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 .
Response to Amendment
The preliminary amendment filed June 18th, 2026, has been entered. Claims 1, 3, 8-11, & 21 are amended. Claims 52-56 are new. Claims 12-20, 22-30, & 32-51 are canceled. Claims 1-11, 21, 31, & 52-56 remain pending.
Claim Objections
Claim 1 is objected to because of the following informalities: “a first and second segmented electrode pair” should be –a first segmented electrode pair and a second segmented electrode pair—; as they are both recited again individually in claim 1. Appropriate correction is required.
Claim 53 is objected to because of the following informalities: “how may segmented electrode pairs” should be – how many segmented electrode pairs —. 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 3, 31, & 54 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 3 recites the limitations “wherein: the plurality of segmented electrode pairs includes a first segmented electrode pair and a second segmented electrode pair”; Independent claim 1 introduces “a first and second segmented electrode pair”; it is unclear if the “a first segmented electrode pair and a second segmented electrode pair” (of claim 3) are the same or different than the “a first and second segmented electrode pair” (of claim 1), which renders the claim indefinite. For examination purposes the examiner is considering them to be the same.
Claim 31 recites “wherein the plurality of first electrode contacts is interconnected by a first conductor buried in a first insulating material; wherein the plurality of second electrode contacts is interconnected by a second conductor buried in a first insulating material”; it is unclear if the “a first insulating material” in which the second conductor is buried is the same as or different than the “a first insulating material” in which the first conductor is buried, as introduced in the claim, which renders the claim indefinite. For examination purposes the examiner is considering them to be the same.
Claim 54 recites “wherein the processor is programmed to generate instructions for a visual display to display indicia for each of a plurality of segmented electrode pairs comprising the surgical device, and where the processor is programmed to update the instructions based upon updated tissue impedance determinations”; claim 52 introduces “a surgical device that includes a plurality of segmented electrode pairs”. First, it is unclear if the “a plurality of segmented electrode pairs” (of claim 54) is the same or different than the “a plurality of segmented electrode pairs” (as introduced in claim 52), which renders the claim indefinite; for examination purposes the examiner is considering them to be the same. Second, it is unclear what is meant by “to generate instructions for a visual display to display indicia for each of a plurality of segmented electrode pairs comprising the surgical device”, it is unclear if each of the segmented electrode pairs comprise the surgical device, the indicia comprising the surgical device, or if the surgical device comprises each of the segmented electrode pairs, which renders the claim indefinite; for examination purposes the examiner is considering the surgical device comprising each of the plurality of segmented electrode pairs.
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.
Claim 31 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hammill (US 20060052779 A1), hereinafter “Hammill”.
Regarding claim 31, as best understood in view of the 112(b) rejection above, Hammill (US 20060052779 A1) discloses an electrosurgical instrument, comprising: an ablation structure including a first electrode and a second electrode; wherein the first electrode includes a plurality of first electrode contacts ([0050], [0057], & [0058]; Figures 4A-4C—element 522; the examiner is considering the first electrode contacts to be the ring electrodes 522); wherein the second electrode includes a plurality of second electrode contacts ([0050], [0057], & [0058]; Figures 4A-4C—element 512; the examiner is considering the second electrode contacts to be the post electrodes 512); wherein the plurality of first electrode contacts and the plurality of second electrode contacts are configured to be available to contact tissue ([0060]; Figure 4C—elements 512 & 522); wherein the plurality of first electrode contacts is interconnected by a first conductor ([0050], [0051], & [0058]; Figures 4A-4C—element 526) buried in a first insulating material ([0052], [0055], & [0057]; Figures 2 & 4A-4C—elements 280 & 514); wherein the plurality of second electrode contacts is interconnected by a second conductor ([0050], [0051], & [0058]; Figures 4A-4C—element 516) buried in a first insulating material ([0052], [0055], & [0057]; Figures 2 & 4A-4C—elements 280 & 514); wherein the plurality of first electrode contacts and the plurality of second electrode contacts lie in a first row ([0050], [0057], & [0058]; Figures 2-4C—elements 512 & 522; the first electrode contacts 522 and second electrode contacts 512 are shown as lying in a first row).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 9, 11, 21, 52, & 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Rusin (US 20140180281 A1), hereinafter “Rusin”, in view of Stewart et al. (US 20190030328 A1), hereinafter “Stewart”.
Regarding claim 1, Rusin discloses an ablation system comprising: a controller ([0043] & [0061]; Figure 5—element 42); an energy generator operatively coupled to the controller ([0043] & [0061]; Figure 1A—element 40); and a surgical device including a plurality of segmented electrode pairs, each of the plurality of segmented electrode pairs including at least two pairs of electrodes ([0053]-[0056]; Figure 2—elements 112a-112f & 122a-122f; each seal plate 112 & 122 includes a plurality of seal plate segments 112a-112f & 122a-122f; each seal plate segments 112a-112f has an opposing seal plate segment 122a-122f that form a pair of electrodes; the seal plate segments on each jaw are arranged such that they are positioned in rows and columns; the examiner is considering “each of the plurality of segmented electrode pairs including at least two pairs of electrodes” to be the segmented electrode pairs in a row (e.g. a first segmented electrode pair defined by the electrode pairs 112a/122a, 112b/122b, & 112c/122c and a second segmented electrode pair defined by the electrode pairs 112d/122d, 112e/122e, & 112f/122f)), the plurality of segmented electrode pairs being operatively coupled to the controller ([0055]) but electrically isolated from one another ([0053]; Figure 2—elements 125a & 12b); wherein the controller is configured to individually power each of the plurality of segmented electrode pairs ([0053] & [0063]; Figure 5—elements 42, 60, 112, & 122) and individually determine an impedance across each of the plurality of segmented electrode pairs ([0063]-[0064]; Figure 5—element 48; the controller 42 can instruct sensor module 48 and the multiplexer 60 to form a measurement circuit between the selected electrode segments 112 & 122; the sensor module includes one or more sensing mechanisms/circuits for sensing various tissue parameters such as tissue impedance) and, distribute an ablation power supply ([0069]; the generator delivers a desired waveform suitable for a particular task (e.g. tissue ablation)) equally and concurrently to the first segmented electrode pair and the second segmented electrode pair of the plurality of segmented electrode pairs ([0082]; more than one electrode segment 112a-112f & 122a & 122f may receive the electrical signal at the same time).
Rusin does not disclose wherein the controller is configured to, if the impedance across at least one of the first and second segmented electrode pair of the plurality of segmented electrode pairs satisfies a predetermined impedance threshold, automatically distribute the ablation power supply to the first segmented electrode pair and the second segmented electrode pair.
Stewart teaches a plurality of segmented electrode pairs comprising a first segmented electrode pair and a second segmented electrode pair ([0089]; Figures 16 & 18—elements 18, “E1-E13”, & “E14-E24”; the examiner is considering the first segmented pair to be the proximal electrodes “E1-E13” and the second segmented pair to be the distal electrodes “E14-E24”); wherein the controller is configured to, if the impedance across at least one of the first and second segmented electrode pair of the plurality of segmented electrode pairs satisfies a predetermined impedance threshold, automatically distribute the ablation power supply to the first segmented electrode pair and the second segmented electrode pair ([0009], [0018], [0089], [0109], [0115]; Figure 16—elements “E1-E13”, & “E14-E24”; the plurality of electrodes are configured to record impedance measurements, the controller is configured to identify the electrodes that are in contact with the area of target tissue to be ablated based on the impedance signals, and deliver the ablation energy to the electrodes that the controller identifies as being in contact with the area of tissue; the examiner is considering the “threshold” to be the impedance value associated with tissue contact).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the impedance sensing and the distribution of the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as disclosed by Rusin, to include wherein the controller is configured to, if the impedance across at least one of the first and second segmented electrode pair of the plurality of segmented electrode pairs satisfies a predetermined impedance threshold, automatically distribute the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as taught by Stewart, as both references and the claimed invention are directed toward ablation systems comprising a plurality of electrodes for selectively delivering energy to tissue. As disclosed by Rusin, the controller may use the impedance measurements to adjust the electrosurgical energy delivered to the segmented electrodes ([0063]-[0064]). As disclosed by Stewart, the plurality of electrodes may record impedance measurements and the controller may determine which of the electrodes are in contact with the area of tissue to be ablated and automatically deliver the ablation energy to the identified electrodes that are in contact with the area of tissue to be ablated and deactivate the electrodes that are in contact with undesirable tissue ([0066] & [0115]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the impedance sensing and the distribution of the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as disclosed by Rusin, to include wherein the controller is configured to, if the impedance across at least one of the first and second segmented electrode pair of the plurality of segmented electrode pairs satisfies a predetermined impedance threshold, automatically distribute the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as taught by Stewart, as such a modification would allow for the segmented electrode pairs to be activated based on sufficient contact with the target tissue area to be ablated and would additionally prevent the segmented electrode pairs from be activated if they are in contact with undesirable tissue.
Regarding claim 2, Rusin in view of Stewart disclose all of the limitations of claim 1, as described above.
Rusin further discloses wherein: the surgical device comprises a surgical clamp that includes a first jaw and a second jaw, where at least one of the first jaw and the second jaw is repositionable ([0046]; Figures 1A & 1B—elements 110 & 120); and the plurality of segmented electrode pairs are distributed across the first jaw and the second jaw ([0047]; Figure 2—elements 112 & 122).
Regarding claim 3, as best understood in view of the 112(b) rejection above, Rusin in view of Stewart disclose all of the limitations of claim 1, as described above.
Rusin further discloses wherein: the plurality of segmented electrode pairs includes a first segmented electrode pair and a second segmented electrode pair ([0053]-[0056]; Figure 2—elements 112a-112f & 122a-122f; the examiner is considering the first segmented electrode pair to be defined by the electrode pairs 112a/122a, 112b/122b, & 112c/122c and the second segmented electrode pair defined by the electrode pairs 112d/122d, 112e/122e, & 112f/122f); the first jaw includes a first electrode and a second electrode of the first segmented electrode pair ([0053]-[0056]; Figure 2—elements 110, 112a, & 112b); the first jaw includes a first electrode and a second electrode of the second segmented electrode pair ([0053]-[0056]; Figure 2—elements 110, 112d, & 112e); the second jaw includes a third electrode and a fourth electrode of the first segmented electrode pair ([0053]-[0056]; Figure 2—elements 120, 122a, & 122b); and the second jaw includes a third electrode and a fourth electrode of the second segmented electrode pair ([0053]-[0056]; Figure 2—elements 120, 122d, & 122e).
Regarding claim 9, Rusin in view of Stewart disclose all of the limitations of claim 1, as described above.
Rusin further discloses wherein: the surgical device includes a first jaw and a second jaw, where at least one of the first jaw and the second jaw is repositionable ([0046]; Figures 1A & 1B—elements 110 & 120); the plurality of segmented electrode pairs includes the first segmented electrode pair, the second segmented electrode pair, a third segmented electrode pair, and a fourth segmented electrode pair ([0053]-[0056]; Figure 2—elements 112a-112f & 122a-122f; see figure below; each seal plate 112 & 122 includes a plurality of seal plate segments 112a-112f & 122a-122f; each seal plate segments 112a-112f has an opposing seal plate segment 122a-122f that form a pair of electrodes; the seal plate segments on each jaw are arranged such that they are positioned in rows and columns; the examiner is considering “each of the plurality of segmented electrode pairs including at least two pairs of electrodes” to be the segmented electrode pairs in a row (e.g. a first segmented electrode pair defined by the first distal-most electrode pair row, the second segmented electrode pair defined by the second distal-most electrode pair row, the third segmented electrode pair defined by the third distal-most electrode pair row, and the fourth segmented electrode pair defined by the fourth distal-most electrode pair row electrode pair row (see figure below)); the first jaw includes a first electrode and a second electrode of each of the first segmented electrode pair, the second segmented electrode pair, the third segmented electrode pair, and the fourth segmented electrode pair ([0053]-[0056]; Figure 2—elements 110 & 112); the second jaw includes a third electrode and a fourth electrode of each of the first segmented electrode pair, the second segmented electrode pair, the third segmented electrode pair, and the fourth segmented electrode pair ([0053]-[0056]; Figure 2—elements 110 & 112); and at least two of the first electrodes of the first jaw are longitudinally distributed along a longitudinal length of the first jaw ([0053]-[0056]; Figure 2—elements 112a & 112d; first electrodes (for example 112a & 112d are shown as extending longitudinally along the first jaw 110).
PNG
media_image1.png
1189
1820
media_image1.png
Greyscale
Regarding method claim 11, Rusin discloses a method of carrying out an ablation process ([0069]) using a plurality of segmented electrode pairs, the method comprising: sandwiching tissue between a first segmented electrode pair, and a second segmented electrode pair, where a first electrode of each segmented electrode pair is on a first side of the tissue, and where a second electrode of each segmented electrode pair is on a second, opposite side of the tissue ([0046], [0047], [0053]-[0056], & [0078]; Figures 1-2—elements 110, 112 (112a-112f), 120, & 122 (122a-122f); the surgeon grasps tissue with the end effector 100; the end effector 100 includes a first and second jaw 110 & 120 each comprising a seal pate 112 & 122; each seal plate 112 & 122 includes a plurality of seal plate segments 112a-112f & 122a-122f; each seal plate segments 112a-112f has an opposing seal plate segment 122a-122f that form a pair of electrodes; the seal plate segments on each jaw are arranged such that they are positioned in rows and columns; the examiner is considering a first segmented electrode pair to be defined by the distal-most row of electrode pairs (112a/122a, 112b/122b, & 112c/122c) and a second segmented electrode pair to be defined by second distal-most row of the electrode pairs (112d/122d, 112e/122e, & 112f/122f)); and individually determining an impedance across the first and second segmented electrode pairs ([0063]-[0064]; Figure 5—element 48; the controller 42 instructs sensor module 48 and the multiplexer 60 to form a measurement circuit between the selected electrode segments 112 & 122; the sensor module includes one or more sensing mechanisms/circuits for sensing various tissue parameters such as tissue impedance) and, automatically distributing an ablation power supply equally and concurrently to the first segmented electrode pair and the second segmented electrode pair ([0069] & [0082]; more than one electrode segment 112a-112f & 122a & 122f may receive the electrical signal at the same time).
Rusin does not disclose if the impedance across at least one of the first segmented electrode pair and the second segmented electrode pair satisfies a predetermined impedance threshold, automatically distributing the ablation power supply to the first segmented electrode pair and the second segmented electrode pair.
Stewart teaches a method of ablating tissue with an ablation device comprising a first segmented electrode pair and a second segmented electrode pair ([0089]; Figures 16 & 18—elements 18, “E1-E13”, & “E14-E24”; the examiner is considering the first segmented pair to be the proximal electrodes “E1-E13” and the second segmented pair to be the distal electrodes “E14-E24”), the method comprising individually determining an impedance across the first and second segmented electrode pairs ([0115]), and if the impedance across at least one of the first segmented electrode pair and the second segmented electrode pair satisfies a predetermined impedance threshold, automatically distributing the ablation power supply to the first segmented electrode pair and the second segmented electrode pair ([0009], [0018], [0089], [0109], [0115]; Figure 16—elements “E1-E13”, & “E14-E24”; the plurality of electrodes record impedance measurements, the controller identifies the electrodes that are in contact with the area of target tissue to be ablated based on the impedance signals, and delivers the ablation energy to the electrodes that the controller identifies as being in contact with the area of tissue; the examiner is considering the “threshold” to be the impedance value associated with tissue contact).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the method of impedance sensing and the distribution of the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as disclosed by Rusin, to include if the impedance across at least one of the first segmented electrode pair and the second segmented electrode pair satisfies a predetermined impedance threshold, automatically distributing the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as taught by Stewart, as both references and the claimed invention are directed toward ablation systems and methods comprising a plurality of electrodes for selectively delivering energy to tissue. As disclosed by Rusin, the controller may use the impedance measurements to adjust the electrosurgical energy delivered to the segmented electrodes ([0063]-[0064]). As disclosed by Stewart, the plurality of electrodes may record impedance measurements and the controller may determine which of the electrodes are in contact with the area of tissue to be ablated and automatically deliver the ablation energy to the identified electrodes that are in contact with the area of tissue to be ablated and deactivate the electrodes that are in contact with undesirable tissue ([0066] & [0115]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of impedance sensing and the distribution of the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as disclosed by Rusin, to include if the impedance across at least one of the first segmented electrode pair and the second segmented electrode pair satisfies a predetermined impedance threshold, automatically distributing the ablation power supply to the first segmented electrode pair and the second segmented electrode pair, as taught by Stewart, as such a modification would allow for the segmented electrode pairs to be activated based on sufficient contact with the target tissue area to be ablated and would additionally prevent the segmented electrode pairs from be activated if they are in contact with undesirable tissue.
Regarding claim 21, Rusin discloses an ablation system comprising: an energy generator ([0043], [0061], & [0069]; Figure 1A—element 40); and a surgical device including a plurality of segmented electrode pairs, each of the plurality of segmented electrode pairs comprising at least two pairs of electrodes ([0053]-[0056]; Figure 2—elements 112a-112f & 122a-122f; each seal plate 112 & 122 includes a plurality of seal plate segments 112a-112f & 122a-122f; each seal plate segments 112a-112f has an opposing seal plate segment 122a-122f that form a pair of electrodes; the seal plate segments on each jaw are arranged such that they are positioned in rows and columns; the examiner is considering “each of the plurality of segmented electrode pairs including at least two pairs of electrodes” to be the segmented electrode pairs in a row (e.g. a first segmented electrode pair defined by the electrode pairs 112a/122a, 112b/122b, & 112c/122c and a second segmented electrode pair defined by the electrode pairs 112d/122d, 112e/122e, & 112f/122f)), the plurality of segmented electrode pairs being electrically isolated from one another but operatively coupled to the energy generator ([0053] & [0055]; Figure 2—elements 125a & 12b); wherein the energy generator is configured to automatically determine whether to individually power or group two or more of the plurality of segmented electrode pairs ([0082]; more than one electrode segment 112a-112f & 122a & 122f may receive the electrical signal at the same time) and individually determining an impedance across each of the plurality of segmented electrode pairs ([0063]-[0064]; Figure 5—element 48; the controller 42 can instruct sensor module 48 and the multiplexer 60 to form a measurement circuit between the selected electrode segments 112 & 122; the sensor module includes one or more sensing mechanisms/circuits for sensing various tissue parameters such as tissue impedance).
Rusin does not disclose wherein the energy generator is configured to automatically determine whether to individually power or group two or more of the plurality of segmented electrode pairs responsive to individually determining the impedance across each of the plurality of segmented electrode pairs.
Stewart teaches an ablation system comprising a plurality of segmented electrode pairs ([0089]; Figures 16 & 18—elements 18, “E1-E13”, & “E14-E24”; the examiner is considering the segmented electrode pairs to be a first segmented pair “E1-E13” and a second segmented pair “E14-E24”); wherein the energy generator is configured to automatically determine whether to individually power or group two or more of the plurality of segmented electrode pairs responsive to individually determining the impedance across each of the plurality of segmented electrode pairs ([0009], [0018], [0089], [0091], [0109], [0115]; Figures 16 & 18—elements “E1-E13”, & “E14-E24”; the plurality of electrodes are configured to record impedance measurements, the generator is configured to identify the electrodes that are in contact with the area of target tissue to be ablated based on the impedance signals, and deliver the ablation energy to the electrodes that the controller identifies as being in contact with the area of tissue; Figure 16 portrays an energy pattern in which a first segmented electrode pair and a second segmented electrode pair are activated and Figure 18 portrays an energy pattern in which only the first segmented electrode pair is activated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the impedance sensing and the powering of the segmented electrode pairs, as disclosed by Rusin, to include wherein the energy generator is configured to automatically determine whether to individually power or group two or more of the plurality of segmented electrode pairs responsive to individually determining the impedance across each of the plurality of segmented electrode pairs, as taught by Stewart, as both references and the claimed invention are directed toward ablation systems comprising a plurality of electrodes for selectively delivering energy to tissue. As disclosed by Rusin, the controller may use the impedance measurements to adjust the electrosurgical energy delivered to the segmented electrodes ([0063]-[0064]). As disclosed by Stewart, the plurality of electrodes may record impedance measurements and the controller may determine which of the electrodes are in contact with the area of tissue to be ablated and automatically deliver the ablation energy to the identified electrodes that are in contact with the area of tissue to be ablated and deactivate the electrodes that are in contact with undesirable tissue ([0066] & [0115]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the impedance sensing and the powering of the segmented electrode pairs, as disclosed by Rusin, to include wherein the energy generator is configured to automatically determine whether to individually power or group two or more of the plurality of segmented electrode pairs responsive to individually determining the impedance across each of the plurality of segmented electrode pairs, as taught by Stewart, as such a modification would allow for the segmented electrode pairs to be activated based on sufficient contact with the target tissue area to be ablated and would additionally prevent the segmented electrode pairs from be activated if they are in contact with undesirable tissue.
Regarding claim 52, Rusin discloses at least one of an ablation controller and an energy generator comprising: an electrical connection configured to engage and establish electrical communication with a surgical device ([0043]; Figure 1A—element 34 & 40) that includes a plurality of segmented electrode pairs, each of the plurality of segmented electrode pairs includes at least two pairs of electrodes ([0053]-[0056]; Figure 2—elements 112a-112f & 122a-122f; each seal plate 112 & 122 includes a plurality of seal plate segments 112a-112f & 122a-122f; each seal plate segments 112a-112f has an opposing seal plate segment 122a-122f that form a pair of electrodes; the seal plate segments on each jaw are arranged such that they are positioned in rows and columns; the examiner is considering “each of the plurality of segmented electrode pairs including at least two pairs of electrodes” to be the segmented electrode pairs in a row); and a processor programmed to receive inputs from the surgical device prior to carrying out a tissue ablation to determine tissue impedance at a plurality of tissue locations, each of the plurality of tissue locations interposing at least one of the plurality of segmented electrode pairs ([0061] & [0063]-[0065]; Figure 5—elements 42, 48, & 60; the processor 42 may instruct the multiplexer 60 to connect sensor module 48 between any two or more electrode segments and the processor 42 may instruct the sensor module 48 to perform measurement between the selected segments (including sensing various tissue parameters such as tissue impedance), the energy delivery to the electrodes may be performed sequentially or simultaneously to the measurements), the processor also programmed to configure whether power will be individually distributed to one of the plurality of segmented electrode pairs or whether power will be distributed equally to multiples of the plurality of segmented electrode pairs to carry out the tissue ablation ([0069], [0080], & [0082]; the controller may send individual electrical signals to each segmented electrode or more than one segmented electrode may receive the electrical signal at the same time).
Rusin does not disclose the processor also programmed to use the determined tissue impedances to configure whether power will be individually distributed to one of the plurality of segmented electrode pairs or whether power will be distributed equally to multiples of the plurality of segmented electrode pairs.
Stewart teaches at least one of an ablation controller and an energy generator configured to connect to a surgical device comprising a plurality of segmented electrode pairs ([0089]; Figures 16 & 18—elements 18, “E1-E13”, & “E14-E24”; the examiner is considering a first segmented pair to be the proximal electrodes “E1-E13” and a second segmented pair to be the distal electrodes “E14-E24”); the processor also programmed to use the determined tissue impedances to configure whether power will be individually distributed to one of the plurality of segmented electrode pairs or whether power will be distributed equally to multiples of the plurality of segmented electrode pairs ([0009], [0018], [0089], [0091], [0109], [0115]; Figures 16 & 18—elements “E1-E13”, & “E14-E24”; the plurality of electrodes are configured to record impedance measurements, the processor is configured to identify the electrodes that are in contact with the area of target tissue to be ablated based on the impedance signals, and deliver the ablation energy to the electrodes that the controller identifies as being in contact with the area of tissue; Figure 16 portrays an energy pattern in which a first segmented electrode pair and a second segmented electrode pair are activated and Figure 18 portrays an energy pattern in which only the first segmented electrode pair is activated).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the impedance sensing and the processor programmed individually distribute the ablation power to one of the plurality of segmented electrode pairs or equally distribute the ablation power to multiples of the plurality of segmented electrode pairs, as disclosed by Rusin, to include the processor also programmed to use the determined tissue impedances to configure whether power will be individually distributed to one of the plurality of segmented electrode pairs or whether power will be distributed equally to multiples of the plurality of segmented electrode pairs, as taught by Stewart, as both references and the claimed invention are directed toward ablation systems comprising a plurality of electrodes for selectively delivering energy to tissue. As disclosed by Rusin, the controller may use the impedance measurements to adjust the electrosurgical energy delivered to the segmented electrodes ([0063]-[0064]). As disclosed by Stewart, the plurality of electrodes may record impedance measurements and the controller may determine which of the electrodes are in contact with the area of tissue to be ablated and automatically deliver the ablation energy to the identified electrodes that are in contact with the area of tissue to be ablated and deactivate the electrodes that are in contact with undesirable tissue ([0066] & [0115]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the impedance sensing and the processor programmed individually distribute the ablation power to one of the plurality of segmented electrode pairs or equally distribute the ablation power to multiples of the plurality of segmented electrode pairs, as disclosed by Rusin, to include the processor also programmed to use the determined tissue impedances to configure whether power will be individually distributed to one of the plurality of segmented electrode pairs or whether power will be distributed equally to multiples of the plurality of segmented electrode pairs, as taught by Stewart, as such a modification would allow for the segmented electrode pairs to be activated based on sufficient contact with the target tissue area to be ablated and would additionally prevent the segmented electrode pairs from be activated if they are in contact with undesirable tissue.
Regarding claim 55, Rusin in view of Stewart disclose all of the limitations of claim 21, as described above.
Rusin further discloses wherein: the surgical device comprises a surgical clamp that includes a first jaw and a second jaw , where at least one of the first jaw and the second jaw is repositionable ([0046]; Figures 1A & 1B—elements 110 & 120); and the plurality of segmented electrode pairs are distributed across the first jaw and the second jaw ([0047]; Figure 2—elements 112 & 122).
Regarding claim 56, Rusin in view of Stewart disclose all of the limitations of claim 21, as described above.
Rusin further discloses the plurality of segmented electrode pairs includes a first segmented electrode pair and a second segmented electrode pair ([0053]-[0056]; Figure 2—elements 112a-112f & 122a-122f; the examiner is considering the first segmented electrode pair to be defined by the electrode pairs 112a/122a, 112b/122b, & 112c/122c and the second segmented electrode pair defined by the electrode pairs 112d/122d, 112e/122e, & 112f/122f); the first jaw includes a first electrode and a second electrode of each of the first segmented electrode pair and the second segmented electrode pair ([0053]-[0056]; Figure 2—elements 110, 112a, 112b, 112d, & 112e); and the second jaw includes a third electrode and a fourth electrode of each of the first segmented electrode pair and the second segmented electrode pair ([0053]-[0056]; Figure 2—elements 120, 122a, 122b, 122d, & 122e).
Claims 4-8 & 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Rusin in view of Stewart and Thompson et al. (US 20140330266 A1), hereinafter “Thompson”.
Regarding claims 4-8, Rusin in view of Stewart disclose all of the limitations of claim 1, as described above.
Rusin further discloses wherein: the controller includes a visual display ([0069]) (claim 4).
Rusin does not disclose the display including visual indicium representing each of the plurality of segmented electrode pairs; and the visual display is updated to reflect progress of an ablation sequence using the plurality of segmented electrode pairs (claim 4); wherein the visual indicium includes numerical representations regarding the progress of the ablation sequence (claim 5); wherein the visual indicium includes colored representations regarding the progress of the ablation sequence (claim 6); wherein the colored representations change as a function of nearing completion of the ablation sequence (claim 7); wherein the colored representations include a first shape denoting the first segmented electrode pair is being powered individually, and a second shape denoting the second segmented electrodes pair is not being powered individually (Claim 8).
Thompson teaches an ablation system comprising a plurality of electrodes ([0048]; Figure 2—element 12) and a display ([0134]; Figures 25-26—element 1001), the display including visual indicium representing each of the plurality of segmented electrode pairs ([0134]; Figures 25-26—elements 1026); and the visual display is updated to reflect progress of an ablation sequence using the plurality of segmented electrode pairs ([0134]-[0135]; Figure 25—elements 1026; while performing ablation the electrodes are depicted by icons 1026 along with the temperature, impedance, and power measurement data, the electrode icon is changed to indicate a successful lesion) (claim 4); wherein the visual indicium includes numerical representations regarding the progress of the ablation sequence ([0134]-[0135]; while performing ablation the electrodes are depicted by icons 1026 along with the temperature, impedance, and power measurement data; the examiner is considering the temperature, impedance, and power measurement data to be the numerical representations) (claim 5); wherein the visual indicium includes colored representations regarding the progress of the ablation sequence ([0134]-[0135]; once the ablation is complete the electrode icon 1026 would be changed to indicate a successful lesion via suitable graphic indicia; suitable graphic indicia can include using a different color) (claim 6); wherein the colored representations change as a function of nearing completion of the ablation sequence ([0134]-[0135]; once the ablation is complete the electrode icon 1026 would be changed to indicate a successful lesion via suitable graphic indicia; suitable graphic indicia can include using a different color) (claim 7); wherein the colored representations include a first shape denoting the first segmented electrode pair is being powered individually, and a second shape denoting the second segmented electrodes pair is not being powered individually ([0134]-[0135]; the selected electrodes for ablation are graphically different from the deselected electrodes by using different colors, a check mark for the selected electrode, and an “X” for the deselected electrode)(claim 8).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the display, as disclosed by Rusin, to include the display including visual indicium representing each of the plurality of segmented electrode pairs; and the visual display is updated to reflect progress of an ablation sequence using the plurality of segmented electrode pairs, as taught by Thompson, as both references and the claimed invention are directed toward ablation devices comprising a plurality of electrodes. As disclosed by Thompson, the display may be an interactive display that is configured to display graphic indicia to indicate: a successful lesion, the selected electrodes for ablation and measurements of the selected electrode during ablation, and deselected electrodes that are not being used for ablation ([0134]-[0135]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the display, as disclosed by Rusin, to include the display including visual indicium representing each of the plurality of segmented electrode pairs; and the visual display is updated to reflect progress of an ablation sequence using the plurality of segmented electrode pairs, as taught by Thompson, as such a modification would provide for a display that provides visual feedback to a user regarding the status of the electrodes and the ablation procedure.
Regarding claim 53, Rusin in view of Stewart disclose all of the limitations of claim 52, as described above.
Rusin further discloses wherein the processor is programmed to generate instructions for a visual display ([0069]).
Rusin does not disclose the instructions for the visual display to display indicia reflecting how may segmented electrode pairs the surgical device includes.
Thompson teaches an ablation system comprising a plurality of electrodes ([0048]; Figure 2—element 12) and a processor programmed to generate instructions ([0051] & [0052]; Figure 3—element 128) for a visual display ([0134]; Figures 25-26—element 1001), the instructions for the visual display to display indicia reflecting how may segmented electrode pairs the surgical device includes ([0134]-[0135]; Figures 25-26—element 1001 & 1026; the display 1001 provides a graphical representation of each electrode, shown by an icon 1026).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the processor is programmed to generate instructions for a visual display, as disclosed by Rusin, to include the instructions for the visual display to display indicia reflecting how may segmented electrode pairs the surgical device includes, as taught by Thompson, as both references and the claimed invention are directed toward ablation systems comprising a plurality of electrodes and displays. As disclosed by Thompson, the display may be an interactive display that is configured to display graphic indicia to indicate: a successful lesion, each electrode of the device, the selected electrodes for ablation and measurements of the selected electrode during ablation, and deselected electrodes that are not being used for ablation ([0134]-[0135]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the processor is programmed to generate instructions for a visual display, as disclosed by Rusin, to include the instructions for the visual display to display indicia reflecting how may segmented electrode pairs the surgical device includes, as taught by Thompson, as such a modification would provide for a display that provides visual feedback to a user regarding the status of the electrodes and the ablation procedure.
Regarding claim 54, as best understood in view of the 112(b) rejection above, Rusin in view of Stewart disclose all of the limitations of claim 52, as described above.
Rusin further discloses wherein the processor is programmed to generate instructions for a visual display ([0069]).
Rusin does not disclose the instructions to display indicia for each of a plurality of segmented electrode pairs comprising the surgical device, and where the processor is programmed to update the instructions based upon updated tissue impedance determinations.
Thompson teaches an ablation system comprising a plurality of electrodes ([0048]; Figure 2—element 12) and a processor programmed to generate instructions ([0051] & [0052]; Figure 3—element 128) for a visual display ([0134]; Figures 25-26—element 1001), the instructions to display indicia for each of a plurality of segmented electrode pairs comprising the surgical device, and where the processor is programmed to update the instructions based upon updated tissue impedance determinations ([0134]-[0135]; Figures 25-26—element 1001 & 1026; the display 1001 provides a graphical representation of each electrode, shown by an icon 1026, the graphical representation can include temperature, impedance, and power measurements of each of the electrodes).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the processor is programmed to generate instructions for a visual display, as disclosed by Rusin, to include the instructions to display indicia for each of a plurality of segmented electrode pairs comprising the surgical device, and where the processor is programmed to update the instructions based upon updated tissue impedance determinations, as taught by Thompson, as both references and the claimed invention are directed toward ablation systems comprising a plurality of electrodes and displays. As disclosed by Thompson, the display may be an interactive display that is configured to display graphic indicia to indicate: a successful lesion, each electrode of the device, the selected electrodes for ablation and measurements (e.g. impedance) of the selected electrode during ablation, and deselected electrodes that are not being used for ablation ([0134]-[0135]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the processor is programmed to generate instructions for a visual display, as disclosed by Rusin, to include the instructions to display indicia for each of a plurality of segmented electrode pairs comprising the surgical device, and where the processor is programmed to update the instructions based upon updated tissue impedance determinations, as taught by Thompson, as such a modification would provide for a display that provides visual feedback to a user regarding the status of the electrodes and the ablation procedure.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rusin in view of Stewart and Vrba et al. (US 20170348049 A1), hereinafter “Vrba”.
Regarding claim 10, Rusin in view of Stewart disclose all of the limitations of claim 1, as described above.
Rusin further discloses the first electrode and the second electrodes of the first segmented electrode pair are oriented parallel to one another ([0053]; Figure 2—elements 112a & 112b).
Rusin does not disclose the first electrode of the first segmented electrode pair overlaps with the second electrode of the second segmented electrode pair in a direction normal to the longitudinal length.
Vrba teaches a first segmented electrode and second segmented electrode ([0213]; the ablation catheter is provided with a plurality of clusters of electrodes, each cluster of electrode comprising a pair of electrodes), the first electrode of the first segmented electrode pair overlaps with the second electrode of the second segmented electrode pair in a direction normal to the longitudinal length ([0213] & [0251]-[0255]; Figures 10A-10F; the electrodes of a cluster may be staggered so as to overlap axially with electrode elements of adjacent clusters).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the first electrode of the first segmented electrode pair and the second electrode of the second segmented electrode pair, as disclosed by Rusin, to include the first electrode of the first segmented electrode pair overlaps with the second electrode of the second segmented electrode pair in a direction normal to the longitudinal length, as taught by Vrba, as both references and the claimed invention are directed toward ablation systems comprising a plurality of segmented electrodes. As disclosed by Rusin, the segmented electrodes may comprise a staggered pattern ([0072]). As disclosed by Vrba, the electrodes may be positioned in various patterns (e.g., spiral patterns, checkered patterns, zig-zag patterns, linear patterns, randomized patterns) so as to customize desired treatment lengths and patterns, for example a first segmented electrode may be staggered and overlap axially with the electrode elements of an adjacent staggered electrode in order to produce an overlapping lesion or alternatively the first segmented electrode may be staggered and may not overlap axially with the electrode elements of the adjacent staggered electrode in order to produce a non-overlapping lesion ([0175], [0188], [0213], & [0251]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first electrode of the first segmented electrode pair and the second electrode of the second segmented electrode pair, as disclosed by Rusin, to include the first electrode of the first segmented electrode pair overlaps with the second electrode of the second segmented electrode pair in a direction normal to the longitudinal length, as taught by Vrba, as such a modification would provide for a known staggered spacing pattern between a plurality of segmented electrodes in order to achieve a desired pattern of ablation.
Conclusion
Accordingly, claims 1-11, 21, 31, & 52-56 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
