DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
The current office action is made responsive to claims filed 01/08/2024.
Acknowledgement is made to the withdrawal of claims 8-16.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 1-7 and 17-20 are pending as rejected below. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 7, 17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brannan (US 20190090929 A1).
Regarding claim 1, Brannan teaches a system for ablating a thyroid nodule (Fig. 1; surgical system 100; [0001], further, in accordance with MPEP 2114 this currently taught structure of a system, would be capable of performing the function of ablating a thyroid nodule, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics), comprising:
an ablation device (Fig. 1; electrosurgical instrument 104) configured to be inserted into a thyroid nodule, the ablation device having an electrode (Fig. 1; electrode 126) configured to be placed within the thyroid nodule and retracted along an axis defined through the thyroid nodule while delivering energy to the thyroid nodule ([0051], [0063]; further, in accordance with MPEP 2114 this currently taught structure of an ablation device having an electrode would be capable of performing the function of being placed within and delivering energy to the thyroid nodule, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics);
an electrosurgical generator (Fig. 1; electrosurgical generator 102) configured to deliver electrosurgical energy to the ablation device and to sense impedance of tissue being ablated by the ablation device ([0036]); and
an audio device (Fig. 2; audio output device 214) in communication with the electrosurgical generator and configured to broadcast a sound correlated with the tissue impedance sensed by the electrosurgical generator ([0043]) such that the audio device changes at least one of a volume, an intensity, a frequency, a periodicity, or a tone of the sound in response to a change in the impedance of the tissue sensed by the electrosurgical generator ([0048]).
Regarding claim 2, Brannan further teaches the system according to claim 1, wherein the audio device is integral with the electrosurgical generator ([0032]).
Regarding claim 4, Brannan further teaches the system according to claim 1, wherein the ablation device is a monopolar ablation device ([0025], [0031]- [0032]).
Regarding claim 5, Brannan further teaches the system according to claim 4, further comprising a return electrode electrically coupled to the electrosurgical generator and configured to be adhered to a patient for returning the energy from the thyroid nodule to the electrosurgical generator ([0031]- [0032]).
Regarding claim 7, Brannan further teaches the system according to claim 1, wherein the audio device is configured to continuously broadcast the sound during delivery of the energy to the thyroid nodule ([0045], [0047]).
Regarding claim 17, Brannan teaches a system for ablating tissue (Fig. 1; surgical system 100; [0001]), the system comprising:
an ablation device (Fig. 1; electrosurgical instrument 104) configured to be inserted to a position adjacent tissue to be ablated, the ablation device having an electrode (Fig. 1; electrode 126) configured to be placed at a first portion of the tissue to be ablated and retracted along an axis defined through the tissue to be ablated for delivering energy to the tissue to be ablated ([0052], [0063]);
an electrosurgical generator (Fig. 1; electrosurgical generator 102) configured to deliver energy to the ablation device and to sense at least one property of tissue being ablated by the ablation device ([0036]); and
an audio device (Fig. 2; audio output device 214) operably coupled to the electrosurgical generator and configured to broadcast a sound correlated with the at least one tissue property sensed by the electrosurgical generator such that the audio device changes a property of the sound in response to a change in the at least one property of the tissue sensed by the electrosurgical generator ([0048]).
Regarding claim 19, Brannan further teaches the system according to claim 17, wherein the property of the sound is at least one of volume, intensity, frequency, periodicity, or tone ([0048]).
Regarding claim 20, Brannan further teaches the system according to claim 17, wherein the tissue to be ablated is a thyroid nodule and the electrode is configured to be retracted along an axis defined through the thyroid nodule while delivering energy to the thyroid nodule ([0051], [0063], further, in accordance with MPEP 2114 this currently taught structure of an ablation device having an electrode would be capable of performing the function of being placed within and delivering energy to the thyroid nodule, as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics).
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.
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US 20190090929 A1) in view of Garcia Kilroy (US 20190005848 A1).
Regarding claim 3, Brannan teaches the system according to claim 1.
However, Brannan fails to teach the system wherein the audio device is configured to broadcast a verbal indication associated with the tissue impedance sensed by the electrosurgical generator.
Brannan does however teach the audio device as being configured to provide the sensory feedback for parameters, such as impedance, in the form of audible signals, such as tones ([0026]- [0027], [0046]- [0048]).
Garcia Kilroy teaches a system for use within a surgical environment (Abstract).
Garcia Kilroy further teaches a variety of known manners of providing feedback by auditory indications to a user such as beeps, tones, or verbal feedback ([0018]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the tone as is taught by Brannan with the verbal feedback as is taught by Garcia Kilroy as both auditory indications perform the same function of providing feedback to a user by an auditory signal, as is taught by Garcia Kilroy, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Regarding claim 18, Brannan teaches the system according to claim 17.
However, Brannan fails to teach the system wherein the audio device is configured to broadcast a verbal indication associated with the at least one property of the tissue sensed by the electrosurgical generator.
Brannan does however teach the audio device as being configured to provide the sensory feedback for parameters, such as impedance, in the form of audible signals, such as tones ([0026]- [0027], [0046]- [0048]).
Garcia Kilroy teaches a system for use within a surgical environment (Abstract).
Garcia Kilroy further teaches a variety of known manners of providing feedback by auditory indications to a user such as beeps, tones, or verbal feedback ([0018]).
Therefore, it would have been obvious to a person having ordinary skill before the effective filing date to have substituted the tone as is taught by Brannan with the verbal feedback as is taught by Garcia Kilroy as both auditory indications perform the same function of providing feedback to a user by an auditory signal, as is taught by Garcia Kilroy, and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06(II).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Brannan (US 20190090929 A1) in view of Nishina (US 20100063392 A1).
Regarding claim 6, Brannan teaches the system according to claim 1.
However, Brannan fails to teach the system further comprising an ultrasound imaging device configured to visualize the thyroid nodule and movement of the electrode within the thyroid nodule during ablation of the thyroid nodule.
Nishina teaches an ablation system which is guided so as to determine the area to be treated and the area which has been determined to have been treated during an ablation procedure (Abstract, [0098], [0102], [0111], [0119], [0121] teach the system comprising an electrode portion, an ultrasound transducer for receiving ultrasound images of the ablation target area and guiding the electrode through the tissue by the use of the ultrasound transducer).
Nishina further teaches the system as being guided by an ultrasound transducer (Abstract).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ultrasound transducer for imaging the tissue to be ablated, as is taught by Nishina, into the system for ablating tissue as is taught by Brannan, to produce the predictable result of guiding an electrode within tissue to be treated during an ablation procedure, as is taught by Nishina, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794