostasis, will vary with the level of driving power applied” in Col. 6, ll. 65-Col. 7, ll. 17; thereby the power level indicator is configured to provide tactile feedback indicative of the ultrasonic vibrations).
Regarding Claim 16, Witt teaches further comprising a generator 302 configured to provide the ultrasonic vibrations to the ultrasonic blade, wherein the handpiece and the generator form a unitary assembly when assembled (Figs. 8 and 12 shows the system including the clamp coagulator 12, generator 302 and the feedback control module 300 through plug connector 235, where in the assembled, plugged configuration the whole system is interpreted to be a unitary assembly; furthermore, Manwaring teaches containing the power generator 30 into a foot pedal 20 coupled to the handheld surgical tool 50 to thereby form a unitary assembly when assembled as seen in Fig. 2, where system 10 is considered to be a unitary assembly in the assembled configuration to make it portable).
Regarding Claim 17, Witt teaches further comprising a switch, wherein the generator is configured to provide the ultrasonic vibrations to the ultrasonic blade based on actuation of the switch (“power controller may include at least one electrical switch for selectively controlling the energy supplied to the instrument to coagulate tissue, or to cut tissue, depending on the electrical switch setting” Col. 3, ll. 1-7 and Col. 9, ll. 21-29).
Regarding Claim 18, Witt in view of Manwaring teaches wherein the power level indicator comprises a light emitting diode (“for example, a series of lights 52 could be used to indicate power level” [0085] of Manwaring).
Regarding Claim 20, Witt teaches further comprising:
an input interface (switch) configured to receive an input from a user, wherein the input is indicative of a power level to apply to the ultrasonic blade (“power controller may include at least one electrical switch for selectively controlling the energy supplied to the instrument to coagulate tissue, or to cut tissue, depending on the electrical switch setting” Col. 3, ll. 1-7 and Col. 9, ll. 21-29);
Regarding Claim 32, Witt in view of Manwaring teaches further comprising a sensor to sense an impedance of the tissue, wherein the tissue state indicator is operable to provide feedback indicative of the change in state of the tissue occurring based on the sensed impedance (Col. 11, ll. 46-Col. 13, ll. 10 of Witt).
Regarding Claim 33, Witt in view of Manwaring teaches further comprising: a transducer (Col. 4, ll. 37-54) operable to provide the ultrasonic vibrations; and a sensor to sense an impedance of the transducer, wherein the tissue state indicator is operable to provide feedback indicative of the change in state of the tissue occurring based on the sensed impedance (Col. 12, ll. 58-Col. 13, ll. 10 and claims 15-19).
Regarding Claim 39, Witt teaches the invention as applied above, but does not teach further comprises a power level indicator configured to provide audible feedback.
In the same field of invention, Manwaring teaches “a series of lights 52 could be used to indicate power level, or the handheld surgical tool 50 could include a switch, rotary dial, set of buttons, touchpad or slide 54 that communicates with the power source 30 to regulate power” in [0085] thereby providing a visual feedback indicative of a power level.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date filing date of the current invention to add a series of lights indicative of the power level to the handpiece of Witt in order to allow the user to visually track the power level during use and include a switch, rotary dial, set of buttons, touchpad or slide that communicates with the power source to regulate power by a user during use.
Although Manwaring teaches the use of a visual feedback indicative of a power level on the handpiece, but not audible. Witt teaches “feedback signal may, for example, provide a visual audible or tactile signal to a user, and/or may provide instructions to a control unit to automatically alter the energy supply to the tissue” Col. 2, ll. 63-67 and Col. 9, ll. 21-29.
Response to Arguments
Applicant’s arguments with respect to claims 12-18, 20 and 32-43 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794